National Organic Program Summary

Introduction

This summary was prepared to help agricultural professionals understand the basic requirements of organic certification. It is not comprehensive and is not a substitute for the regulatory text. Producers and handlers who seek certification are encouraged to read the National Organic Program (NOP) rule in its entirety and contact their certification agent if they have specific questions about certification of their operations. Certification agencies seeking guidance on accreditation are encouraged to contact the USDA staff responsible for the accreditation program.

• Subpart A: Definitions
• Subpart B: Applicability
• Subpart C: Organic Production and Handling Requirements
  
  • Crop Production
  • Livestock Production
  • Handling
• Subpart D: Labels, Labeling, and Market Information
• Subpart E: Certification
• Subpart F: Accreditation and Certifying Agents
• Subpart G: Administrative
  
  • The National List of Allowed and Prohibited Substances
  • State Organic Programs
  • Fees
  • Compliance
  • Adverse Action Appeal Process

Subpart A: Definitions

The regulation defines key terms used in the standards. Other words not defined are assumed to be under their common meaning.

Subpart B: Applicability

The NOP is a labeling law that applies to all products identified as ‘organic,’ in whole or in part. Operations that produce and handle organic products must be certified under the NOP, with a few significant exemptions and exclusions.

§205.100 What has to be certified.

1. All organic production and handling operations are required to be certified unless they are exempt or excluded from certification.
2. Production or handling operation certified by an accredited certifier prior to October 21, 2002 remain certified.
3. Anyone who knowingly sells or labels a product as ‘organic’ that does not comply with the NOP may be subject to a $11,000 civil penalty, per violation.
4. It is a Federal offense subject to fines and up to five years imprisonment to make a false statement under the NOP to USDA officials, state program officials, or accredited certifying agents.

§205.101 Exemptions and exclusions from certification.

Exemptions

1. Producers and handlers that sell less than $5,000 worth of organic products per year are exempt from organic certification requirements. Such products must be produced and handled according to NOP Regulations in order to be labeled “organic.”
2. Organic products from exempt producers and handlers may not be used as organic ingredients in processed organic food products or as organic feed by certified organic livestock producers, but may be sold at farmers' markets, roadside stands, and retail stores as organic.
3. Retail food stores are exempt from organic certification requirements.
4. Processors that produce products with less than 70 percent organic ingredients or limit their organic claims to the information panel are exempt from organic certification requirements.
5. Exempt handlers must maintain records to track organic ingredients and verify quantities of organic products produced.

Exclusions

1. Handlers that only sell packaged organic food products, such as produce and grocery distributors, are excluded from organic certification requirements.
2. Retailers, including establishments that prepare and serve food to consumers, are also excluded from the organic certification requirements.
3. Excluded operations must prevent commingling of organic and nonorganic products; prevent contamination of organic products with prohibited substances; must maintain records of organic handling activities for at least 3 years; and are subject to specific label requirements.

§205.102 Use of the term, “organic.”

The NOP requirements apply to agricultural products sold, labeled, or represented as “100 percent Organic,” “Organic,” and “Made with Organic Ingredients.”

§205.103 Recordkeeping by certified operations.

Operations must maintain records that fully disclose all activities and transactions of the operation; demonstrate compliance with the Act; are maintained for 5 years; and are available for inspection.

§205.105 Allowed and prohibited substances, methods, and ingredients in organic production and handling.

1. Synthetic substances are prohibited for use in crop or livestock production unless specifically allowed on the National List.
2. Nonsynthetic (natural) substances are allowed in crop or livestock production unless specifically prohibited on the National List.
3. Nonagricultural substances used in or on processed organic products must be on the National List.
4. Nonorganic agricultural substances used in or on processed organic products must be on the National List.
5. Genetically modified organisms (defined as “excluded methods”) are prohibited for use in organic production or handling, except for animal vaccines that appear on the National List.
6. Ionizing radiation is prohibited to preserve or disinfect organic food.
7. Sewage sludge is prohibited.

Subpart C: Organic Production and Handling Requirements

§205.200 General.

Organic production practices (for crop and livestock operations) must maintain or improve the natural resources of the operation, including soil and water quality.

§205.201 Organic production and handling system plan.

