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 COMPLIANCE
DIVISION OF ENFORCEMENT
Effective Date: October 1, 2012
1. DIVISION OF ENFORCEMENT (DJJHHA).
A. Serves as the Center’s point of contact for enforcement policy and priority inquiries, including recalls, from other agency units, industry, and other parties.
B. Manages reviews of regulatory actions recommended by agency field offices and other Agency components. Guides field offices activities, when necessary, in developing scientifically and legally supportable actions. Participates in case development strategy calls with the field and other Agency components.
C. Works with other Center and Agency units to develop compliance and enforcement strategies to address cross-cutting regulatory issues or emerging compliance challenges. Develops innovative enforcement solutions to novel, complex, and precedent-setting regulatory problems.
D. Evaluates import and domestic inspectional, investigational, and analytical evidence and determines whether to pursue a regulatory action or alternative remedy.
E. Evaluates recall recommendations, obtains scientific and technical support to document health risks associated with recalled products, and ensures that recall actions are consistent with Agency and Center policies.
F. Assists agency legal offices and field units and the Department of Justice in developing legal documents including declarations, obtaining experts, responding to interrogatories, and providing trial or other requested assistance. Represents the Center at enforcement negotiations.
G. Serves as an expert resource on foreign product compliance and participates in agency discussions, decisions, and fact finding for import and international issues for foreign country, product, and industry assessments.
H. Serves as the Center focal point for consumer complaints and daily Reportable Food Registry (RFR) / Risk Control Review activities. Maintains the Center RFR database and guides field follow-up to RFR reports.
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.