§ 205.201 Organic production and handling system plan. ( a ) The producer or handler of a production or handling operation, except as exempt under § 205.101, intending to sell, label, or represent agricultural products as “100 percent organic,” “organic,” or “made with organic (specified ingredients or food group(s))” must develop an organic production or handling system plan that is agreed to by the producer or handler and an accredited certifying agent. An organic system plan must meet the requirements set forth in this section for organic production or handling. An organic production or handling system plan must include: ( 1 ) A description of practices and procedures to be performed and maintained, including the frequency with which they will be performed;
( 2 ) A list of each substance to be used as a production or handling input, indicating its composition, source, location(s) where it will be used, and documentation of commercial availability, as applicable;
( 3 ) A description of the monitoring practices and procedures to be performed and maintained, including the frequency with which they will be performed, to verify that the plan is effectively implemented. This must include a description of the monitoring practices and procedures to verify suppliers in the supply chain and organic status of agricultural products received, and to prevent organic fraud, as appropriate to the certified operation's activities, scope, and complexity;
( 4 ) A description of the recordkeeping system implemented to comply with the requirements established in § 205.103;
( 5 ) A description of the management practices and physical barriers established to prevent commingling of organic and nonorganic products on a split operation and to prevent contact of organic production and handling operations and products with prohibited substances; and
( 6 ) Additional information deemed necessary by the certifying agent to evaluate compliance with the regulations.
( b ) A producer may substitute a plan prepared to meet the requirements of another Federal, State, or local government regulatory program for the organic system plan: *Provided,* That, the submitted plan meets all the requirements of this subpart.
( c ) In addition to paragraph (a) of this section, a producer group operation's organic system plan must describe its internal control system. The description of the internal control system must: ( 1 ) Define the organizational structure, roles, and responsibilities of all personnel;
( 2 ) Identify producer group production units and locations;
( 3 ) Describe measures to protect against potential conflicts of interest and protect internal control system personnel from retribution;
( 4 ) Define geographic proximity criteria for producer group members and producer group production units;
( 5 ) Describe procedures for accepting new members into the producer group operation, including initial inspection and compliance determination;
( 6 ) Describe characteristics of high-risk producer group members and producer group production units;
( 7 ) Describe how shared resources, including production practices and inputs, are procured and provided to all producer group members and personnel;
( 8 ) Describe how training, education, and technical assistance is provided to producer group members and internal control system personnel;
( 9 ) Describe the system of records used to demonstrate compliance with this part, including traceability and mass-balance audits; and
( 10 ) Describe how internal monitoring, surveillance, inspection, sanctions, and auditing are used to assess the compliance of all producer group members.
[65 FR 80637, Dec. 21, 2000, as amended at 88 FR 3622, Jan. 19, 2023]