Contains Nonbinding Recommendations 
 
 
Requirements for Additional 
Traceability Records for Certain 
Foods:  
What You Need to Know About 
the FDA Regulation:  
Guidance for Industry 
 
 Small Entity Compliance Guide 
 
 
 
 
Additional copies are available from: 
Office of Analytics and Outreach 
Center for Food Safety and Applied Nutrition, 
Food and Drug Administration 
5001 Campus Drive 
College Park, MD 20740 
http://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-rules-guidance-industry 
 
 
You may submit electronic or written comments regarding this guidance at any time. Submit 
electronic comments to http://www.regulations.gov.  Submit written comments on the 
guidance to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.  All comments should 
be identified with the docket number FDA-2023-D-1336. 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition 
Office of Analytics and Outreach 
 
 
 
May 2023 
  Contains Nonbinding Recommendations 
 
 
 
Table of Contents 
I.  Introduction ......................................................................................................................................... 5 
II.  Key Terms ........................................................................................................................................... 6 
III.  Questions and Answers ...................................................................................................................... 7 
A.  Who is Subject to the Food Traceability Rule? ( 1.1300) .............................................................. 7 
B.  What is the Food Traceability List? ( 1.1310) ................................................................................ 7 
C.  When Must I Comply with the Food Traceability Rule? ................................................................ 7 
D.  Who Is Exempt from the Food Traceability Rule? ( 1.1305) ........................................................ 7 
E.  What Traceability Plan Must I Have for Foods on the FTL that I Manufacture, Process, Pack, 
or Hold? ( 1.1315) ................................................................................................................................... 16 
F.  When Must I Update My Traceability Plan? ................................................................................. 16 
G.  When Must I Assign Traceability Lot Codes to Foods on the FTL? (1.1320 and 1.1345(b)(1))
  16 
H.  What Records Must I Keep and Provide When I Harvest a Raw Agricultural Commodity 
(RAC) (Other Than a Food Obtained from a Fishing Vessel) on the FTL? ( 1.1325(a)) ................. 17 
I.  What Records Must I Keep and Provide When I Cool a Raw Agricultural Commodity (Other 
Than a Food Obtained from a Fishing Vessel) on the FTL Before It is Initially Packed? ( 
1.1325(b)) ................................................................................................................................................... 17 
J.  What Records Must I Keep When I Am Performing the Initial Packing of a Raw Agricultural 
Commodity (Other Than a Food Obtained from a Fishing Vessel) on the FTL? ( 1.1330(a)) ........ 18 
K.  What Additional Information Must I Keep When I Am Performing the Initial Packing of 
Sprouts (Except Soil- or Substrate-Grown Sprouts Harvested Without Their Roots)? ( 1.1330(b))
  18 
L.  What Records Must I Keep When I Am Performing the Initial Packing of a Raw Agricultural 
Commodity (Other than a Food Obtained from a Fishing Vessel) on the FTL That I Received From 
a Person Who Is Not Subject to the Food Traceability Rule? ( 1.1330(c)) ........................................ 19 
M.  What Records Must I Keep When I Am the First Land-Based Receiver of a Food on the FTL 
that was Obtained From a Fishing Vessel? ( 1.1335) ........................................................................... 19 
N.  What Records Must I Keep and Provide When I Ship a Food on the FTL? ( 1.1340) ............. 20 
O.  What Records Must I Keep When I Receive a Food on the FTL? ( 1.1345(a), (c)) .................. 20 
P.  What Records Must I Keep When I Receive a Food on the FTL from a Person Who Is Not 
Subject to the Food Traceability Rule? ( 1.1345(b)) ............................................................................ 21 
Q.  What Records Must I Keep When I Transform a Food on the FTL? ( 1.1350) ........................ 21 
R.  Under What Circumstances Will FDA Modify the Requirements of the Food Traceability Rule 
That Apply to a Food or Type of Entity or Exempt a Food or Type of Entity from the 
Requirements of the Food Traceability Rule? ( 1.1360(a)) ................................................................. 22 
S.  What Records Must I Maintain if I Am Subject to FDAs Food Facility Registration 
Requirements  but I Qualify for Modified Requirements or an Exemption from the Food 
Traceability Rule Requirements? ( 1.1360(b)) ..................................................................................... 22 
T.  When Will FDA Consider Whether to Adopt Modified Requirements or Grant an Exemption 
from the Requirements of the Food Traceability Rule? ( 1.1365) ...................................................... 22 
  2  Contains Nonbinding Recommendations 
 
U.  What Must Be Included in a Petition Requesting Modified Requirements or an Exemption 
from the Requirements? ( 1.1370) ......................................................................................................... 23 
V.  What Information Submitted in a Petition Requesting Modified Requirements or an 
Exemption, or Information in Comments on Such a Petition, is Publicly Available? ( 1.1375) ...... 23 
W.  What Process Applies to a Petition Requesting Modified Requirements or an Exemption? ( 
1.1380) ........................................................................................................................................................ 23 
X.  What Process Will FDA Follow When Adopting Modified Requirements or Granting an 
Exemption on Our Own Initiative? ( 1.1385) ....................................................................................... 24 
Y.  When Will Modified Requirements That We Adopt or an Exemption That We Grant Become 
Effective? ( 1.1390) .................................................................................................................................. 24 
Z.  Under What Circumstances May FDA Revise or Revoke Modified Requirements or an 
Exemption? ( 1.1395) .............................................................................................................................. 24 
AA. What Procedures Apply if FDA Tentatively Determines that Modified Requirements or an 
Exemption Should Be Revised or Revoked? ( 1.1400) ......................................................................... 24 
BB. Under What Circumstances Will FDA Waive One or More of the Requirements of the Food 
Traceability Rule for an Individual Entity or a Type of Entity? ( 1.1405) ........................................ 25 
CC. When Will FDA Consider Whether to Waive a Requirement of the Food Traceability Rule? ( 
1.1410) ........................................................................................................................................................ 25 
DD. How May I Request a Waiver for an Individual Entity? ( 1.1415) ............................................ 25 
EE. What Process Applies to a Request for a Waiver for an Individual Entity? ( 1.1420) ............. 26 
FF.  What Must Be Included in a Petition Requesting a Waiver for a Type of Entity? ( 1.1425) ... 26 
GG. What Information Submitted in a Petition Requesting a Waiver for a Type of Entity, or 
Information in Comments on Such a Petition, Is Publicly Available? ( 1.1430) ............................... 26 
HH. What Process Applies to a Petition Requesting a Waiver for a Type of Entity? ( 1.1435) ....... 26 
II.  What Process Will FDA Follow When Waiving a Requirement of the Food Traceability Rule 
on Our Own Initiative? ( 1.1440) ........................................................................................................... 27 
JJ.  Under What Circumstances May FDA Modify or Revoke a Waiver? ( 1.1445) ....................... 27 
KK. What Procedures Apply If FDA Tentatively Determines that a Waiver Should be Modified or 
Revoked? ( 1.1450) .................................................................................................................................. 27 
LL. How Must I Maintain Records Required by the Food Traceability Rule? ( 1.1455(a)) ........... 28 
MM.  Can Another Entity Establish and Maintain Records for Me? ( 1.1455(b)) ...................... 28 
NN. When Must I Make Required Records Available to FDA? ( 1.1455(c)(1)) ................................ 28 
OO. May I Store Records Offsite? ( 1.1455(c)(2)) ................................................................................ 28 
PP.  What Additional Requirements Apply If There Is a Threat to the Public Health? ( 
1.1455(c)(3)) ............................................................................................................................................... 29 
QQ. When There Is a Threat to The Public Health, Who Does Not Have to Provide the Requested 
Information in an Electronic Sortable Spreadsheet? ( 1.1455(c)(3)(iii)) ............................................ 29 
RR. What If I Am Unable to Provide the Requested Information in an Electronic Sortable 
Spreadsheet Because of Religious Beliefs? ( 1.1455(c)(3)(iv)) ............................................................. 30 
SS.  Must I Maintain All Records in English? ( 1.1455(c)(4)) ............................................................ 30 
TT. How Long Must I Keep the Required Records? ( 1.1455(d)) ...................................................... 30 
UU. If I Keep Electronic Records, Must I Comply with the Requirements of 21 CFR Part 11? ( 
1.1455(e)) .................................................................................................................................................... 30 
  3  Contains Nonbinding Recommendations 
 
VV. If I Already Keep Records of Some of the Information Required Under the Food Traceability 
Rule, Must I Duplicate These Existing Records to Comply with the Rule? ( 1.1455(f)) .................. 30 
WW. Must I Keep All the Required Information in a Single Set of Records? ( 1.1455(g)) ............. 30 
XX. What Consequences Could Result from Failing to Comply with the Requirements of the Food 
Traceability Rule? ( 1.1460) ................................................................................................................... 31 
YY. When and How Will FDA Update the FTL? ( 1.1465) ................................................................ 31 
IV.  Definitions .......................................................................................................................................... 32 
V.  Resources ........................................................................................................................................... 37 
 
 
 
 
 
 
  4  Contains Nonbinding Recommendations 
 
Requirements for Additional 
Traceability Records for Certain 
Foods:  
What You Need to Know About 
the FDA Regulation:  
Guidance for Industry 
 
 Small Entity Compliance Guide 
 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA, the 
Agency, or we) on this topic.  It does not establish any rights for any person and is not binding on 
FDA or the public.  You can use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff 
responsible for this guidance as listed on the title page.  
 
