Tag Archives: proposed rule

FDA

FDA Releases More Resources for Food Traceability Proposed Rule, Risk-Ranking Model for Food Tracing

By Food Safety Tech Staff
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FDA

Yesterday FDA released more resources to help stakeholders in understanding the FSMA Food Traceability proposed rule. The Risk-Ranking Model for Food Tracing is designed to help users learn more about the methods and criteria for scoring commodity-hazard pairs, along with the results of the scoring that are used to determine the foods included on the Food Traceability List [https://www.fda.gov/food/food-safety-modernization-act-fsma/food-traceability-list].

The agency also published a pre-recorded webinar about the proposed rule, featuring Frank Yiannas, deputy commissioner for food policy and response, and Angela Fields, a traceability expert with FDA’s Coordinated Outbreak Response and Evaluation Network.

Other resources include a flowchart to assist with determining who is subject to the rule and a glossary of key terms.

Checklist

2020 FSC Episode 4 Wrap: FDA: There’s a Strong Business and Public Health Case for Better Traceability

By Maria Fontanazza
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Checklist

One year ago the FDA held an at-capacity public meeting to discuss its latest initiative, the New Era of Smarter Food Safety. At the time, the agency was planning to release the blueprint for the New Era in the spring of 2020. In fact, the FDA was just days away from unveiling it when the COVID-19 pandemic hit in March. The blueprint was put aside and it was all hands on deck, as the agency worked with the food industry to ensure companies continued operating, as they were deemed a part of America’s critical infrastructure. From there, the agency navigated through uncharted waters with the food industry and its stakeholders. It signed an MOU with USDA in an effort to prevent disruptions at FDA-regulated food facilities and address shortages of PPE, disinfection and sanitation supplies. It announced that it would conduct remote inspections and extended the comment period for the Laboratory Accreditation Program Proposed Rule. It released a COVID-19 food safety checklist with OSHA to help guide companies through employee health, social distancing, and the operational issues that have entered into play as a result of the pandemic. Food companies and the supply chain were facing an enormous challenge.

“I always thought we had one of the best food systems in the world… by and large we have an amazing food system,” said Frank Yiannas deputy commissioner for food policy and response during last week’s keynote address at the 2020 Food Safety Consortium Virtual Conference Series. “We just experienced the biggest test on the food system in 100 years. Have we passed the test? I don’t think anyone would say we scored 100%… but by and large we passed the test.” Yiannas added that COVID-19 has exposed some strengths and weaknesses in the food system as well. He also emphasized a point that he has been driving home throughout the pandemic: “The virus that causes COVID-19 is not a virus that is transmitted by food. It is a respiratory virus and generally transmitted in very different ways.”

The FDA released the blueprint for the New Era of Smarter Food Safety, which incorporated some lessons learned from COVID-19, in July. Traceability is a big part of agency’s new era initiative, and the pandemic further put a spotlight on the need for better tracking and tracing in the food industry. And under FSMA, FDA is required to “establish a system that will enhance its ability to track and trace both domestic and imported foods”. In working to meet this requirement, FDA proposed the FSMA rule on food traceability last month.

Yiannas said the proposed rule has the potential to lay the foundation for meaningful harmonization and called aspects of the proposed rule game changing. It establishes two critical components that are the leading edge of food traceability: It defines critical tracking events (i.e., what are the types of events in the food system that required those events to be kept) and key data elements (i.e., the data elements that must be captured at those critical tracking events). “These two things are big ideas for traceability,” said Yiannas. “They will allow us to harmonize how traceability is to be done, allow us to scale and allow for greater interoperability.” The proposed rule also creates a traceability list that identifies foods based on a risk-ranking model for food tracing.

FDA is encouraging comments on the proposed rule and is holding three meetings (November 6, November 18 and December 2) to discuss the proposed traceability rule. “We are going to create the final rule together,” said Yiannas.

Follow this link to the 2020 Food Safety Consortium Virtual Conference Series, which provides access to 14 episodes of critical industry insights from leading subject matter experts! We look forward to your joining us virtually.

Food Safety Consortium

2020 FSC Episode 5 Preview: Food Labs

By Food Safety Tech Staff
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Food Safety Consortium

This week’s episode of the 2020 Food Safety Consortium Virtual Conference Series promises to be an insightful discussion on topics critical to food laboratories. The following are some highlights:

  • Developing Your Technology During a Pandemic/COVID Testing Food, with Douglas Marshall, Ph.D., Eurofins
  • Viral Landscape of Testing, with Vik Dutta, bioMérieux; Prasant Prusty, Pathogenia, Inc.; Efi Papafragkou, Ph.D., FDA; and Erin Crowley, Q Laboratories
  • The FSMA Proposed Rule on Laboratory Accreditation and the Impacts on Labs and Lab Data Users, with Douglas Leonard, ANAB
  • Tech Talk from PathogenDX

The event begins at 12 pm ET. Haven’t registered? Follow this link to the 2020 Food Safety Consortium Virtual Conference Series, which provides access to 14 episodes of critical industry insights from leading subject matter experts! We look forward to your joining us virtually.

