The US Government released a reorganization plan this past week, and among the items listed, was a proposal to reorganize food safety functions into one agency, The Federal Food Safety Agency, which would fall under USDA.
Easier said then done. Will it have an impact on overall safety of the food supply? Will savings of reducing duplication over time outweigh cost of reorganization?
Delivering Government Solutions in the 21st Century
Reform Plan and Reorganization Recommendations
https://www.whitehouse.gov/wp-content/uploads/2018/06/Government-Reform-and-Reorg-Plan.pdf
Reorganize Primary Federal Food Safety Functions into a Single Agency, the Federal Food Safety Agency
Departments of Agriculture and Health and Human Services
Summary of Proposal: This proposal would address the current fragmented Federal oversight of
food safety by reorganizing the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) and the food safety functions of the U.S. Department of Health and Human Services’ U.S. Food and Drug Administration (FDA) into a single agency within USDA. USDA demonstrates strong and effective leadership in food safety and maintains an expert understanding of food safety issues from the farm to the fork. This proposal would cover virtually all the foods Americans eat.
THE CHALLENGE
For more than forty years, the Government Accountability Office (GAO) has reported that the fragmented Federal oversight of food safety “has caused inconsistent oversight, ineffective coordination, and inefficient use of resources,1” and food safety has been on GAO’s list of high-risk areas since 2007. FSIS and FDA are the two primary agencies with major responsibilities for regulating food and the substances that may become part of food. FSIS is responsible for the safety of meat, poultry, processed egg products, and catfish, while FDA is responsible for all other foods, including seafood and shelled eggs.
There are many examples of how illogical our fragmented and sometimes duplicative food safety system can be. For example: while FSIS has regulatory responsibility for the safety of liquid eggs, FDA has regulatory responsibility for the safety of eggs while they are inside of their shells; FDA regulates cheese pizza, but if there is pepperoni on top, it falls under the jurisdiction of FSIS; FDA regulates closed-faced meat sandwiches, while FSIS regulates open-faced meat sandwiches.
To address this fragmented and illogical division of Federal oversight, FSIS and the food safety functions of the FDA would be consolidated into a single agency within USDA called the Federal Food Safety Agency.
GAO and other experts have recommended merging Federal food safety functions as a potential solution to this fragmentation. The National Research Council and the Institute of Medicine (now known as the Health and Medicine Division of the National Academies of Sciences, Engineering, and Medicine) have ecommended that the core Federal food safety responsibilities should reside in a single entity or agency, with a unified administrative structure, clear mandate, a dedicated budget, and full responsibility for the oversight of the entire U.S. food supply.
THE OPPORTUNITY
The new Federal Food Safety Agency would pursue a modern, science-based food safety regulatory
regime drawing on best practices of both USDA and HHS, with strong enforcement and recall mechanisms, expertise in risk assessment, and enforcement efforts across all food types based on scientifically supported practices. The Agency would serve as the central point for coordinating with State and local entities and food safety stakeholders, rationalizing and simplifying the Federal food safety regulatory regime. The reform would reduce duplication of inspection at some food processing facilities, improve outreach to consumers and industry, and achieve savings over time while ensuring robust and coordinated food safety oversight.
While the FDA and FSIS currently have very different regulatory regimes, consolidating FSIS and the food safety functions of FDA would allow for a better allocation of resources based on risk, better communication during illness outbreaks, and improved policy and program planning through development of a single strategic plan.
WHAT WE’RE PROPOSING AND WHY IT’S THE RIGHT THING TO DO
The irrational divisions of responsibility between FDA and FSIS have evolved since the early days of U.S. food regulation. The Congress created separate statutory frameworks, spurred in part by various food safety concerns and incidents of the day, originally to address the widespread marketing of intentionally adulterated foods and the unsafe and unsanitary conditions in meat packing plants in the early 1900s. Over the years, the Congress added new authorities to meet new challenges. Over time, the different legislative authorities that govern the two agencies have resulted in two distinct regulatory regimes, cultures, and approaches to addressing food safety. Thus, fully integrating FSIS and the food safety functions of FDA ould ultimately require a reconciliation of underlying legislative authorities and regulatory approaches.
Food Safety and Inspection Service Approach
FSIS is responsible for the safety of domestic and imported meat, poultry, processed eggs, and catfish. Meat and poultry undergo continuous (i.e., 100 percent) inspection during slaughter, and one or more Federal inspectors are on site during all hours that a slaughter plant is operating, and present for every shift in processing plants. FSIS is involved in many areas of food processing and food distribution: the inspection of domestic products, imports, and exports; conducting risk assessments; and educating the public about the importance of food safety. FSIS ensures the safety of imported products through a three-part equivalence process that includes an analysis of the country’s legal and regulatory structure, initial and periodic on-site audits to ensure equivalence with FSIS standards, and a continual point-of-entry e-inspection of products from the exporting country.
Food and Drug Administration Approach
FDA is responsible for the safety of all U.S. domestic and imported foods except meat, poultry, processed ggs, and catfish. FDA conducts inspections of most establishments that manufacture, process, pack, or old foods. FDA requires food importers to verify that their foreign suppliers have adequate preventive controls in place to ensure that the food they produce is safe, and FDA can refuse entry into the United States of food from a foreign facility if FDA is denied access by the facility or the country in which the facility is located. FDA also has a systems recognition program, which determines whether another country has comparable regulatory programs and public health outcomes to the United States. Systems recognition allows FDA to avoid duplication of effort while leveraging the high-quality work done by regulatory authorities in each country. Given the scope of FDA’s responsibilities, FDA inspects food establishments based on risk. As required by law, FDA must inspect 100 percent of high-risk domestic food facilities every three years. FDA physically inspects less than two percent of imported foods annually at the ports. Where FSIS and FDA statutory and/or regulatory regimes overlap, some establishments fall under the jurisdiction of both agencies.
Locating the Federal Food Safety Agency at USDA
USDA is well poised to house the Federal Food Safety Agency. USDA is a strong leader in food safety; has a thorough understanding of food safety risks and issues all along the farm to fork continuum; and many agencies within USDA focus on food safety.
The Agricultural Research Service (ARS) spends about $112 million on in-house food safety research, and ARS scientists work with both FSIS and FDA to help develop research priorities and food safety practices. In addition, many other programs at USDA have food safety elements, from helping to manage wildlife on farms, to monitoring animal health, to collecting pesticide residue data on fruits and vegetables. USDA also has established relationships between State departments of agriculture, local farms, and processing facilities, and is thus keenly aware of food safety issues at all levels.
Following the food reorganization, FDA (which would be renamed the “Federal Drug Administration”) would focus on drugs, devices, biologics, tobacco, dietary supplements, and cosmetics. \
The proposed consolidation would merge approximately 5,000 full-time equivalent (FTE) employees
and $1.3 billion from FDA with about 9,200 FTEs and $1 billion in resources in USDA. In the long term, the Administration expects this proposal would result in improvements in food safety outcomes, policy and program consistency, and more efficient use of taxpayer resources.
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