All producers and handlers are required to have an organic system plan, approved by an accredited certification agency, which must:

1. Identify the practices and procedures performed.
2. List all materials that will be applied to the land or used within the handling facility, including information on the composition, source, and location where the substance is used. If use of a material is restricted, the plan must address those restrictions.
3. Describe the monitoring practices used to evaluate the effectiveness of the organic plan.
4. Describe the recordkeeping system used by the operation.
5. Describe how the operation prevents commingling or contamination of organic food products.
6. Certifying agents may require additional items to be included in the plan to determine if an operation meets the organic requirements.

Crop Production

§205.202 Land requirements.

1. Fields or parcels from which organic crops are harvested must meet specific soil fertility and crop nutrient management standards.
2. Prohibited substances cannot be applied within three years of the harvest of an organic crop.
3. Distinct, defined boundaries and buffer zones must be established to prevent drift, runoff, or any other source of unintended contamination of an organic crop by a prohibited material applied to adjoining land that is not under organic management.

§205.203 Soil fertility and crop nutrient management practice standard.

1. Organic producers must select tools and practices that maintain or improve soil quality and minimize soil erosion.
2. Producers are required to rotate crops, plant cover crops, and use plant and animal materials to maintain or improve soil organic matter content in a manner that does not contaminate crops, soil, or water by plant nutrients, pathogens, heavy metals, or residues of prohibited substances.
3. Producers are also required to maintain or improve soil quality by adding animal and plant materials.
4. Manure must be composted or must be incorporated into the soil at least 120 days before crops with edible portions that are in contact with the soil are harvested for human consumption; or 90 days prior to harvest for crops whose edible portion does not contact soil or soil particles.
5. Compost must be made according to parameters of method, time and temperature designed to reduce pathogens.
6. Mined minerals are allowed, with mined minerals of high solubility subject to restrictions.
7. Synthetic fertility inputs on the National List are allowed, subject to restrictions.
8. Synthetic fertilizers not on the National List and sewage sludge are prohibited.
9. The burning of crop residues is prohibited, except to prevent disease or to stimulate seed germination.
10. Ash from the burning of plant or animal material is allowed, but manure ash is prohibited.

§205.204 Seeds and planting stock practice standard.

1. Annual seedlings must be organically grown, unless the USDA grants a temporary variance due to a natural disaster.
2. Perennial transplants must be organically grown for one year prior to harvest.
3. Organic seeds are required. An exception may be made only if a variety or its equivalent is commercially unavailable. Organic seeds must be used for organic edible sprouts, with no exceptions.
4. Seeds cannot be treated with prohibited substances, even when they are not organically produced, unless treatment is required by phytosanitary restrictions.
5. Genetically engineered seeds, planting stock, and seed innoculants are prohibited.

§205.205 Crop rotation practice standard.

Producers of annual crops must maintain or improve soil organic matter; provide pest management; manage nutrients; provide erosion control; and provide habitat by rotating, planting, and maintaining cover crops, catch crops, and beneficial habitat. Perennial crop producers must meet the some objectives by using alley cropping, inter cropping, and hedgerows to introduce biodiversity, in lieu of a crop rotation.

§205.206 Crop pest, weed, and disease management practice standard.

1. Producers must use cultural and biological practices to prevent crop pests, weeds, and diseases, such as crop rotation, nutrient management, and sanitation measures.
2. Insect pests may be prevented by beneficial insects, natural habitat enhancement, and the use of lures, traps and repellents.
3. Weeds may be controlled by mulching with biodegradable materials, mowing, grazing, mechanical cultivation, hand weeding, or flame, electrical or heat treatments.
4. If plastic mulch is used, it must be removed at the end of the growing or harvest season.
5. Biological or botanical substances or materials on the National List may be used only if preventative practices are not adequate to prevent or control pests, weeds or diseases.
6. Producers must not use lumber treated with arsenic or other prohibited substances for new installations or replacement purposes in direct contact with soil or livestock.

§205.207 Wild-crop harvesting practice standard.

Wild crops can be sold and labeled as organic as long as no prohibited materials have been applied to the land for 3 years prior to harvest and harvest of the crop is not destructive to the environment and will sustain the growth and production of the wild crop.

Livestock Production

§205.236 Origin of livestock.