 
I.  Introduction 
On January 4, 2011, President Obama signed the FDA Food Safety Modernization Act (FSMA) 
(Pub. L. 111-353) into law.  As a component of FSMAs overhaul of U.S. food safety law to better 
ensure the safety and security of the nations food supply, section 204(d) of FSMA requires that 
FDA establish recordkeeping requirements for facilities that manufacture, process, pack, or hold 
foods the Agency designates as high-risk to facilitate the rapid and effective traceability of such 
foods.  These recordkeeping requirements are additional to the food traceability requirements 
under section 414 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (added to the FD&C 
Act in title III, subtitle A, section 306, of the Public Health Security and Bioterrorism Preparedness 
and Response Act of 2002 (the Bioterrorism Act) (Pub. L. 107-188)) and the implementing 
regulations in subpart J of part 1 of title 21 of the Code of Federal Regulations ( 1.326 to 1.368) 
(the subpart J regulations). In section 204(d)(1) of FSMA, Congress directed FDA to adopt 
additional recordkeeping requirements to prevent or mitigate foodborne illness outbreaks and 
address credible threats of serious adverse health consequences or death to humans or animals 
resulting from certain foods being adulterated under section 402 of the FD&C Act or misbranded 
with respect to allergen labeling under section 403(w) of the FD&C Act. 
 
On November 21, 2022, FDA published the final rule entitled, Requirements for Additional 
Traceability Records for Certain Foods (Food Traceability Rule) (87 FR 70910). The regulation 
can be found at 21 CFR part 1, subpart S ( 1.1300-1.1465). 
 
  5  Contains Nonbinding Recommendations 
 
We have prepared this Small Entity Compliance Guide (SECG) in accordance with section 212 of 
the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121, as amended by 
Public Law 110-28).  This guidance document is intended to help small entities, including farms 
and small businesses, comply with the requirements of the Food Traceability Rule as established in 
21 CFR part 1, subpart S.  The regulations are binding and have the full force and effect of law.   
 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe our current thinking on a topic and should be viewed 
only as recommendations, unless specific regulatory or statutory requirements are cited.  The use 
of the word should in FDA guidances means that something is suggested or recommended, but not 
required. 
 
II.  Key Terms 
The Food Traceability Rule uses a number of terms in specific ways.  A full list of these terms 
appears in this guidance beginning on page 32.  Table 1 lists some of the key terms used in this 
document. 
Table 1  Key Terms Used in the Food Traceability Rule 
Term  Definition 
Critical Tracking Event  Event in the supply chain of a food involving the harvesting, 
(CTE)  cooling (before initial packing), initial packing of a raw 
agricultural commodity (RAC) other than a food obtained from 
a fishing vessel, first land-based receiving of a food obtained 
from a fishing vessel, shipping, receiving, or transformation of 
the food. 
Food Traceability List (FTL)  The list of foods for which additional traceability records are 
required to be maintained, as designated in accordance with 
section 204(d)(2) of the FSMA. The term FTL includes both the 
foods specifically listed and foods that contain listed foods as 
ingredients, provided that the listed food that is used as an 
ingredient remains in the same form (e.g., fresh) in which it 
appears on the list. 
Key Data Element (KDE)  Information associated with a CTE for which a record must be 
maintained and/or provided. 
Kill step  Lethality processing that significantly minimizes pathogens in a 
food. 
Location description  Key contact information for the location where a food is 
handled, specifically the business name, phone number, physical 
location address (or geographic coordinates), and city, State, and 
zip code for domestic locations and comparable information for 
foreign locations, including country. 
Traceability Lot  A batch or lot of food that has been initially packed (for raw 
agricultural commodities other than food obtained from a fishing 
vessel), received by the first land-based receiver (for food 
obtained from a fishing vessel), or transformed. 
Traceability Lot Code (TLC)  A descriptor, often alphanumeric, used to uniquely identify a 
  6  Contains Nonbinding Recommendations 
 
Term  Definition 
traceability lot within the records of the traceability lot code 
source. 
Traceability Lot Code source  The place where a food was assigned a TLC. 
Traceability Lot Code source  An alternative method for providing FDA with access to the 
reference  location description for the traceability lot code source as 
required under this subpart. Examples of a traceability lot code 
source reference include, but are not limited to, the FDA Food 
Facility Registration Number for the traceability lot code source 
or a web address that provides FDA with the location 
description for the traceability lot code source. 
 
III.  Questions and Answers 
A.  Who is Subject to the Food Traceability Rule? ( 1.1300) 
 
The requirements of the Food Traceability Rule apply to persons who manufacture, process, pack, 
or hold foods that appear on the Food Traceability List. FDA published the FTL on its website, 
https://www.fda.gov/food/food-safety-modernization-act-fsma/food-traceability-list.  
 
 
B.  What is the Food Traceability List? ( 1.1310) 
 
The Food Traceability List (FTL) identifies the foods for which additional traceability records are 
required under the Food Traceability Rule.  The additional recordkeeping requirements apply to the 
foods specifically listed on the FTL, and to foods that contain listed foods as ingredients, provided 
that the listed food that is used as an ingredient remains in the same form (e.g., fresh) in which it 
appears on the list. 
 
C.  When Must I Comply with the Food Traceability Rule? 
 
The compliance date for all persons subject to the Food Traceability Rule is Tuesday, January 20, 
2026.  
 
D.  Who Is Exempt from the Food Traceability Rule? ( 1.1305) 
 
Certain persons and foods are fully exempt from the requirements of the Food Traceability Rule, 
while others may be eligible for partial exemptions. FDA has developed a software tool to help you 
determine whether an exemption may apply to you. You can access the tool at: 
https://collaboration.fda.gov/tefcv13/.  
 
 
 
 
  7  Contains Nonbinding Recommendations 
 
 
Table 2  Full and Partial Exemptions from the Food Traceability Rule 
Exemption  Additional Details  Citation 
Farm (or farm activities of a  Farm or farm mixed-type facility with an   
farm mixed-type facility) with  average annual monetary value of produce  1.1305(a)(1)(i) 
respect to the produce they  sold during the previous 3-year period of  
grow, when the farm is not a  $25,000 (on a rolling basis) or less, 
covered farm under 21 CFR  adjusted for inflation using 2011 as the 
112.4(a) (a provision in the  baseline year for calculating the adjustment 
produce safety regulation) 
Produce farm averaging  Calculation based on average annual sum   
$25,000 or less in sales of  of the monetary value of sales of produce  1.1305(a)(1)(ii) 
produce and market value of  and the market value of produce 
produce, adjusted for inflation  manufactured, processed, packed, or held 
using 2020 as the baseline year  without sale (e.g., held for a fee) during the 
previous 3-year period 
Shell egg producers with  Exemption applies to the shell eggs   1.1305(a)(2) 
<3,000 laying hens at a  produced at that farm 
particular farm 
Producers of raw agricultural  Calculation based on average annual sum   1.1305(a)(3) 
commodities (RACs) other than  of the monetary value of sales of RACs 
produce or shell eggs averaging  and the market value of RACs 
$25,000 or less in sales of  manufactured, processed, packed, or held 
RACs and market value of  without sale (e.g., held for a fee) during the 
RACs, adjusted for inflation  previous 3-year period 
using 2020 as the baseline year 
Farm when food produced on     1.1305(b) 
that farm is sold or donated 
directly to a consumer by the 
owner, operator, or agent in 
charge of the farm 
  8  Contains Nonbinding Recommendations 
 
Exemption  Additional Details  Citation 
Food produced and packaged  (1)  The packaging of the food remains in   1.1305(c) 
on a farm that meets certain  place until the food reaches the consumer, 
packaging and labeling criteria  and such packaging maintains the integrity 
of the product and prevents subsequent 
contamination or alteration of the product; 
and 
(2)  The labeling of the food that reaches 
the consumer includes the name, complete 
address (street address, town, State, 
country, and zip or other postal code for a 
domestic farm and comparable information 
for a foreign farm), and business phone 
number of the farm on which the food was 
produced and packaged.  FDA will waive 
the requirement to include a business 
phone number, as appropriate, to 
accommodate a religious belief of the 
individual in charge of the farm. 
Produce that receives  Conditions set forth in 21 CFR 112.2(b),   1.1305(d)(1) 
commercial processing that  which is part of the produce safety 
adequately reduces the presence  regulation, must be met for the produce 
of microorganisms of public 
health significance  
Shell eggs when all eggs     1.1305(d)(2) 
produced at the particular farm 
receive a treatment (as defined 
in 21 CFR 118.3) in accordance 
with 21 CFR 118.1(a)(2), which 
is part of the shell egg 
regulation  
Food that you subject to a kill  You keep: (i) The information specified in   1.1305(d)(3) 
step, provided that you maintain   1.1345 for your receipt of the food to 
certain information in records  which you apply the kill step (unless you 
have entered into a written agreement 
concerning your application of a kill step to 
the food in accordance with  1.1305(d)(6); 
and  
(ii) A record of your application of the kill 
step; 
Food that you change such that     1.1305(d)(4) 
the food is no longer on the 
FTL, provided that you 
maintain records containing the 
information specified in  
1.1345 for your receipt of the 
food you change 
  9  Contains Nonbinding Recommendations 
 
