§ 205.400 General requirements for certification.

A person seeking to receive or maintain organic certification under the regulations in this part must: (a) Comply with the Act and applicable organic production and handling regulations of this part; (b) Establish, implement, and update annually an organic production or handling system plan that is submitted to an accredited certifying agent as provided for in § 205.201; (c) Permit on-site inspections with complete access to the production or handling operation, including noncertified production and handling areas, structures, and offices by the certifying agent as provided for in § 205.403; (d) Maintain all records applicable to the organic operation for not less than 5 years beyond their creation and allow authorized representatives of the Secretary, the applicable State organic program's governing State official, and the certifying agent access to such records during normal business hours for review and copying to determine compliance with the Act and the regulations in this part, as provided for in § 205.103; (e) Submit the applicable fees charged by the certifying agent; and (f) Immediately notify the certifying agent concerning any: (1) Application, including drift, of a prohibited substance to any field, production unit, site, facility, livestock, or product that is part of an operation; and (2) Change in a certified operation or any portion of a certified operation that may affect its compliance with the Act and the regulations in this part. (g) In addition to paragraphs (a) through (f) of this section, a producer group operation must: (1) Be organized as a person; (2) Use centralized processing, distribution, and marketing facilities and systems; (3) Be organized into producer group production units; (4) Maintain an internal control system to implement the practices described in § 205.201(c) and ensure compliance with this part; (5) Ensure that all agricultural products sold, labeled, or represented as organic are produced only by producer group members using land and facilities within the certified operation; (6) Ensure that producer group members do not sell, label, or represent their agricultural products as organic outside of the producer group operation unless they are individually certified; (7) Report to the certifying agent, at least annually, the name and location of all producer group members and producer group production units, the agricultural products produced, estimated yields, and size of production areas; (8) Conduct internal inspections of each producer group member, at least annually, by internal inspectors with the member present, which must include mass-balance audits and reconciliation of each producer group member's and each producer group production unit's yield and group sales; (9) Implement recordkeeping requirements to ensure traceability from production at each producer group member and production unit through handling to sale and transport; (10) Implement procedures to ensure all production and handling by the producer group operation is compliant with the USDA organic regulations and the Act; and (11) Address any other terms or conditions determined by the Administrator to be necessary to enforce compliance with the USDA organic regulations and the Act.