Contains Nonbinding Recommendations 
Guidance for Industry 
FDA Records Access Authority Under 
Sections 414 and 704 of the Federal Food, 
Drug, and Cosmetic Act 
    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 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 
Table of Contents 
 
 
 
I.    Introduction   
 
II.    Background  
 
III.   Questions and Answers  
 
 
 
 
  2  Contains Nonbinding Recommendations 
Guidance for Industry1  
FDA Records Access Authority Under Sections 414 and 704 of the 
Federal Food, Drug, and Cosmetic Act 
 
 
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  
 
This guidance document provides updated information pertaining to the Food and Drug 
Administrations (FDA) authority to access and copy records under sections 414 and 704 of the 
Federal Food, Drug, and Cosmetic Act (FD&C Act).  This guidance is a revision of FDAs 
November 2005 guidance entitled Guidance for Industry and FDA Staff: Guidance for records 
access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002; Final Guidance.  FDAs staff manuals, the Regulatory 
Procedures Manual (RPM) and Investigations Operations Manual (IOM), contain operational 
and procedural steps for FDA staff to follow for accessing records under sections 414 and 704 of 
the FD&C Act; therefore, that information has been removed from this guidance. Both the RPM 
and IOM are located on FDAs website, www.fda.gov.  
 
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the Agency's 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 Agency guidances means that something is suggested or 
recommended, but not required.  
 
II.  Background  
 
The FDA Food Safety Modernization Act (FSMA) (Public Law 111-353) was signed into law on 
January 4, 2011. Section 101 of FSMA amends section 414(a) and 704(a)(1)(B) of the FD&C 
Act (21 U.S.C. 350c(a) and 374(a)(1)(B)).  Section 414 was originally added to the FD&C Act 
by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the 
                                                 
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.    Contains Nonbinding Recommendations 
Bioterrorism Act) (Public Law 107-188).  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.  FSMA expands FDAs access to records beyond 
records relating to the specific suspect article of food to records relating to any other article of 
food that the FDA reasonably believes is likely to be affected in a similar manner.  In addition, 
FDA can now access records if 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.  The Bioterrorism Act also amended section 704(a)(1)(B) of the FD&C 
Act to include a cross-reference to section 414.  Section 101 of FSMA amends this section, 
which pertains to factory inspections, by updating the cross-reference to refer to the amended 
version of section 414(a). 
 
FDAs access to records under section 414 is separate from previously existing routine records 
access provided in commodity specific regulations, such as the Low-Acid Canned Food 
regulations (21 CFR part 113), the Acidified Food regulations (21 CFR part 114), the Juice 
Hazard Analysis and Critical Control Point (HACCP) Systems regulations (21 CFR part 120), 
the Fish and Fishery Products regulations (21 CFR part 123), and the Infant Formula regulations 
(21 CFR part 106). These commodity specific record access regulations were not amended by 
FSMA.  
 
III.  Questions and Answers 
 
1.  Does FDAs records access authority under sections 414(a) and 704(a) of the FD&C Act 
apply to records relating to human food and/or animal food? 
 
Yes. The term food means (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, as defined in section 
201(f) of the FD&C Act (21 U.S.C. 321(f)). 
 
2.  Does FDAs records access authority under sections 414(a) and 704(a) apply to both 
domestic and foreign persons? 
 
Yes. FDAs records access authority under sections 414(a) and 704(a) applies to both domestic 
and foreign persons (excluding farms and restaurants) who manufacture, process, pack, transport, 
distribute, receive, hold, or import articles of food when the circumstances in section 414(a)(1) 
or (2) of the FD&C Act are met.  A persons refusal to permit FDA to access and copy any 
record as required by section 414(a) or 704(a) is a prohibited act under section 301(e) of the 
FD&C Act (21 U.S.C. 331(e)).  The term person has the same meaning as defined in section 
201(e) of the FD&C Act to include individual, partnership, corporation, and association.    
FDA prefers that requested records relating to the manufacture, processing, packing, 
transportation, distribution, receipt, holding or importation of food that is intended for or enters 
the U.S. supply chain to be provided to the Agency in English.  
  Contains Nonbinding Recommendations 
 
3(a).  Under what circumstances may FDA access and copy records under section 414(a) of 
the FD&C Act? 
 