Exemption  Additional Details  Citation 
Food that you receive that has     1.1305(d)(5) 
previously been subjected to a 
kill step or that has previously 
been changed such that the food 
is no longer on the FTL 
Food that will be subjected to a  (i)  There is a written agreement between   1.1305(d)(6) 
kill step by an entity other than  the shipper of the food and the receiver 
a retail food establishment,  stating that the receiver will apply a kill 
restaurant, or consumer; or that  step to the food or change the food such 
will be changed by an entity  that it is no longer on the FTL; or  
other than a retail food  (ii)  There is a written agreement between 
establishment, restaurant, or  the shipper of the food and the receiver 
consumer, such that the food  stating that an entity in the supply chain 
will no longer be on the FTL,  subsequent to the receiver will apply a kill 
provided that there are certain  step to the food or change the food such 
written agreements  that it is no longer on the FTL and that the 
receiver will only ship the food to another 
entity that agrees, in writing, it will: 
(A)  Apply a kill step to the food or change 
the food such that it is no longer on the 
FTL; or  
(B) Enter into a similar written agreement 
with a subsequent receiver stating that a 
kill step will be applied to the food or that 
the food will be changed such that it is no 
longer on the FTL. 
(iii)  Any such written agreement must 
include the effective date, printed names 
and signatures of the persons entering into 
the agreement, and the substance of the 
agreement; and 
(iv)  Such written agreement must be 
maintained by both parties for as long as it 
is in effect and must be renewed at least 
once every 3 years. 
Produce that is listed as rarely  Asparagus; beans, black; beans, great   1.1305(e) 
consumed raw in 21 CFR  Northern; beans, kidney; beans, lima; 
112.2(a)(1), which is part of the  beans, navy; beans, pinto; beets, garden 
produce safety regulation  (roots and tops); beets, sugar; cashews; 
cherries, sour; chickpeas; cocoa beans; 
coffee beans; collards; corn, sweet; 
cranberries; dates; dill (seeds and weed); 
eggplants; figs; ginger; hazelnuts; 
horseradish; lentils; okra; peanuts; pecans; 
peppermint; potatoes; pumpkins; squash, 
winter; sweet potatoes; and water 
chestnuts. 
  10  Contains Nonbinding Recommendations 
 
Exemption  Additional Details  Citation 
Raw bivalve molluscan     1.1305(f) 
shellfish that are covered by the 
requirements of the National 
Shellfish Sanitation Program, 
subject to the requirements of 
21 CFR part 123, subpart C, 
and 21 CFR 1240.60, or 
covered by a final equivalence 
determination by FDA for raw 
bivalve molluscan shellfish 
Persons who manufacture,     1.1305(g) 
process, pack, or hold food on   
the FTL during or after the time   
when the food is within the   
exclusive jurisdiction of the   
USDA under the Federal Meat   
Inspection Act (21 U.S.C. 601     
et seq.), the Poultry Products 
Inspection Act (21 U.S.C. 451 
et seq.), or the Egg Products 
Inspection Act (21 U.S.C. 1031 
et seq.) 
  11  Contains Nonbinding Recommendations 
 
Exemption  Additional Details  Citation 
Commingled raw agricultural  Commingled means the RAC is   1.1305(h)(1) 
commodities, except that this  combined or mixed after harvesting but 
exemption does not apply to  before processing. Processing means 
fruits and vegetables covered by  operations that alter the general state of the 
the Produce Safety Regulation  commodity, such as canning, cooking, 
(21 CFR part 112).   freezing, dehydration, milling, grinding, 
pasteurization, or homogenization. A 
commodity is combined or mixed only 
when the combination or mixing involves 
food from different farms under different 
company management; except that for food 
obtained from a fishing vessel, a 
commodity is combined or mixed only 
when the combination or mixing involves 
food from different landing vessels and 
occurs after the vessels have landed. 
 
If a person who manufactures, processes, 
packs, or holds such commingled RAC is 
required to register with FDA under 
section 415 of the FD&C Act with respect 
to the manufacturing, processing, packing, 
or holding of the RAC, such person must 
maintain records identifying the immediate 
previous source of such RAC and the 
immediate subsequent recipient of such 
food in accordance with 21 CFR  1.337 
and 1.345.  Such records must be 
maintained for 2 years. 
 
  12  Contains Nonbinding Recommendations 
 
Exemption  Additional Details  Citation 
A raw agricultural commodity  The definition of commingled applies. In   1.1305(h)(2) 
that will become a commingled  addition:(i)  There is a written agreement 
RAC provided that certain  between the shipper of the RAC and the 
conditions are met. This  receiver stating that the receiver will 
exemption does not apply to  include the commodity as part of a 
fruits and vegetables covered by  commingled RAC; or  
the Produce Safety Regulation  (ii)  There is a written agreement between 
(21 CFR part 112).  the shipper of the RAC and the receiver 
stating that an entity in the supply chain 
subsequent to the receiver will include the 
commodity as part of a commingled RAC 
and that the receiver will only ship the 
RAC to another entity that agrees, in 
writing, it will either: 
(A)  Include the RAC as part of a 
commingled RAC; or  
(B)  Enter into a similar written agreement 
with a subsequent receiver stating that the 
RAC will become part of a commingled 
RAC; 
(iii)  Any such written agreement must 
include the effective date, printed names 
and signatures of the persons entering into 
the agreement, and the substance of the 
agreement; and 
(iv)  Such a written agreement must be 
maintained by both parties for as long as it 
is in effect and must be renewed at least 
once every 3 years. 
 
If a person who manufactures, processes, 
packs, or holds such commodity is required 
to register with FDA under section 415 of 
the FD&C Act with respect to the 
manufacturing, processing, packing, or 
holding of the applicable RAC, such 
person must maintain records identifying 
the immediate previous source of such 
RAC and the immediate subsequent 
recipient of such food in accordance with 
21 CFR  1.337 and 1.345.  Such records 
must be maintained for 2 years. 
  13  Contains Nonbinding Recommendations 
 
Exemption  Additional Details  Citation 
Retail food establishments and     1.1305(i) 
restaurants with an average 
annual monetary value of food 
sold or provided during the 
previous 3-year period of no 
more than $250,000 (on a 
rolling basis), adjusted for 
inflation using 2020 as the 
baseline year for calculating the 
adjustment 
Retail food establishment or  The retail food establishment or restaurant   1.1305(j) 
restaurant with respect to a food  must maintain a record documenting the 
that is produced on a farm and  name and address of the farm that was the 
both sold and shipped directly  source of the food for 180 days. 
to the retail food establishment 
or restaurant by the owner, 
operator, or agent in charge of 
that farm 
Both entities when a purchase is  The retail food establishment or restaurant   1.1305(k) 
made by a retail food  that makes the purchase must maintain a 
establishment or restaurant  record (e.g., a sales receipt) documenting 
from another retail food  the name of the product purchased, the date 
establishment or restaurant, and  of purchase, and the name and address of 
the purchase occurs on an ad  the place of purchase 
hoc basis outside of the buyers 
usual purchasing practice (e.g., 
not pursuant to a contractual 
agreement to purchase food 
from the seller). 
An institution operating a child  The school food authority or relevant food   1.1305(l) 
nutrition program authorized  procurement entity must maintain a record 
under the Richard B. Russell  documenting the name and address of the 
National School Lunch Act or  farm that was the source of the food for 
Section 4 of the Child Nutrition  180 days 
Act of 1966, or any other entity 
conducting a farm to school or 
farm to institution program, 
with respect to a food that is 
produced on a farm (including 
food produced and packaged on 
the farm) and sold or donated to 
the school or institution 
  14  Contains Nonbinding Recommendations 
 
Exemption  Additional Details  Citation 
The owner, operator, or agent in  If such person is required to register with   1.1305(m) 
charge of a fishing vessel; and  FDA under section 415 of the FD&C Act 
also any persons who  with respect to the manufacturing, 
manufacture, process, pack, or  processing, packing, or holding of the 
hold the food that is obtained  applicable food, such person must maintain 
from the fishing vessel, until  records identifying the immediate previous 
such time as the food is sold by  source of such food and the immediate 
the owner, operator, or agent in  subsequent recipient of such food in 
charge of the fishing vessel  accordance with 21 CFR  1.337 and 
1.345.  Such records must be maintained 
for 2 years. 
 
 
Transporter of food  A person who has possession, custody, or   1.1305(n) 
control of an article of food for the sole 
purpose of transporting the food, whether 
by road, rail, water, or air. 
Nonprofit food establishment  A charitable entity that prepares or serves   1.1305(o) 
food directly to the consumer or otherwise 
provides food or meals for consumption by 
humans or animals in the United States. 
The term includes central food banks, soup 
kitchens, and nonprofit food delivery 
services. To be considered a nonprofit food 
establishment, the establishment must meet 
the terms of section 501(c)(3) of the U.S. 
Internal Revenue Code (26 U.S.C. 
501(c)(3)). 
Persons who manufacture,     1.1305(p) 
process, pack, or hold food for 
personal consumption 
Persons who hold food on  Such persons:   1.1305(q) 
behalf of specific individual  (1)  Are not parties to the transaction 
consumers provided certain  involving the food they hold; and 
conditions are met  (2)  Are not in the business of distributing 
food. 
Food for research or evaluation  Such food:   1.1305(r) 
use provided certain conditions  (1)  Is not intended for retail sale and is not 
are met  sold or distributed to the public; and 
(2)  Is accompanied by the statement Food 
for research or evaluation use. 
 
 
 
 
  15  Contains Nonbinding Recommendations 
 
Traceability Plan 
E.  What Traceability Plan Must I Have for Foods on the FTL that I Manufacture, 
Process, Pack, or Hold? ( 1.1315) 
 
If you are subject to the requirements of the Food Traceability Rule, you must establish and 
maintain a traceability plan containing the following information: 
(1)  A description of the procedures you use to maintain the records you are required to 
keep under the Food Traceability Rule, including the format and location of these records;  
(2)  A description of the procedures you use to identify foods on the FTL that you 
manufacture, process, pack, or hold;  
(3)  A description of how you assign traceability lot codes to foods on the FTL in 
accordance with  1.1320, if applicable;  
(4)  A statement identifying a point of contact for questions regarding your traceability plan 
and records; and  
(5)  If you grow or raise a food on the FTL (other than eggs), a farm map showing the areas 
in which you grow or raise such foods.  The farm map must show the location and name of 
each field or other growing area where you grow a food on the FTL, including geographic 
coordinates and any other information needed to identify the location of each field or 
growing area.  For aquaculture farms, the farm map must show the location and name of 
each container (e.g., pond, pool, tank, cage) in which you raise seafood on the FTL, 
including geographic coordinates and any other information needed to identify the location 
of each container. 
 
