ORA-WIDE PROCEDURE

Food and Drug Administration

Office of Regulatory Affairs

Document #:

FMD-152

(DIR-000044)

Page 1 of 7

Title: 

FMD-152 Produce Safety Dispute Mitigation and Resolution 

Procedures

Revision 

00

Effective Date

01/31/2019

Uncontrolled if printed, or not accessed through QMiS

For the most current and official copy, check QMiS.

Sections in This Document

1. Purpose ....................................................................................................................................1

2. Scope .......................................................................................................................................2

3. Background...............................................................................................................................2

4. References ...............................................................................................................................2

5. Procedures/Responsibilities .....................................................................................................2

5.1. Pre-Dispute Procedures and Protocol............................................................................2

Resources and Other Dispute Resolution Processes Already Available During 

and Post- Inspection ........................................................................................4

5.2. Informal Dispute Resolution Process .............................................................................5

5.3. Formal Dispute Resolution Process and Panel..............................................................5

6. Glossary/Definitions..................................................................................................................6

7. Records ....................................................................................................................................7

8. Supporting Documents .............................................................................................................7

9. Document History .....................................................................................................................7

10. Change History.........................................................................................................................7

11. Attachments..............................................................................................................................7

1. Purpose

The purpose of this Field Management Directive (FMD) is to define a dispute 

resolution process for produce safety that:

1. Reflects the partnership approach to produce safety inspections and 

facilitates strengthened relationships leading to proactive engagement 

and improved communication among all regulatory parties; 

2. Can be used to resolve disputes between agencies with produce safety 

regulatory authority (whether implementing the federal Produce Safety 

Rule or comparable state regulations), but is not intended to resolve 

disputes between a regulator and industry; and 

3. Helps ensure that regulatory partners issue consistent inspection 

findings across all inspections, keeping in mind: 

a. Food and Drug Administration (FDA) can revise its own 

inspectional observation documents where appropriate and issue 

an amended document;
ORA-WIDE PROCEDURE

Food and Drug Administration

Office of Regulatory Affairs

Document #:

FMD-152

(DIR-000044)

Page 2 of 7

Title: 

FMD-152 Produce Safety Dispute Mitigation and Resolution 

Procedures

Revision 

00

Effective Date

01/31/2019

Uncontrolled if printed, or not accessed through QMiS

For the most current and official copy, check QMiS.

b. States have their own process for how to revise their respective 

observational documents; 

c. This informal mechanism could be used before or after the 

issuance of inspectional observation documents; and 

d. Should be used sparingly, and only when there are significant 

and time-sensitive disputes about the suitability of including 

certain items on an inspectional observation document.

2. Scope

This document applies only to the Office of Human and Animal Food 

Operations (OHAFO) divisions in Office of Regulatory Affairs (ORA).

3. Background

FDA and states agree that disputes should be resolved at the lowest level 

possible within their respective organizations, and all parties are committed to 

the goal of minimizing disputes through training, education, and clear, distinct, 

and up-to-date policies and procedural documents. When disputes do occur, 

this dispute resolution process, collaboratively developed by FDA and states, 

should be used whenever possible. Because this dispute mitigation and 

resolution process contains new operations and is focused towards a new type 

of inspection, these procedures will be piloted and refined as needed.

4. References

A. None

5. Procedures/Responsibilities

5.1. Pre-Dispute Procedures and Protocol

A. FDA and states will jointly develop inspectional procedures to promote 

uniformity and consistency of produce safety inspectional processes.

B. Procedures specific to produce safety inspections should be designed 

in accordance with FDA and state regulatory authorities’ mission to 

protect the public health while remaining focused both on the 
ORA-WIDE PROCEDURE

Food and Drug Administration

Office of Regulatory Affairs

Document #:

FMD-152

(DIR-000044)

Page 3 of 7

Title: 

FMD-152 Produce Safety Dispute Mitigation and Resolution 

Procedures

Revision 

00

Effective Date

01/31/2019

Uncontrolled if printed, or not accessed through QMiS

For the most current and official copy, check QMiS.

educational needs of farmers under a new regulatory scheme and 

prevention of contamination.

C. It is critical that FDA and states set up procedures for documenting 

produce safety inspectional observations, focusing on assuring that 

conditions with significant public health impacts are recorded (for FDA, 

in accordance with 21 USC 704(b)). Verbal discussion and all other 

communication mechanisms available to the investigator/inspector will 

also be used to communicate recommended and/or required 

improvements with farmers.

