FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS
FOOD AND DRUG ADMINISTRATIONOFFICE OF FOODS
OFFICE OF FOODS AND VETERINARY MEDICINE
CENTER FOR FOOD SAFETY AND APPLIED NUTRITION
OFFICE OF APPLIED RESEARCH AND SAFETY ASSESSMENT
DIVISION OF TOXICOLOGY
Effective Date: October 1, 2012
1. DIVISION OF TOXICOLOGY (DJJHIC).
A. Provides the Center and Agency leadership in the areas of developmental/reproductive toxicology, hepatotoxicity and neuro-and immunotoxicology.
B. Recommends, develops, coordinates and conducts research to assess the toxic effects of substances for which the Center has regulatory responsibilities and investigates mechanisms of the underlying toxicological reactions independently and in collaboration with other Centers, Agencies and entities in support of the Center’s goals.
C. Interacts, collaborates with and provides support to external programs in designing appropriate experiments which assess the toxic effects of substances for which the Center has regulatory responsibilities.
D. Develops and/or validates systems that may serve to refine, reduce or replace animal models.
E. Conducts toxicological studies which support the Center’s regulatory responsibilities including: assessing and collecting data applicable to guideline development, the evaluation of petitions and proposals, the review of current tolerances, providing recommendations on toxicological product evaluation criteria, the review of protocols relating to the review and approval process of new substances and for the reaffirmation of marketed substances.
2. AUTHORITY AND EFFECTIVE DATE.
The functional statements for this Division were approved by the Secretary of Health and Human Services effective October 1, 2012.