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Canadian Food Inspection Agency peer review of United States National Organic Program

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Abbreviations and special terms used in the report

AIA

Accreditation and International Activities

AMS

Agricultural Marketing Service

CA

Competent Authority

CB

Certification Body

CFIA

Canadian Food Inspection Agency

COR

Canada Organic Regime

FOIA

Freedom of Information Act

ISO

International Standards Organization

NC

Non-Conformity

NOP

National Organic Program

NOSB

National Organic Standards Board

OFPA

Organic Food Products Act (1990)

OMRI

Organic Materials Review Institute

PSL

Permitted Substances List

US

United States

USCOEA

United States-Canada Organic Equivalence Arrangement

USDA

United States Department of Agriculture

Executive summary

This report summarizes observations made during the Canadian Food Inspection Agency's (CFIA) September 2018 on-site assessment of the United States Department of Agriculture National Organic Program (USDA NOP).

The objective of the assessment was to determine the extent to which the United States' competent authority (United States Department of Agriculture; USDA) demonstrates conformity with the requirements specified in the United States - Canada Organic Equivalence Arrangement (USCOEA).

The assessment was conducted from September 17 to 26, 2018. It included meetings with the competent authority, 2 Certification Bodies (CBs) and two primary production units (farm).

The key elements of the assessment included the following:

  1. Authorities
    • Current organic legislative authorities, including regulations, standards, codes of practice, and arrangements. In particular:
      • authority to recognize and certify parties involved in the USDA NOP
      • authority to carry out monitoring and surveillance activities
      • authority to respond to non-compliances where risk has been identified, for example recalls, other control and enforcement activities
  2. Government organization and resources
    • The roles and responsibilities of the various government departments and authorities involved in the USDA NOP
    • The resources, responsibilities, functions, and coordination between the parties involved in the USDA NOP
    • Resources and competencies of the parties involved in the delivery of the USDA NOP
  3. Enforcement and surveillance activities
    • The role of the USDA and the CBs in inspection, surveillance, and enforcement of the organic regulations

The assessment determined that the USDA NOP has implemented a control system for the certification of organic operators that is supported by good collaboration between the USDA NOP and the CBs.

This system guarantees that agricultural organic products certified under the USDA Organic Regulations (7 CFR Part 205) can be exported and marketed in Canada as meeting the terms of the USCOEA.

This report provides recommendations which highlight opportunities for improvement and enhancement of the implementation of the USDA NOP.

The observations and recommendations contained in this report are based on information gathered by the assessment team through the CFIA Peer review questionnaire, personal interviews with personnel, and on-site observation. They represent the collective understanding of the members of the assessment team.

1.0 Background

The United States-Canada Organic Equivalence Arrangement (USCOEA) was signed in 2009.

As per the conditions of the arrangement, and following advanced notice from the CFIA, the United States Department of Agriculture (USDA) Agricultural Marketing Service (AMS) National Organic Program (NOP) agreed to accommodate the CFIA's request to conduct an evaluation (on-site peer review) to verify how the NOP accredited Certification Bodies (CBs) carry out the requirements of the USDA NOP.

2.0 Objectives of the on-site assessment

The objective of the assessment was to determine the extent to which the United States' competent authority (USDA) demonstrated conformity with the requirements specified in the USCOEA (2009).

3.0 On-site assessment criteria

The following references were used during the on-site assessment:

  1. The Canada Organic Regime (COR) procedures for peer reviews
  2. United States-Canada Organic Equivalence Arrangement (USCOEA) Letter
  3. USDA Organic Regulations (7 CFR Part 205)
  4. Organic Food Production Act (OFPA) of 1990
  5. National Organic Program Handbook: Guidance and Instructions for Accredited Certifying Agents and Certified Operations
  6. ISO/IEC 17011:2017 Conformity assessment - Requirements for accreditation bodies accrediting conformity assessment bodies

4.0 On-site assessment protocol

The CFIA's audit team planned and conducted the on-site assessment in a manner which allowed the team to obtain sufficient information to confirm the observations and conclusions described thereafter. The on-site peer review was conducted according to the Canada Organic Regime Peer Review Procedure and included visits to the following organizations:

Organisation Date
USDA NOP headquarters September 17-18, 2018
Certification Body (CB) 1 – Headquarters September 20, 2018
Organic livestock and agriculture farm September 21, 2018
Certification Body (CB) 2 – Headquarters September 24, 2018
Orchard farm September 25, 2018

As part of the on-site assessment, the CFIA audit team reviewed each level of the USDA NOP (administration, accreditation, certification and production) to confirm that the responsible authorities have the necessary controls in place to ensure compliance with the USDA Organic Regulations. In doing so, the team:

5.0 Overview of the US organic sector

In January 2011, the U.S. Department of Commerce added codes for selected organic products to the U.S. trade code system.

