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How Does the PC Rule Relate to Heavy Metal Levels in Baby Food?

When this report was publicized several weeks ago it had an inflammatory tone to it that I felt would continue to burn for a while.  It was evident that FDA would be put under pressure for a robust response and that industry sectors would worry about whether “they were next” for scrutiny.

So it is not surprising that there is a  further response from FDA to the Congressional Report citing high levels of heavy metals in baby foods for which it recommended specific actions be taken by FDA (detailed in TAG’s February 25 Insights article). Recently the agency announced actions it is taking to further reduce toxic elements in baby and toddler foods. With even the name of the Congressional Report: “Baby foods are tainted with dangerous levels of arsenic, lead, cadmium, and mercury” taking over media headlines and generating parental concern, there was no question that FDA would need to take some action and that industry would be impacted. 

That impact became clear earlier this month when FDA issued a letter to industry reminding baby and toddler food manufacturers “of their existing responsibilities related to these efforts” and noting further initiatives that will be implemented for the safety of these foods. Those existing responsibilities revolve primarily around the Preventive Controls Rule.

Under the PC Rule, manufacturers must consider chemical hazards that may be present in foods through a hazard analysis. As listed in 21 CFR 117.130(b)(1)(ii), chemical hazards include “radiological hazards, substances such as pesticide and drug residues, natural toxins, decomposition, unapproved food or color additives, and food allergens.” Although natural toxins, including heavy metals, are present in the environment – in air, water and soil – and are unavoidable in the general food supply, even relatively low levels can be dangerous, particularly in the foods of babies, young children, and other vulnerable populations.

Because of that, the PC Rule requires that facilities have and implement a written food safety plan with a hazard analysis – including analysis of natural toxins. The hazard analysis must:

  • Identify and evaluate, based on experience, illness data, scientific reports, and other information, known or reasonably foreseeable hazards for each type of food manufactured, processed, packed, or held at the facility.
  • Assess the severity of the illness or injury if the hazard were to occur and the probability that the hazard will occur in the absence of preventive controls.
  • If it is determined that there is a hazard could occur, a preventive control must be established and maintained.

In this case, the emphasis is on the natural toxins/heavy metals of arsenic, mercury, cadmium and lead which occur naturally in the environment, so can be in the ingredients used for baby and toddler foods. But because they can cause serious health risks in these vulnerable populations, they need to be significantly limited in their foods. So heavy metals would constitute a chemical hazard requiring a preventive control to significantly minimize the potentially high levels of the toxic elements at or below the regulated levels. And that hazard analysis and the determined preventive controls must be included in the written Food Safety Plan.

As FDA stated, this is an existing responsibility under FSMA. But because of the increased concern, the agency intends to increase its inspections, taking any appropriate compliance and enforcement actions. So if you produce any foods for babies or young children, we would advise you (particularly those cited in the Congressional Report) to conduct your own internal assessments to first determine if the levels of heavy metals in your products would raise concern, then ensure that you have no gaps in your hazard analysis and written components of your food safety plan around heavy metals. But I see three huge challenges:

  1. There is little written by FDA around regulatory standards for heavy metals other than in seafood, rice, some juices, water, and candy.
  2. Given the nature of heavy metals in the soil, even when you find high levels it is very difficult to manage your ingredient sourcing and supply chain to mitigate these issues.
  3. Communicating the facts to the public will not be easy. As noted in the title of the Congressional Report it is very easy to create a perception that foods are dangerous. It is much more difficult to properly communicate a risk/benefit message around consumption of heavy metals, especially in vulnerable populations like newborns and small children.

Moving forward I recommend that you  keep an eye on this space, as FDA has further stated that it will be issuing guidance to identify action levels for contaminants in key foods, with plans to revisit those levels on a regular basis and lower them if appropriate; providing guidance to industry on how to meet their obligations under current regulations; boosting sampling of foods for babies and young children, including sharing results; supporting research and development on toxic elements and steps industry can take to further reduce levels. The agency also will be finalizing an action level for inorganic arsenic in infant rice cereal and developing additional action levels, finalizing draft guidance on reducing inorganic arsenic in apple juice and publishing draft guidance for action levels for lead in juices increasing sampling and reporting; ramping up consumer communication, and holding a public workshop to discuss the science of levels resulting in developmental impacts and solutions for protection.

So while this may not be a problem that is easily solved, it is important for you to be able to state – with confidence – that you are following all FDA recommended guidelines and regulatory requirements.

If you have questions about heavy metal levels in your products or how to reduce them, give TAG a call. We can help.

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