By Wayne Persky |
Food safety regulation in the United States is the responsibility of two departments of the federal government. The United States Department of Agriculture (USDA) is responsible for overseeing the way that basic agricultural production such as meat, milk, eggs, vegetables, etc. are handled. And the Food and Drug Administration (FDA) is in charge of regulating manufactured foods that have undergone extensive processing and packaging — basically, everything that is not regulated by USDA.
The two departments operate using completely different policies.
The United States Department of Agriculture (USDA) provides inspection services for meat and poultry processing plants. Specifically, the Food Safety and Inspection Service (FSIS), which is part of the USDA, is responsible for ensuring that meat, poultry, and egg products are safe, wholesome, and accurately labeled.
FSIS conducts continuous on-site inspections.
Every meat and poultry processing plant that produces products for interstate commerce is required to have USDA inspection. Inspectors from FSIS are present at these facilities to oversee the processing and ensure compliance with federal regulations. Additionally, FSIS inspectors are also present at ports of entry to inspect imported meat and poultry products to ensure they meet U.S. safety standards.
Some smaller facilities are subject to state inspections.
Note that while FSIS inspects many processing plants, not every single facility in the country is inspected by the USDA. Some smaller operations may be subject to state inspection programs, provided those programs are deemed to be at least equal to federal standards.
Constant USDA inspection is mandatory, not optional.
It's illegal for federally inspected meat processing plants to operate without an Official USDA Inspector on site. The Federal Meat Inspection Act (FMIA) requires that all meat processing plants that operate under federal inspection have a USDA inspector present during processing to ensure compliance with regulations and to safeguard public health. Operating without an inspector would violate federal law and could lead to severe penalties, including closure of the facility and legal action.
By contrast, FDA oversight is relatively limited.
Unlike USDA, the FDA does not typically post inspectors at food manufacturing sites on a continuous basis. Instead, the FDA conducts inspections of food manufacturing facilities periodically, based on a risk-based approach. These inspections can be scheduled or unannounced and are aimed at ensuring compliance with food safety regulations.
The frequency of inspections can vary depending on factors such as the type of food being produced, the facility's compliance history, and the potential risk associated with the products. High-risk facilities may be inspected more frequently, while lower-risk facilities might have longer intervals between inspections.
The frequency of inspections can vary depending on factors such as the type of food being produced, the facility's compliance history, and the potential risk associated with the products. High-risk facilities may be inspected more frequently, while lower-risk facilities might have longer intervals between inspections.
Congress passed the FSMA in December 2010.
The Food Safety Modernization Act (FSMA) was passed to address the increasing number of foodborne illnesses in the United States. The law represents a significant shift from a reactive to a preventive approach in food safety. It was driven by concerns over the safety of the U.S. food supply, highlighted by several high-profile outbreaks of foodborne diseases. FSMA aims to ensure that the U.S. food supply is safe by focusing on preventing contamination rather than simply responding to it after it occurs.
The FSMA mandates that high-risk domestic food facilities be inspected (by the FDA) at least once every three years and non-high-risk facilities at least once every five years. The FDA conducts these inspections, prioritizing them based on a risk-based approach. This includes not only routine inspections but also targeted inspections related to specific food safety risks, such as outbreaks or compliance follow-ups.
The FSMA mandates that high-risk domestic food facilities be inspected (by the FDA) at least once every three years and non-high-risk facilities at least once every five years. The FDA conducts these inspections, prioritizing them based on a risk-based approach. This includes not only routine inspections but also targeted inspections related to specific food safety risks, such as outbreaks or compliance follow-ups.
Does the FDA actually comply with the FSMA?
While these goals are set, there have been challenges in consistently meeting these inspection frequencies. If they have met the FSMA goal of preventing contamination rather than simply responding to it after it occurs, that's certainly not obvious. FDA claims to have resource constraints and a vast number of facilities to regulate. But when FDA's oversight methods are compared with USDA's constant inspection services, one has to wonder what the FDA does with their time and money.
For almost 7 decades, the FDA has operated with a glaring problem.
A recent medical Xpress article discussed a major problem with the way the FDA operates. (New York University, 2024, August 9).1 The FDA has largely delegated the responsibility of determining the safety of food ingredients to the food industry itself. This is done through the "Generally Recognized as Safe" (GRAS) designation, which allows companies to decide whether an ingredient is safe without necessarily notifying the FDA or sharing safety data. This lack of oversight means that potentially harmful substances can be added to foods without government review.
The GRAS system was originally intended for substances that were already widely recognized as safe, like common spices, and on December 9, 1958, the FDA published a list of GRAS substances and incorporated the list in Title 21 of the Code of Federal Regulations. Since then, the FDA has basically allowed companies to self-regulate, leading to a situation where many new substances are added to foods with minimal to no oversight. In 2021, a federal court case upheld the FDA's approach, which effectively leaves the safety of many food ingredients unverified by independent scientists or the government.
