Hello.
My name is Nichole Nolan,
and I'm a policy analyst
in FDA's Office of Food Defense Communications
and Emergency Response.
I'm delighted to have this opportunity
to review FDA's Reportable Food Registry requirements with you today.
On September 27, 2007,
President George W. Bush signed into law
the Food and Drug Administration Amendments Act of 2007.
The law amended the Federal Food, Drug, and Cosmetic Act
by creating a new section, 417,
entitled "The Reportable Food Registry,"
which required FDA to establish an electronic portal
by which instances of reportable food may be submitted.
The congressionally identified purpose
of the Reportable Food Registry
is to provide a reliable mechanism to track patterns of adulteration in food
in order to support efforts by FDA
to target limited inspection resources to protect public health.
As of September 8, 2009, when the electronic portal opened,
industry is required to file a report through the portal
when there is a reasonable probability
that the use of or exposure to an article of food
will cause serious adverse health consequences or death
to humans or animals.
Once a report is submitted to FDA via the portal,
the system automatically provides the submitter
with an FDA-issued unique identification number.
What foods are covered by the Reportable Food Registry?
The RFR applies to all FDA-regulated products
except dietary supplements and infant formula
because they are subject to other sections
of the Federal Food, Drug, and Cosmetic Act.
Examples of FDA-regulated foods are beverages,
including bottled water and alcohol,
fruits and vegetables,
fish and seafood,
dairy products and shell eggs,
raw agricultural commodities for use as food,
canned and frozen foods,
bakery goods, snack foods, and candy,
and animal feeds and pet food.
I'd like to point out that the RFR
does not apply to products regulated exclusively by the USDA,
such as meat, poultry, and certain egg products.
Who is required to use the Reportable Food Registry?
Food facilities that manufacture, process, pack, or hold food
for animal or human consumption in the United States
are required to register with FDA
under section 415(a) of the Federal Food, Drug, and Cosmetic Act,
which I will refer to for the remainder of this presentation
as "the Act."
All registered food facilities
except those producing dietary supplements or infant formula
are required to use the RFR
if they determine that they have a reportable food.
What exactly 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.
FDA interprets the definition of a reportable food
to include those foods that would meet the definition
of a Class-I recall situation,
meaning that there is a reasonable probability
that the use of or exposure to a violative product
will cause serious adverse health consequences or death.
Examples of Class-I recall situations
are provided in FDA's RFR Guidance document.
There are two types of submissions.
Mandatory for industry
and voluntary for government public-health officials.
For mandatory submissions,
a responsible party must submit a report to FDA
regarding instances of reportable food.
A responsible party is defined
as the person who submits the registration information to FDA
for a food facility that manufactures, processes, packs, or holds food
for human or animal consumption in the United States
under section 415a of the Act.
Failure to comply is a prohibited act
under the Federal Food, Drug, and Cosmetic Act
and subject to penalties.
Government public-health officials
may voluntarily use the reportable food electronic portal
to report information
that may come in to them about reportable foods.
However, they should not file a report on any firm's behalf.
If a government public-health official identifies a reportable food
as part of inspection or regulatory activities,
he or she can inform the facility that the firm may be required
to submit a reportable food report.
The law required FDA to establish an electronic portal
to receive reportable food submissions
and to promptly review the information submitted.
An FDA risk-control review team was set up to do a prompt review
of every reportable food report submitted
in order to determine
whether the situation meets the definition of a reportable food.
Reportable food submissions meeting the definition
are entered into the registry.
In May 2010, the Department of Health and Human Services,
of which FDA is a component,
launched a new user-friendly electronic portal
called the Safety Reporting Portal.
The Safety Reporting Portal is a gateway for industry
to report not only reportable foods, but also adverse events
involving pet foods and pet treats, as well as animal drugs.
The safety reporting portal provides more user-friendly conveniences
that reporters to the RFR did not have
with the original Reportable Food Portal.
If a submitter establishes a free account,
there are several benefits.
Any new reports are pre-populated
with the submitter's contact information.
Amended reports are pre-populated
with all the information from the original submission.
Both completed and partial reports are saved to be consulted,
amended, or added to as necessary.
And submitters can see a list of all reports they have submitted
in the past.
If a responsible party chooses to report as a guest user,
the report cannot be saved
and any previous submissions cannot be viewed.
A reportable food must be reported no later than 24 hours
after a responsible party determines
that an article of food is a reportable food.
The report must be submitted through the electronic portal.