F.  When Must I Update My Traceability Plan? 
 
You must update your traceability plan as needed to ensure that it reflects your current practices 
and that you meet the requirements of the rule. You must keep your previous traceability plan for 2 
years after you update it. 
 
G.  When Must I Assign Traceability Lot Codes to Foods on the FTL? (1.1320 and 
1.1345(b)(1)) 
 
For foods on the FTL, you must assign a traceability lot code when you do any of the following:   
  Initially pack a raw agricultural commodity other than a food obtained from a fishing 
vessel; 
  Perform the first land-based receiving of a food obtained from a fishing vessel;  
  Transform a food; or 
  Receive a food from a person to whom the Food Traceability Rule does not apply, provided 
you are not a retail food establishment or restaurant.   
You must not establish a new traceability lot code when you conduct other activities for a food on 
the FTL. For example, you must not establish a new traceability lot code when you ship a food on 
the FTL. 
 
  16  Contains Nonbinding Recommendations 
 
Records of Critical Tracking Events 
H.  What Records Must I Keep and Provide When I Harvest a Raw Agricultural 
Commodity (RAC) (Other Than a Food Obtained from a Fishing Vessel) on the FTL? ( 
1.1325(a)) 
If you harvest a RAC on the FTL, and the RAC is not obtained from a fishing vessel, you must 
keep records containing the following information: 
(i)  The location description for the immediate subsequent recipient (other than a transporter) of 
the food; 
(ii)  The commodity and, if applicable, variety of the food; 
(iii)  The quantity and unit of measure of the food (e.g., 75 bins, 200 pounds); 
(iv)  The location description for the farm where the food was harvested; 
(v)  For produce RACs, you must maintain a record that contains the name of the field or other 
growing area from which the food was harvested (which must correspond to the name used by 
the grower), or other information identifying the harvest location at least as precisely as the field 
or other growing area name. 
(vi)  For aquacultured food, you must maintain a record that contains the name of the container 
(e.g., pond, pool, tank, cage) from which the food was harvested (which must correspond to the 
container name used by the aquaculture farmer) or other information identifying the harvest 
location at least as precisely as the container name.  
(vii)  The date of harvesting; and 
(viii)  The reference document type and reference document number. 
You must provide the above information (except for the reference document type and number), 
along with your business name and phone number, to the initial packer of the RAC you harvest, 
either directly or through the supply chain. The information can be provided in electronic, paper, or 
other written form. 
 
I.  What Records Must I Keep and Provide When I Cool a Raw Agricultural Commodity 
(Other Than a Food Obtained from a Fishing Vessel) on the FTL Before It is Initially 
Packed? ( 1.1325(b)) 
If you cool a RAC on the FTL before it is initially packed, and the RAC is not obtained from a fishing 
vessel, you must keep records containing the following information: 
 
(i)  The location description for the immediate subsequent recipient (other than a transporter) of the 
food;  
(ii)  The commodity and, if applicable, variety of the food; 
(iii)  The quantity and unit of measure of the food (e.g., 75 bins, 200 pounds);  
  17  Contains Nonbinding Recommendations 
 
(iv)  The location description for where you cooled the food; 
(v)  The date of cooling;  
(vi)  The location description for the farm where the food was harvested; and 
(vii)  The reference document type and reference document number. 
 
You must provide this information (except for the reference document type and number) to the initial 
packer of the RAC that you cool, either directly or through the supply chain. The information can be 
provided in electronic, paper, or other written form. 
J.  What Records Must I Keep When I Am Performing the Initial Packing of a Raw 
Agricultural Commodity (Other Than a Food Obtained from a Fishing Vessel) on the 
FTL? ( 1.1330(a)) 
For each traceability lot of a RAC on the FTL you initially pack, when the RAC was not obtained 
from a fishing vessel, you must maintain records containing the following information and linking 
this information to the traceability lot: 
 
(1)  The commodity and, if applicable, variety of the food received; 
(2)  The date you received the food; 
(3)  The quantity and unit of measure of the food received (e.g., 75 bins, 200 pounds); 
(4)  The location description for the farm where the food was harvested; 
(5)  For produce, the name of the field or other growing area from which the food was 
harvested (which must correspond to the name used by the grower), or other information 
identifying the harvest location at least as precisely as the field or other growing area name; 
(6)  For aquacultured food, the name of the container (e.g., pond, pool, tank, cage) from 
which the food was harvested (which must correspond to the container name used by the 
aquaculture farmer) or other information identifying the harvest location at least as 
precisely as the container name; 
(7)  The business name and phone number for the harvester of the food; 
(8)  The date of harvesting; 
(9)  The location description for where the food was cooled (if applicable); 
(10)  The date of cooling (if applicable); 
(11)  The traceability lot code you assigned;  
(12)  The product description of the packed food;  
(13)  The quantity and unit of measure of the packed food (e.g., 6 cases, 25 reusable plastic 
containers, 100 tanks, 200 pounds); 
(14)  The location description for where you initially packed the food (i.e., the traceability 
lot code source), and (if applicable) the traceability lot code source reference; 
(15)  The date of initial packing; and 
(16)  The reference document type and reference document number. 
 
K.  What Additional Information Must I Keep When I Am Performing the Initial 
Packing of Sprouts (Except Soil- or Substrate-Grown Sprouts Harvested Without Their 
Roots)? ( 1.1330(b)) 
 
For each traceability lot of sprouts (except soil- or substrate-grown sprouts harvested without their 
roots) you initially pack, in addition to the information required under  1.1330(a) (see Section II.J 
XX), you must also maintain records containing the following information and linking this 
  18  Contains Nonbinding Recommendations 
 
information to the traceability lot:   
 
(1)  The location description for the grower of seeds for sprouting and the date of seed 
harvesting, if either is available; 
(2)  The location description for the seed conditioner or processor, the associated seed lot 
code, and the date of conditioning or processing;  
(3)  The location description for the seed packinghouse (including any repackers), the date 
of packing (and of repacking, if applicable), and any associated seed lot code assigned by 
the seed packinghouse; 
(4)  The location description for the seed supplier, any seed lot code assigned by the seed 
supplier (including the master lot and sub-lot codes), and any new seed lot code assigned by 
the sprouter; 
(5)  A description of the seeds, including the seed type or taxonomic name, growing 
specifications, type of packaging, and (if applicable) antimicrobial treatment;  
(6)  The date of receipt of the seeds by the sprouter; and 
(7)  The reference document type and reference document number. 
 
L.  What Records Must I Keep When I Am Performing the Initial Packing of a Raw 
Agricultural Commodity (Other than a Food Obtained from a Fishing Vessel) on the FTL 
That I Received From a Person Who Is Not Subject to the Food Traceability Rule? ( 
1.1330(c)) 
 
For each traceability lot of a RAC (other than a food obtained from a fishing vessel) on the FTL 
you initially pack that you receive from a person who is not subject to the Food Traceability Rule, 
you must maintain records containing the following information and linking this information to the 
traceability lot: 
 
(1)  The commodity and, if applicable, variety of the food received; 
(2)  The date you received the food; 
(3)  The quantity and unit of measure of the food received (e.g., 75 bins, 200 pounds); 
(4)  The location description for the person from whom you received the food; 
(5)  The traceability lot code you assigned; 
(6)  The product description of the packed food; 
(7)  The quantity and unit of measure of the packed food (e.g., 6 cases, 25 reusable plastic 
containers, 100 tanks, 200 pounds); 
(8)  The location description for where you initially packed the food (i.e., the traceability lot 
code source), and (if applicable) the traceability lot code source reference; 
(9)  The date of initial packing; and 
(10)  The reference document type and reference document number. 
 
M.  What Records Must I Keep When I Am the First Land-Based Receiver of a Food on 
the FTL that was Obtained From a Fishing Vessel? ( 1.1335) 
 
For each traceability lot of a food obtained from a fishing vessel for which you are the first land-
based receiver, you must maintain records containing the following information and linking this 
information to the traceability lot: 
 
(a)  The traceability lot code you assigned; 
  19  Contains Nonbinding Recommendations 
 
(b)  The species and/or acceptable market name for unpackaged food, or the product 
description for packaged food;  
(c)  The quantity and unit of measure of the food (e.g., 300 kg); 
(d)  The harvest date range and locations (as identified under the National Marine Fisheries 
Service Ocean Geographic Code, the United Nations Food and Agriculture Organization 
Major Fishing Area list, or any other widely recognized geographical location standard) for 
the trip during which the food was caught; 
(e)  The location description for the first land-based receiver (i.e., the traceability lot code 
source), and (if applicable) the traceability lot code source reference; 
(f)  The date the food was landed; and 
(g)  The reference document type and reference document number. 
 
N.  What Records Must I Keep and Provide When I Ship a Food on the FTL? ( 1.1340) 
 
For each traceability lot of a food on the FTL you ship, you must maintain records containing the 
following information and linking this information to the traceability lot: 
 
(1)  The traceability lot code for the food; 
(2)  The quantity and unit of measure of the food (e.g., 6 cases, 25 reusable plastic 
containers, 100 tanks, 200 pounds); 
(3)  The product description for the food;  
(4)  The location description for the immediate subsequent recipient (other than a 
transporter) of the food; 
(5)  The location description for the location from which you shipped the food; 
(6)  The date you shipped the food;  
(7)  The location description for the traceability lot code source, or the traceability lot code 
source reference; and 
(8)  The reference document type and reference document number. 
 
You must provide this information, except for the reference document type and reference 
document number, to the immediate subsequent recipient that is not a transporter of each 
traceability lot that you ship. The information can be provided in electronic, paper, or other written 
form. 
 
You do not have to keep and provide records of the above information for any shipment of a RAC 
not obtained from a fishing vessel that occurs before the RAC is initially packed.  
 