1. Poultry and edible poultry products (meat and eggs) must be from poultry that has been under organic management since the second day of life.
2. Slaughter stock (animals raised for their meat, e.g. cattle, pigs, sheep) must be under organic management since the last third of gestation.
3. Dairy animals must be under organic management for at least one year prior to the production of organic milk.
4. A producer may feed farm-raised, third-year transitional feed and forage for one year prior to organic milk production.
5. Once an entire, distinct dairy herd has been converted to organic production, all dairy animals shall be under organic management from the last third of gestation.
6. Breeder stock may be brought onto an organic farm from a nonorganic operation prior to the last third of gestation. Breeder stock must be under organic management during the last third of gestation in order to produce organic offspring.
7. Animals must not be rotated between organic and nonorganic production.
8. Livestock producers must maintain records that preserve the identity of all organic animals and edible and nonedible organic products.

§205.237 Livestock feed.

1. Organic livestock must be fed organic feed.
2. Organic feed may contain feed additives and feed supplements that are either non-synthetic (natural) or are synthetic and appear on the National List. Agricultural ingredients, such as carriers, in feed supplements must be organic.
3. Animal drugs cannot be used to promote growth.
4. Feed supplements or additives cannot be used in amounts in excess of basic nutritional needs of the animal species at a given stage of life and must comply with FDA regulations.
5. Feeds containing urea, manure, mammalian or poultry slaughter by-products, antibiotics (including ionophores), or plastic pellets are prohibited.
6. Organic livestock producers must not prevent, withhold, restrain, or otherwise restrict ruminant animals from actively grazing during the grazing season.
7. During the grazing season, at least 30% of ruminant animals' dry matter intake shall be from grazing. 
   (Note: "Grazing season" is defined as "the period of time when pasture is available for grazing, due to natural precipitation or irrigation. Grazing season dates vary because of mid-summer heat/humidity, significant precipitation events, floods, hurricanes, droughts or winter weather events. Grazing season may be extended by the grazing of residual forage as agreed in the operation's organic system plan. Due to weather, season, or climate, the grazing season may or may not be continuous. Grazing season may range from 120 days to 365 days, but not less than 120 days per year.")  
8. Ruminant livestock producers must:
   a) in the operation's organic system plan, describe the total feed ration for each type and class of animal produced, including all feed produced on farm, all purchased feed, the percentage of each feed type, (including pasture), in the total ration, and list all feed supplements and additives;
   b) document the amount of each type of feed acutally fed to each type and class of animal;
   c) document changes made to all rations throughout the year in response to seasonal grazing changes; and
   d) provide the method used by the operation for calculating dry matter demand and dry matter intake.

§205.238 Livestock health care practice standard.

1. Organic livestock producers must use preventative health care practices such as: selection of disease- and parasite-resistant species and breeds; vaccination; balanced nutrition; sanitation; pasture rotation; exercise; freedom of movement; and stress reduction. Organic livestock producers may perform physical alterations to promote an animal’s welfare, if they are performed in a manner that minimizes pain and stress.
2. When preventative practices are not adequate to prevent sickness, producers may use medications that are either non-synthetic or synthetic and allowed on the National List.
3. Synthetic internal parasiticides may be used on breeder stock prior to the last third of gestation and on dairy stock at least 90 days prior to organic milk production, when preventative measures fail.
4. Antibiotics are prohibited for all slaughter stock, poultry, and dairy stock.
5. It is prohibited to administer any medication or drug in the absence of illness.
6. Hormones are prohibited.
7. It is prohibited to withhold medical treatment from a sick animal to preserve it organic status. Livestock and products from livestock treated with prohibited substances must be clearly identified and not sold as organic.

§205.239 Livestock living conditions.

1. Producers must give livestock access to the outdoors, shelter, fresh air, exercise areas, fresh air, clean water for drinking, and establish clean, dry living conditions that accommodate the animal’s heath and natural behavior.
2. Ruminants are required to have access to pasture during the grazing season, which must not be less than 120 days/year. Ruminants must receive at least 30% of their dry matter intake from grazing pasture during the grazing season.
3. Organic animals must be provided with appropriate clean, dry bedding. If the bedding is comprised of forage, it must be organic.
4. Animals may be temporarily confined because of inclement weather; the animal’s stage of life; risk to the animal’s health or safety; preventative health care procedures or treatments; sorting, shipping, breeding, birthing or milking; youth projects, demonstrations or fairs; shearing; or risk to soil or water quality.
5. Ruminant slaughter animals are excempt from 30% dry matter intake from grazing requirements during a finishing period, which shall not exceed one-fifth of the animal's total life or 120 days, whichever is shorter.
6. The producer must manage manure to optimize the recycling of nutrients and avoid contamination of crops, soil or water.

