Organizations tell FDA they want it to continue its inspection mandate
Editor’s Note: Here is a letter signed by a coalition of organizations and sent to Janet Woodcock, MD, the FDA’s Acting Commissioner of Food and Drugs.
Dear Dr Woodcock,
The undersigned organizations, representing the food industry, consumers, and national and local food safety regulators, write to express our support for the FDA’s compliance with the National Inspection Frequency Mandates of the Food Safety Modernization Act ( FSMA) and to provide a collaborative approach to address the inspection challenges and opportunities outlined in your recent report “Roadmap to Resilience for FDA Inspection Oversight” (hereafter “Roadmap to FDA”). inspection ”).
This year marks the 10th anniversary of the promulgation of the FSMA. The regulatory framework is largely in place, but your Inspection Roadmap report reminds us that there is still a lot of work to be done to put in place a modernized inspection program – a program that makes the best use of all available resources. and responds to the law’s vision of risk-based prevention, overall accountability, and consumer confidence in the safety of the food supply. We propose that the FDA build on its inspection roadmap and New Era initiatives by leading a stakeholder engagement process to explore ways to meet the FSMA’s national inspection frequency mandates and better protect public health by modernizing inspections. The undersigned stakeholders specifically request a seat at the table to discuss inspection modernization with the FDA and how to make the most of state regulatory technology and resources.
the Association of Consumer Brands (Consumer Brands) champions the industry Americans depend on every day, representing more than 1,700 iconic brands. From household and personal care products to food and beverage products, the consumer packaged goods industry plays a vital role in fueling the U.S. economy, contributing $ 2 trillion to U.S. GDP and supporting more than 20 million American jobs. Consumer Brands advocates smart and consistent regulatory frameworks that are risk-based, based on the latest scientific knowledge, and that promote choice and build consumer confidence in the industries we represent. We also support modernized regulatory oversight approaches that ensure the production of safe products while facilitating the effective and efficient use of regulatory and industrial resources.
The Food Security Coalition (SFC) brings together consumer, public health and labor organizations to advocate for improvements to the food safety system. Coordinated by the Consumer Federation of America, the Coalition has played a central role in introducing changes to food inspection systems at the USDA and FDA since 1986.
The Association of Food and Drug Managers (AFDO) was established in 1896 as a forum for education, discussion, debate and problem solving between local, state and federal regulatory authorities. The organization’s historic motto “Uniformity through Cooperation and Communication” has fostered open debate, discussion, problem solving and consensus building. among state, local and federal regulatory programs. AFDO is currently engaged with the Food Protection Partnership, Seafood HACCP Alliance (SHA), Food Safety Preventive Controls Alliance (FSPCA), Produce Safety Alliance (PSA), and in collaborative efforts to advance the development of a nationally integrated food safety system, including assisting the FDA in fulfilling FSMA mandates.
We all adhere to the goals of reducing foodborne illness and building consumer confidence in the safety of the US food supply. We also share a deep and enduring commitment to the successful implementation of the FSMA, which provides the legal and regulatory framework to achieve these goals.
We understand how difficult COVID-19 has been for all FDA inspection activity, including FSMA mandated food safety inspections. We admire the dedication of FDA leadership and field staff to doing their best under very difficult circumstances. We also applaud the FDA’s innovative approaches to providing oversight of food facilities during the pandemic and the focus on modernizing inspection in the “New Era of Smarter Food Safety – The FDA Blueprint. for the future “.
We are concerned, however, with the FDA’s suggestion in the Inspection Roadmap document that Congress should review and possibly modify or repeal the FSMA’s inspection frequency mandate for national food facilities. We support a risk-based inspection strategy, but we see no conflict between such a strategy and the FSMA’s national inspection mandate, which establishes a benchmark frequency for inspecting national facilities and gives the FDA has broad discretion to prioritize inspections based on the agency’s risk assessment. Indeed, we see the inspection mandate as an essential part of managing the risk of foodborne illness and, for this reason, we oppose the weakening of this important provision of the FSMA.
In addition, FSMA frequencies are minimum inspection frequencies, not just targets and not caps. They should be treated as such. The ORA has steadily reduced the number of contract inspections with many states in recent years. We believe this is the wrong approach, as states provide additional inspection capabilities and can often perform inspections at lower cost. The FDA should take advantage of states that can perform equivalent FDA audited inspections and increase the FDA workforce in areas where states do not have the necessary capacity. It is important that government personnel are properly trained as a prerequisite for conducting inspections under FDA contracts and that the FDA provides oversight to ensure that consistent and quality inspections are conducted by them. state contractors. With better work planning and inventory coordination between the FDA and state agencies, the FDA and states can ensure that the FDA not only meets but exceeds the FSMA’s national inspection frequency mandates. To this end, the Food Protection Partnership’s vision, supported by the FDA, of “mutual dependence for a safer food supply” provides a strong framework for a truly integrated national food safety system.
In considering the modernization of inspection, it is important to remember that frequency mandates served as a cornerstone of the agreements that led to the promulgation of the FSMA. In addition to serving the goal of risk-based disease prevention, these mandates were intended to be a core part of the FDA’s responsibility to maintain an adequate inspection program and for the food industry to comply with new FSMA requirements. These warrants also provide assurance to consumers that there will be at least some direct oversight of facilities that produce and handle food. If the FDA does not have the resources to fulfill the FSMA’s national inspection frequency mandate, we urge the agency and administration to seek the necessary funds from Congress – a request we will strongly support.
As a first step towards a collaborative approach to modernizing food inspection, we urge the FDA to engage in dialogue with us and other stakeholders to improve understanding of the data and the analysis underlying the process. Roadmap inspection report. We recognize that changes may be warranted to the FSMA’s overseas inspection mandate, which previous administrations and Congress have not adequately funded, and which the FDA has never come close to fulfilling. . Like inspections of domestic food facilities, inspections abroad are important and should be more frequent than they are today. However, they are one of the many tools available to the FDA to verify foreign companies’ compliance with FSMA requirements.
In summary, the FDA’s food inspection program plays a critical role in protecting consumers from foodborne illness and supporting confidence in the food supply. We look forward to working with the FDA in a process of modernizing and supporting the program for future success. We encourage the FDA to engage with its stakeholders, including the signatories to this letter, as it considers inspection and compliance modernization going forward.
– Roberta Wagner of the Consumer Brands Association
– Thomas Gremillion from the Safe Foods Coalition
– Steven Mandernach Executive Director of the Association of Food and Drug Officials
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