(UPDATED THROUGH OCTOBER 2011)

• SUBPART F-ACCREDITATION OF CERTIFYING AGENTS
• SUBPART G - ADMINISTRATIVE (including the National List)

(UPDATED THROUGH OCTOBER 2011)

• SUBPART F - ACCREDITATION OF CERTIFYING AGENTS

  Subpart F-Accreditation of Certifying Agents

  205.500 Areas and duration of accreditation.

  (a) The Administrator shall accredit a qualified domestic or foreign applicant in the areas of crops, livestock, wild crops, or handling or any combination thereof to certify a domestic or foreign production or handling operation as a certified operation.

  (b) Accreditation shall be for a period of 5 years from the date of approval of accreditation pursuant to 205.506.

  (c) In lieu of accreditation under paragraph (a) of this section, USDA will accept a foreign certifying agent's accreditation to certify organic production or handling operations if:

  (1) USDA determines, upon the request of a foreign government, that the standards under which the foreign government authority accredited the foreign certifying agent meet the requirements of this part; or

  (2) The foreign government authority that accredited the foreign certifying agent acted under an equivalency agreement negotiated between the United States and the foreign government.

  205.501 General requirements for accreditation.

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  (a) A private or governmental entity accredited as a certifying agent under this subpart must:

  (1) Have sufficient expertise in organic production or handling techniques to fully comply with and implement the terms and conditions of the organic certification program established under the Act and the regulations in this part;

  (2) Demonstrate the ability to fully comply with the requirements for accreditation set forth in this subpart;

  (3) Carry out the provisions of the Act and the regulations in this part, including the provisions of 205.402 through 205.406 and 205.670;

  (4) Use a sufficient number of adequately trained personnel, including inspectors and certification review personnel, to comply with and implement the organic certification program established under the Act and the regulations in subpart E of this part;

  (5) Ensure that its responsibly connected persons, employees, and contractors with inspection, analysis, and decision-making responsibilities have sufficient expertise in organic production or handling techniques to successfully perform the duties assigned.

  (6) Conduct an annual performance evaluation of all persons who review applications for certification, perform on-site inspections, review certification documents, evaluate qualifications for certification, make recommendations concerning certification, or make certification decisions and implement measures to correct any deficiencies in certification services;

  (7) Have an annual program review of its certification activities conducted by the certifying agent's staff, an outside auditor, or a consultant who has expertise to conduct such reviews and implement measures to correct any noncompliances with the Act and the regulations in this part that are identified in the evaluation;

  (8) Provide sufficient information to persons seeking certification to enable them to comply with the applicable requirements of the Act and the regulations in this part;

  (9) Maintain all records pursuant to 205.510(b) and make all such records available for inspection and copying during normal business hours by authorized representatives of the Secretary and the applicable State organic program's governing State official;

  (10) Maintain strict confidentiality with respect to its clients under the applicable organic certification program and not disclose to third parties (with the exception of the Secretary or the applicable State organic program's governing State official or their authorized representatives) any business-related information concerning any client obtained while implementing the regulations in this part, except as provided for in 205.504(b)(5);

  (11) Prevent conflicts of interest by:

  (i) Not certifying a production or handling operation if the certifying agent or a responsibly connected party of such certifying agent has or has held a commercial interest in the production or handling operation, including an immediate family interest or the provision of consulting services, within the 12-month period prior to the application for certification;

  (ii) Excluding any person, including contractors, with conflicts of interest from work, discussions, and decisions in all stages of the certification process and the monitoring of certified production or handling operations for all entities in which such person has or has held a commercial interest, including an immediate family interest or the provision of consulting services, within the 12-month period prior to the application for certification;

  (iii) Not permitting any employee, inspector, contractor, or other personnel to accept payment, gifts, or favors of any kind, other than prescribed fees, from any business inspected: Except, That, a certifying agent that is a not-for-profit organization with an Internal Revenue Code tax exemption or, in the case of a foreign certifying agent, a comparable recognition of not-for-profit status from its government, may accept voluntary labor from certified operations;

  (iv) Not giving advice or providing consultancy services, to certification applicants or certified operations, for overcoming identified barriers to certification;

  (v) Requiring all persons who review applications for certification, perform on-site inspections, review certification documents, evaluate qualifications for certification, make recommendations concerning certification, or make certification decisions and all parties responsibly connected to the certifying agent to complete an annual conflict of interest disclosure report; and

  (vi) Ensuring that the decision to certify an operation is made by a person different from those who conducted the review of documents and on-site inspection.

  (12)(i) Reconsider a certified operation's application for certification and, if necessary, perform a new on-site inspection when it is determined, within 12 months of certifying the operation, that any person participating in the certification process and covered under 205.501(a)(11)(ii) has or had a conflict of interest involving the applicant. All costs associated with a reconsideration of application, including onsite inspection costs, shall be borne by the certifying agent.

  (ii) Refer a certified operation to a different accredited certifying agent for recertification and reimburse the operation for the cost of the recertification when it is determined that any person covered under 205.501(a)(11)(i) at the time of certification of the applicant had a conflict of interest involving the applicant.

  (13) Accept the certification decisions made by another certifying agent accredited or accepted by USDA pursuant to 205.500;

  (14) Refrain from making false or misleading claims about its accreditation status, the USDA accreditation program for certifying agents, or the nature or qualities of products labeled as organically produced;

  (15) Submit to the Administrator a copy of:

  (i) Any notice of denial of certification issued pursuant to 205.405, notification of noncompliance, notification of noncompliance correction, notification of proposed suspension or revocation, and notification of suspension or revocation sent pursuant to 205.662 simultaneously with its issuance; and

  (ii) A list, on January 2 of each year, including the name, address, and telephone number of each operation granted certification during the preceding year;

  (16) Charge applicants for certification and certified production and handling operations only those fees and charges for certification activities that it has filed with the Administrator;

  (17) Pay and submit fees to AMS in accordance with 205.640;

  (18) Provide the inspector, prior to each on-site inspection, with previous on-site inspection reports and notify the inspector of its decision regarding certification of the production or handling operation site inspected by the inspector and of any requirements for the correction of minor noncompliances;

  (19) Accept all production or handling applications that fall within its area(s) of accreditation and certify all qualified applicants, to the extent of its administrative capacity to do so without regard to size or membership in any association or group; and

  (20) Demonstrate its ability to comply with a State's organic program to certify organic production or handling operations within the State.

  (21) Comply with, implement, and carry out any other terms and conditions determined by the Administrator to be necessary.

  (b) A private or governmental entity accredited as a certifying agent under this subpart may establish a seal, logo, or other identifying mark to be used by production and handling operations certified by the certifying agent to indicate affiliation with the certifying agent: Provided, That, the certifying agent:

  (1) Does not require use of its seal, logo, or other identifying mark on any product sold, labeled, or represented as organically produced as a condition of certification and

  (2) Does not require compliance with any production or handling practices other than those provided for in the Act and the regulations in this part as a condition of use of its identifying mark: Provided, That, certifying agents certifying production or handling operations within a State with more restrictive requirements, approved by the Secretary, shall require compliance with such requirements as a condition of use of their identifying mark by such operations.

  (c) A private entity accredited as a certifying agent must:

  (1) Hold the Secretary harmless for any failure on the part of the certifying agent to carry out the provisions of the Act and the regulations in this part;

  (2) Furnish reasonable security, in an amount and according to such terms as the Administrator may by regulation prescribe, for the purpose of protecting the rights of production and handling operations certified by such certifying agent under the Act and the regulations in this part; and

  (3) Transfer to the Administrator and make available to any applicable State organic program's governing State official all records or copies of records concerning the person's certification activities in the event that the certifying agent dissolves or loses its accreditation; Provided, That, such transfer shall not apply to a merger, sale, or other transfer of ownership of a certifying agent.

  (d) No private or governmental entity accredited as a certifying agent under this subpart shall exclude from participation in or deny the benefits of the National Organic Program to any person due to discrimination because of race, color, national origin, gender, religion, age, disability, political beliefs, sexual orientation, or marital or family status.

  205.502 Applying for accreditation.

  (a) A private or governmental entity seeking accreditation as a certifying agent under this subpart must submit an application for accreditation which contains the applicable information and documents set forth in 205.503 through 205.505 and the fees required in 205.640 to: Program Manager, USDA-AMS-TMP-NOP, Room 2945—South Building, P.O. Box 96456, Washington, DC 20090—6456.

  (b) Following the receipt of the information and documents, the Administrator will determine, pursuant to 205.506, whether the applicant for accreditation should be accredited as a certifying agent.

