Domestic Mutual Reliance Work in Human and Animal Food East Division 2

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The Division of Human and Animal Food East 2 (HAFE2) encompasses Delaware, the District of Columbia, Maryland, New Jersey, Pennsylvania, Virginia and West Virginia.

For more information on Rapid Response Teams, Manufactured Food Regulatory Program Standards, and other programs, please see FDA and State Counterparts.

Delaware

The state of Delaware does not currently perform inspections under FDA contract, though FDA engages with the Delaware Department of Agriculture and the Delaware Department of Health and Social Services on numerous public health topics and regulatory guidance. State employees maintain active pocket credentials or certificates of commissioning. The DDA also participates in the Produce Safety Cooperative Agreement.

Areas of Collaboration

Produce inspections
Annual meetings
Regulatory guidance
Inventory and operational status requests
Regulatory meetings with the state and the division’s compliance branch to discuss non-compliance of firms and bring firms into voluntary compliance
On-the-job training for state inspectors
Regulated industry information sharing
Product recalls

Additional Resources

District of Columbia

The District of Columbia does not currently perform inspections under FDA contract, though FDA engages with the District of Columbia Department of Health to integrate food safety resources.

Areas of Collaboration

Training to augment the Retail Food Safety Program
Joint inspections of facilities when needed
Utilizing state inspectional data to assist with casework performed
Inventory and operational status requests
Regulatory meetings with the state and the division’s compliance branch to discuss non-compliance of firms and bring firms into voluntary compliance
On-the-job training for state inspectors
Regulated industry information sharing
Product recalls

Additional Resources

District of Columbia Department of Health

Maryland

The FDA engages with the Maryland Department of Health and the Maryland Department of Agriculture to perform contract inspections. The FDA relies on the state’s expertise in acidified foods, hazard analysis critical control point systems, current good manufacturing practices, and preventive controls inspections in the human food program area. State employees enter and inspect under FDA authority, thus maintaining federal credentials. Maryland also participates in the Produce Safety Cooperative Agreement.

Areas of Collaboration

Training
Joint inspections of facilities when needed
Utilizing state inspectional data to assist with casework performed
Inventory and operational status requests
Sharing compliance activities
Work planning sessions
Joint inspections of pharmacies engaged in compounding human and animal drugs
Communicating on produce safety to include sharing of inventory, sampling results, or need for joint inspection in response to an outbreak
Rapid Response Team
Regulatory meetings with the state and the division’s compliance branch to discuss non-compliance of firms and bring firms into voluntary compliance
On-the-job training for state inspectors
Regulated industry information sharing
Product recalls

Additional Resources

New Jersey

The FDA engages with the New Jersey Department of Health (NJDH) and the New Jersey Department of Agriculture (NJDA) to perform contract inspections. The FDA relies on the state’s expertise in Seafood hazard analysis critical control point systems, current good manufacturing practices (cGMP), and preventive controls (PC) inspections in the human food program area, and the NJDA performs Part 507 GMP, full PC, bovine spongiform encephalopathy, and veterinary feed directive inspections in the animal food program area. State employees enter and inspect facilities under FDA authority, thus maintaining active FDA credentials. The NJDA also participates in the Produce Safety Cooperative Agreement.

Areas of Collaboration

Produce inspections
Public warning letters
Joint inspections of facilities when needed
Food Safety Task Force
Regulatory meetings with the state and the division’s compliance branch to discuss non-compliance of firms and bring firms into voluntary compliance
On-the-job training for state inspectors
Regulated industry information sharing
Product recalls

Additional Resources

Pennsylvania

The FDA engages with the Pennsylvania Department of Agriculture (PDA) to perform contract inspections. The FDA relies on the state’s expertise in current good manufacturing practices (cGMP) and preventive controls (PC) inspections in the human food program area, Part 507 cGMP, Full PC, VFD traceback inspections, and 100% of medicated feed mill inspections in the animal food area. Pennsylvania’s human food regulations meet or exceed those enforced by FDA, and as such, PDA employees enter and inspect facilities under their own jurisdiction. State inspectors of the animal food program maintain active pocket credentials. The PDA also participates the Produce Safety Cooperative Agreement Program.

In October 2023, the FDA announced the signing of a partnership agreement with the Pennsylvania Department of Agriculture’s Bureau of Food Safety & Laboratory Services that will focus on inventory reconciliation, reducing foodborne illness risk, and minimizing duplication of work.

Areas of Collaboration

Joint inspections of facilities when needed
Public warning letters
Sharing compliance activities
Utilizing state inspectional data to assist with casework performed
Work planning sessions
Rapid Response Team
Regulatory meetings with the state and the division’s compliance branch to discuss non-compliance of firms and bring firms into voluntary compliance
On-the-job training for state inspectors
Regulated industry information sharing
Product recalls

Additional Resources

Pennsylvania Department of Agriculture (PDA)

Virginia

The FDA engages with the Virginia Department of Agriculture and Consumer Services (VDACS) Office of Dairy and Foods to perform contract inspections. The FDA relies on the state’s expertise in Seafood hazard analysis critical control point (HACCP), Juice HACCP, Acidified Foods, current good manufacturing practices (cGMP), and preventive controls inspections in the human food program areas. The VDACS Office of Plant Industry Services performs Licensed Medicated Feed, Non-Licensed Medicated Feed, Part 507 GMP, and bovine spongiform encephalopathy inspections in the animal foods program area. State employees enter and inspect facilities under FDA authority, thus maintaining active FDA credentials. The VDACS also participates the Produce Safety Cooperative Agreement Program.

In October 2022, the FDA signed a domestic mutual reliance partnership agreement with the Virginia Department of Agriculture and Consumer Services.

Areas of Collaboration

Work planning sessions
Utilizing state inspectional data to assist with casework performed
Sharing sample analyses to remove violative products from the market
Sharing compliance activities
Joint inspections of facilities when needed
Food Safety Task Force
Public warning letters
Rapid Response Team
Regulatory meetings with the state and the division’s compliance branch to discuss non-compliance of firms and bring firms into voluntary compliance
On-the-job training for state inspectors
Regulated industry information sharing
Product recalls

Additional Resources:

West Virginia

The FDA engages with the West Virginia Department of Agriculture and the West Virginia Department of Health and Human Resources, Bureau of Public Health to perform contract inspections. The FDA relies on the state’s expertise in acidified foods, hazard analysis critical control point systems, current good manufacturing practices, and preventive controls inspections in the human food program area. State employees enter and inspect under FDA authority, thus maintaining federal credentials. West Virginia also participates in the Produce Safety Cooperative Agreement.

Areas of Collaboration

Training
Joint activities, including inspections of manufacturers and warehouses
Sharing of facilities inventory, inspection history, and compliance activities
Annual joint work planning sessions
Joint inspections of pharmacies engaged in compounding human and animal drugs
Communicating on produce safety to include sharing of inventory, sampling results, or need for joint inspection in response to an outbreak
Voluntary Rapid Response Team
Regulatory meetings with the state and the division’s compliance branch to discuss non-compliance of firms and bring firms into voluntary compliance
On-the-job training for state inspectors
Regulated industry information sharing
Product recalls