Draft Guidance for Industry  
Questions and Answers Regarding the 
Reportable Food Registry as Established by 
the Food and Drug Administration 
Amendments Act of 2007 (Edition 2) 
Additional copies from: 
Office of Food Defense, Communication and Emergency Response, HFS-005 
Center for Food Safety and Applied Nutrition 
Food and Drug Administration 
5001 Campus Drive
College Park, MD  20740 
(Tel) 301-436-1500 
http://www.fda.gov/FoodGuidances 
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure 
that the agency considers your comment on this draft guidance before it begins work on the final 
version of the guidance, submit written or electronic comments on the draft guidance within 60 
days of publication in the Federal Register of the notice announcing the availability of the draft 
guidance.  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.  Submit electronic comments to http://www.regulations.gov.  All comments should be 
identified with the docket number listed in the notice of availability that publishes in the Federal 
Register. 
For questions regarding this draft document contact the Center for Food Safety and Applied 
Nutrition (CFSAN) at 301-436-1500 or the Center for Veterinary Medicine (CVM) at 240-276-
9200 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition (CFSAN) 
Center for Veterinary Medicine (CVM) 
Office of Regulatory Affairs (ORA) 
May 2010          
Table of Contents 
 
 
 I.     Introduction 
 
II.     Background 
 
III.    Questions and Answers 
 
A.  Reportable Food Electronic Portal 
B.  Effective Date and Enforcement 
C.  Responsible Party 
D.  Reportable Food 
E.  Submitting a Reportable Food Report 
F.  Data for Initial Report 
G. Submitting an Amended Reportable Food Report 
H. Supply Chain Information 
I.  Notifications 
J.  Additional Contacts 
K. Recordkeeping and Documentation 
L.  Animal Feed or Food Diversion 
M. Federal, State, and Local Public Health Officials 
N.  Foreign Facility Information 
 
  2         
Contains Nonbinding Recommendations 
 
 
1
Draft Guidance for Industry  
Questions and Answers Regarding the Reportable Food Registry as 
Established by the Food and Drug Administration Amendments Act 
of 2007 (Edition 2)  
 
 
This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's) 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 such 
approach satisfies the requirements of the applicable statutes and regulations. If you wish 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 document represents a draft of the second edition of guidance intended to assist those 
parties responsible for complying with the Reportable Food Registry requirements prescribed by 
the Food and Drug Administration Amendments Act of 2007 (Pub. L.110-085).  As required by 
section 1005(f) of this law, in September 2009, FDA issued guidance to industry about 
submitting reports of instances of reportable food through the electronic portal and providing 
notifications to other persons in the supply chain of such articles of food.  When finalized, this 
second edition of that guidance document will provide further guidance to industry on those 
topics and in addition will address inquiries that the agency has received through its Reportable 
Food Registry help desk and/or by other means since the implementation of the Reportable Food 
Registry on September 8, 2009.   New questions and answers are identified with the date that 
they were added to the guidance.  Questions and answers identified as amended have been 
changed since their appearance in the earlier version of the guidance in order to improve the 
guidances clarity.  Questions and answers that have been altered only in non-substantive ways 
(e.g., by adding citations or making grammatical changes) are not marked as amended.  To 
facilitate adding new questions and answers to future editions of this guidance without requiring 
every question and answer to be re-numbered, we have changed the numbering system in this 
                                                 
1 This draft guidance has been prepared by the Office of Food Defense, Communication and Emergency Response 
in the Center for Food Safety and Applied Nutrition, in cooperation with the Center for Veterinary Medicine, the 
Office of Regulatory Affairs, the Office of Information Management and the Office of Emergency Operations at the 
U.S. Food and Drug Administration.   
  3  
 
edition from previous editions and therefore the questions and answers in this edition are not 
numbered the same as in previous editions.     
 
 
FDA's guidance documents, including this draft 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 
 
On September 27, 2007, the President signed into law the Food and Drug Administration 
Amendments Act of 2007 (FDAAA).  This law amends the Federal Food, Drug, and Cosmetic 
Act (FD&C Act) by creating a new section 417, Reportable Food Registry.  Section 417 requires 
the Secretary of Health and Human Services (the Secretary) to establish within the Food and 
Drug Administration (FDA) a Reportable Food Registry.  The congressionally-identified purpose 
of the Reportable Food Registry is to provide a reliable mechanism to track patterns of 
adulteration in food [which] would support efforts by the Food and Drug Administration to target 
limited inspection resources to protect the public health (Pub. L. 110-085, section 1005(a)(4)).  
The Secretary has delegated to the Commissioner of Food and Drugs the responsibility for 
administering the FD&C Act, including section 417.  To further the development of the 
Reportable Food Registry, section 417 of the FD&C Act requires FDA to establish an electronic 
portal by which instances of reportable food must be submitted to FDA by responsible parties 
and may be submitted by public health officials.  After receipt of reports through the electronic 
portal, FDA is required to review and assess the information submitted for purposes of 
identifying reportable food, submitting entries to the Reportable Food Registry, issuing an alert 
or notification as FDA deems necessary, and exercising other existing food safety authorities 
under this Act to protect the public health.        
 
This guidance document contains questions and answers relating to the requirements under 
section 417 of the FD&C Act, including (1) how, when, and where to submit reports to FDA; (2) 
who is required to submit reports to FDA; (3) what is required to be submitted to FDA; and (4) 
what may be required when providing notifications to other persons in the supply chain of an 
article of food.    
 
III.  Questions and Answers 
 
A.  Reportable Food Electronic Portal 
 
A.1  [Amended May 2010] How will FDA implement the FDAAA requirement to 
establish an electronic portal? 
 
The Reportable Food electronic portal was initially implemented as an FDA 
electronic system for collecting, submitting and processing reportable food 
  2  
 
reports.  As of May 24, 2010, the Reportable Food electronic portal will be a 
part of the FDA-National Institutes of Health (NIH) Safety Reporting Portal 
(Safety Reporting Portal).   The Safety Reporting Portal facilitates the 
process of reporting several categories of safety information to the FDA and 
the NIH, including safety information related to reportable foods, pet foods, 
animal drugs, and NIH gene replacement therapy centers. 
 
A.2  When did the Reportable Food electronic portal first become available? 
 
The Reportable Food electronic portal has been available on the FDA.GOV 
website since September 8, 2009.   
 
A.3  [Amended May 2010] Is the new Reportable Food electronic portal as 
described in this guidance the final version?  
 
This new version of the Reportable Food electronic portal is released as part 
of the launch of the larger Agency Safety Reporting Portal.  We anticipate this 
to be the final version, subject to minor adjustments and system 
enhancements. 
 
FDA intends that the Reportable Food electronic portal will stay consistent 
with current FDA Web policy, which currently includes supporting the most 
widely used versions of Internet Explorer and Firefox browsers.  
 
A.4  [Amended May 2010] How can I access the Reportable Food electronic 
portal?  
 
The Reportable Food electronic portal remains available through a link on the 
FDA.GOV web site home page (http:/www.fda.gov) under the heading 
Report a Problem.  Alternatively, as of May 24, 2010, you can access the 
Reportable Food electronic portal through the Safety Reporting Portal by 
entering the following URL into your browser: 
http://www.safetyreporting.hhs.gov.  Upon entering the site, select 
Reportable Food report and you will be directed to the appropriate portal.  
 