O.  What Records Must I Keep When I Receive a Food on the FTL? ( 1.1345(a), (c)) 
 
For each traceability lot of a food on the FTL you receive, you must maintain records containing 
the following information and linking this information to the traceability lot: 
 
(1)  The traceability lot code for the food; 
(2)  The quantity and unit of measure of the food (e.g., 6 cases, 25 reusable plastic 
containers, 100 tanks, 200 pounds); 
(3)  The product description for the food;  
(4)  The location description for the immediate previous source (other than a transporter) 
for the food;  
(5)  The location description for where the food was received; 
  20  Contains Nonbinding Recommendations 
 
(6)  The date you received the food; 
(7)  The location description for the traceability lot code source, or the traceability lot code 
source reference; and 
(8)  The reference document type and reference document number. 
 
 
You do not need to keep records of this information for receipt of any RACs not obtained from a 
fishing vessel that you receive before the food is initially packed, or for receipt of a food obtained 
from a fishing vessel if you are the first land-based receiver of that food.  
 
P.  What Records Must I Keep When I Receive a Food on the FTL from a Person Who Is 
Not Subject to the Food Traceability Rule? ( 1.1345(b)) 
 
For each traceability lot of a food on the FTL you receive from a person to whom the Food 
Traceability Rule does not apply, you must maintain records containing the following information 
and linking this information to the traceability lot: 
 
(1)  The traceability lot code for the food, which you must assign if one has not already 
been assigned (except that this requirement does not apply if you are a retail food 
establishment or restaurant); 
(2)  The quantity and unit of measure of the food (e.g., 6 cases, 25 reusable plastic 
containers, 100 tanks, 200 pounds); 
(3)  The product description for the food; 
(4)  The location description for the immediate previous source (other than a transporter) 
for the food; 
(5)  The location description for where the food was received (i.e., the traceability lot code 
source), and (if applicable) the traceability lot code source reference;  
(6)  The date you received the food; and 
(7)  The reference document type and reference document number. 
 
Q.  What Records Must I Keep When I Transform a Food on the FTL? ( 1.1350) 
For each new traceability lot of food you produce through transformation, you must maintain 
records containing the following information and linking this information to the new traceability 
lot: 
For the food on the FTL that you use in transformation (if applicable), the following 
information: 
(i)  The traceability lot code for the food; 
(ii)  The product description for the food to which the traceability lot code applies; and 
(iii)  For each traceability lot used, the quantity and unit of measure of the food used from 
that lot.  
 
For the food you produced through transformation, the following information: 
(i)  The new traceability lot code for the food; 
(ii)  The location description for where you transformed the food (i.e., the traceability lot 
code source), and (if applicable) the traceability lot code source reference; 
(iii)  The date transformation was completed; 
(iv)  The product description for the food; 
  21  Contains Nonbinding Recommendations 
 
(v)  The quantity and unit of measure of the food (e.g., 6 cases, 25 reusable plastic 
containers, 100 tanks, 200 pounds); and 
(vi)  The reference document type and reference document number for the transformation 
event. 
 
For each traceability lot produced through transformation of a RAC (other than a food obtained 
from a fishing vessel) on the FTL that was not initially packed prior to your transformation of the 
food, you must maintain records containing the information specified in  1.1330(a) or (c) (see 
Sections II.J and II.L), and, if the RAC is sprouts, the information specified in  1.1330(b) (see 
Section II.K).  
 
Retail food establishments and restaurants do not have to maintain records of this information for 
foods they do not ship (e.g., foods they sell or send directly to consumers). 
 
Procedures for Modified Requirements and Exemptions 
 
R.  Under What Circumstances Will FDA Modify the Requirements of the Food 
Traceability Rule That Apply to a Food or Type of Entity or Exempt a Food or Type of 
Entity from the Requirements of the Food Traceability Rule? ( 1.1360(a)) 
FDA will modify the requirements of the Food Traceability Rule applicable to a food or type of 
entity, or exempt a food or type of entity from the requirements of this rule, 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.  
 
S.  What Records Must I Maintain if I Am Subject to FDAs Food Facility Registration 
Requirements  but I Qualify for Modified Requirements or an Exemption from the Food 
Traceability Rule Requirements? ( 1.1360(b)) 
If modified requirements or an exemption of the type described in  1.1360(a) (see Question R) 
apply to you and you are required to register with FDA under section 415 of the FD&C Act (in 
accordance with the Food Facility Registration regulation) with respect to the manufacturing, 
processing, packing, or holding of the applicable food, you must maintain records identifying the 
immediate previous source of such food and the immediate subsequent recipient of such food in 
accordance with 21 CFR  1.337 and 1.345 for 2 years.   
T.  When Will FDA Consider Whether to Adopt Modified Requirements or Grant an 
Exemption from the Requirements of the Food Traceability Rule? ( 1.1365) 
FDA will consider modifying the requirements of the Food Traceability Rule applicable to a food 
or type of entity, or exempting a food or type of entity, on our own initiative or in response to a 
citizen petition submitted under 21 CFR 10.30 by any interested party. More information on how 
to submit a citizen petition can be found at https://www.fda.gov/regulatory-information/dockets-
management/instructions-submitting-citizen-petitions-cps-electronically.  
 
  22  Contains Nonbinding Recommendations 
 
U.  What Must Be Included in a Petition Requesting Modified Requirements or an 
Exemption from the Requirements? ( 1.1370) 
 
In addition to meeting the requirements on the content and format of a citizen petition in 21 CFR 
10.30, a petition requesting modified requirements or an exemption from the requirements of the 
Food Traceability Rule must: 
 
(a)  Specify the food or type of entity to which the modified requirements or exemption 
would apply; 
(b)  If the petition requests modified requirements, specify the proposed modifications to 
the requirements of the Food Traceability Rule; and 
(c)  Present information demonstrating why application of the requirements requested to be 
modified or from which exemption is requested is not necessary to protect the public 
health. 
 
V.  What Information Submitted in a Petition Requesting Modified Requirements or an 
Exemption, or Information in Comments on Such a Petition, is Publicly Available? ( 
1.1375) 
 
FDA will presume that information submitted in a petition requesting modified requirements or an 
exemption from the requirements of the Food Traceability Rule, as well as information in 
comments submitted on such a petition, does not contain information exempt from public 
disclosure under 21 CFR part 20, Public Information, and will be made public as part of the docket 
associated with the petition.   
 
W.  What Process Applies to a Petition Requesting Modified Requirements or an 
Exemption? ( 1.1380)  
In general, the procedures set forth in 21 CFR 10.30, Citizen Petition, govern FDAs response to a 
petition requesting modified requirements or an exemption from the Food Traceability Rule.  FDA 
will publish a notice in the Federal Register requesting information and views on a submitted 
petition, including information and views from persons who could be affected by the modified 
requirements or exemption if the petition were granted. An interested person may submit 
comments on such a petition in accordance with 21 CFR 10.30(d). 
 
FDA will respond to the petitioner in writing, as follows: 
(1)  If we grant the petition either in whole or in part, we will publish a notice in the 
Federal Register setting forth any modified requirements or exemptions and the reasons for 
them. 
(2)  If we deny the petition (including a partial denial), our written response to the 
petitioner will explain the reasons for the denial. 
 
FDA 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).   
 
  23  Contains Nonbinding Recommendations 
 
X.  What Process Will FDA Follow When Adopting Modified Requirements or Granting 
an Exemption on Our Own Initiative? ( 1.1385) 
If FDA, on our own initiative, determines that adopting modified requirements or granting an 
exemption from the requirements of the Food Traceability Rule for a food or type of entity is 
appropriate, we will publish a notice in the Federal Register setting forth the proposed modified 
requirements or exemption and the reasons for the proposal.  The notice will establish a public 
docket so that interested persons may submit written comments on the proposal. After considering 
any comments timely submitted, we will publish a notice in the Federal Register stating whether 
we are adopting modified requirements or granting an exemption, and the reasons for our decision. 
 
Y.  When Will Modified Requirements That We Adopt or an Exemption That We Grant 
Become Effective? ( 1.1390) 
Any modified requirements that FDA adopts or exemption that we grant will become effective on 
the date that notice of the modified requirements or exemption is published in the Federal Register, 
unless otherwise stated in the notice. 
 
Z.  Under What Circumstances May FDA Revise or Revoke Modified Requirements or 
an Exemption? ( 1.1395) 
FDA may revise or revoke modified requirements or an exemption if we determine that such 
revision or revocation is necessary to protect the public health. 
 
AA. What Procedures Apply if FDA Tentatively Determines that Modified Requirements 
or an Exemption Should Be Revised or Revoked? ( 1.1400) 
If FDA tentatively determines that we should revise or revoke modified requirements or an 
exemption, we will provide the following notifications: 
 
(1)  We will notify the person that originally requested the modified requirements or 
exemption (if we adopted modified requirements or granted an exemption in response to a 
petition) in writing at the address identified in the petition; and 
(2)  We will publish a notice in the Federal Register of our tentative determination that the 
modified requirements or exemption should be revised or revoked and the reasons for our 
tentative decision.  The notice will establish a public docket so that interested persons may 
submit written comments on our tentative determination. 
 
After considering any comments timely submitted, we will publish a notice in the Federal Register 
of our decision whether to revise or revoke the modified requirements or exemption and the 
reasons for the decision.  If we do revise or revoke the modified requirements or exemption, the 
effective date of the decision will be 1 year after the date of publication of the notice, unless 
otherwise stated in the notice. 
 
