A unified food safety agency is needed to ensure that foods are safe for the consuming public.
The current collection of federal agencies responsible for ensuring the safety of foods emerged out of the requirements of the Pure Food and Drug Act of 1906. Although that long period of growth has produced a large, multiagency regulatory system, it has been a somewhat haphazard growth, marked by much disagreement about how best to achieve success.
Near the center of today’s debates sits a question about why four different agencies—two at the U.S. Food and Drug Administration (FDA), one at the U.S. Department of Agriculture (USDA), and one at the U.S. Environmental Protection Agency (EPA)—are necessary to carry out the mission of keeping our food safe.
A close look at the history of the current system is necessary for a fair appraisal of its performance. For present purposes, however, I need only point out that many expert observers have for years called for the merger of the food safety programs of these agencies into a single agency. The most recent set of such proposals began with a report from the Government Accountability Office in 1994, and similar proposals continue to appear. But none of these proposals has gotten very far, perhaps because the agencies involved have been running at full speed and possess very little capacity for participation in such a demanding effort.
These proposals are largely based on the view that situating institutions with closely similar missions into a single organization is necessary to avoid introducing a host of impediments to success, such as conflicting approaches to similar problems and differences in priorities. One important and serious downside of the system we currently have concerns the difficulties encountered in attempting to evaluate the quality and effectiveness of the entire system when it is so fragmented. This problem may explain why there has been no comprehensive evaluation of our entire food safety system and no significant evidence about its effectiveness.
The case for merging the several U.S. food safety programs into a single agency would be strengthened if there were evidence that the fragmentation that now exists had somehow created significant inefficiencies or had led to avoidable public health problems. These conditions might have arisen, for example, because of differences in FDA and USDA programs aimed at controlling foodborne diseases, but there seems to have been no independent investigation of the matter. It is not possible to make rational decisions about the best approach for achieving a goal without a serious investigation of the relative merits of competing approaches.
The arguments for creating a single agency for food safety that have been put forward by several credible individuals and organizations are compelling enough to place this goal at the top of a post-2028 regulatory agenda. The difficulties that will have to be overcome to realize this goal are fairly serious, but achieving it and ensuring a management program dedicated to its singular mission will create an effective and efficient food safety system. I refer to this singular system, for now, as FOODS. I must emphasize, however, that the successful drugs and medical devices programs of FDA would in no way be affected by any of the changes I am proposing to create FOODS.
A new FOODS agency would be positioned to adopt the most advanced risk assessment and management programs. Such programs are necessary to develop an understanding of the safety of regulated substances, or lack thereof, and to guide efforts to ensure that unsafe products do not reach consumers. Risk assessments would be conducted by scientists at FOODS to determine the probability that a regulated substance will pose a risk to health. A substance would be considered safe if the health risk it poses is so small as to be judged an insignificant threat to health. If safety criteria are not met, the substance would be either prohibited or subject to a risk management program that achieves safety by limiting human exposures.
At present, regulatory agencies use two different methods to assess the health risks of chemicals that can cause some form of toxicity. For chemicals that have been shown to induce cancer, it is assumed that there is a risk of cancer at any exposure. Risks decline as exposures decline, and at some exposure point, risks become so small as to approach zero. Depending upon applicable law and the ways in which human exposure to such a substance occurs, regulators may completely prohibit exposures or require that exposures be limited to those levels posing extremely small risks. This is termed a risk-based approach.
If the substance under review has been shown to produce toxic effects other than cancer, a system for deciding whether a given exposure is safe or unsafe has been in use since at least the 1950s. Unlike the above risk-based system, this approach depends upon the use of so-called safety factors to establish levels of safe exposure. These safety factors, however, have no quantitative relationship to risk, and it is not possible to know how much risk is being accepted at any limits on human exposures established based on the use of this system. Given the fact that it is possible to derive quantitative measures of risk for any form of toxicity, it is not clear why regulators persist in using this 70-year-old approach.
A new FOODS agency should adopt quantitative measures of risk for all regulated chemicals. Decision-making based on risk allows us to know how much risk regulators find acceptable, and it is the only basis for truly consistent and readily understandable decisions.
On the subject of carcinogens, a recent report from the Environmental Defense Fund lists 25 chemicals that have carcinogenic properties as being present in foods. The sources of these chemicals, their exposure and risk levels, and the reasons they have not been eliminated or otherwise controlled appear to be unanswered questions. The unexplained reasons for the presence of these substances in food suggest that there is an inherent deficiency in the U.S. food safety regulatory system. A new FOODS agency would never refrain from properly addressing this and other such matters.
Ensuring safety for food additives, other ingredients, pesticide and veterinary drug residues, and contaminants is a necessary part of any program to ensure the availability of healthy foods. But it is not sufficient. Evaluations of the overall effects on health of various diets require an understanding of whether nutritional requirements are met and whether other measures of health are not compromised. The determination of a food’s, or an ingredient’s, health profile requires more study than is required to investigate the safety of a single substance. FOODS would not be responsible for conducting such studies. Rather, it would be responsible for evaluating the reliability of any health claims made by manufacturers who have carried out such studies. For example, in the case of ultra-processed foods, FOODS would evaluate the current studies surrounding the health detriments claimed to be associated with consumption of these foods and make decisions about whether and how regulations should apply to this category. Because the range of issues on the agenda of a new FOODS agency would be quite wide and not at all easily dealt with, having the best possible risk assessment and management program would be necessary for FOODS to succeed.
But designing the best risk-assessment program is far from enough to ensure that the U.S. food safety system is the best that it can be. The four major food-related agencies at present possess significantly different congressional authorizing, appropriating, and oversight authorities, several of which have led to the very different ways in which FDA and the USDA’s Food Safety and Inspection Service, for example, carry out their congressionally mandated regulatory activities. These agencies have disparate histories and cultures. Policymakers and planners ignore such organizational and human-factor complications to their—and our—peril. And no such major reorganization should be undertaken without careful planning to minimize the risks inevitably incurred by the reorganization—which would take multiple years to plan and carry out—while doing everything possible to maximize the benefits of the effort.
Nonetheless, that planning must start now.
This essay is part of a series titled, “Rebuilding the U.S. Regulatory System.”
