FORMAL RECOMMENDATION BY THE

NATIONAL ORGANIC STANDARDS BOARD (NOSB) 

TO THE NATIONAL ORGANIC PROGRAM (NOP) 

Date: _August 17, 2005________

Subject: __NOSB Statement on ANSI Audit of NOP Accreditation________ 

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):

Recommendation # 1 – The next audit of the NOP accreditation program should assess 

the NOP’s adherence to the accreditation procedures in subpart F of the Final Rule and

evaluate the NOP’s accreditation decisions, in addition to adherence to ISO/IEC Guide 

61, in order to fully comply with §205.509. 

Recommendation # 2 – The NOP should address the need for a quality manual and 

follow a quality system that fully documents all accreditation functions, policies, and 

procedures. This information may be in a quality manual or the quality manual may 

reference information contained in separate procedure, policy, and standards manuals.

Recommendation # 3 – NOP should document that explanations of the regulations are 

developed by impartial persons or committees who possess the necessary technical 

competence in the requisite subject matter. 

Recommendation # 4 – The NOP should establish a clear wall, described in the NOP 

Quality Manual, between its accreditation activities and other certification-related 

functions specified in the Final Rule, including how it handles suspensions, revocations, 

complaints, appeals, and enforcement actions. 

Recommendation # 5 – NOSB endorses the NOP’s response to “Finalize policy 

document that more clearly identifies delegations of authority and personnel responsible 

for the activities below: 

a) Accreditation activities 

b) Formulation of policy matters relating to the operation of the accreditation body 

c) Supervision of implementation of NOP policies 

d) Decisions on accreditation and the criteria for those decisions 

e) Delegation of authority to committees 

f) Individuals or offices within AMS performing specific activities on behalf of the 

NOP 

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Procedures for website maintenance.” The NOSB encourages the Secretary to provide 

adequate support to accomplish the tasks listed above in a timely manner. 

Recommendation # 6 – NOP should establish or clearly demonstrate the existence of job 

descriptions with minimum qualification requirements for auditors and technical experts 

who provide advice on or verify compliance with organic regulations. 

Recommendation # 7 – In preparation for the next audit, the NOP should demonstrate 

that the document and data management system being implemented fully complies with 

the requirements of ISO/IEC Guide 61. 

Recommendation # 8 – The NOSB continues to encourage NOP to merge NOP and ISO 

Guide 65 requirements into one accreditation system to facilitate trade and reduce costs 

and bureaucracy for certifying agents. 

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 Statement on the 

National Organic Program Response to the 

American National Standards Institute Peer Evaluation Report on 

NOP Certifier Accreditation Operations 

Approved by the 

National Organic Standards Board 

August 16, 2005 

Introduction: 

The USDA National Organic Program (NOP) and the National Organic Standards Board (NOSB) 

are implementing procedures for ongoing peer review of the NOP accreditation program. Under 

the procedures, the NOP accreditation program will be audited by an independent peer 

auditing/review organization at least once every three years. Once the audit is completed, the 

NOP will draft a detailed response to the audit report. Both the audit report and the NOP 

response will be provided to the NOSB for review. The NOSB, on behalf of the organic 

community, will evaluate the audit report and NOP response and work with the NOP to provide a 

sufficiency assessment to the Secretary in order to implement the audit findings, enhance 

implementation of the NOP accreditation program, and facilitate constructive dialog between the 

NOP and NOSB. It is the goal of this process to provide input to the Secretary within one year 

after each audit report is submitted to the NOP. 

Background: 

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In 2003, the NOP contracted with the American National Standards Institute (ANSI) to conduct a 

peer review audit of NOP certifier accreditation operations. The purpose of the audit was to 

provide NOP managers with information necessary to improve the quality of NOP services, 

support compliance with international accreditation protocols, and meet the requirement for peer 

review of the Organic Foods Production Act of 1990.1

 

ANSI conducted the audit based on the International Organization for Standardization (ISO) 

International Electrotechnical Commission (IEC) Guide 61, General Requirements for 

Assessment and Accreditation of Certification Bodies. On November 15, 2004, the NOP received 

the final ANSI Peer Evaluation Report. On December 8, 2004, NOP received a revised final 

report from ANSI. The NOP issued a written response to the ANSI report, also dated December 

8, 2004. 

The NOSB has been asked by NOP to evaluate the audit report and NOP response and provide 

a sufficiency assessment to the Secretary to assist in implementation of the audit findings. The 

NOSB’s comments and recommendations are contained in this document. 

NOSB Statement: 

The NOSB has reviewed the ANSI report and the NOP’s response. The NOSB commends the

NOP for contracting with ANSI to conduct the review, and for providing thoughtful responses to 

the findings in the ANSI report. As noted in the ANSI audit report, many NOP accreditation

activities, especially those conducted by the Audit Review and Compliance division, are 

functioning well, while others need improvement. The NOSB further acknowledges that the NOP 

is actively addressing deficiencies noted in the ANSI audit report. 

The ANSI review of NOP is considered by the NOSB to be a comprehensive, professional, and 

independent peer review of the NOP accreditation program for adherence to accreditation 

procedures of ISO/IEC Guide 612

. Other than the items discussed below, the NOSB accepts and 

supports the NOP’s responses to the ANSI findings with no comment. 

