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Unleaded Juice: FDA’s challenge of continuous improvement and compliance assurance

Tom Neltner, Senior Director, Safer Chemicals

This is the sixth in our Unleaded Juice blog series exploring how the Food and Drug Administration (FDA) sets limits for toxic elements like lead, arsenic, and cadmium in food and the implications for the agency’s Closer To Zero program. 

A core tenet of FDA’s Closer to Zero program is the “Cycle of Continuous Improvement” represented by the image below on the program’s webpage. The four-stage, outer ring represents FDA’s process for revising its action levels for food contaminants. The inner, grey ring describes the agency’s on-going monitoring, research, and compliance program.


This approach makes sense, and we fully support it. However, the success of this approach relies on FDA addressing several significant structural weaknesses.

  • Future funding is not guaranteed: In March 2022, Congress appropriated $11 million in Fiscal Year 2022 (FY22) funding for FDA’s maternal and infant health work—in part to support the agency’s efforts to reduce arsenic, lead, and cadmium in children’s foods. Last year’s request and appropriations were a significant increase over previous years, but that funding level is not guaranteed for future years.
  • Action levels are guidance—not legally binding requirements: FDA’s action levels for contaminants in food are established in guidance. The guidance introduction makes it clear that “The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract.” It assumes that the food industry—from the largest multinational corporation to the smallest entrepreneur—will comply.
  • The agency has limited means to monitor compliance: FDA largely relies on physical inspections and market sampling, supplemented by voluntary reporting, to assure compliance with action levels. Inspections at high-risk facilities must occur every three years (but likely have been delayed due to the COVID pandemic). We understand that most facilities will see an inspector once every eight years. This is particularly problematic because FDA says it lacks the authority to require food companies to provide requested documents without the physical inspection, and the agency does not require ongoing testing and reporting by companies for action levels.
  • Action levels must be consistently strong enough to drive research and impact markets: FDA correctly points to its success in setting an action level for inorganic arsenic in infant rice cereal as a model to lower contamination. Unfortunately, the model assumes the action level for a contaminant is set low enough to result in research investments and increased product and ingredient testing and to provide FDA with sufficient information to act on problems. This is not the case for lead in juice.
     
    We explore each of these weaknesses below.

    Adequate funding is essential to success

    In May 2021, FDA provided its FY22 budget request to Congress; it included $97 million in additional funds for core food safety programs. One element of the request was $18 million to hire 26 new staff members for maternal and infant health and nutrition—up from $4 million. Closer to Zero was one of five activities that funding would support. FDA provided a fact sheet detailing the request, which gave the request greater emphasis.

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

    That same month, in its FY23 budget justification FDA repeated its request for an additional $18 million. Currently, the House Appropriation Committee’s report that accompanies the appropriations bill says $7 million for the Closer to Zero program for FY23[2] as part of a larger appropriation  for maternal and infant nutrition.

    Setting action levels in nonbinding guidance makes enforcement difficult

    In 1994, FDA issued regulations for bottled water, setting enforceable limits on lead and other contaminants. If industry exceeds the limits, it must recall the product and is subject to fines for violating the law. In our experience, the risk of a recall and fines prompts companies to monitor their products and suppliers carefully and to set tight 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 guidance comes with a disclaimer: “The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract.”

    The agency relies on guidance rather than rulemaking because it sees the former as faster and less burdensome. Guidance can be effective if cautious companies treat it as an enforceable limit. But not all companies are cautious—especially those that lack the resources or sophistication to recognize the risks from exceeding the action level, pay for sufficient sampling and appropriate analysis at credible labs, and actively manage their suppliers.

    FDA lacks the means to ensure compliance with action levels

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

    While physical inspections are essential, they are conducted every 3 years for high-risk facilities: it can be as long as every 8 years for others. This is too infrequent to spot problems with food before consumers are harmed.

    Most agencies, including FDA’s drugs program and EPA, also have the authority to require that the regulated community provide compliance information without a physical inspection. However, FDA has concluded that it lacks those authorities for food. Therefore, a food inspector must physically visit a facility to review compliance programs and testing results. The pandemic has made the problems with this shortcoming abundantly clear, prompting FDA to ask Congress for specific authority earlier this year. We support this request.

    Just as we rely on EPA to test for air and water quality, we know that having FDA testing foods in the marketplace and monitoring for disease outbreaks is critical. But FDA requires very little regular reporting—leaving the agency to react to rather than prevent problems. For substances like lead and arsenic—where the harm can be subtle and may take years to manifest—it has serious limitations.