  205.503 Applicant information.

  A private or governmental entity seeking accreditation as a certifying agent must submit the following information:

  (a) The business name, primary office location, mailing address, name of the person(s) responsible for the certifying agent's day-to-day operations, contact numbers (telephone, facsimile, and Internet address) of the applicant, and, for an applicant who is a private person, the entity's taxpayer identification number;

  (b) The name, office location, mailing address, and contact numbers (telephone, facsimile, and Internet address) for each of its organizational units, such as chapters or subsidiary offices, and the name of a contact person for each unit;

  (c) Each area of operation (crops, wild crops, livestock, or handling) for which accreditation is requested and the estimated number of each type of operation anticipated to be certified annually by the applicant along with a copy of the applicant's schedule of fees for all services to be provided under these regulations by the applicant;

  (d) The type of entity the applicant is (e.g., government agricultural office, for-profit business, not-for-profit membership association) and for:

  (1) A governmental entity, a copy of the official's authority to conduct certification activities under the Act and the regulations in this part,

  (2) A private entity, documentation showing the entity's status and organizational purpose, such as articles of incorporation and by-laws or ownership or membership provisions, and its date of establishment; and

  (e) A list of each State or foreign country in which the applicant currently certifies production and handling operations and a list of each State or foreign country in which the applicant intends to certify production or handling operations.

  205.504 Evidence of expertise and ability.

  A private or governmental entity seeking accreditation as a certifying agent must submit the following documents and information to demonstrate its expertise in organic production or handling techniques; its ability to fully comply with and implement the organic certification program established in 205.100 and 205.101, 205.201 through 205.203, 205.300 through 205.303, 205.400 through 205.406, and 205.661 and 205.662; and its ability to comply with the requirements for accreditation set forth in 205.501:

  (a) Personnel. (1) A copy of the applicant's policies and procedures for training, evaluating, and supervising personnel;

  (2) The name and position description of all personnel to be used in the certification operation, including administrative staff, certification inspectors, members of any certification review and evaluation committees, contractors, and all parties responsibly connected to the certifying agent;

  (3) A description of the qualifications, including experience, training, and education in agriculture, organic production, and organic handling, for:

  (i) Each inspector to be used by the applicant and

  (ii) Each person to be designated by the applicant to review or evaluate applications for certification; and

  (4) A description of any training that the applicant has provided or intends to provide to personnel to ensure that they comply with and implement the requirements of the Act and the regulations in this part.

  (b) Administrative policies and procedures. (1) A copy of the procedures to be used to evaluate certification applicants, make certification decisions, and issue certification certificates;

  (2) A copy of the procedures to be used for reviewing and investigating certified operation compliance with the Act and the regulations in this part and the reporting of violations of the Act and the regulations in this part to the Administrator;

  (3) A copy of the procedures to be used for complying with the recordkeeping requirements set forth in 205.501(a)(9);

  (4) A copy of the procedures to be used for maintaining the confidentiality of any business-related information as set forth in 205.501(a)(10);

  (5) A copy of the procedures to be used, including any fees to be assessed, for making the following information available to any member of the public upon request:

  (i) Certification certificates issued during the current and 3 preceding calender years;

  (ii) A list of producers and handlers whose operations it has certified, including for each the name of the operation, type(s) of operation, products produced, and the effective date of the certification, during the current and 3 preceding calender years;

  (iii) The results of laboratory analyses for residues of pesticides and other prohibited substances conducted during the current and 3 preceding calender years; and

  (iv) Other business information as permitted in writing by the producer or handler; and

  (6) A copy of the procedures to be used for sampling and residue testing pursuant to 205.670.

  (c) Conflicts of interest. (1) A copy of procedures intended to be implemented to prevent the occurrence of conflicts of interest, as described in 205.501(a)(11).

  (2) For all persons who review applications for certification, perform on-site inspections, review certification documents, evaluate qualifications for certification, make recommendations concerning certification, or make certification decisions and all parties responsibly connected to the certifying agent, a conflict of interest disclosure report, identifying any food- or agriculture-related business interests, including business interests of immediate family members, that cause a conflict of interest.

  (d) Current certification activities. An applicant who currently certifies production or handling operations must submit: (1) A list of all production and handling operations currently certified by the applicant;

  (2) Copies of at least 3 different inspection reports and certification evaluation documents for production or handling operations certified by the applicant during the previous year for each area of operation for which accreditation is requested; and

  (3) The results of any accreditation process of the applicant's operation by an accrediting body during the previous year for the purpose of evaluating its certification activities.

  (e) Other information. Any other information the applicant believes may assist in the Administrator's evaluation of the applicant's expertise and ability.

  205.505 Statement of agreement.

  (a) A private or governmental entity seeking accreditation under this subpart must sign and return a statement of agreement prepared by the Administrator which affirms that, if granted accreditation as a certifying agent under this subpart, the applicant will carry out the provisions of the Act and the regulations in this part, including:

  (1) Accept the certification decisions made by another certifying agent accredited or accepted by USDA pursuant to 205.500;

  (2) Refrain from making false or misleading claims about its accreditation status, the USDA accreditation program for certifying agents, or the nature or qualities of products labeled as organically produced;

  (3) Conduct an annual performance evaluation of all persons who review applications for certification, perform on-site inspections, review certification documents, evaluate qualifications for certification, make recommendations concerning certification, or make certification decisions and implement measures to correct any deficiencies in certification services;

  (4) Have an annual internal program review conducted of its certification activities by certifying agent staff, an outside auditor, or a consultant who has the expertise to conduct such reviews and implement measures to correct any noncompliances with the Act and the regulations in this part;

  (5) Pay and submit fees to AMS in accordance with 205.640; and

  (6) Comply with, implement, and carry out any other terms and conditions determined by the Administrator to be necessary.

  (b) A private entity seeking accreditation as a certifying agent under this subpart must additionally agree to:

  (1) Hold the Secretary harmless for any failure on the part of the certifying agent to carry out the provisions of the Act and the regulations in this part;

  (2) Furnish reasonable security, in an amount and according to such terms as the Administrator may by regulation prescribe, for the purpose of protecting the rights of production and handling operations certified by such certifying agent under the Act and the regulations in this part; and

  (3) Transfer to the Administrator and make available to the applicable State organic program's governing State official all records or copies of records concerning the certifying agent's certification activities in the event that the certifying agent dissolves or loses its accreditation; Provided, That such transfer shall not apply to a merger, sale, or other transfer of ownership of a certifying agent.

  205.506 Granting accreditation.

  (a) Accreditation will be granted when:

  (1) The accreditation applicant has submitted the information required by 205.503 through 205.505;

  (2) The accreditation applicant pays the required fee in accordance with 205.640(c); and

  (3) The Administrator determines that the applicant for accreditation meets the requirements for accreditation as stated in 205.501, as determined by a review of the information submitted in accordance with 205.503 through 205.505 and, if necessary, a review of the information obtained from a site evaluation as provided for in 205.508.

  (b) On making a determination to approve an application for accreditation, the Administrator will notify the applicant of the granting of accreditation in writing, stating:

  (1) The area(s) for which accreditation is given;

  (2) The effective date of the accreditation;

  (3) Any terms and conditions for the correction of minor noncompliances; and

  (4) For a certifying agent who is a private entity, the amount and type of security that must be established to protect the rights of production and handling operations certified by such certifying agent.

  (c) The accreditation of a certifying agent shall continue in effect until such time as the certifying agent fails to renew accreditation as provided in 205.510(c), the certifying agent voluntarily ceases its certification activities, or accreditation is suspended or revoked pursuant to 205.665.

  205.507 Denial of accreditation.

  (a) If the Program Manager has reason to believe, based on a review of the information specified in 205.503 through 205.505 or after a site evaluation as specified in 205.508, that an applicant for accreditation is not able to comply or is not in compliance with the requirements of the Act and the regulations in this part, the Program Manager shall provide a written notification of noncompliance to the applicant. Such notification shall provide:

  (1) A description of each noncompliance;

  (2) The facts upon which the notification of noncompliance is based; and

  (3) The date by which the applicant must rebut or correct each noncompliance and submit supporting documentation of each such correction when correction is possible.

  (b) When each noncompliance has been resolved, the Program Manager will send the applicant a written notification of noncompliance resolution and proceed with further processing of the application.

  (c) If an applicant fails to correct the noncompliances, fails to report the corrections by the date specified in the notification of noncompliance, fails to file a rebuttal of the notification of noncompliance by the date specified, or is unsuccessful in its rebuttal, the Program Manager will provide the applicant with written notification of accreditation denial. An applicant who has received written notification of accreditation denial may apply for accreditation again at any time in accordance with 205.502, or appeal the denial of accreditation in accordance with 205.681 by the date specified in the notification of accreditation denial.

  (d) If the certifying agent was accredited prior to the site evaluation and the certifying agent fails to correct the noncompliances, fails to report the corrections by the date specified in the notification of noncompliance, or fails to file a rebuttal of the notification of noncompliance by the date specified, the Administrator will begin proceedings to suspend or revoke the certifying agent's accreditation. A certifying agent who has had its accreditation suspended may at any time, unless otherwise stated in the notification of suspension, submit a request to the Secretary for reinstatement of its accreditation. The request must be accompanied by evidence demonstrating correction of each noncompliance and corrective actions taken to comply with and remain in compliance with the Act and the regulations in this part. A certifying agent whose accreditation is revoked will be ineligible for accreditation for a period of not less than 3 years following the date of such determination.

