Partnership for Food Protection (PFP) is a multi-agency collaboration aimed at protecting the food supply and public health through mutual reliance. The PFP is comprised on representatives from federal, state and local government with expertise in human and animal food, epidemiology, laboratory, animal health, environment, and public health. It promotes communication and integration amongst partners and provides resources, risk-informed insight, and best practices to improve the system that partners can use to inform and enhance their work to protect public health.
Laboratory Science Workgroup
The PFP is comprised on dynamic workgroups whose mission is to advance the integrated food safety system. The Laboratory Science workgroup works to create resources that build confidence among stakeholders in the integrity and scientific validity of laboratory analytical data and facilitate regulatory agency utilization of this data.
Laboratory Best Practices Manual
The Human and Animal Food Testing Laboratories Best Practices Manual provides a set of tools, definitions, and references that laboratories can use to improve their operations. It identifies essential elements critical to the quality of regulatory data. Documenting the quality of both sampling and analysis is essential to ensure the defensibility of laboratory generated data. This document also aligns with the ISO/IEC 17025:2017 standard.
The Human & Animal Food Regulatory Compliance Review Checklist is designed to assist a human and animal food testing organization in preparing a data package intended for review by a compliance officer for possible regulatory action. In addition, this checklist is structured to aid compliance officers in the review of data packages. Familiarity with the elements of this checklist will assist regulatory management, inspection and laboratory groups in planning their sample collections and analyses to assure they can provide essential regulatory information. The checklist can also serve as a data package index, to assure that all necessary information is included and easily located. A Word version of the checklist is also available.
Major Laboratory Initiatives
Major Laboratory Initiatives repository captures information related to current national integration programs that contain a laboratory component. The work group created the respository to summarize current integration efforts related to networks and capacity building, laboratory quality management systems, and program-specific funding.
FDA ORA Data Exchange
About the FDA ORA Data Exchange
FDA Office of Regulatory Affairs Data Exchange (ORA DX) is a Partnership for Food Protection (PFP) initiative that contributes to the development of the Integrated Food Safety System by enabling electronic sharing of food safety information and data between the FDA, public health agencies and various regulatory partners. The Office of Regulatory Affairs Partners Portal, coupled with the
National Food Safety Data Exchange (NFSDX) and other FDA systems, provides partners with a web-based platform that supports bi-directional information exchange.
ORA DX currently enables collaborators to electronically submit contracted inspection information to FDA, search FDA firm information and conduct State-to-State Firm searches. PFP recently worked to expand ORA DX capabilities to share laboratory data between state laboratories and FDA.
In the past, laboratories shared regulatory data through the Electronic Laboratory Exchange Network (eLEXNET). As of September 2020, eLEXNET was decommissioned as FDA looks to transition data exchange through the ORA DX.
APHL Involvement with NFSDX
APHL collaborated with the PFP Laboratory Science and IT Workgroups to map laboratory data elements and test the capabilities of sharing laboratory data. This includes providing knowledge of data exchange programs, laboratory information management systems (LIMS), state IT infrastructure, and more. APHL staff work to maintain coordination between these two PFP workgroups in efforts to expand laboratory data exchange capabilities.
The following states are working to pilot the exchange of FDA collected samples to test system capabilities:
- New York
- West Virginia