[AIB Update] Cover Story

A thorough understanding of this electronic portal designed to track food adulteration is essential for every food processing professional.
 

On September 8, 2009, the FDA launched an electronic portal called the Reportable Food Registry (RFR). The RFR was created and established as part of section 417 of the Federal Food, Drug and Cosmetic Act (FDCA) as part of the amendments included in the Food and Drug Administration Amendments Act (FDAAA) passed into law on September 27, 2007.

The passing of the act in 2007 included a requirement for the establishment of the electronic portal, known as the RFR, with the intent of enabling the FDA to track adulteration in the food industry more quickly and reliably and identify trends and patterns to better target its inspection resources to protect public health. So why the need for establishing this portal when most companies already partner with their local FDA offices and other government agencies when a recall situation occurs?

What triggered the need? Issues such as melamine in pet food products, the peanut butter recall and the microbiological issues that have been identified with produce prompted Congress to ask the FDA what legal obligations existed for FDA to be notified when issues were identified. Prior to the legislation passed in September 2007, there was no requirement to report recalls or recallable issues to the FDA. With the passing of the legislation and creation of the RFR, Congress enabled the FDA to have access to information to more effectively and efficiently identify issues with potential health hazards.

What is a reportable food? A reportable food is defined as "An article of food (other than dietary supplements or infant formula) for which there is a reasonable probability that the use or exposure to such articles of food will cause adverse health consequences or death to humans or animals." Dietary supplements and infant formulas are excluded from the RFR because they are regulated differently.

How do you determine what is a reportable food? Will the FDA provide guidance if you call them? The short answer is no, the FDA will not determine for you whether or not you should enter a product into the registry. The FDA expects each facility to use expert knowledge to determine whether or not a food meets this definition. This can be internally or externally provided. Some examples of situations where the food would be considered reportable include:

• Class I Recall: Any Class I recall by FDA definition would be "a situation 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." Examples include biological contamination of product with E. coli 0157:H7 or C. botulinum toxin. Any Class II recall meeting the definition must also be included in the RFR.

• Hard Particles: Examples include glass, metal, wood or hard plastic between 7 mm and 24 mm. The reporting facility will need to determine if this is an isolated or single issue (customer complaint) or if it is truly an adulteration of product (multiple customer complaints or investigation leads to discovery of an issue). This is where expert knowledge and evaluation of the situation will be the determining factors of a reportable food. Plant stems or other defects indigenous to a product are typically not considered a food safety issue.

• Labeling: The most common example of this is undeclared allergens—the Big 8 Allergens as identified by the FDA.

• Animal Feed: Examples of issues that would have to be reported include elevated heavy metals or melamine.

• Other Examples: Other examples include presumptive microbiological test results with sufficient reliability to indicate that there is an issue with the food, an initial positive microbiological test with a subsequent negative test, notification by a supplier, or identification of an issue at a receiving plant. The FDA has taken the stance that you cannot test your way out of a positive result. If the initial test of a food is positive for Salmonella, then that is the test of record for that food item.

What is the definition of food? The definition of a food is "articles used for food or drink for man or other animals (other than infant formula), chewing gum, and articles used for components of any such article." This also includes primary food contact packaging materials where the contamination of the food contact packaging material could lead to contamination and/or adulteration of the product contained within.

What has to be reported? Adulteration of a food must be reported any time that it has been transferred or released to another person. A person is defined as a company, individual, partnership, corporation or association. Transfer is defined as when the physical custody of the food is transferred, regardless of who owns or controls the food. If a food safety problem is detected after a company ships the product, even if the company still owns and controls the food and would be able to retrieve and destroy the product before it reaches the consumer, the FDA still considers this a transfer.

What does not need to be reported? Products that are regulated under other requirements or by different agencies are not reported into the RFR. This would include items such as infant formula, dietary supplements and products that are under USDA jurisdiction.

Hazardous food, as defined above, does not have to be reported to the RFR if:

• Adulteration originated with the responsible party AND

• Adulteration was detected prior to transfer to another person AND

• The responsible party corrected the adulteration, destroyed or caused destruction of the product. Disposal of the product into animal feed requires FDA approval.

All three elements must be met for this not to be considered a reportable food.

Who has to use the RFR? By FDA definition, all registered food facilities that manufacture, process, pack or hold food for human or animal consumption in the United States under section 415(a) of the FD&C Act (21 U.S.C 350d) are required to document a reportable food in the RFR. Plants in foreign countries must also report into the RFR if they are exporting into the U.S.

What is the role of the responsible party? The responsible party is the person, or designee, who submits the registration information to FDA for a facility that manufactures, processes, packs or holds food for human or animal consumption. The responsible party is required to:

• report as soon as practical, but no later than 24 hours after a responsible party determines that an article of food is reportable.

• submit the required data in the initial report.

• investigate the cause of the adulteration if the reportable food originated from the responsible party.

• amend reports as necessary.

• consult with the FDA and follow up as necessary.

• if consultation with the FDA so requires, notify the immediate or previous source or subsequent recipients of the reportable food.

• maintain records related to each report received, notification made, and report submitted to the FDA for a period of two years.

