Unleaded Juice: The FDA’s Challenge to Continuous Improvement and Compliance Assurance

Action levels should be regularly strong enough to drive research and impact markets: The FDA rightly points to its success in setting an action level for inorganic arsenic in infant rice cereal as a model for reducing contamination. Unfortunately, the model assumes that the action level for a contaminant is set low enough to drive research investment and increased product and ingredient testing and to provide the FDA with enough information to act on the problems. This is not the case with lead in juice.

We explore each of these weaknesses below.

Adequate funding is essential for success

In May 2021, FDA submitted its FY22 budget request to Congress; it included $97 million in additional funding for key food safety programs. One of the components of the request was for $18 million to hire 26 new staff for maternal and child health and nutrition, up from $4 million previously. closer to zero was one of five activities that the funding would support. The FDA provided an information sheet detailing the request, which put more emphasis on the request.

In March 2022, six months after the fiscal year has begun, Congress has finally approved federal appropriations. The law was accompanied by a report noting that $11 million in new funding was for maternal and child health and nutrition, including Closer to Zero.[1]

That same month, in its FY23 budget justification, the FDA reiterated its request for an additional $18 million. Currently, the House Appropriation Committee report that accompanies the supply bill indicates $7 million for the closer to zero program for FY23[2] as part of a broader credit for maternal and child nutrition.

Defining action levels in non-binding guidelines makes enforcement difficult

In 1994, the FDA issued regulations for bottled water, setting enforceable limits on lead and other contaminants. If the industry exceeds the limits, they must recall the product and face fines for breaking the law. In our experience, the risk of recalls and fines prompt companies to carefully monitor their products and suppliers and set strict internal standards.

But for action levels (such as those for arsenic or lead in juice), the agency relies on guidance that “represents the [FDA’s] current thinking on this topic. This advice is accompanied by a disclaimer: “The contents of this document do not have the force of law and are not intended to bind the public in any way, unless specifically incorporated in a contract.”

The agency relies on advice rather than rule-making, as it considers the former to be faster and less restrictive. Guidance can be effective if prudent companies treat it as an enforceable limit. But not all companies are prudent, especially those that lack the resources or sophistication to recognize the risks of exceeding the action level, pay for sufficient sampling and proper analysis at credible labs, and actively manage their suppliers. .

The FDA does not have the means to ensure compliance with action levels

Most environmental regulations require the regulated community to make detailed reports of test results and evidence of potential problems. In contrast, the FDA lacks a similar regulatory infrastructure for food, relying instead on physical inspections, market sampling, and voluntary reporting.

If the physical inspections are essential, they are carried out every 3 years for the installations at risk: they can go up to every 8 years for the others. It’s too rare to spot food issues before consumers are harmed.

Most agencies, including the FDA Drug Program and the EPA, also have the authority to require the regulated community to provide compliance information without physical inspection. However, the FDA concluded that it did not have these authorities for the foods. Therefore, a food inspector must physically visit a facility to review compliance programs and test results. The pandemic has made the issues with this shortcoming starkly clear, prompting the FDA to ask Congress for specific authority earlier this year. We support this request.

Just as we rely on the EPA to test air and water quality, we know it’s critical for the FDA to test foods in the marketplace and monitor for outbreaks. But the FDA requires very little regular reporting, leaving it up to the agency to react rather than prevent problems. For substances like lead and arsenic, where the damage can be subtle and can take years to manifest, this has serious limitations.

It would be better to require more timely reports. However, another mechanism to enforce adherence to action levels could be the FDA’s new Laboratory Accreditation Program for Food Analysis (LAAF). The December 2021 rules establishing this program allow the FDA to ensure that labs perform food testing and properly analyze samples. It also requires companies to submit their food test results and supporting information to the FDA.

But there’s yet another downside: Companies are only required to use the program’s labs under certain circumstances, such as when there’s an import alert or regulatory limit. And there is no option for voluntary reporting of test results.

Strong action levels research and testing to ensure compliance

Action levels should encourage industry to test. But if limits only affect a small percentage of the market — as is the case with the FDA’s proposal to lower lead levels in juice — companies have little incentive to invest in continuous improvement. .

In contrast, high levels of action will prompt companies and federal agencies like the USDA’s Agricultural Research Service to invest in research to identify best practices and manage their supplies more tightly. The inorganic arsenic limits proposed by the FDA in 2016 for infant rice cereal are a prime example. When the agency proposed the limits, it said 53% of products sampled from retail stores in 2014 exceeded the limit. Four years later, less than 24% exceeded the limit – still too many, but significant progress.

The proposed limits have also led food companies, growers, and the USDA to invest in research to understand best practices for growing, harvesting, processing, and preparing rice to reduce inorganic arsenic.

Despite sustained attention to this issue, we have yet to see this result for other cultures. 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 narrowly missed the funding cut because 25% of grant reviewers ranked the issue as a low priority, despite public announcements from the FDA and USDA that contamination of food with toxic elements children is a high priority.

Even with strong limits, continuous improvement will require the FDA to have a stronger mechanism to drive research and testing. It should consider the possibility of using guidance to establish current action levels, as well as future targets, to help industry prepare. For example, a certain percentage reduction in the action level every few years which could be adjusted based on compliance information as the deadline approaches.

Conclusion

For the FDA closer to zero continuous improvement program, the agency needs stable funding from Congress. It also needs more robust mechanisms to ensure compliance, including the authority to secure relevant information without physical inspection. And finally, it must set more protective action levels and send a clear signal to the public and industry that the agency is likely to tighten action levels in the years to come.

[1] See page 33 of 98 in the PDF.

[2] See pages 117 and 125. The $7 million is part of the $8.5 million for maternal and child health.


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