For organic exports, the number of tracked products expanded from 23 in 2011 to 33 in 2016. For organic imports, tracked products increased from 16 in 2011 to 31 in 2016. Some of the tracked organic commodities, especially imported ones, have more than one variety due to high demand for differentiated goods.

U.S. organic exports that are tracked mostly are fruit and vegetables. They reached $548 million in 2016. Top U.S. organic exports (in value) in 2016 were apples, grapes, and lettuce. Although the United States exported organic products to 79 countries, Canada and Mexico accounted for 70 % of the value of tracked U.S. organic exports in 2016. Japan, Taiwan, and South Korea were also among the United States' top trading partners for organic products in 2016.

U.S. organic imports that are tracked equaled $1.65 billion in 2016.Top U.S. organic imports in 2016 included bananas, coffee, and olive oil (all of which the United States does not produce in large quantities), as well as corn and soybeans (to meet growing demand for organic livestock feed). Türkiye, Mexico, Italy, Peru, and Ecuador supplied 43 % of tracked U.S. organic imports. In 2016, 87 countries supplied the tracked organic products to the United States.

According to the Organic Trade Association organic sales in the U.S. totalled a new record of $49.4 billion in 2017, up 6.4 % from the previous year and reflecting new sales of nearly $3.5 billion. The organic food market hit $45.2 billion in sales, also breaking through to a new record for an increase of 6.4 %. Sales of organic non-food products rose by 7.4 % to $4.2 billion, setting another new benchmark. Fruits and vegetables continued to be the largest organic food category, recording $16.5 billion in sales in 2017 on 5.3 % growth. Fresh produce accounted for 90 % of organic fruit and vegetable sales. Sales of organic dried beans, along with dried fruits and vegetables, were a stand-out subsector in the category, increasing by 9 % and reflecting growing demand for legumes and plant-based productsFootnote 1.

5.1 National legislation and national standards

The USDA NOP's organic control system is based on the following legal authorities:

  1. Organic Food Production Act (OFPA) of 1990
  2. USDA Organic Regulations (Title 7 Part 205 of the Code of Federal Regulations)
  3. National Organic Program Handbook: Guidance and Instructions for Accredited Certifying Agents and Certified Operations

5.2 Structure of the USDA AMS NOP

The NOP covers the activities performed by operators at all stages of the production, preparation and distribution chain from farm to fork. Operators are free to choose any of the CBs offering certification services in the United States and internationally.

The CBs are directly accredited and supervised by the NOP. The CBs charge operators a fee for their certification services.

5.2.1 The USDA AMS NOP

The competent authority (CA) for organic production in the United States is the USDA AMS NOP. The NOP, part of USDA's AMS, has regulatory oversight responsibilities for the organic standards and the accreditation of organic certifying agents.

The NOP is responsible for:

The NOP is organized into four divisions:

  1. Office of the Deputy Administrator
  2. Standards Division
  3. Accreditation and International Activities (AIA) Division
  4. Compliance and Enforcement Division

5.2.2 Office of the Deputy Administrator

The Office of the Deputy Administrator is comprised of 5 people. The Office is responsible for:

USDA provides organic certification cost share opportunities for organic producers and handlers. Beginning March 20, 2017, organic producers and handlers can work with the USDA Farm Service Agency (FSA) office to apply for federal reimbursement to assist with the cost of receiving and maintaining organic certification.

5.2.3 Standards division

The Standards Division is comprised of 9 people. The Standards Division is responsible for:

The Standards division works closely with the National Organic Standards Board (NOSB) which is a Federal Advisory Board made up of 15 public volunteers from across the organic community. The volunteers are appointed on a 5 year term. The Board meets twice per year.

The NOSB considers and makes recommendations to the Secretary on a wide range of issues involving the production, handling, and processing of organic products. The NOSB is also responsible for reviewing the National List of Allowed and Prohibited Substances.

5.2.4 Accreditation and international activities division (AIA)

The AIA Division is comprised of 9 people. The AIA is responsible for administering the NOP's accreditation activities and international equivalency arrangements. These activities include, but are not limited to:

The AIA Division Director may delegate specific tasks related to these activities to qualified NOP personnel, other AMS Programs, or qualified State or private organizations, but retains final responsibility for their proper execution.

5.2.5 Compliance and enforcement division

The Compliance and Enforcement Division enforces the Organic Foods Product Act and the USDA Organic Regulations.

