FORMAL RECOMMENDATION BY THE

NATIONAL ORGANIC STANDARDS BOARD (NOSB) 

TO THE NATIONAL ORGANIC PROGRAM (NOP) 

Date: _August 17, 2005________

Subject: __NOSB Policy and Procedures Manual________ 

Chair: ____Jim Riddle______________________________________ 

 (sign) 

Recommendation

The NOSB hereby recommends to the NOP the following: 

Rulemaking Action: ________ 

Guidance Statement: ________ 

Other: ____X____ 

Statement of the Recommendation (including Recount of Vote):

The NOSB adopted revisions to its Policy and Procedures Manual. The revisions include a extensive 

policy for NOP/NOSB collaboration and an introduction to chemistry to be used by Board members in the 

materials review process. 

BOARD VOTE – AUGUST 16, 2005 

13 yes, 0 no, 1 absent 

Rationale Supporting Recommendation (including consistency with OFPA and NOP):

Rationale provided in text of recommendation below. 

Response by the NOP:

Updated 2/25/05 
NATIONAL ORGANIC STANDARDS BOARD 

National Organic Standards Board Policy & Procedures Manual ii 

Current As of October 3, 2005 

POLICY AND PROCEDURES 

MANUAL

Adopted October 19, 2002 

Revised August 18, 2005
National Organic Standards Board Policy & Procedures Manual i 

Current As of October 3, 2005 

NOSB POLICY AND PROCEDURES MANUAL

TABLE OF CONTENTS

INTRODUCTION............................................................................................................. 4

SECTION I ...................................................................................................................... 5 

NOSB VISION STATEMENT: ......................................................................................... 5

NOSB MISSION STATEMENT: ...................................................................................... 5

DUTIES OF THE BOARD AND OFFICERS.................................................................... 5

Duty of Care ......................................................................................................... 6 

Duty of Loyalty...................................................................................................... 7 

Duty of Obedience................................................................................................ 7 

Maintaining Professional and Ethical Standards................................................... 7 

Professional Conduct ........................................................................................... 7 

Conflict of Interest................................................................................................. 8 

SECTION II ................................................................................................................... 10 

BOARD MEMBER JOB DESCRIPTIONS..................................................................... 10

Composition of the Board_Toc99413555 ........................................................... 10

Board Member Standards .................................................................................. 10 

Conducting Business.......................................................................................... 11 

SECTION III .................................................................................................................. 12 

OFFICER RESPONSIBILITIES..................................................................................... 12 

ELECTION OF OFFICERS ........................................................................................... 12 

EXECUTIVE COMMITTEE ........................................................................................... 13 

MEETINGS ................................................................................................................... 13 

SECTION IV.................................................................................................................. 14 

BOARD COMMITTEES................................................................................................. 14 

COMMITTEE MEETINGS............................................................................................. 15 

STANDING COMMITTEES........................................................................................... 15 

Certification, Accreditation, and Compliance Committee.................................... 15 

Crops Committee................................................................................................ 15 

Livestock Committee .......................................................................................... 15 

Materials Committee........................................................................................... 15 

Handling Committee........................................................................................... 16 

Policy Development Committee.......................................................................... 16 

TASK FORCES .................................................................................................. 16 

SECTION V................................................................................................................... 17 

DUTIES OF COMMITTEE CHAIRS .............................................................................. 17 

COMMITTEE AND BOARD PROCEDURES ON RECOMMENDATIONS.................... 17

NOSB AND NOP COLLABORATION PROCESS......................................................... 18

Formal Collaboration Procedures between NOSB and NOP.............................. 18 
National Organic Standards Board Policy & Procedures Manual ii 

Current As of October 3, 2005 

General Procedures for Formal Collaboration 18 ............................................... 18 

Special Circumstances ....................................................................................... 19 

1. Materials proposed to be added to the National List............................ 19 

2. Standards development or modification for formal recommendation ... 19 

3. Standards interpretation and Q and A submitted to the NOP .............. 20 

4. Compliance and enforcement .............................................................. 20 

FORM FOR FORMAL RECOMMENDATION .............................................................. 21 

FORM EXAMPLE FOR FORMAL RECOMMENDATION.............................................. 22 

SECTION VI 

MISCELLANEOUS POLICIES ...................................................................................... 23 

NOSB Policy for Presenters Invited by Committees ........................................... 23 

NOSB Policy for Surveys Conducted On Behalf of NOSB ................................. 23 

NOSB Policy for Public Comment at NOSB Meetings........................................ 24

SECTION VII................................................................................................................. 25 

NOSB PRINCIPLES OF ORGANIC PRODUCTION AND HANDLING ......................... 25

NOSB GUIDANCE ON COMPATIBILITY WITH A SYSTEM OF SUSTAINABLE 

AGRICULTURE AND CONSISTENCY WITH ORGANIC FARMING AND 

HANDLING.................................................................................................................... 27

SECTION VIII................................................................................................................ 28

PROCEDURES OF THE NOSB.................................................................................... 28 

NATIONAL ORGANIC PROGRAM MATERIALS REVIEW PROCESS ........................ 28

Phase 1: Receipt of Petition .............................................................................. 28 

Phase 2: Examination of Petition for Completeness and Eligibility .................... 28 

Phase 3: Evaluation by Contractor .................................................................... 29 

Phase 4: Sufficiency Determination................................................................... 29 

Phase 5: Action by NOSB Materials Chairperson and committee on 

substances being petitioned to or from from the National list (Crops, Livestock 

or Handling ......................................................................................................... 30 

Phase 6: Action by full NOSB............................................................................ 30 

TECHNICAL ADVISORY PANEL (TAP) CONTRACT PROCEDURES ........................ 31 

STATEMENT OF WORK .............................................................................................. 31 

AGENCY NEED ............................................................................................................ 31 

1. Background................................................................................................... 31 

2. Mission of USDA/AMS/NOP.......................................................................... 31 

3. Specific Task................................................................................................. 32 

4. Minimum Skills and Experience Requirements ............................................. 33 

5. Place of Performance.................................................................................... 33 

6. Government Furnished Equipment and Facility ............................................ 33 

7. Compensation............................................................................................... 33 

8. Period of Performance .................................................................................. 33 

9. Scope of Performance .................................................................................. 33 

Phase 1 ---Data Gathering and Compilation (120 days) ............................... 34 

Phase 2---Evaluation against Criteria (100 days).......................................... 34 
National Organic Standards Board Policy & Procedures Manual iii 

Current As of October 3, 2005 

Phase 3---Recommendation (42 days) ......................................................... 34 

Evaluation Factors for Award.............................................................................. 34 

Other Evaluation Factors.................................................................................... 35 

Reporting Requirments....................................................................................... 35 

Information to be Included in a Petition .............................................................. 36 

EVALUATION CRITERIA FOR SUBSTANCES ADDED TO NATIONAL LIST ............. 39 

NOSB RECOMMENDED DECISION FORM ................................................................ 42 

NOSB COMMITTEE RECOMMENDATION FORM ...................................................... 43 

PROCEDURES FOR MATERIALS REVIEW PROCESS FOR NOSB.......................... 44 

SUNSET REVIEW PROCESS ...................................................................................... 45 

APPENDEX................................................................................................................... 49 

DECISION MAKING PROCEDURES FOR THE NOP ................................................. 52 

FACA Facts ........................................................................................................ 49

Duties of the Designated Officer......................................................................... 52 

Parliamentary Procedure at a Glance................................................................. 52 

Basic Chemistry.................................................................................................. 53 
National Organic Standards Board Policy & Procedures Manual 4 

Current As of October 3, 2005 

INTRODUCTION 

This document is intended as a guide for all members of the National Organic 

Standards Board (NOSB). Board members are entrusted with a strong responsibility to 

treat the business of the Board as fiduciaries for all members of the organic community 

and the public at large. 

The Board’s primary role is to advise, rather than administer and implement. As in every 

business, the Board’s success depends heavily upon the ability to understand each 

other’s respective role, and to develop the working relationship necessary within those 

roles. 

This manual is designed to assist the Board in its responsibilities. New Board members 

are encouraged to review this manual in depth. Existing members are advised to 

periodically review the contents to refresh their understanding of the Board’s role and 

their duties. 

New policies and revisions to existing policies and procedures will be incorporated into 

the NOSB Policy and Procedures Manual from time to time, as determined by the 

Board. 
National Organic Standards Board Policy & Procedures Manual 5 

Current As of October 3, 2005 

SECTION I 

NOSB VISION STATEMENT

The NOSB’s vision is an agricultural community rooted in organic principles and values 

that instills trust among consumers, producers, processors, retailers and other 

stakeholders. Consistent and sustainable organic standards guard and advance the 

integrity of organic products and practices. 

NOSB MISSION STATEMENT

To achieve its vision, the NOSB provides effective and constructive advice, clarification 

and guidance concerning the National Organic Program (NOP) to the Secretary of 

Agriculture, seeking to represent a consensus of the organic community. In carrying out 

the mission, key activities of the Board are: 

• Assist in the development and maintenance of organic standards and 

regulations; 

• Review petitioned materials for inclusion on the National List of Approved and 

Prohibited Substances (National List); 

• Recommend changes to the National List; 

• Communicate with the organic community, including conducting public 

meetings, soliciting and taking public comments; 

• Communicate, support and coordinate with the NOP staff; 

• Provide information and education on the NOP. 

DUTIES OF THE BOARD AND OFFICERS

The Organic Foods Production Act of 1990 (OFPA) defines the following specific 

responsibilities for the Board starting at 6518(k) 

(1) IN GENERAL.—The Board shall provide recommendations to the Secretary 

regarding the implementation of this title. 

(2) NATIONAL LIST.—The Board shall develop the proposed National List or 

proposed amendments to the National List for submission to the Secretary in 

accordance with section 2118. 

(3) TECHNICAL ADVISORY PANELS.—The Board shall convene technical 

advisory panels to provide scientific evaluation of the materials considered for 

inclusion in the National List. Such panels may include experts in agronomy, 

entomology, health sciences and other relevant disciplines. 
National Organic Standards Board Policy & Procedures Manual 6 

Current As of October 3, 2005 

(4) SPECIAL REVIEW OF BOTANICAL PESTICIDES.—The Board shall, prior to 

the establishment of the National List, review all botanical pesticides used in 

agricultural production and consider whether any such botanical pesticide should 

be included 

in the list of prohibited natural substances. 

(5) PRODUCT RESIDUE TESTING.—The Board shall advise the Secretary 

concerning the testing of organically produced agricultural products for residues 

caused by unavoidable residual environmental contamination. 

(6) EMERGENCY SPRAY PROGRAMS.—The Board shall advise the Secretary 

concerning rules for exemptions from specific requirements of this title (except 

the provisions of section 2112) with respect to agricultural products produced on 

certified organic farms if such farms are subject to a Federal or State emergency 

pest or disease treatment program. 

 (Additional Duties included in OFPA but not limited to): 

 6518(n)PETITIONS. The Board shall establish procedures under which 

 persons may petition the Board for the purpose of evaluating substances for 

 inclusion on the National List. 

 6509(d)(2) STANDARDS. The National Organic Standards Board shall 

 recommend to the Secretary standards in addition to those in paragraph (1) for 

 the care of livestock to ensure that such livestock is organically produced. 

To fulfill their responsibilities, Board members agree to adhere to three duties as 

described in this Manual: 

• Duty of Care 

• Duty of Loyalty 

• Duty of Obedience

Duty of Care

The Duty of Care calls upon a member to participate in the decisions of the Board and 

to be informed as to the data relevant to such decisions. In essence, the Duty of Care 

requires that a member: 

• Be reasonably informed—It is the duty of all Board members to seek and study 

the information needed to make a reasoned decision and/or recommendation on 

all business brought before the Board. The NOP will provide some of that 

information, but other information must be developed from independent sources. 

• Participate in decisions—Board members are bound by responsibility to be active 

participants in decision-making. Absence from a meeting is no protection from 

the responsibility for decisions made at the meeting. 

• Make decisions with the care of an ordinary prudent person in a similar 

position—The law does not expect Board members to act as super human. It 

simply requires Board members to exercise judgment of an ordinary prudent 

person who may be faced with a similar issue. 
National Organic Standards Board Policy & Procedures Manual 7 

Current As of October 3, 2005 

Duty of Loyalty 

The Duty of Loyalty requires Board members to exercise their power in the interest of 

the public and not in their own interest or the interest of another entity or person. A 

Board member’s loyalty is to the organic community and the public at large. In 

dispatching their Duty of Loyalty, Board members must: 

• Address conflicts of interest—Board members bring to the NOSB particular areas 

of expertise based upon their personal and business interests in organic 

production and marketing. Board members may have interests in conflict with 

those of the public interests. Board members must be conscious of the potential 

for such conflicts and act with candor and care in dealing with such situations. 

