Food Safety
search
cart
facebook twitter linkedin
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Food Safety
  • NEWS
    • Latest News
    • White Papers
  • PRODUCTS
  • TOPICS
    • Contamination Control
    • Food Types
    • Management
    • Process Control
    • Regulatory
    • Sanitation
    • Supply Chain
    • Testing and Analysis
  • PODCAST
  • EXCLUSIVES
    • Food Safety Five Newsreel
    • eBooks
    • FSM Distinguished Service Award
    • Interactive Product Spotlights
    • Videos
  • BUYER'S GUIDE
  • MORE
    • ENEWSLETTER >
      • Archive Issues
      • Subscribe to eNews
    • Store
    • Sponsor Insights
  • WEBINARS
  • FOOD SAFETY SUMMIT
  • EMAG
    • eMagazine
    • Archive Issues
    • Editorial Advisory Board
    • Contact
    • Advertise
  • SIGN UP!
ManagementRegulatoryBest PracticesFood DefenseRecall/Crisis ManagementFDAGuidelines

FDA Seeks Industry Input on How to Facilitate Consumer Notification of Adulterated Foods

August 5, 2014

The Food Safety Modernization Act (FSMA) is designed to shift the food safety paradigm from reacting to food safety problems after they occur to preventing them from occurring in the first place. Nevertheless, even with the implementation of thoughtful, sophisticated food safety prevention plans, it is inevitable that some food products that may cause foodborne illness will evade preventative protocols and enter the stream of commerce. A review of the U.S. Food and Drug Administration’s (FDA) website dedicated to food recalls proves that observation correct. In the past month alone, FDA has posted on its website notices for more than 14 food products that were recalled stemming from concerns about Salmonella and Listeria contamination, among other potential food safety-related harms.
 
FSMA requires changes to the Reportable Food Registry (RFR) that may transform the RFR into one of the first lines of consumer protection where a food product that may cause serious harm to consumers has reached the marketplace. As originally envisioned, the RFR was designed to identify and track unsafe foods within the food supply chain. Now, with the amendments required by FSMA, the RFR’s goal, in addition to tracking unsafe food within the supply chain, is to:

• Provide consumers with critical information about potentially contaminated foods in an effort to identify those products before consumption

• Notify consumers that they may have been exposed to an adulterated food

Given the speed with which a company must act where events trigger application of the RFR—within 24 hours of determining that it is a responsible party for a reportable food product—it is prudent for companies to prepare for notifying FDA of a reportable event by drafting and practicing a plan that sets forth detailed protocols the company will follow in case one of its food products triggers the obligation to file a report with the RFR.

But questions remain what precisely should be reported in order to make the RFR effective in protecting consumers? FDA wants your input. To that end, it has extended until August 18, 2014, the period for submitting comments on the proposed rulemaking entitled “Implementation of the Food and Drug Administration Food Safety Modernization Act (FSMA) Amendments to the Reportable Food Registry (RFR) Provisions of the Federal Food, Drug and Cosmetic Act.”

The RFR has been in effect since 2009, pre-dating FSMA. A responsible party must submit a report to FDA through the RFR electronic portal within 24 hours of learning that 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 (i.e., a similar standard for a Class I recall). That obligation is not limited to the manufacturer of the reportable food product. Rather, for purposes of the RFR, a “responsible person” is any food facility that must register with FDA that manufactures, processes, packs or holds food. The failure by a responsible party to report a reportable food even can result in criminal liability.

Among other obligations in addition to promptly reporting a reportable food, a responsible party must:

• Submit certain information regarding the reportable food, including the date on which the responsible party determined that the food should be reported, a description of the food and its quantity, and the nature and extent of its adulteration

• Investigate the root cause of the adulteration if the reportable food originated with the responsible party and report the findings when determined

• Maintain for at least 2 years records that relate to each report submitted to the RFR and allow FDA to inspect those records

• Provide notification to immediate suppliers and immediate customers of the reportable food

FDA encourages companies to engage in self-help in an effort to avoid report obligations. That is, a responsible party is not required to submit a reportable food report where:

• The adulteration originates with the responsible party

• The responsible party detects the adulteration prior to transfer of the food product to another party

• The responsible party corrects the adulteration or destroys the product

As indicated, FSMA mandates changes to the RFR that make it a more important tool to protect consumers. Under FSMA, FDA:

• May require a responsible party to submit “consumer-oriented information regarding a reportable food,” including a description of the food and the product identification codes for that product, contact information for the responsible party and other information that FDA determines is necessary to enable a consumer to identify whether she has the reportable food in her possession

• Must publish on its website a one-page summary of the consumer-oriented information that can be printed off for purposes of notifying consumers

Further, FSMA requires that within 24 hours of FDA’s publication of the one-page reportable food summary, a grocery store that sold the reportable food and that is part of a 15-or-more unit chain display the summary in a conspicuous location and manner for at least 14 days.

In its effort to better protect consumers, FDA seeks comment on several issues with respect to the FSMA-required amendments to the RFR, including:

• The scope of consumer-oriented information that is needed from a responsible party to facilitate consumer determination whether a reportable food is in the consumers’ possession

• Consumer preferences for receiving RFR information

• The types of stores that should be considered “grocery stores” for purposes of the RFR

• How grocery stores should be made aware of summaries that the FDA has posted on its website

• How grocery stores display summary notices

Food companies continue to have important opportunities to shape the very rules that will govern their operations, impact their success and, should their preventative plans fail, help them protect their consumers and, concomitantly, their brands. Information on the RFR, the FSMA- required amendments to the RFR, and the additional types of information sought by FDA in conjunction with enhancing the RFR can be found on FDA’s website.

John T. Shapiro is partner and member of the Food Industry Team at Freeborn & Peters LLP (Chicago).