The Division's main focus includes strong organic control systems, farm to market traceability and robust enforcement. Their compliance priorities during 2018 included: imported grains and oilseeds, pasture surveillance and fumigation at the ports. The Division handles all complaints about organic products received by the NOP.

5.2.6 Certification bodies (CBs)

NOP accredited CBs are third party organizations that review, inspect and certify organic operations. CBs may be for-profit, not-for-profit, or governmental (state or foreign government).

The USDA NOP's 81 CBs are accredited by the NOP to conduct the following certification activities:

46 of the NOP accredited CBs have their main office in the US. The size of each CB varies depending on the number of clients and their location.

The list of accredited CBs and their current accreditation status is maintained on the NOP Integrity database.

5.2.7 Certified organic operators

At the time of the peer review there were 26,518 certified operations in the US and 41,425 certified operations around the world. The list of certified operators is maintained on NOP's website.

6.0 Implementation of the USDA NOP

6.1 Oversight of the NOP accreditation activities

The USDA NOP is the competent authority responsible for the accreditation of the CBs.

The guidance document NOP 2000 - Accreditation Policies and Procedures describes the general policies and procedures followed by the NOP for the accreditation and monitoring of the CBs.

The NOP's policies and procedures are non-discriminatory and are administered in a non-discriminatory way. The NOP makes its services accessible to all applicants whose requests for accreditation fall within the activities) and limitations as defined within its policies and rules. Access is not conditional upon the applicant's size or membership in an association or group, nor is accreditation conditional upon the number of certifiers already accredited.

The NOP maintains a Quality Manual which describes the general requirements for assessing and accrediting conformity assessment bodies, hereinafter referred to as certifying agents or certifiers, under the United States Department of Agriculture (USDA) organic regulations (7 C.F.R. Part 205).

The NOP has adopted ISO 17011:2004 and applicable guidance documents in the developments of NOP 2000 Accreditation Policies and Procedures. The CFIA confirmed that the NOP is in the process of transitioning to the new ISO 17011: 2017.

The NOP has established requirements for peer review, internal audits, and management reviews. The NOP Quality Manual outlines the general schedule for conducting these activities.

The outcomes from the audits and the reviews are used to identify nonconformities and opportunities to improve the NOP's quality system.

As per the NOP 1000 NOP Quality Manual Rev 04: 2017 the internal audit schedule covers different accreditation-related functions:

Year 1 – Full internal audit of AIA accreditation activities
Year 2 – Internal audit of ODA/Appeals activities
Year 3 – Internal audit of Standards activities (rotating focus based on need)
Year 4 – Internal audit of C&E activities

The CFIA team verified the results from the most recent NOP internal audit which was on the standards activities.

As per the NOP internal audit procedure NOP 1030 as of May 22, 2017 the NOP is required to conduct internal audits of its accreditation activities annually by qualified personnel who are knowledgeable in accreditation, auditing, and the ISO 17011 requirements. This is not in line with the NOP 1000 NOP Quality Manual Rev 04: 2017 which requires the internal audit schedule to cover different accreditation-related functions within a 4 year cycle.

The CFIA team confirmed that NOP is subject to an annual peer review as required by section 205.509 of the USDA NOP.

The purpose of the peer review is to evaluate the NOP's policies, processes, and procedures for conformance to NOP regulations and ISO 17011. The findings from the peer review are considered part of the NOP quality management system, and the Deputy Administrator can make corrective actions to the NOP accreditation processes as is necessary and appropriate. The panel's findings neither bind the NOP to take any action nor affect the NOP's decisions. The findings are to be published and presented at public meetings of the National Organic Standards Board. The CFIA reviewed the 2017 peer review report and the OFIs that were issued to the NOP. The CFIA team confirmed that while NOP uses ISO 17011, NOP abides by United States law when there are conflicts with ISO 17011.

The NOP's top management has established procedures to review its management system at planned intervals to ensure its continuing adequacy and effectiveness in satisfying the relevant requirements, including this document and the stated policies and objectives. These reviews are conducted normally once a year. The CFIA team reviewed a copy of the 2017 NOP management review.

The NOP has established procedures for selecting, training, monitoring the performance and competence of the personnel involved in the assessment process.

As per the NOP internal procedure 2501 the NOP monitors the performance and competence of NOP auditors involved in the accreditation activities. Evaluation worksheets are used to document the evaluation of auditors and auditors in training. Witness audits of auditors are conducted at a minimum of once every 3 years. All NOP auditors go through federal employee performance appraisals each year that specifically includes auditing, as well as other responsibilities. The performance appraisals include quarterly monitoring.

The CFIA team was only able to review a blank evaluation worksheet due to time constrains and NOP personnel availability.

6.2 Accreditation and supervision of the CBs

The USDA NOP AIA division is responsible for the accreditation and the monitoring of the CBs.