The FDA also has stated that it is the responsibility of the facility or the company to ensure that persons named as responsible are kept current along with all other information in the plant registration information.

Timeframe for Reporting: The timeframe for reporting is no later than 24 hours after the responsible party has determined the food is reportable. Notification can come in many forms.

What is Notification? Notification is simply how the responsible party received the information. The formats for notification recognized by the FDA are e-mail, fax, text message, First Class mail, a phone call or personal contact. For any non-paper or electronic format, it is critical to document the time that the notification was received and follow up in writing. The clock for the 24 hours begins when the notification is received. Part of the information that is required to be entered into the portal is when the responsible party became aware of the reportable food, so a time stamp or other time verification must be documented to prove this.

So what happens when a responsible party receives a call on Friday at 5:10 p.m. from their micro lab stating that they have a product that tested positive for L. monocytogenes? Is it okay if the responsible party does not report this until Monday when they are back in the office to check their voicemail? The answer is no. The FDA considers notification to be whenever the notification was received, not when the email or other electronic notification was opened. It does not matter if the responsible person is on vacation, off-site or otherwise unavailable. Therefore, when setting up the mechanism for receiving notifications, the facility must consider having a means of getting this information so that, if necessary, the report can be made within 24 hours of the notification.

Notification can also include that of one up or one down the supply chain.

What is the minimum information that needs to be entered in the portal? When a reportable food is identified, the responsible party is required to enter a minimum amount of information into the portal. It is imperative that the responsible party have the minimum information at the time of initial entry of the data. If you do not enter in the minimum required data, then you will currently not be able to save the report in the portal. If you do not save the report in the portal, then you will not have met the 24-hour deadline.

The portal contains the following six required sections:

• Introduction – Questions regarding the type of report being submitted

• Responsible Party Information – Questions related to the responsible party information and identity of the person submitting the report information.

• Location of the Reportable Food – Questions regarding the location of where the reportable food was first identified and contact information for the people who can provide additional information about this food.

• Problem Origination Site – Questions regarding the location of the suspected or known source of the problem. If this is multiple sites then each site has to enter its information into the RFR.

• Product Problem – Questions about the reportable food and the supply chain including four sub-elements.

Description of problem – A series of questions directed at how the problem was discovered and including the description of the problem.

Received Product Information – This is to be filled out if the product was a received product.

Distributed Product Information – This is filled out when the reportable food was a product that was distributed. This will also include a list of recipients that the food was distributed to. This could include multiple sites.

Product Information – If the food was manufactured at your site, there will be questions about where the reportable food was manufactured, processed, packed or held.

• Submit Report and Confirmation – This section allows you to review the information provided, includes instructions for attaching supplemental information, and the area where the Individual Case Safety Report (ICSR) number is assigned.

There are required fields indicated in each of the six sections. To provide enough information to satisfy the initial reporting requirements, these fields will have to be filled out to be able to generate the ICSR number that will tell you that you have successfully submitted the report.

The minimum information the responsible party must enter into the portal to satisfy the notification requirements is as follows:

• Plant Registration Number

• Date food was determined reportable

• Description of food, including quantity

• Extent or nature of adulteration

• Cause of adulteration

• Disposition of food, when known

• Product information found on the food

Product codes

Use by date

Name of manufacturer/packer

Name of distributor

• Distribution location(s) - One up or one down.

Again, a partial report is accepted as long as the required fields as noted in the form are filled out.

How will you know you were successful at entering and saving information into the portal and it has been received by FDA? After you have either completed the report, or provided at least the minimum required information, you will receive a confirmation page with an ICSR number. This is your official confirmation that the FDA has received your report. This can be printed and includes all the information you entered. The RFR form can be filled out online or downloaded and filled out offline. It may be a good idea to download this form and have it available as a template to ensure you gather the correct information to enter into the portal. The form is available only in English.

So what are the FDA’s responsibilities? The FDA is required to consult with the responsible party and follow up on the reportable food. This includes any communication or requests for amending the report and also notification one up or one down. The FDA will require the subsequent party (the one who was notified) to submit a report, investigate the cause and provide notification.

Who can see the information that I enter into the portal? The information entered into the portal is for FDA use only. It cannot be seen by other persons or companies entering information into the portal. Information from the portal can be requested through the Freedom of Information Act (FOIA). If this request is made, the information in the report will be reviewed to eliminate any proprietary information before it is released.

What are my recordkeeping and documentation requirements? All documentation provided as part of the RFR is required to be kept for two years. Documentation must be readily accessible in case the FDA has additional questions.

If I enter a reportable food into the portal, is it an admission of guilt? The simple answer to this question is no. This is considered to be a report of the food safety status of the product entered into the portal and not an admission of guilt.

So what authority does FDA have in enforcing this? Failure to enter reportable food into the portal within the 24 hour deadline can be prosecuted as a felony.

The RFR was designed to be a tool to allow the FDA to more readily identify food safety issues and patterns to better allocate its resources to protect the public health. It is imperative all in the food industry understand the RFR so that they can comply with and manage reporting of food safety issues to meet the new regulatory requirements. AIB

The author is Director, Product Development, for AIB International.