FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Document Number:

DIR-000081

Revision #: 00

Revised:

31 August 2020

Title: 

FMD-30A: ORA/CFSAN Human Food Program Committee Page 1 of 11

For the most current and official copy, check QMiS.

Sections in This Document

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

2. Scope .................................................................................................................................... 1

3. Responsibility ........................................................................................................................ 2

4. Background ........................................................................................................................... 5

5. References ............................................................................................................................ 5

6. Procedure.............................................................................................................................. 6

6.1. Human Food Program Committee Membership: Selection and Tenure ....................... 6

6.2. Human Food Program Committee Meetings and Frequency ....................................... 9

6.3. Human Food Program Committee Communication ..................................................... 9

6.4. Human Food Program Committee Reporting, Program Metrics, and Activities ............ 9

6.5. Human Food Program Committee Funding ................................................................. 9

7. Glossary/Definitions............................................................................................................. 10

8. Records ............................................................................................................................... 11

9. Supporting Documents ........................................................................................................ 11

10. Document History ................................................................................................................ 11

11. Change History.................................................................................................................... 11

12. Attachments......................................................................................................................... 11

1. Purpose

This Directive provides for the formation and operation of the Office of 

Regulatory Affairs (ORA) – Office of Human and Animal Food Operations 

(OHAFO) and the Center for Food Safety and Applied Nutrition (CFSAN) 

Human Food Program Committee to discuss and address Agency priorities 

and Center initiatives as relates to human foods, dietary supplements, and 

cosmetics. The Committee also identifies workplanning activities and targets, 

develops annual work plans (WP), establishes strategic priorities to include 

inspections, compliance determinations, analytical needs, and import 

operations, and utilizes strategic thinking to recommend solutions to issues 

and challenges.

2. Scope

The scope of this document defines the role of the ORA/CFSAN Human Food

Program Committee. This document covers the roles and responsibilities for 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Document Number:

DIR-000081

Revision #: 00

Revised:

31 August 2020

Title: 

FMD-30A: ORA/CFSAN Human Food Program Committee Page 2 of 11

For the most current and official copy, check QMiS.

the Committee members, as well as the process to collaborate and execute 

the Agency’s priorities for each fiscal year (FY).

3. Responsibility

A. ORA Executive Management

1. Provides support and leadership for the ORA/CFSAN Human Food 

Program Committee.

2. Selects ORA representatives to support the Committee and to 

participate and attend meetings.

B. CFSAN Executive Management 

1. Provides support and leadership for the ORA/CFSAN Human Food 

Program Committee. 

2. Selects CFSAN representatives to support the Committee and to 

participate and attend meetings.

C. ORA/CFSAN Human Food Program Committee

1. Serves as the program managers for ORA and CFSAN. 

2. Serves as principal contact for ORA (field and headquarters (HQ)) 

and CFSAN on matters relating to human food, dietary supplements, 

and cosmetics, including work planning and budget issues.

3. Acts as liaison between ORA and CFSAN on general program 

matters. 

4. Seeks input from ORA and CFSAN units on proposals, programs, 

assignments, and initiatives. 

5. Reviews and provides input for field assignments, compliance 

programs, directives and procedural changes consistent with 

Agency policy.

6. Coordinates and participates in developing program goals, 

strategies, procedures, enforcement initiatives, and evaluation 

measures necessary to assure effective execution of the Agency's 

responsibilities.

7. Advises appropriate offices in the monitoring of program activities, 

assuring that assigned resources are effectively utilized in the 

accomplishment of planned activities.
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8. Regularly communicates to respective ORA and CFSAN units and 

counterparts the status of program activities.

9. Identifies potential issues for evaluation and attention.

10.Keeps the Associate Commissioner for Regulatory Affairs (ACRA) 

and Center Director(s) advised of program policies and directions as 

appropriate. 

D. ORA Committee Representatives

1. Serve as the principal contacts for ORA (field and HQ).

2. Seek input from ORA units on CFSAN proposals, programs, and 

initiatives.

3. Seek input from CFSAN on ORA initiatives.

4. Review and provide feedback on documents related to program 

impacts and priorities.

5. Review and provide input for compliance programs, directives, 

assignments, and procedural changes to be issued by CFSAN to the 

field, consistent with ORA policy.

6. Manage program assignments and resources.

7. Execute program priorities to include human food issues involving 

ORA field laboratories & imports operations. 

