(NaCl)

Anode Cathode

pH 2 – 6 (Acidic EW) pH 7.5 – 13 (Basic EW)

2017 Sunset Timeline Reorganization

 Unity and Alignment across the community, Industry, 

certifiers, Interest groups , trade associations – Just Do It.

 Support was given to groups of like substances – along the lines 

of proposals B and C. 

 Materials need to be reviewed prior to their 5 year 

requirement

 Those reviewed and voted for removal will be removed on 

their original sunset date

 Decisions should be made on current information, not future 

potential information

 Suggestions for additional groupings
PDS Proposal: NOSB 

Policy and Procedures 

Manual (PPM)
Background
Q. Why Revise the PPM?

A.

 Current version woefully out of date almost to the 

point of being irrelevant – has not been updated since 

2012 (4 years)

 Does not reflect the current operating practices of the 

board.

 PPM conflicts with FACA

 Current PPM is confusing - Lots of new NOSB members 

need on-boarding (4 in 2015, 6 in 2016, 5 in 2017).

 Want to preserve good policies.
Q. Who initiated this revision on the PPM?

A. The NOSB
NOP agreed to PDS leadership on revisions
Q. What was the starting place for the 

proposed PPM? 

A. Work of previous PDS

...
Q. What was the NOP’s involvement?

A. Supportive in nature: administrative 

assistance, review, compliance
Q. What was the NOSB’s involvement?

A. Proposed, discussed, and approved 

changes. Considered public input. 
Q. Who has authority over PPM?

 By Law? The USDA –

 OFPA - § 6518 - National Organic Standards Board (a) In general. The 

Secretary shall establish a National Organic Standards Board (in 

accordance with the Federal Advisory Committee Act) (hereafter 

referred to in this section as the “Board”) to assist...

 FACA 8 (b) The head of each agency which has an advisory 

committee shall designate an Advisory Committee Management 

Officer who shall—

(1) exercise control and supervision over the establishment, 

procedures, and accomplishments of advisory committees

established by that agency; 

 By Tradition? The NOSB
Q. Do the PPM revisions reduce NOSB 

authority and independence? 

A.

 Brings PPM into compliance with FACA and OFPA.

 PPM only authoritative on the NOSB, putting 

verbiage in the PPM does not make it binding on 

the NOP.

 Retains NOSB authority and sets collaborative 

nature with NOP based on mutual respect for each 

others roles.
Tensions/Balancing

 Tradition vs compliance with OFPA/FACA

 Current wording vs current operations

 Accuracy vs aspirations

 Independence vs collaboration

 Protest vs compromise
OBJECTIVE

 PPM that complies with OFPA

 PPM that complies with FACA

 PPM that is approved by the NOSB and NOP/AMS

 PPM that accurately reflects current operating procedures

 PPM that fosters transparency and public participation in 

NOSB decision making process

 PPM that respects and builds on past NOSB Policy where it 

does not conflict with the above points

 PPM with a logical structure and with proper grammar

 Continuous Improvement
Public Comment 

Review
NOSB/PDS ability to approve/revise PPM

Public Input

 “The role of the Policy Development Subcommittee has 

been redefined in a way that diminishes the ability of the 

NOSB to establish its own procedures.”

 “Taken together, OFPA and FACA imply that NOP must 

recognize NOSB authority to develop its own operating 

principles.”
NOSB/PDS ability to approve/revise PPM

PPM Proposal

IX. REVISIONS TO THE POLICY AND PROCEDURES MANUAL

• The PDS will review the PPM each year and, working in 

collaboration with the NOP, determine if any updates are 

necessary. 

• Proposed changes will be subject to review and approval 

by the NOP and the full NOSB.
NOSB/PDS ability to approve/revise PPM

OFPA/FACA

 OFPA - § 6518 - National Organic Standards Board (a) In general. 

The Secretary shall establish a National Organic Standards 

Board (in accordance with the Federal Advisory Committee 

Act) (hereafter referred to in this section as the “Board”) to 

assist...

 FACA 8 (b) The head of each agency which has an advisory 

committee shall designate an Advisory Committee Management 

Officer who shall—

(1) exercise control and supervision over the establishment, 

procedures, and accomplishments of advisory committees

established by that agency; 
The section on NOP-NOSB Collaboration has 

become less collaborative

Public Input

 “The separation of the board’s responsibility to carry out its statutory authority 

should not be confused with bureaucratic constraints that preemptively restrain 

board function.”

 ‘OFPA mandates this independent authority, independence is not foreign to 

FACA. Section 5.b.3 of FACA requires that, “the advice and recommendations of 

the advisory committee will not be inappropriately influenced by the appointing 

authority..., but will instead be the result of the advisory committee's 

independent judgment.” We interpret this to mean that you either seek advice 

or your do not seek advice. Once you seek advice (in the case of the NOSB, the 

agency is not seeking advice by Congress had mandated independent outside 

advice with line item authorities), you do not seek to influence that advice. A 

serious form of influence is a government official preemptively telling advisors 

that they may not offer advice because of the associated costs.”

 “OFPA, as pointed out above, requires NOP to consult with the NOSB on a 

number of issues, including ‘developing the program.’”
The section on NOP-NOSB Collaboration has 

become less collaborative.

Public Input

 “At the same time, less emphasis is placed on true collaboration. It is essential 

that the NOSB police itself and adapt to changing circumstances from the NOSB. 

This self-regulation cannot occur if the NOSB does not have the ability to change 

its own official policies, with the appropriate public comment.”

 “In addition, the requirement in OFPA for the Secretary to authorize the board 

to hire a staff director is a clear statutory direction that the NOSB must lead the 

way. Taken together, these two statutes conflict with parts of the statement in 

the proposal that ‘the NOSB cannot direct USDA or bind the Secretary through its 

actions; for example, it cannot obligate funds, contract, make NOP staffing 

decisions, or initiate policies of its own accord.’”
The section on NOP-NOSB Collaboration has 

become less collaborative.

PPM Proposal

NOSB-NOP COLLABORATION 

In 1990, the Organic Foods Production Act (OFPA: 7 U.S.C. 6518 (a)) directed the 

Secretary of Agriculture to “establish a National Organic Standards Board (in 

accordance with the Federal Advisory Committee Act (FACA)) ... to assist in the 

development of standards for substances to be used in organic production and to 

advise the Secretary on any other aspects of the implementation” of the Act. 

