There is renewed interest in Washington behind the idea of creating a single federal agency responsible for overseeing all aspects of food safety. Such an agency would consolidate efforts currently performed by an inefficient patchwork of 16 separate federal government agencies, led by FDA and USDA’s Food Safety Inspection Service (FSIS), which together administer at least 30 different laws relating to food safety and specific food commodities.
Adding to the overall complexity, the federal system is supplemented by more than 3,000 states, localities, tribes, and territories, many of which have their own laws and agencies to inspect facilities and investigate and contain illness outbreaks.
The idea for a single agency appears to be gaining attention following a comprehensive recommendation published earlier this year by the Government Accountability Office (GAO), the investigative arm of Congress; an endorsement for action by several Senate Democrats; and a new study from Harvard University and the Vermont Law School that all urge creation of a national food strategy to address the nation’s fragmented and inefficient food safety system.
Proponents of consolidation hope that the Trump administration, with its stated interests in reducing burdensome government regulations and improving efficiency, will be receptive to the idea, even though the effort is likely to face bureaucratic road bumps and perhaps cost more money than may be saved, at least in the short term.
Not A New Idea
“None of this is new,” says David Acheson, MD, former associate FDA commissioner for foods and founder of The Acheson Group.
“For more than four decades, GAO has identified options for reducing this fragmentation as well as the overlap in food safety oversight, including establishing a single food safety agency, a food safety inspection agency, a data collection and risk analysis center, [and] a coordination mechanism led by a central chair,” Dr. Acheson explains.
In 2007, GAO added the federal oversight of food safety to its list of government areas “at high risk for fraud, waste, abuse, and mismanagement, or most in need of transformation.” In addition to GAO’s recommendations, consolidation proposals have surfaced over the years through congressional legislation, a White House government budget request, and reports issued by the National Academy of Sciences, among others.
Thus far, however, little action has been taken.
While the single agency concept makes theoretical sense, there has been a notable reluctance on the part of federal officials to do much about it. Resistance, in part, has been driven by bureaucratic infighting and a lack of agreement on what exactly should be done, and by whom. Perhaps recognizing this, the latest recommendations from GAO and the universities focus instead on developing a national strategy for food safety oversight, which in turn, could lead to a consensus on how to proceed. “Absent a single agency, having a national strategy makes a lot of sense,” Dr. Acheson adds.
The latest GAO report, “Food Safety: A National Strategy Is Needed to Address Fragmentation in
Federal Oversight,” released in January 2017, is perhaps the agency’s most comprehensive analysis on the topic to date. Drawing from previous reports, it offers the following three examples of the “highly complex” current regulatory system.
- FSIS oversees processed egg products, while FDA is responsible for eggs in their shells (shell eggs). USDA’s Agricultural Marketing Service sets the quality and grade standards for shell eggs (such as Grade A), but USDA’s Animal and Plant Health Inspection Service manages a program to ensure laying hens are free from Salmonella at birth. FDA, however, oversees the safety of the feed that hens eat.
- FSIS inspects manufacturers of packaged open-face meat or poultry sandwiches (those made with one slice of bread) while FDA inspects manufacturers of packaged closed-face meat or poultry sandwiches (those made with two slices of bread).
- FDA has primary responsibility for regulating manufactured frozen pizzas made with cheese, but FSIS has primary responsibility for those made with meat or pepperoni. Multiple other federal agencies play roles in regulating other components of both types of pizza.
“Such distinctions are not only burdensome for food manufacturers, but also fail consumer interest,” said four U.S. senators in a February 2017 letter to President Donald Trump, in support of the GAO recommendations. The senators, Kirsten Gillibrand (D-NY), Richard Durbin (D-IL), Dianne Feinstein (D-CA), and Richard Blumenthal (D-CT), have previously sponsored legislation to improve food safety. Now they urged Trump to quickly begin implementing the GAO’s recommendations, asking him to work with Congress “to request any additional statutory authority or budgetary consideration” that may be needed.
While FDA, FSIS, and the White House Office of Management and Budget (OMB) have taken some steps to address fragmentation and improve interagency food safety coordination, more needs to be done, GAO said. For example, OMB has not addressed an earlier recommendation to develop a government-wide plan for the federal food safety oversight system.
