ANSI Reassessment Report

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Product Certification Accreditation

2018 Peer Review Executive Summary 

For

United States Department of Agriculture 

Agricultural Marketing Service

National Organic Program

Dates of Review Panel: 

May 15 – May 17, 2018

Prepared by

American National Standards Institute 

1899 L Street, 11th Floor 

Washington, DC 20036

Document: Executive Summary

USDA-AG6395S150169-2018-EXS-ANSI-REV00

CONFIDENTIAL

This report contains confidential information and shall not be reproduced and/or distributed 

without the written consent of the American National Standards Institute, unless it is in its
2018 Peer Review Executive Summary

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TABLE OF CONTENTS

TABLE OF CONTENT

I. GENERAL INFORMATION............................................................................................. ...3

II. INTRODUCTION ................................................................................................................. 4

III. PURPOSE OF THE PEER REVIEW................................................................................. 4

IV. SUMMARY............................................................................................................................. 5
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I. GENERAL INFORMATION

Accreditation Body

Name of Reviewed Body United States Department of Agriculture

Agricultural Marketing Services (AMS) 

National Organic Program

Address 1400 Independence Avenue SW, 

Room 2648 South Building 

Washington, DC 20250

Telephone 202-720-3252

Review

Type of Process On-site Assessment Peer Review

On-site Review Dates May 15 to May 17, 2018

Review Standard(s) ISO/IEC 17011:2004 Conformity Assessment – General 

requirements for accreditation bodies accrediting conformity 

assessment bodies

US 7 CFR Part 205, National Organic Program 

ISO/IEC 17011:2017 Conformity Assessment – General

requirements for accreditation bodies accrediting conformity 

assessment bodies

Review Team

Lead Reviewer: Mario Llerenas

Co-Lead Reviewer: Susan Cadorette

Technical Reviewer: Jean Richardson

ANSI Observer(s) Reinaldo Figueiredo, ANSI Senior Program Director 

Elizabeth Okutuga, ANSI Program Coordinator

Report Prepared by:

Mario Llerenas 

Susan Cadorette 

Jean Richardson

Submitted to USDA on: August 22, 2018
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II. INTRODUCTION

The National Organic Program (NOP) is part of the Agricultural Marketing Service (AMS), U.S. 

Department of Agriculture (USDA), and is the organization responsible for activities relating to the 

development, implementation, and administration in accordance with the Organic Foods Production Act 

of 1990 (OFPA) and the USDA organic regulations. Key functions of the NOP include:

• Developing, reviewing, implementing, and interpreting the organic standards

• Enforcing organic production, handling, and labeling standards

• Accrediting, auditing, and training third-party organic certifying agents

The NOP established a peer review panel to satisfy internal requirements regarding adherence to internal 

and regulatory requirements. American National Standards Institute (ANSI) has convened this panel 

effective February 8, 2018 to fulfill the expectation of this requirement.

This Peer Review was conducted pursuant to 7 CFR 205.509, Peer Review Panel, of the USDA Organic 

Regulations. This Peer Review follows a procedure outlined in NOP 1031, and Peer Review of the 

National Organic Program (NOP).

The panel was tasked with the following:

• evaluate the NOP’s polices, processes, and procedures for conformance to NOP regulations and 

ISO/IEC 17011 version 2004 and 2017;

• review implementation of certification body accreditation processes through selected review of five 

files: and

• report the peer review panel findings in writing to the NOP Deputy Administrator and the National 

Organic Standards Board.

III. PURPOSE OF THE PEER REVIEW

Accreditation is the independent evaluation of conformity assessment bodies against recognized standards 

to ensure their impartiality and competence. Through the application of national and international 

standards, government, purchasers, and consumers can have confidence in the certifications provided.

Accreditation bodies are established in many countries with the primary purpose of ensuring that 

conformity assessment bodies are subject to oversight by an authoritative body.

