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We will examine each of the weaknesses below.
Sufficient financial support is essential for success
In May 2021, the FDA submitted FY22 budget request to Congress; It also includes $97 million in additional funding for major food safety programs. Part of the request is $18 million to hire 26 new maternal and infant health and nutrition staff, up from $4 million. Close to zero It was one of the five activities they funded. FDA has provided Fact sheet He gave more attention to the question by explaining the question in detail.
In March 2022, six months later The financial year has begun. Congress finally approved Federal charges. The law in A Report $11 million in new funding is earmarked for maternal and infant health and nutrition, with zero leverage.[1]
In the same month, in it FY23 budget confirmation The FDA reiterated its request for an additional $18 million. At the moment, the report of the budget collection committee of the council is related to the plan for 7 million dollars Close to zero program For FY23[2] A major component of maternal and infant nutrition.
Setting action levels in non-binding guidelines makes enforcement difficult
In the year In 1994, the FDA issued regulations for bottled water Applicable restrictions on lead and other contaminants. If the industry exceeds the limit, it must recall the product and be fined for violating the law. In our experience, the risk of recalls and fines motivates companies to carefully monitor their products and suppliers and establish strict internal standards.
But for action levels (eg for arsenic or It leads to juice), the agency relies on “representative guidance [FDA’s] Current thinking on this topic.” This guide comes with a disclaimer: “The contents of this document have no legal force or effect and are not intended to bind the public in any way unless incorporated into a contract.
The agency relies on the guidelines rather than the guidelines because it sees the former as faster and less burdensome. If careful companies see it as an enforceable limit, the directive can be effective. But not all companies are vigilant—especially those that don’t have the resources or sophistication to identify risks beyond the action level, pay for adequate sampling and analysis, and proactively manage their suppliers.
The FDA does not have a mechanism to ensure compliance with operational standards
Most environmental regulations require the regulated community to provide extensive reporting of test results and potential problems. In contrast, the FDA lacks the same regulatory infrastructure for foods—relying instead on physical inspections, market sampling, and voluntary reporting.
Although physical examinations are very important, they are performed every 3 years for high-risk facilities: for others, it can be as long as every 8 years. It is rare for consumers to identify food-related problems before they are harmed.
Most agencies, including the FDA Drug Program and the EPA, also have the authority to require the regulated community to submit compliance information without a physical examination. However, the FDA has concluded that it lacks those authorities for food. Therefore, a food inspector must visit the facility in person to review compliance programs and inspection results. The outbreak made the problems with this deficiency widely apparent, prompting the FDA to act. Ask Congress for some power earlier this year. We support this request.
Just as we rely on the EPA to test air and water quality, we know that the FDA is critical to testing foods in the marketplace and monitoring disease outbreaks. But the FDA requires very little formal reporting — leaving the agency to react to problems rather than prevent them. For substances like lead and arsenic — whose harm can be subtle and take years to show — it has stricter limits.
More timely reporting would be better. However, another mechanism to strengthen compliance with action standards may be the FDA’s new accreditation of laboratory food analysis (RUN) program. The December 2021 rules establishing that program would give the FDA a mechanism to ensure that laboratories are properly testing and analyzing food samples. It also requires companies to submit their food testing results and supporting data to the FDA.
But there is still another problem: companies are required to use the laboratories in the program only in certain situations, for example when there is an import warning or a regulatory restriction. And there is no option to voluntarily report test results.
Driving strong action levels Research and testing to ensure compliance
Action steps should encourage industries to conduct experiments. But if the restriction only affects a small percentage of the market – like the FDA A proposal to reduce the amount of lead in juice – Companies have little incentive to invest in driving continuous improvement.
In contrast, strong standards of practice compel companies and federal agencies like the USDA’s Agricultural Research Service to invest in research to identify best practices and strictly regulate their offerings. A good example is the FDA’s 2010 The 2016 proposed inorganic arsenic limit is for baby rice grains. When The agency proposed In the year In 2014, 53% of a sample of retail stores exceeded the limit, he said. Four years later, less 24% passed The limit – still a lot, but significant progress.
The proposed limits prompted research investments by food companies, growers and the USDA to understand best practices for growing, harvesting, processing and preparing rice to reduce inorganic arsenic.
Despite the continuous focus on this issue, we have not yet been able to see this effect for other crops. In the year In August 2022, a consortium of universities led by Purdue requested $8 million from the USDA to research best practices for reducing lead, arsenic and cadmium in carrots, sweet potatoes, squash and leafy greens. The project missed the cut because 25% of grant evaluators ranked the issue as a low priority — despite public announcements by both the FDA and USDA that toxin contamination of baby food is a high priority.
Even with strong restrictions, continued improvement requires FDA to have a strong mechanism to drive research and testing. It should consider the option of using guidance to establish current practice standards—as well as future targets—to help industry prepare. For example, a certain percentage reduction in the action level every several years that could be adjusted based on compliance data as the deadline approaches.
Conclusion
For the FDA Close to zero The agency needs stable funding from Congress to make ongoing program improvements. It also requires stronger mechanisms to ensure compliance, including an authority to retain relevant information without physical inspection. And finally, by issuing additional preventive action standards, the agency should clearly communicate to the public and industry that it will strengthen the standards of action in the coming years.
[1] See page 33 of 98 in PDF.
[2] See pages 117 and 125. The $7 million is part of $8.5 million for maternal and infant health.
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