Board members must abide by the NOSB conflict of interest policy. 

• Recognize corporate opportunity—Before a Board member votes upon an issue 

in which they have a direct financial interest, that Board member must disclose 

the transaction to the Board in sufficient detail and adequate time to enable the 

Board to act—or decline to act—in regard to such transaction. 

Duty of Obedience 

Board members are bound to obey the tenants of the laws and regulations governing 

organic production, processing and marketing. To this effect, Board members must: 

• Act within the requirements of the law—Board members must uphold all state 

and federal statutes, including the Federal Advisory Committee Act (FACA – 5 

U.S.C. App. 2 et seq.). 

• Follow the responsibilities of the Board as defined by the Organic Foods 

Production Act of 1990. 

• Follow the requirements specified in the NOSB Policy and Procedures Manual. 

Maintaining Professional and Ethical Standards 

As appointees of the Secretary, NOSB members must maintain high professional and 

ethical standards for the conduct of all activities within and outside of the NOSB. Areas 

of particular concern include professional conduct and conflict of interest. 

• Professional Conduct 

o Public service is a public trust, requiring ethical principles above private gain. 

o NOSB members shall put forth honest effort in the performance of their NOSB 

duties. 

o NOSB members shall make no commitments or promises of any kind 

purporting to bind the Government. 

o NOSB members shall act impartially and not give preferential treatment to 

any organization or individual. 

o NOSB members, committee members and task force members shall not 

engage in a financial transaction using nonpublic information, not allow the 

improper use of nonpublic information to further his/her own private interest or 

that of another, whether through advice or recommendation, or allow the 

unauthorized disclosure of nonpublic information. 
National Organic Standards Board Policy & Procedures Manual 8 

Current As of October 3, 2005 

 

Nonpublic information is defined as information that the 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. This 

includes information that is “routinely exempt from disclosure in 5 U.S.C. 552 

(Freedom of Information Act) 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.” 

o NOSB members, committee members and task force members shall keep 

confidential all information identified by petitioners as confidential business 

information.1

o To the maximum extent possible, NOSB members should speak with one 

voice. Although there may be disagreements within NOSB committee or 

working group sessions, once NOSB members leave the session, they have 

the responsibility to support the integrity of the process, whether or not they 

agree with the final outcome. While NOSB members retain the right to 

express minority opinions, the public airing of dissension could strain 

interpersonal relationships and create distrust and conflict among NOSB 

members. Such stresses could undermine the NOSB’s ability to effectively 

carry out its role as a governmental advisory board. 

o NOSB members with diverse backgrounds are recruited to provide balance to 

the Board. While individual NOSB members represent the segments of the 

population from which they were selected, they also represent the greater 

good of the population as a whole. 

• Conflict of Interest 

The NOSB recognizes that members have been specifically appointed to the 

Board to provide advice and counsel to the Secretary concerning policies related 

to the development of organic standards and the creation and amendment of the 

National List. NOSB members have been appointed because they have 

professional expertise which enables them to advise the Secretary. This 

professional expertise may, at times, present an inherent conflict of interest. To 

prevent overt advocacy for direct financial gain and the appearance of selfinterest or the appearance of wrongful activity, the NOSB has adopted the 

following conflict of interest policy. 

Be it resolved by the National Organic Standards Board: 

Members of the Board shall refrain from taking any official Board action 

from which that Board member is or would derive direct financial gain. 

Board members shall disclose their interest to the Board and the public, 

when they or their affiliated business stand to gain from a vote, which they 

cast in the course of Board business. Under certain circumstances, the 

Board may determine whether it is appropriate for the member to vote. 
National Organic Standards Board Policy & Procedures Manual 9 

Current As of October 3, 2005 

That members of the Board shall refrain from promoting for consideration 

any material, process or practice for which the member is or would derive 

direct financial gain arising out of such Board action. The act of promoting 

such material, process or practice shall include private discussion with 

members of the Board advocating the value of the material, public 

discussion and/or written advocacy. 

A "direct financial gain" is defined as monetary consideration, contractual 

benefit or the expectation of future monetary gain to a Board member, 

including but not limited to, financial gain from a party who manufacture 

distributes or holds exclusive title to a formula for a material or product, 

process or practice. 

 
National Organic Standards Board Policy & Procedures Manual 10 

Current As of October 3, 2005 

SECTION II 

BOARD MEMBER JOB DESCRIPTIONS

The National Organic Standards Board (NOSB) fulfills three important roles 

• The Board serves as the primary linkage to the organic community. In that 

regard, the Board must advise the NOP on the implementation of OFPA. 

• The Board must approve all materials which appear on the National List. 

• The Board maintains the responsibility to protect and defend the integrity of 

organic standards. 

Composition of the Board 6518 (b) 

The Board shall be composed of 15 members, of which: 

(1) four shall be individuals who own or operate an organic farming operation; 

(2) two shall be individuals who own or operate an organic handling operation; 

(3) one shall be an individual who owns or operates a retail establishment with 

significant trade in organic products; 

(4) three shall be individuals with expertise in areas of environmental protection 

and resource conservation; 

(5) three shall be individuals who represent public interest or consumer interest 

groups; 

(6) one shall be an individual with expertise in the fields of toxicology, ecology, or 

biochemistry; and 

(7) one shall be an individual who is a certifying agent as identified under section 

2116 of OFPA. [§2119(b)] 

Board Member Standards

• Participate in meetings—Members must make a commitment to attend meetings 

of the Board. 

• Serve on committees, as assigned—Each member must be willing to serve on 

committees as assigned by the Chair, and to participate in the work of those 

committees. 

• Be informed about the decisions to be made—Board members are expected to 

seek and study the information needed to make a reasoned decision and/or 

recommendation on all business brought before the Board. 

• Fully disclose any conflict of interest positions—Members having any commercial 

or immediate family interest that poses a potential or perceived conflict of interest 

must disclose that conflict to the Board and abide by any decision of the Board in 

dealing with the situation. 
National Organic Standards Board Policy & Procedures Manual 11 

Current As of October 3, 2005 

Conducting Business 

• Quorum—As specified in OFPA, a majority of the members of the Board shall 

constitute a quorum for the purpose of conducting business. [§2119(h)] A 

majority of the members of a Committee, including the Executive Committee, 

shall constitute a quorum for the purpose of conducting business. 

• Decisive votes—As specified in OFPA, two-thirds of the votes cast at a meeting 

of the board at which a quorum is present shall be decisive of any motion 

[§2119(i)]. All abstentions will be recorded as such; however, they will be tallied 

with the majority vote. All Board members who are absent and/or who recuse 

themselves due to conflicts of interest shall be recorded as such; their votes are 

not counted towards the total number of votes cast. 
National Organic Standards Board Policy & Procedures Manual 12 

Current As of October 3, 2005 

SECTION III 

OFFICER RESPONSIBILITIES

Three principal officers – Chair, Vice Chair and Secretary – guide the Board. 

Chair 

The Chair is responsible to assure the integrity of the Board process, including 

effectiveness of meetings and the board’s adherence to its own rules. The Chair shall: 

• Schedule meetings of the Board and the Executive Committee; 

• Draft meeting agendas in consultation with committee chairs and NOP staff; 

• Convene and preside at meetings; 

• Review committee work plans; and 

• Review meeting minutes for accuracy. 

Vice Chair 

The Vice Chair shall act in the absence of the Chair. The Vice Chair shall also be 

responsible for maintenance and upkeep of the Policy and Procedures Manual. 

Secretary 

The Secretary is responsible for the integrity of all legal and governing documents of the 

Board. It is the Secretary’s responsibility to: 

• Record and maintain the official Board proceedings; 

• Circulate draft minutes for approval of the Board; 

• Ensure that minutes of Board actions are available to members of the public; and 

• Transfer custody of the Board minutes to the Secretary’s successor. 

The Secretary may delegate tasks to others, but retains responsibility for the official 

record. 

ELECTION OF OFFICERS

Officers shall be elected for terms of one year by majority vote at the annual fall meeting 

of the Board. Candidates may be self-nominated or nominated by another member of 

the Board. Should an officer resign or fail to serve the full term, the Executive 

Committee shall appoint an interim officer. The interim officer shall serve in the capacity 

until the next regularly scheduled meeting of the Board, during which an election will be 

held to fill the remainder of the term. 
National Organic Standards Board Policy & Procedures Manual 13 

Current As of October 3, 2005 

EXECUTIVE COMMITTEE

The Executive Committee of the NOSB shall be comprised of the Chair, Vice Chair, 

Secretary, and the chairs of the standing committees. The Executive Committee, with 

participation of the NOP, shall meet monthly, as needed, or as called by the Chair, and 

shall conduct business on behalf of the Board, except that the Executive Committee 

shall not take action on any recommendation to the Secretary, including the status of 

materials on the National List. 

MEETINGS

For any in-person meeting, three months’ notice should be provided. To theextent 

possible, the date, time and location of the meeting shall be set by consensus of the 

Board through E-mail or telephone communication. All E-mail requests should allow 48 

hours to respond. For public meetings all NOSB members shall remain at the meeting 

until the adjournment time (set by agenda) or if the Board Chair officially adjourns the 

meeting. 

For full Board conference calls, three weeks’ notice should be given to the members. 

This will reasonably allow for each to schedule the appropriate time to accommodate 

the call. The date and time of the call will be set by a consensus of the Board through 

E-mail or telephone discussion. All E-mail requests for meeting times should allow for 

48 hours to respond. 
National Organic Standards Board Policy & Procedures Manual 14 

Current As of October 3, 2005 

SECTION IV 

BOARD COMMITTEES

Committees play an important role in administering the Board’s responsibilities. 

Committees exist to provide greater depth and clarity in the Board’s responsibility to 

make informed decisions. For example, at the request of the Secretary seeking advice 

on a matter related to the NOP, the full Board may request that a committee conduct 

research and analysis or draft proposed recommendations to be considered by the full 

Board. Except for the Executive Committee, no committees are authorized to act in 

place of the Board. Committees are empowered to analyze information and bring draft 

recommendations to the Board for action. 

Committee chairs are appointed by the Board Chair. The current standing committees 

are: 

• Certification, Accreditation, and Compliance 

• Crops 

• Handling 

• Livestock 

• Materials 

• Policy Development 

The Livestock Committee, the Crops Committee and the Handling Committee will each 

have co-chairs. One co-chair will guide all committee discussion and will oversee the 

committee’s work plan. The other co-chair will be responsible for the committee’s 

consideration of materials and will serve as the liaison to the Materials Committee. 

Committee recommendations are finalized by the NOSB according to the following 

process: 

1. Committee drafts the recommendation. 

2. Draft recommendation is posted for public comment. 

3. Public comments are considered by committee when making recommendation to 

the Board. 

4. Board takes action on the recommendation. 

Board actions may include adoption of the recommendation as presented by the 

committee, amending and then adopting the recommendation, rejecting the 

recommendation, or referring the recommendation back to committee for further 

development. 
National Organic Standards Board Policy & Procedures Manual 15 

Current As of October 3, 2005 

COMMITTEE MEETINGS

Committees may hold meetings via telephone conference calls. Two weeks’ notice 

should be provided in scheduling such calls. The date and time set for the call is a 

product of committee dialog regarding the most conducive schedule. This dialog may 

occur on a previous conference call or through E-mail. All E-mail requests for meeting 

times should allow 48 hours to respond. 

Emergency calls may be scheduled with less notice only after each member is 

contacted to reach a consensus on time and date of the meeting. If the members do 

not respond to E-mail requests, the chair or their designee must contact the member by 

phone. 

STANDING COMMITTEES

Certification, Accreditation, and Compliance Committee

The Certification, Accreditation, and Compliance Committee drafts recommendations for 

consideration by the Board concerning the applicability, certification, accreditation and 

compliance sections of the organic regulations [7CFR Part 205] 

Crops Committee

The Crops Committee drafts recommendations for consideration by the Board 

concerning the crop production section of the organic regulations as contained in [7CFR 

Part 205]. The Crops Committee reviews petitions, technical advisory panel reports, and 

public comments concerning materials used for crop production which have been 

requested for addition to or removal from the National List. 

Livestock Committee 

The Livestock Committee drafts recommendations for consideration by the Board 

concerning the livestock and livestock feed sections of the organic regulations as 

contained in [7CFR Part 205]. The Livestock Committee reviews petitions, technical 

advisory panel reports and public comments concerning materials used for livestock 

production which have been requested for addition to or removal from the National List. 