FDA may access and copy records from domestic and foreign persons who manufacture, 
process, pack, transport, distribute, receive, hold, or import food (excluding farms and 
restaurants) if:  
  (1) FDA has a reasonable belief that the food, and any other food that FDA reasonably 
believes is likely to be affected in a similar manner,  
a)  is adulterated, and 
b)  presents a threat of serious adverse health consequences or death to humans or 
animals.  
  Or, (2) FDA believes that there is a reasonable probability that use of or exposure to the 
food, and any other 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. 
 
3(b).  What records may FDA access and copy if the circumstances under section 414(a) of 
the FD&C Act are met? 
  If the circumstances in (1) are met, FDA may access and copy the records that are needed 
to assist FDA in determining whether the food is adulterated and presents a threat of 
serious adverse health consequences or death to humans or animals 
  If the circumstances in (2) are met, FDA may access and copy the records that are needed 
to assist FDA in determining whether there is a reasonable probability that the use of or 
exposure to the food will cause serious adverse health consequences or death to human or 
animals. 
 
4.  When is FDA likely to exercise its authority under section 414(a) and 704(a) of the 
FD&C Act to access and copy records? 
 
FDA may request to access and copy records whenever the requirements of section 414(a)(1) or 
(2) are satisfied, but requests are most likely to occur when FDA becomes aware of: 
  Reportable food reports, as defined in section 417(a)(2) of the FD&C Act [21 U.S.C. 
350f(a)(2)]  
  Foodborne outbreaks  
  Epidemiological evidence which implicates food causing illness or death 
  Product recalls 
  Adverse event reports 
  Consumer complaints 
  Contains Nonbinding Recommendations 
  Situations in which specific foods (or other foods that are reasonably likely to be affected 
in a similar manner) present a threat of serious adverse health consequences or death to 
humans or animals  
 
5(a).  What are some examples of situations in which food may cause serious adverse health 
consequences or death to humans or animals? 
 
The following are some examples of situations in which food may cause serious adverse health 
consequences or death to humans or animals: 
  Peanut butter contaminated with Salmonella 
  Under-processed canned chili that contains Clostridium botulinum toxin 
  Smoked salmon contaminated with Listeria monocytogenes 
  Cake mix that contains milk that is not declared in the ingredient statement on the label 
  Candy contaminated with peanuts because of cross-contact with another food that 
contained peanuts as an ingredient 
  Baby food that poses a choking hazard 
  Horse feed contaminated with elevated levels of monensin 
  Pet food contaminated with elevated levels of melamine and cyanuric acid 
  Sheep feed that contains elevated levels of copper 
  Swine feed that contains elevated levels of selenium 
 
5(b).  What are some examples of situations in which food is likely to be affected in a 
similar manner and may cause serious adverse health consequences or death to humans 
or animals? 
 
The following are some examples of situations in which food can be considered likely to be 
affected in a similar manner and may cause serious adverse health consequences or death to 
humans or animals:   
  Salmonella outbreak in which, based on epidemiological data, multiple foods are initially 
implicated as potential sources of the Salmonella 
  Articles of food prepared or packed on an identical processing line as another article of 
food which may cause serious adverse health consequences or death to humans or 
animals 
  Articles of food that are processed in shared-use equipment and that equipment was used 
to process an article of food which may cause serious adverse health consequences or 
death to humans or animals 
  Articles of food that were prepared, packed or held under similar conditions as an article 
of food which may cause serious adverse health consequences or death to humans or 
animals 
 
  Contains Nonbinding Recommendations 
6.   What records may FDA access and copy under sections 414(a) and 704(a) of the FD&C 
Act? 
FDAs authority under sections 414(a) and 704(a) of the FD&C Act applies to records that are 
required to be kept by regulation under section 414(b), as well as any other records related to the 
manufacture, processing, packing, transporting, distribution, receipt, holding, or importation of 
the food believed to be affected and any other article of food believed to be affected in a similar 
manner. This applies to records maintained by or on behalf of such person, in any format 
(including paper and electronic formats), and at any location.  FDA recognizes that some persons 
store their records at a location other than the facility where the covered activities take place.  
Because the circumstances of each particular event vary, the scope of an FDA request for records 
may vary in each situation. 
Examples of records that FDA can access and copy include: 
  Manufacturing records 
  Raw materials (ingredients and packaging) receipt records 
  Product distribution records 
  Product inventory records 
  Test records 
  Recall records 
  Reportable food records        
  Customer distribution lists 
  Complaint and adverse event records 
 