Section 6503 (a) of the OFPA requires that the Secretary “shall establish an 

organic certification program ... and shall consult with the NOSB” (6503(c)). The 

National Organic Program (NOP) is the governmental institution responsible for 

implementing the OFPA and is the means through which the NOSB provides advice 

and assistance to the Secretary of Agriculture. The NOSB, as a FACA advisory 

committee, must conduct business in the open, under the requirements of P.L. 

94-409, also known as “Government in the Sunshine Act” (5 U.S.C.552b). 
The section on NOP-NOSB Collaboration has 

become less collaborative.

PPM Proposal

The USDA cannot delegate its authority as a regulatory body to private citizens, 

even when those private citizens are appointed by the Secretary to provide 

advice. Therefore, the NOSB cannot direct USDA or bind the Secretary through its 

actions; for example, it cannot obligate funds, contract, make NOP staffing 

decisions, or initiate policies of its own accord.

However, the NOSB has unique statutory authority related to the recommendation 

of materials as approved or prohibited substances for inclusion on the National 

List. 

The unique nature of the NOSB and its relationship with the NOP, as established 

through OFPA, requires that the volunteer Board, which regularly receives 

stakeholder input through public comment, must work collaboratively with the 

NOP.

Similarly the NOP, as required through OFPA, must consult and collaborate with the 

NOSB
The section on NOP-NOSB Collaboration has 

become less collaborative.

PPM Proposal

Team work and collaboration between the NOSB and the NOP, as well as others in 

the organic community, is needed to maintain, enhance and promote the 

integrity of organic principles and products. Successful collaboration is 

dependent on effective communication and constructive feedback. 

Communication is facilitated by the Advisory Committee Specialist, who 

participates in all NOSB calls. Additionally, the NOP Deputy Administrator or 

designee will participate in all ES calls, and in other standing Subcommittee calls 

upon request and mutual agreement. In addition, each standing Subcommittee 

will be assigned an NOP staff person to provide technical, legal, and logistical 

support.

The work of the NOP and NOSB since the 1990 passage of the OFPA clearly 

demonstrates the need for the high level of collaboration and consultation 

described above. NOP, NOSB and its associated stakeholders must continuously 

work to seek common ground, collaborate and consult in order to build organics 

and maintain organic integrity. Every aspect of this work must take place in a 

manner which clearly demonstrates mutual respect and positive intent.
The section on NOP-NOSB Collaboration has 

become less collaborative.

OFPA/FACA

 OFPA•§ 6503 - National organic production program (c) Consultation. 

In developing the program under subsection (a), and the National List 

under section 6517 of this title, the Secretary shall consult with the 

National Organic Standards Board established under section 6518 of 

this title.

 OFPA - § 6518 - The Secretary shall establish a National Organic 

Standards Board (in accordance with the Federal Advisory Committee 

Act) (hereafter referred to in this section as the “Board”) to assist in 

the development of standards for substances to be used in organic 

production and to advise the Secretary on any other aspects of the 

implementation of this chapter. 

 (j) Other terms and conditions. The Secretary shall authorize the 

Board to hire a staff director and shall detail staff of the Department 

of Agriculture or allow for the hiring of staff and may, subject to 

necessary appropriations, pay necessary expenses incurred by such 

Board in carrying out the provisions of this chapter, as determined 

appropriate by the Secretary.
The section on NOP-NOSB Collaboration has 

become less collaborative.

OFPA/FACA

 FACA 7. (c) The Administrator shall prescribe administrative guidelines 

and management controls applicable to advisory committees, and, to 

the maximum extent feasible, provide advice, assistance, and 

guidance to advisory committees to improve their performance. In 

carrying out his functions under this subsection, the Administrator 

shall consider the recommendations of each agency head with respect 

to means of improving the performance of advisory committees whose 

duties are related to such agency

 FACA 8 (b) The head of each agency which has an advisory committee 

shall designate an Advisory Committee Management Officer who shall—

(1) exercise control and supervision over the establishment, 

procedures, and accomplishments of advisory committees

established by that agency; 
Work Agendas

Public Input

 “The section on NOSB work agendas (formerly workplans) 

removes from the NOSB the authority to initiate agenda 

items.”

 “OFPA gives the leadership role to the NOSB, not the NOP. 

Authority over work agendas must be restored to the 

NOSB.”

 “The NOSB should be allowed unequivocally to retain 

control of its own administrative work plans and agendas 

dictated and specified by the Organic Food Production 

Act.”
Work Agendas

OFPA/FACA

 OFPA - § 6518 - National Organic Standards Board (a) In general. The 

Secretary shall establish a National Organic Standards Board (in 

accordance with the Federal Advisory Committee Act) (hereafter 

referred to in this section as the “Board”) to assist...

 FACA 8 (b) The head of each agency which has an advisory committee 

shall designate an Advisory Committee Management Officer who shall—

(1) exercise control and supervision over the establishment, 

procedures, and accomplishments of advisory committees established 

by that agency; 

 FACA 10. Advisory committee procedures; meetings; notice, publication 

in Federal Register; regulations; minutes; certification; annual report; 

Federal officer or employee, attendance

(f) Advisory committees shall not hold any meetings except at the call 

of, or with the advance approval of, a designated officer or employee 

of the Federal Government, and in the case of advisory committees 

(other than Presidential advisory committees), with an agenda 

approved by such officer or employee.
Work Agenda

PPM Proposal

The NOSB Work agenda is a list of projects for the upcoming semester or year for 

each of the Subcommittees. Agendas are developed via collaboration between the 

NOSB and the NOP and are revised based on AMS-NOP requests, NOSB priorities, 

and public comment. 

Work agendas are developed based on the following criteria: 

• Within Scope: Item must be within the scope of OFPA. NOP must have a clear 

sense of the intent and scope of the work agenda item. The public may petition 

additions or deletions from the National List that will be added to the work 

agenda. In addition, the public may submit comments to the NOSB or write to the 

NOP for potential additions to the work agenda. For the NOSB, work agenda items 

may emerge from discussions on current issues.

• USDA and NOP Priority: Item must be a priority for the USDA/NOP; something 

that the NOP is able to implement in a reasonable timeframe. 

• Clear Need: Item must reflect a clear need for the NOP and/or organic 

community, for which new or additional information or advice is needed. 
Work Agenda

PPM Proposal

The NOSB work agenda establishes Subcommittee work for the upcoming semester 

or year, and is developed through the following process: 

1. NOSB Subcommittees submit to the Executive Subcommittee draft work agenda 

items based on AMS-NOP requests, NOSB priorities, and requests from public 

comment. 