Materials Committee

The Materials Committee drafts recommendations for consideration by the Board 

concerning the National List section of the organic regulations as contained in [7CFR 

Part 205] and OFPA. The Materials Committee works with the NOP, NOSB Committees 

and TAP Contractors in managing the Materials Review Process. In addition to a chair 

appointed by the Board Chair, the Materials Committee shall include in its membership 

one of the co-chairs from each of the Livestock, Crops, and Handling committees. Other 

members may be appointed as needed. 
National Organic Standards Board Policy & Procedures Manual 16 

Current As of October 3, 2005 

Handling Committee

The Handling Committee makes draft recommendations for consideration by the Board 

concerning the handling and labeling sections of the organic regulations as contained in 

[7CFR Part 205]. The Handling Committee reviews petitions, technical advisory panel 

reports and public comments concerning materials used for processing and handling 

which have been requested for addition to or removal from the National List.

Policy Development Committee

The Policy Development Committee works with the NOP to develop priorities for the 

Board. The Policy Development Committee shall make draft recommendations for 

consideration by the Board concerning Board operations, policies, procedures and work 

plans. 

TASK FORCES

As determined by the Board or Executive Committee, task forces shall be appointed to 

explore specific issues and present draft recommendations to the Board or to a 

committee. Task forces may include non-Board members of the public. Each task force 

shall include at least one member of the NOSB. Minutes shall be taken of task force 

meetings. Each task force shall submit a final report to the Board. Each task force shall 

be disbanded when its work has concluded or when the Board determines the task 

force is no longer necessary. 
National Organic Standards Board Policy & Procedures Manual 17 

Current As of October 3, 2005 

SECTION V 

DUTIES OF COMMITTEE CHAIRS

Committee chairs are responsible for the following duties: 

• Schedule committee meetings as needed. 

• Draft committee meeting agendas and work plans in consultation with committee 

members and NOP staff. 

• Convene and preside at committee meetings. 

• Ensure that minutes are taken of committee meetings. 

• Review committee meeting minutes for accuracy. 

• Report the actions of the committee to the Board. 

Committee chairs shall not act unilaterally, especially concerning issues which involve 

statutory responsibilities of the Board. 

COMMITTEE AND BOARD PROCEDURES ON RECOMMENDATIONS

Committee recommendations are developed as follows: 

1. The committee drafts a recommendation; 

2. The draft recommendation is posted for public comment; 

3. Public comments are considered by the committee when making 

recommendation to the Board; and 

4. The Board takes action on the committee recommendation. 

All draft recommendations must be submitted to the NOP at least thirty (30) days prior 

to the next upcoming NOSB meeting in order to be considered at that meeting. 

The Board may take the following actions based on the committee’s recommendation: 

1. Adopt the recommendation as presented by the committee; 

2. Amend and adopt the amended recommendation; 

3. Reject the recommendation; or 

4. Refer the recommendation back to the committee for further development. 

NOSB committees and task forces shall use the following format to present draft policy 

and/or material recommendations for consideration by the Board: 

• Introduction—A brief summary of the issue or statement of the problem. 

• Background—An explanation with sufficient detail and rationale to support a 

proposed recommendation, including reasons why the recommendation should 
National Organic Standards Board Policy & Procedures Manual 18 

Current As of October 3, 2005 

be adopted, historical context, and the regulatory framework pertinent to the 

issue. 

• Recommendation—The concise text of the recommended action. 

• Committee vote—The vote of the committee or task force shall be reported. 

• Minority opinion – If applicable, the dissenting opinion(s) of committee or task 

force members shall be reported. 

 

NOSB AND NOP COLLABORATION PROCESS

Formal Collaboration Procedures between the NOSB and the NOP 

Formal collaboration consists of an interactive relationship between the NOP and the 

NOSB in ways that ensure that NOSB input and feedback is received by the NOP. 

Further processes may be needed for the NOP for more than one means of 

collaborating with, or receiving input from, the NOSB, depending on the type of issues 

that arise and the type of action being contemplated. 

A single approach to collaborating and receiving input from the NOSB may not suffice to 

ensure effective program administration. This observation is based on the following 

factors: 

• The NOSB is a FACA advisory committee, and as such, 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). 

• 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. 

• 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 NOSB cannot direct USDA or bind the Secretary through its actions; for 

example, it can not obligate funds, contract, or initiate policies on its own accord. 

General Procedures for Formal Collaboration 

1. NOP alerts NOSB of the issue and asks for input, or NOSB alerts NOP of the 

issue and formulates input. 

2. Necessary information, including the issue in writing, research, TAP reports or 

other studies shall be provided by the NOP or other organizations regarding the 

issue prior to collaborative discussion. 

3. The issue may be placed on the agenda for the next upcoming NOSB meeting. 

4. NOSB or NOP may ask for public comment on the issue. 

5. NOSB may make a formal recommendation to NOP on the issue. 

6. NOP acts on the recommendation (administratively addresses the issue or 

initiates rule making). 
National Organic Standards Board Policy & Procedures Manual 19 

Current As of October 3, 2005 

Special Circumstances 

There are specific areas in which the formal collaborative process needs to be tailored 

or modified. Examples below include categories of communications between NOP and 

NOSB to address the specific issues accompanied by specific procedures to be 

followed: 

1. Materials proposed to be added to or removed from the National List; 

2. Standards development or modification; 

3. Standards interpretation and questions and answers submitted to the NOP; and 

4. Compliance and enforcement. 

1. 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. Formalized procedures to facilitate the NOSB’s role in reviewing 

and approving materials for the National List include: 

o New petition procedures. 

o Formalized Decision Criteria Forms from the NOSB for providing feedback to 

NOP on their recommended decisions. 

o Sunsetting of materials every five years. 

o New Technical Advisory Panel (TAP) contractor training for TAP contractors 

to facilitate quality TAP reviews to provide essential information. 

o Proposed rules to amend the National List based on NOSB 

recommendations, receive and address comments, and publish the final rule 

amending the National List. 

o Collaborative processes for the review of petitioned substances, including 

utilization of the Decision Tree. 

o Collaboration to determine if draft reports submitted by TAP contractors are 

sufficient (complete, relevant and understandable.) 

2. Standards development or modification for formal recommendation. 

NOSB initiates, through a formal recommendation to NOP, a request for the 

development of new standards or changes to existing standards. The NOSB will 

use the Decision Making Procedures as outlined on page 53 to assist in 

explaining rationale for modifying the existing standards or why new standards 

are needed. NOP will work with the NOSB to develop proposed regulatory 

language that expresses the NOSB’s desired modification. The NOSB should 

make a formal recommendation, during a public Board meeting, to the NOP to 

prompt rule making activity by the NOP. (See examples following this section of 

formal recommendations.) 
National Organic Standards Board Policy & Procedures Manual 20 

Current As of October 3, 2005 

3. Standards interpretation and handling questions and answers submitted to the 

NOP 

In many cases, questions arise from accredited certifying agents (ACA’s) and 

others directed to the NOP about interpreting the existing standards. The follow 

procedures are to be used to handle these questions: 

o Questions submitted to the NOP will be forwarded to the NOSB 

electronically as soon as possible. 

o NOP will alert the NOSB as to how NOP would address the incoming 

question. 

o The Board will assign the appropriate committee to address the question. 

o This committee will receive necessary information from the NOP to help 

resolve the standards interpretation and questions or will be given the 

authority to conduct research. 

o Draft answers to standards interpretation or submitted questions 

developed by committees will be shared with the NOSB and the NOP. 

o The NOSB will act on the committee’s recommended response during its 

next regularly scheduled meeting. 

o If there is a significant difference between NOP and NOSB regarding the 

interpretation or answer to the incoming question, NOP will be formally 

address this at the next public Board meeting. 

o If there is not significant difference between NOP and NOSB on the 

question and answer, NOP will post the question and answer on the NOP 

web site. 

4. Compliance and Enforcement 

Compliance and enforcement are the authority of the regulatory body, (NOP). 

However, there may be significant or sensitive issues that arise as a result of 

compliance and enforcement actions that should prompt NOP to alert the NOSB 

for further discussion. In these instances, the NOP will follow the General 

Procedures for Formal Collaboration as outlined in the beginning of this section. 
FORM FOR FORMAL RECOMMENDATION

In submitting formal recommendations to the NOP, the NOSB will utilize the following 

cover sheet to the greatest extent possible: 

Formal Recommendation by the 

National Organic Standards Board (NOSB) 

to the National Organic Program 

Date _____________ 

Subject ______________________________________________ 

Chair ______________________________________________ 

 (Sign)

Recommendation

The NOSB hereby recommends to the NOP the following: 

 Rulemaking Action ____ 

 Guidance Statement ____ 

 Other ____ 

Statement of the Recommendation (Including Recount of Vote): 

Rationale Supporting Recommendation (including consistency with OFPA and NOP): 

Response by the NOP: 

National Organic Standards Board Policy & Procedures Manual 21 

Current As of October 3, 2005 
National Organic Standards Board Policy & Procedures Manual 22 

Current As of October 3, 2005 

EXAMPLE FORM FOR FORMAL RECOMMENDATION

FORMAL RECOMMENDATION BY THE

NATIONAL ORGANIC STANDARDS BOARD (NOSB) 

TO THE NATIONAL ORGANIC PROGRAM (NOP) 

Date: _March 18, 2005_

Subject: ___Calcium Carbonate Q & As___________________ 

Chair: ___Jim Riddle_______________________________________ 

 (sign) 

Recommendation

The NOSB hereby recommends to the NOP the following: 

Rulemaking Action: ________ 

Guidance Statement: ____X___ 

Other: ________ 

Statement of the Recommendation (including Recount of Vote):

Question # 1: Does the NOP regulation permit livestock producers to use calcium carbonate as 

a feed supplement for livestock intended to be sold, labeled, or represented as organically 

produced? Please provide your rationale. 

NOSB Recommended Answer: Yes. Mined calcium carbonate is a nonsynthetic substance 

allowed for use as a feed supplement or feed additive.

Question # 2: Can a mineral product, such as calcium carbonate, carry the term organic on its 

label? Please provide your rationale. 

NOSB Recommended Answer: No. Section 205.2 defines “organic” as “a labeling term that 

refers to an agricultural product produced in accordance with the Act and the regulations in this 

part.” 

Calcium carbonate is not an agricultural product and therefore does not qualify to carry the term 

“organic” under the NOP regulation. 

NOSB vote: 14 yes, 0 no, 0 abstain 

Rationale Supporting Recommendation (including consistency with OFPA and NOP):

Rationale explained in attached recommendation. 

Response by the NOP:

Updated 2/25/05 
National Organic Standards Board Policy & Procedures Manual 23 

Current As of October 3, 2005 

SECTION VI 

MISCELLANEOUS POLICIES

NOSB Policy for Presenters Invited by Committees 

1. Need for presentation established within the appropriate committee by the 

committee chairperson. 

2. The committee chairperson should notify the NOSB Chair with a request to issue 

an invitation at least 45 days prior to meeting. Exceptions are at the discretion of 

the NOSB Chair. 

3. Presenter(s) must be invited by committee chair and/or NOSB Chair and 

approved by the NOSB Chair. 

4. Reason(s) for presentation, subject area and bio/resume of presenter(s) to be 

circulated via email to entire board at least 2 weeks prior to meeting. 

5. Invited presenter(s) must provide objective information. 

6. Presenter(s) cannot be a petitioner on the topic under discussion. 

7. Presenter(s) must disclose any actual or perceived conflict of interest including 

information concerning who provided funding for the presentation. 

 Adopted June 7, 2001 

NOSB Policy for Surveys Conducted on Behalf of NOSB Committees 

1. All surveys, including electronic surveys, conducted in the name of any NOSB 

Committee, must be approved by the NOSB Executive Committee before they 

are submitted for approval to USDA, which must submit for approval to the Office 

of Management and Budget (OMB); and 

2. A written report summarizing the results of the survey must be submitted to the 

full Board and the NOP as soon as possible after completion. 

 Adopted October 19, 2002 

Amended March 2, 2005 
National Organic Standards Board Policy & Procedures Manual 24 

Current As of October 3, 2005 

NOSB Policy for Public Comment at NOSB Meetings 

1. All persons wishing to comment at NOSB meetings during public comment 

periods must sign up in advance. 

2. Persons will be called upon to speak in the order they sign up. 

3. Unless otherwise indicated by the Chair, each person will be given 5 minutes to 

speak. 

4. Persons must give their names and affiliations for the record. 

5. A person may submit a written proxy to the NOP or NOSB requesting that 

another person speak on his or her behalf. 

6. No person will be allowed to speak during the public comment period for more 

than 10 minutes. 

7. Individuals providing public comment will refrain from any personal attacks and 

from remarks that otherwise impugn the character of any individual. 

 Adopted October 19, 2002 

 Amended March 2, 2005 
National Organic Standards Board Policy & Procedures Manual 25 

Current As of October 3, 2005 

SECTION VII 

NOSB PRINCIPLES OF ORGANIC PRODUCTION AND HANDLING

Adopted October 17, 2001 

1.1 Organic agriculture is an ecological production management system that 

promotes and enhances biodiversity, biological cycles, and soil biological activity. 