A.5  [Added May 2010] When I access the Reportable Food electronic portal 
through the Safety Reporting Portal, I am asked if I want to report as a guest 
or create an account.  What are the benefits of creating an account? 
 
The benefits of creating an account are as follows: 
  You can save time with data entry for initial reports, as the system pre-
populates fields with information (e.g., names, addresses, phone 
numbers, etc.) you provided when establishing the account.   
  You can save a report and finish it at a later time. 
  You can see a list of all of your submitted reports. 
By comparison, if you report as a guest: 
  3  
 
  Reports, or partial reports that you intend to complete later, cannot be 
saved. 
  Previous submissions to the Safety Reporting Portal will not be 
viewable. 
 
A.6  [Amended May 2010] Are there additional instructions on how to use the 
Reportable Food electronic portal? 
 
Yes.  Instructions for completing the Reportable Food electronic portal 
screens within the Safety Reporting Portal are attached as Appendix A to this 
guidance.  In the online version of this guidance, Appendix A will be updated 
as appropriate to reflect future changes to the instructions for completing the 
Reportable Food electronic portal screens.  The online version of this 
guidance will link to the most current version of Appendix A  The same 
information will be found at the link Instructions on every Reportable Food 
electronic portal screen.   
 
A.7  [Amended May 2010] Does the Reportable Food electronic portal allow 
electronic documents to be submitted in addition to the reportable food report? 
 
Yes. As either a guest user or a Safety Reporting Portal account holder, you 
will have an opportunity to submit documents as attachments to both initial 
and amended reports.     
 
A.8  [Amended May 2010] What file types may be submitted as attachments to the 
email you may send to FDA after completing the reportable food report? 
 
The following file types are supported:  
  .pdf - Portable document format.  
  .jpg, .jpeg - Image file formats.  
  .bmp - Bitmap image format. 
  .png - Portable Network Graphics (bitmap image format). 
  .gif - Graphics Interchange Format (bitmap image format). 
  .tif, .tiff - Tagged image file formats.  
  .rtf - Rich text format.  
  .txt - Text format.  
  .xls, .xlsx - Spreadsheet file formats.  
  .doc, .docx - Word processing document formats.  
  .wpd - Word processing document format. 
 
 
  4  
 
A.9  [Amended May 2010] What should I do if the Safety Reporting Portal is not 
operating? 
 
FDA intends to post an announcement on http://www.fda.gov as to how to 
submit a Reportable Food report in the event that the Safety Reporting Portal 
is not operating.  If http://www.fda.gov is not operating, FDA recommends 
that you contact the FDA district office serving your area.  If the FDA district 
office for your area is not listed in your local telephone directory under U.S. 
Government, call 1-888-SAFEFOOD (Monday-Friday, 8:00 AM to 4:00 PM, 
Eastern Standard Time) or 1-888-INFO-FDA.   
 
A.10  [Amended May 2010] How will future upgrades or enhancements of the 
Safety Reporting Portal or Reportable Food electronic portal screens within 
the Safety Reporting Portal be announced? 
 
FDA may announce major upgrades, new versions, or enhancements to the 
Safety Reporting Portal or the Reportable Food electronic portal screens 
within the Safety Reporting Portal in any or all of the following ways, 
depending on the circumstances: publishing a Federal Register notice, making 
web announcements on the Safety Reporting Portal web site, and/or issuing 
press releases or constituent updates. 
 
A.11  [Amended May 2010] Is the Reportable Food electronic portal available in 
other languages? 
 
No.  The Reportable Food electronic portal is only available in English. 
However, FDA intends to make its guidance documents regarding the 
Reportable Food Registry available on the Reportable Food Registry web 
page (http://www.fda.gov/reportablefoodregistry) in Spanish, French, Chinese 
and possibly additional languages as appropriate. 
 
A.12  [Added May 2010]  Is there a test portal or other training materials for the 
Reportable Food electronic portal for industry to use for testing or training 
purposes? 
 
FDA has not developed a test Reportable Food electronic portal.  However, 
instructions for completing a reportable food report and frequently asked 
technical questions are available at http://www.fda.gov/reportablefoodregistry.  
Interested persons may request a set of screen shots of the electronic portal by 
sending an email to RFRSupport@fda.hhs.gov. 
 
A.13  [Added May 2010]  May I submit a reportable food report and/or attachments 
to FDA in languages other than English? 
 
FDA recommends that you submit all reportable food report information and 
attachments in English whenever possible, except (where applicable) 
  5  
 
individuals names, the names of companies, the names of streets, and trade 
names.  If any part of the material you submit is in a foreign language, FDA 
recommends that you include an accurate and complete English translation.    
 
 
B.  Effective Date and Enforcement 
 
B.1  When must I comply with the requirements of the Reportable Food Registry 
(Section 417 of the FD&C Act)? 
 
Under section 1005(e) of FDAAA, the requirements of section 417(d) of the 
FD&C Act (21 U.S.C. 350f(d)) became effective on September 27, 2008, one 
year after FDAAA was signed into law.  Under section 107 of FDAAA, all 
other requirements related to the Reportable Food Registry became effective 
on October 1, 2007.  On May 27, 2008, FDA announced a delay in 
implementation of the Reportable Food Registry and acknowledged that the 
prohibited act provisions would not apply until FDA established the electronic 
portal to implement the Reportable Food Registry.   
 
On September 8, 2009, FDA implemented the Reportable Food Registry 
(Section 417 of the FD&C Act), and the prohibited act provisions of the 
FD&C Act related to the Registry became effective on that date (see section 
301(mm) of the FD&C Act (21 U.S.C. 331(mm))).  However, FDA 
announced its intention to consider exercising enforcement discretion for a 
period of 90 days, until December 8, 2009, in circumstances where FDA 
determined that a responsible party had made a reasonable effort to comply 
with the requirements of section 417 of the FD&C Act and had otherwise 
acted to protect public health.   
 
 
 
 
C.  Responsible Party 
 
C.1  Who is the responsible party that must submit a report regarding instances 
of reportable food to FDA through the Reportable Food electronic portal? 
 
The responsible party is the person who submits the registration under section 
415(a) of the FD&C Act (21 U.S.C. 350d) for a food facility that is required to 
register under section 415(a), at which such article of food is manufactured, 
processed, packed, or held.  Persons who are required to submit a facility 
registration under section 415 of the FD&C Act are the owner, operator, or 
agent in charge of a domestic or foreign facility engaged in manufacturing, 
processing, packing, or holding food for consumption in the United States.  
Person is defined in section 201(e) of the FD&C Act (21 U.S.C. 321(e)) as 
including individuals, partnerships, corporations and associations. 
  6  
 
 
(Sections 201(e) and 417(a)(1) of the FD&C Act). 
 
C.2  If the registration information submitted under section 415(a) of the FD&C 
Act is no longer correct, is a responsible party precluded from submitting a 
Reportable Food report through the portal? 
 