2. The NOP and Executive Subcommittee review the draft NOSB work agenda. The 

content and schedule will be reviewed on an ongoing, as needed basis. 

3. NOP confirms the final NOSB work agenda, and provides written confirmation. 

Work agenda items should be prioritized accordingly:

1. Substance evaluations (e.g., 5-year sunset review, petitions) 

2. NOP requests to the NOSB 

3. NOSB requests to NOP

4. Other projects
Work Agenda

PPM Proposal

Below are descriptions of common NOSB work agenda items and the corresponding 

NOP and NOSB responsibilities. 

• Review of materials proposed to be added to or removed from the National List

The NOSB has the statutory authority to consider and recommend materials for 

addition to, or deletion from, the National List of Approved and Prohibited 

Substances. The NOSB may also make recommendations to add, remove, or modify 

annotations restricting the use of such listed materials.

• Changes to annotation or classification of materials

The NOSB may request to review an existing substance on the National List without 

a new petition when they have justification to support a revision of the annotation 

or reclassification of the substance. This may happen as a result of the sunset 

review process, or as new information is provided in a Technical Review, or from 

public comment. 
Work Agenda

PPM Proposal

Below are descriptions of common NOSB work agenda items and the corresponding 

NOP and NOSB responsibilities. 

• Recommendation for modification of existing standards or new standards 

The NOP may request that the NOSB develop recommendations for new or existing 

standards. The request should be in writing and include a statement of the problem 

to be addressed, background, including the current policy or situation, 

statutory/regulatory authority, legal context, and desired timeframe for receiving 

the recommendation. The request will be posted on the NOP web site.

• Advice on NOP policy and interpretation of standards

The NOSB may provide comments on guidance or policy memos included in the 

Program Handbook, or may also make recommendations for new guidance or 

policies.
Work Agenda

PPM Proposal

Below are descriptions of common NOSB work agenda items and the corresponding 

NOP and NOSB responsibilities. 

• Compliance and Enforcement 

The NOP is responsible for compliance and enforcement. The NOP welcomes NOSB 

input on standards, but NOSB involvement in active investigations or enforcement 

actions is not appropriate. When timely and appropriate, the NOP reports to the 

NOSB the status of enforcement actions and also posts the status on the NOP web 

site.

• Management Review

The NOSB may review the quality management system and internal audits to ensure 

that the NOP is managed effectively and efficiently. For example, the NOSB may be 

asked for informal feedback or to work on specific work agenda items that relate 

to the development or implementation of audit corrective actions.
Conflict of Interest

Public Input

 “The proposal incorporates the NOP changes that are not 

publicly transparent, but divulge potential conflicts only to the 

NOP. The NOP changes also do not divulge the statutory basis of 

the criteria, nor the particular bases for decisions. They allow 

for arbitrary decisions based on vague, nonpublic criteria. The 

COI policies in the current PPM are clear, and allow for a public 

application by the NOSB itself. If the NOP has additional criteria 

that it thinks should be applied, it should state them publicly 

and apply them publicly. “Taken together, OFPA and FACA imply 

that NOP must recognize NOSB authority to develop its own 

operating principles.”
Conflict of Interest

Public Input

 “Discussion of potential conflicts that might exist for 

board members should be discussed in public not in 

private conversation with NOP. In this sense, these 

guidelines overstep the NOP’s authority to control the 

process, since the board has historically conducted 

potential conflicts in public with the board making a 

determination in public.”
Conflict of Interest

OFPA/FACA

 OFPA - § 6518 - National Organic Standards Board (a) In general. The 

Secretary shall establish a National Organic Standards Board (in 

accordance with the Federal Advisory Committee Act) (hereafter 

referred to in this section as the “Board”) to assist...

 FACA 7 (c) The Administrator shall prescribe administrative guidelines 

and management controls applicable to advisory committees, and, to 

the maximum extent feasible, provide advice, assistance, and 

guidance to advisory committees to improve their performance. 

 FACA 8 (b) The head of each agency which has an advisory 

committee shall designate an Advisory Committee Management 

Officer who shall—

(1) exercise control and supervision over the establishment, 

procedures, and accomplishments of advisory committees 

established by that agency; 
Conflict of Interest

OFPA/FACA – GSA Guidance

FACA ADVISORY COMMITTEE MEMBERS APPLICABLE ETHICS STATUTES AND REGULATIONS

SGE - Special Government Employee (a person who serves not more than 130 days out of 

a 365 day period)

FTE - Full-time regular government employees

REP - Representative of particular interest group

I. Executive Orders apply to SGEs and FTEs but not to REPs

II. Standards of Conduct apply to SGEs and FTEs but not to REPs except as noted below.*

III. Conflicts of Interest apply to SGEs except as noted below** and FTEs but not to REPs.

IV. Ethics in Government Act including both the A. Public Financial Form and B. 

Confidential apply to SGEs and FTEs but not to REPs.

* Representative commission members would only be bound by the standards of conduct 

if the commission as a body made it applicable to all members. Representative 

members are reminded that nonpublic information should not be released to the public 

without permission.

** SGE's are treated less restrictively on a number of conflicts of interest laws.
Conflict of Interest 

PPM Proposal

K. DECLARATION OF INTERESTS/Conflict of Interest

NOSB members are classified as representatives under the Federal Advisory Committee Act (FACA). 

Each representative is appointed to articulate the viewpoints and interests of a particular interest 

group. The Organic Foods Production Act (OFPA) prescribes these interest groups, which include 

farmers/growers, handlers, certifiers, environmentalists/conservationists, scientists, consumers 

and public interest groups, and retailers. Representatives are appointed to speak in “we” terms, 

serving as the voice of the group represented (e.g., “we farmers/growers believe...”). As such, 

NOSB members are not expected to provide independent expert advice, but rather advice based on 

the interests of the groups served. 

NOSB members represent the interests of a particular group. As such, many of the interests are 

acceptable interests. An interest is acceptable if it is carried out on behalf of a represented group, 

and if a Board member receives no disproportionate benefit from expressing the interest. True 

conflicts of interest arise when an interest: 

• Directly and disproportionally benefits you or a person associated with that member; 

• Could impair your objectivity in representing your group; or 

• Has the potential to create an unfair competitive advantage. 