Accreditation bodies are evaluated by peers in order to reduce trade barriers and demonstrate the 

competence of the accreditation body operations. Accreditation reduces risk for business and its 

customers by assuring that accredited Conformity Assessment Bodies (CABs) are competent to carry out 

the work they undertake within their scope of accreditation. The purpose of the peer

evaluation is to provide confidence in the operation of the accreditation process, thus providing 

acceptance in the market place of the conformity assessment outcome.
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IV. SUMMARY

The report covers NOP’s compliance with ISO/IEC 17011 and review of NOP’s accreditation 

procedures and decisions. The Review Panel members find that NOP and its staff are in general 

compliance with ISO/IEC 17011 and NOP’s own policies and procedures. During the 2018 on-site 

peer review, the ANSI team identified 10 OFIs, and two recommendations. The following are the 2018 

OFIs identified by the 2018 Peer Review Panel, which are recorded with objective evidence in 

ANSICA:

• 2018-USDA NOP-01-O-LLEM-(17011 v. 2004) 4.2.8 The accreditation body shall 

document its entire structure, showing lines of authority and responsibility.

The NOP Organizational Chart does not show the Quality Manager position.

Evidence: The Organizational Chart does not include a Quality Manager. However, there are 

several references in the procedures for the responsibilities of the Quality Manager. For example: 

1) NOP 1030 Internal Audit Procedure Rev 04 clause 2.1: The Quality Manager schedules... 2) 

NOP 1000 clause 4.3 Management System: The Quality Manager is designated as the responsible 

member.

• 2018-USDA NOP-02-O-LLEM-(17011 v.2004) 4.3.7 The accreditation body, with the 

participation of the interested parties as described in 4.3.2, shall identify, analyze and 

documentthe relationships with related bodies to determine the potential for conflict of interest, 

whether they arise from within the accreditation body or from the activities of the related 

bodies. Where conflicts are identified, appropriate action shall be taken.

There is no documentation for the relationships between the NOP and related bodies; 

and no evidence of the participation of the interested parties.

Evidence: The identification and analysis of the relationship with related bodies to determine the 

potential conflict of interest is not documented. As well, there is no evidence of the participation of 

the interested parties in the identification and analysis (NOP does not have an Impartiality 

Committee).

• 2018-USDA NOP-03-O- ricj-(ISO 17011 v. 2004) 6.1.2 The accreditation body shall have 

access to a sufficient number of assessors, including lead assessors, and experts to cover all of 

its activities.

The NOP does not have a sufficient number of auditors.

Evidence: The number of certifiers accredited by the NOP has increased in recent years. In 2018 

there are 81 CABs, plus 12 new CAB applications, and 54 Satellite Offices, making a total of 147 

entities which require regular audits. There are seven auditors, of whom one is full time, and two 

are subcontracted from the USDA’s Quality Assessment Division (QAD). NOP 2000, Instruction -

Accreditation Policies and Procedures indicates that the total number of auditors and days for onsite renewal and mid-term assessment are established based on the total number of producers and 

scopes for each CAB. Many CABs are very large, with satellite offices in several countries. The 

number of NOP auditors is inadequate to provide regular assessments, prevent potential fraud, and 

minimize risk in a timely manner.
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• 2018-USDA NOP-05-O- ricj-(ISO 17011 v. 2004) 7.5.7. For initial assessments, in addition to 

visiting the main or head office, visits shall be made to all other premises of the CAB from which 

one or more key activities are performed and which are covered by the scope of accreditation.

Satellite offices of certifiers, especially international locations, are not audited on a frequent 

enough basis to reduce risk and prevent potential fraud.

Evidence: File review indicates that some certifiers have many additional satellite offices in numerous 

countries, and these numbers are increasing each year. NOP 2000 requires that all CAB must have 

both a mid-term and five-year site visit with witness audits, although Section 7 of NOP 2000 indicates 

that witness audits are not conducted for every satellite office with each assessment. Section 7 states: 

“A site visit and on-site visit will ultimately take place”. NOP Lead Auditor prepared a five-year plan 

to conduct audits of satellite offices, but at least two large CABs have over 20 satellite offices in 

several countries, which will result in increased risk if they are not more regularly audited, including 

witness audits.