 
  24  Contains Nonbinding Recommendations 
 
Waivers 
BB. Under What Circumstances Will FDA Waive One or More of the Requirements of the 
Food Traceability Rule for an Individual Entity or a Type of Entity? ( 1.1405) 
 
FDA will waive one or more of the requirements of the Food Traceability Rule when we determine 
that: 
 
(a)  Application of the requirements would result in an economic hardship for an individual 
entity or a type of entity, due to the unique circumstances of the individual entity or type of 
entity;  
(b)  The waiver will not significantly impair our ability to rapidly and effectively identify 
recipients of a food to prevent or mitigate a foodborne illness outbreak or to address 
credible threats of serious adverse health consequences or death to humans or animals as a 
result of such food being adulterated under section 402 of the FD&C Act or misbranded 
under section 403(w) of the FD&C Act; and 
(c)  The waiver will not otherwise be contrary to the public interest. 
 
CC. When Will FDA Consider Whether to Waive a Requirement of the Food Traceability 
Rule? ( 1.1410) 
FDA will consider whether to waive a requirement of the Food Traceability Rule on our own 
initiative or in response to the following: 
 
(a)  A written request for a waiver for an individual entity; or 
(b)  A citizen petition requesting a waiver for a type of entity submitted under 21 CFR 
10.30 by any person subject to the requirements of the Food Traceability Rule. 
 
DD. How May I Request a Waiver for an Individual Entity? ( 1.1415) 
You may request a waiver of one or more requirements of the Food Traceability Rule for an 
individual entity by submitting a written request to FDA as described at www.fda.gov.  The request 
for a waiver must include the following: 
 
(a)  The name, address, and point of contact of the individual entity to which the waiver 
would apply; 
(b)  The requirements of the Food Traceability Rule to which the waiver would apply; 
(c)  Information demonstrating why application of the requirements requested to be waived 
would result in an economic hardship for the entity, including information about the unique 
circumstances faced by the entity that result in unusual economic hardship from the 
application of these requirements;  
(d)  Information demonstrating why the waiver will not significantly impair FDAs 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; and  
(e)  Information demonstrating why the waiver would not otherwise be contrary to the 
public interest. 
  25  Contains Nonbinding Recommendations 
 
 
EE. What Process Applies to a Request for a Waiver for an Individual Entity? ( 1.1420) 
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.   
 
Any waiver for an individual entity that FDA grants will become effective on the date we issue our 
response to the waiver request, unless otherwise stated in the response.  
 
FF. What Must Be Included in a Petition Requesting a Waiver for a Type of Entity? ( 
1.1425) 
In addition to meeting the requirements on the content and format of a citizen petition in 21 CFR 
10.30, a petition requesting a waiver for a type of entity must: 
 
(a)  Specify the type of entity to which the waiver would apply and the requirements of the 
Food Traceability Rule to which the waiver would apply; 
(b)  Present information demonstrating why application of the requirements requested to be 
waived would result in an economic hardship for the type of entity, including information 
about the unique circumstances faced by the type of entity that result in unusual economic 
hardship from the application of these requirements;  
(c)  Present information demonstrating why the waiver will not significantly impair FDAs 
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; 
and  
(d)  Present information demonstrating why the waiver would not otherwise be contrary to 
the public interest. 
 
GG. What Information Submitted in a Petition Requesting a Waiver for a Type of Entity, 
or Information in Comments on Such a Petition, Is Publicly Available? ( 1.1430) 
FDA will presume that information submitted in a petition requesting a waiver for a type of entity, 
as well as information in comments submitted on such a petition, does not contain information 
exempt from public disclosure under 21 CFR part 20, Public Information, and will be made public 
as part of the docket associated with the petition.   
 
HH. What Process Applies to a Petition Requesting a Waiver for a Type of Entity? ( 
1.1435) 
In general, the procedures set forth in 21 CFR 10.30 govern FDAs response to a petition 
requesting a waiver.  An interested person may submit comments on such a petition in accordance 
with 21 CFR 10.30(d).  FDA will publish a notice in the Federal Register requesting information 
and views on a submitted petition requesting a waiver for a type of entity, including information 
  26  Contains Nonbinding Recommendations 
 
and views from persons who could be affected by the waiver if we granted the petition.  We will 
respond to the petitioner in writing, as follows: 
 
(1)  If we grant the petition either in whole or in part, we will publish a notice in the 
Federal Register setting forth any requirements we have waived and the reasons for the 
waiver. 
(2)  If we deny the petition (including a partial denial), our written response to the 
petitioner will explain the reasons for the denial. 
 
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).   
 
II.  What Process Will FDA Follow When Waiving a Requirement of the Food 
Traceability Rule on Our Own Initiative? ( 1.1440) 
If FDA, on our own initiative, determines that a waiver of one or more requirements for an 
individual entity or type of entity is appropriate, we will publish a notice in the Federal Register 
setting forth the proposed waiver and the reasons for such waiver.  The notice will establish a 
public docket so that interested persons may submit written comments on the proposal.  After 
considering any comments timely submitted, we will publish a notice in the Federal Register 
stating whether we are granting the waiver (in whole or in part) and the reasons for our decision. 
 
Any waiver for a type of entity that FDA grants will become effective on the date that notice of the 
waiver is published in the Federal Register, unless otherwise stated in the notice. 
 
JJ.  Under What Circumstances May FDA Modify or Revoke a Waiver? ( 1.1445) 
FDA may modify or revoke a waiver if we determine that: 
 
(a)  Compliance with the waived requirements would no longer impose a unique economic 
hardship on the individual entity or type of entity to which the waiver applies; 
(b)  The waiver could significantly impair our ability to rapidly and effectively identify 
recipients of a food to prevent or mitigate a foodborne illness outbreak or to address 
credible threats of serious adverse health consequences or death to humans or animals as a 
result of such food being adulterated under section 402 of the FD&C Act or misbranded 
under section 403(w) of the FD&C Act; or 
(c)  The waiver is otherwise contrary to the public interest. 
 
KK. What Procedures Apply If FDA Tentatively Determines that a Waiver Should be 
Modified or Revoked? ( 1.1450) 
If FDA tentatively determines that we should modify or revoke a waiver for an individual entity, 
we will notify the person that had received the waiver in writing of our tentative determination that 
the waiver should be modified or revoked. The notice will provide the waiver recipient 60 days in 
which to submit information stating why the waiver should not be modified or revoked. 
 
  27  Contains Nonbinding Recommendations 
 
Upon consideration of any information submitted by the waiver recipient, we will respond in 
writing stating our decision whether to modify or revoke the waiver and the reasons for the 
decision. If we modify or revoke the waiver, the effective date of the decision will be 1 year after 
the date of our response to the waiver recipient, unless otherwise stated in the response. 
 
If FDA tentatively determines that we should modify or revoke a waiver for a type of entity, we will 
provide the following notifications:  
(i) We will notify the person that originally requested the waiver (if we granted the waiver in 
response to a petition) in writing at the address identified in the petition.  
(ii) We will publish a notice in the Federal Register of our tentative determination that the waiver 
should be modified or revoked and the reasons for our tentative decision. The notice will establish a 
public docket so that interested persons may submit written comments on our tentative 
determination.  
After considering any comments timely submitted, we will publish a notice in the Federal Register of our 
decision whether to modify or revoke the waiver and the reasons for the decision. If we do modify or revoke 
the waiver, the effective date of the decision will be 1 year after the date of publication of the notice, unless 
otherwise stated in the notice. 
 
Records Maintenance and Availability 
 
LL. How Must I Maintain Records Required by the Food Traceability Rule? ( 1.1455(a)) 
You must keep records as original paper or electronic records or true copies (such as photocopies, 
pictures, scanned copies, or other accurate reproductions of the original records).  Electronic 
records may include valid, working electronic links to the information required to be maintained 
under the Food Traceability Rule.  All records must be legible and stored to prevent deterioration 
or loss. 
 
MM.  Can Another Entity Establish and Maintain Records for Me? ( 1.1455(b)) 
Yes, you may have another entity establish and maintain records required under the Food 
Traceability Rule on your behalf, but you are responsible for ensuring that such records can be 
retrieved and provided onsite within 24 hours of request for official review. 
 
NN. When Must I Make Required Records Available to FDA? ( 1.1455(c)(1)) 
You must make all records required under the Food Traceability Rule available to an authorized 
FDA representative, upon request, within 24 hours (or within some reasonable time to which FDA 
has agreed) after the request, along with any information needed to understand these records, such 
as internal or external coding systems, glossaries, abbreviations, and a description of how the 
records you provide correspond to the information required.  
 
OO. May I Store Records Offsite? ( 1.1455(c)(2)) 
Yes, offsite storage of records is permitted if such records can be retrieved and provided onsite 
  28  Contains Nonbinding Recommendations 
 
within 24 hours of request for official review.  Electronic records are considered to be onsite if they 
are accessible from an onsite location.   
 
PP. What Additional Requirements Apply If There Is a Threat to the Public Health? ( 
1.1455(c)(3)) 
When necessary to help FDA prevent or mitigate a foodborne illness outbreak, or to assist in the 
implementation of a recall, or to otherwise address a threat to the public health, including but not 
limited to situations where FDA has a reasonable belief that an article of food (and any other 
article of food that FDA reasonably believes is likely to be affected in a similar manner) presents a 
threat of serious adverse health consequences or death to humans or animals as a result of the food 
being adulterated under section 402 of the FD&C Act or misbranded under section 403(w) of the 
FD&C Act, you must make available, within 24 hours (or within some reasonable time to which 
FDA has agreed) of a request made in-person or remotely (e.g., by phone) by an authorized FDA 
representative, the information you are required to maintain under the Food Traceability Rule, for 
the foods and date ranges or traceability lot codes specified in the request.  If FDAs request for 
this information is made by phone, we will also provide the request to you in writing upon your 
request; however, you must provide the requested information within 24 hours (or within some 
reasonable time to which FDA has agreed) of the phone request. 
 
Except as specified in  1.1455(c)(3)(iii) and (iv), when the information requested by FDA under 
the above circumstances is information you are required to maintain under  1.1325 through 
1.1350 of the Food Traceability Rule (concerning records of critical tracking events), you must 
provide such information in an electronic sortable spreadsheet, along with any other information 
needed to understand the information in the spreadsheet. 
 