  205.508 Site evaluations.

  (a) Site evaluations of accredited certifying agents shall be conducted for the purpose of examining the certifying agent's operations and evaluating its compliance with the Act and the regulations of this part. Site evaluations shall include an on-site review of the certifying agent's certification procedures, decisions, facilities, administrative and management systems, and production or handling operations certified by the certifying agent. Site evaluations shall be conducted by a representative(s) of the Administrator.

  (b) An initial site evaluation of an accreditation applicant shall be conducted before or within a reasonable period of time after issuance of the applicant's "notification of accreditation." A site evaluation shall be conducted after application for renewal of accreditation but prior to the issuance of a notice of renewal of accreditation. One or more site evaluations will be conducted during the period of accreditation to determine whether an accredited certifying agent is complying with the general requirements set forth in 205.501.

  205.509 Peer review panel.

  The Administrator shall establish a peer review panel pursuant to the Federal Advisory Committee Act (FACA) (5 U.S.C. App. 2 et seq.). The peer review panel shall be composed of not less than 3 members who shall annually evaluate the National Organic Program's adherence to the accreditation procedures in this subpart F and ISO/IEC Guide 61, General requirements for assessment and accreditation of certification/registration bodies, and the National Organic Program's accreditation decisions. This shall be accomplished through the review of accreditation procedures, document review and site evaluation reports, and accreditation decision documents or documentation. The peer review panel shall report its finding, in writing, to the National Organic Program's Program Manager.

  205.510 Annual report, recordkeeping, and renewal of accreditation.

  (a) Annual report and fees. An accredited certifying agent must submit annually to the Administrator, on or before the anniversary date of the issuance of the notification of accreditation, the following reports and fees:

  (1) A complete and accurate update of information submitted pursuant to 205.503 and 205.504;

  (2) Information supporting any changes being requested in the areas of accreditation described in 205.500;

  (3) A description of the measures implemented in the previous year and any measures to be implemented in the coming year to satisfy any terms and conditions determined by the Administrator to be necessary, as specified in the most recent notification of accreditation or notice of renewal of accreditation;

  (4) The results of the most recent performance evaluations and annual program review and a description of adjustments to the certifying agent's operation and procedures implemented or to be implemented in response to the performance evaluations and program review; and

  (5) The fees required in 205.640(a).

  (b) Recordkeeping. Certifying agents must maintain records according to the following schedule:

  (1) Records obtained from applicants for certification and certified operations must be maintained for not less than 5 years beyond their receipt;

  (2) Records created by the certifying agent regarding applicants for certification and certified operations must be maintained for not less than 10 years beyond their creation; and

  (3) Records created or received by the certifying agent pursuant to the accreditation requirements of this subpart F, excluding any records covered by 205.510(b)(2), must be maintained for not less than 5 years beyond their creation or receipt.

  (c) Renewal of accreditation. (1) The Administrator shall send the accredited certifying agent a notice of pending expiration of accreditation approximately 1 year prior to the scheduled date of expiration.

  (2) An accredited certifying agent's application for accreditation renewal must be received at least 6 months prior to the fifth anniversary of issuance of the notification of accreditation and each subsequent renewal of accreditation. The accreditation of certifying agents who make timely application for renewal of accreditation will not expire during the renewal process. The accreditation of certifying agents who fail to make timely application for renewal of accreditation will expire as scheduled unless renewed prior to the scheduled expiration date. Certifying agents with an expired accreditation must not perform certification activities under the Act and the regulations of this part.

  (3) Following receipt of the information submitted by the certifying agent in accordance with paragraph (a) of this section and the results of a site evaluation, the Administrator will determine whether the certifying agent remains in compliance with the Act and the regulations of this part and should have its accreditation renewed.

  (d) Notice of renewal of accreditation. Upon a determination that the certifying agent is in compliance with the Act and the regulations of this part, the Administrator will issue a notice of renewal of accreditation. The notice of renewal will specify any terms and conditions that must be addressed by the certifying agent and the time within which those terms and conditions must be satisfied.

  (e) Noncompliance. Upon a determination that the certifying agent is not in compliance with the Act and the regulations of this part, the Administrator will initiate proceedings to suspend or revoke the certifying agent's accreditation.

  (f) Amending accreditation. Amendment to scope of an accreditation may be requested at any time. The application for amendment shall be sent to the Administrator and shall contain information applicable to the requested change in accreditation, a complete and accurate update of the information submitted pursuant to 205.503 and 205.504, and the applicable fees required in 205.640. 205.511-205.599

  (UPDATED THROUGH OCTOBER 2011)

• SUBPART G - ADMINISTRATIVE

  The National List of Allowed and Prohibited Substances

  205.600 Evaluation criteria for allowed and prohibited substances, methods, and ingredients.

  The following criteria will be utilized in the evaluation of substances or ingredients for the organic production and handling sections of the National List:

  (a) Synthetic and nonsynthetic substances considered for inclusion on or deletion from the National List of allowed and prohibited substances will be evaluated using the criteria specified in the Act (7 U.S.C. 6517 and 6518).

  (b) In addition to the criteria set forth in the Act, any synthetic substance used as a processing aid or adjuvant will be evaluated against the following criteria:

  (1) The substance cannot be produced from a natural source and there are no organic substitutes;

  (2) The substance's manufacture, use, and disposal do not have adverse effects on the environment and are done in a manner compatible with organic handling;

  (3) The nutritional quality of the food is maintained when the substance is used, and the substance, itself, or its breakdown products do not have an adverse effect on human health as defined by applicable Federal regulations;

  (4) The substance's primary use is not as a preservative or to recreate or improve flavors, colors, textures, or nutritive value lost during processing, except where the replacement of nutrients is required by law;

  (5) The substance is listed as generally recognized as safe (GRAS) by Food and Drug Administration (FDA) when used in accordance with FDA's good manufacturing practices (GMP) and contains no residues of heavy metals or other contaminants in excess of tolerances set by FDA; and

  (6) The substance is essential for the handling of organically produced agricultural products.

  (c) Nonsynthetics used in organic processing will be evaluated using the criteria specified in the Act (7 U.S.C. 6517 and 6518).

  205.601 Synthetic substances allowed for use in organic crop production.

  In accordance with restrictions specified in this section, the following synthetic substances may be used in organic crop production: Provided, That, use of such substances do not contribute to contamination of crops, soil, or water. Substances allowed by this section, except disinfectants and sanitizers in paragraph (a) and those substances in paragraphs (c), (j), (k), and (l) of this section, may only be used when the provisions set forth in 205.206(a) through (d) prove insufficient to prevent or control the target pest.

  (a) As algicide, disinfectants, and sanitizer, including irrigation system cleaning systems.

  (1) Alcohols.

  (i) Ethanol.

  (ii) Isopropanol.

  (2) Chlorine materials- Except, That, residual chlorine levels in the water shall not exceed the maximum residual disinfectant limit under the Safe Drinking Water Act.

  (i) Calcium hypochlorite.

  (ii) Chlorine dioxide.

  (iii) Sodium hypochlorite.

  (3) Copper sulfate-for use as an algicide in aquatic rice systems, is limited to one application per field during any 24-month period. Application rates are limited to those which do not increase baseline soil test values for copper over a timeframe agreed upon by the producer and accredited certifying agent.

  (4) Hydrogen peroxide.

  (5) Ozone gas - for use as an irrigation system cleaner only.

  (6) Peracetic acid - for use in disinfecting equipment, seed, and asexually propagated planting material.

  (7) Soap-based algicide/demossers.

  (8) Sodium carbonate peroxyhydrate (CAS 15630-89-4)-Federal law restricts the use of this substance in food crop production to approved food uses identified on the product label.

  (b) As herbicides, weed barriers, as applicable.

  (1) Herbicides, soap-based-for use in farmstead maintenance (roadways, ditches, right of ways, building perimeters) and ornamental crops.

  (2) Mulches.

  (i) Newspaper or other recycled paper, without glossy or colored inks.

  (ii) Plastic mulch and covers (petroleum-based other than polyvinyl chloride (PVC)).

  (c) As compost feedstocks-Newspapers or other recycled paper, without glossy or colored inks.

  (d) As animal repellents - Soaps, ammonium-for use as a large animal repellant only, no contact with soil or edible portion of crop.

  (e) As insecticides (including acaricides or mite control).

  (1) Ammonium carbonate - for use as bait in insect traps only, no direct contact with crop or soil.

  (2) Aqueous potassium silicate (CAS 1312-76-1) - the silica, used in the manufacture of potassium silicate, must be sourced from naturally occurring sand.

  (3) Boric acid - structural pest control, no direct contact with organic food or crops.

  (4) Copper sulfate - for use as tadpole shrimp control in aquatic rice production, is limited to one application per field during any 24-month period. Application rates are limited to levels which do not increase baseline soil test values for copper over a timeframe agreed upon by the producer and accredited certifying agent.

