resulting voluntary recall (and the temporary shutdown of the plant) was a major contributing factor to the infant formula shortage experienced across the United States in 2022. Better understanding of the factors that contribute to Cronobacter spp. contamination of powdered infant formula and the production environment is needed to increase the effectiveness of prevention and management strategies.

Charge Questions for the NACMCF Subcommittee:

1. What are the current prevalence and level of Cronobacter spp. contamination in powdered infant formula in the U.S. market? What is known about Cronobacter spp. in other foods and in the home environment and the frequency with which these foods and environmental sources contribute to human infections?
2. What factors (e.g., virulence factors, host factors, dose of exposure) place an infant at greater risk for Cronobacter spp. infection and serious adverse health consequences or death?
3. What food safety management practices (e.g., facility and equipment design, hygienic zoning and packaging, preventive controls, verification activities) should manufacturers of powdered infant formula employ to further reduce the risk of Cronobacter spp. contamination of formula and the production environment?
4. Given that powdered infant formula is not sterile, how could food safety messaging be improved for infant care providers, with emphasis on use of sterile, ready-to-use formulas for infants at greatest risk and safe infant formula preparation and storage for infant formula in general?

PROTEIN QUALITY AND GROWTH MONITORING STUDIES TO SATISFY QUALITY FACTOR REQUIREMENTS FOR INFANT FORMULA

The National Academies of Sciences, Engineering, and Medicine will convene a committee of experts to undertake a review and assessment of the current scientific evidence on the state of the science regarding methodologies for assessing the biological quality of protein in an infant formula and the state of the science regarding methodologies for assessing the ability of an infant formula to support normal growth (NASEM, 2024). In its review of evidence, the committee will consider:

1. the strengths and weaknesses of study designs that may be in common use in other global regions;

2. the extent to which specific study designs have been validated; and
3. the appropriateness of specific animal models.

The committee will produce a report that includes a detailed evaluation of the state of the science on methodologies for assessing protein quality in infant formula and the ability of infant formula to support normal physical growth. The committee will also recommend alternate study designs and supplementary information that could potentially be used to show whether the biological quality of protein in infant formula and its ability to support normal physical growth have both been met and are consistent with regulatory standards.

UNDERSTANDING BREASTFEEDING PROMOTION, INITIATION, AND SUPPORT ACROSS THE UNITED STATES: AN ANALYSIS

The National Academies of Sciences, Engineering, and Medicine will convene an ad hoc committee of experts to use available data and literature to conduct a consensus study on policies, programs, and investments to better understand the landscape of breastfeeding promotion, initiation, and support across the United States. The study will provide an evidence-based analysis of the macroeconomic, social, and health costs and benefits of the United States’ current breastfeeding rates and goals. The study will build on what is known about inequalities in breastfeeding rates and reducing racial, geographic, and income-related breastfeeding disparities. The committee will identify existing gaps in knowledge and areas for needed research, and will discuss challenges in data collection to address said gaps.

Based on available evidence, the committee will address the following issues and offer conclusions and recommendations:

1. Best practices for clinicians, health care systems, and employers to encourage breastfeeding by new mothers and to support mothers who are currently breastfeeding, including mothers from minority and marginalized populations and those experiencing poverty
2. Macroeconomic, health, and social costs of current U.S. breastfeeding rates
3. Funding mechanisms, state and federal policies, interventions, and systemic, cross-sector, or field innovations that can support exclusive breastfeeding through the first 6 months of life and/or address racial/ethnic and socioeconomic disparities and other marginalizing factors
4. Racial, geographic, and age- and income-related disparities and contributing social determinants of health that impact breastfeeding

rates and access to postpartum maternal care and supportive services (e.g., lactation consultant, doula support, registered dietitians)

5. Leverage of available evidence to meet the Healthy People Maternal, Infant, and Child Health (MICH) breastfeeding goals by 2030

REFERENCES