To provide the framework for creating such a government-wide plan, in June 2016 GAO convened 19 food safety and government performance experts from industry and academia for a two-day meeting to identify and recommend steps to improve the overall system. These recommendations include the following.
- Evaluate and allocate federal government resources on the basis of reducing the risk of foodborne illnesses. This strategy should integrate federal, tribal, state, and local resources to coordinate and take advantage of what’s already being done at other levels of government and by industry.
- Manage risks consistently across commodities. Under FSMA, the frequency and selection of FDA inspections are largely risk-based, but federal laws governing FSIS require inspectors to be present at all times during animal slaughter and part of the time during processing. Changing the laws to align USDA’s inspection model with FDA’s “could benefit industry by reducing the resources companies expend for regulatory compliance rather than for managing risk,” the experts said.
- Consider as a long-term goal the consolidation of all food safety functions into a single new government agency. But because this is not feasible in the near-term, the experts suggested consolidating food safety functions within their respective agencies. For example, food safety within the Department of Health and Human Services (HHS) could be consolidated within FDA, or alternatively, in a new agency separate from FDA but still within HHS.
- Align and coordinate federal support from the various federal agencies to the states; improve the food safety information infrastructure, including how data are collected and shared; improve risk communication with the public; and invest in training and professional development for food safety officials.
Based on the panel’s suggestions, GAO recommended that the Executive Office of the President, in consultation with other agencies and stakeholders, develops a defined national strategy, “establishes high-level sustained leadership, identifies resource requirements, monitors progress, and identifies short- and long-term actions to improve the food safety oversight system.”
Recommendations from Academia
In February 2017, the Center for Agriculture and Food Systems at the Vermont Law School and the Harvard Law School Food Law and Policy Clinic jointly released a 114-page “Blueprint for a National Food Strategy.” Similar to the GAO’s and other government studies, the report criticizes the “piecemeal policy and regulatory framework pertaining to food and agriculture,” noting that the U.S. food system “often works at cross-purposes, providing abundance while creating inefficiencies, and imposing unnecessary burdens on our economy, environment, and overall health.”
“Many federal policies, laws, and regulations guide and structure our food system,” states the report, which received funding from the W.K. Kellogg Foundation. “However these laws are fragmented and sometimes inconsistent, hindering food system improvements.” Like the GAO report, the Vermont/Harvard study is process-oriented, focusing on how rather than on what to do.
Unlike the GAO and other government reports, the academic study adopts a noticeably egalitarian quality by advocating for substantial public engagement and transparency. The following four principles would guide the creation of a national food strategy.
- Identify a lead office or agency within the federal government and give it sufficient resources and authority to compel engagement and action. An interagency working group would coordinate activities, and all efforts would include state, local, and tribal governments as key partners.
- Create an advisory council made up of members of the public and key stakeholders from outside the federal government. Their needs and interests must be obtained and incorporated into the strategy.
- Maintain transparency by providing information to the public on how laws and policies shape the food system; creating a written document that articulates goals and how they will be implemented and measured; and issuing regular progress reports.
- Ensure the strategy is durable by publishing periodic updates that reflect changing social, economic, scientific, and technological factors.
“Using these mechanisms to coordinate laws, policies, information, and perspectives related to the food system can serve to lay the framework for an effective and urgently needed comprehensive national food strategy that promotes the needs and interests of all Americans,” the report concludes.
Government Response to GAO
As is typical with these reports, GAO invited HHS, USDA, and other agencies to review and comment on its recommendations. HHS declined to comment, and USDA disagreed with many of the proposals, including the overall need for a national strategy. But should any major changes to the food safety system actually be considered, USDA called it “imperative” that they be “data-driven, well-designed, collaborative, and, ultimately, continue to enable the United States to have the safest food supply in the world.”
“It is a little disconcerting, but not totally surprising, that USDA felt a national strategy was not needed,” says Dr. Acheson. “Every food company has to manage food safety based on risk, FDA does the same, and FSMA clearly emphasizes that approach. USDA, on the other hand, has never been too keen on adopting a clear risk-based approach. If the White House were to look at optimal ways to manage food safety resources, they would support the need for a risk-based national strategy,” he says.