D. Inspections conducted by FDA will be led by a dedicated cadre with 

training specific to produce safety. Training of investigators/inspectors 

will emphasize that there should be a discussion with management as 

any observations are identified, or on a daily basis, to clearly identify 

any potential observations the investigator/inspector has identified (for 

FDA, per existing procedures), and to serve as an opportunity to clarify 

any unresolved issues and avoid surprises during the closeout of an 

inspection. These practices should be explained to industry to ensure 

understanding and expectations. It is expected that states will use the 

Produce Farm Inspection Observations form in conducting state 

inspections.

E. FDA and states will train investigators/inspectors to recognize 

significant deviations that should be listed on an inspectional 

observation document versus issues where investigators/inspectors 

should have a discussion with a farmer, contact the Regulator Technical 

Assistance Network (“TAN”) or supervisors, or utilize other 

communication mechanisms available before finalizing the document. 

Training will emphasize the types of observations that should be listed 

on the inspectional observation document. FDA and states agree to 

communicate with firms, farms, and other non-regulatory parties within 

the produce supply chain the purpose of the inspectional documents 

that are provided during an inspection.

F. Prior to the closeout of any inspection where FDA is considering issuing 

an inspectional observation document with reportable observations, an 

FDA produce safety compliance staff and/or supervisors will review the 

document. As part of this process, the FDA investigator will discuss 

within FDA to ensure that the observations are documented consistent 

with current agency policy. FDA will strive to have this review occur 

within one business day. FDA will discuss with states before changing 

this approach. This will not apply to state-issued inspectional 

observation documents. States may have their own process in place.
ORA-WIDE PROCEDURE

Food and Drug Administration

Office of Regulatory Affairs

Document #:

FMD-152

(DIR-000044)

Page 4 of 7

Title: 

FMD-152 Produce Safety Dispute Mitigation and Resolution 

Procedures

Revision 

00

Effective Date

01/31/2019

Uncontrolled if printed, or not accessed through QMiS

For the most current and official copy, check QMiS.

G. States with Produce Safety Cooperative Agreements that include 

Competition B/inspection program development funding (under PAR-16-

137) will have primary responsibility for routine on-farm inspections 

within their states (except on federally recognized tribal lands). 

H. If FDA plans to go on a farm for produce safety purposes, including for 

surveillance assignments or outbreak investigations, FDA will invite the 

state to conduct a joint FDA-state inspection or investigation, with the 

option for both parties to fully participate in all aspects of the inspection 

or investigation. 

1. For states not participating in Competition A and/or B, National 

Association of State Departments of Agriculture (NASDA) will 

identify a list of State offices to be contacted and it will update the list 

as necessary. 

2. For investigations, FDA and states will engage the other as early as 

is practical, with both parties acknowledging that time sensitivity may 

be heightened, and protection of public health must remain the 

primary concern. 

3. FDA commits to proactively engage states with Competition B 

funding before issuing an inspectional observation document, except 

when this could jeopardize public health.

4. Efforts will be made to resolve potential disputes before an 

inspectional observation document is issued, but this is not intended 

to encourage minor wording debates on individual items.

I. Where possible, in the interest of timely resolution, a dispute may be 

bifurcated (for example, the scientific matter can be sent to the 

appropriate channel, and the time- sensitive inspection observation 

document issue can enter the informal process).

J. Analysis of trends identified through the dispute resolution process 

(e.g., common issues of dispute) or other matters that emerge will be 

discussed in regular meetings with FDA and NASDA.

Resources and Other Dispute Resolution Processes Already Available 

During and Post- Inspection

A. FDA has an existing process under 21 CFR 10.75 that is available to 

request internal agency review of the decision of an FDA employee.

B. Within Center for Food Safety and Applied Nutrition (CFSAN), there is an 

additional, internal FDA process for scientific disputes, with some formal 

procedures.
ORA-WIDE PROCEDURE

Food and Drug Administration

Office of Regulatory Affairs

Document #:

FMD-152

(DIR-000044)

Page 5 of 7

Title: 

FMD-152 Produce Safety Dispute Mitigation and Resolution 

Procedures

Revision 

00

Effective Date

01/31/2019

Uncontrolled if printed, or not accessed through QMiS

For the most current and official copy, check QMiS.

C. The FDA Regulator TAN can also be used when there are questions during 

the inspectional process to get clarity on issues that are unclear.

5.2. Informal Dispute Resolution Process

Note: It is expected that this process will be used during an open inspection or 

within 30 days after the close-out of an inspection.