No.  Persons who are required to submit a facility registration under section 
415(a) of the FD&C Act are required to update and correct that information in 
a timely manner (Section 415(a)(2) of the FD&C Act).  However, a reportable 
food report may be submitted, and may be required, even if the responsible 
partys registration information needs to be updated.  FDA also encourages 
the individual submitting the reportable food report to provide his or her 
contact information in the reportable food report, especially if the registration 
information is out of date. 
 
(Section 415(a)(2) of the FD&C Act). 
 
C.3  Can an owner, operator, or agent in charge of a facility authorize an individual 
to report an instance of reportable food through the Reportable Food 
electronic portal on their behalf? 
 
Yes.  An owner, operator, or agent in charge of a facility may authorize an 
individual to report an instance of reportable food on their behalf through the 
Reportable Food electronic portal.  FDA notes that an owner, operator or 
agent in charge of a facility may authorize an individual to register their 
facility on their behalf (21 CFR 1.225(c)).  An individual who is authorized by 
the responsible party to submit a reportable food report need not be the same 
individual who is authorized to register a facility.  FDA also encourages the 
individual submitting the reportable food report to provide his or her contact 
information in the reportable food report, especially if the registration 
information does not include the individual reporters contact information. 
 
C.4  [Amended May 2010] Can an individual who did not submit the responsible 
partys initial report submit an amended report on behalf of the responsible 
party? 
 
Yes.  The method for doing this depends on whether the responsible party 
submitted their initial report as a Safety Reporting Portal Account Holder or 
as a guest user. 
   
For security purposes, the Safety Reporting Portal links a single individual to 
an account.  Therefore, if the individual (Party A) who submitted the initial 
report is a Safety Reporting Portal account holder, FDA recommends that the 
Safety Reporting Portal account holder amend the report submitted using 
his/her account.  If this is not possible, another individual (Party B) should 
  7  
 
submit an initial report, and indicate in the descriptive narrative text box 
located in the Problem Summary section (for providing a full account of 
the reportable food issue) that this is an amended report related to Party As 
initial report.  In the same text box, Party B should also include the ICSR 
number provided to Party A when Party A submitted his/her initial report. 
 
If the responsible party (Party A) submitted his/her initial report as a guest 
user they will have been provided a 16-digit Report Identification Key as part 
of the unique number he/she received upon submission of the initial report.  
This number is used to amend the guests submitted report.  Since in this 
situation, the initial report is not connected to an individual account, Party A 
should provide Party B with the Report Identification Key to amend the report 
on Party As behalf.  If this is not possible, Party B should submit an initial 
report, and indicate in the descriptive narrative text box located in the 
Problem Summary section (for providing a full account of the reportable 
food issue) that this is an amended report related to Party As initial report.  
In the same text box, Party B should also include the ICSR number provided 
to Party A when Party A submitted his/her initial report.   
 
Regardless of who submits the report, FDA encourages the submitter of the 
amended report to provide his or her contact information, especially if it was 
not included in the initial report. 
 
 
C.5  [Added May 2010]  If a responsible party has not registered as required under 
section 415(a) of the FD&C Act, what should the responsible party do before 
submitting a reportable food report within the 24-hour time limit? 
 
To submit a reportable food report, you will need the Food Facility 
Registration number for your facility (see section 417(e)(1) of the FD&C 
Act).  Information on how to register and obtain this number is available at:  
http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/Registr
ationofFoodFacilities/OnlineRegistration/default.htm 
 
 
D. Reportable Food 
 
 
D.1  What is a reportable food?   
 
A reportable food is an article of food (other than dietary supplements or 
infant formula) for which there is a reasonable probability that the use of, or 
exposure to, such article of food will cause serious adverse health 
consequences or death to humans or animals.   
 
(Sections 201(ff) and 417(a)(2) of the FD&C Act). 
 
  8  
 
D.2  [Amended May 2010] Does the term article of food include animal feed and 
pet food? 
 
Yes.  Animal feed and pet food are included in the definition of food in the 
FD&C Act (See Question D.3).  
 
(Sections 201(f) and 417(a)(2) of the FD&C Act). 
 
D.3  [Amended May 2010]  How is food defined in the FD&C Act? 
 
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.  Dietary supplements are not food for the purposes of the Reportable 
Food Registry (section 417 of the FD&C Act). 
 
(Sections 201(f) and 201(ff) of the FD&C Act).  
 
D.4  [Added May 2010]  Infant formula and dietary supplements are excluded from 
the requirements of the Reportable Food Registry.  Are there other reporting 
requirements for these foods? 
 
Yes.  Manufacturers, packers and/or distributors whose names appear on the 
label of a dietary supplement marketed in the United States must submit to 
FDA any report received of a serious adverse event associated with that 
dietary supplement when used in the United States, accompanied by a copy of 
the dietary supplements label, under section 761 of the FD&C Act (21 U.S.C. 
379aa-1).  Infant formula manufacturers must comply with notification 
requirements for violative infant formula as established in 21 CFR 107.240. 
 
More information about dietary supplement serious adverse event reporting is 
available at: 
http://www.fda.gov/Food/DietarySupplements/Alerts/ucm111110.htm 
 
More information about infant formula is available at: 
http://www.fda.gov/Food/FoodSafety/Product-
SpecificInformation/InfantFormula/default.htm 
 
D.5  Is a food that presents a Class I recall situation a reportable food? 
 
Yes.  FDA interprets the definition of reportable food to include those foods 
that would meet the definition of a Class I recall situation.  A Class I recall 
situation is one in which there is a reasonable probability that the use of, or 
exposure to, a violative product will cause serious adverse health 
consequences or death (21 CFR 7.3(m)(1)). 
 
(Section 417(a)(2) of the FD&C Act). 
  9  
 
 
D.6  What are some circumstances under which food might be reportable? 
 
The FDA Enforcement Report is published weekly by the Food and Drug 
Administration, Department of Health and Human Services. It contains 
information on actions taken in connection with agency regulatory activities, 
including recalls. The website lists recalls by classification, with Class I 
recalls at the top of the list. Contained within the information for each product 
is the reason for the Class I recall. This information may be helpful in 
providing examples of foods that FDA has considered to present a reasonable 
probability of serious adverse health consequences or death.  While these 
examples can be helpful in understanding the standard for reportable foods, 
they should not be used as a substitute for evaluating the facts of your 
particular situation in order to determine if a food is reportable.  These reports 
can be accessed via the following link: 
 
http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm 
 
Listed below are some examples of previous Class I recall situations: 
 
 
  Peanut butter contaminated with Salmonella.  
  Under-processed canned chili that contained Clostridium botulinum 
toxin.  
  Smoked salmon contaminated with Listeria monocytogenes (Lm).  
  Ice cream that did not declare peanut-derived ingredients but contained 
peanut butter as an ingredient.  
  Baby food that posed a choking hazard.  
  Horse feed contaminated with elevated levels of monensin. 
  Pet food contaminated with elevated levels of melamine and cyanuric 
acid. 
  Sheep feed containing elevated levels of copper. 
  Swine feed containing elevated levels of selenium.  
  
D.7  [Added May 2010] Can a human food containing an undeclared allergen be a 
reportable food? 
 