§205.240 Pasture practice standard.

1. Pastures must be managed as crops in compliance with organic crop production requirements.
2. All organic ruminant producers must implement a pasture management plan as part of the operation's organic system plan. The pasture plan must describe:
   a) The types of pasture provided;
   b) The management practices used to ensure adequate forage is available to meet 30% dry matter intake requirements;
   c) The grazing season for the operation;
   d) Location and sizes of all pastures, as shown on maps;
   e) Types of grazing methods used;
   f) Location and types of fences, location and source of shade, and location and source of water; 
   g) Soil fertility and seeding systems; and 
   h) Measures taken to prevent erosion and protect natural wetlands and riparian areas.

Handling

§205.270 Organic handling requirements.

1. Processors are permitted to use various physical and mechanical methods. Organic food may be cut, separated, extracted, fermented, mixed, dehydrated, heated, chilled, or frozen, among other things. Organic food may also be packaged or enclosed in a container such as a can or jar.
2. All ingredients and processing aids used in “100% organic” food must be 100% organic.
3. All agricultural ingredients in “organic” food must be organic and comprise at least 95% of all ingredients by weight or fluid volume, minus added water and salt.
   1. In the 5% non-organic fraction, allowance is made for agricultural and non-agricultural ingredients that appear on the National List.
   2. Agricultural ingredients on the National List may be used, if the ingredients are verified as not commercially available in organic form.
   3. Volatile solvents and other synthetic processing aids that do not appear on the National List are prohibited for use on organic ingredients or to process organic food.
   4. All organic and non-organic ingredients must not be genetically engineered, grown using sewage sludge, or irradiated if an organic claim is made anywhere on the label.

§205.271 Facility pest management practice standard.

1. Pests must be managed by preventive measures such as habitat management, exclusion, sanitation, and disruption of pest reproduction.
2. Pests may also be managed by mechanical, physical, and non-lethal controls such as traps, or natural and allowed synthetic lures and repellents.
3. If preventative, mechanical, physical, and non-lethal practices are not adequate, the handler may use pesticides that are on the National List consistent with that purpose.
4. If preventative, mechanical, physical, non-lethal, and allowed pesticides are not adequate, the handler may use other pesticides in a plan approved by the certifier, provided that the application is made in a way that prevents the organic products, ingredients or packaging from coming in contact with the pesticide.
5. Pesticides required for government quarantine programs may be applied to organic food.

§205.272 Commingling and contact with prohibited substance prevention practice standard.

1. The handler is required to prevent mixing of organic and nonorganic ingredients or products.
2. The handler must prevent organic products from contacting prohibited substances.
3. Containers and packaging materials must not contain preservatives, fungicides, or fumigants.
4. Containers may be reused as long as they are thoroughly cleaned and pose no risk of contact with prohibited substances.

§205.290 Temporary variances.

1. The USDA may grant temporary variances because of natural disasters or to conduct research.
2. Temporary variances will not be granted for the use of prohibited substances; genetically modified organisms; irradiation; or sewage sludge.

Subpart D: Labels, Labeling, and Market Information

The NOP has five label categories for organic food:

1. 100 percent organic – All ingredients and processing aids must be 100% organic.
2. Organic – At least 95% of ingredients must be organic, with strict limitations on the non-organic ingredients.
3. Made with organic ingredients – At least 70% of ingredients must be organic, with some restrictions on the non-organic ingredients.
4. Products with less than 70% organic ingredients — Organic ingredients cannot exceed 70% of the product, and there are no restrictions on the non-organic ingredients.
5. Organic Livestock feed — Livestock feed sold as organic must conform to the organic livestock feed requirements.

§205.300 Use of the term, “organic.”

The word “organic” may be used only to identify food or ingredients that comply with the NOP. The word “organic” must not be used on a product label to modify a non-organic ingredient. Products for export may be labeled to meet the receiving countries’ specifications as long as they are labeled “for export only.” Products imported to the United States from foreign countries must be certified and labeled according to the NOP regulations.

§205.301 Product Composition.