8. Identify inspectional assignments, sample collections, field exams,

sample analyses as needed to meet Agency priorities.

9. Develop workplans jointly with CFSAN and communicate 

appropriately with the FDA Governance Board (GB).

10.Review new authorities granted by legislation and assist in 

implementation of regulations related to human foods and 

cosmetics.

11.Work with external partners such as states, local and tribal officials, 

and territorial and foreign counterparts in the management of state, 

federal and local relations.

12.Maintain communications with ORA managers and field staff.

13.Identify and coordinate training needs as appropriate for field staff. 

E. CFSAN Committee Representatives

1. Share information and provide insight on Commissioner and CFSAN 

level activities and priorities. 
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2. Serve as the principal contacts for CFSAN interactions and 

communications with ORA.

3. Communicate program strategic priorities and address issues raised 

by the Committee and during the review of documents such as the 

WP, compliance programs and/or assignments. 

4. Develop and share information on the WP, assignments, program 

summaries, and evaluations.

5. Communicate policy, compliance, and enforcement strategies for 

major programs.

6. Establish and share information on inspections, sampling data, and 

priorities.

7. Address requests for resource adjustments throughout the FY.

8. Manage communications with the GB.

9. Share information regarding budget development and budget 

priorities. 

10.Facilitate approval and finalization of FY WP with the GB.

F. Ad Hoc Committee and Invited Representatives

1. Responsible for participating in, and constructively contributing to 

committee activities and accomplishments throughout the year. 

2. Represent field, HQ and CFSAN offices with operational 

responsibility and/or relevant experience with or impacted by the 

human food program areas. 

3. Review and provide feedback on documents related to program 

operations, evaluations, and strategic priorities when appropriate.

4. Communicate strategic objectives, action items or major program 

changes to ORA and CFSAN managers and staff as applicable.

5. Participate in developing program goals, procedures, enforcement 

initiatives, problem solving, and evaluation measures necessary to 

assure effective execution of the Agency's responsibilities.

G. Human Food Program Committee Co-advisors 

1. Provide consultation and senior level advice to the Committee.

2. Serve as liaison with the ORA Senior Management Team and 

CFSAN Leadership Team. 

3. Provide support to the Committee Chairs execution of duties.
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Document Number:

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Revised:

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Title: 

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H. Human Food Program Committee Co-chairs 

1. Provides overall management, operation and direction for the 

Committee. 

I. Human Food Program Committee Vice Chair 

1. Serves in the absence of the ORA Committee Co-chairs and assists 

the Committee Co-chairs in the management, operation and 

direction of the Committee. 

J. Executive Secretary 

1. Responsible for maintaining committee files, creating and storing 

minutes, tracking action items, and preparing other records to 

support Committee activities. 

2. Responsible for distributing and routing materials to members and 

others; planning, scheduling and coordinating Committee meetings.

3. Conducts other administrative activities at the direction of the 

Committee Advisors and Chairs.

4. Background

The Associate Commissioner for Regulatory Affairs previously established a 

system of Field Committees (FMD 30) to assist in managing the ORA 

organization and its implementation of Agency program areas. In May 2017, 

ORA was realigned into distinct product-based regulatory programs to 

strengthen the workforce, improve public health response, and enable staff to 

work more closely with FDA scientific and technical experts on novel and 

complex regulatory challenges. 

As part of the ORA realignment, the specialized OHAFO was established. 

OHAFO was designated to lead ORA’s collaboration with FDA’s CFSAN and 

the Center for Veterinary Medicine (CVM) in protecting the safety of the 

nation's domestically produced and imported human and animal foods, dietary 

supplements, food products derived from animals, cosmetics and animal food 

additives. In addition, OHAFO is responsible for providing advice and counsel 

to FDA leaders regarding human and animal food products, field operations, 

and emergency response activities. 

5. References

A. FMD30 – ORA Program Committees 
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Document Number:

DIR-000081

Revision #: 00

Revised:

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Title: 

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6. Procedure

6.1. Human Food Program Committee Membership: Selection and Tenure

Members of the ORA/CFSAN Human Food Program Committee include 

representatives from the ORA (field and HQ) and CFSAN offices with 

operational responsibilities and/or involved with or impacted by the human 

food program and/or have relevant experiences or expertise in the human food 

program areas.