Food Safety Consortium

2020 FSC Episode 4 Preview: FDA’s Frank Yiannas to Discuss Proposed FSMA Traceability Rule, Updates on New Era of Smarter Food Safety

By Food Safety Tech Staff
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Food Safety Consortium

This week’s keynote episode of the 2020 Food Safety Consortium Virtual Conference Series features more important conversations about COVID-19 and its impact on the food industry. The event will kick off with a special presentation by FDA’s Frank Yiannas. Highlights include:

  • FDA Keynote Address by Frank Yiannas, deputy commissioner for food policy and response
  • COVID-19 Lessons Learned Panel Discussion with Mitzi Baum, STOP Foodborne Illness; Stephanie Dragatsis, Feeding America; Carletta Ooten, Amazon; Spir Marinakis, Maple Leaf Foods; and Craig Wilson, Costco Wholesale
  • Rumor vs. Reality: How to Cope with the Trends of Food Safety During a Pandemic, with Ge Song, Benjamin L. England & Associates, LLC
  • Tech Talk by sponsor Rizepoint and program partner AOAC

We invite you to join us for another lively discussion. The event begins at 12 pm ET on October, 1. Haven’t registered? Follow this link to the 2020 Food Safety Consortium Virtual Conference Series, which provides access to 14 episodes of critical industry insights from leading subject matter experts! We look forward to your joining us virtually.

Frank Yiannas, FDA, Rick Biros, Innovative Publishing, Food Safety Tech, Food Safety Consortium
Although there will be no physical handshaking this year, Frank Yiannas, deputy commission for food policy and response at FDA (left), will join Rick Biros, president of the Food Safety Consortium, for this year’s Virtual Conference Series on October 1. (Photo credit: amyBcreative)
FDA

FDA Proposes FSMA Rule on Food Traceability

By Food Safety Tech Staff
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FDA

Learn more about technology and discussions around food traceability during the 2020 Food Safety Consortium Virtual Conference SeriesKeeping in line with commitments made under FDA’s New Era of Smarter Food Safety, the FDA has announced a food traceability proposed rule to create more recordkeeping requirements for specific foods. The proposed rule, “Requirements for Additional Traceability Records for Certain Foods”, puts additional requirements on companies that manufacture, process, pack or hold foods on the Food Traceability List to establish and maintain records related to critical tracking events (i.e., growing, receiving, transforming, creating and shipping).

Foods on the proposed traceability list have been selected based on a risk-ranking model for food tracing and include:

  • Cheese
  • Shell eggs
  • Nut butter
  • Cucumbers
  • Herbs
  • Leafy greens
  • Melons
  • Peppers
  • Sprouts
  • Tomatoes
  • Tropical tree fruits
  • Fresh-cut fruits and vegetables
  • Finfish
  • Crusteaceans
  • Mollusks
  • Ready-to-eat deli salads

The requirements of the proposed rule pertain to the above-foods as a standalone product as well as when an ingredient in a product.

 

FDA Proposed Rule, Draft Guidance to Ensure Safe Imported Foods

By Food Safety Tech Staff
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The agency wants to establish a user fee program to facilitate audits.

About 15% of the U.S. food supply is imported. And within that figure nearly 80% of seafood, 50% of fresh fruit, and 20% of vegetables come from outside the United States, according to FDA. Under FSMA, the commitment to ensuring the safety of imported foods is a high priority. FDA is releasing a proposed rule, and a companion draft guidance document, to aid foreign entities in proving that they are meeting food safety import requirements.

The proposed rule, “User Fee Program to Provide for Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications”, is scheduled for publication Friday, July 24. FDA has named the following key groups that would be charged fees:

  • Accreditation bodies (ABs) submitting applications or renewal applications for recognition in the third-party accreditation program
  • Recognized ABs and accredited CBs that are participating in the third-party accreditation program and subject to FDA monitoring
  • Certification bodies (CBs) submitting applications or renewal applications for direct accreditation

In addition to naming those subject to the user fee, the proposed rule defines how the fees would be computed and collected, the agency’s public notification process, and what happens if those subject to the fee do not pay it (i.e., suspension of recognition).

In the draft guidance, “Third-Party Auditor/Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards”, FDA makes recommendations on third-party auditor/certification body qualifications.  If finalized, the document will remain a companion guidance to the final rule.