Unleaded Juice: FDA’s Challenge for Continuous Improvement and Compliance

Action levels should be sequentially strong enough to drive research and influence markets: The FDA correctly points to its success in setting an action level for inorganic arsenic in infant rice porridge as a model for reducing contamination. Unfortunately, the model assumes that the action level for a contaminant is set low enough to lead to investment in research and increased testing of products and ingredients and to provide FDA with enough information to act on the problems. This does not apply to lead in juice.

We explore each of these weaknesses below.

Adequate funding is essential to success

In May 2021, FDA submitted its FY22 budget request to Congress; included $97 million in additional funds for essential food safety programs. One element of the request was $18 million to hire 26 new staff for maternal and infant health and nutrition — an increase of $4 million. Closer to zero was one of the five activities the funding will support. The FDA provided a fact sheet detailing the request, which gave more emphasis to the request.

In March 2022, six months after fiscal year began, Congress finally approved federal appropriations. The legislation was accompanied by a report noting that $11 million in new funding was earmarked for maternal and infant 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 Appropriations Committee report that accompanies the appropriations bill says $7 million for Closer to zero program for FY23[2] as part of larger appropriations for maternal and infant nutrition.

Setting action levels in non-binding guidelines makes implementation difficult

In 1994, the FDA issued regulations for bottled water setting applicable limits for lead and other contaminants. If the industry exceeds the limits, it must recall the product and is subject to fines for breaking the law. In our experience, the risk of recalls and fines causes companies to closely 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 guidelines that “represent [FDA’s] current thinking on this subject.” This guide comes with a disclaimer: “The contents of this document do not have the force and effect of law and are not intended to bind the public in any way unless expressly included in a contract.”

The agency relies on guidance rather than rulemaking because it sees the former as faster and less burdensome. Guidelines can be effective if prudent companies treat them as an enforceable constraint. But not all companies are cautious – especially those that lack the resources or sophistication to recognize the risks of exceeding the action level, pay for sufficient sampling and appropriate analysis in trusted laboratories, and actively manage their suppliers.

FDA does not have the means to enforce compliance with action levels

Most environmental regulations require the regulated community to make extensive reports on test results and evidence of potential problems. In contrast, the FDA has no similar regulatory infrastructure for food—instead, it relies on physical inspections, market sampling, and voluntary reporting.

Although physical inspections are essential, they are carried out every 3 years for high-risk facilities: it can even be every 8 years for others. It is too rare to detect food problems before consumers are harmed.

Most agencies, including the FDA and EPA drug program, also have the authority to require the regulated community to provide compliance information without physical inspection. However, the FDA concluded that these food authorities were lacking. Therefore, the food inspector must physically visit the facility to review compliance programs and test results. The pandemic made the problems with this flaw all too 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 that FDA testing food on the market and monitoring for disease outbreaks is critical. But the FDA requires very little regular reporting — leaving the agency to react rather than prevent problems. For substances like lead and arsenic – where harm can be subtle and take years to manifest – there are serious restrictions.

It would be best to require more timely reporting. However, another mechanism to improve compliance with action levels may be FDA’s new Laboratory Accreditation for Food Analysis (LAAF) program. The December 2021 rules establishing this program provide FDA with the means to ensure that laboratories are properly testing food and analyzing samples. It also requires companies to submit their food testing results and supporting information to the FDA.

But there’s another downside: Companies are required to use the labs in the program only under certain circumstances, such as when there’s an import warning or regulatory limit. And there is no option to volunteer test results.

Strong action levels stimulate compliance research and testing

Action levels should prompt industry to conduct testing. But if restrictions affect only a small percentage of the market—as is the case with the FDA’s proposal to reduce lead levels in juice—companies have little incentive to invest in driving continuous improvement.

In contrast, strong action levels 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 rigorously. A prime example is the FDA’s 2016 proposed inorganic arsenic limits for rice infant formula. When the agency proposed the limits, it said 53 percent of products taken from retail stores in 2014 exceeded the limit. Four years later, less than 24% exceed the limit – still too many, but significant progress.

The proposed restrictions also spur investment in research by food companies, growers and the USDA to understand the best practices for growing, harvesting, processing and preparing rice to reduce inorganic arsenic.

Despite constant 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 just missed the funding cut because 25 percent of grant reviewers rated the problem as a low priority—despite public announcements by the FDA and USDA that toxic contamination of baby food is a high priority.

Even with strong restrictions, continued improvement will require the FDA to have a stronger mechanism to incentivize research and testing. It should consider the option of using guidelines 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 that can be adjusted based on compliance information as the deadline approaches.

Conclusion

For the FDA Closer to zero program to drive continuous improvement, the agency needs steady funding from Congress. It also needs more robust mechanisms to ensure compliance, including powers to secure relevant information without physical verification. Finally, it should set more protective action levels and clearly signal to the public and industry that the agency is likely to tighten action levels in the coming years.

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

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

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