Yes.  A human food containing an undeclared major food allergen as defined 
in the Food Allergen Labeling and Consumer Protection Act (FALCPA) may 
be a reportable food as described above (Question D.6). This is the case 
regardless of how the major food allergen was incorporated into the human 
food.  More information on FALCPA and food allergen labeling can be found 
at: 
http://www.fda.gov/Food/LabelingNutrition/FoodAllergensLabeling/default.h
tm . 
 
  10  
 
D.8  Are products regulated exclusively by the USDA subject to the reportable 
food registry requirements? 
 
No.  Food that is within the exclusive jurisdiction of the U.S. Department of 
Agriculture (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.) is excluded from the 
requirements of the reportable food registry while that food is under the 
exclusive jurisdiction of USDA.   
 
D.9  [Amended May 2010] I received a confirmed positive microbiological test 
result indicating the presence of a pathogen in a food.  Based on this test 
result, I determined the food to be reportable.  However, I retested the food 
for the pathogen and the second test result did not indicate the presence of the 
pathogen in the food.  Should I still consider the food to be reportable?  
 
Yes.  There are a number of explanations why a food may test positive for a 
pathogen in one test and negative in one or more additional tests although the 
food continues to be contaminated.  For example, the distribution of a 
pathogen in the food may not be homogeneous.  Therefore, absent other 
circumstances clearly demonstrating the inaccuracy of the first test result, the 
first test result upon which the reportable food determination was made should 
be considered valid. 
 
D.10  [Added May 2010]  If a food facility enters into a contract with a farmer 
whereby the food facility agrees it will purchase the produce grown by that 
farmer when that produce is harvested, and the facility tests the produce in the 
field before it is harvested and determines that it meets the definition of a 
reportable food, must the food facility that contracted with the farmer submit a 
reportable food report?   
 
No, the food facility that contracted with the farmer and tested the produce in 
the field is not required to submit a reportable food report, provided that the 
facility did not manufacture, process, pack, or hold the produce and therefore 
never became a responsible party with respect to the produce.  However, if the 
field had been harvested and the contaminated produce had been moved to the 
food facility, the facility would have become a responsible party because it 
held the food and would be required to submit a reportable food report.  
Provided that the farm is not a facility required to register with FDA under 
section 415(a) of the FD&C Act, the farm is not a responsible party under 
section 417 and is not required to submit a report. 
 
(Section 417(a)(1) of the FD&C Act). 
 
D.11  [Added May 2010]  A domestic facility that is required to register with FDA 
under section 415(a) of the FD&C Act manufactures food for consumption in 
  11  
 
the United States and for export.  Is the facility required to submit a reportable 
food report to FDA if it determines that a food that it manufactured solely for 
export presents a reasonable probability that use of, or exposure to, the food 
will cause serious adverse health consequences or death to humans or 
animals? 
 
Yes.  If you are a responsible party, as discussed in Question C.1, and you 
determine that an article of food you manufactured, processed, packed, or held 
is a reportable food, you are required to submit a report through the 
Reportable Food electronic portal for such food even if it is intended solely 
for export, unless you qualify for the exemption from reporting in section 
417(d)(2) of the FD&C Act (see Question E.3).  A reportable food is an 
article of food (other than dietary supplements or infant formula) for which 
there is a reasonable probability that the use of, or exposure to, such article of 
food will cause serious adverse health consequences or death to humans or 
animals.  A responsible party, with respect to an article of food, is a person 
who submits the registration under section 415(a) of the FD&C Act for a food 
facility that is required to register under that section, at which such article of 
food is manufactured, processed, packed or held.  While food facilities are 
required to register under section 415(a) of the FD&C Act if they are engaged 
in manufacturing, processing, packing, or holding food for consumption in the 
United States, responsible parties reporting duties with respect to reportable 
foods under section 417 of the FD&C Act are not limited to food for 
consumption in the United States. 
 
(Sections 417(a) and 415(a) of the FD&C Act). 
 
 
E. Submitting a Reportable Food Report 
 
 
E.1  When is a responsible party required to report an instance of reportable food 
to FDA?   
 
A responsible party is required to submit a report to FDA through the 
Reportable Food electronic portal as soon as practicable, but in no case later 
than 24 hours after determining that an article of food is a reportable food. 
 
(Section 417(d)(1) of the FD&C Act).  
 
E.2  Is a responsible party required to investigate and report the cause of the 
adulteration?  
 
Yes, if the adulteration of the article of food may have originated with the 
responsible party, the responsible party is required to investigate the cause of 
the adulteration and report their findings when known. 
 
  12  
 
(Sections 417(d)(1)(B) and 417(e)(5) of the FD&C Act).   
 
E.3  When is a responsible party not required to submit a reportable food report to 
FDA for food that would otherwise be reportable? 
 
A responsible party is not required to submit a reportable food report when all 
of the following criteria are met: 
 
  The adulteration originated with the responsible party; AND 
  The responsible party detected the adulteration prior to any transfer to 
another person of such article of food; AND  
  The responsible party  
o  corrected such adulteration; or  
o  destroyed or caused the destruction of such article of food.   
 
(Section 417(d)(2)(A)-(C) of the FD&C Act). 
 
E.4  When does a transfer to another person occur under section 417(d)(2)(B) of 
the FD&C Act? 
 
A transfer to another person occurs when the responsible person releases the 
food to another person.  Person is defined in section 201(e) of the FD&C 
Act as including individuals, partnerships, corporations and associations.   
 
FDA does not consider an intra-company transfer in a vertically integrated 
company to be a transfer to another person, where the company maintains 
continuous possession of the article of food.  For example, if Company A 
owns a processing plant, warehouse facility, and distribution facility, the intra-
company transfer from the processing plant to the warehouse facility and/or 
the warehouse facility to the distribution facility would not be considered a 
transfer to another person. 
 
(Sections 417(d)(2)(B) and 201(e) of the FD&C Act). 
     
E.5  If a reportable food is shipped to a third-party warehouse, but the responsible 
party maintains ownership and direct control over distribution, must the 
responsible party submit the reportable food report?  
 
Yes.  Transfer to another person occurs when the responsible person releases 
the food to another person.  Person is defined in section 201(e) of the 
FD&C Act (21 U.S.C. 321(e)) as including individuals, partnerships, 
corporations and associations.  In this situation, the warehouse operator is a 
distinct legal person.  
 
(Sections 417(d)(2)(B) and 201(e) of the FD&C Act). 
 
  13  
 
E.6  When does the 24-hour reporting requirement start?  For example, if I conduct 
a test that, if positive, would trigger the reporting requirement, does the 24-
hour clock start when I receive a presumptive positive result, or when I 
confirm that positive result? 
 
A responsible party must submit a report to the Reportable Food electronic 
portal as soon as practicable, but in no case later than 24 hours after 
determining that an article of food is a reportable food.  Some test methods do 
not yield presumptive positive results with sufficient reliability to create a 
reasonable probability that the use of, or exposure to, the related article of 
food will cause serious adverse health consequences or death to humans or 
animals; however, in some cases a presumptive positive result could indicate 
such a reasonable probability.  In contrast, for a confirmed positive, a test 
method would be expected to be sufficiently reliable to trigger the reporting 
requirement.  Therefore, you must evaluate your particular circumstances to 
determine your reporting obligation.  FDA recommends that persons in the 
supply chain use a validated test method whenever possible; follow up any 
presumptive positive result with additional testing to obtain a final result; 
and take appropriate action to protect public health when confirmation of a 
presumptive positive test result is pending.  
 