The appearance of a personal conflict and loss of impartiality, while not a true conflict, must be 

considered when conducting NOSB business. 
Conflict of Interest

PPM Proposal

Declarations of Interest/Conflicts of Interest Procedures 

Board members are appointed in part because of their interests. As such, each NOSB member needs 

to actively consider their interests with respect to topics being considered by the Board, and 

identify whether these interests would create appearance problems. This consideration should 

occur at two specific points during the Board’s work on a particular topic. The first consideration 

should occur at the Subcommittee level, when a Subcommittee begins work on material or topic. 

The second is when a discussion document or proposal advances from the Subcommittee to the full 

Board for consideration. 

At the Subcommittee Level

NOSB members represent the diverse interests of a broad stakeholder community, and make 

recommendations that may have wide-reaching regulatory impacts across all of these interest 

groups. As such, NOSB member actions are carefully scrutinized. 

Given this, the NOP has provided the following guidelines for NOSB members working at the 

Subcommittee level: 

• Avoid leading projects for which you could reasonably be viewed by others as having a 

particular interest that would hinder your ability to objectively and fairly represent broader group 

interests, and to allow other members to represent theirs. If leading a project would likely lead 

others to believe you are “self-dealing” to benefit yourself or someone close to you, you should 

refrain from leading. 
Conflict of Interest

PPM Proposal

• If you feel you may have an appearance problem or conflict of interest, you should inform the 

DFO that a conflict may exist, and describe the nature of that conflict. You should also tell the 

subcommittee impacted that you may have a conflict; sharing as much or as little about the nature 

of the conflict with other board members as you wish. After this declaration, you may continue to 

contribute to the discussion on the topic. As long as it is known there is a conflict of interest, the 

conflict does not preclude the member from contributing his or her input to the subcommittee. 

• If you are uncertain as to whether an interest constitutes an appearance problem or a true 

conflict, then contact the DFO to discuss it. In this case, the NOP, working with the USDA office of 

ethics as needed, will make the determination about whether a problem exists.

At the Full Board Level

Once discussion documents and proposals are posted for public comment, each NOSB member is to 

review the documents across all Subcommittees, and research any potential conflicts of interest 

due to organizational affiliation or relationships. 

The following procedures will take place at the Board level: 

1. Approximately 2-4 weeks before the meeting, the NOP’s DFO will provide a matrix to all NOSB 

members that lists the items being considered at the meeting. 

2. If you determine that you do have a conflict of interest, use the matrix to disclose that 

information and to declare a recusal from voting on the item(s). 
Conflict of Interest 

PPM Proposal

3. If you are not sure whether an interest is acceptable or poses a problem, or if you are 

uncertain whether recusal is needed, contact the NOP DFO to discuss. The NOP – working with the 

USDA office of ethics as needed - will make the determination about whether a conflict of interest 

exists, and will instruct the member accordingly as to whether to vote or not. 

4. Return your completed matrix approximately one week before the board meeting. The NOP 

will then use these to compile a list of all recusals for the meeting. 

5. At the meeting, at the beginning of each subcommittee session or at a time designated at the 

discretion of the board chair, the DFO will state: “the following board members have a conflict of 

interest with the following documents, and will not be voting: e.g. Bob has a conflict and will 

recuse himself from the proposals CleanGreenA and GreatChemB (etcetera).” 

6. Once the DFO completes listing the recusals, the NOSB Subcommittee chair leading the session 

may invite additional information from members on a voluntary basis, with a statement such as: “if 

Board members wish to disclose information about their conflict, or any other information about 

their interests, they are welcome to do so at this time.” This is to be stated as a general and 

voluntary invitation; no specific NOSB member is to be called on. 

7. For any documents deferred to the last day of the meeting, the DFO will repeat the 

declaration of statement above at the start of the voting session for each subcommittee. When it is 

time to vote, the NOSB member recusing her/his self should state “recuse” when it is his or her 

time to vote. 
Advisory Committee Specialist/Staff Director

Public Input

 “Neither version addresses the provision of §6518(j) of 

OFPA, “The Secretary shall authorize the Board to hire a 

staff director.”

 “The section on the Advisory Committee Specialist 

(formerly Executive Director) deletes this sentence: “The 

most important function of the ED is to facilitate the 

operation of the Board, while helping to maintain and 

strengthen its independence.”
Advisory Committee Specialist/Staff Director

OFPA/FACA

 OFPA - § 6518 - The Secretary shall authorize the Board to 

hire a staff director and shall detail staff of the 

Department of Agriculture or allow for the hiring of staff 

and may, subject to necessary appropriations, pay 

necessary expenses incurred by such Board in carrying 

out the provisions of this chapter, as determined 

appropriate by the Secretary.
Advisory Committee Specialist/Staff Director 

History from NOSB minutes

 May 1993 – Hal Ricker referred to as Staff Director, not hired by NOSB

 April 1995 – Hal Ricker referred to as Program leader

 April 1996 – Hal Ricker referred to as Program Manager

 May 2002 – Public calls for the hiring of a staff director in public 

comment

 2004 – Appropriations made and NOSB FACA budget enlarged for 

hiring of a staff director

 October 2004 – Barbra Robinson AMS Deputy Administrator talks about 

hiring of a Staff Director

 Must be a federal employee supervised by a federal employee

 They cannot work at the direction of the Board.

 Staff director to fulfill the Board's expectations. This staff director, the 

duties and the responsibilities of this staff member will be to work with the 

Board

 Combined NOSB draft job description with USDA job description for Board 

Specialist

 Need for collaboration between NOSB/NOP on this role was noted
Advisory Committee Specialist/Staff Director

History

 August 2005 – Job description posted for Executive Director

 April 2006 – Valerie Frances announced as Executive Director, 

Katherine Benham hired as Advisory Board Specialist

 October 2010 – Lisa Ahramjian announced as replacement for Valerie

 2011 Katherine Benham transfers out of AMS and position is not 

refilled; Lisa A transitions roles in NOP

 November 2011 – Lorraine Coke fills Board Specialist/Executive 

Director role temporarily

 May 2012 – Michelle A announced as Advisory Board Specialist USDA 

title for the Executive Director job description

 April 2013 – New calls from Public for hiring of Staff Director by the 

NOSB, asserts position is Deputy Administrator
Advisory Committee Specialist/Staff Director 

