FDA Issues Draft Guidance on Action Levels of Lead in Food For Babies and Young Children

FDA issued Action Levels for Lead in Food Intended for Babies and Young Children: Draft Guidance for Industry. This document presents "the background and rationale for FDA’s action levels for lead in processed food intended for babies and young children:

• 10 parts per billion (ppb) for fruits, vegetables (excluding single-ingredient root vegetables), mixtures (including grain and meat-based mixtures), yogurts, custards/puddings, and single-ingredient meats;
• 20 ppb for root vegetables (single ingredient); and
• 20 ppb for dry infant cereals

"These action levels reflect levels of lead at which FDA may regard the food as adulterated"

This Draft Guidance comes after a push to establish limits for heavy metals in baby food.

Lead is a challenge with regard to growing and processing food.  From the guidance, 

"Lead is widely present in the environment due to both its natural occurrence and to human activities that have introduced it into the environment. Because lead may be present in environments where food crops used to make food intended for babies and young children are grown, various foods may contain small amounts of lead. Potential sources of lead in food include contaminated soil where crops are grown, contaminated water, atmospheric deposition from industrial activities, and old lead-containing equipment used to process food. As a result of  the first three sources, agricultural crops (e.g., root vegetables) can take up lead from contaminated soil and contaminated soil may be deposited on plant surfaces (e.g., leafy vegetables and cereal grains). Studies suggest that manufacturers may be able to reduce lead levels in food by using practices such as thoroughly peeling root vegetables and thoroughly washing fruits and vegetables, particularly leafy vegetables (Refs. 3, 4, 5, 6). It is possible in some cases for manufacturers who have found elevated lead levels in sources of food intended for babies and young children to choose sources of food or food ingredients with lower lead levels or no detectable lead. Manufacturers could also consider increased testing of ingredients or finished products that are historically known to contain elevated lead levels; this is particularly important for ingredients or finished products intended for babies and young children. Additionally, manufacturers could consider examining their facilities, processes, and equipment to ensure that they are not contributing to lead in their products (Refs. 7, 8)."