QQ. When There Is a Threat to The Public Health, Who Does Not Have to Provide the 
Requested Information in an Electronic Sortable Spreadsheet? ( 1.1455(c)(3)(iii)) 
You may provide the information requested by FDA under 21 CFR 1.1455(c)(3) in a form other 
than an electronic sortable spreadsheet if you are:   
(A) A farm whose average annual sum of the monetary value of their sales of raw 
agricultural commodities and the market value of raw agricultural commodities they 
manufacture, process, pack, or hold without sale (e.g., held for a fee) during the 
previous 3-year period is no more than $250,000 (on a rolling basis), adjusted for 
inflation using 2020 as the baseline year for calculating the adjustment;   
(B)  A retail food establishment or restaurant with an average annual monetary value of 
food sold or provided during the previous 3-year period of no more than $1 million (on 
a rolling basis), adjusted for inflation using 2020 as the baseline year for calculating 
the adjustment; or  
(C)  A person (other than a farm, retail food establishment, or restaurant) whose average 
annual sum of the monetary value of their sales of food and the market value of food 
they manufacture, process, pack, or hold without sale (e.g., held for a fee) during the 
previous 3-year period is no more than $1 million (on a rolling basis), adjusted for 
inflation using 2020 as the baseline year for calculating the adjustment. 
 
  29  Contains Nonbinding Recommendations 
 
RR. What If I Am Unable to Provide the Requested Information in an Electronic Sortable 
Spreadsheet Because of Religious Beliefs? ( 1.1455(c)(3)(iv)) 
FDA will withdraw a request for an electronic sortable spreadsheet under  1.1455(c)(3)(ii), as 
appropriate, to accommodate a religious belief of a person asked to provide such a spreadsheet. 
 
SS. Must I Maintain All Records in English? ( 1.1455(c)(4)) 
Records do not have to be maintained in English.  However, upon FDA request, you must provide 
within a reasonable time an English translation of records required under the Food Traceability 
Rule. 
 
TT. How Long Must I Keep the Required Records? ( 1.1455(d)) 
Except as specified otherwise in the Food Traceability Rule, you must maintain records containing 
the required information for 2 years from the date you created or obtained the records. 
 
UU. If I Keep Electronic Records, Must I Comply with the Requirements of 21 CFR Part 
11? ( 1.1455(e)) 
Records that are established or maintained to satisfy the requirements of the Food Traceability 
Rule and that meet the definition of electronic records in 21 CFR 11.3(b)(6) are exempt from the 
requirements of 21 CFR part 11 (Electronic Records; Electronic Signatures).  However, records 
that satisfy the requirements of the Food Traceability Rule but that are also required under other 
applicable statutory provisions or regulations remain subject to part 11, if not otherwise exempt. 
 
VV. If I Already Keep Records of Some of the Information Required Under the Food 
Traceability Rule, Must I Duplicate These Existing Records to Comply with the Rule? ( 
1.1455(f)) 
No, you do not need to duplicate existing records you have (e.g., records that you keep in the 
ordinary course of business or that you maintain to comply with other Federal, State, Tribal, 
territorial, or local regulations) if they contain the information required by the Food Traceability 
Rule.  You may supplement any such existing records as necessary to include all of the information 
required by the rule.   
 
WW. Must I Keep All the Required Information in a Single Set of Records? ( 1.1455(g)) 
No, you do not have to keep all of the information required by the Food Traceability Rule in a 
single set of records.  However, your traceability plan must indicate the format and location of the 
records you are required to keep under the rule, in accordance with  1.1315(a)(1). 
 
 
 
 
 
  30  Contains Nonbinding Recommendations 
 
Consequences of Failure to Comply 
XX. What Consequences Could Result from Failing to Comply with the Requirements of 
the Food Traceability Rule? ( 1.1460) 
The violation of any recordkeeping requirement under section 204 of the FSMA, including the 
violation of any requirement of the Food Traceability Rule, is prohibited under section 301(e) of 
the FD&C Act, except when such violation is committed by a farm. 
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 the FSMA (other than the 
requirements under subsection (f) of that section), including the requirements of the Food 
Traceability Rule, have not been complied with regarding such article. 
 
Updating the FTL 
YY. When and How Will FDA Update the FTL? ( 1.1465) 
FDA intends to update the FTL approximately every five years, subject to available resources.  
First, we would update the Risk-Ranking Model for Food Tracing with new data and information.  
As part of this process, we intend to provide stakeholders with a mechanism to submit relevant 
data for the Agencys consideration.  Based on the data and the updated Model, we could develop a 
proposed revised FTL.  We would then publish a notice in the Federal Register stating the 
proposed changes and the reasons for the changes. The notice would also request information and 
views on the proposed changes. After considering any information and views submitted on the 
proposed changes to the FTL, we would publish a second notice in the Federal Register stating 
whether we are making any changes to the FTL and the reasons for the decision. If FDA revises 
the list, we will also publish the revised list on our website.  
Any deletions from the FTL would become effective immediately.  Any additions to the FTL 
would become effective two years after the date of the Federal Register notice announcing the 
revised list, unless we state otherwise in the notice.  This period of time would provide entities 
handling any new additions to the FTL sufficient time to come into compliance.  
 
 
 
   
  31  Contains Nonbinding Recommendations 
 
IV. Definitions 
The definitions of terms in section 201 of the FD&C Act apply to such terms when used in the 
Food Traceability Rule. In addition, the following definitions apply to words and phrases as they 
are used in the rule: 
 
Commingled raw agricultural commodity means any commodity that is combined or mixed after 
harvesting but before processing, except that the term commingled raw agricultural commodity 
does not include types of fruits and vegetables that are raw agricultural commodities to which the 
standards for the growing, harvesting, packing, and holding of produce for human consumption in 
21 CFR part 112 apply.  For the purpose of this definition, a commodity is combined or mixed 
only when the combination or mixing involves food from different farms under different company 
management; except that for food obtained from a fishing vessel, a commodity is combined or 
mixed only when the combination or mixing involves food from different landing vessels and 
occurs after the vessels have landed.  Also, for the purpose of this definition, the term processing 
means operations that alter the general state of the commodity, such as canning, cooking, freezing, 
dehydration, milling, grinding, pasteurization, or homogenization. 
 
Cooling means active temperature reduction of a raw agricultural commodity using hydrocooling, 
icing (except icing of seafood), forced air cooling, vacuum cooling, or a similar process. 
 
Critical tracking event means an event in the supply chain of a food involving the harvesting, 
cooling (before initial packing), initial packing of a raw agricultural commodity other than a food 
obtained from a fishing vessel, first land-based receiving of a food obtained from a fishing vessel, 
shipping, receiving, or transformation of the food. 
 
Farm means farm as defined in 21 CFR 1.328.  For producers of shell eggs, farm means all 
poultry houses and grounds immediately surrounding the poultry houses covered under a single 
biosecurity program, as set forth in 21 CFR 118.3. 
 
First land-based receiver means the person taking possession of a food for the first time on land 
directly from a fishing vessel.   
 
Fishing vessel means any vessel, boat, ship, or other craft which is used for, equipped to be used 
for, or of a type which is normally used for fishing or aiding or assisting one or more vessels at sea 
in the performance of any activity relating to fishing, including, but not limited to, preparation, 
supply, storage, refrigeration, transportation, or processing, as set forth in the Magnuson-Stevens 
Fishery Conservation and Management Act (16 U.S.C. 1802(18)). 
 
Food Traceability List means the list of foods for which additional traceability records are required 
to be maintained, as designated in accordance with section 204(d)(2) of the FSMA.  The term 
Food Traceability List includes both the foods specifically listed and foods that contain listed 
foods as ingredients, provided that the listed food that is used as an ingredient remains in the same 
form (e.g., fresh) in which it appears on the list.  
 
Harvesting applies to farms and farm mixed-type facilities and means activities that are 
traditionally performed on farms for the purpose of removing raw agricultural commodities from 
the place they were grown or raised and preparing them for use as food.  Harvesting is limited to 
activities performed on raw agricultural commodities, or on processed foods created by 
  32  Contains Nonbinding Recommendations 
 
drying/dehydrating a raw agricultural commodity without additional manufacturing/processing, on 
a farm.  Harvesting does not include activities that transform a raw agricultural commodity into a 
processed food as defined in section 201(gg) of the FD&C Act.  Examples of harvesting include 
cutting (or otherwise separating) the edible portion of the raw agricultural commodity from the 
crop plant and removing or trimming part of the raw agricultural commodity (e.g., foliage, husks, 
roots, or stems).  Examples of harvesting also include cooling, field coring, filtering, gathering, 
hulling, shelling, sifting, threshing, trimming of outer leaves of, and washing raw agricultural 
commodities grown on a farm. 
 
Holding means storage of food and also includes activities performed incidental to storage of a 
food (e.g., activities performed for the safe or effective storage of that food, such as fumigating 
food during storage, and drying/dehydrating raw agricultural commodities when the 
drying/dehydrating does not create a distinct commodity (such as drying/dehydrating hay or 
alfalfa)).  Holding also includes activities performed as a practical necessity for the distribution of 
that food (such as blending of the same raw agricultural commodity and breaking down pallets), 
but does not include activities that transform a raw agricultural commodity into a processed food as 
defined in section 201(gg) of the FD&C Act.  Holding facilities could include warehouses, cold 
storage facilities, storage silos, grain elevators, and liquid storage tanks. 
 
Initial packing means packing a raw agricultural commodity (other than a food obtained from a 
fishing vessel) for the first time. 
 
Key data element means information associated with a critical tracking event for which a record 
must be maintained and/or provided in accordance with the Food Traceability Rule. 
 
