Infant toxicology: state of the science and considerations in evaluation of safety.
Differences in the physiology and biological susceptibilities of adults and infants have led to growing interest in safety evaluation methods for exposures from infant formula packaging. In addition to potential physiological differences, infants aged 0-6 months may consume a sole source of food, infant formula or breast milk, and consume higher amounts of food relative to body weight compared to adults. While the duration of the exposure is short compared to the expected lifespan of the individual, it occurs during a period of important developmental processes. The purpose of this document is to (1) review key biological and exposure elements that may impact the evaluation of safety for food contact products intended for use by infants, (2) summarize the current reproductive and developmental toxicity testing protocols available, and (3) identify potential data gaps concerning this period of development.
United States Food and Drug Administration, Center For Food Safety and Applied Nutrition, Office of Food Additive Safety, Division of Food Contact Notifications, United States. Electronic address: april.kluever@fda.hhs.gov.
April
A
Neal-Kluever
United States Food and Drug Administration, Center For Food Safety and Applied Nutrition, Office of Food Additive Safety, Division of Food Contact Notifications, United States.
Jason
J
Aungst
United States Food and Drug Administration, Center For Food Safety and Applied Nutrition, Office of Food Additive Safety, Division of Food Contact Notifications, United States.
Yan
Y
Gu
United States Food and Drug Administration, Center For Food Safety and Applied Nutrition, Office of Food Additive Safety, Division of Food Contact Notifications, United States.
Karen
K
Hatwell
United States Food and Drug Administration, Center For Food Safety and Applied Nutrition, Office of Food Additive Safety, Division of Food Contact Notifications, United States.
Kristi
K
Muldoon-Jacobs
Oak Ridge Institute for Science and Education (ORISE), United States.
Ayesha
A
Liem
United States Food and Drug Administration, Center For Food Safety and Applied Nutrition, Office of Food Additive Safety, Division of Food Contact Notifications, United States.
Adejoke
A
Ogungbesan
United States Food and Drug Administration, Center For Food Safety and Applied Nutrition, Office of Food Additive Safety, Division of Food Contact Notifications, United States.
Mary
M
Shackelford
D002657:Child Development; D004032:Diet; D004703:Endocrine System / Q000187:drug effects / Q000254:growth & development; D023381:Endpoint Determination; D018857:Food Packaging; D006801:Humans; D007107:Immune System / Q000187:drug effects / Q000254:growth & development; D007223:Infant; D007225:Infant Food / Q000032:analysis*; D009420:Nervous System / Q000187:drug effects / Q000254:growth & development; D011181:Postnatal Care; D015203:Reproducibility of Results; D012098:Reproduction / Q000187:drug effects; D018570:Risk Assessment; D018675:Toxicity Tests / Q000379:methods*; D066007:Toxicokinetics
Developmental toxicology; Infants; Safety assessment; Toxicology