The NOP accreditation process consists of several stages. The first is the application stage in which a documentation adequacy (desk) review is conducted in 3 months and a pre-decision assessment (on-site) is conducted in 3 to 9 months.

Once accredited the CBs are subject to monitoring as per the NOP accreditation cycle specified in the NOP 2000 instruction. The NOP accreditation cycle is as follows:

Initial 5 year accreditation cycle covers initial audit (0-24 moths) and renewal audit (54 -72) months. The subsequent 5 year cycle covers mid-term audit (24-36 months) and renewal audit (54 -72) months.

The NOP accreditation cycle is not in line with section 7.9.3 of the ISO 17011: 2017 which specifies that the time frame between consecutive on-site assessments shall not exceed two years because NOP abides by United States law when there are conflicts with ISO 17011.

As per §205.500, the CB accreditation is valid for 5 years but it does not expire as long as the CBs submit their renewal application package no later than 6 months before the fifth anniversary of accreditation for a 5-year cycle.

The CFIA team noted that this approach is not in line with section 7.9.1 of the SO 17011 which states that the accreditation cycle shall not be longer than five years.

At the time of the peer review 37 (18 USA and 19 international CBs) of the NOP accredited CBs did not have their accreditation renewed within 5 years. All CBs were at different stages of their renewal assessment.

As part of the discussion with the NOP, the CFIA team confirmed that the timeframe for the 5-year renewal was not always met due to a lack of sufficient assessors. The CFIA team verified that a schedule was in place for the oversight of the CBs that did not meet the 5-year renewal timeframe. The NOP is in the process of hiring 2 full-time auditors to complete the assessments of the CBs in a timely manner.

The NOP has developed standardized checklists that are used by the NOP auditors when conducting various auditing activities. The checklists are publicly available on the NOP website.

Findings from the NOP assessment are shared verbally with the CB during the closing meeting. The NC report is drafted by another NOP staff (reviewer) who classifies the findings as NCs. NOP has not established clear timelines for completing the NC report. The CFIA team observed that timing of the review varies depending on the nature of the findings and the NOP staff work load.

The CB is given 30 days after the NC letter is received to address the NC. The CB may request an extension of about 1-2 weeks to address the NCs. The NC report is made publicly available once the corrective actions are reviewed and approved by the NOP reviewer. If the CB does not provide corrective actions, then the NOP can issue a notice of proposed suspension.

In addition to the office audit, the NOP conducts witness audits. The number of witness audits is minimum one per scope. The audits are scheduled around the time the office audit is conducted. The CFIA team confirmed that as part of one of the CB reassessment audit three witness audits (crop, livestock and processing) were conducted.

As per the NOP 2000 procedure NOP auditors may conduct review audits to assess a certifier's ability to fully comply with and implement an NOP certification program, assess the certifier's oversight of the operation, and determine whether the operation's compliance with the regulations observed during the review audit matches the findings in the inspection report.

The CFIA team was not able to determine how many review audits NOP should conduct since the NOP 2000 procedure is not clear on this requirement.

The NOP's surveillance activities focus on compliance to the Regulations, for example: risk assessment, risk-based planning of inspections, effective management of complaints, and positive chemical residues.

All CBs are assigned an Accreditation Manager who is the main point of contact with the NOP. The CB contacts the manager for any inquiries or changes they have within their organization.

CBs are required to submit an annual report to the NOP before their accreditation anniversary date as per section 205.510 of the NOP regulations. The CBs use NOP 2024-1, the Annual Report Checklist to submit annual report information to the NOP. The goal of the report is to identify any changes that have occurred in the CB's organization since the previous assessment or annual report, as applicable. Information requested for the annual report include: areas and duration of accreditation and evidence of expertise and ability (such as personnel, administrative policies and procedures and current certification activities). If the NOP requires clarification regarding the reports, they request this information from the CB.

The CFIA team verified that both CBs visited as part of the peer review provided their annual reports to the NOP on time.

Currently, the NOP receives residue testing results from multiple sources, which may include market surveillance (such as retail and wholesale points). The NOP refers positive residue results detected above the level of quantification and/or where a tolerance does not exist for the product in question to the CB. The NOP directs CBs to investigate when the residue is above the regulatory tolerance set by the USDA organic regulations. If the result is above the tolerance level, the NOP will notify the certified operation of the test results and indicate that the product may not be sold as organic. CBs issue notices of noncompliance associated with residue results as per the instructions in NOP 2613, Responding to Results from Pesticide Residue Testing.

Positive chemical residue tests from the CFIA are forwarded to the NOP for follow-up. The CFIA team verified how these results were communicated with the appropriate CBs.