Kill step means lethality processing that significantly minimizes pathogens in a food. 
 
Location description means key contact information for the location where a food is handled, 
specifically the business name, phone number, physical location address (or geographic 
coordinates), and city, State, and zip code for domestic locations and comparable information for 
foreign locations, including country.   
 
Manufacturing/processing means making food from one or more ingredients, or synthesizing, 
preparing, treating, modifying, or manipulating food, including food crops or ingredients.  
Examples of manufacturing/processing activities include:  Baking, boiling, bottling, canning, 
cooking, cooling, cutting, distilling, drying/dehydrating raw agricultural commodities to create a 
distinct commodity (such as drying/dehydrating grapes to produce raisins), evaporating, 
eviscerating, extracting juice, formulating, freezing, grinding, homogenizing, irradiating, labeling, 
milling, mixing, packaging (including modified atmosphere packaging), pasteurizing, peeling, 
rendering, treating to manipulate ripening, trimming, washing, or waxing.  For farms and farm 
mixed-type facilities, manufacturing/processing does not include activities that are part of 
harvesting, packing, or holding.  
 
Mixed-type facility means an establishment that engages in both activities that are exempt from 
registration under section 415 of the FD&C Act and activities that require the establishment to be 
registered.  An example of such a facility is a farm mixed-type facility, which is an establishment 
that is a farm, but also conducts activities outside the farm definition that require the establishment 
to be registered. 
 
Nonprofit food establishment means a charitable entity that prepares or serves food directly to the 
  33  Contains Nonbinding Recommendations 
 
consumer or otherwise provides food or meals for consumption by humans or animals in the 
United States.  The term includes central food banks, soup kitchens, and nonprofit food delivery 
services.  To be considered a nonprofit food establishment, the establishment must meet the terms 
of section 501(c)(3) of the U.S. Internal Revenue Code (26 U.S.C. 501(c)(3)). 
 
Packing means placing food into a container other than packaging the food and also includes re-
packing and activities performed incidental to packing or re-packing a food (e.g., activities 
performed for the safe or effective packing or re-packing of that food (such as sorting, culling, 
grading, and weighing or conveying incidental to packing or re-packing)), but does not include 
activities that transform a raw agricultural commodity into a processed food as defined in section 
201(gg) of the FD&C Act. 
 
Person includes an individual, partnership, corporation, and association. 
 
Point of contact means an individual having familiarity with an entitys procedures for traceability, 
including their name and/or job title, and their phone number. 
 
Produce means produce as defined in 21 CFR 112.3. 
 
Product description means a description of a food product and includes the product name 
(including, if applicable, the brand name, commodity, and variety), packaging size, and packaging 
style.  For seafood, the product name may include the species and/or acceptable market name. 
 
Raw agricultural commodity means raw agricultural commodity as defined in section 201(r) of 
the FD&C Act. 
 
Receiving means an event in a foods supply chain in which a food is received by someone other 
than a consumer after being transported (e.g., by truck or ship) from another location.  Receiving 
includes receipt of an intracompany shipment of food from one location at a particular street 
address of a firm to another location at a different street address of the firm. 
 
Reference document means a business transaction document, record, or message, in electronic or 
paper form, that may contain some or all of the key data elements for a critical tracking event in the 
supply chain of a food.  A reference document may be established by you or obtained from another 
person.  Reference document types may include, but are not limited to, bills of lading, purchase 
orders, advance shipping notices, work orders, invoices, database records, batch logs, production 
logs, field tags, catch certificates, and receipts. 
 
Reference document number means the identification number assigned to a specific reference 
document.   
 
Restaurant means a facility that prepares and sells food directly to consumers for immediate 
consumption.  Restaurant does not include facilities that provide food to interstate conveyances, 
central kitchens, and other similar facilities that do not prepare and serve food directly to 
consumers. 
(1)  Entities in which food is provided to humans, such as cafeterias, lunchrooms, cafes, 
bistros, fast food establishments, food stands, saloons, taverns, bars, lounges, catering 
facilities, hospital kitchens, day care kitchens, and nursing home kitchens are restaurants; 
and 
(2)  Pet shelters, kennels, and veterinary facilities in which food is provided to animals are 
  34  Contains Nonbinding Recommendations 
 
restaurants. 
 
Retail food establishment means an establishment that sells food products directly to consumers as 
its primary function.  The term retail food establishment includes facilities that manufacture, 
process, pack, or hold food if the establishments primary function is to sell from that 
establishment food, including food that it manufactures, processes, packs, or holds, directly to 
consumers.  A retail food establishments primary function is to sell food directly to consumers if 
the annual monetary value of sales of food products directly to consumers exceeds the annual 
monetary value of sales of food products to all other buyers.  The term consumers does not 
include businesses.  A retail food establishment includes grocery stores, convenience stores, and 
vending machine locations.  A retail food establishment also includes certain farm-operated 
businesses selling food directly to consumers as their primary function. 
(1)  Sale of food directly to consumers from an establishment located on a farm includes 
sales by that establishment directly to consumers: 
(i)  At a roadside stand (a stand situated on the side of or near a road or thoroughfare 
at which a farmer sells food from his or her farm directly to consumers) or farmers 
market (a location where one or more local farmers assemble to sell food from their 
farms directly to consumers); 
(ii)  Through a community supported agriculture program.  Community supported 
agriculture (CSA) program means a program under which a farmer or group of 
farmers grows food for a group of shareholders (or subscribers) who pledge to buy a 
portion of the farmers crop(s) for that season.  This includes CSA programs in 
which a group of farmers consolidate their crops at a central location for distribution 
to shareholders or subscribers; and  
(iii)  At other such direct-to-consumer sales platforms, including door-to-door sales; 
mail, catalog and internet order, including online farmers markets and online 
grocery delivery; religious or other organization bazaars; and State and local fairs. 
(2)  Sale of food directly to consumers by a farm-operated business includes the sale of 
food by that farm-operated business directly to consumers: 
(i)  At a roadside stand (a stand situated on the side of or near a road or thoroughfare 
at which a farmer sells food from his or her farm directly to consumers) or farmers 
market (a location where one or more local farmers assemble to sell food from their 
farms directly to consumers); 
(ii)  Through a community supported agriculture program.  Community supported 
agriculture (CSA) program means a program under which a farmer or group of 
farmers grows food for a group of shareholders (or subscribers) who pledge to buy a 
portion of the farmers crop(s) for that season.  This includes CSA programs in 
which a group of farmers consolidate their crops at a central location for distribution 
to shareholders or subscribers; and 
(iii)  At other such direct-to-consumer sales platforms, including door-to-door sales; 
mail, catalog and internet order, including online farmers markets and online 
grocery delivery; religious or other organization bazaars; and State and local fairs. 
(3)  For the purposes of this definition, farm-operated business means a business that is 
managed by one or more farms and conducts manufacturing/processing not on the farm(s). 
 
Shipping means an event in a foods supply chain in which a food is arranged for transport (e.g., by 
truck or ship) from one location to another location.  Shipping does not include the sale or 
shipment of a food directly to a consumer or the donation of surplus food.  Shipping includes 
sending an intracompany shipment of food from one location at a particular street address of a firm 
to another location at a different street address of the firm. 
  35  Contains Nonbinding Recommendations 
 
Traceability lot means a batch or lot of food that has been initially packed (for raw agricultural 
commodities other than food obtained from a fishing vessel), received by the first land-based 
receiver (for food obtained from a fishing vessel), or transformed.  
 
Traceability lot code means a descriptor, often alphanumeric, used to uniquely identify a 
traceability lot within the records of the traceability lot code source.   
 
Traceability lot code source means the place where a food was assigned a traceability lot code.  
 
Traceability lot code source reference means an alternative method for providing FDA with access 
to the location description for the traceability lot code source as required under the Food 
Traceability Rule.  Examples of a traceability lot code source reference include, but are not limited 
to, the FDA Food Facility Registration Number for the traceability lot code source or a web 
address that provides FDA with the location description for the traceability lot code source.  
 
Transformation means an event in a foods supply chain that involves manufacturing/processing a 
food or changing a food (e.g., by commingling, repacking, or relabeling) or its packaging or 
packing, when the output is a food on the FTL.  Transformation does not include the initial packing 
of a food or activities preceding that event (e.g., harvesting, cooling). 
 
Transporter means a person who has possession, custody, or control of an article of food for the 
sole purpose of transporting the food, whether by road, rail, water, or air.  
 
You means a person subject to the Food Traceability Rule under 21 CFR 1.1300. 
 
 
 
 
  36  Contains Nonbinding Recommendations 
 
V.  Resources 
Exemption tool: https://collaboration.fda.gov/tefcv13/ 
FDAs Food Traceability Final Rule website: https://www.fda.gov/food/food-safety-
modernization-act-fsma/fsma-final-rule-requirements-additional-traceability-records-certain-
foods 
Federal Register Notice: Requirements for Additional Traceability Records for Certain Foods: 
https://www.federalregister.gov/documents/2022/11/21/2022-24417/requirements-for-
additional-traceability-records-for-certain-foods 
Food Traceability List: https://www.fda.gov/food/food-safety-modernization-act-fsma/food-
traceability-list  
Food Traceability Rule Citations: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-
A/part-1/subpart-S 
Food Traceability Rule: Critical Tracking Events and Key Data Elements - Clickable PDF: 
https://www.fda.gov/media/163132/download  
Frequently Asked Questions on FSMAs Food Traceability Rule: https://www.fda.gov/food/food-
safety-modernization-act-fsma/frequently-asked-questions-fsma-food-traceability-rule 
FSMA Inflation Adjusted Cut Offs: https://www.fda.gov/food/food-safety-modernization-act-
fsma/fsma-inflation-adjusted-cut-offs  
 
  37  Contains Nonbinding Recommendations 
 
 
  38