Development of an Enhanced Systematic Process for FDA’s Post-Market Assessment of Chemicals in Food; Public Meeting; Request for Comments

Dear Deputy Commissioner Jones: The Northwest Horticultural Council (NHC) writes today to provide comment regarding Docket No. FDA-2024-N-3609-0001, the "Development of an Enhanced Systemic Process for the FDA's Post-Market Assessment of Chemicals in Food." The NHC represents the growers, packers, and shippers of apples, pears, and cherries in Washington, Oregon, and Idaho. Our growers produce 64 percent of the apples (supplying 74 percent of the U.S. fresh market), 85 percent of the fresh pears, and 67 percent of the fresh sweet cherries grown in the United States. It is indisputable that the fruits produced by the growers we represent are healthful and contribute to a nutritious diet in both children and adults. The NHC firmly believes that regulatory decisions must be based on sound science that is representative of the topic at hand and conducted in a manner that is applicable to real world conditions. We therefore appreciate the science-based approach proposed in the "Discussion Paper on the Development of an Enhanced Systematic Process for the FDA's Post-Market Assessment of Chemicals." In particular, we are pleased that the agency intends to evaluate the quality and impact of scientific information identified through the food chemical signal monitoring process prior to determining whether it will be used in an assessment. Unfortunately, it appears that the agency is poised to base regulatory policy decisions as it relates to heavy metals in food based on a study that does not meet scientific rigor. In particular, we are concerned with the small sample size, lack of information necessary to indicate whether the data utilized is representative of real world conditions, and the lack of transparency in the methodology utilized in the study entitled "Infants' and young children's dietary exposures to lead and cadmium: FDA total dietary study 2018-2020" by Dana Hoffman-Pennesi, Sarah Winfield, Alexandra Gavelek, Sofia M. Santillana Farakos, and Judith Spungen of FDA, which was published by the Taylor & Francis Group in August of 2024 (Hoffman-Pennesi, et al., 2024). Please see the attachment for a copy of the NHC's full comments outlining these concerns. In spite of these significant deficiencies, the published paper states that the study "…serves as a baseline for dietary lead and cadmium estimated exposures for the FDA's (Closer to Zero) program, which is focused on reducing exposures and prioritizing the types of research and regulatory efforts for reducing exposures to lead and cadmium." In conclusion, the NHC supports the concept of a science-based approach to a systematic process for the post-market assessment of chemicals by FDA, in particular the evaluation of the quality and impact of scientific information identified through the food chemical signal monitoring process prior to determining whether it will be used in an assessment. We are concerned that the scientific information provided in the study entitled "Infants' and young children's dietary exposures to lead and cadmium: FDA total dietary study 2018-2020" fails to meet an acceptable quality standard due to the many reasons mentioned in our attached comments. We strongly urge the agency to not utilize the study's conclusions as a basis for their regulatory efforts on heavy metals. Sincerely, NORTHWEST HORTICULTURAL COUNCIL Kate Tynan Senior Vice President