6.3 CB's organizational and resource requirements

The CFIA audit team visited the headquarters of 2 CBs located in the US.

Both CBs have well-developed quality systems and related procedures. Additionally, both CBs use an electronic database to save and track all certification related activities and information.

The CFIA team observed that both CBs are adequately resourced and have invested resources to train their staff including inspectors. In compliance with ISO 17065, both CBs have developed impartiality procedures to ensure employees are free of conflict of interest.

The CBs have well-established certification systems which allow them to schedule the operators' inspections on time while ensuring a good rotation of inspectors.

Both CBs conduct annual program review of their certification activities as well as management reviews as per the ISO 17065 requirements. The CBs are required to share the results of the review with the NOP. The NCs resulting from the review are tracked and communicated with the staff to address them on time.

Copies of the CBs internal annual reviews and management reviews were reviewed by the CFIA team.

As per clause 6.1.2 of ISO 17065, both CBs have implemented procedures to ensure that on-site inspections are conducted by trained inspectors. The inspectors are subject to a formal performance monitoring process by their CBs, who identify the type of training needed by the inspectors. The CFIA team observed that both CBs require all inspectors to have International Organic Inspectors Association (IOIA) training.

The CFIA team verified that both CBs maintain a database with the list of qualifications for each inspector. Inspectors are required to have regular trainings which include workshops and online activities to reinforce their knowledge of the Regulations and any new changes in the organic program.

The CFIA team verified that both CBs have a complaint procedure in place. The CBs have dedicated staff to address complaints and record all complaints in their database. Once a complaint is received, it is assigned to a reviewer through the database. The timeframes for addressing complaints can vary depending on the complexity of the complaint. The CBs have a process in place for submitting complaints directly to the NOP.

The CFIA team observed that when a temporary variance was required, a request and justification was submitted by the CB to the NOP. When a decision is made by the NOP, communication is provided to the CB. The CB communicates this decision to the operators through email.

The CFIA team confirmed that the NOP provides public notice of temporary variances through publication on their website.

The USDA organic regulations do not require the CBs to conduct market place surveillance. However, the CFIA team noted that both CBs conduct retail surveillance of organic products by checking the labels and logos on products.

The CFIA team confirmed that both CBs were aware of the terms of the USCOEA arrangement including the requirement to verify the critical variances. The arrangement's requirements are captured in the Organic System Plan (OSP) and in the inspector checklist.

Although the NOP Policy Memorandum updated January 27, 2012 allows for flexibility to who can issue attestation with the statement "Certified in compliance with the terms of the US-Canada Organic Equivalency Arrangement" it was confirmed that both CBs issue the document themselves.

The CFIA team indicated that this requirement will need to be further discussed with NOP and revised to ensure consistency in the verification process.

6.4 CB's certification process

The CBs have well-established certification processes, infrastructure, procedures and tools to deliver their certification activities effectively. Once an application for certification is received, the CBs sign a Terms of Agreement document with the applicant. The application is reviewed and an on-site inspection is scheduled.

The duration of inspection varies depending on the nature and complexity of the farm and/or processing facility. During each inspection, inspectors are required to verify that the inputs used by famers and operators are approved for use.

The CFIA team observed that the CBs use their own internal process to assess inputs. In a case of a disagreement between CBs regarding an input, the NOP provides the final decision. In the situation that an input was approved but should not have been, the CB takes responsibility for the error and the operator is required to cease using the input. The organic integrity of the product is still maintained.

The CFIA team noted that each CB had their own procedures for assigning inspectors for on-site inspections. Currently, the NOP does not have a requirement for the rotation of inspectors and each CB follows their own procedure. It was noted that inspectors who visit an operation on a consistent basis may become too familiar with the production and management of the operation which could affect impartiality.

As a result of the inspections, the CB inspectors issue findings to the operator. Each CB has a specific timeframe within which the inspectors have to prepare and submit an inspection report to the CB. The inspection report and the findings are reviewed and classified based on the NOP penalty matrix by the CB certification committee. The CB may decide to add or remove NCs at their discretion.

Usually the operator is given 30 days to address the NCs but sometimes extensions can be granted by the CB. Once the inspection is finalised and all NCs are addressed, the CB makes a certification decision and each operator receives an updated certification document. On average, it takes approximately 2-3 months for the certification process to be completed and certification decision to be made.

If no actions are taken after 30 days or the agreed upon time frame, the CB can initiate suspension. Both CBs have procedures in place for the suspension and reinstatement of operators. The suspension period can vary and is up to the CBs discretion based on the complexity of the issue. The period of suspension can range from 2 months to 2 years. The NOP does not have requirements for the duration of suspension.