 
E.7  [Amended May 2010]  If I receive a food from my supplier that I determine to 
be a reportable food and I contain the problem and do not ship any of the 
reportable food, am I required to submit a report? 
 
Yes.  A responsible party who determines that a food that it received is a 
reportable food must submit a report even if the responsible party has not 
transferred the food.  The exception in section 417(d)(2)(A)-(C) does not 
apply (see Question E.3).    
 
E.8  [Amended May 2010] Will a reportable food report be issued a number by 
FDA? 
 
Yes.  FDA will issue a unique number for that instance of reportable food to 
the person who submits the report.  For Safety Reporting Portal account 
holders, this unique number consists of the ICSR number.  For guest users, 
this unique number has two parts: the ICSR number and the 16-digit Report 
Identification Key. 
 
(Section 417(d)(4) of the FD&C Act). 
 
E.9  [Added May 2010  this Q&A was previously published by FDA on March 
19, 2010 in separate guidance entitled Guidance for Industry:  Submitting a 
Report for Multiple Facilities to the Reportable Food Electronic Portal as 
Established by the Food and Drug Administration Amendments Act of 
  14  
 
2007.]  My company determined that it has a reportable food and the food is 
located at more than one of our facilities.  Can my company submit one 
combined report that includes all of the information that would be submitted 
in separate reports from each facility?  
Yes, you may submit a combined report for a specific reportable food 
situation that involves more than one of your facilities, such as manufacturing 
and processing facilities, storage facilities, and/or distribution facilities. The 
owner, operator, or agent in charge of each facility may authorize an 
individual to submit a combined report on their behalf through the Reportable 
Food electronic portal, in lieu of each responsible party for each facility 
submitting a separate reportable food report for the specific reportable food. 
The combined report must include all of the required data elements. 
To complete the screens in the Reportable Food electronic portal, the 
authorized individual may provide the required information for only one of 
the facilities. The required information relating to all of the facilities, which 
may also include the facility for which the screens were completed, may be 
provided in a separate attachment in tabular or spreadsheet format, but should 
be provided in a manner that clearly associates each facility with the required 
information that is specific for that facility. 
  
The file types that are supported as attachments are identified in Question 
A.8.  
If using a tabular or spreadsheet format, FDA recommends that responsible 
parties use the following column headings, in the order listed, for the required 
(*) and optional information for each facility:  
Name of facility*  
Food facility registration number*  
Contact name  
Contact phone number  
Street address*  
City*  
State*  
Zip code* 
 
E.10  [Added May 2010]  Our manufacturing facility receives bulk trailer shipments 
of ingredients from our suppliers.  A truck driver brings a trailer full of bulk 
ingredients onto our property, drops off the trailer, and drives away.  
  15  
 
However, as company policy, we do not off-load the trailers that are delivered 
to our facility or take ownership of the food in the trailers until after we test a 
sample of the food and determine that the food is acceptable.  If we reject a 
shipment, i.e., return the food to the supplier, because the sample results 
indicate that the food is a reportable food, are we required to submit a 
reportable food report?  
 
Yes, provided that you are a facility required to register with FDA under 
section 415(a) of the FD&C Act, you must submit a report for the food you 
determined to be a reportable food, even though you returned the food to your 
supplier. FDA considers that your facility held the reportable food because 
the trailers were no longer in transit once they were dropped off on your 
property.  Thus, you are a responsible party with regard to the reportable food.  
Provided that the adulteration did not originate with you, you do not meet the 
criteria for the exemption from reporting in section 417(d)(2) (see Question 
E.3). 
   
(Sections 417(a)(1) and (d)(2)(B) of the FD&C Act). 
 
F.  Data for Initial Report 
 
F.1  [Amended May 2010] What are the data elements that a responsible party 
must include in an initial report to FDA? 
 
The following data elements must be included in an initial report:  
 
(1) The registration numbers of the responsible party under section 415(a)(3) 
of the FD&C Act;  
(2) The date on which the article of food was determined to be a reportable 
food; 
(3) A description of the article of food including the quantity or amount;  
(4) The extent and nature of the adulteration;  
(5) The results of any investigation of the cause of the adulteration if it may 
have originated with the responsible party, when known;  
(6) The disposition of the article of food, when known; and 
(7) The product information typically found on packaging including product 
codes, use-by dates, and the names of manufacturers, packers, or 
distributors sufficient to identify the article of food. 
 
In addition, upon submission of a report, a unique number as discussed in 
response to Question E.8 above will be issued through the Reportable Food 
electronic portal to the person submitting the report.  This unique number will 
be used by responsible parties for submitting amended reports and providing 
notifications. 
 
(Sections 417(d)(1)(A), 417(d)(4), and 417(e) of the FD&C Act). 
  16  
 
 
F.2  Will an initial report that does not include all of the data elements described in 
(1)-(7) in Question F.1 above be accepted by the Reportable Food electronic 
portal?  
 
Yes.  The Reportable Food Registry provisions recognize that the responsible 
party may not have sufficient information to include all seven data elements in 
its report within 24 hours of becoming aware of a reportable food (i.e., 
elements (5) and (6) above must be reported when known).  FDA has 
designed the Reportable Food electronic portal to accept initial reports with a 
subset of the required data elements.  If a required data element has not been 
provided or is incorrect, FDA recommends that the responsible party submit 
an amended report to FDA including the new or corrected information 
immediately. 
 
(Sections 417(d)(1)(A) and 417(e) of the FD&C Act). 
 
F.3  [Amended May 2010] Are required data elements clearly indicated in the 
Reportable Food electronic portal? 
 
Yes.  Required data elements for initial submissions are clearly indicated by 
asterisks (*) in the Reportable Food electronic portal.   
  
G.  Submitting an Amended Reportable Food Report 
 
G.1  [Amended May 2010] What may FDA require a responsible party to do 
following FDAs receipt of a report?  
 
After consultation with the responsible party, FDA may require the 
responsible party to perform, as soon as practicable, but in no case later than 
the time specified by FDA, one or more of the following actions:  
 
  Amend the report the responsible party submitted to FDA to include the 
contact information for the immediate previous source(s) and/or immediate 
subsequent recipient(s) of the article of food directly linked in the supply 
chain and notified by the responsible party;  
  Provide notification to the immediate previous source(s) and/or immediate 
subsequent recipient(s) of the article of food that includes some or all of the 
following data elements:   
(1) the date on which the article of food was determined to be a reportable 
food; 
(2) a description of the article of food including the quantity or amount;  
(3) the extent and nature of the adulteration;  
(4) the results of any investigation of the cause of the adulteration if it may 
have originated with the responsible party, if known;  
(5) the disposition of the article of food, when known;  
  17  
 
(6) the product information typically found on packaging including 
product codes, use-by dates, and the names of manufacturers, packers, 
or distributors sufficient to identify the article of food;   
(7) contact information for the responsible party;  
(8) the contact information for parties directly linked in the supply chain 
and notified by the responsible party;  
(9)  the unique report number issued through the Reportable Food 
electronic portal to the person submitting the report;  
(10) the actions that the recipient of the notification shall perform (i.e., 
submit a report to FDA, investigate the cause of the adulteration, 
and/or provide a notification to the recipients immediate previous 
source(s) and/or immediate subsequent recipient(s)), as may be 
specified by FDA; and 
(11) any other information FDA may require.  
 