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

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

    Strong action levels drive research and testing to ensure compliance

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

    By contrast, strong action levels will drive companies and federal agencies like USDA’s Agricultural Research Service to make investments in research to identify best practices and to manage their supplies more tightly. An excellent example is FDA’s 2016 proposed inorganic arsenic limits for infant rice cereal. When the agency proposed the limits, it said 53% of the products sampled from retail stores in 2014 exceeded the limit. Four years later, less than 24% exceeded the limit – still too much, but significant progress.

    The proposed limits also drove research investments by food companies, growers, and USDA to understand best practices to grow, harvest, process, and prepare rice to reduce inorganic arsenic.

    Despite sustained attention on this issue, we have yet to see this result for other crops. In August 2022, a consortium of universities led by Purdue requested $8 million from USDA to research best practices to reduce lead, arsenic, and cadmium in carrots, sweet potatoes, squash, and leafy greens. The project just missed the funding cut because 25% of grant reviewers scored the issue as a low priority—despite public announcements by both FDA and USDA that toxic element contamination of children’s food is a high priority.

    Even with strong limits, continuous improvement will require FDA to have a stronger mechanism to drive research and testing. It should consider the option 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 several years that could be adjusted based on compliance information as the deadline approaches.

    Conclusion

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

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

    [2] See page 117 and 125. The $7 million is part of the $8.5 million for Maternal and Infant Health.

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Unleaded Juice: FDA needs to start with public health—not market impact

Tom Neltner, Senior Director, Safer Chemicals 

This is the fifth in our Unleaded Juice blog series exploring how the Food and Drug Administration (FDA) sets limits for toxic elements like lead, arsenic, and cadmium in food and its implications for the agency’s Closer To Zero program. 

FDA’s approach to setting draft action levels for lead in juice is based on two ill-conceived presumptions:

  • Action levels should not impact more than 5% of the market. Unfortunately, FDA does not appear to consider market trends or whether the products were made using best practices shown to reduce contamination.
  • Action levels should help ensure 90% of young children have a dietary intake of lead that is below FDA’s Interim Reference Level, the maximum daily intake from food. Unfortunately, this effectively ignores the top 10% or 2.4 million of the most-exposed young children.[1]

To its credit, the agency has shown it is willing to go beyond the 5% impact for three types of juices (grape at 12%, pomegranate at 6%, and prune at 6%),[2] and it has proposed the most protective lead-in-juice standards in the world. However, for a heavy metal like lead where relatively short-term exposures can result in long-term harm to young children’s developing brains, the current approach has serious weaknesses.

We think the agency should evaluate alternatives that impact more than 5% of the market and protect more than 90% of children. And when FDA evaluates impacts, it should assess the socioeconomic benefits of the alternatives. For substances like lead (and arsenic), these societal benefits can be quantified using established methods. In a previous blog, we showed that reducing young children’s overall dietary intake of lead by just 6% would yield $1 billion a year in benefits. The agency should compare these benefits to the investments that industry would need to make to achieve these action levels using best practices.

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Broken GRAS: FDA must declare abandoned uses of ortho-phthalates are not GRAS.

Maricel Maffini, EDF consultant and Tom Neltner, Chemicals Policy Director

This blog is the sixth in our Broken GRAS series where we explore the Food and Drug Administration’s (FDA) Generally Recognized as Safe (GRAS) voluntary notification system for novel chemicals added to food.

In May, FDA removed its approval for all uses of 19 ortho-phthalates (aka phthalates) and some uses for two more because it agreed with the industry petition claiming the uses had been abandoned. During the comment period when the petition was filed and again when the decision was published, Earthjustice, EDF, and others warned FDA that despite the removal of approvals, a company could still use any of the abandoned phthalates without the agency’s knowledge by determining on its own that the use was Generally Recognized as Safe (GRAS).

In its decision, FDA implicitly acknowledged that this could indeed happen. After explaining what a GRAS safety determination[1] entails and how its voluntary GRAS notification program[2] works, the agency said:

In the future, if a manufacturer wishes to establish safe conditions of use for one or more of these substances in food contact applications, we expect the manufacturer to submit either a food additive petition or a food contact substance notification prior to market entry because these intended uses were previously authorized under section 409 of the FD&C Act.[3]

Since the agency has no way of knowing that a company determined a substance’s use was GRAS or that it was actually in use, FDA’s expectation is little more than a hope. The agency’s own studies show that the abandoned phthalates show up in food and in food contact materials. Many other studies have shown the same thing, including one that found an unapproved phthalate in fast food.