PPM Proposal

H. Advisory Committee Specialist 

The Advisory Committee Specialist (ACS) is an NOP staff member who is assigned to support 

the NOSB. The Advisory Committee Specialist prepares the Advisory Committee’s and 

Subcommittees’ meeting agendas and notes, and attends all meetings. The position of 

Advisory Committee Specialist (formerly called Executive Director) was added in 2005 to 

facilitate communication and collaboration between the NOP and the NOSB. Advisory 

Committee Specialist duties include but are not limited to:

• Ensuring that all FACA and OFPA requirements are implemented 

• Managing calendars and work agendas to facilitate Subcommittee and NOSB activities

• Arranging, facilitating, and documenting the NOSB Subcommittee conference calls

• Ensuring NOSB members have all necessary materials and information to provide 

informed, structured and timely recommendations to the NOP 

• Conducting meeting planning activities for the semi-annual NOSB meetings, including 

preparation of Federal Register notices and press releases, and facilitation of public comments 

• Coordinating the NOSB nomination and chartering process

• Facilitating training of NOSB members

• Managing information reporting and communication between the NOSB and NOP
Public Information

Public Input

 “if NOP wants to constantly stress the importance of FACA in 

issuing directives to the NOSB, why isn’t it following FACA when 

it comes to public disclosure and true transparency? The fact 

that USDA regards responding to requests as such a low priority 

indicates contempt for the law (FACA) and public participation 

in making decision.”

 “As such, any restriction to public access, beyond what FOIA 

provides for, is contrary to FACA.” 
Public Information

OFPA/FACA

 OFPA - § 6518 - National Organic Standards Board (a) In general. The 

Secretary shall establish a National Organic Standards Board (in 

accordance with the Federal Advisory Committee Act) (hereafter 

referred to in this section as the “Board”) to assist...

 FACA § 10. (b) Subject to section 552 of title 5, United States Code, 

the records, reports, transcripts, minutes, appendixes, working 

papers, drafts, studies, agenda, or other documents which were 

made available to or prepared for or by each advisory committee 

shall be available for public inspection and copying at a single 

location in the offices of the advisory committee or the agency to 

which the advisory committee reports until the advisory committee 

ceases to exist.
Public Information

OFPA/FACA and GSA guidance

 FACA § 8 (b) The head of each agency which has an advisory 

committee shall designate an Advisory Committee Management 

Officer who shall—

(3) carry out, on behalf of that agency, the provisions of section 552 

of title 5, United States Code, with respect to such reports, records, 

and other papers.

 FACA Guidance GSA: Representative commission members would only 

be bound by the standards of conduct if the commission as a body 

made it applicable to all members. Representative members are 

reminded that nonpublic information should not be released to the 

public without permission.
Public Information

PPM Proposal

•Recordkeeping

Records of the NOSB shall be handled in accordance with General Records 

Schedule 26, Item 2 or other approved agency records disposition schedule. 

These records shall be available for public inspection and copying, subject to the 

Freedom of Information Act, 5 U.S.C. 552. Information about the NOSB is 

available online at: http://www.ams.usda.gov/rules-regulations/organic/nosb

While meeting transcripts are not required under FACA, the NOP provides 

transcripts or meeting notes to support the transparency of NOSB meetings and 

to support subsequent rulemaking activities. Minutes of each NOSB meeting, as 

approved by the DFO and the NOSB Chair and Secretary, shall contain a record of 

the persons present, a complete and accurate description of matters discussed 

and conclusions , and the outcome of voting. 
Public Information

PPM Proposal

• FACA requires (5 U.S.C. App. Section 10 (b) ): “Subject to section 552 of title 

5, United States Code, the records, reports, transcripts, minutes, appendixes, 

working papers, drafts, studies, agenda, or other documents which were made 

available to or prepared for or by each advisory committee shall be available for 

public inspection and copying at a single location in the offices of the advisory 

committee or the agency to which the advisory committee reports until the 

advisory committee ceases to exist.”

Any request for FACA records must be made to the NOP.

• While requests for FACA Board records do not have to go through the formal 

FOIA request process, those records must be reviewed by AMS/NOP before 

release, to determine whether any FOIA exemptions apply (e.g., personal 

information, business proprietary information). In addition, OFPA itself requires 

that no confidential business information be released, so emails and documents 

need to be reviewed before release to ensure that this requirement is met. 
Public Information

PPM Proposal

• Freedom of Information Act (FOIA; 5 U.S.C. 552). Under this Act, the public 

may request documents and other information pertaining to USDA actions. NOSB 

communications with USDA (including email) are subject to these requests, with 

limited exemptions. Some USDA information is routinely exempt from disclosure 

in or otherwise protected from disclosure by statute, Executive Order or 

regulation; is designated as confidential by the agency or program; or has not 

actually been disseminated to the general public and is not authorized to be 

made available to the public upon request. When there is a FOIA request for 

information, the USDA will review all relevant information and determine what 

qualifies for release, then provide it to the requestor. 
Public Information

PPM Proposal

2) Additional Standards of Conduct

NOSB members should adhere to the following basic “standards of conduct” while 

in government service:

• Refrain from sharing working documents with the public. Working 

documents are defined as information that a board member gains by reason of 

participation in the NOSB and that he/she knows, or reasonably should know, has 

not been made available to the general public: e.g. is not on the NOP or other 

public websites, or is a draft document under development by an NOSB 

Subcommittee. 

• Do not circulate draft Subcommittee documents until they are finalized and 

publicly available to all on the AMS/NOP website. 
Sunset Voting Procedures

Public Input

 “The most disturbing change found in the draft proposal 

PPM and in NOSB policy in general is the complete 

reversal of the material Sunset Review process. This 

change was made without proper notice and public 

comment in 2013.”

 At a minimum, the results of this lawsuit should be 

realized before the Sunset policy is revisited with proper 

attention to public comment and debate (as claimed by 

the legal challenges).
Sunset Voting Procedures

PPM Proposal

VII. Sunset Review Process 

The Organic Foods Production Act of 1990 (OFPA) authorizes a National List of Allowed and 

Prohibited Substances (7 U.S. C. Section 6517). Sections 6517 (e) mandates a Sunset Provision 

as follows: 

“No exception or prohibition in the National list shall be valid unless the National Organic 

Standards Board has reviewed such exemption or prohibition as provided in this section 

within 5 years of such exemption or prohibition being adopted and the Secretary has 

renewed such exemption or prohibition.”