A risk-based approach to identify and prevent fraud suggests that some satellite offices could apply 

to become a separate CAB, and that an additional number of auditors are needed to conduct regular 

audits of the growing number of satellite offices.

Fraud prevention could be addressed by conducting a number of audits, both unannounced and 

regular audits, in a specific geographic area where risk has been identified, such as Eastern 

European countries, or Texas/California. See also OFI above for 6.1.2 for additional full-time NOP 

Auditors.

• 2018-USDA NOP-06-O- ricj-(ISO 17011 v. 2004) 7.7.2. The assessment team shall conduct the 

assessment of the conformity assessment services of the CAB at the premises of the CAB from which 

one or more key activities are performed and, where relevant, shall perform witnessing at other 

selected locations where the CAB operates, to gather objective evidence that the applicable scope 

the CAB is competent and conforms to the relevant standard(s) and other requirements for

accreditation.

7 CFR §205.670 Inspection and testing of agricultural products to be sold or labeled as “100 percent 

organic,” “organic,” or “made with organic (specified ingredients or food group(s)).”

Procedures for residue sampling are not clearly understood or followed by international CAB 

and satellite offices.

Evidence: All certifiers are required to conduct at least 5% residue sampling (205.670(d)). NOP 2613 

Responding to Results from Pesticide Residue Testing does not address the full range of potential 

residues or drift, and is not written in manner which is readily understood or appropriately interpreted 

by foreign certification bodies and foreign satellite offices. This increases the potential for fraud. A 

risk-based review of procedures related to residue and other sampling should be implemented.

• 2018-USDA NOP-08-O- ricj-(ISO 17011 v. 2004) 6.1.1. The accreditation body shall have a 

sufficient number of competent personnel (internal, external, temporary, or permanent, full time 

or part-time) having the education, training, technical knowledge, skills and experience necessary 

for handling the type, range and volume of work performed.

There is insufficient NOP personnel to handle the number of complaints and

enforcement actions required of the C&E division.

Evidence: There were 349 complaints received by the NOP between May 2017 and 2018. The trend is 
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an increase in complaints and a need for enforcement. There are presently 11 NOP staff in C&E which 

is an inadequate number to address, in a timely manner, the increased need for investigations, fraud 

prevention, and enforcement activities. A Quality Manager may help streamline complaint handling.

• 2018-USDA NOP-09-O-CADS-(17011 v.2004) 5.2.1 The accreditation body's top management 

shall define and document policies and objectives, including a quality policy, for its activities, and 

it shall provide evidence of commitment to quality and to compliance with the requirements of this 

International standard. The management shall ensure effective communication of the needs of 

interested parties. The management shall also ensure that the policies are understood, 

implemented and maintained at all levels of the accreditation body. The objectives should be 

measurable and shall be consistent with the accreditation body's policies.

NOP should establish stronger quantitative objectives and key performance indicators for 

effective measurement and monitoring to achieve the Administration's goals.

Evidence: The NOP Strategic Plan for 2015-2018 lists four key performance measures; however, only 

two are currently regularly tracked, and there are new measures that are tracked that were not defined 

in the plan. Key performance measures change over time as Administration priorities shift.

• 2018-USDA NOP-10-O-CADS-(17011) 5.3 The accreditation body shall establish 

procedures to control all documents (internal and external) that relate to its accreditation 

activities. The procedures shall define the controls needed.

Several documents were found to be out of compliance with the document control procedure.

Evidence: NOP 1010 does not describe control of external documents in accordance with copyright 

laws as currently practiced by NOP management. NOP 1010 does not specify which types of 

documents must be forwarded by the program to Office of General Counsel for comment.

