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SMG 1315.5
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, DALLAS, TX
ARKANSAS REGIONAL LABORATORY
Effective Date: 08/07/2012
1. ARKANSAS REGIONAL LABORATORY (DLLRWG).
A. Plans, schedules, and controls regional laboratory operations; formulates, implements, and coordinates domestic and import analytical work plans and schedules with offices being served.
B. Conducts laboratory testing and analysis of samples to:
1. Assess their compliance with applicable laws and regulations enforced by the Agency;
2. Determine the extent to which findings provide evidence of violative conditions and practices; and
3. Obtain information through national surveillance programs for the purpose of identifying potential problems or trends.
C. Provides evidence related to analytical findings as request.
D. Conducts research to develop and refine methodology used in the analysis of samples and to explore new systems of analysis.
E. Serves as the regional 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. Provides assistance to Food and Drug Administration (FDA) district offices in the conduct of complex food and animal drug inspections requiring an in-depth knowledge of laboratory techniques and practices, and potential causes of adulteration.
G. Serves as a resource for analyses requiring complex instrumental analyses.
H. Maintains Liaison with scientists and scientific bodies with interests pertinent to laboratory activities.
2. GENERAL CHEMISTRY BRANCH (DLLRWGA).
A. Performs laboratory analyses and examinations of samples collected to assess each sample's compliance with laws and regulations enforced by the Agency; and to assess the extent to which reconditioning, reprocessing, and relabeling actions have brought violative commodities into compliance.
B. Conducts research to develop and refine methodology used in the analyses of samples and to explore new techniques and systems of analysis.
C. Provides expert advice and training regarding laboratory techniques and technological developments to other federal agencies; to state, local and foreign counterpart agencies, and to industry.
D. Provides court testimony regarding analytical findings as requested.
E. Plans, schedules, and manages branch operations; and formulates, implements, and coordinates work plans with offices served.
F. Assists investigational staff in the conduct of inspections and investigations involving complex testing procedures and production processes.
G. Maintains liaison with scientists and scientific institutions, with interest pertinent to laboratory activities.
H. Implements an effective internal quality assurance program to assure the reliability of analytical results.
I. Serves as a resource in scientific knowledge, laboratory methodology, and techniques applicable to solving field problems pertinent to chemical analyses.
3. PESTICIDE CHEMISTRY BRANCH (DLLRWGB).
A. Performs pesticide analyses and examinations of samples to assess each sample's compliance with applicable laws and regulations enforced by the Agency and to assess the extent to which reconditioning, reprocessing, and relabeling actions have brought violative commodities into compliance.
B. Conducts research to develop and modify methodology used in the analysis of samples and to explore new techniques and systems of analysis.
C. Assists investigational staff in the conduct of inspections and investigations involving complex testing procedures and production processes.
D. Provides expert advice and training related to pesticide techniques and technological developments to other Federal agencies; to State, local and foreign counterpart agencies, and to industry.
E. Provides court testimony regarding analytical findings as requested.
F. Maintains liaison with scientists and scientific institutions, with interest pertinent to laboratory activities.
G. Plans and monitors branch operations; formulates, implements, and coordinates the accomplishment of pesticide work plans for district offices served.
H. Implements an effective internal quality assurance program to assure the reliability of analytical results.
I. Serves as a resource in scientific knowledge, laboratory methodology, and techniques applicable to solving field problems pertinent to chemical analyses.
4. MICROBIOLOGY BRANCH (DLLRWGC).
A. Performs microbiological analyses of samples collected to assess each sample's compliance with laws and regulations enforced by the Agency; and to assess each sample's compliance with laws and regulations enforced by the Agency.
B. Conducts research to develop and refine methodology used in the analyses of microbiological samples and to explore new techniques and systems of analysis.
C. Provides expert advice and training regarding laboratory techniques and technological developments to other federal agencies; to state, local and foreign counterpart agencies, and to industry.
D. Serves as a resource in scientific knowledge, laboratory methodology, and techniques applicable to solving field problems pertinent to microbiological analyses.
E. Provides court testimony regarding analytical findings as requested.
F. Plans, schedules, and manages branch operations; and formulates, implements, and coordinates work plans with offices served.
G. Assists investigational staff in the conduct of inspections and investigations involving complex testing procedures and processes which may result in microbiologically contaminated products.
H. Maintains liaison with scientists and scientific institutions, with interest pertinent to laboratory activities.
I. Implements an effective internal quality assurance program.
J. Conducts research in a variety of aspects regarding microbiological concerns.
5. AUTHORITY AND EFFECTIVE DATE.
The functional statements for the Arkansas Regional Laboratory were approved by the Commissioner of Food and Drugs, effective August 7, 2012.