Recommendations: 

On behalf of the organic community, the NOSB offers the following recommendations to assist 

the NOP in the improvement of the accreditation program and compliance with the requirements 

of §205.509 and ISO Guide 61: 

 

1. Scope of audit - The ANSI audit did not assess the NOP’s adherence to the accreditation

procedures in subpart F of the Final Rule or evaluate the NOP’s accreditation decisions, as 

required by section 205.509 of the Final Rule. 

Recommendation # 1 – The next audit of the NOP accreditation program should assess the 

NOP’s adherence to the accreditation procedures in subpart F of the Final Rule and evaluate the 

NOP’s accreditation decisions, in addition to adherence to ISO/IEC Guide 61, in order to fully 

comply with §205.509. 

2. ANSI findings 2.1.2.k and 2.1.4 – ANSI noted that the overall quality system for accreditation is 

not documented in a quality manual. While the NOP response mentions the need to “finalize 

documents,” it does not address the absence of a quality manual. 

 

1 National Organic Program Response to the American National Standards Institute Peer Evaluation Report on NOP 

Certifier Accreditation Operations, December 8, 2004.

2 Since the Final Rule was published, ISO Guide 61 has been updated and renamed to ISO 17011.

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Recommendation # 2 – The NOP should address the need for a quality manual and follow a 

quality system that fully documents all accreditation functions, policies, and procedures. This

information may be in a quality manual or the quality manual may reference information contained 

in separate procedure, policy, and standards manuals. 

3. ANSI finding 2.1.1.3 – ANSI noted that NOP does not define the process for developing 

explanations of the regulations and program requirements by “impartial committees or persons 

possessing the necessary technical competence.” In response, NOP referenced the Good 

Guidance document, but did not address the need for impartial committees or persons with 

technical competence. 

Recommendation # 3 – NOP should document that explanations of the regulations are 

developed by impartial persons or committees who possess the necessary technical competence 

in the requisite subject matter. 

4. ANSI finding 2.1.2.l – ANSI found that the NOP does not have policies and procedures to 

distinguish between accreditation activities and other activities performed. The NOP response did 

not demonstrate how it separates its accreditation functions from other activities related to 

certification, such as the handling of suspensions, revocations, complaints, appeals, and 

enforcement actions. 

Recommendation # 4 – The NOP should establish a clear wall, described in the NOP Quality 

Manual, between its accreditation activities and other certification-related functions specified in

the Final Rule, including how it handles suspensions, revocations, complaints, appeals, and 

enforcement actions. 

 

5. ANSI findings 2.1.2.c and 2.2.1.3 – In response to these findings, NOP states that it will, 

“Finalize policy document that more clearly identifies delegations of authority and personnel 

responsible for the activities below: 

g) Accreditation activities

h) Formulation of policy matters relating to the operation of the accreditation body 

i) Supervision of implementation of NOP policies 

j) Decisions on accreditation and the criteria for those decisions 

k) Delegation of authority to committees 

l) Individuals or offices within AMS performing specific activities on behalf of the NOP 

m) Procedures for website maintenance.” 

Recommendation # 5 – NOSB endorses the NOP’s response and encourages the Secretary to 

provide adequate support to accomplish the tasks listed above in a timely manner. 

6. ANSI finding 2.2.1.2 – ANSI found that the NOP does not define the minimum criteria for 

competence for auditors and technical experts. Finding 2.2.2 states, “Auditors who serve as

technical experts have not received training on verification methods employed in the organic 

certification sector.” The NOP response describes Federal job procedures, but does not directly 

address the finding. 

Recommendation # 6 – NOP should establish or clearly demonstrate the existence of job 

descriptions with minimum qualification requirements for auditors and technical experts who 

provide advice on or verify compliance with organic regulations. 

7. ANSI finding 2.1.7.2 – ANSI stated, “The accreditation body does not have procedures for 

controlling all documents and data related to accreditation functions.” NOP responded by stating 

that it is “in the process of incorporating itself into the records management system established by 

AMS.” There is no further discussion or description of the proposed AMS records management 

system, or if it complies with ISO requirements for document and data control. 

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Recommendation # 7 – In preparation for the next audit, the NOP should demonstrate that the 

document and data management system being implemented fully complies with the requirements 

of ISO/IEC Guide 61. 

8. ANSI finding 3.1.1.2.a – ANSI found that NOP does not require that certifying agents comply

with the relevant provisions of ISO/IEC Guide 65. The NOP response discusses “annual 

updates,” but does not address the fact that NOP-accredited certifying agents are not required to 

comply with ISO Guide 65. The USDA offers ISO Guide 65 accreditation to organic certifying 

agents as a separate fee-for-service program. This leads to increased expenses and bureaucracy 

for certifying agents who choose to participate, and constitutes a barrier to trade for agents who 

are not ISO 65 accredited. 

Recommendation # 8 – The NOSB continues to encourage NOP to merge NOP and ISO Guide 

65 requirements into one accreditation system to facilitate trade and reduce costs and 

bureaucracy for certifying agents. 

Conclusion: 

As stated, the NOSB commends the NOP for contracting with ANSI to conduct the review, and for 

providing thoughtful responses to the findings in the ANSI report. 

The NOSB understands that creation and operation of the NOP accreditation program are huge

undertakings. The NOSB stands ready to assist the NOP in developing and implementing work 

plans, policies, and procedures to provide for continuous improvement of the program. 

Committee vote: 

Yes – 4; No – 0; Abstention – 0; Absent – 1 

Board vote: 

Yes – 13; No – 0; Abstention – 0; Absent – 1 

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