  (5) Elemental sulfur.

  (6) Lime sulfur - including calcium polysulfide.

  (7) Oils, horticultural - narrow range oils as dormant, suffocating, and summer oils.

  (8) Soaps, insecticidal.

  (9) Sticky traps/barriers.

  (10) Sucrose octanoate esters (CAS 42922-74-7; 58064-47-4)-in accordance with approved labeling.

  (f) As insect management. Pheromones.

  (g) As rodenticides.

  (1) Sulfur dioxide-underground rodent control only (smoke bombs).

  (2) Vitamin D3.

  (h) As slug or snail bait. Ferric phosphate (CAS 10045-86-0).

  (i) As plant disease control.

  (1) Aqueous potassium silicate (CAS 1312-76-1)-the silica, used in the manufacture of potassium silicate, must be sourced from naturally occurring sand.

  (2) Coppers, fixed - copper hydroxide, copper oxide, copper oxychloride, includes products exempted from EPA tolerance, Provided, That, copper-based materials must be used in a manner that minimizes accumulation in the soil and shall not be used as herbicides.

  (3) Copper sulfate - Substance must be used in a manner that minimizes accumulation of copper in the soil.

  (4) Hydrated lime.

  (5) Hydrogen peroxide.

  (6) Lime sulfur.

  (7) Oils, horticultural, narrow range oils as dormant, suffocating, and summer oils.

  (8) Peracetic acid - for use to control fire blight bacteria.

  (9) Potassium bicarbonate.

  (10) Elemental sulfur.

  (11) Streptomycin, for fire blight control in apples and pears only.

  (12) Tetracycline, for fire blight control only and for use only until October 21, 2012.

  (j) As plant or soil amendments.

  (1) Aquatic plant extracts (other than hydrolyzed) - Extraction process is limited to the use of potassium hydroxide or sodium hydroxide; solvent amount used is limited to that amount necessary for extraction.

  (2) Elemental sulfur.

  (3) Humic acids - naturally occurring deposits, water and alkali extracts only.

  (4) Lignin sulfonate - chelating agent, dust suppressant, floatation agent.

  (5) Magnesium sulfate - allowed with a documented soil deficiency.

  (6) Micronutrients-not to be used as a defoliant, herbicide, or desiccant. Those made from nitrates or chlorides are not allowed. Soil deficiency must be documented by testing.

  (i) Soluble boron products.

  (ii) Sulfates, carbonates, oxides, or silicates of zinc, copper, iron, manganese, molybdenum, selenium, and cobalt.

  (7) Liquid fish products - can be pH adjusted with sulfuric, citric or phosphoric acid. The amount of acid used shall not exceed the minimum needed to lower the pH to 3.5.

  (8) Vitamins, B1, C, and E.

  (9) Sulfurous acid (CAS 7782-99-2) for on-farm generation of substance utilizing 99% purity elemental sulfur per paragraph (j)(2) of this section.

  (k) As plant growth regulators. Ethylene gas - for regulation of pineapple flowering.

  (l) As floating agents in postharvest handling.

  (1) Lignin sulfonate.

  (2) Sodium silicate - for tree fruit and fiber processing.

  (m) As synthetic inert ingredients as classified by the Environmental Protection Agency (EPA), for use with nonsynthetic substances or synthetic substances listed in this section and used as an active pesticide ingredient in accordance with any limitations on the use of such substances.

  (1) EPA List 4 - Inerts of Minimal Concern.

  (2) EPA List 3 - Inerts of unknown toxicity-for use only in passive pheromone dispensers.

  (n) Seed preparations. Hydrogen chloride (CAS 7647-01-0)-for delinting cotton seed for planting. (o) - (z)

  205.602 Nonsynthetic substances prohibited for use in organic crop production.

  The following nonsynthetic substances may not be used in organic crop production:

  (a) Ash from manure burning.

  (b) Arsenic.

  (c) Calcium chloride, brine process is natural and prohibited for use except as a foliar spray to treat a physiological disorder associated with calcium uptake.

  (d) Lead salts.

  (e) Potassium chloride-unless derived from a mined source and applied in a manner that minimizes chloride accumulation in the soil.

  (f) Sodium fluoaluminate (mined).

  (g) Sodium nitrate-unless use is restricted to no more than 20% of the crop's total nitrogen requirement; use in spirulina production is unrestricted until October 21, 2005.

  (h) Strychnine.

  (i) Tobacco dust (nicotine sulfate). (j) - (z)

  205.603 Synthetic substances allowed for use in organic livestock production.

  In accordance with restrictions specified in this section the following synthetic substances may be used in organic livestock production:

  (a) As disinfectants, sanitizer, and medical treatments as applicable.

  (1) Alcohols.

  (i) Ethanol-disinfectant and sanitizer only, prohibited as a feed additive.

  (ii) Isopropanol-disinfectant only.

  (2) Aspirin-approved for health care use to reduce inflammation.

  (3) Atropine (CAS 51-55-8)-federal law restricts this drug to use by or on the lawful written or oral order of a licensed veterinarian, in full compliance with the AMDUCA and 21 CFR part 530 of the Food and Drug Administration regulations. Also, for use under 7 CFR part 205, the NOP requires:

  (i) Use by or on the lawful written order of a licensed veterinarian; and

  (ii) A meat withdrawal period of at least 56 days after administering to livestock intended for slaughter; and a milk discard period of at least 12 days after administering to dairy animals.

  (4) Biologics-Vaccines.

  (5) Butorphanol (CAS 42408-82-2)-federal law restricts this drug to use by or on the lawful written or oral order of a licensed veterinarian, in full compliance with the AMDUCA and 21 CFR part 530 of the Food and Drug Administration regulations. Also, for use under 7 CFR Part 205, the NOP requires:

  (i) Use by or on the lawful written order of a licensed veterinarian; and

  (ii) A meat withdrawal period of at least 42 days after administering to livestock intended for slaughter; and a milk discard period of at least 8 days after administering to dairy animals.

  (6) Chlorhexidine-Allowed for surgical procedures conducted by a veterinarian. Allowed for use as a teat dip when alternative germicidal agents and/or physical barriers have lost their effectiveness.

  (7) Chlorine materials-disinfecting and sanitizing facilities and equipment. Residual chlorine levels in the water shall not exceed the maximum residual disinfectant limit under the Safe Drinking Water Act.

  (i) Calcium hypochlorite.

  (ii) Chlorine dioxide.

  (iii) Sodium hypochlorite.

  (8) Electrolytes-without antibiotics.

  (9) Flunixin (CAS 38677-85-9)-in accordance with approved labeling; except that for use under 7 CFR part 205, the NOP requires a withdrawal period of at least two-times that required by the FDA.

  (10) Furosemide (CAS 54-31-9)-in accordance with approved labeling; except that for use under 7 CFR part 205, the NOP requires a withdrawal period of at least two-times that required that required by the FDA.

  (11) Glucose.

  (12) Glycerine-Allowed as a livestock teat dip, must be produced through the hydrolysis of fats or oils.

  (13) Hydrogen peroxide.

  (14) Iodine.

  (15) Magnesium hydroxide (CAS 1309-42-8)-federal law restricts this drug to use by or on the lawful written or oral order of a licensed veterinarian, in full compliance with the AMDUCA and 21 CFR part 530 of the Food and Drug Administration regulations. Also, for use under 7 CFR part 205, the NOP requires use by or on the lawful written order of a licensed veterinarian.

  (16) Magnesium sulfate.

  (17) Oxytocin - use in postparturition therapeutic applications.

  (18) Paraciticides. Ivermectin-prohibited in slaughter stock, allowed in emergency treatment for dairy and breeder stock when organic system plan-approved preventive management does not prevent infestation. Milk or milk products from a treated animal cannot be labeled as provided for in subpart D of this part for 90 days following treatment. In breeder stock, treatment cannot occur during the last third of gestation if the progeny will be sold as organic and must not be used during the lactation period for breeding stock.

  (19) Peroxyacetic/peracetic acid (CAS 79-21-0)-for sanitizing facility and processing equipment.

  (20) Phosphoric acid-allowed as an equipment cleaner, Provided , That, no direct contact with organically managed livestock or land occurs.

  (21) Poloxalene (CAS 9003-11-6)-for use under 7 CFR part 205, the NOP requires that poloxalene only be used for the emergency treatment of bloat.

  (22) Tolazoline (CAS 59-98-3)-federal law restricts this drug to use by or on the lawful written or oral order of a licensed veterinarian, in full compliance with the AMDUCA and 21 CFR part 530 of the Food and Drug Administration regulations. Also, for use under 7 CFR part 205, the NOP requires:

  (i) Use by or on the lawful written order of a licensed veterinarian;

  (ii) Use only to reverse the effects of sedation and analgesia caused by Xylazine; and

  (iii) A meat withdrawal period of at least 8 days after administering to livestock intended for slaughter; and a milk discard period of at least 4 days after administering to dairy animals.

