Contains Nonbinding Recommendations 
Guidance for Industry 
What You Need To Know About 
Establishment, Maintenance, and 
Availability of Records  
Small Entity Compliance Guide 
Additional copies are available from: 
Outreach and Information Center, HFS-009 
Center for Food Safety and Applied Nutrition 
Food and Drug Administration 
5001 Campus Drive
College Park, MD 20740  
(Tel) 1-888-723-3366  
http://www.fda.gov/FoodGuidances 
You may submit either 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 listed in the notice of availability that publishes in the Federal Register.   
U.S. Department of Health and Human Services 
Food and Drug Administration 
Office of Foods and Veterinary Medicine 
Center for Food Safety and Applied Nutrition  
Center for Veterinary Medicine 
Office of Regulatory Affairs 
April 2014  Contains Nonbinding Recommendations 
Guidance for Industry1 
What You Need To Know About Establishment and Maintenance of 
Records 
Small Entity Compliance Guide 
 
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this 
topic.  It does not create or confer any rights for or on any person and does not operate to bind 
FDA or the public.  You can use an alternative approach if the approach satisfies the 
requirements of the applicable statutes and regulations.  If you want to discuss an alternative 
approach, contact the FDA staff responsible for implementing this guidance.  If you cannot 
identify the appropriate FDA staff, call the telephone number listed on the title page of this 
guidance.  
 
I. Introduction 
 
On February 23, 2012, the Food and Drug Administration (FDA) published an interim final rule 
(IFR) in the Federal Register (77 FR 10658) that amended its regulation on the availability of 
records to be consistent with the amendments to section 414(a) of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) made by section 101 of the FDA Food Safety Modernization Act 
(FSMA) (Public Law 111-353). The IFR became effective on March 1, 2012.  April 4, 2014, 
FDA issued a final rule in the Federal Register adopting without change the requirements in the 
IFR. 
 
Previously, this guidance document, issued in December 2004, served as the Small Entity 
Compliance Guide (SECG) for 21 CFR Part 1, Subpart J in accordance with section 212 of the 
Small Business Regulatory Enforcement Fairness Act (Public Law 104-121).  The SECG 
restated in plain language the legal requirements for the establishment and maintenance of 
records set forth in 21 CFR Part 1, Subpart J implementing section 414 of the FD&C Act, as 
added by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 
(the Bioterrorism Act) (Public Law 107-188). Because FDA issued an IFR and subsequent final 
rule amending certain requirements in 21 CFR Part 1, Subpart J to be consistent with the 
amendments to section 414(a) of the FD&C Act made by section 101 of FSMA, FDA is updating 
this SECG in April 2014 to provide guidance intended to help any entity, regardless of size, 
comply with this regulation.  This document continues to serve as FDAs SECG for 21 CFR Part 
1, Subpart J, including the amendments to this regulation made by the IFR and finalized without 
change.  
 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities. Instead, guidances describe the Agencys current thinking on a topic and should 
                                                 
1 This guidance has been prepared by the Office of Compliance in the Center for Food Safety and Applied Nutrition 
in cooperation with the Center for Veterinary Medicine at the U.S. Food and Drug Administration. 
 
  2  Contains Nonbinding Recommendations 
be viewed only as recommendations, unless specific regulatory or statutory requirements are 
cited. The use of the word should in Agency guidances means that something is suggested or 
recommended, but not required.  
 
II. Background 
 
Section 414(b) of the FD&C Act directs FDA to issue regulations that establish requirements 
regarding the establishment and maintenance of records  for not longer than two years  by 
persons (excluding farms and restaurants) who manufacture, process, pack, transport, distribute, 
receive, hold, or import food.  To implement this provision, the Agency issued a final regulation 
on the establishment and maintenance of records in 2004 (69 FR 71561, Dec. 9, 2004) and 
certain parts of the regulations were subsequently corrected in 2005 (70 FR 8726, Feb. 23, 2005).  
The records that must be kept by these regulations are those that are needed by FDA for 
inspection, to allow FDA to identify the immediate previous sources and immediate subsequent 
recipients of food, including its packaging. This, in turn, will help address credible threats of 
serious adverse health consequences or death to humans or animals.  
 