(Sections 417(d)(6) and 417(e) of the FD&C Act). 
   
G.2  [Amended May 2010] Will a new unique number be assigned to amended 
reports?  
 
Yes.  Every submission (initial or amended report) receives a new unique 
number that is provided in the confirmation.   
 
(Section 417(d)(4) of the FD&C Act). 
 
G.3  [Amended May 2010] How do I amend a report after I have submitted it?  
 
As a Safety Reporting Portal Account Holder, log in into your account.  
Choose the report you want to amend from your list of submitted reports.  The 
most recent version of the report will load for you to amend.  Edit the report 
as appropriate and click submit.    
 
As a Guest User, enter as a guest again and then select the option Follow-up 
on a report previously submitted as a guest portal user. You will then need to 
enter the 16-digit Report Identification Key you received upon submitting the 
most recent version of the report.  The most recent version of the report will 
load for you to amend.  Edit the report as appropriate and click submit.  
Please note that Report Identification Keys are linked to report versions and 
only the most recent key will function. 
 
See also Question C.4. 
 
 
(Sections 417(d)(4), 417(d)(6)(A), and 417(d)(8) of the FD&C Act). 
 
G.4  What is the time frame for filing amended reports?  
  18  
 
 
After consultation with the responsible party, FDA may require the 
responsible party to amend the report.  FDA will specify the time frame for 
completing the amended report during or after the consultation.  In addition, if 
at any time a responsible party determines that a required data element has not 
been provided or is incorrect, FDA recommends that the responsible party 
submit an amended report to FDA including the new or corrected information 
immediately. 
 
(Sections 417(d)(1)(A), 417(d)(6), 417(d)(7), and 417(e) of the FD&C Act). 
 
 
H.  Supply Chain Information 
 
 
H.1  Will the Reportable Food electronic portal allow the submission of contact 
information for immediate previous source(s) and/or immediate subsequent 
recipient(s) of the article of food directly linked in the supply chain and 
notified by the responsible party as an attachment to a report, or will 
responsible parties need to directly enter each partys contact information into 
the portal? 
 
The portal will ask (if applicable) for information for at least one immediate 
previous source or immediate subsequent recipient.  We encourage reporters 
to enter all distribution information into the portal.  However, if you have a 
large volume of distribution information, you may provide it to FDA in an 
email attachment using one of the file types listed in Question A.8. 
 
H.2  Are restaurants, delicatessens, supermarkets, and retail outlets considered 
immediate subsequent recipients within the meaning of section 417 of the 
FD&C Act? 
 
Yes, if a restaurant, delicatessen, supermarket, or retail outlet is the entity that 
acquired the reportable food directly from the responsible party, FDA 
considers that entity to be an immediate subsequent recipient within the 
meaning of section 417 of the FD&C Act. 
 
(Sections 417(d)(6)(B)(i)-(ii), 417(d)(7)(C)(i)-(ii), and 417(e)(9) of the FD&C 
Act). 
     
  
I.  Notifications 
 
I.1  [Amended May 2010] If a responsible party (Party A) notifies the immediate 
previous source(s) and/or immediate subsequent recipient(s) of the article of 
food (Party B), as required by FDA, should Party B submit a report to FDA 
  19  
 
and provide a notification to Party Bs own immediate previous source(s) 
and/or immediate subsequent recipient(s)?  
 
Yes, if Party B meets the definition of a responsible party, Party B should 
submit  a report to FDA as soon as practicable, and within 24 hours after 
receiving the notification regarding the reportable food.  FDA may require 
Party B to submit a report to FDA as soon as practicable, but in no case later 
than a time specified by FDA, and/or to provide a notification to Party Bs 
own immediate previous source(s) and/or immediate subsequent recipient(s) 
of the reportable food.  See the response to Question I.5 for more information.  
 
(Sections 417(d)(6) and 417(d)(7) of the FD&C Act). 
 
I.2  [Amended May 2010] If a responsible party (Party A) submits a report to 
FDA as required by section 417(d)(1) of the FD&C Act and receives a 
notification from another responsible party (Party B) concerning the same 
article of food that was the subject of Party As report to FDA, does Party A 
have to submit an additional report to FDA or provide additional notifications 
to the immediate previous source(s) and/or immediate subsequent recipient of 
the article of food? 
 
No.  Party A does not have to submit an additional report to FDA or provide 
additional notifications to the immediate previous source(s) and/or immediate 
subsequent recipient(s) of the article of food. However, Party A is required to 
amend its report to FDA to include Party Bs contact information and the 
unique ICSR number issued to Party Bs report so that FDA can link the two 
reports in the Reportable Food Registry.  
 
(Section 417(d)(8) of the FD&C Act). 
 
I.3  [Amended May 2010]  If I receive allegations of product problems from 
sources such as consumer complaints and restaurant complaints, but not from 
a facility registered under section 415(a) of the FD&C Act, am I required to 
submit a report to the Reportable Food electronic portal? 
 
If you receive allegations of product problems from consumers, restaurants, or 
other sources, you should follow up on the allegations and investigate to the 
extent necessary to ensure that the foods comply with the requirements of the 
FD&C Act and other applicable laws. If you are a responsible party under 
section 417 and you determine that a food you manufactured, processed, 
packed or held is a reportable food, you must submit a reportable food report 
to FDA as soon as practicable, but in no case later than 24 hours after 
determining that the article of food is a reportable food.  Note that FDA 
considers that you have received a notification within the meaning of section 
417(d)(7) of the FD&C Act if a responsible party who is registered under 
section 415(a) and has previously filed a reportable food report contacts you 
  20  
 
and provides you with an FDA-issued ICSR number for linkage to previous 
report(s).   
 
(Sections 417(d)(1) and 417(d)(7) of the FD&C Act). 
 
I.4  [Amended May 2010] When FDA requires a responsible party to provide 
notifications, if there are multiple immediate previous sources or multiple 
immediate subsequent recipients of the reportable food, may FDA require the 
responsible party to provide notifications to all such parties? 
 
Yes.  When FDA requires a responsible party to provide notifications to its 
immediate previous sources and/or immediate subsequent recipients of a 
reportable food, such notifications may be required for all of the responsible 
partys immediate previous sources and/or immediate subsequent recipients of 
the reportable food. 
 
(Sections 417(d)(6)(B)(i)-(ii) and 417(d)(7)(C)(i)-(ii) of the FD&C Act). 
 
I.5  What activities may FDA require a responsible party that is the immediate 
previous source or immediate subsequent recipient of an article of food to 
perform after receiving a notification?  
 