  (23) Xylazine (CAS 7361-61-7)-federal law restricts this drug to use by or on the lawful written or oral order of a licensed veterinarian, in full compliance with the AMDUCA and 21 CFR part 530 of the Food and Drug Administration regulations. Also, for use under 7 CFR part 205, the NOP requires:

  (i) Use by or on the lawful written order of a licensed veterinarian;

  (ii) The existence of an emergency; and

  (iii) A meat withdrawal period of at least 8 days after administering to livestock intended for slaughter; and a milk discard period of at least 4 days after administering to dairy animals.

  (b) As ical treatment, external parasiticide or local anesthetic as applicable.

  (1) Copper sulfate.

  (2) Iodine.

  (3) Lidocaine - as a local anesthetic. Use requires a withdrawal period of 90 days after administering to livestock intended for slaughter and 7 days after administering to dairy animals.

  (4) Lime, hydrated - as an external pest control, not permitted to cauterize physical alterations or deodorize animal wastes.

  (5) Mineral oil - for topical use and as a lubricant.

  (6) Procaine - as a local anesthetic, use requires a withdrawal period of 90 days after administering to livestock intended for slaughter and 7 days after administering to dairy animals.

  (7) Sucrose octanoate esters (CAS 42922-74-7; 58064-47-4)-in accordance with approved labeling.

  (c) As feed supplements-None.

  (d) As feed additives.

  (1) DL-Methionine, DL-Methionine-hydroxy analog, and DL-Methionine-hydroxy analog calcium (CAS 59-51-8; 63-68-3; 348-67-4)-for use only in organic poultry production until October 1, 2012, at the following maximum levels of synthetic methionine per ton of feed: laying chickens-4 pounds; broiler chickens-5 pounds; turkeys and all other poultry-6 pounds.

  (2) Trace minerals, used for enrichment or fortification when FDA approved.

  (3) Vitamins, used for enrichment or fortification when FDA approved.

  (e) As synthetic inert ingredients as classified by the Environmental Protection Agency (EPA), for use with nonsynthetic substances or synthetic substances listed in this section and used as an active pesticide ingredient in accordance with any limitations on the use of such substances.

  (1) EPA List 4-Inerts of Minimal Concern. (2)

  (f) Excipients, only for use in the manufacture of drugs used to treat organic livestock when the excipient is: Identified by the FDA as Generally Recognized As Safe; Approved by the FDA as a food additive; or Included in the FDA review and approval of a New Animal Drug Application or New Drug Application. (g)-(z)

  205.604 Nonsynthetic substances prohibited for use in organic livestock production.

  The following nonsynthetic substances may not be used in organic livestock production:

  (a) Strychnine. (b)-(z)

  205.605 Nonagricultural (nonorganic) substances allowed as ingredients in or on processed products labeled as "organic" or "made with organic (specified ingredients or food group(s))."

  The following nonagricultural substances may be used as ingredients in or on processed products labeled as "organic" or "made with organic (specified ingredients or food group(s))" only in accordance with any restrictions specified in this section.

  (a) Nonsynthetics allowed:

  Acids (Alginic; Citric-produced by microbial fermentation of carbohydrate substances; and Lactic).

  Agar-agar.

  Animal enzymes-(Rennet-animals derived; Catalase-bovine liver; Animal lipase; Pancreatin; Pepsin; and Trypsin).

  Bentonite.

  Calcium carbonate.

  Calcium chloride.

  Calcium sulfate-mined.

  Carrageenan.

  Dairy cultures.

  Diatomaceous earth-food filtering aid only.

  Egg white lysozyme (CAS 9001-63-2)

  Enzymes-must be derived from edible, nontoxic plants, nonpathogenic fungi, or nonpathogenic bacteria.

  Flavors, nonsynthetic sources only and must not be produced using synthetic solvents and carrier systems or any artificial preservative.

  Gellan gum (CAS 71010-52-1)-high-acyl form only.

  Glucono delta-lactone-production by the oxidation of D-glucose with bromine water is prohibited.

  Kaolin.

  L-Malic acid (CAS 97-67-6).

  Magnesium sulfate, nonsynthetic sources only.

  Microorganisms-any food grade bacteria, fungi, and other microorganism.

  Nitrogen-oil-free grades.

  Oxygen-oil-free grades.

  Perlite-for use only as a filter aid in food processing.

  Potassium chloride.

  Potassium iodide.

  Sodium bicarbonate.

  Sodium carbonate.

  Tartaric acid-made from grape wine.

  Waxes-nonsynthetic (Carnauba wax; and Wood resin).

  Yeast-nonsynthetic, growth on petrochemical substrate and sulfite waste liquor is prohibited (Autolysate; Bakers; Brewers; Nutritional; and Smoked-nonsynthetic smoke flavoring process must be documented).

  (b) Synthetics allowed:

  Activated charcoal (CAS 7440-44-0; 64365-11-3)-only from vegetative sources; for use only as a filtering aid.

  Alginates.

  Ammonium bicarbonate-for use only as a leavening agent.

  Ammonium carbonate-for use only as a leavening agent.

  Ascorbic acid.

  Calcium citrate.

  Calcium hydroxide.

  Calcium phosphates (monobasic, dibasic, and tribasic).

  Carbon dioxide.

  Cellulose-for use in regenerative casings, as an anti-caking agent (non-chlorine bleached) and filtering aid.

  Chlorine materials-disinfecting and sanitizing food contact surfaces, Except, That, residual chlorine levels in the water shall not exceed the maximum residual disinfectant limit under the Safe Drinking Water Act (Calcium hypochlorite; Chlorine dioxide; and Sodium hypochlorite).

  Cyclohexylamine (CAS 108-91-8)-for use only as a boiler water additive for packaging sterilization.

  Diethylaminoethanol (CAS 100-37-8)-for use only as a boiler water additive for packaging sterilization.

  Ethylene-allowed for postharvest ripening of tropical fruit and degreening of citrus.

  Ferrous sulfate-for iron enrichment or fortification of foods when required by regulation or recommended (independent organization).

  Glycerides (mono and di)-for use only in drum drying of food.

  Glycerin-produced by hydrolysis of fats and oils.

  Hydrogen peroxide.

  Lecithin-bleached.

  Magnesium carbonate-for use only in agricultural products labeled "made with organic (specified ingredients or food group(s))," prohibited in agricultural products labeled "organic".

  Magnesium chloride-derived from sea water.

  Magnesium stearate-for use only in agricultural products labeled "made with organic (specified ingredients or food group(s))," prohibited in agricultural products labeled "organic".

  Nutrient vitamins and minerals, in accordance with 21 CFR 104.20, Nutritional Quality Guidelines For Foods.

  Octadecylamine (CAS 124-30-1)-for use only as a boiler water additive for packaging sterilization.

  Ozone.

  Pectin (low-methoxy).

  Peracetic acid/Peroxyacetic acid (CAS 79-21-0)-for use in wash and/or rinse water according to FDA limitations. For use as a sanitizer on food contact surfaces.

  Phosphoric acid-cleaning of food-contact surfaces and equipment only.

  Potassium acid tartrate.

  Potassium carbonate.

  Potassium citrate.

  Potassium hydroxide-prohibited for use in lye peeling of fruits and vegetables except when used for peeling peaches during the Individually Quick Frozen (IQF) production process.

  Potassium iodide-for use only in agricultural products labeled "made with organic (specified ingredients or food group(s))," prohibited in agricultural products labeled "organic".

  Potassium phosphate-for use only in agricultural products labeled "made with organic (specific ingredients or food group(s))," prohibited in agricultural products labeled "organic".

  Silicon dioxide.

  Sodium acid pyrophosphate (CAS 7758-16-9)-for use only as a leavening agent.

  Sodium citrate.

  Sodium hydroxide-prohibited for use in lye peeling of fruits and vegetables.

  Sodium phosphates-for use only in dairy foods.

  Sulfur dioxide-for use only in wine labeled "made with organic grapes," Provided, That, total sulfite concentration does not exceed 100 ppm.

  Tartaric acid-made from malic acid.

  Tetrasodium pyrophosphate (CAS 7722-88-5)-for use only in meat analog products.

  Tocopherols-derived from vegetable oil when rosemary extracts are not a suitable alternative.

  Xanthan gum. (c)-(z)

  205.606 Nonorganically produced agricultural products allowed as ingredients in or on processed products labeled as "organic."

  Only the following nonorganically produced agricultural products may be used as ingredients in or on processed products labeled as "organic," only in accordance with any restrictions specified in this section, and only when the product is not commercially available in organic form.

  (a) Casings, from processed intestines.

  (b) Celery powder.

  (c) Chia ( Salvia hispanica L. ).

  (d) Colors derived from agricultural products.

  (1) Annatto extract color (pigment CAS 1393-63-1)-water and oil soluble.

  (2) Beet juice extract color (pigment CAS 7659-95-2).