Information about a reportable food submitted to the FDA by other means
does not fulfill the RFR reporting requirements.
The responsible party must investigate
the cause of the adulteration
if the reportable food originated with the responsible party
and the responsible party must submit certain date elements
in the initial report
and provide supplemental reports
if additional information or corrections are needed.
Here is a very important point.
A responsible party is not required to report
if 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.
A transfer to another person occurs
when the responsible party releases the food to another person.
"Person" is defined in section 201(e) of the Act
as including individuals, partnerships, corporations,
and associations.
Currently, FDA does not consider an inter-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 inter-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.
After a responsible party submits a reportable food report
through the portal and consults with FDA,
the responsible party may be asked
to notify the immediate previous source
and immediate subsequent recipients of the article of food.
The responsible party must also maintain records
related to each report received,
notifications made,
and the reports submitted to FDA for two years.
The data elements required for the mandatory industry reports
include the FDA Food Facility Registration Number,
the date the food was determined to be reportable,
a description of the food, including quantity or amount,
the extent and nature of the adulteration,
results of the responsible party's investigation
of the cause of the adulteration,
and disposition of the article of food,
product information typically found on packaging
sufficient to identify the food,
and contact information for the responsible party,
in addition to the contact information
for the parties directly linked in the supply chain.
Information not immediately available for the initial report
can be supplied in supplemental reports.
In January 2011,
FDA published the first annual RFR report
that consisted of data from the portal's opening
on September 8, 2009, through September 7, 2010.
Now I would like to share some of the key findings with you.
Since the portal opened on September 8, 2009,
we have received both domestic and international reports,
and we have received three reports
from U.S. state public-health agencies.
We also received questions from industry via the RFR help desks.
There are two help desks established
to provide support to industry,
as well as to public health officials.
Questions on policy, procedure,
and interpretation
about the Reportable Food Registry
can be e-mailed
to RFRsupport@fda.hhs.gov.
IT technical
and computer-related questions
about the Reportable Food Registry
electronic portal
can be submitted to support.srp @jbsinternational.com.
Of the 2,240 RFR entries received in the RFR's first year of operation,
the 229 primary RFR entries included 201 concerning human food,
13 concerning pet food, and 15 concerning animal feed.
Undeclared allergens or intolerances
were the second most frequent reason.
16 reports, with nine being undeclared sulfites
in dried fruits and vegetables.
RFR-driven FDA activities
include the development of guidance in publications.
Because of reportable food submissions
involving Salmonella and nuts and nut products,
FDA intends to include an annex on nuts
in the guidance for industry currently under development
on Salmonella in low-moisture foods.
FDA is preparing a publication
explaining FDA's sulfite regulation and labeling requirements
as a result of reportable food data
concerning imported dried fruits and vegetables
containing undisclosed sulfites.
In two cases, reportable food submissions
triggered follow-up investigations by FDA,
resulting in two firms being placed on import alert.
FDA issued six import bulletins
to increase surveillance by FDA investigators at ports of entry
as a result of reportable food submissions.
As a result of the RFR data,
FDA issued four field assignments for increased inspection and sampling
of certain imported and domestic products.
The RFR has shown that it can help
prevent foods likely to cause illness
from reaching consumers
before outbreaks
or reactions to undeclared allergens
or intolerances occur
and can help expedite the removal
of foods likely to cause illness
from commerce.
Industry is increasingly detecting
contamination incidents
through their own testing.
Access to this information
through the RFR permits FDA
to verify appropriate corrective
measures have been taken.
These reports are revealing new
problems that industry can address
by implementing additional
preventative controls
in consultation with the FDA.
FDA will finalize the current draft RFR guidance
after reviewing comments from industry.
We are making international outreach a priority.
Currently, approximately 167,000 domestic
and 254,000 foreign facilities
that manufacture, process, pack, or hold food
for human and animal consumption in the United States
have registered with the FDA.
The requirement to submit reportable food reports applies to all of them.
This video is intended to help registered facilities
understand the reporting responsibilities to the RFR.
Printed copies of the "RFR at a Glance" one-page summary
are now available in English, Chinese, French, and Spanish,
and they can be ordered by the e-mail address provided on the screen.
All visiting international delegations will be given in an RFR presentation.
All RFR resources listed here,
including a link to the RFR electronic portal,
are available on FDA's website
at www.fda.gov/reportablefoodregistry.
I want to thank you for your interest in the Reportable Food Registry.
Working together, we can protect public health.