- METHOD DEVELOPMENT AND VALIDATION SPECIAL PROJECT FDA LFFM: Discipline-Special Projects; Method Development and Validation at CT AES Project Summary- This proposal is being submitted in response to RFA-PAR-20-105 Laboratory Flexible Funding Model (LFFM)(U19). The Connecticut Agricultural Experiment Station (CT AES) has a 145-year history of food safety research, including 15 years as a member of the FDA Food Emergency Response Network (FERN) Chemistry Cooperative Agreement Program (cCAP), and 8 years of funding under 4 different FDA ISO food safety CAPs. For this Method Development and Validation Project, the goal is conduct preliminary, short-term or exploratory investigations that focus on the feasibility of a new method and/or technology. We propose 9 projects that include activities such as proof of concept for new analytical approaches, method development for representative food matrices, single laboratory validations of methods, matrix or platform extensions or multi-laboratory validation research studies. Some of these projects could become multi-year projects, dependent on results and FDA approval. We also recognize that project opportunities may change annually, as requested by FDA. These projects are: 1) Single laboratory validation of LC-MS/MS methods for pesticides in new matrices. 2) Multi-laboratory validation of Elemental Analysis Manual method EAM 4.12: analysis of bottled water by ICP- MS. 3) Protein analysis by LC-HRMS and LC-MS/MS. 4) Portable Hand-Held X-Ray Fluorescence Determination of Toxic Elements EAM 4.9. 5) Multi-laboratory validation of method for Arsenic speciation in seafood using LC-ICP-MS. 6) Detection of PFASs in animal feed using LC-HRMS/MS. 7) Multi-laboratory validation LC/MS/MS method for vet drug residues in raw milk, milk, and powdered milk. 8) Non-targeted analysis of unknown toxins in food using LC- HRMS/MS, Compound Discoverer, and Hydrophilic Interaction Chromatography (HILIC). 9) Single laboratory validation of mycotoxins in hemp and hemp-derived products. The CT AES has demonstrated the expertise, capability, and adaptability to fully meet the objectives of this RFA through our successful participation in a number of FDA CAPs. Receipt of this new award from FDA will significantly enhance the ability of the CT AES specifically, and CT in general, to meet the program goals laid out in the RFA, and as described by the President?s Food Safety Working Group, the Partnership for Food Protection and the Food Safety Modernization Act. 1

Public Health Relevance

The Connecticut Agricultural Experiment Station 123 HUNTINGTON STREET, P.O. BOX 1106, NEW HAVEN, CONNECTICUT 06504 Putting Science to Work for Society Protecting Agriculture, Public Health, and the Environment Founded 1875 RFA-PAR-20-105 Laboratory Flexible Funding Model (LFFM)(U19) Project Narrative: The specific aims of this Special Project are to meet the requirements of RFA-PAR- 20-105 Laboratory Flexible Funding Model (LFFM)(U19). For this Special Projects Track, the goal is conduct preliminary, short-term or exploratory investigations that focus on the feasibility of a new method and/or technology. We propose 9 projects that include activities such as proof of concept for new analytical approaches, method development for representative food matrices, single laboratory validations of methods, matrix or platform extensions or multi-laboratory validation research studies. Some of these projects could become multi-year projects, dependent on results and FDA approval, but are initially planned for one year in duration. We also recognize that project opportunities may change annually, as requested by FDA. Phone: (203) 974-8500 Fax: (203) 974-8502 Toll Free: 1-(877) 855-2237 WWW.CT.GOV/CAES An Affirmative Action/Equal Opportunity Employer

Agency
National Institute of Health (NIH)
Institute
Food and Drug Administration (FDA)
Type
Research Program--Cooperative Agreements (U19)
Project #
1U19FD007094-01
Application #
10170743
Study Section
Special Emphasis Panel (ZFD1)
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
Connecticut Agricultural Experiment Sta
Department
Type
DUNS #
877902333
City
New Haven
State
CT
Country
United States
Zip Code
06511