FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS
FOOD AND DRUG ADMINISTRATION
OFFICE OF GLOBAL REGULATORY OPERATIONS AND POLICY
OFFICE OF REGULATORY AFFAIRS
OFFICE OF OPERATIONS
REGIONAL FIELD OFFICE, SOUTHWEST REGION, DALLAS, TX
DISTRICT OFFICE - KANSAS CITY, MO
Effective Date: 08/07/2012
1. DISTRICT OFFICE - KANSAS CITY, MO (DLLRWC).
A. Provides managerial direction to that portion of the Agency's field programs assigned to the District to achieve compliance with the laws and regulations for which the District is responsible through appropriate voluntary correction or regulatory action.
B. Manages resource allocations, money, and people and evaluates use of the resources to assure program accomplishments.
C. Conducts investigations and inspections and analyzes samples of foods, drugs, and other commodities for which the Agency has regulatory responsibility.
D. Determines the acceptability of items, subject to the Agency's jurisdiction, for entry into this country through examination of available records, product inspection, or by sampling and laboratory examination of the product followed by release, detention, and/or refusal.
E. Conducts administrative (Sec. 305-Citation) meetings on alleged violations and initiates appropriate enforcement action.
F. Recommends legal action to Headquarters and the Office of the Chief Counsel and maintains a working liaison with U.S. Attorneys and U.S. Marshals in implementing approved actions.
G. Provides analytical and inspectional support in programs for which the Agency has responsibility.
H. Conducts research to develop and refine analytical methodology and to explore new systems of analysis.
I. Manages and evaluates program activities, measures accomplishments against annual field workplan objectives, initiates management and program analyses, manages a quality assurance program, and advises the Regional Food and Drug Director regarding strategy changes needed to reach existing or modified objectives.
J. Develops short- and long-range workplans, staffing needs, and budgetary proposals for the District's assigned portion of nationwide and regional programs.
K. Advises the Regional Food and Drug Director and appropriate Headquarters components on new or emerging problems and trends, future program needs and priorities, State legislative activities, manpower, equipment, financial needs, and long-range planning.
L. Manages, evaluates, and audits the program aspects of Federal-State contracts.
M. Manages an equal employment opportunity and career development and training program.
N. Conducts public affairs and information programs; receives and responds to consumer inquiries and complaints.
O. Coordinates emergency activities by maintaining liaison with other Federal agencies and by providing assistance to States and localities in the event of a national disaster or other emergency.
P. Provides management support for all program and operational activities, including budget and fiscal, contracts and procurement, personnel management, and the management of facilities, services, and supplies.
Q. Maintains working liaison with other Federal offices providing support services to the Agency.
R. Manages and directs District automated data processing and management.
S. Conducts studies and surveys of issues, operations and procedures, and evaluations to measure program effectiveness and accomplishments against the field workplan objectives.
T. Coordinates the equal employment opportunity, internal security, safety, and emergency preparedness programs.
2. INVESTIGATIONS BRANCH (DLLRWC3).
A. Inspects establishments subject to laws and regulations enforced by the Agency; collects samples for analysis; performs field examinations; and prepares reports on findings of each inspection.
B. Evaluates inspectional and analytical findings relative to compliance or noncompliance and recommends appropriate follow up. Makes recommendations to other District Offices when regulatory action is indicated.
C. Performs special investigations, including District responsibilities under the Government-wide Quality Assurance Program; investigates reports of adverse experience with any Agency-regulated products; and performs epidemiological investigations of food poisonings and premarketing clearance investigations of drugs and devices.
D. Monitors recalls and performs follow-up activities to assess recall effectiveness and prevent recurrences.
E. Provides inspectional and investigational support to the Headquarters components as needed.
F. Plans, schedules, and controls inspectional operations; and formulates, implements, and coordinates domestic and import investigational workplans.
G. Provides counsel and training regarding inspectional techniques and technical developments to other Federal agencies; to State, local, and foreign counterpart agencies; and to industry in order to promote voluntary compliance efforts.
H. Maintains cooperative relationships with State and local counterpart agencies and develops work and information sharing agreements.
I. Manages, evaluates, and audits the program aspects of Federal-State contracts.
J. Prepares and provides evidence of investigational findings as requested.
K. Maintains liaison with U.S. Customs officials to facilitate investigations and sampling of articles being imported or offered for import.
L. Detains medical devices after appropriate clearance has been obtained by the District Compliance Branch, and, in cooperation with USDA, detains meat, poultry, or egg products that may be violative.
M. Receives and responds to consumer complaints.
Resident Posts: Wichita KS (DLLRWC3A); Omaha NE (DLLRWC3B); Des Moines IA (DLLRWC3D); and Springfield MO (DLLRWC3E).
Inspect establishments subject to laws and regulations enforced by the Agency; conduct special investigations; collect samples for analysis; perform field analyses; and prepare reports on findings of each inspection and/or investigation. Maintain cooperative relationships with State and local counterpart agencies, and develop work and information sharing agreements. Present public education and information programs to schools and other organizations.