The NOP published a Federal Register notice on Sept. 16, 2013 (78 FR 56811) describing 

current procedures for sunset review. Through the sunset review process, the NOSB can 

recommend to USDA the removal of substances based on adverse impact on human health, 

the environment, or other criteria under the Organic Foods Production Act (OFPA). If upon 

review the NOSB believes the substance no longer fits the criteria for an exemption or 

prohibition, the NOSB can recommend (by a decisive two-thirds vote, 7 USC Section 6158 (i)) 

to remove the substance from the National List. After the NOSB has completed this "sunset" 

review, the USDA must renew or remove the substances on the National List to complete the 

process. All substances under sunset review will be considered over two NOSB meetings, to 

provide ample opportunity for public notice and comment. The NOSB observes the following 

procedure. 
Sunset Voting Procedures

PPM Proposal

The NOSB observes the following procedure. 

Definition:

Observe: to fulfill or comply with (a social, legal, ethical, 

or religious) obligation

Does not say:

Accept

Approve

Support
Sunset Voting Procedures

PPM Proposal

A. Steps in the Sunset Review Process (See Member Guide for forms used in these steps.) 

Step 1: The NOSB Subcommittees submit the initial Sunset List Summary for posting which 

may include requests for specific information. The NOP posts the list as well as the NOSB 

Meeting Announcement in the Federal Register which invites comments, at least 30 days 

prior to the first public meeting on these sunset substances.

Step 2: The public submits written comments, which are analyzed by Subcommittees.

Step 3 (Public Meeting #1): Subcommittees summarize background and public comment & 

receive oral comment.

Step 4: Subcommittees analyze written and oral comments from Meeting #1 and prepare a 

Preliminary Review that includes a motion to remove the substance from the National List. 

The NOP publishes the next meeting announcement in the Federal Register, inviting comment 

on the Preliminary Reviews, which are posted on the NOP website. 

Step 5: Written public comments submitted and analyzed by Subcommittees.
Sunset Voting Procedures

PPM Proposal

Step 6 (Public Meeting #2): Subcommittees present Preliminary Review, receive oral 

comment, and discuss the proposal with the full Board. When presented to the full NOSB, 

reviews will contain a motion and second taken in Subcommittee. Motions for removal based 

on the Preliminary Review are voted on by the full Board, and require a decisive two-thirds 

(2/3) majority to pass.

o At Meeting #2, the NOSB completes the Sunset Review and submits the final documents 

to the NOP. 

Step 7: AMS reviews the NOSB Sunset Review and considers rulemaking action for any 

recommended removals. This will include a proposed rule open for public comment before a 

final rule amendment is published. 

Step 8: AMS issues Federal Register Notice announcing renewal of applicable substances.
Minority View/Opinion

Public Input

 “Keeping a record of minority opinions is essential for the 

NOSB’s operation at both the subcommittee and whole-board 

level.”

 The new draft deletes the inclusion of the minority opinion as a 

separate document (when it’s applicable at all).These changes 

to the text have the effect of silencing the minority opinion and 

must be changed.

 A view cannot be determined a “minority” view until after a 

vote is taken. It is also contrary to the purpose of an advisory 

committee to set a deadline dictating when new information 

may be introduced, particularly when a vote crystalizes the 

minority view.
Minority View/Opinion

PPM Proposal

•When it is not possible for a Subcommittee, during its regular deliberations on 

conference calls, to reach consensus on a proposed document/recommendation as it 

is being reviewed, and there are substantive irreconcilable differences, a minority of 

the Subcommittee may develop a written minority view for review by all members of 

the Subcommittee. The Subcommittee Chair has the responsibility to facilitate the 

process for the minority view.

A minority view should: 

o Be short and concise, and include reasons for opposing the Subcommittees 

recommendation; 

o Should not include any data or information not introduced on a Subcommittee 

call; 

o Should be submitted in a timely manner, and will not be accepted after the 

Subcommittee has voted on its recommendation; 

o Will be included as a separate section at the end of the recommendation.
The NOSB was carefully chartered by Congress to facilitate 

both a valid consensus among very diverse stakeholders on 

the numerous questions of interpretation, as well as provide 

the special ―“gatekeeper” function with respect to 

substances that the Secretary would allow for use in organic 

production and processing.

-Kathleen Merrigan
Conflict of Interest for Technical Reviews

Public Input

 “As part of these policies and procedures, the authors of 

the Technical Reviews and/or parties to a Technical 

Advisory Panel should be public knowledge. This 

transparency is a necessary part of the political process 

and cannot be ignored. Luckily, the PDS responded 

favorably to public comment and added that contractors 

will now be named on Technical Reviews. However, it is 

imperative that the authors – the scientists and technical 

experts themselves – are also identified to NOSB members 

and the public on any Technical Reviews or Technical 

Advisory Panels in which they participate.”
Conflict of Interest for Technical Reviews 

PPM Proposal

The NOP will seek Technical Reviews from a range of experts. The 

name of the contracted party will appear on the Technical Review. 

All Federal contracts, including those issued by USDA/NOP to 

Technical Report contractors, are governed by the Federal 

Acquisition Regulations (FAR). The FAR includes a “Subpart 3.11— Preventing Personal Conflicts of Interest for Contractor Employees 

Performing Acquisition Functions,” which requires contractors to 

identify and prevent personal conflicts of interest for their 

covered employees. “Personal conflict of interest” means a 

situation in which a covered employee has a financial interest, 

personal activity, or relationship that could impair the employee’s 

ability to act impartially and in the best interest of the 

Government when performing under the contract. Link: 

https://www.acquisition.gov/far/current/pdf/FAR.pdf
Conflict of Interest for Technical Reviews

FAR

 FAR – 3.1101 “Personal conflict of interest” means a situation in 

which a covered employee has a financial interest, personal 

activity, or relationship that could impair the employee’s ability 

to act impartially and in the best interest of the Government 

when performing under the contract. (A de minimis interest that 

would not “impair the employee’s ability to act impartially and in 

the best interest of the Government” is not covered under this 

definition.) 

(1) Among the sources of personal conflicts of interest are—

(i) Financial interests of the covered employee, of close family 

members, or of other members of the covered employee’s 

household;
Conflict of Interest for Technical Reviews

FAR

(ii) Other employment or financial relationships (including seeking 

or negotiating for prospective employment or business); and

(iii) Gifts, including travel.