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Over 7 million children exceed FDA’s new daily maximum intake level of lead

Tom Neltner, Senior Director, Safer Chemicals

This is the fourth in our Unleaded Juice blog series exploring how the Food and Drug Administration (FDA) sets limits for toxic elements like lead, arsenic, and cadmium in food and the implications for the agency’s Closer To Zero program.

In June, after issuing its proposed action levels for lead in juice, FDA tightened its Interim Reference Levels (IRLs) for lead to 2.2 µg/day for children and 8.8 µg/day for females of childbearing age—a drop of 27% from the original IRLs it established in 2018. We estimate this change increased the number of children over the IRL for lead from 2.2 million to more than 7 million.

The agency describes IRLs as daily maximum intake levels for lead in food and beverages. FDA scientists said the change was made to match the Centers for Disease Control and Prevention’s (CDC) October 2021 revised blood lead reference value.  This value is commonly known as the elevated blood lead level (EBLL).[1] FDA uses the “interim” label in recognition that there is no known safe level of exposure to lead and the neurotoxic harm it can cause. FDA anticipates matching the IRLs to future reductions in CDC’s reference value as the U.S. makes progress in reducing children’s exposure to lead.

We applaud FDA’s decision to tighten the IRLs. It is a good example of the type of continuous improvement to which FDA committed in its Closer to Zero Action Plan, which aims to lower levels of lead, cadmium, mercury, and inorganic arsenic in food that babies and young children eat and drink.

The challenge now is to translate the tighter daily maximum intake level into action levels for specific foods. Next steps for FDA should include:

  • Further tightening its recently proposed action level for lead in juice.
  • Using the revised lead IRLs as:
    • The basis for its proposal for foods commonly consumed by babies and young children – currently stuck in the review process at the White House’s Office of Management and Budget (OMB).
    • A model for FDA’s anticipated IRLs for inorganic arsenic and cadmium under its Closer to Zero program.

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Tara Flour: A Reminder of the Real-Life Consequences of Broken GRAS

Tom Neltner, Senior Director, Safer Chemicals and Maricel Maffini, EDF consultant

This blog is the fifth in our Broken GRAS series where we explore the Food and Drug Administration’s (FDA) Generally Recognized as Safe (GRAS) system for novel chemicals added to food.

In the spring, folks who ordered from a company that sells pre-assembled smoothies and other frozen foods for home delivery, started getting sick—really sick—after consuming an item called “French Lentil and Leek Crumbles” (Crumbles). Daily Harvest, the manufacturer, recalled the product on June 17. A month later, Daily Harvest said it had ruled out various food-borne pathogens, mycotoxins, heavy metals, and major allergens and had “identified tara flour as the cause of the issue.”

By the end of July, FDA reported the product had been linked to 329 illnesses and 113 hospitalizations in 36 states—a surprising number for a product that sold only 28,000 items. Consumer Reports described the health effects as fever, fatigue, vomiting, diarrhea, and liver problems. At least 25 people who consumed the Crumbles required surgery to remove their gallbladders. Read More »

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Unleaded Juice: Getting Credible Lab Results is Essential

Tom Neltner, Senior Director, Safer Chemicals

This is the third in our Unleaded Juice blog series exploring how the Food and Drug Administration (FDA) sets limits for toxic elements like lead, arsenic, and cadmium in food and the implications for the agency’s Closer To Zero program.

FDA’s move to establish action levels on lead in juice – and eventually other foods that young children eat or drink – is an important step forward. While we believe that the action levels need to be tougher, any action level has a limited value if labs that analyze samples for contamination provide results that buyers, regulators, or consumers cannot trust.

We recommend that labs meet four criteria to provide credible results:

  • Be accredited under international standards for testing and calibration of labs (ISO/IEC 17025);
  • Use the analytical method based on FDA’s Method 4.7 [PDF, 1.16MB];
  • Demonstrate proficiency in a third-party, blinded test to quantify lead, arsenic, and cadmium to around 6 parts per billion (ppb); and
  • Provide a written report of results at that level.

Here is the list of labs that met these criteria as of August 2021. See below for our in-depth analysis.

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