3. SCIENCE OPERATIONS BRANCH (DLLRWC4).
A. Plans, schedules, and controls laboratory operations; and formulates, implements, and coordinates laboratory workplans.
B. Performs laboratory analysis of samples to:
1. Assess their compliance with laws and regulations enforced by the Agency; and
2. Obtain information through national surveillance programs for the purpose of identifying potential problems or trends.
C. Provides evidence regarding analytical findings as requested.
D. Conducts research to develop and refine methodology used in the analysis of samples and to explore new systems of analysis.
E. Serves as a resource in scientific knowledge and provides expert advice and training regarding laboratory techniques and technological developments to other Federal agencies, State and local agencies, foreign counterpart agencies, and industry.
F. Maintains liaison with scientists and scientific bodies with interests pertinent to laboratory activities.
G. Provides analytical support to Headquarters components as needed.
H. Participates in team inspections as necessary.
4. TOTAL DIET AND PESTICIDE RESEARCH CENTER (DLLRWC5).
A. Develops, refines, and extends analytical methodology for determining pesticide and industrial chemical residues and elements in foods, animal feeds, and related materials; conducts studies to develop and adapt analytical methodology, techniques, and instrumentation for use in the Total Diet Studies (TDS).
B. Develops and maintains the capability to conduct complex analyses for pesticide and industrial chemical residues of special public health concern. Performs these types of analyses as necessary. Performs difficult and/or unusual analyses of TDS samples which cannot be readily processed by the Total Diet Laboratory (TDL). Develops systems to automate analysis and data handling for pesticide residue and elements analyses and the TDS.
C. Conducts and participates in collaborative studies of analytical methods. Transfers methodology developed through research efforts to ORA regulatory laboratories and the TDL as appropriate.
D. Provides expert technical scientific assistance and consultative services to the Agency in areas related to pesticide and industrial chemical residue and elements analyses. Trains FDA and other visiting chemists in pesticide and industrial chemical residue and Total Diet analyses.
E. Investigates and conducts research to determine the existence of new/and or unusual potentially hazardous pesticide and industrial chemical residues in foods, animal feeds and related materials; gathers information on pesticide usage. Conducts research to identify significant unidentified chemical contaminants in foods, animal feeds, and related materials.
F. Assists the Center for Food Safety and Applied Nutrition in the:
1. development of revised model diets;
2. development of protocols for analysis of individual foods to determine contaminant or nutrient levels in the complete diet;
3. Preparation of scientific and consumer oriented documents covering the total diet studies.
G. Assists the Center for Veterinary Medicine in the development of protocols for the analysis of animal feeds to determine pesticide and industrial chemical residues.
H. Assists headquarter program managers in preparing compliance programs for pesticides and the TDS.
Resident Posts: St. Louis, MO (DLLRWC6); and Davenport IA (DLLRWC6B).
Inspects establishments subject to laws and regulations enforced by the Agency; conducts special investigations; collects samples for analysis; performs field analyses; and prepares reports on findings of each inspection and/or investigation. Maintains cooperative relationships with State and local counterpart agencies, and develops work and information sharing agreements. Presents consumer education and information programs to schools and other organizations.
5. COMPLIANCE BRANCH (DLLRWC7).
A. Reviews and evaluates evidence and findings indicating a possible lack of compliance with Agency-enforced laws and regulations; determines the most suitable course of action and, if necessary, recommends legal action to Headquarters, and the Office of the Chief Counsel; and maintains working liaison with the U.S. attorneys and U.S. marshals in implementing approved action.
B. Assures the court-ordered actions are completed on time and in total fulfillment of the court's order.
C. Conducts administrative (Sec. 305-Citation) meetings on alleged violations and initiates enforcement action.
D. Issues warning letters to regulated industry appropriate to violative conditions found, and issues notices of detention and refusals on violative import products.
E. Answers inquiries from other Federal agencies, foreign missions, industry, and importers regarding interpretations of Agency-enforced laws and regulations, case status, and enforcement policies.
F. Institutes and coordinates detentions and refusals of violative products offered for import.
G. Assists State and local cooperative officials in the development of uniform legislation, codes, and regulations. Advises cooperative officials on interpretation of Federal laws, regulations and enforcement policies, and provides consultation relative to joint regulatory approaches.
H. Assists the Investigations Branch in obtaining a clearance from centers and the District Director for administrative device and other detentions; prepares related correspondence; and assists in preparations for detention hearings.
I. Plans, organizes, and implements in cooperation with other field components, comprehensive industry education, training, and technical advice programs designed to promote voluntary compliance and self regulation by industries and industry associations, research institutions, and professional practitioners.
J. Directs a freedom of information program consistent with Agency policy.
6. AUTHORITY AND EFFECTIVE DATE.
The functional statements for this District were approved by the Commissioner of Food and Drugs, effective August 7, 2012.