Through an interim final rule, FDA amended the records availability requirement in the 
regulations on establishment, and maintenance of records to implement the expansion of records 
access in the FD&C Act as amended by FSMA. Prior to the passage of FSMA, section 414(a) of 
the FD&C Act provided the Secretary (by delegation FDA) with access to records relating to 
food that was reasonably believed to be adulterated and present a threat of serious adverse health 
consequences or death to humans or animals. The FSMA amendments and interim final rule 
expand FDAs former records access beyond records relating to the specific suspect article of 
food to records relating to any other article of food that FDA reasonably believes is likely to be 
affected in a similar manner.  In addition, FDA can access records relating to articles of food for 
which the Secretary believes that there is a reasonable probability that the use of or exposure to 
the article of food, and any other article of food that the FDA reasonably believes is likely to be 
affected in a similar manner, will cause serious adverse health consequences or death to humans 
or animals.  This expanded records access further improves FDAs ability to respond to and 
contain threats of serious adverse health consequences or death to humans or animals. 
   
III. Discussion This guidance was created to inform domestic persons in the U.S. who 
manufacture, process, pack, transport, distribute, receive, hold, or import food for humans or 
animals, and foreign persons who transport food in the U.S., about final regulations that establish 
requirements regarding the establishment and maintenance of records.   
 
A. Establishment and Maintenance of Records 
 
i. Who must establish and maintain records? 
 
Domestic persons in the U.S. that manufacture, process, pack, transport, distribute, 
receive, hold or import food; foreign persons that transport food; and persons who place 
food directly in its finished container.  For these regulations, the term persons include 
individuals, partnerships, corporations, and associations.  
 
  3  Contains Nonbinding Recommendations 
ii. How is food defined for purposes of this regulation? 
 
Food is defined in section 201(f) of the Federal Food, Drug, and Cosmetic Act [21 
U.S.C. 321(f)],which defines food as: (1) articles used for food or drink for man or 
other animals, (2) chewing gum, and (3) articles used for components of any such 
article.  Examples of food include: 
 
  Dietary supplements and dietary ingredients 
  Infant formula 
  Beverages (including alcoholic beverages and bottled water) 
  Fruits and vegetables 
  Fish and seafood 
  Dairy products and shell eggs 
  Raw agricultural commodities for use as food or components of food 
  Canned and frozen foods 
  Bakery goods, snack food, and candy (including chewing gum) 
  Live food animals 
  Animal feeds and pet food 
 
iii. Who is excluded entirely or in part from these regulations? 
 
Excluded Entirely 
 
  Farms 
  Foreign persons, except for foreign persons who transport food in the U.S. 
  Restaurants are excluded entirely. A combination restaurant/retail facility is  
excluded entirely if sales of food it prepares and sells to consumers for 
immediate consumption are more than 90 percent of its total food sales. 
  Persons performing covered activities with food to the extent that the food is 
within the exclusive jurisdiction of the U.S. Department of Agriculture 
  Persons who manufacture, process, pack, transport, distribute, receive, hold, 
or import food for personal consumption 
  Persons who receive or hold food on behalf of specific individual consumers 
and who are not also parties to the transaction and who are not in the business 
of distributing food (e.g., concierge in an apartment building) 
  Persons who manufacture, process, pack, transport, distribute, receive, hold, 
or import food packaging (the outer packaging of food that bears the label and 
does not contact the food), except for those persons who also engage in a 
covered activity with respect to food (see next page) 
 
Excluded from the Requirement to Establish and Maintain Records, but not the Record 
Availability Requirements for Existing Records 
 
  Fishing vessels not engaged in processing 
  4  Contains Nonbinding Recommendations 
  Retail food establishments that employ 10 or fewer full-time equivalent 
employees 
  Non-profit food establishments 
  Persons who manufacture, process, pack, transport, distribute, receive, hold, 
or import food are subject to the record availability requirements with respect 
to its packaging (the outer packaging of food that bears the label and does not 
contact the food) 
  Persons who manufacture, process, pack, transport, distribute, receive, hold, 
or import food contact substances other than the finished container that 
directly contacts the food 
  Persons who manufacture, process, pack, transport, distribute, receive, hold, 
or import the finished container that directly contacts the food, except for 
those persons who place food directly in contact with its finished container 
   
 
Additional Partial Exclusions 
 
  Persons who distribute food directly to consumers (the term consumers does 
not include businesses) are excluded from the requirement to establish and 
maintain records to identify the immediate subsequent recipients (they are 
subject to the requirements to identify the immediate previous sources) 
  Persons who operate retail food establishments that distribute food to persons 
who are not consumers must establish and maintain records to identify the 
immediate subsequent recipients only to the extent the information is 
reasonably available 
 
iv. What records must be established and maintained by non-transporters of food? 
 