1. 100 percent organic – All ingredients and processing aids used in 100% organic food must be 100% organic.
2. Organic – At least 95% of ingredients must be organic. All agricultural ingredients in the product must be either organic or on the National List and not commercially available in organic form. All non-organic agricultural ingredients must not be genetically engineered; irradiated; produced from sewage sludge; or be produced with a volatile synthetic solvent. All non-agricultural ingredients and processing aids used must be approved on the National List.
3. Made with organic ingredients – At least 70% of ingredients must be organic. All non-organic agricultural ingredients must not be genetically engineered; irradiated; or produced from sewage sludge. All non-agricultural ingredients and processing aids must be approved on the National List.
4. Products with less than 70% organic ingredients. All organic ingredients must be produced in compliance with the NOP regulations. There are no restrictions on the non-organic ingredients used in this labeling category.
5. Livestock feed – Organic livestock feed must include only organic agricultural ingredients, including organic fillers and carriers, and approved feed additives and supplements.

§205.302 Calculating the percentage of organically produced ingredients.

The percentage of organic ingredients is calculated by dividing the sum of the organic ingredients by the sum of all ingredients, by weight or fluid volume at formulation, minus any added water and salt. Water and salt are excluded from ingredient calculations and are ineligible to be labeled as organic.

§205.303 Packaged products labeled “100 percent organic” or “organic.”

• Optional: Products in these categories may display on the principal display panel the term “100 percent organic” or “organic” as appropriate; the percentage of organic ingredients; the USDA seal; and the seal of the state or private certification agency.
• Required: Products in these categories must identify each organic ingredient as organic and the name of the certifying agent.

§205.304 Packaged products labeled “made with organic (specified ingredients or food groups(s)).”

• Optional: Products in this category may display on the principal display panel the term “made with organic (specified ingredients)” as appropriate in letters that do not exceed one-half the size of the product identity; the percentage of organic ingredients, and the seal of the state or private certification agency.
• Required: Products in this category must identify each organic ingredient and the certifying agent.
• Prohibited: Products in this category must not display the USDA seal.

§205.305 Multi-ingredient packaged products with less than 70 percent organically produced ingredients.

• Optional: Products in this category may identify each organic ingredient in the ingredient statement; if the organic ingredients are identified on the ingredients statement then the percentage of organic ingredients may be displayed on the information panel.
• Prohibited: Products in this category must not display the word “organic” on the principal display panel; the USDA seal; the seal of the state or private certification agency; or the statement “Certified organic by … (name of certifying agent).”

§205.306 Labeling of livestock feed.

• Optional: Organic livestock feed may display the following on any package panel: the USDA seal; the seal of the state or private certification agency; the term “100 percent organic” or “organic” as appropriate; and identify each organic ingredient.
• Required: Organic livestock feed must display the name of the certifying agent on the information panel.

§205.307 Labeling of nonretail containers used for only shipping or storage of raw or processed agricultural products labeled as “100 percent organic,” “organic,” or “made with organic (specified ingredients or food group(s)).”

• Optional: These products may display identification of the product as organic; the name of the certifying agent; the seal of the state or private certification agency; and the USDA seal.
• Required: These products must display the production lot number to maintain identity of organic products. Products for export may be labeled in accordance with foreign labeling requirements provided that they are labeled “For Export Only.”

§205.308 Agricultural products in other than packaged form (e.g. produce, bulk food) at the point of retail sale that are sold, labeled, or represented as “100 percent organic” or “organic.”

• Optional: Retailers may display on non-packaged “100 percent organic” and “organic” products (e.g. produce, bulk food) as follows: the term “100 percent organic” or “organic” as appropriate; the seal of the state or private certification agency; and the USDA seal.

§205.309 Agricultural products in other than packaged form (e.g. bulk food) at the point of retail sale that are sold, labeled, or represented as “made with organic (specified ingredients or food groups).

• Optional: Retailers may display on non-packaged “made with organic (specified ingredients)” products (e.g. bulk food) as follows: the seal of the state or private certification agency; the term “made with organic (specified ingredients)” as appropriate in letters that do not exceed one-half the size of the product identity; and each organic ingredient identified.

§205.310 Agricultural products produced on an exempt or excluded operation.

• Optional: Organic products from exempt or excluded operations may identify organic products as organic. These organic products may not be used as an organic ingredient in processed organic products or as organic feed by an organic livestock producer.
• Prohibited: Organic products from exempt or excluded operations must not display: the USDA seal; the seal of a state or private certification agency; or otherwise represent the product as certified organic.

§205.311 USDA Seal.

