FDA Pens Mutual Reliance Agreements with Four States

Last week, the U.S. Food and Drug Administration announced that California, Florida, Utah and Wisconsin have entered into domestic mutual reliance agreements with the agency. These Mutual Reliance agreements facilitate a coordinated effort between the FDA and individual states with goals to reduce human foodborne illness outbreaks, reduce duplication of regulatory oversight and increase public health protection by focusing on areas of higher risk.

“Foodborne illness outbreaks are largely preventable but can have devasting consequences for consumers,” said Erik Mettler, assistant commissioner for partnerships and policy in the FDA’s Office of Regulatory Affairs (ORA). “The FDA is committed to keeping Americans safe. As part of our commitment, we are using these partnerships to strengthen our relationship with our state regulatory partners and improve industry compliance with applicable food safety requirements to reduce foodborne illness outbreaks.”

These new mutual reliance agreements help the FDA to work in cooperation with the states of California, Florida, Utah and Wisconsin to rely on, coordinate with and leverage one another’s work, data and actions to achieve a safer national food supply. As envisioned in the FDA Food Safety Modernization Act (FSMA), the Partnership for Food Protection and the New Era of Smarter Food Safety blueprint, the mutual reliance agreements will enhance the existing relationships with states and government counterparts, moving the nation toward an Integrated Food Safety System.

“A strong, integrated system is essential to a safe food supply. Mutual reliance between the FDA and individual states is one example of the many actions the agency is taking to address our nation’s increasingly complex food production and distribution systems,” said Michael Rogers, assistant commissioner for the Office of Human and Animal Food Operations in the FDA’s ORA. “We expect that as more states sign mutual reliance agreements, it will help reduce redundancy and duplication of effort, optimize the impact of our collective oversight, and allow us to build on the long-standing relationships that we have with our state regulatory partners. This is truly a step forward towards achieving a seamless integrated food safety system between the federal and state regulators.”

The FDA will collaborate with partner states on data sharing, risk prioritization, inspections, outbreak investigations, development and monitoring of key metrics and laboratory capacity, among many other key focus areas. The domestic mutual reliance framework provides opportunities for the FDA and partners to jointly identify needs to better protect the public and leverage work from other regulatory programs. In addition, it will provide knowledge to build quality management systems and infrastructures to support national regulatory standards, including those related to resource allocation, training, outreach and information exchange.

FSMA was signed into law in 2011 and enables the FDA to focus on the prevention of foodborne illness rather than relying primarily on reacting to problems after they occur. The Act provides the FDA with authority to achieve higher rates of compliance with prevention and risk-based food safety standards. In addition, the FDA has the authority to better respond and contain food safety concerns when they do occur. 

Posted 10/11/21

FDA Assesses Impact of Whole Genome Sequencing Program

The U.S. Food and Drug Administration published a study on the effectiveness of the GenomeTrakr Whole Genome Sequencing (WGS) Network, a scientific tool that helps the FDA detect, investigate and limit the spread of foodborne illness outbreaks linked to FDA-regulated foods. The FDA estimates that the program was likely cost effective in its second year of implementation and at current funding levels, the program is generating $100 million to $450 million in net annual health benefits.

The results of the study also suggest that for each additional 1,000 WGS isolate sequences added to the database for a given pathogen, there is a reduction of approximately six illnesses per year associated with that pathogen. The program helped decrease foodborne illness in the U.S. within the first year after launch and the effect of the program on human health shows clear improvements over time, as the WGS database grows.

Read full article....

Webinar Announcement: Part 2 - Feeling Stuck: Learn How to Empower Yourself for Success!

In this AFDO webinar, Amanda Ferris takes us through the Habit Finder assessment and how to interpret your own assessment results.  The tool will help identify your unique blind spots and explore practical ways to relieve mental pressure and leverage your strengths. This will allow you to experience more fulfillment, joy, and achievement as healthier habits of thinking result in the success you deserve.

We will dive directly into your assessment results and where you are compared to other colleagues. For the best experience possible do these three things:

This Week 
Join the WAFDO Virtual Educational Conference

Registration is open for the WAFDO Virtual Conference scheduled for Tuesday and Wednesday, October 12-13.  This year’s conference reflects the ever-evolving food and medical device industries with topics that include:

• Guam’s initiative to educate youth through a food safety storybook
• Seal Oil Case Study -- examining use and regulation of this indigenous food of Alaska
• Belizean Artisanal Fisheries: international relations, food import considerations, and legislation abroad with local case study
• Overview of seafood safety supply chain and the FDA’s pre-arrival clearance process
• Food safety considerations pertaining to ethnic and novel foods in your community
• California case study on micro-enterprise home kitchens
• Efficacy of virtual inspections for retail food inspections
• Implementation of the Incident Command System in Environmental Health
• Cannabis industry update
• Clinical trial delays and the impact it has on marketing new pharmaceutical products
• Drug claims in personal care products
• How not to annoy reviewers during your FDA Drug Approval Process

Save the Date: NEHA-FDA RFFM
Grant Program Webinar October 13

AFDO Food Defect Resources Now Available 

 

• Association of Food & Drug Officials (AFDO)
• Feeding America
• Food Bank of the Rockies 
• The National Restaurant Association
• Central Texas Food Bank 

Spaces Still Available
Root Cause Analysis for Retail Food Safety Session Offered in December and January

AFDO Resource Survey Topic of Magazine Podcast

 

2021 FSPCA Annual Conference

OTED Offers Free Virtual Retail Food Training

Paster Training, Inc. 

• Preventive Controls for Human Food (PCHF), Full and Part 2
• Intentional Adulteration Vulnerability Assessment (IAVA)
• Foreign Supplier Verification Program (FSVP), Full and Part 2
• Current Good Manufacturing Practices (cGMPs)

• Certified Protection Food Manager (CPFM)
• Food Handler/Food Employee
• HACCP Manager
• HACCP Employee
• Food Defense
• SPANISH TRAINING AVAILABLE!!!!!

EAS Consulting Group Training 

The Food Safety Doctor LLC 

• Online: November 9, 2021 (Evening Session)

Laws and Regulations Committee Update

A collection of current food, drug, device, and consumer product regulatory issues and news