Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry; Availability

Attached are additional comments focusing on the Informational Quality Act aspects. We are also submitted corrected comments submitted on March 26 with links fixed.

See attached for full comment The Environmental Defense Fund (EDF) appreciates the opportunity to comment on Food and Drug Administration's (FDA) recently released draft guidance for action levels for lead in food intended for babies and young children. The proposed action levels are: •10 parts per billion (ppb) for fruits, vegetables (excluding single-ingredient root vegetables), mixtures, yogurts, custards/puddings, and single-ingredient meats; •20 ppb for root vegetables (single ingredient); and •20 ppb for dry infant cereals. If finalized without change, these levels would be the most stringent in the world, including current European standards of 20 ppb adopted in 2021. For that FDA deserves credit. We also compliment FDA for its clear statement in the proposal regarding the risks posed by lead: "Even low lead exposure can harm children's health and development, specifically the brain and nervous system. Neurological effects of lead exposure during early childhood include learning disabilities, behavior difficulties, and lowered IQ. Lead exposures also may be associated with immunological, cardiovascular, renal, and reproductive and/or developmental effects. Because lead can accumulate in the body, even low-level chronic exposure can be hazardous over time." [References omitted] Nonetheless, FDA needs to do more to translate that clear statement into real progress. It must do better in three areas in order to strengthen its Closer to Zero Initiative: •Improve the draft action levels by more closely applying the criteria FDA described in the draft guidance; •Improve the process that FDA uses to develop and communicate this and future action levels in its Closer to Zero Initiative; and •Along with USDA and industry, encourage and invest in research to reduce lead in baby food. These improvements are important for two reasons. First, these proposed action levels will reduce babies' and young toddlers' dietary exposure to lead by a mere 3.6%, according to an analysis commissioned by Healthy Babies Bright Futures (HBBF) that the organization will share in its separate comments on the proposal. While we recognize that 3.6% technically fulfills the goal of getting closer to zero, it is far too little to address the challenge posed by lead to children. Second, millions of babies and young toddlers currently exceed the agency's Interim Reference Level – essentially as daily maximum intake level – of 2.2 micrograms of lead per day (µg/day). For young children living in a home without lead pipes or lead paint, diet is the dominant source of their lead exposure. Potential sources of lead in food include contaminated soil where crops are grown, contaminated water, atmospheric deposition from industrial activities and small-engine aircraft, food containers and handling equipment (including brass and bronze in water fixtures and tin alloys used to make food cans), and old lead-containing equipment used to process food.