To: All OIA North America File Reviewers and Inspectors
Date: October 12, 2010
SUBJECT: Summary of Organic System Plan Changes for Inspectors Conducting Interim Inspections
Currently, OIA North America provides each inspector a copy of the file of the operation to be inspected, as well as a copy of the previous year’s inspection report (where applicable) for each inspection assigned to an inspector. In cases where the inspection is an interim or additional inspection it is also necessary to provide the inspector with a summary of all changes to the Organic System Plan which have been implemented since the original certification was granted. In many cases operators make changes to inputs and ingredient suppliers, as well as adding additional products for certification after receiving initial certification. While these changes are included in the annual renewal application submitted by the operation, in interim inspections this information will take the form of communications via email and documents submitted by the operation directly to OIA North America. For the inspector to be able to fully assess the operator’s compliance during an onsite inspection, it is imperative that the inspector be provided with these changes to the previously approved organic system plan. This memorandum establishes a policy and practice to ensure that such changes are communicated to inspectors on a consistent basis.
II. Appropriate Regulatory Provisions from the USDA NOP Final Rule.
NOP s. 205.403(c)(2), Verification of Information, states: “The on-site inspection of an operation must verify: That the information, including the organic production or handling system plan . . . accurately reflects the practices used or to be used by the applicant for certification or by the certified operaton.”
III. Policy on organic system plan changes and interim inspections
In order to ensure compliance with the NOP regulations and to ensure operation of a quality program, OIA North America hereby creates the following policies addressing Organic System Plan changes by operations, and communication of changes to inspectors for interim or additional inspections:
1. Changes to Organic System Plan by Certified Operations: Certified operations may update or change any aspect of their organic production or handling plan at any time by providing the request in writing and requesting approval of the change from OIA North America. OIA North America may request additional information or the completion of specific forms in order to conduct the review of the requested change(s). OIA North America will review the requested change and documentation provided and will make a decision to approve or disapprove the change within a reasonable time. A failure to inform OIA North America of a change to the approved Organic System Plan will result in OIA North America issuing a Notice of Noncompliance. A change that cannot be approved under the USDA NOP regulations, which is implemented by an operator without informing OIA North America, may result in suspension or revocation of certification.
2. Written Communications of Changes to Organic System Plan Incorporated into Organic System Plan: The organic production or handling plan is more than just the formal application originally submitted to OIA North America for approval. It also consists of all written communications of requested changes and approvals to the plan. All written communications related to changes in the Organic System Plan are incorporated into the Organic System Plan once approved by OIA North America and become a permanent part of the operator’s file. Such written communications, which may take the form of email communications, supersede the relevant portion of the originally submitted application and plan once approved by OIA North America. Where there is a contradiction between the original application and subsequent written communication of changes approved by OIA North America, the subsequent written communications control.
3. Inspectors to Be Provided with Organic System Plan Changes Summary for Interim Inspections:For any additional or interim inspection conducted outside of the initial onsite inspection and the annual renewal inspection, OIA North America shall provide the inspector, along with any other documentation necessary for the inspection, a memorandum outlining any changes to the original application and plan submitted by the operator, including changes to: products certified, inputs approved for use by the operator, ingredient suppliers or formulas, and any other material changes to the original Organic System Plan. Inspectors are expected to be familiar with the memorandum of changes and to supplement the original plan and application as described in the memorandum and to inspect against the summarized changes in addition to all other aspects of the Organic System Plan.
Please contact OIA North America if you have any questions about this policy.