  (3) Beta-carotene extract color, derived from carrots (CAS 1393-63-1).

  (4) Black currant juice color (pigment CAS: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3).

  (5) Black/Purple carrot juice color (pigment CAS: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3).

  (6) Blueberry juice color (pigment CAS: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3).

  (7) Carrot juice color (pigment CAS 1393-63-1).

  (8) Cherry juice color (pigment CAS: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3).

  (9) Chokeberry-Aronia juice color (pigment CAS: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3).

  (10) Elderberry juice color (pigment CAS: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3).

  (11) Grape juice color (pigment CAS: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3).

  (12) Grape skin extract color (pigment CAS: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3).

  (13) Paprika color (CAS 68917-78-2)-dried, and oil extracted.

  (14) Pumpkin juice color (pigment CAS 127-40-2).

  (15) Purple potato juice (pigment CAS: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3).

  (16) Red cabbage extract color (pigment CAS: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3).

  (17) Red radish extract color (pigment CAS: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3).

  (18) Saffron extract color (pigment CAS 1393-63-1).

  (19) Turmeric extract color (CAS 458-37-7).

  (e) Dillweed oil (CAS 8006-75-5).

  (f) Fish oil (Fatty acid CAS: 10417-94-4, and 25167-62-8)-stabilized with organic ingredients or only with ingredients on the National List, 205.605 and 205.606.

  (g) Fortified cooking wines.

  (1) Marsala.

  (2) Sherry.

  (h) Fructooligosaccharides (CAS 308066-66-2).

  (i) Galangal, frozen.

  (j) Gelatin (CAS 9000-70-8).

  (k) Gums-water extracted only (Arabic; Guar; Locust bean; and Carob bean).

  (l) Hops ( Humulus luplus ).

  (m) Inulin-oligofructose enriched (CAS 9005-80-5).

  (n) Kelp-for use only as a thickener and dietary supplement.

  (o) Konjac flour (CAS 37220-17-0).

  (p) Lecithin-unbleached.

  (q) Lemongrass-frozen.

  (r) Orange shellac-unbleached (CAS 9000-59-3).

  (s) Pectin (high-methoxy).

  (t) Peppers (Chipotle chile).

  (u) Starches.

  (1) Cornstarch (native).

  (2) Rice starch, unmodified (CAS 977000-08-0)-for use in organic handling until June 21, 2009.

  (3) Sweet potato starch-for bean thread production only.

  (v) Tragacanth gum (CAS 9000-65-1).

  (w) Turkish bay leaves.

  (x) Wakame seaweed (Undaria pinnatifida).

  (y) Whey protein concentrate.

  205.607 Amending the National List.

  (a) Any person may petition the National Organic Standard Board for the purpose of having a substance evaluated by the Board for recommendation to the Secretary for inclusion on or deletion from the National List in accordance with the Act.

  (b) A person petitioning for amendment of the National List should request a copy of the petition procedures from the USDA at the address in 205.607(c).

  (c) A petition to amend the National List must be submitted to: Program Manager, USDA/AMS/TMP/NOP, 1400 Independence Ave., SW., Room 4008-So., Ag S 0268, Washington, DC 20250. 205.608-205.619 205.608-205.619

  State Organic Programs

  205.620 Requirements of State organic programs.

  (a) A State may establish a State organic program for production and handling operations within the State which produce and handle organic agricultural products.

  (b) A State organic program must meet the requirements for organic programs specified in the Act.

  (c) A State organic program may contain more restrictive requirements because of environmental conditions or the necessity of specific production or handling practices particular to the State or region of the United States.

  (d) A State organic program must assume enforcement obligations in the State for the requirements of this part and any more restrictive requirements approved by the Secretary.

  (e) A State organic program and any amendments to such program must be approved by the Secretary prior to being implemented by the State.

  205.621 Submission and determination of proposed State organic programs and amendments to approved State organic programs.

  (a) A State organic program's governing State official must submit to the Secretary a proposed State organic program and any proposed amendments to such approved program.

  (1) Such submission must contain supporting materials that include statutory authorities, program description, documentation of the environmental conditions or specific production and handling practices particular to the State which necessitate more restrictive requirements than the requirements of this part, and other information as may be required by the Secretary.

  (2) Submission of a request for amendment of an approved State organic program must contain supporting materials that include an explanation and documentation of the environmental conditions or specific production and handling practices particular to the State or region, which necessitates the proposed amendment. Supporting material also must explain how the proposed amendment furthers and is consistent with the purposes of the Act and the regulations of this part.

  (b) Within 6 months of receipt of submission, the Secretary will: Notify the State organic program's governing State official of approval or disapproval of the proposed program or amendment of an approved program and, if disapproved, the reasons for the disapproval.

  (c) After receipt of a notice of disapproval, the State organic program's governing State official may submit a revised State organic program or amendment of such a program at any time.

  205.622 Review of approved State organic programs.

  The Secretary will review a State organic program not less than once during each 5-year period following the date of the initial program approval. The Secretary will notify the State organic program's governing State official of approval or disapproval of the program within 6 months after initiation of the review. 205.623-205.639

  Fees

  205.640 Fees and other charges for accreditation.

  Fees and other charges equal as nearly as may be to the cost of the accreditation services rendered under the regulations, including initial accreditation, review of annual reports, and renewal of accreditation, shall be assessed and collected from applicants for initial accreditation and accredited certifying agents submitting annual reports or seeking renewal of accreditation in accordance with the following provisions:

  (a) Fees-for-service. (1) Except as otherwise provided in this section, fees-for-service shall be based on the time required to render the service provided calculated to the nearest 15-minute period, including the review of applications and accompanying documents and information, evaluator travel, the conduct of on-site evaluations, review of annual reports and updated documents and information, and the time required to prepare reports and any other documents in connection with the performance of service. The hourly rate shall be the same as that charged by the Agricultural Marketing Service, through its Quality Systems Certification Program, to certification bodies requesting conformity assessment to the International Organization for Standardization "General Requirements for Bodies Operating Product Certification Systems" (ISO Guide 65).

  (2) Applicants for initial accreditation and accredited certifying agents submitting annual reports or seeking renewal of accreditation during the first 18 months following the effective date of subpart F of this part shall receive service without incurring an hourly charge for service.

  (3) Applicants for initial accreditation and renewal of accreditation must pay at the time of application, effective 18 months following February 20, 2001, a nonrefundable fee of $500.00 which shall be applied to the applicant's fees-for-service account.

  (b) Travel charges. When service is requested at a place so distant from the evaluator's headquarters that a total of one-half hour or more is required for the evaluator(s) to travel to such place and back to the headquarters or at a place of prior assignment on circuitous routing requiring a total of one-half hour or more to travel to the next place of assignment on the circuitous routing, the charge for such service shall include a mileage charge administratively determined by the U.S. Department of Agriculture and travel tolls, if applicable, or such travel prorated among all the applicants and certifying agents furnished the service involved on an equitable basis or, when the travel is made by public transportation (including hired vehicles), a fee equal to the actual cost thereof. Travel charges shall become effective for all applicants for initial accreditation and accredited certifying agents on February 20, 2001. The applicant or certifying agent will not be charged a new mileage rate without notification before the service is rendered.

  (c) Per diem charges. When service is requested at a place away from the evaluator's headquarters, the fee for such service shall include a per diem charge if the employee(s) performing the service is paid per diem in accordance with existing travel regulations. Per diem charges to applicants and certifying agents will cover the same period of time for which the evaluator(s) receives per diem reimbursement. The per diem rate will be administratively determined by the U.S. Department of Agriculture. Per diem charges shall become effective for all applicants for initial accreditation and accredited certifying agents on February 20, 2001. The applicant or certifying agent will not be charged a new per diem rate without notification before the service is rendered.

  (d) Other costs. When costs, other than costs specified in paragraphs (a), (b), and (c) of this section, are associated with providing the services, the applicant or certifying agent will be charged for these costs. Such costs include but are not limited to equipment rental, photocopying, delivery, facsimile, telephone, or translation charges incurred in association with accreditation services. The amount of the costs charged will be determined administratively by the U.S. Department of Agriculture. Such costs shall become effective for all applicants for initial accreditation and accredited certifying agents on February 20, 2001.

  205.641 Payment of fees and other charges.

  (a) Applicants for initial accreditation and renewal of accreditation must remit the nonrefundable fee, pursuant to 205.640(a)(3), along with their application. Remittance must be made payable to the Agricultural Marketing Service, USDA, and mailed to: Program Manager, USDA-AMS-TMP-NOP, Room 2945-South Building, P.O. Box 96456, Washington, DC 20090—6456 or such other address as required by the Program Manager.

  (b) Payments for fees and other charges not covered under paragraph (a) of this section must be:

  (1) Received by the due date shown on the bill for collection;

  (2) Made payable to the Agricultural Marketing Service, USDA; and

  (3) Mailed to the address provided on the bill for collection.