A. Identify the dispute and attempt to resolve through discussion at the lowest 

level possible, which may be discussion between State Supervisors or a 

State Supervisor and an ORA Produce Safety Network Branch Chief.

B. FDA may issue an amended inspectional observations document if FDA 

determines that there were errors or that an observation should not have 

been listed based on agency policy. (The correction can happen in a matter 

of days for FDA; states may have their own processes in place).

C. Unresolved disputes will be escalated to supervisors on both sides.

D. State Director or Program Manager and/or FDA will decide whether to 

escalate disputes to the next level.

E. Unresolved disputes may utilize the Formal Dispute Resolution Panel.

5.3. Formal Dispute Resolution Process and Panel 

A. Unresolved disputes can be escalated to an ORA OHAFO Program 

Director who will convene a panel facilitated by the ORA Ombudsman’s 

Office (in most cases by telephone or other electronic means). A state may 

trigger this formal process after discussions with a farm, if the state 

believes the issue needs to be further disputed.

B. Panel members should not be directly involved in the dispute and must be 

FDA employees, or state officials commissioned by FDA. Parties can 

submit documentation from any relevant source.

1. The panel, assembled by the ORA Ombudsman’s Office in 

consultation with NASDA, may consist of:

a. An appointee from the FDA Food Safety Modernization Act 

(FSMA) team;

b. One or more appointees from the FDA Produce Safety Network;

c. Two or more State appointees from a list of approximately 20 

candidates; and

d. Additional Subject Matter Experts, Technical Experts, or Policy 

Experts, identified by either side, to meet specific needs.
ORA-WIDE PROCEDURE

Food and Drug Administration

Office of Regulatory Affairs

Document #:

FMD-152

(DIR-000044)

Page 6 of 7

Title: 

FMD-152 Produce Safety Dispute Mitigation and Resolution 

Procedures

Revision 

00

Effective Date

01/31/2019

Uncontrolled if printed, or not accessed through QMiS

For the most current and official copy, check QMiS.

2. All parties (FDA and the impacted state[s]) have a chance to present 

their positions to the panel.

3. The members of the panel will each individually provide his or her 

recommendations, which could involve actions not proposed by 

either party, to the ORA OHAFO Program Director who decides.

C. If any party determines that the issue needs to be further escalated, the 

issue may be raised to ORA’s Assistant Commissioner for Human and 

Animal Foods Operations for a decision.

D. If any party determines that the issue needs to be further escalated, the 

issue may be raised to the Associate Commissioner for Regulatory Affairs 

for a decision.

E. Further FDA review is discretionary.

F. The process under 21 CFR 10.75 is available.

G. If the Program Director or Assistant Commissioner determines that an 

observation on an inspectional observation document was erroneous or 

should not have been listed based on agency policy, the Agency will:

1. Issue an amended document to the firm along with a cover letter 

describing the changes made

a. The amended inspectional observation document will be issued 

as a clean version, unless the inspected entity specifically 

requests a redline version with the changes.

b. The original document will remain, subject to federal records 

retention and disclosure requirements of the Agency. If the 

original document is released, the amended document will be 

included. 

6. Glossary/Definitions

A. CFSAN: Center for Food Safety and Applied Nutrition

B. FDA: Food and Drug Administration 

C. FMD: Field Management Directive 

D. FSMA: Food Safety Modernization Act 

E. NASDA: National Association of State Departments of Agriculture 

F. OHAFO: Office of Human and Animal Food Operations
ORA-WIDE PROCEDURE

Food and Drug Administration

Office of Regulatory Affairs

Document #:

FMD-152

(DIR-000044)

Page 7 of 7

Title: 

FMD-152 Produce Safety Dispute Mitigation and Resolution 

Procedures

Revision 

00

Effective Date

01/31/2019

Uncontrolled if printed, or not accessed through QMiS

For the most current and official copy, check QMiS.

G. ORA: Office of Regulatory Affairs 

H. TAN: Technical Assistance Network

7. Records

None

8. Supporting Documents

None

9. Document History

* - D: Draft, I: Initial, R: Revision, C: Cancel

10. Change History

11. Attachments

None

Revision Status*

(D, I, R, C)

Date Author Name and Title Approving Official Name and 

Title

00 I 01/31/2019

Michael Rogers, 

Assistant Commissioner 

for Human and Animal 

Foods Operations

Michael Rogers, 

Assistant Commissioner for 

Human and Animal Foods 

Operations

Revision Change

00 Initial Release