 

>
Author(s): John T. Shapiro

Share This Story

Looking for a reprint of this article?
From high-res PDFs to custom plaques, order your copy today!

Recommended Content

JOIN TODAY
to unlock your recommendations.

Already have an account? Sign In

  • people holding baby chicks

    Serovar Differences Matter: Utility of Deep Serotyping in Broiler Production and Processing

    This article discusses the significance of Salmonella in...
    Contamination Control
    By: Nikki Shariat Ph.D.
  • woman washing hands

    Building a Culture of Hygiene in the Food Processing Plant

    Everyone entering a food processing facility needs to...
    Management
    By: Richard F. Stier, M.S.
  • graphical representation of earth over dirt

    Climate Change and Emerging Risks to Food Safety: Building Climate Resilience

    This article examines the multifaceted threats to food...
    Contamination Control
    By: Maria Cristina Tirado Ph.D., D.V.M. and Shamini Albert Raj M.A.
Manage My Account
  • eMagazine Subscription
  • Subscribe to eNewsletter
  • Manage My Preferences
  • Website Registration
  • Subscription Customer Service

More Videos

Sponsored Content

Sponsored Content is a special paid section where industry companies provide high quality, objective, non-commercial content around topics of interest to the Food Safety Magazine audience. All Sponsored Content is supplied by the advertising company and any opinions expressed in this article are those of the author and not necessarily reflect the views of Food Safety Magazine or its parent company, BNP Media. Interested in participating in our Sponsored Content section? Contact your local rep!

close
  • mold
    Sponsored byIFC

    Tackling Mold Remediation in Food Processing Plants

  • a worker in a food processing plant
    Sponsored byLPS® DETEX®

    How a Beverage Facility Improved Food Safety and Compliance with Detectable Packaging Solutions

  • Two men standing in a produce storage facility having a discussion.
    Sponsored byOrkin Commercial

    Staying Compliant With FSMA

Popular Stories

carton of dozen brown eggs

Salmonella Outbreak Linked to Eggs Ends With One Dead, 38 Hospitalized

close-up macaroni noodles with FDA logo overlay

FDA to Revoke 52 ‘Obsolete and Unnecessary’ Standards of Identity for Food Products

blue iced donuts next to pie of sugar with blue written in it

FDA Authorizes Use of Fourth ‘Natural’ Food Dye, Gardenia Blue

Events

July 22, 2025

Beyond the Binder: Digital Management of Food Safety

Live: July 22, 2025 at 3:00 pm EDT: During this webinar, attendees will learn best practices for the use of digital food safety management systems across industry and regulatory agencies.

August 7, 2025

Achieve Active Managerial Control of Major Risk Factors Using a Food Safety Management System

Live: August 7, 2025 at 2:00 pm EDT: From this webinar, attendees will learn about changes to the FDA Food Code, which now includes a requirement for FSMS. 

August 28, 2025

Strategies for Rodent Control in Distribution Facilities

Live: August 28, 2025 at 2:00 pm EDT: From this webinar, attendees will learn how to understand rodent behavior and innovative strategies for rodent management.

View All

Products

Global Food Safety Microbial Interventions and Molecular Advancements

Global Food Safety Microbial Interventions and Molecular Advancements

See More Products
Environmental Monitoring Excellence eBook

Related Articles

  • Jerky Treats Linked to Thousands of Pet Illnesses; FDA Solicits Consumer Input

    See More
  • Microphone in a conference room used for receiving public comment

    FDA Seeks Input on New Method for Ranking Chemicals in Food for Post-Market Assessments

    See More
  • cargo ship at sea

    FDA Seeks Feedback on Certification Program for Exported Human Foods

    See More

Related Products

See More Products
  • food-safety-making.jpg

    Food Safety: Making Foods Safe and Free From Pathogens

  • 9781498721776.jpg

    Handbook of Food Processing: Food Safety, Quality, and Manufacturing Processes

  • 1444333348.jpg

    Handbook of Food Safety Engineering

See More Products

Events

View AllSubmit An Event
  • December 12, 2024

    Cooking Instructions Validation: How to Ensure the Safety of Not-Ready-to-Eat Products

    On Demand: From this webinar, attendees will be able to identify the different requirements for ready-to-eat and not-ready-to-eat products.
View AllSubmit An Event

Related Directories

  • On Target Packaging

    On Target Packaging is a production/maintenance servicer for combination and check weighers. We do not sell or process food, but provide service/repairs, and equipment for the food industry
  • OneVision Corp.

    We develop, manufacture, sell and support can seam inspection and weighing systems to food and beverage canners, can makers, and specialty manufacturers (oil filter, aerosol cans, composite cans). Founded in 1994, we've installed and support more than 350 can seam inspection systems around the world.
×

Never miss the latest news and trends driving the food safety industry

eNewsletter | Website | eMagazine

JOIN TODAY!
  • RESOURCES
    • Advertise
    • Contact Us
    • Directories
    • Store
    • Want More
  • SIGN UP TODAY
    • Create Account
    • eMagazine
    • eNewsletter
    • Customer Service
    • Manage Preferences
  • SERVICES
    • Marketing Services
    • Reprints
    • Market Research
    • List Rental
    • Survey/Respondent Access
  • STAY CONNECTED
    • LinkedIn
    • Facebook
    • Instagram
    • X (Twitter)
  • PRIVACY
    • PRIVACY POLICY
    • TERMS & CONDITIONS
    • DO NOT SELL MY PERSONAL INFORMATION
    • PRIVACY REQUEST
    • ACCESSIBILITY

Copyright ©2025. All Rights Reserved BNP Media.

Design, CMS, Hosting & Web Development :: ePublishing