For non-transporters (i.e., persons who own food or who hold, manufacture, process, 
pack, import, receive, or distribute food for purposes other than transportation), the 
records have to: 
 
1.  Identify the immediate non-transporter previous sources, whether foreign or domestic, 
of all foods received, including: 
  The name of the firm; address; telephone number; fax number and e-mail address, 
if available; 
  Type of food, including brand name and specific variety (e.g., Brand X cheddar 
cheese, not just cheese; romaine lettuce, not just lettuce); 
  Date received; 
  Quantity and type of packaging (e.g., 12 oz. bottles); 
  Identify the immediate transporter previous sources, including the name, address, 
telephone number  and, if available, fax number and e-mail address. Persons 
who manufacture, process, or pack food also must include lot or code number or 
other identifier, if the information exists. 
 
  5  Contains Nonbinding Recommendations 
2.  Identify the immediate non-transporter subsequent recipients of all foods released, 
including: 
 
  The name of the firm; address; telephone number; fax number and e-mail address, 
if available; 
  Type of food, including brand name and specific variety; 
  Date released; 
  Quantity and type of packaging; 
  Identify the immediate transporter subsequent recipients, including the name, 
address, telephone number  and, if available, fax number and e-mail address. 
Persons who manufacture, process, or pack food also must include lot or code 
number or other identifier, if the information exists. 
  Information that is reasonably available to identify the specific source of each 
ingredient that was used to make every lot of finished product. 
 
v. What records must be established and maintained by transporters of food? 
 
The term transporters includes persons who have possession, custody, or control of 
an article of food in the U.S. for the sole purpose of transporting the food, whether by 
road, rail, water, or air.  The term transporters also includes foreign persons that 
transport food in the U.S., regardless of whether the foreign persons have possession, 
custody, or control of food for the sole purpose of transporting it. 
   
For transporters, records have to include names of the transporters immediate 
previous source and transporters immediate subsequent recipient, origin and 
destination points, date shipment received and date released, number of packages, 
description of freight, route of movement during the time the food was transported, 
and transfer point(s) through which the shipment moved. 
 
vi. Do transporters have alternative methods of meeting the requirements of the rule? 
 
Persons who have possession, custody, or control of food in the U.S.  for the sole 
purpose of transporting the food  or foreign persons who transport food in the U.S., 
regardless of whether they have possession, custody, or control of the food  for the sole 
purpose of transporting that food  have five alternative methods (depending on the mode 
of transportation) of meeting the requirements of the final rule. 
 
Alternative Methods for Food Transporters 
 
1.  Establishing and maintaining the records described above 
2.  Establishing and maintaining specified information that is in the records required 
of roadway interstate transporters by the Department of Transportations Federal 
Motor Carrier Safety Administration contained in 49 CFR 373.101 and 373.103 as 
of December 9, 2004 
3.  Establishing and maintaining specified information that is in the records required 
of rail and water interstate transporters by the Department of Transportations 
  6  Contains Nonbinding Recommendations 
Surface Transportation Board contained in 49 CFR 1035.1 and 1035.2 as of 
December 9, 2004 
4.  Establishing and maintaining specified information that is in the records required 
of international air transporters by the Warsaw Convention 
5.  Entering into an agreement with a non-transporter immediate previous source or 
immediate subsequent recipient (if located in the U.S.) to establish, maintain, or 
establish and maintain the required records in options 1, 2, 3, or 4. Section 1.352 of 
the final rule specifies what must be included in such agreements 
 
B. How must the records be maintained? 
 
FDA is specifying the information a covered entity must keep, but not specifying the form in 
which the records must be maintained. The records may be kept in any format, paper or 
electronic, provided they contain all the required information. 
 
i. Can existing records be used to satisfy the requirements of these regulations? 
 
The regulations do not require duplication of existing records, if these records contain all 
of the required information. 
 
ii. How long must the records be retained? 
 
The rule requires records to be created when food is received, released, or transported 
except to the extent the information is contained in existing records. The period for which 
the records must be retained depends on the perishability of the food: 
 
Type of food  Record retention  Record retention period for  
period  transporters or persons keeping 
for non- records on their behalf 
transporters 
Food having significant risk of      
spoilage, loss of value, or loss of  6 months  6 months 
palatability within 60 days 
Food having significant risk of spoilage,     
loss of value, or loss of palatability   1 year  1 year 
occurring after a minimum of 60 days,  
but within 6 months 
Food having significant risk of spoilage,      
loss of value, or loss of palatability   2 years  1 year 
occurring no sooner than 6 months 
Animal food, including pet food  1 year  1 year 
 
 
 
 
 
  7  Contains Nonbinding Recommendations 
iii. Where must the records be retained? 
 
At the establishment where the activities covered in the records occurred (onsite) or at a 
reasonably accessible location. 
 
