Editor’s note: Following is a letter signed by a coalition of organizations and delivered to Janet Woodcock, M.D., FDA Acting Commissioner of Food and Drugs.
Dear Dr. Woodcock,
The undersigned organizations, representing the food industry, consumers, and state and local food safety regulators, write to express our support for FDA’s compliance with the Food Safety Modernization Act (FSMA) domestic inspection frequency mandates, and to suggest a collaborative approach to addressing the inspection challenges and opportunities outlined in your latest report”Resiliency Roadmap for FDA Inspectional Oversight” (hereafter”Inspection Roadmap”).
This season marks the 10th anniversary of FSMA’s enactment. The regulatory framework is largely in place, but your Inspection Roadmap report is a reminder that much work remains to reach a modernized inspection application — one that produces the best use of all available resources and meets the law’s vision of risk-based avoidance, thorough liability, and customer confidence in the security of the food supply. We suggest that FDA build on its Inspection Roadmap and New Era initiatives by directing a stakeholder participation process to explore ways to fulfill the domestic review frequency mandates in FSMA and better protect public health through modernizing inspections. The undersigned stakeholders specifically request a chair at the table to go over review modernization with FDA and how to most effectively leverage technology and state regulatory resources.
The Consumer Brands Association (Consumer Brands) champions the business whose products Americans depend on daily, representing over 1,700 iconic brands. From personal and household attention to food and drink products, the consumer-packaged goods sector plays a vital role in powering the U.S. economy, contributing $2 billion to the U.S. GDP, also encouraging more than 20 million American jobs. Consumer Brands advocates for smart, uniform regulatory frameworks which are risk-based, founded on the most current science and that promote choice and build consumer trust across the sectors we represent. We also encourage updated regulatory supervision approaches that guarantee the production of safe products while facilitating the efficient and effective utilization of both regulatory and business resources.
The Safe Food Coalition (SFC) brings together consumer, public health, and labor organizations to advocate for improvements to the food safety system. Coordinated by Consumer Federation of America, the Coalition has played a critical role in ushering in changes to the food inspection systems in USDA and FDA because 1986.
The Association of Food and Drug Officials (AFDO) was formed in 1896 as a forum for education, discussion, debate, and problem resolution among local, national and state regulatory officials. The organization’s historical motto”Uniformity through Cooperation and Communication,” has fostered open debate, discussion, problem-solving and consensus-building among state, federal and local regulatory programs. AFDO is currently engaged with the Partnership for Food Protection, Seafood HACCP Alliance (SHA), Food Safety Preventive Controls Alliance (FSPCA), Produce Safety Alliance (PSA), and also in collaborative efforts to progress development of a nationally integrated food safety system, including assisting FDA in fulfilling the mandates of FSMA.
We all embrace the aims of reducing foodborne disease and strengthening consumer confidence in the security of the American food supply. In addition, we discuss a deep and abiding commitment to the effective execution of FSMA, which offers the regulatory and legal framework for achieving these goals.
We understand how challenging COVID-19 has been for many of FDA’s inspection activities, including the FSMA-mandated food security inspections. We respect the dedication of FDA’s leadership and field staff to perform the best they could under very difficult conditions. We also applaud FDA’s innovative approaches to providing oversight of food facilities throughout the pandemic and also the focus on inspection modernization in”New Era of Smarter Food Safety — FDA’s Blueprint for the Future.”
We are concerned, however, by FDA’s proposal in the Inspection Roadmap document that Congress must revisit and possibly modify or repeal the FSMA inspection frequency mandate for domestic food facilities. We support using a risk-based review