A. The ORA/CFSAN Human Food Program Committee composition 

consists of the following:

1. Program Director: One (1) 

a. To serve as Human Food Program Committee Co-advisor, 

selected by ORA Assistant Commissioner for Human and Animal 

Foods Operations (ACO) in consultation with the ACRA and 

CFSAN Director for an indefinite term at the discretion of the 

ACO.

2. Center Senior Director: One (1) 

a. To serve as Human Food Program Committee Co-advisor 

selected by the Center Director and the ORA Assistant 

Commissioner for Human and Animal Foods Operations (ACO) 

in consultation with the ACRA and CFSAN Director for an 

indefinite term at the discretion of the Center Director.

3. Program Division Director: One (1) 

a. To serve as Human Food Program Committee Co-chair selected 

by the ACO in consultation with the Human Food Program 

Committee Advisor for a 3-year term. Subsequent one (1) year 

extensions may be authorized at the discretion of the ACO. 

4. CFSAN Senior Director: One (1) 

a. To serve as Human Food Program Committee Co-chair selected 

by the CFSAN Director in consultation with the ACO and Human 

Food Program Committee Advisor for a 3-year term. Subsequent 

one (1) year extensions may be authorized at the discretion of 

the CFSAN Director.

5. Program Division Director or equivalent: One (1)
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Document Number:

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Revision #: 00

Revised:

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Title: 

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a. To serve as Human Food Committee Vice Chair selected by the 

ACO in consultation with the Human Food Program Committee 

Advisor for a 3-year term and mirror any extensions of the ORA 

Committee Co-chair. At the end of this term, the Vice Chair 

assumes the position of the ORA Co-chair.

6. Executive Secretary: One (1) 

a. Selected by the Committee Chairs to serve an indefinite term at 

the discretion of the Chairs.

7. Program Division Directors or equivalent: One to Two (1-2)

a. To serve as a Committee Member (s), selected by the 

Committee Chairs to serve an indefinite term at the discretion of 

the Chairs.

8. Division of Import Operations (DIO) Senior Director or Import 

Manager: One (1)

a. To serve as a Committee Member, selected by the Committee 

Chairs in consultation with the DIO Director to serve an indefinite 

term at the discretion of the Chairs.

9. Office of State Cooperative Programs (OSCP) Director or Branch 

Director: One (1)

a. To serve as a Committee Member, selected by the Committee 

Chairs in consultation with the OSCP Director to serve an 

indefinite term at the discretion of the Chairs. 

10.ORS Senior Director or Laboratory Director: One (1)

a. To serve as a Committee Member, selected by the Committee 

Chairs in consultation with the ORS Director to serve an 

indefinite term at the discretion of the Chairs. 

11.State Liaison: One (1)

a. To serve as Committee Member, selected by the Committee 

Chairs and Advisors for an indefinite term at the discretion of the 

Chairs.

12.Field Managers (below the level of Program Division Director): Three 

to Five (3-5)

a. Select at least one of each: Director, Investigations Branch (DIB), 

Director, Compliance Branch (DCB), Supervisory Consumer 

Safety Officer (SCSO).
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Document Number:

DIR-000081

Revision #: 00

Revised:

31 August 2020

Title: 

FMD-30A: ORA/CFSAN Human Food Program Committee Page 8 of 11

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b. To serve as Committee Member(s), selected by the Committee 

Chairs and Advisors for an indefinite term at the discretion of the 

Chairs.

13.Technical Expert(s): One to Two (1-2) 

a. Select as needed from such positions as Consumer Safety 

Officer (CSO), Compliance Officer (CO), Analyst, and/or National 

or Program Expert

b. To serve as Committee Member(s) selected by the Field Food 

Committee Chairs and Advisors to serve an indefinite term at the 

discretion of the Chairs.

c. Other Technical Experts may be called upon as needed, on a 

case-by-case basis to temporarily assist with specific projects 

and initiatives.

14.CFSAN Division Directors or Managers: Two to Three (2-3) 

a. To serve as Committee Members, selected by the Human Food 

Program Committee Advisor and Chairs to serve an indefinite 

term at the discretion of the Chairs.

15.CFSAN Technical Experts: Two to Three (2-3)

a. To serve as Committee Members, selected by the Human Food 

Program Committee Advisor and Chairs to serve an indefinite 

term at the discretion of the Chairs.

