FDA is working to decrease exposure to toxic elements for babies and young children to as low as possible. The new action plan, entitled Closer to Zero, will aim to reduce the toxic elements in foods commonly eaten by babies and young children. The plan follows a February 2021 Congressional report calling on federal regulators to set stricter standards on baby food manufacturers after an investigation into these foods found toxic heavy metals, including arsenic, present.
FDA’s action plan will follow an approach that includes research, regulatory, and outreach efforts. It will start by evaluating existing data from routine testing of the food supply, exposure, risk assessments, and other relevant scientific information. The agency will also consult with stakeholders and experts and will take what it discovers to make any needed adjustments and finalize action levels.
It’s difficult to determine which foods are tainted with heavy metals. “Reducing levels of toxic elements in foods is complicated and multifaceted,” said Janet Woodcock, FDA’s acting commissioner, in a statement. “It is crucial to ensure that measures taken to limit toxic elements in foods do not have unintended consequences—like eliminating from the marketplace foods that have significant nutritional benefits or reducing the presence of one toxic element while increasing another.”
Some believe that, since the plan is designed to produce recommendations and not final standards, FDA has set the bar too low. “Generally, it’s a good sign that FDA has developed a timeline to help guide their work, since it creates some accountability,” Laurie Beyranevand, director for the center for agriculture and food systems at Vermont Law School in South Royalton, tells Food Quality & Safety. “However, FDA is proposing setting action levels for these substances rather than enforceable tolerance levels. From a legal perspective, this may not go far enough ,since action levels are nonbinding—meaning they cannot be used as the basis for an enforcement action, whereas a tolerance level set by regulation can.”
Given the magnitude of this issue and the significant public health challenges this presents to a vulnerable population, she believes interim action levels may be appropriate as the agency develops tolerance levels through regulation, but the public may feel more comfortable with a stronger level of agency oversight.
“From a legal perspective, action levels present an additional challenge in the sense they may not be considered final agency action given their nonbinding nature,” Beyranevand says. “Consequently, if advocates seek to challenge the action levels ultimately set by FDA, they may run into obstacles in court preventing them from doing so.”
FDA says that its data shows that children are not at an immediate health risk from exposure to toxic elements at the levels found in foods today, so, while there is a desire to decrease the amount, it believes its short- and long-term goals for achieving continued improvements in reducing levels of toxic elements in these foods over time is justified.