A certified operation whose certification has been suspended may at any time, unless otherwise stated in the notification of suspension, submit a request for reinstatement of its certification. The request is submitted to the CB who forwards it to the NOP. The NOP generally provides a decision for the reinstatement in 30 – 90 days.

The NOP does not have requirements for during what time of year the inspections should be completed. Generally, the timing of the on-site inspections of the operators every year is typically done during different periods of the year. This is to create variability in the inspections. For processing facilities, there is no requirement for organic products to be processed at the time of the inspection.

The NOP 2609 - Unannounced Inspections document recommends that the CBs conduct unannounced inspections of 5% of their operators per year.

Additionally, CBs are required to collect residue samples from 5% of their operators annually. When the CB receives a positive residue result from the NOP, the NOP provides instructions of how to follow-up and timeframes for by when the follow up should be completed.

The CFIA team observed that both CBs perform unannounced inspections and collect samples from 5% of their operators. Generally, the CBs combine unannounced inspections with sampling. The CBs determine the operators that are to be inspected and sampled based on risk factors such as complaints or other triggers. Inspectors do not decide to sample on their own as the CB plans in advance where samples are taken. All inspectors have access to sampling instructions, forms and sampling equipment. Sampling training via webinar is provided on an annual basis and on an additional as-needed basis. If a positive result is received, an investigation is conducted by the operator and a deadline of 30 days is given to report back to the CB. The CB issues an exclusion from organic sale for the affected product if the result is greater than the 5% of the maximum residue limit.

6.5 Certification and supervision of operators

6.5.1 Certification of organic farms and packing facilities

The CFIA's assessment team visited one apple farm and one livestock/crop farm/packing facility. The facilities produce both organic and conventional products. The apple products are for both domestic and export consumption whereas the livestock/crop farm products are solely for domestic consumption.

The CFIA team observed 2 inspections conducted by 2 inspectors from 2 different CBs. Before conducting the inspections, the inspectors prepared for the inspections using information available in the electronic database. This included all information about the farms such as the OSP, past reports, organizational information of the operator, etc.

Both inspectors used checklists that were developed by their CB based on the USDA organic regulations that require a yes/no answer. The inspectors are encouraged to add their comments if the response is a yes or no.

The inspections included an opening meeting, a tour of the farm, review of relevant documentation, inputs verification, traceability exercise, and closing meeting. The CFIA team observed how the inspector took samples using a sampling kit provided by the CB.

Both inspected facilities had conventional and organic production. The facilities had controls in place to segregate and differentiate between conventional and organic product during production, packaging and storage.

The CFIA team observed that operators used inputs before submitting information of their use for verification to the CBs. The operators waited for the CBs to inspect them to verify their use and to update their Organic System Plan (OSP).

The CFIA team was not able to confirm how one of the inspectors was able to verify if organic seeds were not commercially available.

At the end of the inspections, the CB inspectors conducted a closing meeting. Both inspectors explained that all findings will be classified by the CB after review of their report. An exit report was not provided to the operator as this is not a requirement by the NOP.

6.6 NOP management of complaints

The compliance and enforcement division of the NOP manages all complaints. They receive over 500 complaints and inquiries each year regarding organic labels on non-organic products, fraud, labelling errors and prohibited substances and methods. The Division responds to approximately 1/3 of these complaints with education information which resolves the customer's needs. About 2/3 of the remaining complaints are to determine whether there was a violation of organic regulations. Initial enforcement action relating to the complaints may include settlements, adverse action, notice of warnings and notice of closure due to no violation, etc.

Approximately 10% of complaints are referred to the certifiers for investigation. The NOP may request documents to review, an on-site investigation with proposed adverse actions, or an evaluation of the evidence to determine whether an investigation is necessary. Certifiers must respond within 45 days. Extensions may be granted but must be requested in writing. If the CB fails to respond, a notice of non-compliance may be issued.

Approximately 75% of the complaints received by the NOP are related to uncertified operations. In these cases, the NOP may use the following tools: initial warning notices, cease and desist orders, civil penalties and settlement agreements, etc. If a complaint includes evidence of a violation, the NOP may send an initial warning letter which includes a summary of the violation, the potential penalties for non-compliance, and requests for corrective actions within a defined timeframe. If the NOP has evidence of a wilful violation, then the NOP may send a cease and desist notice. If an operation fails to comply, or appeals an NOP action, the NOP may file a complaint for a hearing with an Administrative Law Judge. If a complaint shows potential criminal violations, then the NOP may refer an investigation to the USDA Office of the Inspector General.

When an operation has corrected the violation, the NOP closes the complaint with a notice of resolution. The NOP will notify the complainant of the closure of the complaint.