  (c) The Administrator shall assess interest, penalties, and administrative costs on debts not paid by the due date shown on a bill for collection and collect delinquent debts or refer such debts to the Department of Justice for litigation.

  205.642 Fees and other charges for certification.

  Fees charged by a certifying agent must be reasonable, and a certifying agent shall charge applicants for certification and certified production and handling operations only those fees and charges that it has filed with the Administrator. The certifying agent shall provide each applicant with an estimate of the total cost of certification and an estimate of the annual cost of updating the certification. The certifying agent may require applicants for certification to pay at the time of application a nonrefundable fee which shall be applied to the applicant's fees-for-service account. The certifying agent may set the nonrefundable portion of certification fees; however, the nonrefundable portion of certification fees must be explained in the fee schedule submitted to the Administrator. The fee schedule must explain what fee amounts are nonrefundable and at what stage during the certification process fees become nonrefundable. The certifying agent shall provide all persons inquiring about the application process with a copy of its fee schedule. 205.643-205.649

  Compliance

  205.660 General.

  (a) The National Organic Program's Program Manager, on behalf of the Secretary, may inspect and review certified production and handling operations and accredited certifying agents for compliance with the Act or regulations in this part.

  (b) The Program Manager may initiate suspension or revocation proceedings against a certified operation:

  (1) When the Program Manager has reason to believe that a certified operation has violated or is not in compliance with the Act or regulations in this part; or

  (2) When a certifying agent or a State organic program's governing State official fails to take appropriate action to enforce the Act or regulations in this part.

  (c) The Program Manager may initiate suspension or revocation of a certifying agent's accreditation if the certifying agent fails to meet, conduct, or maintain accreditation requirements pursuant to the Act or this part.

  (d) Each notification of noncompliance, rejection of mediation, noncompliance resolution, proposed suspension or revocation, and suspension or revocation issued pursuant to 205.662, 205.663, and 205.665 and each response to such notification must be sent to the recipient's place of business via a delivery service which provides dated return receipts.

  205.661 Investigation of certified operations.

  (a) A certifying agent may investigate complaints of noncompliance with the Act or regulations of this part concerning production and handling operations certified as organic by the certifying agent. A certifying agent must notify the Program Manager of all compliance proceedings and actions taken pursuant to this part.

  (b) A State organic program's governing State official may investigate complaints of noncompliance with the Act or regulations in this part concerning organic production or handling operations operating in the State.

  205.662 Noncompliance procedure for certified operations.

  (a) Notification. When an inspection, review, or investigation of a certified operation by a certifying agent or a State organic program's governing State official reveals any noncompliance with the Act or regulations in this part, a written notification of noncompliance shall be sent to the certified operation. Such notification shall provide:

  (1) A description of each noncompliance;

  (2) The facts upon which the notification of noncompliance is based; and

  (3) The date by which the certified operation must rebut or correct each noncompliance and submit supporting documentation of each such correction when correction is possible.

  (b) Resolution. When a certified operation demonstrates that each noncompliance has been resolved, the certifying agent or the State organic program's governing State official, as applicable, shall send the certified operation a written notification of noncompliance resolution.

  (c) Proposed suspension or revocation. When rebuttal is unsuccessful or correction of the noncompliance is not completed within the prescribed time period, the certifying agent or State organic program's governing State official shall send the certified operation a written notification of proposed suspension or revocation of certification of the entire operation or a portion of the operation, as applicable to the noncompliance. When correction of a noncompliance is not possible, the notification of noncompliance and the proposed suspension or revocation of certification may be combined in one notification. The notification of proposed suspension or revocation of certification shall state:

  (1) The reasons for the proposed suspension or revocation;

  (2) The proposed effective date of such suspension or revocation;

  (3) The impact of a suspension or revocation on future eligibility for certification; and

  (4) The right to request mediation pursuant to 205.663 or to file an appeal pursuant to 205.681.

  (d) Willful violations. Notwithstanding paragraph (a) of this section, if a certifying agent or State organic program's governing State official has reason to believe that a certified operation has willfully violated the Act or regulations in this part, the certifying agent or State organic program's governing State official shall send the certified operation a notification of proposed suspension or revocation of certification of the entire operation or a portion of the operation, as applicable to the noncompliance.

  (e) Suspension or revocation. (1) If the certified operation fails to correct the noncompliance, to resolve the issue through rebuttal or mediation, or to file an appeal of the proposed suspension or revocation of certification, the certifying agent or State organic program's governing State official shall send the certified operation a written notification of suspension or revocation.

  (2) A certifying agent or State organic program's governing State official must not send a notification of suspension or revocation to a certified operation that has requested mediation pursuant to 205.663 or filed an appeal pursuant to 205.681, while final resolution of either is pending.

  (f) Eligibility. (1) A certified operation whose certification has been suspended under this section may at any time, unless otherwise stated in the notification of suspension, submit a request to the Secretary for reinstatement of its certification. The request must be accompanied by evidence demonstrating correction of each noncompliance and corrective actions taken to comply with and remain in compliance with the Act and the regulations in this part.

  (2) A certified operation or a person responsibly connected with an operation whose certification has been revoked will be ineligible to receive certification for a period of 5 years following the date of such revocation, Except, That, the Secretary may, when in the best interest of the certification program, reduce or eliminate the period of ineligibility.

  (g) Violations of Act. In addition to suspension or revocation, any certified operation that:

  (1) Knowingly sells or labels a product as organic, except in accordance with the Act, shall be subject to a civil penalty of not more than the amount specified in 3.91(b)(1)(xxxvii) of this title" per violation.

  (2) Makes a false statement under the Act to the Secretary, a State organic program's governing State official, or a certifying agent shall be subject to the provisions of section 1001 of title 18, United States Code.

  205.663 Mediation.

  Any dispute with respect to denial of certification or proposed suspension or revocation of certification under this part may be mediated at the request of the applicant for certification or certified operation and with acceptance by the certifying agent. Mediation shall be requested in writing to the applicable certifying agent. If the certifying agent rejects the request for mediation, the certifying agent shall provide written notification to the applicant for certification or certified operation. The written notification shall advise the applicant for certification or certified operation of the right to request an appeal, pursuant to 205.681, within 30 days of the date of the written notification of rejection of the request for mediation. If mediation is accepted by the certifying agent, such mediation shall be conducted by a qualified mediator mutually agreed upon by the parties to the mediation. If a State organic program is in effect, the mediation procedures established in the State organic program, as approved by the Secretary, will be followed. The parties to the mediation shall have no more than 30 days to reach an agreement following a mediation session. If mediation is unsuccessful, the applicant for certification or certified operation shall have 30 days from termination of mediation to appeal the certifying agent's decision pursuant to 205.681. Any agreement reached during or as a result of the mediation process shall be in compliance with the Act and the regulations in this part. The Secretary may review any mediated agreement for conformity to the Act and the regulations in this part and may reject any agreement or provision not in conformance with the Act or the regulations in this part. 205.664

  205.665 Noncompliance procedure for certifying agents.

  (a) Notification. When an inspection, review, or investigation of an accredited certifying agent by the Program Manager reveals any noncompliance with the Act or regulations in this part, a written notification of noncompliance shall be sent to the certifying agent. Such notification shall provide:

  (1) A description of each noncompliance;

  (2) The facts upon which the notification of noncompliance is based; and

  (3) The date by which the certifying agent must rebut or correct each noncompliance and submit supporting documentation of each correction when correction is possible.

  (b) Resolution. When the certifying agent demonstrates that each noncompliance has been resolved, the Program Manager shall send the certifying agent a written notification of noncompliance resolution.

  (c) Proposed suspension or revocation. When rebuttal is unsuccessful or correction of the noncompliance is not completed within the prescribed time period, the Program Manager shall send a written notification of proposed suspension or revocation of accreditation to the certifying agent. The notification of proposed suspension or revocation shall state whether the certifying agent's accreditation or specified areas of accreditation are to be suspended or revoked. When correction of a noncompliance is not possible, the notification of noncompliance and the proposed suspension or revocation may be combined in one notification. The notification of proposed suspension or revocation of accreditation shall state:

  (1) The reasons for the proposed suspension or revocation;

  (2) The proposed effective date of the suspension or revocation;

  (3) The impact of a suspension or revocation on future eligibility for accreditation; and

  (4) The right to file an appeal pursuant to 205.681.

  (d) Willful violations. Notwithstanding paragraph (a) of this section, if the Program Manager has reason to believe that a certifying agent has willfully violated the Act or regulations in this part, the Program Manager shall send a written notification of proposed suspension or revocation of accreditation to the certifying agent.

  (e) Suspension or revocation. When the accredited certifying agent fails to file an appeal of the proposed suspension or revocation of accreditation, the Program Manager shall send a written notice of suspension or revocation of accreditation to the certifying agent.

  (f) Cessation of certification activities. A certifying agent whose accreditation is suspended or revoked must:

  (1) Cease all certification activities in each area of accreditation and in each State for which its accreditation is suspended or revoked.