It emphasizes the use of management practices in preference to the use of offfarm inputs, taking into account that regional conditions require locally adapted 

systems. These goals are met, where possible, through the use of cultural, 

biological, and mechanical methods, as opposed to using synthetic materials to 

fulfill specific functions within the system. 

1.2 An organic production system is designed to: 

1.2.1 Optimize soil biological activity; 

1.2.2 Maintain long-term fertility; 

1.2.3 Minimize soil erosion; 

1.2.4 Maintain or enhance the genetic and biological diversity of the production system 

and its surroundings; 

1.2.5 Utilize production methods and breeds or varieties that are well adapted to the 

region; 

1.2.6 Recycle materials of plant and animal origin in order to return nutrients to the 

land, thus minimizing the use of non-renewable resources; 

1.2.7 Minimize pollution of soil, water, and air; and 

1.2.8 Become established on an existing farm or field through a period of conversion 

(transition), during which no prohibited materials are applied and an organic plan 

is implemented. 

1.3 The basis for organic livestock production is the development of a harmonious 

relationship between land, plants, and livestock, and respect for the physiological 

and behavioral needs of livestock. This is achieved by: 

1.3.1 Providing good quality organically grown feed; 

1.3.2 Maintaining appropriate stocking rates; 

1.3.3 Designing husbandry systems adapted to the species' needs; 

1.3.4 Promoting animal health and welfare while minimizing stress; and 

1.3.5 Avoiding the routine use of chemical allopathic veterinary drugs, including 

antibiotics. 

1.4 Organic handling practices are based on the following principles: 

1.4.1 Organic processors and handlers implement organic good manufacturing and 

handling practices in order to maintain the integrity and quality of organic 

products through all stages of processing, handling, transport, and storage; 

1.4.2 Organic products are not commingled with non-organic products, except when 

combining organic and non-organic ingredients in finished products which 

contain less than 100% organic ingredients; 

1.4.3 Organic products and packaging materials used for organic products do not 

come in contact with prohibited materials; 

1.4.4 Proper records, including accurate audit trails, are kept to verify that the integrity 

of organic products is maintained; and 
National Organic Standards Board Policy & Procedures Manual 26 

Current As of October 3, 2005 

1.4.5 Organic processors and handlers use practices that minimize environmental 

degradation and consumption of non-renewable resources. Efforts are made to 

reduce packaging; use recycled materials; use cultural and biological pest 

management strategies; and minimize solid, liquid, and airborne emissions. 

1.5 Organic production and handling systems strive to achieve agro-ecosystems that 

are ecologically, socially, and economically sustainable. 

1.6 Organic products are defined by specific production and handling standards that 

are intrinsic to the identification and labeling of such products. 

1.7 Organic standards require that each certified operator must complete, and submit 

for approval by a certifying agent, an organic plan detailing the management of 

the organic crop, livestock, wild harvest, processing, or handling system. The 

organic plan outlines the management practices and inputs that will be used by 

the operation to comply with organic standards. 

1.8 Organic certification is a regulatory system which allows consumers to identify 

and reward operators who meet organic standards. It allows consumers to be 

confident that organic products are produced according to approved 

management plans in accordance with organic standards. Certification requires 

informed effort on the part of producers and handlers, and careful vigilance with 

consistent, transparent decision making on the part of certifying agents. 

1.9 Organic production and handling operations must comply with all applicable 

local, state, and federal laws and address food safety concerns adequately. 

1.10 Organic certification, production, and handling systems serve to educate 

consumers regarding the source, quality, and content of organic foods and 

products. Product labels must be truthful regarding product names, claims, and 

content. 

1.11 Genetic engineering (recombinant and technology) is a synthetic process 

designed to control nature at the molecular level, with the potential for 

unforeseen consequences. As such, it is not compatible with the principles of 

organic agriculture (either production or handling). Genetically 

engineered/modified organisms (geo/gmo’s) and products produced by or 

through the use of genetic engineering are prohibited. 

1.12 Although organic standards prohibit the use of certain materials such as synthetic 

fertilizers, pesticides, and genetically engineered organisms, they cannot ensure 

that organic products are completely free of residues due to background levels in 

the environment. 
National Organic Standards Board Policy & Procedures Manual 27 

Current As of October 3, 2005 

NOSB GUIDANCE ON COMPATIBILITY WITH A SYSTEM OF SUSTAINABLE 

AGRICULTURE AND CONSISTENCY WITH ORGANIC FARMING AND HANDLING

A significant task of the NOSB is to determine the suitability of materials for use in 

organic production and handling. Among the criteria the Board must consider, OFPA 

requires the NOSB to determine the compatibility of a material with organic practices. 

The following questions were developed by the NOSB to assist in determining the 

compatibility of materials with organic practices. 

In order to determine if a substance, its use, and manufacture are compatible with a 

system of sustainable agriculture and consistent with organic farming and handling, and 

in consideration of the NOSB Principles of Organic Production and Handling, the 

following factors are to be considered: 

1. Does the substance promote plant and animal health by enhancing the soil’s 

physical chemical, or biological properties? 

2. Does use of the substance encourage and enhance preventative techniques 

including cultural and biological methods for management of crop, livestock, 

and/or handling operations? 

3. Is the substance made from renewable resources? If the source of the product is 

non-renewable, are the materials used to produce the substance recyclable? Is 

the substance produced from recycled materials? Does use of the substance 

increase the efficiency of resources used by organic farms, complement the use 

of natural biological controls, or reduce the total amount of materials released 

into the environment? 

4. Does use of the substance have a positive influence on the health, natural 

behavior, and welfare of livestock? 

5. Does the substance satisfy expectations of organic consumers regarding the 

authenticity and integrity of organic products? 

6. Does the substance allow for an increase in the long-term viability of organic 

farm operations? 

7. Is there evidence that the substance is mined, manufactured, or produced 

through reliance on child labor or violations of applicable national labor 

regulations? 

8. If the substance is already on the National List, is the proposed use of the 

substance consistent with other listed uses of the substance? 

9. Is the use of the substance consistent with other substances historically allowed 

or disallowed in organic production and handling? 

10. Would approval of the substance be consistent with international organic 

regulations and guidelines, including Codex? 

11. Is there adequate information about the substance to make a reasonable 

determination on the substance's compliance with each of the other applicable 

criteria? If adequate information has not been provided, does an abundance of 

caution warrant rejection of the substance? 

12. Does use of the substance have a positive impact on biodiversity? 

Adopted April 29, 2004 - 13 yes, 0 no, 1 absent 
National Organic Standards Board Policy & Procedures Manual 28 

Current As of October 3, 2005 

SECTION VIII 

PROCEDURES OF THE NOSB

NATIONAL ORGANIC PROGRAM MATERIALS REVIEW PROCESS 

Evaluation Procedures for Substances Petitioned for Addition or Removal from the 

National List. 

Phase 1: Receipt of Petition 

During this phase the National Organic Program (NOP) will: 

• Notify the petitioner via letter and/or electronic mail of receipt of the petition. 

Phase 2: Examination of Petition for Completeness and Eligibility 

During this phase the NOP will: 

• Determine whether the petition is complete 

• Determine if the petitioned substance is eligible for petition under the Organic 

Foods Production Act and its implementing regulations; document this review 

using the NOP-OFPA checklist. 

• Determine whether the petitioned use is approved under the statutory and 

regulatory authority of the Environmental Protection Agency (EPA) or the Food 

and Drug Administration (FDA), if applicable; 

• Identify and secure any confidential business information (CBI) designated by the 

petitioner; 

• Notify, as applicable, the petitioner via letter and/or electronic mail of 

determination of completeness and eligibility, and acknowledge the designation 

of certain information as CBI. 

• Upon determination of completeness and eligibility, the following actions will be 

taken: 

o Publish the petition on NOP website; and 

o Notify the National Organic Standards Board (NOSB) materials committee 

chairperson and the chairperson of the committee that the substance is being 

petitioned for addition or prohibition from the National List (Crops, Livestock 

or Handling). This notification will be sent via letter and/or electronic mail and 

inform the chairs that the petition is complete, provide OFPA review and 

EPA/FDA determination checklist, and request identification of any questions 

the appropriate committee wishes to be specifically addressed in the 

contractor’s report. The NOSB materials committee, working with other 

applicable NOSB committees, has 21 working days to submit any questions 

to the NOP. The questions requested by the committee should include items 

that need specific background information provided and be based on the 

OFPS criteria. 
National Organic Standards Board Policy & Procedures Manual 29 

Current As of October 3, 2005 

o Notify the contractor of the determination of completeness and eligibility via 

letter and/or electronic mail. This letter will constitute official notice to the 

contractor to perform an evaluation of the petitioned substance. 

• Notify, as applicable, the petitioner via letter and/or electronic mail of determining 

the petition to be incomplete or ineligible. 

Phase 3: Evaluation by Contractor 

During this phase the contractor will: 

• Conduct activities necessary to provide responses to evaluation questions 

contained in the Statement of Work (SOW) and any additional questions 

identified by the NOSB as described above; 

• Use the evaluation report template to prepare and distribute to the NOP a draft 

evaluation report in electronic format. 

Phase 4: Sufficiency Determination 

During this phase the NOP will: 

• Submit a copy of the draft evaluation report for review to the NOSB materials 

committee and the committee that the substance is being petitioned for addition 

or prohibition from the National List (Crops, Livestock or Handling); 

• Review the draft evaluation report against the following performance criteria. 

The report will be acceptable when it: 

o Is consistent in format, level of detail and tone; 

o Is technically objective and free from opinions or conjecture; 

o Is written in a style appropriate for non-technical readers (e.g. free of 

technical jargon); 

o Is prepared using a well-defined and consistent procedure consisting of 

information gathering, information synthesis and document preparation, and 

quality assurance; 

o Is based on the best available information that can be obtained within the 

designated time frame; 

o Is thoroughly supported using literature citations; and, 

o Addresses all evaluation questions as set out in the SOW. 

During this phase the NOSB materials committee and the committee that the substance 

is being petitioned for addition or prohibition from the National List (Crops, Livestock or 

Handling) will: 

• Review the draft evaluation report against the following performance criteria. 

The report will be acceptable when it: 

o Is consistent in format, level of detail and tone; 

o Is technically objective and free from opinions or conjecture; 

o Is written in a style appropriate for non-technical readers (e.g. free of 

technical jargon); 

o Is prepared using a well-defined and consistent procedure consisting of 

information gathering, information synthesis and document preparation, and 

quality assurance; 
National Organic Standards Board Policy & Procedures Manual 30 

Current As of October 3, 2005 

o Is based on the best available information that can be obtained within the 

designated time frame; 

o Is thoroughly supported using literature citations; and, 

o Addresses all evaluation questions as set out in the SOW. 

• Notify the NOP in letter and/or electronic mail the acceptance of the report within 

21 days of receiving the draft report. If the report is not accepted by the NOSB 

materials and the committee that the substance is being petitioned for addition or 

prohibition from the National List (Crops, Livestock or Handling), the committees 

must provide to the NOP in letter and/or electronic mail the specific areas of the 

report that were concluded to be insufficient, the rationale for drawing such a 

conclusion and the improvements to be made so that the document can be 

determined sufficient. 

• Upon concurrence by the NOP that the report is insufficient, the NOP will notify 

the contractor by letter and/or electronic mail of the areas of the report that are 

insufficient, the rationale for drawing such a conclusion and the improvements to 

be made so that the document can be determined sufficient. The time frame 

required for the completion of the changes will be determined through mutual 

agreement between the contractor and the NOP. 

Phase 5: Action by NOSB Materials Chair and the Committee that the Substance 

Is Being Petitioned for Addition or Prohibition from the National List (Crops, 

Livestock or Handling) 

During this phase the NOSB materials Chair and the committee that the substance is 

being petitioned for addition or prohibition from the National List (Crops, Livestock or 

Handling) will: 

• Convene at a mutually convenient time to review, discuss and recommend an 

action on the petitioned substance. The committee may convene a Technical 

Advisory Panel by electronic mail or conference call to provide scientific 

evaluation of the petitioned substance, as provided by OFPA 6518(k)(3). The 

NOSB materials committee or delegated committee must convene and 

recommend an action on the petitioned substance no later than 30 days before a 

scheduled meeting of the full NOSB. 

During this phase the NOP will: 

• Publish the recommendation of the NOSB materials committee and the 

committee that the substance is being petitioned for addition or prohibition from 

the National List (Crops, Livestock or Handling) on the NOP website and request 

public comment on the recommendation. 

Phase 6: Action by Full NOSB 

During this phase the NOP will: 

• Set as an agenda item for the next meeting of the NOSB time sufficient to 

discuss and make a recommendation by the full NOSB on the petitioned 

substance. 
National Organic Standards Board Policy & Procedures Manual 31 

Current As of October 3, 2005 

TECHNICAL ADVISORY PANEL (TAP) CONTRACT PROCEDURES

Statement of Work 

Request for Proposals to Perform Technical Advisory Panel Evaluation of Substances 

Petitioned for Inclusion on or Removal from the National Organic Program's National 

List of Allowed and Prohibited Substances. 

