About FDA
SMG 1312.4
FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS
FOOD AND DRUG ADMINISTRATION
OFFICE OF GLOBAL AND REGULATORY OPERATIONS AND POLICY
OFFICE OF REGULATORY AFFAIRS
OFFICE OF OPERATIONS
REGIONAL FIELD OFFICE, CENTRAL REGION, CHICAGO, IL
FORENSIC CHEMISTRY CENTER
Effective Date: 08/07/12
1. FORENSIC CHEMISTRY CENTER (DLLRLC).
A. Serves as a national resource for forensic chemistry associated with problems in compliance testing, methods development, and required field investigations and inspections.
B. Provides specialized forensic chemistry analytical services for project activities related to product tampering, chemical profile identification, and product elemental profiles and provides rapid response to analytical support during tampering emergencies, and Agency Forensic chemistry operations.
C. Maintains liaison with national and international scientists and scientific bodies; other Federal, State, and local government officials; and industry personnel having interests pertinent to Center activities.
D. Develops and operates forensic evaluation of consumer and industrial products, medical devices, pharmaceuticals, and other regulated products.
E. Advises the Regional Food and Drug Director and appropriate Headquarters components on new and emerging problems and trends, future program needs and priorities, manpower, equipment, financial needs, and long-range planning.
F. Develops and conducts research to predict the potential health impact of both actual and alleged product tampering.
G. Designs and conduct research to demonstrate the physical and chemical effects of poisons on food and drug products and studies the effects of the products on stability and bioavailability of the poisons.
H. Develops and transfers analytical procedures to other Agency laboratories to test large numbers of samples, and develops and transfers test that can be used by the Agency investigators in the field to detect tampering.
I. Responds to requests for analytical assistance from other Agency units working on other types of investigations such as counterfeit drugs, illegal steroids, chemical contamination, etc.
J. Develops joint research products with universities, industry, and other Federal, State, and international government agencies and provides training services in the operational aspects of forensic chemistry and other related compliance program areas.
K. Conducts on-site investigations requiring specialized expertise and experience in forensic chemistry and maintains the Agency's state-of-the-art expertise in forensic chemistry.
L. Manages and evaluates program activities, continuously measures achievements, and advises to the Regional Food and Drug Director of strategy needed to reach objectives or of the need to adjust objectives.
2. INORGANIC CHEMISTRY BRANCH (DLLRLC1).
A. Plans. Schedules, and manages branch analytical operations and formulates, implements, and coordinates laboratory work plans with Agency components being serviced.
B. Designs and conducts experiments to demonstrate the physical and chemical effects of inorganic poisons on food and drug products and studies the effects of the products on the stability and bioavailability of the poisons.
C. Develops analytical procedures that can be used to establish the inorganic, elemental chemical profile of poisons and other deleterious substances placed in food and drugs or naturally occurring in foods.
D. Operates a quality control program to assure reliability of analytical results obtained in the Agency and other specific laboratories to whom delegated responsibilities have been given.
E. Develops forensic chemistry analytical procedures that can be used in other laboratories to test large numbers of samples for inorganic chemicals and field tests that can be used by Agency investigators to detect tampering. Develops and maintains the capability to respond immediately to all tampering incidents throughout the United States and abroad, including rapid development of methodology, analysis of samples, and critical evaluation of results.
F. Responds to requests for forensic chemistry assistance from Agency components, Federal, State, and international governments and industry working on other types of investigations such as counterfeit drugs, illegal steroids, chemical contamination, etc.
G. Serves as a resource in scientific knowledge and provides expert advise, testimony, and training regarding forensic chemistry techniques and technological developments to scientific bodies and institutions, other Federal, State, and local agencies, foreign counterpart agencies, industries, and courts.
H. Conducts in-depth research analysis to identify suspected toxic trace contaminants in foods, animal feeds, and related materials.
I. Develops joint projects with university faculty, graduate students, other Federal, State, and local governments, and industry.
J. Assists investigators with on-site investigations requiring specialized expertise in forensic inorganic chemistry.
3. ORGANIC CHEMISTRY BRANCH (DLLRLC2).
A. Plans, schedules, and manages branch analytical operations and formulates, implements, and coordinates laboratory work plans with Agency components being serviced.
B. Designs and conducts experiments to demonstrate the physical and chemical effects of organic poisons on food and drug products and studies the effects of the products on the stability and bioavailability of the poisons.
C. Develops analytical procedures that can be used to establish the organic, elemental chemical profile of poisons and other deleterious substances placed in food and drugs or naturally occurring in foods.
D. Develops forensic chemistry analytical procedures that can be used in other laboratories to test large numbers of samples for organic chemicals and field tests that can be used by Agency investigators to detect tampering. Develops and maintains the capability to respond immediately to all tampering incidents throughout the United States and abroad, including rapid development of methodology, analysis of samples, and critical evaluation of results.
E. Responds to requests for forensic chemistry assistance from Agency components, Federal, State, and international governments and industry working on other types of investigations such as counterfeit drugs, illegal steroids, chemical contamination, etc.
F. Serves as a resource in scientific knowledge and provides expert advise, testimony, and training regarding forensic chemistry techniques and technological developments to scientific bodies and institutions, other Federal, State, and local agencies, foreign counterpart agencies, industries, and courts.
G. Conducts in-depth research analysis to identify suspected toxic trace contaminants in foods, animal feeds, and related materials.
H. Operates a quality control program to assure reliability of analytical results obtained in the Agency and other specific laboratories to whom delegated responsibilities have been given.
I. Develops joint projects with university faculty, graduate students, other Federal, State, and local governments, and industry.
J. Assists investigators with on-site investigations requiring specialized expertise in forensic inorganic chemistry.
4. AUTHORITY AND EFFECTIVE DATE.
The functional statements for this District Office were approved by the Commissioner of Food and Drugs, effective August 7, 2012.