Subpart E: Certification

§205.400 General Requirements for certification.

1. Persons seeking to receive or maintain organic certification must: comply with the standards; establish, implement, and annually update an organic system plan; be inspected annually; maintain records for five years; and pay annual application/certification fees.
2. Certified operations are required to immediately notify the certifying agent: if a prohibited substance has been applied or contaminates any part of the organic operation; and of any changes to the operation or portion of the operation that may affect its organic status.

§205.401 Application for certification.

An applicant must describe the operation that is applying for certification; submit an organic system plan; and pay the appropriate fees. The certifying agent needs to be informed if the operation has previously applied for certification, and tell the certifying agent of any previous findings of non-compliance and the corrective actions taken on those non-compliances.

§205.402 Review of application.

1. The certifying agent must review the application and inform the applicant whether the operation appears to comply with the NOP.
2. The certifying agent must schedule an inspection to determine whether the applicant qualifies for certification.
3. The applicant may withdraw application at any time.

§205.402 On-site inspections.

1. Initial inspection must be conducted within six months, at a time when compliance with the standards and the plan can be observed.
2. Certifying agents have the discretion to conduct additional inspections, which may be either announced or unannounced.
3. Inspectors must be knowledgeable about the operation.
4. The inspection must verify whether the operation: (a) complies with the NOP; (b) is carrying out the organic system plan; and (c) is not using prohibited substances.
5. Inspectors must conduct an exit interview to discuss known issues of concern and identify missing information. The inspector does not make the certification decision, however.
6. The certifying agent must provide a copy of the inspection report to the inspected operation.

§205.404 Granting certification.

1. The certifying agent must review the on-site inspection report within a reasonable time frame and grant certification, if the operation is in compliance with the organic regulations.
2. The criteria for granting certification are: 1) the applicant’s operation is in compliance with the organic standards; and 2) the applicant is able to conduct operations in accordance with its organic system plan.
3. Once certified, a producer’s or handler’s organic certification continues until it is suspended or revoked by the State Organic Program, or voluntarily withdrawn from the program by the applicant.

§205.405 Denial of certification (Note: This pertains to new applicants only).

1. When an applicant does not comply with the NOP, the certifying agent must notify the applicant of: a) each noncompliance; and b) the deadline to rebut or correct the noncompliance.
2. The applicant has the choice to correct or rebut the noncompliance.
3. A notice of denial of certification is issued when a correction of noncompliance is not possible; when an applicant fails to respond to a notice of noncompliance; or when the corrective actions are not sufficient to qualify for certification.
4. A notice of denial of certification must state the reasons for denial, include information about the applicant’s right to reapply for certification, request mediation, or file an appeal of the denial.
5. An applicant may be denied certification for willfully making a false statement or misrepresenting the applicant’s operation.

§205.406 Continuation of certification (Note: This pertains to renewal applicants only).

1. Certified operations must annually submit an updated organic system plan and pay renewal fees to continue certification.
2. An on-site inspection must be conducted within six months of the renewal date.
3. When a certified operation does not comply with the NOP, the certifying agent must notify the applicant of: a) each noncompliance; and b) the deadline to rebut or correct the noncompliance.
4. The operator has the choice to correct or rebut the noncompliance.
5. A notice of proposed suspension or revocation of certification is issued when a certified operation fails to correct the non-compliance by the deadline and must state: a) the reasons for the proposed revocation; b) the proposed effective date; and c) the right to appeal or request mediation.

Subpart F: Accreditation and Certifying Agents

§205.500 Areas and Duration of Accreditation.

1. The NOP accredits domestic and foreign agents to certify organic production and/or handling operations.
2. Certifying agents may be accredited for crop certification, livestock certification, wild crop certification, handling certification or any combination of certification areas.
3. Accreditation is granted for five years.
4. Foreign certifying agents may be accepted by USDA if: a) the foreign certifier is accredited by the USDA; b) the foreign certifier is accredited by the foreign government authority to meet NOP requirements; or c) the foreign government that accredited the certifier has an equivalency agreement with the United States.

§205.501 General Requirements for Accreditation.

1. A certifier must have the competence and capacity to fulfill minimum requirements and carry out specific duties without conflict of interest.
2. All certifiers must accept the certification decisions made by any other certifying agent accredited or accepted by USDA.
3. Certifiers may not require any additional requirements as a condition for allowing the use of its seal or logo.