7.0 USDA NOP communication with the CBs and operators

The CFIA team confirmed that the communication between the different parties involved in the implementation of the USDA organic regulations is well established, open and often a two-way dialogue. On an annual basis, the CBs submit a report to the NOP on any changes to the CB including certificates issued, inspection activities and an updated list of operators.

The NOP regularly provides trainings on any changes to the regulation, updates in the organic program or any upcoming challenges or issues faced. These trainings are made available on the NOP website.

8.0 Closing meeting

A closing meeting was held with representatives of the United States' competent authority on September 26, 2018. During the meeting, the CFIA assessment team presented a summary of their observations and recommendations. The USDA NOP had the opportunity to discuss these findings. Next steps were then discussed and agreed upon.

9.0 Overall conclusions

All representatives involved in the assessment, from the staff at the USDA NOP and the CBs to the operators, were helpful, responsive, and accommodating to the assessment team during the on-site assessment.

Overall, the CFIA team determined that the competent authority provides good oversight of the NOP and, there is good collaboration between the USDA NOP and the CBs.

There is strong commitment and understanding from all parties involved in the implementation of the USDA Organic Regulations.

There is good understanding of the US-Canada Organic Equivalency Recognition Arrangement and the requirements to accept organic products from Canada and to export organic products to Canada. This instills confidence that the organic products exported to Canada meet the terms of the Arrangement.

10.0 Observations

The NOP was invited to provide response to the CFIA observations listed in the table below:

No CFIA Observations
1. The CFIA team observed that operators used inputs before submitting information of their use for verification to the CBs. The operators waited for the CBs to inspect them to verify input use and to update their OSP.
2.

Under the USDA organic regulations, §205.204 - seeds and planting stock practice standard (a) the producer must use organically grown seeds, annual seedlings, and planting stock: except, that,

(1) nonorganically produced, untreated seeds and planting stock may be used to produce an organic crop when an equivalent organically produced variety is not commercially available. The CFIA team was not able to identify how the inspector was able to verify if organic seeds were not commercially available.
3. The NOP could not provide evidence at the time of the peer review that the chemical residue letters sent from the CFIA to the NOP in 2018 were forwarded to the CBs.
4. Under the National Organic Program Handbook, Document 2609, Unannounced Inspections section 4.1.6, the CB should direct the inspector to a portion of the operation to review during an unannounced inspection. The CFIA team observed that this requirement was not followed in a consistent manner by the CBs. One of the CBs left the decision on what is to be inspected to the inspector's discretion.
5. The CFIA team was not able to verify how the peer review findings have been implemented as per §205.509 of the USDA organic regulations since NOP is not required to comply with ISO 17011 requirements.
6. The NOP could not provide evidence at the time of the peer review how the NOP personnel involved in accreditation activities are monitored in order to identify training needs as per section 6.3 in ISO 17011: 2017 and NOP internal procedure 2501.
7. The NOP could not provide evidence at the time of the peer review as to how the NOP maintained up-to-date records of personnel involved in the accreditation process as per section 6.4 in ISO 17011: 2004 (new 6.3 of ISO 17011: 2017).
8. The NOP could not provide evidence at the time of the peer review as to how the NOP meets section 6.1.2 of ISO 17011 which requires the accreditation body to have access to a sufficient number of assessors, including lead assessors, and experts to cover all of its activities.
9. The CFIA team observed that the accreditation renewals of the certification bodies were not done on time due to lack of sufficient assessors for the accreditation activities. The CFIA team was not given copy of the NOP schedule for the oversight of the accredited CBs.
10.

The CFIA team observed that the NOP internal audit procedure NOP 1030 is not in line with section 9.7 in ISO 17011:2017 and the section 4.7 of NOP:1000 Quality Manual regarding the scheduling of the internal audits of NOP accreditation activities annually.

No evidence was provided to confirm that the NOP Quality Manager creates a corrective action plan for each NC and OFI which is sent to the NOP Division Director(s) and the NOP Deputy Administrator.

11.0 Next steps

The NOP provided responses to the CFIA observations listed in the table above. The responses are included in Annex A below.

The final report will be posted on the CFIA external website as per the terms of the USCOEA.

