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Resources for You

Guide
pour l’industrie : Questions et réponses concernant le Registre de denrées
alimentaires à signaler (« Reportable Food Registry » (RFR)) tel qu’établi par
le « Food and Drug Administration Amendments Act » de 2007 (FDAAA) (2ème
édition)

Orientación
preliminar para la industria: Preguntas y respuestas sobre el Registro de
incidentes sanitarios en productos agroalimentarios, según lo establecido por
la Ley de Enmiendas de la Administración de Medicamentos y Alimentos (FDA) de
2007 (Edición 2)

行业指南草案：关于美国食品药品管理局2007年修正法案规定的应通报食品注册的问答
(第2版)

-

Draft Guidance for Industry: Questions and Answers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)

Contains Nonbinding Recommendations

Available in PDF.

Additional copies are available from:
Additional copies
from:
Office of Food Defense, Communication and Emergency Response,
HFS-005
Center for Food Safety and Applied Nutrition
Food and Drug
Administration
5100 Paint Branch Parkway
College Park, MD 20740
(Tel)
301-436-1500
http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/default.htm

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10.115(g)(5)), to ensure that the agency considers your comment on this draft
guidance before it begins work on the final version of the guidance, submit
written or electronic comments on the draft guidance within 60 days of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availability of the draft guidance.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

Introduction

Background

Questions
and Answers

Reportable
Food Electronic Portal

Effective
Date and Enforcement

Responsible
Party

Reportable
Food

Submitting
a Reportable Food Report

Data
for Initial Report

Submitting
an Amended Reportable Food Report

Supply
Chain Information

Notifications

Additional
Contacts

Recordkeeping
and Documentation

Animal
Feed or Food Diversion

Federal,
State, and Local Public Health Officials

Foreign
Facility Information

Contains Nonbinding Recommendations

Draft Guidance for Industry1
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 guidance’s 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 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
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:

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.

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/default.htm 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/default.htm 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/Food/FoodSafety/FoodSafetyPrograms/RFR/UCM2019388.htm)
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/Food/FoodSafety/FoodSafetyPrograms/RFR/UCM2019388.htm.
Interested persons may request a set of screen shots of the electronic portal by
sending an email to [email-masked].

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) 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.

(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 party’s 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 reporter’s contact information.

C.4 [Amended May 2010] Can an individual who did not submit the responsible
party’s 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 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 A’s 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 guest’s 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 A’s 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 A’s 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/RegistrationofFoodFacilities/
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).

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
supplement's 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/ucm2006741.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).

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/UCM2007297.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/ucm2006883.htm.

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 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.

(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

corrected such adulteration; or

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).

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 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. 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).

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 FDA’s 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;
(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 recipient’s 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?

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 party’s 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 and provide a notification to Party B’s 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 B’s 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 A’s 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 B’s contact information and the unique
ICSR number issued to Party B’s 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 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
party’s 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 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 business’s 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.,
“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?

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 FOIA under section
552(b) (5 U.S.C. 552(b)), and by part 20 of FDA’s 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 FDA’s
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 FDA’s 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 Agency’s Compliance
Policy Guide 7126.20, Diversion of Adulterated Food to Acceptable Animal Feed
Use, and can be found on FDA’s website at http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074694.htm.

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 party’s 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/ucm2008077.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 [email-masked].

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?

Any foreign food facility that manufactures, processes, packs, or holds food
for human or animal consumption 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 party’s duty to report
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.

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.

2.All food and food products, including animal feed and
pet food under FDA’s 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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