§205.502 Applying for accreditation.

Those who seek to be accredited as certifying agents must first apply to the USDA.

§205.503 Applicant information.

An applicant for accreditation must provide the USDA information about the entity; the area of operation, such as crops, livestock or processing; whether the entity is a government, for-profit, or non-profit; and locations where it will operate.

§205.504 Evidence of expertise and ability.

An applicant for accreditation must document its expertise in organic production and handling; qualified personnel; administrative policies; procedures to prevent conflicts of interest; and current certification activities.

§205.505 Statement of agreement.

State and private certification agencies must agree to accept the certification decisions made by another USDA-accredited certifier; refrain from making false or misleading claims in regards to its accreditation status; conduct annual performance evaluations of all persons; have an internal review process; pay required fees; and meet other terms and conditions.

§205.506 Granting accreditation

1. A certifier is accredited when: a) the required information is submitted; b) the fees are paid; and c) the NOP determines that the accreditation criteria have been met.
2. Accreditation is granted for one or more specific areas such as crops, livestock, wild crops, or handling.

§205.507 Denial of accreditation.

If an applicant is unable to comply with the NOP, the NOP must inform the applicant that the application for accreditation has been denied and inform the applicant: a) of each non-compliance; b) the facts behind each non-compliance; and c) the deadline to rebut or correct each non-compliance.

§205.508 Site evaluations.

The NOP conducts site evaluations at least once during the five-year accreditation period to examine a certifier’s compliance with the NOP.

§205.509 Peer review panel

The NOP will establish a peer review panel to review the NOP accreditation policies and procedures and ensure the procedures meet international standards for the assessment and accreditation of certification bodies.

§205.510 Annual report, recordkeeping, and renewal of accreditation.

1. Accredited certifiers must submit an annual report that includes: any changes to the certification program; a description of measures taken to address the terms and conditions of the accreditation; the most recent performance evaluations; the annual program review; and the required fees.
2. Certifiers must maintain required records for ten years.
3. Certifiers must apply every five years to renew their accreditation at least six months prior to the expiration date of their accreditation.

Subpart G: Administrative

The National List of Allowed and Prohibited Substances

Nonsynthetic (natural) substances are allowed to be used in production unless they are specifically prohibited. All synthetic substances are prohibited in production unless specifically allowed. For more information on specific substances, refer to the NOP rule and the OMRI Generic Materials List.

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

Items are added to the National List based on the criteria established in the Organic Foods Production Act. Synthetic processing aids and adjuvants are subject to additional criteria.

§205.601 Synthetic substances allowed for use in organic crop production.

The use of allowed synthetic substances must not contaminate crops, soil, or water. Approved substances, except for disinfectants and sanitizers, may only be used when proactive management practices are insufficient to prevent or control target pests. Synthetic substances that may be used in organic crop production are specified for the following uses and applications:

• algicides, disinfectants, and sanitizers
• herbicides
• compost feedstocks
• insecticides, acaricides, and pheromones
• plant disease controls
• plant and soil amendments
• plant growth regulators
• inert ingredients
• seed preparations

Most of these substances are subject to limits on their use or manufacture, as stated in the rule and restrictive annotations.

§205.602 Nonsynthetic substances prohibited for use in organic crop production.

Natural substances that may not be used in organic crop production are listed in this section, including elemental contaminants, mined minerals of high solubility and salt indexes; and botanical insecticides.

§205.603 Synthetic substances allowed for use in organic livestock production.

Synthetic substances that may be used in organic livestock production are specified for the following uses and applications:

• disinfectants, sanitizers, and medical treatments
• topical treatments, external parasiticides, or local anesthetics
• feed additives and supplements
• excipients and inert ingredients

Most of these substances are subject to limits in the rule and restrictive annotations.

§205.604 Nonsynthetic substances prohibited for use in organic livestock production.

Lists nonsynthetic substances that may not be used in organic livestock production, including botanical preparations.

§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)).”

This part of the National List includes nonagricultural substances that may be used as ingredients or processing aids in or on processed products labeled as “organic” or “made with organic (specified ingredients or food group(s))” subject to restrictions in their annotation. The list is divided into non-synthetic and synthetic substances.

§205.606 Nonorganically produced agricultural products allowed as ingredients in or on processed products labeled as “organic” or “made with organic (specified ingredients or food group(s)).”