(2) For example, financial interests referred to in paragraph (1) of 

this definition may arise from—

(i) Compensation, including wages, salaries, commissions, 

professional fees, or fees for business referrals;

(ii) Consulting relationships (including commercial and professional 

consulting and service arrangements, scientific and technical advisory 

board memberships, or serving as an expert witness in litigation);

(iii) Services provided in exchange for honorariums or travel expense 

reimbursements;
Conflict of Interest for Technical Reviews

FAR

(iv) Research funding or other forms of research support;

(v) Investment in the form of stock or bond ownership or partnership 

interest (excluding diversified mutual fund investments);

(vi) Real estate investments;

(vii) Patents, copyrights, and other intellectual property interests; or

(viii) Business ownership and investment interests.
Public Comment:

 Electronic Participation

Presence at a Meeting the PPM must be specific regarding 

the conditions under which electronic participation will be 

allowed and what mechanisms will be used to approve 

such participation

PPM Proposal

Quorum: As specified in OFPA, a majority of the members 

of the NOSB shall constitute a quorum for the purpose of 

conducting business. (7 USC 6518 (h)). In cases of a 

medical situation preventing attendance in person, a 

virtual presence is permitted. 
Public Comment:

 NOSB authority over National List not clearly stated

Proposed PPM

I. The primary roles and duties of the National Organic Standards Board (NOSB):

• Propose amendments to the National List of Allowed and Prohibited 

Substances

I.C Mission: Key activities of the Board include: 

• Reviewing petitioned materials for inclusion on or removal from the National 

List of Approved and Prohibited Substances (National List) 

• Recommending changes to the National List 

III.E. However, the NOSB has unique statutory authority related to the 

recommendation of materials as approved or prohibited substances for inclusion 

on the National List. 

III.F The NOSB has the statutory authority to consider and recommend materials 

for addition to, or deletion from, the National List of Approved and Prohibited 

Substances. The NOSB may also make recommendations to add, remove, or 

modify annotations restricting the use of such listed materials.
Public Comment:

 Unclear if Robert’s Rules is used:

PPM Proposal

C. PARLIAMENTARY PROCEDURES

The NOSB adopted the use of Robert’s Rules of Order in March 1992, but 

modified its use as only a non-mandatory guide in May 1993. Roberts 

Rules may be adapted to meet the special requirements of a group. 

Because the NOSB is also subject to the OFPA, FACA and USDA, a 

designated NOP staff member may act as an informal Parliamentarian to 

advise the Chair.
Public Comment:

 Roll call voting

PPM Proposal

Voting may be by show of hands, roll call, or by use of modern voting devices.
Other Important 

Changes
 Webinars for Public Comment

 Prohibition on withdrawal of petitions already reviewed 

by Subcommittee

 Establishment of COI procedures for Technical Reviews

 Description of roles of subcommittee

 Establishment of GMOs as a standing purpose for the 

Materials Subcommittee

 Establishment of research priorities as a standing 

purpose for the Materials Subcommittee

 Creates a document that flows logically, grammatically 

correct
Public Comment, 

to be reviewed by 

PDS for future 

revisions
Public Comment: 

 Make it clear order of precedence of rules (ie, 

OFPA, FACA, Charter, other laws/regulations, 

PPM, RONR)

 Guidance on detail level and timeliness of 

subcommittee notes

 Review Public communications policy from 2012 

for inclusion

 Definitions for certain terms

 Guidance to the Secretary on Appointments

 Voting for election of officers

 Voting record is part of the minutes
Public Comment: 

 Clarification on roles of the USDA DFO and USDA 

CMO

 Publication of voting records with meeting 

transcripts

 Minutes from the Administrative team

 Meeting Minutes – documents provided to the 

committee

 Add The General Services Administration memo to 

Committee Management Officers on FACA public 

information access should be included in the PPM

 Timing of public comments and publications

 Hiring of the Staff Director
In summary –

...80 slides later
Tensions

 Tradition vs compliance with OFPA/FACA

 Historic wording vs current operations

 Accuracy vs aspirations

 Independence vs collaboration

 Protest vs compromise
OBJECTIVE

 PPM that complies with OFPA

 PPM that complies with FACA

 PPM that is approved by the NOSB and NOP/AMS

 PPM that accurately reflects current operating procedures

 PPM that fosters transparency and public participation in 

NOSB decision making process

 PPM that respects and builds on past NOSB Policy where it 

does not conflict with the above points

 PPM with a logical structure and with proper grammar

 Continuous Improvement
Compliance with 

OFPA/FACA

Prescribes and 

describes 

current 

operating 

procedures

Consistent with 

tradition and 

history

Proposed 

PPM
Ancillary Substance 

Review Flow Chart
1. Petition comes in or Sunset process starts

2. Technical Report (TR) is commissioned

2a. TR will have chart of ancillary substances in use 

organized by functional class

2b. TR will evaluate ancillaries along with substance 

for each OFPA and Handling criteria.

2c. Any that could be used that do not meet criteria 

will be flagged.

2d. Any on the lists (IARC or NTP) of problematic 

ones will be flagged.

3. NOSB reviews TR

3a. All information in the TR is evaluated, including 

the use of Ancillaries. The criteria in the Ancillary 

Substance Framework document (baseline) are used by 

the NOSB.

3b. Any that are flagged in the process above will be in 

the proposal or posting for public comment.

3c. NOSB prepares proposal (for petitions) or first 

posting (for sunset) with the list of proposed ancillaries.

4. Posted for public comment

4a. Public offers comments about chart of ancillary 

substances used. Additions of new ones and concerns 

about any that have been reviewed may be raised.
5. NOSB passes proposal or completes Sunset Review with 

accepted ancillary substances along with it, and indicate which 

substances are prohibited. For sunset review, any that are 

expressly to be prohibited will have another proposal for 

prohibition.

6. NOP publishes rule with those actions above.

7. ACA responsibilities once rulemaking is complete:

7a. Consult chart of ancillaries associated with a substance.

7b. Anything on the chart is allowed.

7c. If a new ancillary appears, the criteria and template 

suggested in the current proposal can be used to collect the 

required information. The template is optional.