  (2) Transfer to the Secretary and make available to any applicable State organic program's governing State official all records concerning its certification activities that were suspended or revoked.

  (g) Eligibility. (1) A certifying agent whose accreditation is suspended by the Secretary under this section may at any time, unless otherwise stated in the notification of suspension, submit a request to the Secretary for reinstatement of its accreditation. The request must be accompanied by evidence demonstrating correction of each noncompliance and corrective actions taken to comply with and remain in compliance with the Act and the regulations in this part.

  (2) A certifying agent whose accreditation is revoked by the Secretary shall be ineligible to be accredited as a certifying agent under the Act and the regulations in this part for a period of not less than 3 years following the date of such revocation. 205.666-205.667

  205.668 Noncompliance procedures under State organic programs.

  (a) A State organic program's governing State official must promptly notify the Secretary of commencement of any noncompliance proceeding against a certified operation and forward to the Secretary a copy of each notice issued.

  (b) A noncompliance proceeding, brought by a State organic program's governing State official against a certified operation, shall be appealable pursuant to the appeal procedures of the State organic program. There shall be no subsequent rights of appeal to the Secretary. Final decisions of a State may be appealed to the United States District Court for the district in which such certified operation is located.

  (c) A State organic program's governing State official may review and investigate complaints of noncompliance with the Act or regulations concerning accreditation of certifying agents operating in the State. When such review or investigation reveals any noncompliance, the State organic program's governing State official shall send a written report of noncompliance to the Program Manager. The report shall provide a description of each noncompliance and the facts upon which the noncompliance is based. 205.669

  Inspection and Testing, Reporting, and Exclusion from Sale

  205.670 Inspection and testing of agricultural product to be sold or labeled "organic."

  (a) All agricultural products that are to be sold, labeled, or represented as "100 percent organic," "organic," or "made with organic (specified ingredients or food group(s))" must be made accessible by certified organic production or handling operations for examination by the Administrator, the applicable State organic program's governing State official, or the certifying agent.

  (b) The Administrator, applicable State organic program's governing State official, or the certifying agent may require preharvest or postharvest testing of any agricultural input used or agricultural product to be sold, labeled, or represented as "100 percent organic," "organic," or "made with organic (specified ingredients or food group(s))" when there is reason to believe that the agricultural input or product has come into contact with a prohibited substance or has been produced using excluded methods. Such tests must be conducted by the applicable State organic program's governing State official or the certifying agent at the official's or certifying agent's own expense.

  (c) The preharvest or postharvest tissue test sample collection pursuant to paragraph (b) of this section must be performed by an inspector representing the Administrator, applicable State organic program's governing State official, or certifying agent. Sample integrity must be maintained throughout the chain of custody, and residue testing must be performed in an accredited laboratory. Chemical analysis must be made in accordance with the methods described in the most current edition of the Official Methods of Analysis of the AOAC International or other current applicable validated methodology determining the presence of contaminants in agricultural products.

  (d) Results of all analyses and tests performed under this section:

  (1) Must be promptly provided to the Administrator; Except, That, where a State organic program exists, all test results and analyses shall be provided to the State organic program's governing State official by the applicable certifying party that requested testing; and

  (2) Will be available for public access, unless the testing is part of an ongoing compliance investigation.

  (e) If test results indicate a specific agricultural product contains pesticide residues or environmental contaminants that exceed the Food and Drug Administration's or the Environmental Protection Agency's regulatory tolerences, the certifying agent must promptly report such data to the Federal health agency whose regulatory tolerance or action level has been exceeded.

  205.671 Exclusion from organic sale.

  When residue testing detects prohibited substances at levels that are greater than 5 percent of the Environmental Protection Agency's tolerance for the specific residue detected or unavoidable residual environmental contamination, the agricultural product must not be sold, labeled, or represented as organically produced. The Administrator, the applicable State organic program's governing State official, or the certifying agent may conduct an investigation of the certified operation to determine the cause of the prohibited substance.

  205.672 Emergency pest or disease treatment.

  When a prohibited substance is applied to a certified operation due to a Federal or State emergency pest or disease treatment program and the certified operation otherwise meets the requirements of this part, the certification status of the operation shall not be affected as a result of the application of the prohibited substance: Provided, That:

  (a) Any harvested crop or plant part to be harvested that has contact with a prohibited substance applied as the result of a Federal or State emergency pest or disease treatment program cannot be sold, labeled, or represented as organically produced; and

  (b) Any livestock that are treated with a prohibited substance applied as the result of a Federal or State emergency pest or disease treatment program or product derived from such treated livestock cannot be sold, labeled, or represented as organically produced: Except, That:

  (1) Milk or milk products may be sold, labeled, or represented as organically produced beginning 12 months following the last date that the dairy animal was treated with the prohibited substance; and

  (2) The offspring of gestating mammalian breeder stock treated with a prohibited substance may be considered organic: Provided, That, the breeder stock was not in the last third of gestation on the date that the breeder stock was treated with the prohibited substance. 205.673-205.679

  Adverse Action Appeal Process

  205.680 General.

  (a) Persons subject to the Act who believe they are adversely affected by a noncompliance decision of the National Organic Program's Program Manager may appeal such decision to the Administrator.

  (b) Persons subject to the Act who believe that they are adversely affected by a noncompliance decision of a State organic program may appeal such decision to the State organic program's governing State official who will initiate handling of the appeal pursuant to appeal procedures approved by the Secretary.

  (c) Persons subject to the Act who believe that they are adversely affected by a noncompliance decision of a certifying agent may appeal such decision to the Administrator, Except, That, when the person is subject to an approved State organic program, the appeal must be made to the State organic program.

  (d) All written communications between parties involved in appeal proceedings must be sent to the recipient's place of business by a delivery service which provides dated return receipts.

  (e) All appeals shall be reviewed, heard, and decided by persons not involved with the decision being appealed.

  205.681 Appeals.

  (a) Certification appeals. An applicant for certification may appeal a certifying agent's notice of denial of certification, and a certified operation may appeal a certifying agent's notification of proposed suspension or revocation of certification to the Administrator, Except, That, when the applicant or certified operation is subject to an approved State organic program the appeal must be made to the State organic program which will carry out the appeal pursuant to the State organic program's appeal procedures approved by the Secretary.

  (1) If the Administrator or State organic program sustains a certification applicant's or certified operation's appeal of a certifying agent's decision, the applicant will be issued organic certification, or a certified operation will continue its certification, as applicable to the operation. The act of sustaining the appeal shall not be an adverse action subject to appeal by the affected certifying agent.

  (2) If the Administrator or State organic program denies an appeal, a formal administrative proceeding will be initiated to deny, suspend, or revoke the certification. Such proceeding shall be conducted pursuant to the U.S. Department of Agriculture's Uniform Rules of Practice or the State organic program's rules of procedure.

  (b) Accreditation appeals. An applicant for accreditation and an accredited certifying agent may appeal the Program Manager's denial of accreditation or proposed suspension or revocation of accreditation to the Administrator.

  (1) If the Administrator sustains an appeal, an applicant will be issued accreditation, or a certifying agent will continue its accreditation, as applicable to the operation.

  (2) If the Administrator denies an appeal, a formal administrative proceeding to deny, suspend, or revoke the accreditation will be initiated. Such proceeding shall be conducted pursuant to the U.S. Department of Agriculture's Uniform Rules of Practice, 7 CFR part 1, Subpart H.

  (c) Filing period. An appeal of a noncompliance decision must be filed within the time period provided in the letter of notification or within 30 days from receipt of the notification, whichever occurs later. The appeal will be considered "filed" on the date received by the Administrator or by the State organic program. A decision to deny, suspend, or revoke certification or accreditation will become final and nonappealable unless the decision is appealed in a timely manner.

  (d) Where and what to file. (1) Appeals to the Administrator must be filed in writing and addressed to: Administrator, USDA, AMS, c/o NOP Appeals Staff, S0203, Room 302-Annex, 1400 Independence Avenue, SW., Washington, DC 20250-0203.

  (2) Appeals to the State organic program must be filed in writing to the address and person identified in the letter of notification.

  (3) All appeals must include a copy of the adverse decision and a statement of the appellant's reasons for believing that the decision was not proper or made in accordance with applicable program regulations, policies, or procedures. 205.682-205.689

  Miscellaneous

  205.690 OMB control number.

  The control number assigned to the information collection requirements in this part by the Office of Management and Budget pursuant to the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35, is OMB number 0581—0191. 205.691-205.699
  
  

  Go back to U.S. Organic Foods Production Act(Subparts A-E).

  
  
  

  Reference

  National Archives and Records Administration. Title 7 - Agriculture. Subtitle B - Regulations of the Department of Agriculture. Chapter I - Agricultural Marketing Service (Standards, Inspections, Marketing Practices), Department of Agriculture. Subchapter M - Organic Foods Production Act Provisions. Part 205 - National Organic Program . Electronic Code of Federal Regulations (e-CFR), November 8, 2011.