C. What are the record availability requirements? 
 
When 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, is adulterated and 
presents a threat of serious adverse health consequences or death to humans or animals, or 
when FDA believes that there is a reasonable probability that the use of or exposure to an 
article of food, and any other article of food that FDA reasonably believes is likely to be 
affected in a similar manner, will cause serious adverse health consequences or death to 
humans or animals, any records or other information accessible to FDA under section 414 or 
704(a) of the FD&C Act (21 U.S.C. 350c and 374(a)) must be made readily available for 
inspection and photocopying or other means of reproduction.  Such records and other 
information must be made available as soon as possible, not to exceed 24 hours from the time 
of receipt of the official request, from an officer or employee duly designated by the 
Secretary of Health and Human Services who presents appropriate credentials and a written 
notice.  The records requested may be related to the manufacture, processing, packing, 
transporting, distribution, receipt, holding, or importation of such an article of food that are 
maintained by, or on behalf of, an entity subject to the recordkeeping regulation, and at any 
location. 
 
i. What records are excluded from records access? 
 
Recipes, financial data, pricing data, personnel data, research data, and sales data are 
excluded from these requirements. A recipe is defined as the formula, including 
ingredients, quantities, and instructions necessary to manufacture a food product. 
Therefore, records relating only to the ingredients of a food product, and not the other 
two components of a recipe, are not excluded. 
 
ii. What procedures does FDA intend to follow before requesting access to records? 
 
FDA has issued a new guidance that presents additional information about records 
access. This document is available through links on FDAs homepage, www.fda.gov.  
Further, FDAs operational guidance to its staff regarding records access, which details 
the internal procedures the Agency follows, is provided in the Investigations Operations 
Manual (IOM) (Section 5.4.1.3) and the Regulatory Procedures Manual (RPM) (chapter 
10-4), both available through links on FDAs homepage.  
 
iii. How does FDA intend to make a request to access or copy records? 
 
Once FDA makes the necessary determination following the procedures described in the 
IOM and RPM for making requests for records access under section 414(a) of the FD&C 
Act, an investigator or other FDA personnel  upon presentation of credentials  will 
  8  Contains Nonbinding Recommendations 
provide a written notice (FDA 482c Notice of Inspection  Request for Records) to the 
owner, operator, or agent in charge. The FDA investigator or FDA personnel will inform 
that person of the records request and FDAs legal authority to obtain these records. FDA 
may request additional records related to the implicated article of food and other articles 
of food that FDA reasonably believes are likely to be affected in a similar manner at a 
later time under the same authority. 
 
iv. How will FDA maintain the confidentiality of any protected information in the 
records it obtains? 
 
Information obtained under the records access provisions of sections 414(a) and 704(a) 
may include, but is not limited to, a companys non-public confidential commercial or 
trade secret information. Several statutes (e.g., Trade Secrets Act (18 U.S.C. 1905), 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(j)), and Freedom of Information 
Act (5 U.S.C. 552) and the Agencys information disclosure regulations at 21 CFR Parts 
20 and 21 govern the Agencys disclosure of information to the public. FDA personnel 
will comply with all applicable protections, procedures, and legal requirements against 
the unauthorized disclosure of non-public information, such as any trade secret or 
confidential commercial information. 
 
D. What will happen if the required records are not established and maintained? 
 
The failure to establish and maintain the required records or failure to make them available to 
FDA are prohibited acts under section 301(e) of the FD&C Act [21 U.S.C. 331(e)]. The 
Federal government can bring a civil action in Federal court to enjoin persons who commit a 
prohibited act. The Federal government also can bring a criminal action in Federal court to 
prosecute persons who commit a prohibited act. 
 
E. When is compliance with the recordkeeping regulation required? 
 
All businesses covered by this rule were required to comply by December 9, 2005, except 
small and very small businesses. Small businesses (11-499 full-time equivalent employees 
(FTEs)) were required to comply by June 9, 2006, and very small businesses (10 or fewer 
FTEs) were required to comply by December 11, 2006.  The term, full-time equivalent 
employees or FTEs, means all individuals employed by the person claiming the exemption. 
The number of full-time equivalent employees is determined by dividing the total number of 
hours of salary or wages paid directly to employees of the person and of all of its affiliates by 
the number of hours of work in 1 year, 2,080 hours (i.e., 40 hours x 52 weeks). 
The interim final rule amending the records availability requirements to be consistent with 
changes to the FD&C Act made by FSMA became effective on March 1, 2012. 
 
 
 
 
 
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