7d. Information received must then be screened against the 

IARC and NTP lists.
Carrageenan

National Organic Standards Board

April 2016

Analysis of Issues & Input
Carrageenan

• Classification & Environmental Criteria

• Bias and Expertise

• Science related to Human Health

• Experimental Methods

• Degradation

• Inflammation

• “Sensitivity”

• Alternatives

• Next Steps for Handling Subcommittee
Carrageenan – Classification

Carrageenan – Environmental Criteria

In the 2012 NOSB review, it was stated that we would wait to address classification until the 

Final Guidance on Classification of Materials is published. This is still our position.

If it is available before the fall meeting posting deadline, we will address classification.

Public comment indicates that there is more than 1 method used to extract and purify 

carrageenan and some methods may be synthetic while others are non-synthetic.

A separate Technical Report (TR) has been commissioned to address the impacts 

on the environment of the production and harvest of all types of marine plants 

used in agriculture and processed food. If that report is received on time, we will 

use the information in our second Sunset posting. If not, the issue will be taken 

up separately in regard to all marine plant products on the National List.
Carrageenan – Bias and Expertise

A significant amount of comment is related to the issue of bias in the scientific literature 

over who conducts and funds experimental studies and who reviews them.

Both sides publish in peer reviewed journals, including:

Challenging Carrageenan Supporting Carrageenan

Journal of Diabetes Research (2015) Food and Chemical Toxicology (2016)

Diabetes (1991) FAO JECFA Monographs (2014) 

Environ Health Perspectives (2001) Food Additives Contamination (2014)

Food and Cosmetics Toxicology (1976) Journal of Pharmacy and Pharmacology 

(2008)

Food Hydrocolloids (1996) Critical Reviews in Toxicology (2002, 2014)

Journal of Biological Chemistry (2010, 2015) Journal of Applied Microbiology (1996)

Journal of Allergy and Clinical Immunology 

(2015)

The Toxicologist: Supplement to Toxicological 

Sciences (2016)

Biochim Biophys Acta (2014) Journal of Food Chemistry (2001)
Carrageenan – Bias and Expertise

To the left are the members of the 

JECFA Expert Committee who 

reviewed the status of 

Carrageenan for the WHO. 

Below are the authors of the 

review report.
Carrageenan – Science: Experimental Method

• Older studies did not distinguish between degraded and undegraded

carrageenan.

• Carrageenan is a substance that binds tightly to protein and passes through the 

digestive system. Studies in which it is administered in water without protein, 

injected, or introduced artificially into tissues that are not part of the digestive 

system are questionable.

• In vitro studies have been challenged because the behavior of cells in test tubes 

may not be comparable to in vivo digestive systems.

• Scientist disagree over which animals are appropriate test subjects. Rats and 

mice have different digestive systems than humans. Piglet studies have been 

challenged and primate studies are few.

• A key tenet of the scientific method is that a result from one lab should be 

able to be replicated by other labs using the same experimental parameters. So 

far this has not been directly done and published, particularly on the glucose 

intolerance issue.
Carrageenan – Science: Degradation

• Undegraded, or native, carrageenan (CAS#9000-07-1) is the type that is used 

in food. It has an average molecular weight of 200 to 800 kDa. A substance 

called poligeenan (CAS #53973-98-1) is a degraded form that has been treated 

with a strong acid to create a low molecular weight substance with industrial 

uses. It has an average molecular weight of 10 – 20 kDa.

• Native carrageenan may partially degrade in digestion, but it will be in a full 

range of molecular weights from 200 kDa downwards. This is very hard to 

measure.

• A key question is how much the native carrageenan breaks down and what 

level of degradation could be harmful. 

• Studies have indicated that most of the carrageenan ingested is excreted in 

feces.

• The hypothesis of the degraded carrageenan being absorbed into tissue or 

causing harm has not been proven. Some studies are published showing 

inflammation and other problems, while other studies have not shown 

problems.
Carrageenan – Science: Inflammation

• A series of studies has shown that carrageenan can induce a complex 

inflammatory cascade in human intestinal epithelial cells (TR 2015) These 

studies were in vitro using cells from one individual.

• Other studies did not associate food-grade carrageenan with inflammation.

• Results are mixed in animal studies that administered carrageenan through 

drinking water. (TR 2015) 

• The ability for carrageenan to bind to TLR4 and trigger the inflammatory 

cascade has been challenged in the literature.

• The NOSB Technical Report states, “Definitive conclusions regarding the 

varying degrees of human susceptibility to inflammation effects of carrageenan 

cannot be made from the available literature.”

• The NOSB previously looked at an article published in 2015 by Chassaing et.

al. regarding potential for all dietary emulsifiers to impact the gut microbiota of 

mice promoting inflammation and colitis. These issues may not be unique to 

carrageenan.
Carrageenan – Science: Sensitivity

• In the 2012 Sunset Review we received public comment from at least 7 

individuals who described themselves as sensitive to carrageenan who 

experienced adverse effects that stopped when they removed carrageenan 

from their diet. In this batch of public comment we received more of these 

experiences.

• One of these commenters searched the medical literature and only found one 

report of adverse reactions.

• Many public commenters this time denied the reality of these complaints 

because they are anecdotal and not backed by scientific literature.

• However, it appears that this is not in the literature because it has not been 

studied. No commenter on either side brought a population study on whether 

these concerns are attributable to carrageenan, nor is there any type of study 

that proves that all humans are subject to inflammation caused by 

carrageenan.

• Carrageenan is required to be on food labels with a few exceptions, including 

beer. Therefore those wishing to avoid it have the ability to do so.
Carrageenan – Alternatives – 1

Food Product Made without 

carrageenan?

Chocolate Milk yes and no

Whipping and heavy cream yes

Protein shakes (with milk proteins) no

Milk Powders no

Yogurt, sour cream, and cottage cheese no comments 

received.

sugar free spreads - gelling agent yes and no

puddings no

fruit fillings no

gummi bears yes

Vegan marshmallows no
Carrageenan – Alternatives – 2

Food Product Made without 

carrageenan?

frozen soy dessert no

Soy milk Yes and no

capsules for supplements, vegetarian no

Infant formula no

Processed meats yes and no

non-dairy beverages (nut and grain milks) yes and no

beer no
Carrageenan – Next Steps

The NOSB Handling Subcommittee will fully evaluate all the public 

comment received between now and the fall meeting.

Any new published research studies between now and then should 

be sent to Michelle Arsenault. Please provide actual text and not just 

abstracts or links to articles that require payment.

There will be another comment period open in October before the 

fall meeting. We encourage more comments at that time regarding 

alternatives to the use of carrageenan.