7.  What records may FDA not access and copy under sections 414(a) and 704(a) of the 
FD&C Act? 
 
FDA's authority to access records under sections 414(a) and 704(a) of the FD&C Act does not 
apply to the following records: 
  Records from farms, as defined in 21 CFR 1.328  Farm means a facility in one general 
physical location devoted to the growing and harvesting of crops, the raising of animals 
(including seafood), or both.  Washing, trimming of outer leaves, and cooling produce are 
considered part of harvesting.  The term farm includes:   
1.  Facilities that pack or hold food, provided that all food used in 
such activities is grown, raised, or consumed on that farm or 
another farm under the same ownership: and 
2.  Facilities that manufacture/process food, provided that all food 
used in such activities is consumed on that farm or another farm 
under the same ownership. 
  Records from restaurants, as defined in 21 CFR 1.328  Restaurant means a facility that 
prepares and sells food directly to consumers for immediate consumption.  Restaurant 
  Contains Nonbinding Recommendations 
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.  
Facilities in which food is directly 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.  Pet shelters, kennels, and veterinary facilities in which food is directly 
provided to animals are restaurants. 
  Records relating to food that is within the exclusive jurisdiction of the Secretary of 
Agriculture pursuant to 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.) 
  Recipes, as defined in 21 CFR 1.328 - A recipe" is the formula, including ingredients, 
quantities, and instructions necessary to manufacture a food.  Because a recipe must have 
all three elements, a list of the ingredients used to manufacture a food, without quantity 
information and manufacturing instructions, is not a recipe.  
  Financial data  
  Pricing data 
  Personnel data  
  Research data 
  Sales data other than shipment data regarding sales   
 
8.  What actions may FDA take when a firm refuses to permit access to records? 
 
The refusal to permit access to or copying of records requested under section 414(a) of the 
FD&C Act is a prohibited act under section 301(e) of the FD&C Act [21 U.S.C. 331(e)]. In 
response to such a refusal, FDA may initiate civil or criminal action, as necessary.  In addition, 
FDA may refuse admission of food offered for import into U.S. commerce by a firm that refused 
to permit FDA to access records.   
 
Depending on the situation, FDA may initiate additional administrative, judicial, or other action, 
as appropriate, in conjunction with a records access request. These additional actions are distinct 
from a records access request and the existence of a records access request does not alter the 
process or timeframes established for these additional actions. Moreover, refusal to permit FDA 
access to records is not a prerequisite for using these additional actions. Such additional actions 
may include: 
  Suspension of the food facilitys registration, thus preventing the firm from importing or 
exporting food or introducing food into interstate or intrastate commerce 
  Administrative detention of the food to control its movement 
  Seizure of the food  
  Issuance of a mandatory recall order for the food  
  Injunction against the firm 
  Contains Nonbinding Recommendations 
9.  How will FDA maintain the confidentiality of any protected information in records it 
obtains? 
Information obtained under the records access provisions of sections 414(a) and 704(a) of the 
FD&C Act may include, but is not limited to, a company's non-public confidential commercial 
or trade secret information. Several statutes (e.g., Trade Secrets Act (18 U.S.C. 1905), FD&C 
Act (21 U.S.C. 331(j)), the Freedom of Information Act, (5 U.S.C. 552) and the agency's 
information disclosure regulations at 21 CFR Parts 20 and 21 govern the agency's disclosure of 
information to the public. For both foreign and domestic firms, 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. FDA 
personnel may disclose non-public information otherwise protected from disclosure to the public, 
if that disclosure is permitted by law and FDA's procedures (see e.g. 21 U.S.C. 375(b)). For 
example, FDA's regulations (set forth in 21 CFR Parts 20 and 21) permit agency officials to 
disclose certain non-public information to other federal, state, local, or foreign government 
officials, or to FDA's contractors, when that disclosure is carried out according to law and FDA's 
procedures.