RE: Action Levels for Lead in Food Intended for Babies and Young Children: Draft Guidance for Industry; Availability

Baby being fed baby food

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Docket No. FDA-2022-D-0278

CSPI respectfully submits these final comments on lead in food intended for babies and young children to the docket (Docket No. FDA-2022-D-0278) (the Draft Baby Food Guidance). CSPI supports efforts by the FDA to reduce children’s dietary exposure to lead.

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March 27, 2023

RE: Action Levels for Lead in Food Intended for Babies and Young Children: Draft Guidance for Industry; Availability (Docket No. FDA-2022-D-0278)

The Center for Science in the Public Interest (CSPI) respectfully submits these comments on FDA’s draft action levels and guidance on lead in food intended for babies and young children to the docket (Docket No. FDA-2022-D-0278). CSPI supports the efforts undertaken by the U.S. Food and Drug Administration (FDA) to reduce children’s dietary exposure to lead.

CSPI is a non-profit consumer education and advocacy organization that has worked since 1971 to improve the public’s health through better nutrition and safer food. The organization does not accept government grants or corporate donations. A core part of CSPI’s mission is providing consumers with current information about their health and well-being. CSPI publishes Nutrition Action, which provides science-based advice on health and nutrition to hundreds of thousands of readers. CSPI regularly advocates for greater transparency, disclosure, and the safety of food ingredients.

There is no safe level of lead exposure for children, a fact recognized by FDA and other U.S. and global health authorities. Reviews by Rice et al. and Mushak concluded that infants and young children are especially susceptible to the neurotoxic effects of heavy metals because their brains are still developing and because they absorb lead at higher rates than adults. Reducing heavy metal contamination in children’s foods is essential to protecting public health.

As there are currently no standards for lead in children’s foods, we applaud the fact that the FDA has drafted action levels for lead of 10 ppb for fruits, vegetables, mixtures, yogurts, custards/puddings, and single-ingredient meats and 20 ppb for single-ingredient root vegetables and dry infant cereals. Additionally, we are encouraged by the recent reduction of the interim reference level (IRL) for lead in children from 3 µg/day (used in the juice guidance) to 2.2 µg/day in the current guidance. The IRL is “a measure of exposure from food that the FDA may use to determine if the amount of exposure to an individual element across foods could result in a specific health impact.” While the level of 2.2 µg/day may still be too high considering that no level of lead exposure is safe, it is an improvement from the previously established IRL. We urge the agency to utilize the 2.2 µg/day level or below when it finalizes both the current draft guidance and the draft guidance for juice.

While we are supportive of the agency’s goal and recognize that these action levels will help reduce children’s dietary lead exposures, we have concerns about the manner in which these action levels were derived and find the lack of detail in the draft guidance lowers our confidence that these proposed action levels are the most protective action levels the agency could propose.

Unlike in FDA’s draft guidance on lead in juice, which explicitly used a problematic achievability-driven approach to setting action levels (i.e., the agency specified that action levels were set using an approach intended to ensure 95% of products on the market would meet the standard), in the present draft guidance, the agency framed its approach as one driven by exposure. In comments submitted to the agency last June, CSPI criticized FDA for its use of an achievability-driven approach when proposing action levels for lead in juice. Thus, we were encouraged to see this purported refocusing on exposure, rather than achievability. However, due to a lack of detail, it is unclear how the agency operationalized this shift in focus. In particular, it is unclear what the quantitative exposure benchmarks of success were and whether those benchmarks were directly used as the foundation for the proposed action levels for lead in foods intended for children. We are concerned that these action levels were arbitrarily derived and give undue deference to achievability.

Moreover, CSPI considers the term “achievability,” as used by the FDA in its Closer to Zero Action Plan, to be a misnomer. As with juice, the agency defined achievability in this draft guidance based on current levels of contamination (i.e., what the market has already achieved). Instead, achievability should be based on what is attainable through implementation of existing best practices or development of new best practices to limit lead in these products (i.e., what industry can achieve in the future with the most advanced efforts to drive lead contamination to zero using existing or novel techniques). In other words, if there are manufacturers that have already developed and implemented effective methods for limiting lead content in finished baby food products, FDA should determine what level of lead contamination in the market might be achieved if all manufacturers implemented those same practices.

Therefore, in these comments, we ask that FDA further revise its approach to better ground the Closer to Zero action plan in public health protection. FDA should establish an explicit public health goal, draft action levels required to achieve that goal, assess achievability (as we define it above, not as defined currently by FDA) in accomplishing that goal, and consider whether exceptions or flexibility are necessary while improvements to agricultural and manufacturing processes are sought and implemented to further reduce lead contamination in children’s foods.

Furthermore, we present results from a novel analysis we performed in response to the fear that enactment of strict action levels would result in reduced availability of nutritious foods for infants and young children. We show that the baby food industry requires less than 0.5% of all the carrots and sweet potatoes available on the U.S. market to meet the demands of children under 24 months of age. These findings should be considered when assessing the achievability of the baby food industry meeting strict health-protective action levels for root vegetable products. Responsible sourcing practices, either currently available or feasibly developed, should be able to reserve the least contaminated sweet potatoes and carrots for products specifically produced for babies and young children, while industry also strives to reduce heavy metal contamination across the whole sweet potato and carrot markets.

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