Agency Need 

See Statement of Work, 1.0 Background.

1. Background 

The Organic Foods Production Act of 1990 (OFPA), as amended, requires the 

Secretary of Agriculture (Secretary) to establish a National List of Allowed and 

Prohibited Substances (National List). This list identifies the synthetic substances 

that may be used, and the nonsynthetic substances that cannot be used, by 

organic production and handling operations. The OFPA authorizes the National 

Organic Standards Board (NOSB) to develop and forward to the Secretary a 

recommended Proposed National List, and subsequent proposed amendments 

to it. The OFPA provides that persons may petition the NOSB to evaluate a 

substance for inclusion on or removal from the National List 

The NOSB submitted a Proposed National List to the Secretary that was 

subsequently published on December 21, 2000, as part of the National Organic 

Program (NOP) final rule, 65 Fed. Reg. 80548-80684, (2000). Based on 

information supplied to the NOSB by trade associations, certification 

organizations and other organic industry sources, there are many substances 

currently used in organic production and handling that have not been evaluated 

by the NOSB for inclusion on the National List. Evaluations of these substances 

must be expedited to prevent the possible disruption of well-established and 

accepted production, handling, and processing systems. 

Section 2119 of the OFPA (7 U.S.C. 6518 (k)(3)) provides that the NOSB shall 

convene Technical Advisory Panels (TAP) to provide scientific evaluation of 

substances for inclusion on the National List. TAP evaluations assist the NOSB 

in evaluating substances being considered for addition to or removal from the 

National List. The NOP, on behalf of the NOSB, establishes contracts to conduct 

the TAP evaluations. 

 2. Mission of USDA/AMS/NOP 

The mission of NOP is to establish national standards governing the marketing of 

certain agricultural products as organically produced. The NOP is assisted by the 

NOSB, which provides policy advice in carrying out the program, including 

advising the Secretary on substances for inclusion on or removal from the 

National List. 

The NOSB reviews information from various sources in evaluating substances for 

inclusion on or removal from the National List. Sources include TAP evaluations, 

the Environmental Protection Agency, the Food and Drug Administration, the 
National Organic Standards Board Policy & Procedures Manual 32 

Current As of October 3, 2005 

National Institute of Environmental Health Studies, and public comment. The 

NOSB submits its recommendations, along with the results of the required 

evaluation and technical advisory panel evaluation for each substance, to the 

Secretary for consideration in accordance with the requirements of section 

2118(d) of the OFPA (7 U.S.C. 6517(d)). 

3. Specific Task 

The contractor(s) shall furnish technical advisory panel evaluations for crop 

production, livestock production, and processing substances submitted to the 

NOSB in response to petition notices, such as was published in the Federal

Register on July 13, 2000, as well as other substances requiring evaluation as 

determined by the NOP. 

For crop and livestock production substances, the contractor(s) shall use the 

criteria in Section 2119 of the OFPA (7 U.S.C. 6518 (m)(l-7)). The criteria are: 

o The potential of the substance for detrimental chemical interactions with 

other materials used in organic farming systems; 

o The toxicity and mode of action of the substance and of its breakdown 

products or any contaminants, and their persistence in the environment; 

o The probability of environmental contamination during manufacture, use, 

misuse or disposal of the substance; 

o Its effects on human health; 

o The effects of the substance on biological and chemical interactions in the 

agroecosystem; 

o The alternatives to using the substance; and, 

o The compatibility of the substance with a system of sustainable 

agriculture. 

For processing substances, the contractor(s) shall use the criteria approved 

at the February 10, 1999, NOSB meeting. The criteria are: 

o Processing aid or adjuvant cannot be produced from a natural source and 

has no organic ingredients as substitutes; 

o Manufacture, use, and disposal do not have adverse effects on the 

environment and are done in a manner compatible with organic handling 

as described in section 6513 of the OFPA; 

o The nutritional quality of the food is maintained and the material itself or its 

breakdown products do not have adverse effects on human health as 

defined by applicable Federal regulations; 

o The primary purpose is not as a preservative or used only to 

recreate/improve flavors, colors, textures, or nutritive value lost during 

processing, except in the latter case as required by law; 

o It is Generally Recognized as Safe (GRAS) by FDA when used in 

accordance with Good Manufacturing Practices (GMP) and contains no 
National Organic Standards Board Policy & Procedures Manual 33 

Current As of October 3, 2005 

residues of heavy metals or other contaminants in excess of FDA 

tolerances; 

o Its use is compatible with the principles of organic handling; and, 

o There is no other way to produce a similar product without its use and it is 

used in the minimum quantity required to achieve the process. 

4. Minimum Skills and Experience Requirements 

Contractor(s) shall utilize qualified individuals or organizations who have 

specialized knowledge of the petitioned substances. Contractor(s) must have 

demonstrable expertise in organic production and handling or scientific 

disciplines such as veterinary medicine, chemistry, food technology, microbiology 

or toxicology. Contractor(s) must be familiar with the requirement for technical 

advisory panels described in the Organic Foods Production Act of 1990. 

5. Place of Performance 

Contractor(s) shall perform all task related activity within the United States of 

America at specific locations determined by contractor(s). During the contract 

period, the contractor(s) shall travel at contractor(s)’s expense to NOSB 

meetings for the purpose of disseminating substance review findings to the 

NOSB and general public. 

6. Government Furnished Equipment and Facility 

None, except that the NOP shall provide Contractor(s), on a non-routine basis, 

with substance review petitions, ancillary documents or other applicable 

information in possession of NOP. 

7. Compensation 

The NOP may award multiple contracts for tasks outlined in this statement of 

work. Contractor(s) shall be compensated at a firm-fixed price rate not to exceed 

$4,000.00 per substance reviewed. Total compensation shall not exceed 

$100,000.00. 

8. Period of Performance 

September 30, 2001 – September 30, 2002 (262 working days)(Holiday time off 

is at contractor(s)’ discretion.) 

9. Scope of Performance 

Phase 1: Data Gathering and Compilation (120 days) 

Phase I is not to exceed 120 days for any one substance. During this phase the 

contractor(s) provider shall perform the following activities: 

o Characterize [the] substance(s) and identify uses and applications; 

o Determine whether [the] substance(s) are synthetic or non-synthetic (See 

7.S.C. 6502 (21) for definition of synthetic); 
National Organic Standards Board Policy & Procedures Manual 34 

Current As of October 3, 2005 

o Determine [the] substance(s) chemical or biological composition and 

possible impact on human/animal health and the environment; 

o Identify [the] substance(s) relevant toxicological studies, including 

ensuring substance does not contain residues of heavy metals or other 

environmental contaminants in excess of Food and Drug Administration 

Action Level or Environmental Protection Agency tolerances; 

o Determine [the] substance(s) persistence in the environment; 

o Determine [the] substance(s) effect on soil structure and ecology; 

o Identify alternatives to the use of the substance(s); 

o Determine [the] substance(s) historical use in organic production, 

processing and handling; and 

o Determine [the] substance(s) status under OFPA and with other 

government agencies. 

Additionally, within 45 days of commencement of Phase I, the contractor(s) must 

notify the NOP in writing of any substance(s) not appropriate for National List 

evaluation. Other substances for evaluation may be substituted upon agreement 

between the NOP, the NOSB, and the contractor(s). 

Phase 2: Evaluation against Criteria (100 days) 

Phase II is not to exceed 100 days for any one substance. The contractor(s) shall 

engage no less than three evaluators for each substance. No current member of 

the NOSB may serve as an evaluator. Evaluators may use data from all relevant 

sources. Evaluators shall make recommendations to the contractor(s) as to the 

substance’s status as synthetic or non-synthetic and whether, in either case, the 

substance should be added to or removed from the National List. 

Phase 3: Recommendation (42 days) 

Phase III is not to exceed 42 days for any one substance. Contractor(s) shall 

provide the NOP with a recommendation regarding each substance's suitability 

for inclusion on or removal from the National List. All data and analyses collected 

in Phase I and II will be forwarded to the NOP upon the completion of Phase III in 

accordance with the reporting requirements stated below. 

Evaluation Factors for Award 

The NOP may award multiple contracts for tasks outlined in this statement of work. 

Contractor(s) selection will be based on evaluation of proposals in accordance with the 

responses received to the criteria outlined in Section 4.0, Minimum Skills and 

Experience Requirements and Section 9.0, Scope of Tasks. Award will be made to that 

offeror whose combination of technical experience and cost represents the best value to 

the Government and is most advantageous (cost, and other factors considered), and 

which is within the available NOP resources. 

The NOP also reserves the right to reject any or all proposals received and/or request 

clarification or modification of proposals. The NOP reserves the right to determine a 

competitive range for negotiation based upon the technical and cost acceptability of 
National Organic Standards Board Policy & Procedures Manual 35 

Current As of October 3, 2005 

proposals. In addition, the NOP reserves the right to award a contract without 

discussions. 

Cost evaluation will include an analysis of the total cost and cost elements (if applicable) 

to perform the required work. The total costs supplied by the offeror shall constitute the 

total firm-fixed unit price for that service or deliverable. 

Proposals that are unrealistic in terms of technical commitment, or unreasonably low or 

high in costs, will be deemed reflective of an inherent lack of technical competence or 

as indicative of a failure to comprehend the complexity involved in the contract 

requirements. Such may be grounds for rejection of the proposal. 

Other Evaluation Factors 

Technical proposals will be initially evaluated with respect to six (6) major factors for 

determination of the competitive range. Technical factors are listed in descending order 

of importance. The technical proposal is of greater importance than the cost proposal; 

when technical proposals are relatively equal in technical merit, cost will increase in 

importance. 

Technical Factors: 

Factor 1 Overall Technical Approach; Proposed Methodology; Demonstrated 

Understanding of the Scope of Work and the Requirements 

Factor 2 Previous Demonstrated Experience and Past Performance 

Factor 3 Quality Control 

Factor 4 Capability and Experience of Key Personnel 

Factor 5 Project Management and Support Capability 

Factor 6 Reasonableness of Cost 

Reporting Requirements 

Progress reports are due to the NOP each 60 days after the contract award date. A final 

report is due within 60 days of the end of the contract period. The contractor(s) shall 

forward five copies of the bi-monthly progress reports and the final report and all 

deliverables to the NOP in Washington DC. Documents should be addressed to: 

Richard H. Mathews, Program Manager, National Organic Program, USDA-AMS-TMNOP, 1400 Independence Avenue, S.W., Room 4008-So., Ag Stop 0268, Washington, 

D.C. 20250-0200, Attention: Substance Evaluations. 

The narrative in the progress reports should refer back to the stated objectives and 

timeline of the original contract proposal. Beneath each objective, the objective's current 

status should be reported. Any substantive diversion from a stated objective, or any 

deviation from the proposed timeline should be explained. Only the activities required 

under the contract should be reported. At a minimum, the progress reports should also 

include the following: 

1. A short summary of the accomplishments for the reporting period; 

2. Progress on completing individual project tasks; 

3. The planned and actual schedules for task completion; 
National Organic Standards Board Policy & Procedures Manual 36 

Current As of October 3, 2005 

4. Projected accomplishments for the next reporting period; and, 

5. Data on financial expenditures by task category. 

Any deliverables required under the contract should be submitted upon completion and 

addressed to: Richard H. Mathews, Program Manager, National Organic Program, 

USDA-AMS-TM-NOP, 1400 Independence Avenue, S.W., Room 4008-So., Ag Stop 

0268, Washington, D.C. 20250-0200, Attention: Substance Evaluations. 

Information to be Included in a Petition

Any person may petition to add a substance to or remove a substance from the National 

List of Allowed and prohibited Substances by submitted the information and follwing the 

procedures identified below. 

[JR – I added a short introduction to explain what this section is and why it is here.] 

ITEM A

The petitioner should identify which of the following categories the substance is being 

petitioned for inclusion on or removal from the National List: 

1. Synthetic substance's allowed for use in organic crop production; 

2. Nonsynthetic substances prohibited for use in organic crop production; 

3. Synthetic substances allowed for use in organic livestock production; 

4. Nonsynthetic substances prohibited for use in organic livestock production; 

5. Nonagricultural (nonorganic) substances allowed in or on processed products 

labeled as “organic'' or “made with organic (specified ingredients)'; or 

6. Nonorganic agricultural substances not commercially available in organic form. 

ITEM B

The petitioner must submit the following information: 

1. The substance’s common name. 

2. The manufacturer’s name, address, and telephone number. 

3. The intended or current use of the substance such as use as a pesticide, animal 

feed additive, processing aid, nonagricultural ingredient, sanitizer, or disinfectant. 