The article points out the potential health risks associated with this system, particularly in the context of ultra-processed foods that may contain numerous unreviewed ingredients. Examples include potassium bromate, a chemical linked to cancer that is banned in several countries but still allowed in the U.S.
The GRAS system was originally intended for substances that were already widely recognized as safe, like common spices, and on December 9, 1958, the FDA published a list of GRAS substances and incorporated the list in Title 21 of the Code of Federal Regulations. Since then, the FDA has basically allowed companies to self-regulate, leading to a situation where many new substances are added to foods with minimal to no oversight. In 2021, a federal court case upheld the FDA's approach, which effectively leaves the safety of many food ingredients unverified by independent scientists or the government.
The article points out the potential health risks associated with this system, particularly in the context of ultra-processed foods that may contain numerous unreviewed ingredients. Examples include potassium bromate, a chemical linked to cancer that is banned in several countries but still allowed in the U.S.
Some states are taking food safety matters into their own hands:
Due to the FDA’s inaction, some states have begun banning certain harmful chemicals, like potassium bromate. This patchwork approach to food safety regulation highlights the gaps left by the federal government.
The authors of the article suggest several needed reforms.
And those reforms include requiring companies to publicly disclose GRAS determinations and their safety data to the FDA, and strengthening the agency's ability to review and regulate food additives and GRAS substances already on the market. They also propose that Congress could allocate more resources to the FDA or implement a user fee program to fund these regulatory activities. It's worth noting that USDA does not charge any user fees for providing inspectors for meat processing plants during normal hours of operation, for example. They only charge user fees if a processor requests inspection outside of normal working hours.
Do FDA's methods play a role in increasing public health issues?
An original research article published in the The American Journal of Public Health expands on the public health implications of the FDA's regulatory approach, associating the proliferation of unreviewed and potentially unsafe ingredients in the U.S. food supply with rising rates of diet-related diseases, toxicity, and cancer (Pomeranz, Leib, and Mozaffarian, 2024).2 The article underscores the consequences of the FDA's reliance on the food industry's self-regulation under the GRAS system.
The authors argue that a significant loophole in federal law allows food companies to add new substances to foods without adequate oversight. This system permits companies to classify substances as GRAS without submitting safety data to the FDA, leading to a situation where many potentially harmful ingredients are in widespread use without public knowledge or scientific scrutiny.
The article criticizes the FDA’s lack of a formal and systematic approach to reviewing food additives and GRAS substances that are already on the market. The agency’s post-market authority to remove harmful substances is seen as flawed and unreliable, with very few substances ever being reevaluated or removed from the food supply despite emerging evidence of harm.
The authors argue that a significant loophole in federal law allows food companies to add new substances to foods without adequate oversight. This system permits companies to classify substances as GRAS without submitting safety data to the FDA, leading to a situation where many potentially harmful ingredients are in widespread use without public knowledge or scientific scrutiny.
The article criticizes the FDA’s lack of a formal and systematic approach to reviewing food additives and GRAS substances that are already on the market. The agency’s post-market authority to remove harmful substances is seen as flawed and unreliable, with very few substances ever being reevaluated or removed from the food supply despite emerging evidence of harm.
Like the NYU article,
the American Journal of Public Health article notes that states have begun to fill the regulatory gaps left by the FDA, but it also calls for federal action. The authors propose policy changes to ensure that the FDA can fulfill its mission of ensuring a safe food supply, such as requiring greater transparency from food companies, enhancing the FDA’s review processes, and providing more resources to the agency.
The FDA is currently undergoing a reorganization process.
The reorganization efforts aim to streamline operations, enhance transparency, and improve the agency's ability to respond to food safety risks. While these efforts have the potential to be effective, their success will ultimately depend on the implementation of these changes and the ability of the FDA to adapt to evolving food safety challenges
Who's in charge?
The FDA’s current reorganization efforts, particularly those related to food safety, are typically overseen by senior leadership within the agency, such as the Commissioner of Food and Drugs and other key officials in the Office of Food Policy and Response. It's doubtful that anyone is holding their breath, hoping for sweeping, and effective changes that will actually improve the safety of our food.
References
1. New York University. (2024, August 9). How a legal loophole allows unsafe ingredients in US foods. Medical Xpress, Retrieved from https://medicalxpress.com/news/2024-08-legal-loophole-unsafe-ingredients-foods.html?utm_source=nwletter&utm_medium=email&utm_campaign=daily-nwletter
2. Pomeranz, J. L., Leib, E. M. B., and Mozaffarian, D. (2024). Regulation of Added Substances in the Food Supply by the Food and Drug Administration Human Foods Program. American Journal of Public Health (AJPH), 0, e1_e10. Retrieved from https://ajph.aphapublications.org/doi/abs/10.2105/AJPH.2024.307755