FDA may require such a responsible party to perform, as soon as practicable, 
but in no case later than a time specified by FDA, one or more of the 
following actions: 
 
  Submit a report to FDA through the Reportable Food electronic portal 
that includes the data elements listed in the answer to question G.1 
above and any other information FDA deems necessary.  
  Investigate the cause of the adulteration, if the adulteration of the 
article of food may have originated with the responsible party. 
  Provide a notification to the immediate previous source(s) and/or 
immediate subsequent recipient(s) that includes the data elements 
listed in the answer to question G.1 above.  
 
(Section 417(d)(7)(A)-(C) of the FD&C Act). 
 
I.6  How do responsible parties provide a notification to the immediate previous 
source(s) and/or immediate subsequent recipient(s) of the article of food?  
 
Notification to the immediate previous source(s) and/or immediate subsequent 
recipient(s) of the article of food may be accomplished by electronic 
communication methods such as e-mail, fax or text messaging or by 
telegrams, mailgrams, or first class letters.  Notification may also be 
accomplished by telephone calls or other personal contacts but FDA 
  21  
 
recommends that such notifications also be confirmed in writing and/or 
documented in an appropriate manner. 
 
I.7  After consultation with the responsible party, what are some specific 
examples of information regarding the reportable food that FDA may require 
to be included in a notification to the immediate previous source(s) and/or 
immediate subsequent recipient(s)?  
 
  Product name, brand name, product description, UPC codes, lot 
number 
  Use-by or expiration date or other date-related information;  
  Product label for ease in identifying the product at retail/user level; 
  Nature of the problem and the potential health hazard; 
  The businesss contact details;  
  Quantity by lot, dates and amounts shipped or received;  
  Instructions on what to do with the product; 
  A description of the disposition of the product; 
  The unique report number (ICSR number) provided by FDA.   
 
(Sections 417(d)(6)(B) and 417(d)(7)(C) of the FD&C Act). 
 
I.8  Assume that I received notification from another responsible party (Party A), 
and then submitted a report to FDA through the Reportable Food electronic 
portal and received my own ICSR number.  When I provide notifications to 
my own suppliers and distributors, either voluntarily or after being directed to 
by FDA, which ICSR number would I include in my notifications  the ICSR 
number that I received as part of the notification from Party A, or the ICSR 
number that I received when I submitted my own reportable food report to 
FDA after I was notified by Party A? 
 
Under the circumstances described in your question, you should include in 
your notifications to your suppliers and distributors the ICSR number that was 
provided to you in the notification from Party A.  This ICSR number will 
allow FDA to link reportable food reports that are related to the initial report 
and the reportable food. 
 
 
I.9  [Added May 2010]  I was not able to obtain an ICSR number from the facility 
that notified me that a food I received was a reportable food.  An ICSR 
number is required to complete the report.  What should I do to submit the 
report without the number? 
 
If you received a notification from another responsible party, but that party 
did not provide the ICSR number and you can not contact that party to obtain 
the required ICSR number, you should enter up to eleven numeric zeroes (i.e., 
  22  
 
00000000000) in response to the question What is the FDA-issued ICSR 
number for this Reportable Food provided by the site that notified you? 
 
 
J.  Additional Contacts 
 
J.1  Should responsible parties call the FDA district office and notify state and 
local public health or regulatory officials if they determine that an article of 
food is a reportable food? 
 
Yes.  FDA encourages responsible parties to contact their FDA district office 
and state or local public health or regulatory officials as soon as possible if 
they determine that an article of food is a reportable food.  Calling the FDA 
district office and state or local health officials does not relieve the responsible 
party of the responsibility to submit an electronic report as soon as practicable 
but in no case later than 24 hours after determining that an article of food is a 
reportable food. 
 
(Section 417(d)(1) of the FD&C Act). 
 
J.2  Does calling the FDA district office and/or local or state public health officials 
about a reportable food relieve the responsible party of the responsibility to 
submit a report?  
 
No. Responsible parties are required to submit a report through the Reportable 
Food electronic portal to FDA as soon as practicable but in no case later than 
24 hours of determining that an article of food is a reportable food (Section 
417(d)(1)(A) of the FD&C Act).  Calling an FDA district office and/or a local 
or state public health official does not relieve the responsible party of this 
responsibility.  
 
J.3  If I have submitted my report within 24 hours, worked with the FDA district 
office on follow-up questions, or have provided documentation or additional 
information to the FDA district office, could I be required to submit an 
amended report?  
 
Yes.  After FDA consults with the responsible party, FDA may require the 
responsible party to amend its report to include the contact information for 
parties directly linked to the responsible party in the supply chain and notified 
of the reportable food by the responsible party.  
  
(Section 417(d)(6)(A) of the FD&C Act).  
 
K.  Recordkeeping and Documentation 
 
K.1  What are the recordkeeping requirements for responsible parties?  
  23  
 
 
The responsible party shall maintain records related to each report received, 
notification made, and report submitted to the FDA under section 417 of the 
FD&C Act for 2 years.   
 
(Section 417(g) of the FD&C Act). 
 
K.2  Can FDA examine or inspect my records related to reports received, 
notifications made, and/or reports submitted to FDA under section 417 of the 
FD&C Act? 
 
Yes.  FDA may request records related to each report received, notification 
made, and report submitted to the FDA under section 417 of the FD&C Act, 
and a responsible party shall permit inspection of such records as provided for 
in section 414 of the FD&C Act.   
 
(Sections 414 and 417(g) of the FD&C Act). 
 
K.3  Is a report to FDA or notification of instances of reportable food an admission 
that the food involved is adulterated or caused or contributed to a death, 
serious injury, or serious illness?   
 
No.  A report or notification of a reportable food shall not be considered an 
admission that the food involved is adulterated or caused or contributed to a 
death, serious injury, or serious illness.  Any report or notification of an 
instance of reportable food is considered a safety report under section 756 of 
the FD&C Act (21 U.S.C. 379v), Safety Report Disclaimers, and may be 
accompanied by a statement, which shall be part of any report that is released 
for public disclosure, that denies that the report or notification constitutes an 
admission that the product involved caused or contributed to a death, serious 
injury, or serious illness.   
 
(Sections 417(i) and 417(j) of the FD&C Act).  
 
K.4  Will the information collected in a reportable food report be available for 
public disclosure? 
 
Under section 417(h) of the FD&C Act, a record in the Reportable Food 
Registry is subject to a request under the Freedom of Information Act (FOIA) 
(5 U.S.C. 552), except that FDA registration numbers and information derived 
from such registrations are protected from disclosure to the extent that they 
would disclose the identity or location of a specific registered person, as 
provided by section 415(a)(4) of the FD&C Act.  In addition, certain 
information, including but not limited to trade secrets and confidential 
commercial or financial information, are protected from disclosure under 
  24  
 
FOIA under section 552(b) (5 U.S.C. 552(b)), and by part 20 of FDAs 
regulations (21 CFR part 20).       
 
(Sections 415(a)(4) and 417(h) of the FD&C Act). 
 
 
K.5  [Added May 2010] If FDA determines that food for which a reportable food 
report was submitted through the Reportable Food electronic portal does not 
meet the definition of a reportable food, will FDA purge the report from its 
records? 
 