4. A list of the crop, livestock, or handling activities for which the substance will be 

used. If used for crops or livestock, the substance's rate and method of 

application must be described. If used for handling (including processing), the 

substance’s mode of action must be described. 

5. The source of the substance and a detailed description of its manufacturing or 

processing procedures from the basic component(s) to the final product. 

Petitioners with concerns for confidential business information can follow the 

guidelines in the Instructions for Submitting Confidential Business Information 

(CBI) listed in #13. 

6. A summary of any available previous reviews by State or private certification 

programs or other organizations of the petitioned substance. 
National Organic Standards Board Policy & Procedures Manual 37 

Current As of October 3, 2005 

7. Information regarding EPA, FDA, and State regulatory authority registrations, 

including registration numbers. 

8. The Chemical Abstract Service (CAS) number or other product numbers of the 

substance and labels of products that contains the petitioned substance. 

9. The substance's physical properties and chemical mode of action including (a) 

chemical interactions with other substances, especially substances used in 

organic production; (b) toxicity and environmental persistence; (c) environmental 

impacts from its use or manufacture; (d) effects on human health; and, (e) effects 

on soil organisms, crops, or livestock. 

10. Safety information about the substance including a Material Safety Data Sheet 

(MSDS) and a substance report from the National Institute of Environmental 

Health Studies. 

11. Research information about the substance which includes comprehensive 

substance research reviews and research bibliographies, including reviews and 

bibliographies which present contrasting positions to those presented by the 

petitioner in supporting the substance's inclusion on or removal from the National 

List. 

12. A “Petition Justification Statement'' which provides justification for one of the 

following actions requested in the petition: 

o When petitioning for the inclusion of a synthetic substance on the National 

List, the petition should state why the synthetic substance is necessary for the 

production or handling of an organic product. The petition should also 

describe the nonsynthetic substances or alternative cultural methods that 

could be used in place of the petitioned synthetic substance. Additionally, the 

petition should summarize the beneficial effects to the environment, human 

health, or farm ecosystem from use of the synthetic substance that support 

the use of it instead of the use of a nonsynthetic substance or alternative 

cultural methods. 

o When petitioning for the removal of a synthetic substance from the National 

List, the petition must state why the synthetic substance is no longer 

necessary or appropriate for the production or handling of an organic product. 

o When petitioning for the inclusion on the National List of a nonsynthetic or 

nonagricultural substance as a prohibited substance, the petition must state 

why the nonsynthetic or nonagricultural substance should not be permitted in 

the production or handling of an organic product. 

o When petitioning for the removal from the National List of a nonsynthetic or 

nonagricultural substance as a prohibited substance, the petition must state 

why the nonsynthetic or nonagricultural substance should be permitted in the 

production or handling of an organic product. 

13. A Commercial Confidential Information Statement which describes the specific 

required information contained in the petition that is considered to be Confidential 

Business Information (CBI) or confidential commercial information and the basis 

for that determination. Petitioners should limit their submission of confidential 

information to that needed to address the areas for which this notice requests 
National Organic Standards Board Policy & Procedures Manual 38 

Current As of October 3, 2005 

information. Instructions for submitting CBI to the National List Petition process 

are presented in the instructions below: 

o Financial or commercial information the applicant does not want disclosed for 

competitive reasons can be claimed as CBI. Applicants must submit a written 

justification to support each claim. 

o “Trade secrets'' (information relating to the production process, such as 

formulas, processes, quality control tests and data, and research 

methodology) may be claimed as CBI. This information must be (1) 

commercially valuable, (2) used in the applicant's business, and (3) 

maintained in secrecy. 

o Each page containing CBI material must have “CBI Copy'' marked in the 

upper right corner of the page. In the right margin, mark the CBI information 

with a bracket and “CBI.'' 

o The CBI-deleted copy should be a facsimile of the CBI copy, except for 

spaces occurring in the text where CBI has been deleted. Be sure that the 

CBI-deleted copy is paginated the same as the CBI copy. (The CBI-deleted 

copy of the application should be made from the same copy of the application 

which originally contained CBI.) Additional material (transitions, 

paraphrasing, or generic substitutions, etc.) should not be included in the CBIdeleted copy. 

o Each page with CBI-deletions should be marked “CBI-deleted'' at the upper 

right corner of the page. In the right margin, mark the place where the CBI 

material has been deleted with a bracket and “CBI- deleted.'' 

o If several pages are CBI-deleted, a single page designating the numbers of 

deleted pages may be substituted for blank pages. (For example, “pages 7 

through 10 have been CBI-deleted.'') 

o All published references that appear in the CBI copy should be included in the 

reference list of the CBI-deleted copy. Published information usually cannot 

be claimed as confidential. 

National List substance evaluations conducted by the NOSB will involve a public and 

open process. No confidential information will be available for public inspection. 

The NOP Program Manager may request additional information from the petitioner 

following receipt of the petition. 
National Organic Standards Board Policy & Procedures Manual 39 

Current As of October 3, 2005 

EVALUATION CRITERIA FOR SUBSTANCES ADDED TO THE 

NATIONAL LIST 

Category 1. Adverse impacts on humans or the environment? Substance ___________________

Question Yes No N/A1 Documentation 

(TAP; petition; regulatory agency; other) 

1. Are there adverse effects on 

 environment from 

 manufacture, use, or 

 disposal? [§205.600 b.2] 

2. Is there environmental 

 contamination during 

 manufacture, use, misuse, or 

 disposal? [§6518 m.3] 

3. Is the substance harmful to 

 the environment? 

 [§6517c(1)(A)(i);6517(c)(2)(A)i] 

4. Does the substance contain List 

 1, 2, or 3 inerts? [§6517 c (1 ) 

 (B)(ii); 205.601(m)2] 

5. Is there potential for detrimental 

 chemical interaction with other 

 materials used? 

 [§6518 m.1] 

6. Are there adverse biological and 

 chemical interactions in agro-

 ecosystem? [§6518 m.5] 

7. Are there detrimental 

 physiological effects on soil 

 organisms, crops, or livestock? 

 [§6518 m.5] 

8. Is there a toxic or other adverse 

 action of the material or its 

 breakdown products? 

 [§6518 m.2] 

9. Is there undesirable persistence 

 or concentration of the material 

 or breakdown products in 

 environment?[§6518 m.2] 

10. Is there any harmful effect on 

 human health? [§6517 c (1)(A) 

 (i) ; 6517 c(2)(A)I; §6518 m.4] 

11. Is there an adverse effect on 

 human health as defined by 

 applicable Federal regulations? 

 [205.600 b.3] 

12. Is the substance GRAS when 

 used according to FDA’s good 

 manufacturing practices? 

 [§205.600 b.5] 

13. Does the substance contain 

residues of heavy metals or other 

contaminants in excess of FDA 

tolerances? [§205.600 b.5] 

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b) are N/A—not applicable. 
National Organic Standards Board Policy & Procedures Manual 40 

Current As of October 3, 2005 

Category 2. Is the Substance Essential for Organic Production? Substance _________________ 

Question Yes No N/A1 Documentation 

(TAP; petition; regulatory agency; other) 

1. Is there a natural source of 

 the substance? 

 [§205.600 b.1] 

2. Is there an organic 

 substitute? [§205.600 b.1] 

3. Is the substance essential 

 for handling of organically 

 produced agricultural 

 products? [§205.600 b.6] 

4. Is there a wholly natural 

 substitute product? 

 [§6517 c (1)(A)(ii)] 

5. Is the substance used in 

 handling, not synthetic, but 

 not organically produced? 

 [§6517 c (1)(B)(iii)] 

6. Is there any alternative 

 substances? [§6518 m.6] 

7. Is there another practice 

 that would make the 

 substance unnecessary? 

 [§6518 m.6] 

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 

(b)are N/A—not applicable. 
National Organic Standards Board Policy & Procedures Manual 41 

Current As of October 3, 2005 

Category 3. Is the substance compatible with organic production practices? 

Substance ____________________

Question Yes No N/A1 Documentation 

(TAP; petition; regulatory agency; other) 

1. Is the substance compatible 

with organic handling? 

[§205.600 b.2] 

2. Is the substance consistent 

with organic farming and 

handling? [§6517 c (1)(A)(iii); 

6517 c (2)(A)(ii)] 

3. Is the substance compatible 

with a system of sustainable 

agriculture? [§6518 m.7] 

4. Is the nutritional quality of 

the food maintained with the 

substance? [§205.600 b.3] 

5. Is the primary use as a 

preservative? [§205.600 b.4] 

6. Is the primary use to 

recreate or improve flavors, 

colors, textures, or nutritive 

values lost in processing 

(except when required by law, 

e.g., vitamin D in milk)? 

[205.600 b.4] 

7. Is the substance used in 

production, and does it contain 

an active synthetic ingredient 

in the following categories: 

a. copper and sulfur 

compounds; 

b. toxins derived from bacteria; 

c. pheromones, soaps, 

horticultural oils, fish 

emulsions, treated seed, 

vitamins and minerals? 

d. livestock parasiticides and 

medicines? 

e. production aids including 

netting, tree wraps and seals, 

insect traps, sticky barriers, 

row covers, and equipment 

cleaners? 

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b) 

are N/A—not applicable. 
National Organic Standards Board Policy & Procedures Manual 42 

Current As of October 3, 2005 

NOSB RECOMMENDED DECISION FORM 

Form NOPLIST2. Full Board Transmittal to NOP 

For NOSB Meeting: _____________________ Substance: ___________________________ 

A. Evaluation Criteria (Documentation attached; committee recommendation attached) 

 Criteria Satisfied? 

1. Impact on humans and environment Yes  No  (see B below) 

2. Availability criteria Yes  No  (see B below) 

3. Compatibility & consistency Yes  No  (see B below) 

B. Substance fails criteria? 

Criteria category: _________ 

Comments: 

C. Proposed Annotation: ______________________________________ 

___________________________________________________________ 

Basis for annotation: 

To meet criteria above: ____ Criteria: _______________ 

Other regulatory criteria: ____ Citation:_______________ 

D. Final Board Action & Vote: Motion by: ____________________ Second:____________________________ 

 

 Vote: 

 

 Yes: _____ 

 

 No: _____ 

 Abstain: _____ 

 

 1—substance voted to be added as “allowed” on National List 

Annotation: ___________________________________________________________________ 

 ___________________________________________________________________ 

 2—substance to be added to “prohibited” paragraph of National List 

Describe why a prohibited substance:_______________________________________________ 

_____________________________________________________________________________ 

 3—substance was rejected by vote for amending National List 

Describe why material was rejected:________________________________________________ 

_____________________________________________________________________________ 

 4-substance was recommended to be deferred 

Describe why deferred; if any follow-up is needed. If follow-up needed, who conducts followup._____________________________________________________________________ 

Agricultural Nonagricultural Crops 

Synthetic Not synthetic Livestock 

Allowed1 Prohibited2 Handling 

No restriction Deferred4 Rejected3

E. Approved by NOSB Chair to transmit to NOP: 

______________________________________ _________________________ 

 Dave Carter, NOSB Chair Date 

F. NOP Action: Include in FR to amend National List: 

 Return to NOSB  Reason: ____________________________________________________________________ 

_____________________________________ _________________________ 

 Richard H. Mathews, Program Manager Date 
National Organic Standards Board Policy & Procedures Manual 43 

Current As of October 3, 2005 

NOSB COMMITTEE RECOMMENDATION FORM 

Form NOPLIST1. Committee Transmittal to NOSB 

For NOSB Meeting: _____________________ Substance: ___________________________ 

Committee: Crops  Livestock  Handling 

A. Evaluation Criteria (Documentation attached; committee recommendation attached) 

 Criteria Satisfied? 

4. Impact on humans and environment Yes  No  (see B below) 

5. Availability criteria Yes  No  (see B below) 

6. Compatibility & consistency Yes  No  (see B below) 

B. Substance fails criteria? 

Criteria category: _________ 

Comments: 

C. Proposed Annotation: _________________________________________ 

______________________________________________________________ 

Basis for annotation: 

To meet criteria above: ____ Criteria: _______________ 

Other regulatory criteria: ____ Citation:_______________ 

D. Recommended Committee Action & Vote: Motion by: __________________________ 

 Seconded:____________________________ 

 

 Vote: 

 

 Yes: _____ 

 

 No: _____ 

 Abstain: _____ 

 

 1—substance voted to be added as “allowed” on National List 

Annotation: ___________________________________________________________________ 

 ___________________________________________________________________ 

 2—substance to be added to “prohibited” paragraph of National List 

Describe why a prohibited substance:_______________________________________________ 

_____________________________________________________________________________ 

 3—substance was rejected by vote for amending National List 

Describe why material was rejected:________________________________________________ 

_____________________________________________________________________________ 

 4-substance was recommended to be deferred 

Describe why deferred; if follow-up is needed. If follow-up needed, who will follow 

up_____________________________________________________________________ 

_____________________________________________________________________________ 

Agricultural Nonagricultural Crops 

Synthetic Not synthetic Livestock 

Allowed1 Prohibited2 Handling 

No restriction Deferred4 Rejected3

E. Approved by Committee Chair to transmit to NOSB: 

______________________________________ _________________________ 

 Committee Chair Date 
National Organic Standards Board Policy & Procedures Manual 44 

Current As of October 3, 2005 

PROCEDURES FOR THE MATERIALS REVIEW PROCESS FOR NOSB MEMBERS 

1. Upon receipt of the TAP reviews each member should read the report prepared 

by the contractor, along with the submitted petition, additional information and 

recommendations of the contracted panel of experts. 