The NOP Records Plan and Disposition Schedule is still awaiting approval and formalized entry 

into the NOP management system. In the meantime, the records plan is being implemented in the 

program, except for the disposition schedule. All records are being retained; the disposition 

schedule will take effect when the procedure is approved.

The Master List NOP 1006 was not updated when NOP 4001 was reinstated and approved. NOP 

4001-1, 4001-2 and 4001-3 have been archived but are still referenced in NOP 4001. According to 

management, new staff have not been fully trained on the document control process. C&E Internal 

Procedure "Complaints Regarding the National Organic Program's Accreditation Activities and 

Accredited Certifying Agents" effective 7/1/2015 is not traceable to the management system. Also 

refer to OFI #1 regarding Quality Manager.

• 2018-USDA NOP-11-O-CADS-(17011) 7.9.4 The accreditation body shall provide an 

accreditation certificate to the accredited CAB. This accreditation certificate shall identify (on the 

front page, if possible) the following:

o the unique identity of the accreditedCAB;

o all premises from which one or more key activities are performed and which are 

covered by the accreditation;

The accreditation certificate does not identify all premises from which one or more key activities 

are performed and covered by the accreditation and the physical addresses associated with the 

certification body.

Evidence:

Organic Integrity Database:
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o Satellite offices and their locations are not listed on thecertificate.

o P.O. Box number is identified for the certifier rather than a physicaladdress.

• 2018-USDA NOP-12-O-CADS-(17011) 8.3.2 The accreditation body shall take effective 

measures to ensure that the accredited CAB

a) fully conforms with the requirements of the accreditation body for claiming 

accreditation status, when making reference to its accreditation in communication media 

such as theInternet, documents, brochures, or advertising,

b) only uses the accreditation symbols for premises of the CAB that are specifically 

included in the accreditation,

c) does not make any statement regarding its accreditation that the accreditation body 

may consider misleading or unauthorized,

d) takes due care that no report or certificate nor any part thereof is used in a 

misleading manner,

e) upon suspension or withdrawal of its accreditation (however determined), discontinues its 

use of all advertising matter that contains any reference to an accredited status,and

f) does not allow the fact of its accreditation to be used to imply that a product, process,

system or person is approved by the accreditation body.

There is an opportunity for NOP to provide further protections for its USDA Organic seal

Evidence: The use of the USDA Organic seal is prescribed by CFR 7 §205.311. NOP 200A February 

2014 The Terms of Accreditation identify the contractual requirements for accreditation. It does not 

contain specific terms describing the obligations of the certification body to use the seal only as 

allowed by the regulations. NOP does not have a separate license agreement for the use of the seal.

Although probability of misuse is currently low and NOP has legal control of the use of the seal, and 

the impact of misuse and fraud of the seal represents a potential for risk. Additional measures, such 

as to add provisions in the existing terms of agreement could increase awareness with certification 

bodies of their obligations and further protect the NOP.

Recommendation 1:

Given the changing organic marketplace and increased complexities, it is recommended that the NOP 

provide additional training opportunities to NOP staff and auditors, specifically in the areas of risk 

assessment and investigative methods for fraud prevention. A Training Manager could ensure greater 

consistency, frequency, and depth of training for auditors.

Recommendation 2:

Training Manager position at the NOP could develop and provide NOP webinars for CAB staff and 

inspectors worldwide so everyone has easy access to a consistent source of educational training via the 

NOP. Certifier audit trail exercises do not always provide adequate detail to verify and fully document 

the audit trail including full supply chain. Certification bodies generate inspection /checklists for 

inspectors to use, and these checklists vary considerably between certifiers. For example, some 

inspector checklists may not prompt an inspector to conduct a mass balance over a specific time period, 

or a conduct a audit trail exercise with enough detail to verify full traceability of all locations in a supply 

chain. As a result, the inspector may not provide adequate information for the certifier.

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