Proposed Application: Enhancement of California?s Integrated Food Safety and Security System The Food and Drug Laboratory Branch (FDLB), California Department of Public Health (CDPH) is submitting the following proposal for FOA# PAR-20-105, under disciplines of Microbiology (A), Chemistry (B), and discipline D Special Projects. FDLB has been an FDA FERN laboratory since 2008. FDLB has the capability and capacity to fulfill the goals of the referenced cooperative agreement program in terms of the experience and expertise of its trained staff, available facilities, established validated equipment, and its on-going participation in FERN training, surveillance, proficiency testing, and other cooperative agreement programs activities. FDLB is the primary testing laboratory for State food and drug regulatory agency which enrolled in California?s Manufactured Food Regulatory Program Standards. 1. Three projects in Chemistry area (PI: Dr. Dadong Xu, Dadong.Xu@cdph.ca.gov): (1) Discipline B Track 1, Food Defense (150 samples): We are proficient in all three FERN chemistry methods (CHE.0006, CHE.0008, and EAM 4.7) as well as FDLB-developed methods to carry out the tasks for this track, with capacity of more than 150 samples; 2) Discipline B Track 2, Human Food Product Testing (500 samples): We have the capability and capacity to perform human food product testing for a variety of analytes, such as natural toxins, toxic metals, seafood toxins, and some pesticides. We will be able to enhance our testing capability in additional analytes including vitamins and drug residues; 3) Discipline D Special Projects, Track 3, Method Development / Validation in Chemistry: We apply to participate in all the single and multi-laboratory validations for histamine, arsenic speciation in seafood, bottled water analysis using ICP-MS, and veterinary drug residues in milk products. 2. Eight Projects in Microbiology area (PI: Dr. David Kiang, David.Kiang@cdph.ca.gov): Discipline A track (1) Food Defense- We have the capacity to analyze all the proposed food and food products related to microbiological contamination through intentional means and to enhance the network capacity and readiness of state BLS2+ and BSL3 laboratories; track (2) Human Food Product Testing- We can improve the food testing surveillance programs through microbiological analysis of food products and environmental samples; track (3) Animal Food Product Test- We can analyze animal food products for microbiological contaminants and improve the animal food testing surveillance program for the state; Track (4) Whole Genome Sequencing; track ( 5) Microbiology Capability/Capacity development 2020-21; Discipline D Special Projects, track (1) Sample collection for microbiology and Chemistry; track (2) NFSDX and ORAPP integration; track (3) Method Development/Validation for microbiology - We will participate in the two multi-lab validations.

Public Health Relevance

FDA Laboratory Flexible Funding Model (U19) Cooperative Agreement, FOA PAR-20-105 The proposed projects that will be performed within California Department of Public Health, Food and Drug Laboratory Branch will greatly enhance the capacity and capabilities of California's human and animal food testing to support the State integrated food safety system. The application includes multiple tracks under Microbiology, Chemistry, and Special Projects disciplines. These projects, when properly funded, will provide quick emergency response testing and surge capacity in large scale events, produce large amount of data through surveillance activities to find contamination trends and identify emerging issues for food supplies, and expand the methodologies, types of analytes, and food matrices through method development and validation activities.

Agency
National Institute of Health (NIH)
Institute
Food and Drug Administration (FDA)
Type
Research Program--Cooperative Agreements (U19)
Project #
1U19FD007104-01
Application #
10175989
Study Section
Special Emphasis Panel (ZFD1)
Program Officer
Keppley, Laurie
Project Start
2020-09-01
Project End
2025-06-30
Budget Start
2020-09-01
Budget End
2021-06-30
Support Year
1
Fiscal Year
2020
Total Cost
Indirect Cost
Name
California Department of Public Health
Department
Type
DUNS #
799150615
City
Sacramento
State
CA
Country
United States
Zip Code
95814