2. Questions or clarification of the review may be answered by further review of the 

literature provided by the TAP contractor or by the Chair of the committee 

contacting the contractor directly. Questions regarding the process can be 

directed to the Chair of the Materials Committee. 

3. The materials are either directed to the processing, crops or livestock 

committee(s) depending on the specified use(s) of the material as stated in the 

petition. NOSB members assigned to those committees shall conduct a 

thorough review of the material and vote on whether it is synthetic or 

nonsynthetic and if it should be allowed or prohibited for specific use as either a 

crop, livestock or processing material. Materials may be followed by an 

annotation which restricts their use. Recommended annotations applicable to 

the material must be voted on by committee. 

4. Committee draft recommendations will be submitted to the NOP at least thirty 

(30) days prior to the next NOSB meeting where the material will be considered. 

5. The Chair of each committee will present the Board with the committee’s written 

votes and recommendations during the Materials Review process at the NOSB 

meeting. The recommendation should come in the form of a motion which must 

be seconded by an NOSB member to move forward. The process will follow 

Robert’s Rules of Order in which the Chair would open the motion for discussion. 

The Chair shall ask if any Board members have conflicts of interest. After 

discussion board members will vote on the motion. 

6. NOP staff will record the votes of the each NOSB member and announce 

whether or not the motion passed. 

7. If the motion fails the Board Chair asks for a new motion and the procedure is 

repeated until a final motion is passed by a 2/3 majority. 
SUNSET REVIEW PROCESS 

NATIONAL LIST

SUNSET REVIEW PROCESS

NOP receives comments, forwards to NOSB, and posts to the NOP Website

(All comments shall be in NOSB posession no later than 7 days after the closing date of public comment)

NOP publishes a FR notice for an Advanced Notice of Public Rulemaking. (Allow 60 days for Public Comment)

OGC Review and Departmental Clearance

(60 days)

NOP Develops Regulatory Review work plan and drafts Advanced Notice of Public Rulemaking

(60 days)

OVERVIEW OF THE SUNSET PROCESS-STEPS COMPLETED

 FEDERAL REGISTER NOTICE 

 RECEIPT OF PUBLIC COMMENTS 

 COMMITTEES FORWARDED RECOMMENDED SUBSTANCES 

FOR FURTHER TECHNICAL REVIEW TO NOP 

NATIONAL LIST

SUNSET REVIEW PROCESS

National Organic Standards Board Policy & Procedures Manual 45 

Current As of October 3, 2005 

NOSB Final Vote

Additional Public Comments Received

Committee Recommendations

(Renewal, Removal, Defer)

30 days prior to NOSB Meeting

Committee Conference Calls

(calls scheduled as needed)

Complete Sunset Material Review Forms

NOSB Notified of Comments

(within 5 days of NOP receipt)

Notification to Materials Chair

Notification to Committee Chair

Additional Comments Received

on Posted Materials

NOSB Notified of Additional Comments

Comments Posted on NOP Website

(within 5 days of NOP receipt)

Posted by Category

Handling(H), Crops(C), Livestock(L)

NOP Receives Public Comments
National Organic Standards Board Policy & Procedures Manual 46 

Current As of October 3, 2005 

SUNSET PROCESS-IN PROGRESS

 COMMITTEES REVIEWING SUBSTANCES UNDER SUNSET 

REVIEW 

 COMMITTEES REVIEWING PUBLIC COMMENTS 

 COMMITTEES DRAFTING RECOMMENDATIONS ON 

SUBSTANCES 

 COMMITTEES FORWARDING SUBSTANCES FOR ADDITIONAL 

TECHNICAL REVIEW BASED ON PUBLIC COMMENTS 

Committee substance Forms

 Sunset Review Committee Forms 

 Name of Substance 

 National List Section, use and annotation if applicable 

 Comment (s) code number (s) 

 Status (record number of comments) 

 Renewal ( ) 

 Removal ( ) 

 Summary of comment (s) 

 Committee recommendation 

Committee Recommendations

Committees will recommend to the full Board a determination on each 

substance for renewal, removal or deferral to seek specific technical 

information from the TAP contractors. TAP contractors shall be used to 

verify information provided by the commenters, research or seek additional 

information requested by the committee. 

Public Comment and Final NOSB Vote on Recommendations

 Each committee will provide their recommendation to the board on each 

substance 30 days prior to the full Board meeting. The recommendation 

will be posted on the website and open to public comment. 

 NOSB Final Vote 

Rulemaking on NOSB Recommendations

 NOP Rulemaking 

 dockets of materials for renewal based on the assumption that deferred 

materials may take some additional time for review and a full board vote 

After each NOSB meeting, the NOP would begin rulemaking on those 

substances that were voted for renewal. The materials committee 

anticipates at least two. 
National List

Sunset Review Process 

Final rule is Final

(No later than October 21, 2007)

Congressional Review

(60 days)

OMB Review

(90 days)

Interagency Review

(90 days)

OGC Review

(90 days)

NOP Drafts Final Rule

(90 days)

Sunset Timeline

NOSB Final Vote

NOSB Recommendation

30 days prior to meeting

NOSB Final Vote

NOSB Recommendation

30 days prior to meeting

NOSB Final Vote

NOSB Recommendation

30 days prior to meeting

NOSB Final Vote

NOSB Recommendation

30 days prior to meeting

NOSB Sunset Material Review

90 days from end of public comment

NOP Receives Public Comment

60 days

NOP publishes a FR notice

OGC Review and Departmental Clearance

NOP Develops Regulatory Review

National Organic Standards Board Policy & Procedures Manual 47 

Current As of October 3, 2005 
Sunset Timeline 

Final rule is Final

(No later than October 21, 2007)

Congressional Review

Completed by September 2007

OMB Review

Completed by July 2007

Interagency Review

Completed by April 2007

OGC Review

completed by January 2007

NOP Drafts Final Rule

completed by November 2006

National Organic Standards Board Policy & Procedures Manual 48 

Current As of October 3, 2005 
National Organic Standards Board Policy & Procedures Manual 49 

Current As of October 3, 2005 

APPENDEX 

DECISION MAKING PROCEDURES FOR THE NOP 

1. Define the Problem 

a. What is the problem? 

b. Identify where we are now. 

i. State the present condition in no more than two 

sentences. 

c. Identify where we want to be. 

i. State the future objective in no more than two sentences. 

2. Analyze the Problem

a. Why is there a problem? 

b. Is the evidence of the problem supported by credible and compelling facts or 

data? 

i. What are the facts or data used to draw an affirmative conclusion? 

c. Who does this problem affect? 

d. What is the problem's effect? 

e. In what time frame must the problem be resolved? 

f. If the problem deserves immediate attention, what other priorities must be 

adjusted to accommodate this problem? 

g. If the problem deserves immediate attention, what are the consequences of a 

delay? 

3. Develop Possible Solutions

a. Propose ideas for possible solutions 

b. Evaluate ideas for possible solutions 

i. List pros for each possible solution 

ii. List cons for each possible solution 

c. Select a Solution 

i. Is the recommended solution legal? 

ii. Is the recommended solution practical? 

iii. Is the recommended solution supported by credible and compelling 

facts or data? 

1. What are the facts or data used to draw an affirmative conclusion? 

iv. How does the recommended solution solve the problem? 

v. How does the recommended solution meet the time frame identified in 2(b)? 

d. Review recommended solution for unintended consequences. 

4. Develop Action Plan 

a. Develop Action Steps 

i. Identify action steps to bridge the gap between present condition and 

future objective using the recommended solution. 

b. Approve Action Plan 

c. Implement Action Plan 

Final - 5/9/2003 
National Organic Standards Board Policy & Procedures Manual 50 

Current As of October 3, 2005 

FACA FACTS

1. The Federal Advisory Committee Act (FACA) (5 U.S.C. App.2) and its 

implementing regulations (41 CFR Part 101-6.10) govern the creation, operation, 

and termination of advisory committees in the Executive Branch of the Federal 

Government. The National Organic Standards Board (NOSB) is a Department of 

Agriculture (USDA) non-discretionary advisory committee required by the 

Organic Foods Production Act of 1990, as amended. 

2. Advisory committees must be chartered before they can meet or conduct any 

business. Charters must be renewed every two years or they will be terminated 

under the sunset provisions of Section 14 of the FACA, unless otherwise 

provided by law. 

3. Advisory committee meetings are required to be open to the public, with limited 

exceptions as provided for in Section 552b of title 5, United States Code. 

Meetings not subject to FACA include NOSB briefing meetings initiated by USDA 

to exchange facts and information, such as member orientation, and NOSB 

committee meetings. Such meetings are not subject to FACA because they are 

not conducted for the purpose of providing the USDA with NOSB advice or 

recommendations. 

4. Designated Federal Officials must approve all meetings and agendas, and attend 

meetings. The NOP program manager is the NOSB’s Designated Federal 

Official. 

5. Meeting notices and agendas must be published in the Federal Register to 

accommodate public participation. Although not required by FACA, the NOP 

strives to: 

 a. Post a provisional agenda, on its web site, no later than 60 days 

before the meeting is scheduled to begin, 

 b. Post a final agenda, on its web site, no later than 45 days before 

the meeting is scheduled to begin, and 

 c. Publish notice of the meeting in the Federal Register no later than 

30 days before the meeting is scheduled to begin. 

6. Detailed minutes will be kept and must contain: 

 a. Date and location of the meeting, 

 b. A record of the persons present, 

c. A complete and accurate description of matters discussed and 

 conclusions reached, and 

 d. Any advice or recommendations provided by the committee. 
National Organic Standards Board Policy & Procedures Manual 51 

Current As of October 3, 2005 

7. Advisory committee documents must be available for public inspection and 

copying until the committee ceases to exist. 

8. Interested persons shall be permitted to attend, appear before, or file statements 

with any advisory committee, subject to reasonable rules or regulations. 

9. Additional information may be found at the FACA homepage - 

 http://policyworks.gov/org/main/mc 

DUTIES OF THE DESIGNATED FEDERAL OFFICER

The Designated Federal Officer assigned to the National Organic Standards Board and 

its committees, under the Federal Advisory Committee Act (U.S.C. App.2) and its 

implementing regulations (41 CFR Part 101-6.10), is the National Organic Program’s 

Program Manager. The Program Manager: 

1. Must approve or call the meeting of the NOSB; 

2. Must approve the agenda; 

3. Must attend the meetings; 

4. Shall adjourn the meetings when such adjournment is in the public interest; and 

5. Chairs the meeting when directed by the Secretary of Agriculture or the 

Secretary’s designee. 
National Organic Standards Board Policy & Procedures Manual 52 

Current As of October 3, 2005 

PARLIAMENTARY PROCEDURE AT A GLANCE 

TO DO THIS YOU SAY THIS May you 

interrupt 

speaker? 

Must you 

be 

seconded? 

Is the 

motion 

debatable? 

Vote 

required 

Adjourn the meeting I move that we 

adjourn 

no yes no majority 

Recess the meeting I move that we 

recess until... 

no yes no majority 

Complain about noise, room 

temperature, etc. 