B. Ad Hoc Committee and Invited Representatives: (As Needed)

1. To include ORA or CFSAN representatives involved with or 

impacted by the human food program from the following areas: 

a. Federal-State Relations or Partnerships

b. Science (laboratory) 

c. Imports

d. Foreign Offices/Program

e. Resources/Work Planning

f. Criminal Investigations

g. Compliance & Enforcement

h. Risk Management 

i. Quality System Management
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Document Number:

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Revised:

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Title: 

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j. Operational Policy

2. To serve as Committee Members or on Ad-Hoc Committees, 

selected by the Human Food Program Committee Advisor and 

Chairs to serve an indefinite term at the discretion of the Chairs. 

6.2. Human Food Program Committee Meetings and Frequency

A. At a minimum, the ORA/CFSAN Human Food Program Committee 

meets annually face-to-face in a central location preferably during the 

first half of each calendar year. 

B. The Committee meets jointly with the ORA/CVM Animal Food Program 

Committee for a period during the face-to-face annual meeting. 

C. The Committee has monthly virtual meetings.

D. During the year, the Committee has at least one virtual meeting jointly 

with the ORA/CVM Animal Food Program Committee.

6.3. Human Food Program Committee Communication

A. The Committee Chairs and executive secretary communicate with other 

program committee chairs on a regular basis. 

1. To assure uniformity in policies and procedures among the various 

Agency program areas.

B. The Committee Chairs standardize the way committee meeting notes 

are prepared and distributed. 

1. To assure content of minutes and notes are accurate and properly 

suitable for use, distribution, and/or action. 

2. To clearly identify issues that have not yet been adopted as official 

policy.

6.4. Human Food Program Committee Reporting, Program Metrics, and Activities

A. During the Human Food Committee meetings, the Committee may 

identify assignments that require monitoring during the FY.

1. The Committee determines the strategic evaluation mechanisms for 

food committee assignments and activities. 

2. The Committee establishes a process for memorializing decisions 

and meeting notes. 

6.5. Human Food Program Committee Funding

A. ORA and CFSAN funds Committee members attendance and 

participation in Committee activities and meetings where appropriate.
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Document Number:

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Revised:

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Title: 

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B. ORA and CFSAN support costs and resources associated with the 

membership outlined in this Field Management Directive (FMD). 

C. For ORA funding, the ORA Committee Chair, in consultation with the 

Committee Advisors prepares and submits a budget proposal to the 

ORA Office of Management (OM) at the beginning of each fiscal year 

(or when specified by OM). 

1. To provide funding for attendance and participation to include a 

face-to-face meeting of the Committee annually if possible as well as 

any other travel or expenses required by the Chair and/or other 

committee members as appropriate. 

2. To support requests for Committee special projects and/or initiatives. 

3. Upon receipt, OM reviews the budget proposal and provides the 

Committee with a budget that is managed by the Human Food 

Committee Chairs.

7. Glossary/Definitions

A. Acronyms

1. ACRA: Associate Commissioner for Regulatory Affairs

2. ACO: Assistant Commissioner for Office of Human and Animal 

Foods Operations

3. CFSAN: Center for Food Safety and Nutrition

4. CO: Compliance Officer

5. CSO: Consumer Safety Officer 

6. CVM: Center for Veterinary Medicine

7. DCB: Director, Compliance Branch

8. DIB: Director, Investigations Branch

9. DIO: Division of Import Operations 

10.FMD: Field Management Directive

11.FY: Fiscal Year

12.GB: FDA Governance Board

13.HQ: Headquarters 

14.OHAFO: Office of Human and Animal Foods Operations
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15.OM: Office of Management

16.ORA: Office of Regulatory Affairs

17.OSCP: Office of State Cooperative Programs

18.ORS: Office of Regulatory Science

19.SCSO: Supervisory Consumer Safety Officer

20.WP: Work Plan

8. Records

None

9. Supporting Documents

None 

10. Document History

Revision

#

Status*

(D, I, R)

Date Author Name and Title Approving Official Name 

and Title

00 I SEE DATE IN 

HEADER

CHARLES BECOAT

DEPUTY DIRECTOR, OHAFO 

EAST PROGRAM

MICHAEL ROGERS 

ASSISTANTCOMMISSIONER, 

OHAFO PROGRAM

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

11. Change History

Revision 

#

Change

00 NOT APPLICABLE

12. Attachments

None