FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS
FOOD AND DRUG ADMINISTRATION
OFFICE OF FOODS AND VETERINARY MEDICINE
CENTER FOR FOOD SAFETY AND APPLIED NUTRITION
OFFICE OF FOOD SAFETY
Effective Date: October 1, 2012
1. OFFICE OF FOOD SAFETY (DJJHD).
A. Develops regulations, guidance, policy, programs, position papers, and advisory opinions, and recommends research priorities for issues related to food safety within the scope of the responsibility of the Office.
B. Conducts food safety assessments of chemical or microbial contamination.
C. Provides toxicological evaluations and quantitative risk assessments related to the presence of industrial chemicals, process induced toxicants and toxic elements in food.
D. Provides expert advice to the Center Director, Deputy Center Directors, and other Center, Agency, and government officials, as well as industry, international and other organizations on food safety programs and policies.
E. Provides expertise in acidified and low acid food technologies, including the registration and evaluation of filed processes.
F. As necessary, reviews industry petitions and regulatory actions, including information about proposed enforcement actions that is provided by the Office of Compliance, to determine if those actions within OFS’s purview are supported by relevant science and established program priorities, policy, and guidance; determines, where policy or guidance do not exist, whether the Office can provide expert scientific testimony to support the actions; and provides technical review of laboratory analyses supporting proposed enforcement actions.
2. RETAIL FOOD AND COOPERATIVE PROGRAMS COORDINATION STAFF (DJJHD1).
A. Supports interaction and collaboration among Federal and State partners in each of the three cooperative program areas which are shellfish safety, milk safety and retail food protection, and coordinates activities in support of the Partnership for Food Protection.
B. Maintains the Interstate Certified Shellfish Shippers List, the Interstate Milk Shippers List and the list of jurisdictions enrolled in the Voluntary National Retail Food Regulatory Program Standards.
C. Serves as Agency liaison with State partners, other Federal agencies, and industry associations in administering the federal portion of the federal/state cooperative retail food protection program.
D. Develops and promotes the adoption and implementation of the FDA Food Code, the National Retail Food Regulatory Program Standards and related agency policy for sound public health practices.
E. Identifies and characterizes existing emerging and potential health hazards associated with preparation and service of food at the retail level.
F. Provides technical support, geographic information systems capacity, and outreach to FDA staff and other Federal, State, and Local officials on the Food Code and other agency guidance related to retail food protection.
3. PRODUCE SAFETY STAFF (DJJHD2).
A. Develops, collects, and interprets data regarding the microbial safety and defense of fresh and fresh-cut produce.
B. Develops policy, regulations, regulatory guidelines, advisory opinions, position papers, and compliance strategies and policy on the microbial safety of fresh and fresh-cut produce
C. Reviews petitions on the microbial safety of fresh and fresh-cut produce related to this office
D. Serves as the agency focal point for the development and evaluation of programs and the implementation of the laws and regulations related to this office regarding microbial safety of fresh and fresh-cut produce.
E. Serves as the principal Center liaison on microbial fresh and fresh cut produce safety programs and policies with industry, Federal, State, and foreign governments, and other organizations outside the Agency.
F. Provides expert program policy, scientific and technical advice, and assistance to the Center Director, FDA senior officials , ,FDA field and external stakeholders on microbial fresh and fresh-cut produce safety and defense issues, field programs, produce initiatives, the conduct of international activities including the development and implementation of bilateral agreements, and other related activities.
G. Reviews proposed regulatory actions referred by the Office of Compliance for program policy consideration and provides technical evaluation and necessary scientific support on cases related to the microbial safety of fresh and fresh-cut produce.
4. AUTHORITY AND EFFECTIVE DATE.
The functional statements for this Office were approved by the Secretary of Health and Human Services, effective October 1, 2012.