Annex A: Summary of NOP's response to the Canadian Food Inspection Agency (CFIA) observations from the peer review report on United States' organic system (2018)

No CFIA Observations NOP Response to Observations
1.0 The CFIA team observed that operators used inputs before submitting information of their use for verification to the CBs. The operators waited for the CBs to inspect them to verify input use and to update their OPS. Certified operations are required to notify CBs of changes that may affect compliance with the USDA organic regulations. Pre-approval for changes is not a regulatory requirement; however, operations that implement changes without pre-approval do so at their own risk. This does not represent a change in NOP policy from the time of USCOEA establishment.
2.0

Under the USDA organic regulations, §205.204 - seeds and planting stock practice standard (a) the producer must use organically grown seeds, annual seedlings, and planting stock: except, that,

(1) nonorganically produced, untreated seeds and planting stock may be used to produce an organic crop when an equivalent organically produced variety is not commercially available. The CFIA team was not able to identify how the inspector was able to verify if organic seeds were not commercially available.

The seed verification observed by CFIA was not in line with NOP policy; during an NOP assessment of the CB, such an observation would likely result in a noncompliance issued to the CB. USDA provides guidance to CBs on this subject in NOP 5029, Seeds, Annual Seedlings, and Planting Stock in Organic Crop Production. USDA monitors CB inspector training at each CB assessment, including witness assessments.
3.0 The NOP could not provide evidence at the time of the peer review that the chemical residue letters sent from the CFIA to the NOP in 2018 were forwarded to the CBs. USDA confirmed that the chemical residue letters were sent to the relevant CBs. USDA is in the process of developing a new database to enhance current tracking for all compliance and enforcement inquiries and complaints about USDA organic products.
4.0 Under the National Organic Program Handbook, Document 2609, Unannounced Inspections section 4.1.6, the CB should direct the inspector to a portion of the operation to review during an unannounced inspection. The CFIA team observed that this requirement was not followed in a consistent manner by the CBs. One of the CBs left the decision on what is to be inspected to the inspector's discretion. As discussed with CFIA during the review, when USDA followed up with the CB regarding this observation, the CB submitted documentary evidence showing that inspectors are given specific instructions on the scope of unannounced inspections.
5.0 The CFIA team was not able to verify how the peer review findings have been implemented as per §205.509 of the USDA organic regulations since NOP is not required to comply with ISO 17011 requirements. The NOP annual Operating Plan includes a section dedicated to tracking actions resulting from the various internal and third-party audits of NOP systems. This document was provided to the reviewers.
6.0 The NOP could not provide evidence at the time of the peer review how the NOP personnel involved in accreditation activities are monitored in order to identify training needs as per section 6.3 in ISO 17011: 2017 and NOP internal procedure 2501. NOP personnel performance is monitored quarterly and training plans are updated annually. Performance elements are reviewed with individuals to inform a training development plan. This does not represent a change in NOP from the time of USCOEA establishment. USDA also keeps an annual log of training undertaken by accreditation personnel; this log was shared with the reviewers during the peer review.
7.0 The NOP could not provide evidence at the time of the peer review as to how the NOP maintained up-to-date records of personnel involved in the accreditation process as per section 6.4 in ISO 17011: 2004 (new 6.3 of ISO 17011: 2017). USDA maintains records of the training and experience of personnel managing or performing accreditation activities. Personnel performance evaluation includes responsibilities within the accreditation process, and personnel performance is monitored quarterly. USDA shared some of these records during the peer review. However, all individual performance records must be reviewed onsite; the NOP Lead auditor was not available for interview and there was not enough time to accomplish this during the peer review.
8.0 The NOP could not provide evidence at the time of the peer review as to how the NOP meets section 6.1.2 of ISO 17011 which requires the accreditation body to have access to a sufficient number of assessors, including lead assessors, and experts to cover all of its activities. USDA completes all required accreditation and assessment activities. As discussed during the peer review, USDA is in the process of hiring additional assessors to improve efficiency.
9.0 The CFIA team observed that the accreditation renewals of the certification bodies were not done on time due to lack of sufficient assessors for the accreditation activities. The CFIA team was not given copy of the NOP schedule for the oversight of the accredited CBs. As discussed during the peer review, USDA maintains a monitoring schedule. Each USDA-accredited CB is on a 5-year monitoring cycle, during which a minimum of two audits are performed and the CB is required to submit annual reports. This does not represent a change in NOP from the time of USCOEA establishment.
10.0

The CFIA team observed that the NOP internal audit procedure NOP 1030 is not in line with section 9.7 in ISO 17011:2017 and the section 4.7 of NOP:1000 Quality Manual regarding the scheduling of the internal audits of NOP accreditation activities annually.

No evidence was provided to confirm that the NOP Quality Manager creates a corrective action plan for each NC and OFI which is sent to the NOP Division Director(s) and the NOP Deputy Administrator.

 The NOP annual Operating Plan includes a section dedicated to tracking actions resulting from the various internal and third-party audits of NOP systems The 2017 management review report specifically discusses the operating plan as the corrective action tracking tool that summarizes all actions emerging from past audits. The operating plan is part of the management review.
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