Question of 

privilege 

yes no no no vote 

Suspend further consideration of 

something 

I move that the 

motion be laid on 

the table 

no yes no majority 

End debate I move the previous 

question 

no yes no 2/3 vote 

Postpone consideration of something I move we post 

pone this matter 

until... 

no yes yes majority 

Have something studied further I move to refer the 

motion to the 

committee 

no yes yes majority 

Amend a motion I move to amend... no yes yes majority 

Introduce business (a primary motion) I move that... no yes yes majority 

Object to procedure or to a personal 

affront 

Point of order yes no no chair 

decides 

Request information Point of information yes no no no vote 

Ask for a vote by actual count to verify 

a voice vote 

I call for a division no no no no vote 

Object to the consideration of some 

undiplomatic matter

I object to the 

consideration of the 

question 

yes no no 2/3 vote 

Take up a matter previously tabled I move to take from 

the table 

no yes no majority 

Reconsider something already 

disposed of 

I move to 

reconsider... 

yes yes yes majority 

Consider something vote out of its 

scheduled order 

I move we suspend 

the rules and 

consider... 

no yes no 2/3 vote 

Vote on a ruling by the chair I appeal the 

decision of the 

chair 

yes yes yes majority 
National Organic Standards Board Policy & Procedures Manual 53 

Current As of October 3, 2005 

Basic Chemistry 

 

 The science of chemistry deals with the structure of matter--material things--and 

the changes that matter undergoes. Matter can exist in any size, shape, or color. It is 

solid, liquid, or gas; living or nonliving. Chemistry seeks to identify the simplest parts of 

matter; how they are separated and purified; how they are put together; how they are 

rearranged to produce new forms of matter; and what energy is absorbed or released 

when such rearrangements are made (Matta and Wilbraham, 1986). A distinction 

should be made between chemical and physical changes. The OFPA and NOS 

definition of synthetic specifically mentions chemical change but not physical change. A 

physical property is a quality or condition of a substance that can be observed or 

measured without changing the substance’s composition. It can be specified without 

reference to any other substance. Other physical properties of matter include color, 

solubility, mass, odor, hardness, density, electrical conductivity, magnetism, melting 

point and boiling point. Physical properties help chemists identify substances (Matta 

and Wilbraham, 1986). When contractors are hired to technical review of substances 

for the NOSB and USDA/NOP, they typically list the physical properties of the 

substances in their review because this is the common way in which substances are 

described. 

 Physical changes may result when the temperature of a substance 

changes. Raising the temperature of a solid may turn it into a liquid (i.e., ice turns into 

water). A conversion without causing a change in the composition of the substance is 

called a physical change (Matta and Wilbraham, 1986). When ice undergoes the 

physical change of melting, this change does not change the nature of water. The 

physical properties are the same for water that has been frozen and melted as for water 

that has been converted into steam and then condensed (Matta and Wilbraham, 1986). 

Historically, the organic industry and the NOSB have acknowledged that physical 

changes do not render a substance synthetic. 

 However, there are some substances that have been identified where high 

temperatures during manufacturing do engender a chemical change in the substance. 

An example is mined minerals. Historically, the industry and NOSB has recognized that 

burning or excessive heating of mined mineral is considered to render them synthetic. 

Formerly, NOSB defined mined minerals as any naturally-occurring non-living 

substance derived from the earth or water. A mined mineral cannot have undergone 

molecular change through heating, acidification, basification or fortification with 

synthetic materials (NOSB Final Recommendation Addendum Number 25, Definitions 

and Interpretations, Austin, Texas, 1995). Therefore, heat can alter the physical 

properties of a substance and for other substances act as a catalyst in chemical 

reactions or change. 

 In a chemical reaction, the starting substance or substances, referred to as 

reactants, are changed into new substances or products. Chemists use an arrow as a 

shorthand form of the phrase “are changed into”; reactants Æ products (Matta and 

Wilbraham, 1986). An example to distinguish between physical and chemical changes 

is illustrated when sulfur (a solid) is added to iron filings (a solid). They may be 

separated unchanged from a mixture of the two substances mixed together. This 

separation is an example of a physical change. If the mixture of these two substances 

is heated, a chemical change takes place and the sulfur and iron are changed into a 

nonmagnetic substance, iron sulfide: Iron + SulfurÆ Iron Sulfide (Matta and Wilbraham, 
National Organic Standards Board Policy & Procedures Manual 54 

Current As of October 3, 2005 

1986). A substances’ composition and behavior in chemical reactions--its chemical 

reactivity--comprise its chemical properties. 

What is a substance? 

 In chemistry, a pure substance is a homogenous material that has a definite 

chemical composition throughout. There are two kinds of pure substances. One kind 

can be decomposed into two or more different substances by simple chemical change; 

these are called compounds. There are many millions of compounds. 

An example of a compound is pure table salt, which can be decomposed into sodium 

and chlorine by an appropriate process. Many of the substances on the National Lists 

of Synthetic substances allowed for use in organic crop and livestock production 

(Sections 205.601 and 205.603) are compounds. Examples include: isopropanol, 

chlorine dioxide, ammonium carbonate, lime sulfur and copper sulfate. 

 The second kind of pure substances are called elements, which cannot be 

decomposed by chemical change. There are 90 natural elements, examples are gold, 

copper, oxygen, sulfur and hydrogen. Elements cannot be separated into simpler 

substances by chemical reactions. An example of an element on the National List is 

sulfur (elemental) for crop production (205.601(e)(3))( Boikess and Edelson, 1978). 

 Mixtures consist of a physical blend or two or more substances in which the 

combined substances retain their identity. Most materials found in nature are mixtures. 

Mixtures can be either homogeneous (same composition throughout) or heterogeneous 

(has non-uniform composition). A solution is a type of a mixture where there is a 

homogeneous combination of different substances. The difference between a 

heterogeneous mixture and a solution is that any sample of a solution has the same 

composition, while the composition of a mixture is not the same throughout. Solutions 

may be gaseous, liquid or solid. Examples of mixtures on the National List are aquatic 

plants and fish emulsions. The various compounds and elements that make up these 

products are within the plant, animal or mineral. When a particular component of the 

plant is desired for use in an agricultural input it typically has to be extracted and in 

many cases undergo additional chemical reactions to make it into a substance that is 

functional when combined with other substances. 

 A distinction should be drawn between a mixture and a compound. The 

elements making up a compound cannot be recovered without a chemical 

change. The substances making up a mixture or solution can. Some mixtures can be 

separated into their various components by simple physical methods. An example is a 

gray-colored mixture produced by stirring together powdered yellow sulfur and black 

iron filings. The individual particles of sulfur and iron can be readily distinguished from 

one another under a microscope. The mixture is easy to separate because the iron 

filings can be removed from the mixture with a magnet leaving sulfur behind. Both the 

sulfur and the iron are unchanged in composition (example from Matta and Wilbraham, 

1986). 

 The substances making up a mixture or a solution need not be elements. For 

example, one can prepare a solution by dissolving salt, a compound, in water another 

compound. In addition, the substances making up a mixture or a solution can be 

combined in varying proportions. The elements in a compound have fixed proportions. 
National Organic Standards Board Policy & Procedures Manual 55 

Current As of October 3, 2005 

(paragraph found in Boikess and Edelson, 1978). Main groups of compounds can be 

classified based on similar chemical properties. The following are descriptions of each 

group (Boikess and Edelson , 1978). 

Salts: a compound of a metal and nonmetal, or of a metal with a negative polyatomic 

group. Compounds that have an ammonium group (NH4

+

) instead of a metal are also 

classified as salts. Some salts are NaCl, KCl, KMnO4 and NH4Cl. A salt is an ionic 

solid a room temperature. Most have two ionic components (a) a cation, which can be a 

polyatomic group such as ammonium or a monoatomic metal such as Na+

, K+, Ca2+ or 

Mn3+ and (b) an anion, which can be a negative polyatomic group or a monoatomic ion 

such as Cl-

 or NH3

-

. A solid salt consists of ions in close association. When the salt 

dissolves in water, the ions are separated. Substances that exist as ions in solution are 

called electrolytes. When NaCl dissolves in water, the correct formula is Na+

 + Cl-. This 

formula treats the component ions of the salts as independent entities, which is 

approximately how they behave in water solution. Salts are called strong electrolytes 

because they usually separate completely into ions in water. (Boyd text) 

Acids: a compound that is a source of H+

 ions. An acid is usually a compound of 

hydrogen and a nonmetal or a negative polyatomic group. Unlike salts, acids usually 

are not aggregates of ions. An acid may be a gas (hydrochloric), liquid (sulfuric) or a 

solid (oxalic). Like salts, acids tend to form ions when the dissolve in water. When a 

substance separates into ions it is said to dissociate. Some acids dissociate completely 

and are called strong acids. Most acids dissociate only partially when dissolved in 

water. These are called weak acids, they are weak electrolytes. 

Bases: a compound that is a source of OH-

 ions in water solution. A compound of a 

cation and the OH- anion is a base. Bases resemble salts in many ways. They are 

ionic solids that dissociate into ions when dissolved in water. Bases that contain a 

cation and OH-

 are generally dissociate completely in water and are classified as strong 

bases. Some strong bases are NaOH (sodium hydroxide) and KOH (potassium 

hydroxide). Compounds that do not contain hydroxide ions are defined as bases if they 

produce OH-

 ions by reaction with water. An example is ammonia (NH3) which reacts 

with water to produce hydroxide ions. 

Nonelectrolytes: Compounds containing only nonmetals usually exist as discrete 

molecules, rather than collections of ions. These compounds do not dissociate into ions 

when they dissolve in water. Many organic compounds are nonelectrolytes and they 

will not dissolve appreciably in water i.e. oil. Some will dissolve in water, although they 

will not dissociate into ions i.e. sugar, and ethyl alcohol. 

Oxides: is a binary compound of any element with oxygen, when the oxygen has an 

oxidation number of -2. Almost every element forms at least on oxide. The properties of 

oxides vary widely- depending on the element they may resemble a salt, acid, base or 

non electrolyte. 

What constitutes a chemical change? 

 The chemical properties of a substance are those that describe the way in which 

it can undergo change, either alone or in interactions with other substances, to form 

different materials. Such changes are called chemical reactions. The chemical 
National Organic Standards Board Policy & Procedures Manual 56 

Current As of October 3, 2005 

properties that are characteristic of any substance can be described- iron combines 

readily with oxygen to form the compound called rust. (Boikess and Edelson, 1978). 

The following are common types of chemical reactions that describe what is happening 

when different substances and compounds interact (Boikess and Edelson ,1978). 

1. Addition or combination reaction: Two substances combine to form one: 

2Na+Cl2----2NaCl 

2. Decomposition reactions: One compound breaks into two or more compounds or 

elements. CaCO3-------CaO + CO2

3. Displacement reactions: Substances exchange parts. There are many types of 

these reactions but one of the most important is called metathesis which is the 

exchange of ions by two ionic compounds, with the anion of one compound 

joining the cation of the other compound and vice versa. AB+CD-ÆAD + CB 

 1. Hydrolysis is a displacement reaction of a substance or ion with water. 

 Water is a source of both H+

 and OH- ions. The OH- anion combines 

 with the positive portion of the compound that is hydrolyzed. This 

 positive portion may be a cation or an atom with a positive oxidation 

 number. The H+

 cation combines with the negative portion of the 

 compound, which may be an anion or an atom with a negative oxidation 

 number. 

2. Acid-base reaction: an acid is a substance that can donate a proton, 

and a base is a substance that can accept a proton. 

 Since many materials used in organic agriculture are derived from plants and 

animals it is important to mention chemical reactions that occur in by products of these 

organisms. In living organisms, enzymes play the role in catalyzing a specific reaction 

or type of reactions. Proteins are substances extracted from living organisms that 

maybe utilized in materials that are petitioned for use in organic production. Proteins 

are sensitive to relatively small changes in pH, temperature, or solvent composition may 

cause them to denature. Denaturation causes physical change, the most observable 

result is loss of biological activity. Except for cleavage of disulfide bonds, denaturation 

stems from changes in secondary, tertiary, or quaternary structures through disruption 

of noncovalent interactions, such as hydrogen bonds, salt linkages and hydrophobic 

reactions. Common denaturing agents include the following: 

1. Heat--most become denatured when heated above 50-60 degrees C. 

2. Large changes in pH--adding concentrated acid or alkali to a protein in a 

aqueous solution causes changes in the charged character of ionizable side 

chains and interferes with salt linkages. 

3. Detergents--treating a protein with sodium dodecylsulfate (SDS), a detergent, 

causes the native conformation to unfold and exposes the nonpolar protein side 

chains to the aqueous environment. These side chains are then stabilized by 

hydrophobic interaction with hydrocarbon chains of the detergent. 

4. Organic Solvents- such as alcohols, acetone or ether. 

5. Mechanical treatment. Most globular proteins denatured in aqueous solution if 

they are stirred or shaken vigorously. 

6. Urea and guanidine hydrochloride- These substances can cause disruption of 

protein hydrogen bonding and hydrophobic interactions. 
National Organic Standards Board Policy & Procedures Manual 57 

Current As of October 3, 2005 

Denaturation can be partial or complete. It can also be reversible or irreversible. 

Irreversible denaturation causes a fundamental change in the protein, in particular 

destroying any physiological (biological) activity. In the case of reversible denaturation, 

the change may only be temporary (Brown, 1988). 

References: 

Boikess, R.S. and Edelson, E. Chemical Principles. Harper and Row, New York, 1978. 

Brown, W.H. Introduction to Organic Chemistry. Brooks/Cole Publishing Company, 

California, 1988. 

Matta, Michael, and Wilbraham, A.C. General, Organic and Biological Chemistry. 

Benjamin/Cummings Publishing Company, California, 1986.