After receipt of reports through the electronic portal, FDA is required to 
review and assess the information submitted for purposes of identifying 
reportable food and submitting entries to the Reportable Food Registry.  Any 
report submitted through the electronic portal that is later determined to not be 
a reportable food will be marked and annotated as such and therefore not 
entered into the Reportable Food Registry, but will still remain in FDAs 
records, subject to normal record retention requirements. 
 
 
L.  Animal Feed or Food Diversion 
 
L.1  [Amended May 2010] I am interested in diverting my reportable food to use 
in animal feed.  What has been FDAs position with respect to the use of 
adulterated food in animal feed?  
 
FDA has developed procedures for requests to divert human or animal food 
considered to be adulterated for its intended use to other animal feed use.  See 
also Questions L.2 and L.3.  
 
L.2  Where should I submit a request to divert human or animal food to animal 
feed? 
 
You should submit a request to divert human food or animal food to animal 
feed in writing to the FDA district office that is responsible for the geographic 
area in which the food is located.  A directory of FDA District Offices can be 
found at http://www.fda.gov/ICECI/Inspections/IOM/ucm124008.htm. 
 
L.3  Where can the procedures for submitting requests to FDA for human or 
animal food diversion to animal feed be located? 
 
Procedures for requesting diversion are outlined in the Agencys Compliance 
Policy Guide 7126.20, Diversion of Adulterated Food to Acceptable Animal 
Feed Use, and can be found on FDAs website at  
http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidance
Manual/ucm074694.htm. 
  25  
 
 
M. Federal, State and Local Public Health Officials 
 
M.1  [Amended May 2010]  May Federal, state, and local public health officials 
submit instances of reportable food to FDA? 
   
Federal, state and local public health officials may submit voluntary reports 
regarding instances of reportable food that are identified through their 
regulatory or public health food safety activities to FDA through the 
Reportable Food electronic portal. Reports that may be submitted by federal, 
state or local public health officials do not satisfy a responsible partys duty to 
report instances of reportable food to FDA.  
 
(Section 417(b)(1)(A) of the FD&C Act). 
 
M.2  If a federal, state or local public health official identifies a reportable food as 
part of inspection or regulatory activities, can the public health official inform 
the facility that they may be required to submit a report? 
 
Yes.  The public health official may inform the facility they may be required 
to submit a report. 
 
M.3  [Added May 2010]  Should consumers submit reports to the Reportable Food 
electronic portal?  
  
No.  FDA has established other systems for receiving and responding to 
consumer emergencies, complaints, questions, and concerns about FDA-
regulated foods.  In emergencies, consumers should call FDA at 301-443-
1240, which is staffed 24 hours a day, every day.  For less urgent situations, 
consumers can call the FDA consumer complaint coordinator for their area.  A 
list of consumer complaint coordinators is posted at 
http://www.fda.gov/Safety/ReportaProblem/ConsumerComplaintCoordinators
/default.htm.  Consumers may also submit reports of pet food (including pet 
treats and chews) complaints to the Pet Food Report electronic portal in the 
Safety Reporting Portal.  In addition, consumers can address questions and 
concerns about FDA regulated foods to 1-888-SAFEFOOD (1-888-723-3366) 
or consumer@fda.gov. 
. 
 
N.  [Added May 2010] Foreign Facility Information 
 
N.1  [Added May 2010]  Do the requirements of the Reportable Food Registry 
apply to foreign human food/animal food producers? 
 
  26  
 
Any foreign food facility that manufactures, processes, packs, or holds food 
for human or animal consumption2 in the United States is required to register 
under section 415(a) of the FD&C Act, unless food from the facility 
undergoes further manufacturing/processing (including packing) by another 
facility outside the United States, unless such subsequent activity is of a de 
minimis nature (Section 415(b)(3) of the FD&C Act [21 U.S.C. 350d(b)(3)] 
and 21 CFR 1.226(a)).  A foreign facility that is required to register under 
section 415(a) of the FD&C act can be a responsible party who is required to 
report via the Reportable Food electronic portal (http://rfr.fda.gov) within 24 
hours of determining that there is a reasonable probability that the use of, or 
exposure to, an article of food that the facility manufactured, packed, 
processed, or held will cause serious adverse health consequences or death to 
humans or animals under section 417 of the FD&C Act. 
 
(Sections 415(a), 415(b)(3), and 417(a)(1) of the FD&C Act.) 
 
N.2  [Added May 2010]  Does FDA work with foreign governments when it 
receives a reportable food report about an imported or exported food? 
 
Yes. FDA works with foreign governments, as needed, to address reportable 
food reports using existing procedures.  FDA reviews and assesses the 
information submitted in a reportable food report, issues an alert or 
notification as necessary, and cooperates with other existing food safety 
authorities to protect public health.  
 
N.3  [Added May 2010]  Can an owner, operator, or agent in charge of a foreign 
facility that is required to register under Section 415(a) of the FD&C Act 
authorize an individual to report an instance of reportable food through the 
Reportable Food electronic portal on their behalf? 
 
Yes.  See Question C.3. 
 
N.4  [Added May 2010]  May a foreign public health official submit a reportable 
food report?   
 
If a foreign public health official acquires information on a reportable food, 
that official may submit a voluntary report to the reportable food electronic 
portal.  Section 417(d)(3) provides that Federal, state, or local public health 
officials may submit voluntary reports to the reportable food registry.  FDA 
considers that foreign public health officials may also wish to voluntarily 
provide such information to FDA, and FDA will accept such reports through 
the reportable food electronic portal.  Reports that are submitted by foreign 
government officials do not satisfy a responsible partys duty to report 
                                                 
2 All food and food products, including animal feed and pet food under FDAs jurisdiction, are required to be 
reported if they meet the definition of a reportable food.  See Questions D.1 and D.2 for more information on 
reportable food. 
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instances of reportable food to FDA.  FDA encourages these officials to 
follow their report by informing the responsible party that it may be required 
to submit its own report.  
 
 
N.5  [Added May 2010]  Does a foreign facility that is required to register under 
Section 415(a) of the FD&C Act and that exports human food/animal food to 
the United States as well as to other countries need to submit a reportable food 
report if the reportable food is shipped elsewhere, but not to the United States? 
 
No, the foreign facility is not required to submit a reportable food report but 
the FDA encourages the facility to notify the recipient of the food and take 
appropriate action.   
 
 
N.6  [Added May 2010]  If a foreign facility that is required to register under 
section 415(a) of the FD&C Act received food produced in the United States 
that is a reportable food, is the foreign facility required to report? 
 
Yes.  If the foreign facility receiving the reportable food is a responsible party 
with respect to the food as defined in 417(a)(1) of the FD&C Act, and 
determines that the food is reportable, the foreign facility must submit a 
reportable food report within 24 hours after determining that the food is 
reportable.   
 
 
N.7  [Added May 2010]  A foreign facility that is required to register under Section 
415(a) of the FD&C Act and that exported human food/animal food to the 
United States subsequently determines that the food it exported is a reportable 
food.  If FDA requires submission of information regarding the immediate 
subsequent recipients of the food, must the facility submit information about 
non-U.S. recipients of the food? 
 
No.  FDA may require the foreign facility to identify the U.S. recipients of the 
food.  However, FDA encourages the submitter to notify other recipients of 
the food and take appropriate action. 
 
 
 
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