The agricultural ingredients on this part of the National List are permitted only when they are verified as commercially unavailable in an organic form. Many also have restrictive annotations.

§205.607 Amending the National List.

Any person may file a petition to add materials to or remove from the National List.

State Organic Programs

The NOP provides four options for states.

1. A state may be a state certifying agent.
2. A state may have a State Organic Program, which has authority to enforce the NOP in the state.
3. A state may be a state certifying agent and have a State Organic Program.
4. A state may choose to not have a State Organic Program or be a state certifying agent.

§205.620 Requirements of State Organic Programs

1. Any State may establish a State Organic Program subject to USDA approval.
2. State Organic Programs must meet the NOP requirements and assume enforcement obligations of the NOP.
3. A state may have more restrictive requirements because of environmental conditions or specific production or handling practices, if the restriction is approved by the USDA.

§205.621 Submission and determination of proposed State Organic Programs and amendments to approved State Organic Programs.

A state must apply to the USDA in order for a State Organic Program to be approved under the NOP.

§205.622 Review of approved State Organic Programs.

The NOP must review State Organic Programs at least once every five years.

Fees

Sections 205.640 and 205.641 205.642.

The USDA establishes costs for accreditation.

§205.642 Fees and other charges for certification.

1. Certifiers are required to charge reasonable fees for the certification services they provide.
2. Certifiers are required to publish their fee schedules and provide justification for any nonrefundable fees that are charged.

Compliance

The NOP compliance proceedings are similar to administrative procedures of many states.

§205.660 General

The NOP may conduct inspections or initiate revocation proceedings against a certified operation or a certifying agent’s accreditation.

§205.661 Investigation of certified operations.

Certifying agents and State Organic Programs may investigate complaints of noncompliance with the NOP regulations.

§205.662 Noncompliance procedure for certified operations.

Certifiers and State Organic Programs must follow specific procedures for any compliance action to provide due process for certified operations including notification; resolution options; proposed suspension or revocation notices; responses to willful violations; and suspension or revocation of certification.

§205.663 Mediation.

Mediation is not mandated but is offered as an option to settle a noncompliance proceeding.

§205.665 Noncompliance procedure for certifying agents and 205.668 Noncompliance procedures under State Organic Programs.

The USDA must follow noncompliance proceedings against certifying agents and State Organic Programs respectively found in violation of the NOP.

§205.670 Inspection and testing of agricultural product to be sold or labeled “organic.”

1. Organic food products must be available for sampling by State Organic Programs and certifying agents for pesticide residues, products of genetic engineering, or other prohibited substances, when there is reason to believe that the product is contaminated or come into contact with a prohibited substance.
2. Sample collection, handling, and analysis must meet specific requirements.
3. The certifying agent must provide the NOP the results of all analyses, which are available to the public.
4. Tests are conducted at the certifying agent’s or State Organic Program’s expense.

§205.671 Exclusion from organic sale.

1. The NOP establishes a tolerance level at 5% of the Environmental Protection Agency’s tolerance levels for registered pesticides.
2. Products with residues detected above 5% of the EPA tolerance level, and products with unavoidable residual environmental contamination for which tolerances have been established, cannot be sold as organic.

§205.672 Emergency pest or disease treatment.

1. Allows Federal or State emergency pest or disease control programs to apply prohibited substances to a certified organic operation.
2. Prohibits any crop or product that has come into contact with a prohibited substance to be sold as organic, if the contact occurred as the result of an emergency pest or disease treatment.

Adverse Action Appeal Process

§205.680 General and §205.681 Appeals.

A person who believes that they are adversely affected by a noncompliance decision of the National Organic Program, a State Organic Program, or a certifying agent are allowed to appeal to a U.S. District Court rather than a State Court.

References and Citations

• Agricultural Marketing Service regulations [Online]. United States Department of Agriculture. Available at: http://www.ams.usda.gov/AMSv1.0/ams.fetchTemplateData.do?template=TemplateF&navID=RegulationsNOPNationalOrganicProgramHome&rightNav1=RegulationsNOPNationalOrganicProgramHome&topNav=&leftNav=&page=NOPResourceCenterRegulations&resultType=&acct=noprulemaking (verified 16 March 2010)
• Agricultural Marketing Service National Organic Program Handbook [Online]. United States Department of Agriculture. Available at: http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5096778
  (verified 4 September 2012)