FOOD AND DRUG ADMINISTRATION
OFFICE OF FOODS AND VETERINARY MEDICINE
CENTER FOR FOOD SAFETY AND APPLIED NUTRITION
OFFICE OF FOOD ADDITIVE SAFETY
DIVISION OF PETITION REVIEW
Effective Date: October 1, 2012
1. DIVISION OF PETITION REVIEW (DJJHGC).
A. Provides Center guidance and coordinates the technical evaluation of regulatory and scientific issues regarding direct food additives, food irradiation, and color additives, including industry actions.
B. Evaluates toxicological, nutritional, and microbiological data and information, and chemical data (including data on probable human exposure) submitted to the Agency by petitioners or from other sources, that pertain to the safety of direct food additives, irradiated food, and of color additives in foods, drugs, medical devices, or cosmetics.
C. Consults with prospective petitioners prior to filing, concerning proposed new uses of direct food additives and color additives, advising on petition content and approaches to meet statutory standards. Advises petitioners and other interested parties of any inadequacies that may preclude requested action on petitions reviewed by this Division.
D. Writes and amends, as needed, direct food additive and color additive regulations, procedural regulations, and guidelines to implement the provisions of the Federal Food, Drug, and Cosmetic Act specific to direct food additives and color additives.
E. Develops and redirects, as necessary, current policies, compliance efforts, and research dealing with direct food additive and color additive issues.
F. Develops and maintains information on the safety and use of direct food additives and color additives. Responds to stakeholder inquiries and processes Freedom of Information requests in a timely and efficient manner.
2. AUTHORITY AND EFFECTIVE DATE.
The functional statements for this Division were approved by the Secretary of Health and Human Services on, effective October 1, 2012.