Basic Information about United States Department of Agriculture National Organic Program (USDA-NOP)
Operators who plan to sell organic products to the United States must conduct their organic production in compliance with the United States Department of Agriculture National Organic Program—USDA NOP. Below you may find the basic information on USDA-NOP. For more details, you can also access our content articles prepared comparatively with other Regulations.
The USDA-NOP consists of 4 factors and must be evaluated together for proper understanding. These are:
- 7 CFR Part205 –Organic Regulation;
https://www.ecfr.gov/current/title-7/subtitle-B/chapter-I/subchapter-M/part-205?toc=1
- Program Handbook; This compilation of guidance documents, policy memos, and instructions is intended to clarify policies and assist those who own, manage, or certify organic operations with complying with NOP regulations.
https://www.ams.usda.gov/rules-regulations/organic/handbook
- Organic Foods Production Act of 1990; The Act that established the NOP and its authority to enforce agricultural products sold, labeled, or represented as “organic” within the U.S.
https://www.ams.usda.gov/sites/default/files/media/Organic%20Foods%20Production%20Act%20of%201990%20(OFPA).pdf
- Preamble; If you are interested in the history of the NOP standards, you may want to review the preamble to the final rule, which established the National Organic Program.
https://www.ams.usda.gov/rules-regulations/resource-center-preamble
For the United States, the NOP Final Rule is the ‘valid organic regulation.’
All products to be labeled as “organic” must comply with the criteria defined for organic production and processing throughout the production chain, and these criteria are defined in the Final Rule.
Compliance with these laws must be verified and certified by a Certifying agent accredited by the United States Department of Agriculture.
Therefore, we strongly recommend that you always access the most up-to-date information on NOP rules from the relevant documents on the USDA NOP web page.
https://www.ams.usda.gov/rules-regulations/organic
https://www.ams.usda.gov/grades-standards/organic-standards
Strengthening Organic Enforcement (SOE):
As of March 19, 2024, USDA-NOP updated its Regulation and some related guidance documents in order to strengthen organic enforcement.
Some reasons why Strengthening Organic Enforcement became necessary:
- The insufficiency of definitions in the Standard, especially in complex global supply chains, has created opportunities for fraud in organic products. When the NOP Standard was first implemented, the number of firms and activities under exemption and exception was low and the quantities of organic products were also very small. However, since then, the organic market has grown enormously, and this growth has allowed some firms and activities in the supply chain to operate without being recorded and certified.
- Provisions of the 2018 Farm Bill
- Many recommendations from the National Organic Standards Board
Goals of Strengthening Organic Enforcement:
- Reducing the number of uncertified entities, developing information sharing processes
- Strengthens recordkeeping and supply chain traceability
- Strengthening the oversight of accredited certifying agents
- Simplifying the verification of organic operation certificates, issuance of operation certificates and electronic import certificates in the USDA Organic Integrity Database (OID)
USDA NOP 7 CFR Part205 Subparts
Subpart A: Definitions (205.1, 205.2, 205.3)
Subpart B: Applicability (205.100, 205.101, 205.102, 205.103, 205.105)
Subpart C: Organic Production and Handling Requirements
(205.200 to 205.210, 205.236 to 205.242, 205.270 to 205.273, 205.290)
Subpart D: Labels, labeling, and market information (205.300 to 205.311)
Subpart E: Certification (205.400 to 205.406)
Subpart F: Accreditation of Certifying Agents (205.500 to 205.511)
Subpart G: Administrative (205.600 to 205.607, 205.620 to 205.622, 205.640 to 205.642, 205.660 to 205.668, 205.670 to 205.672, 205.680 to 205.681)
USDA NOP Product Categories
Crops, Livestock, Processed Products, Wild crops
According to USDA NOP, mushroom production falls under the category of crop and, as of March 21, 2025, is explained in much greater detail in § 205.210. The deadline given for full compliance of organic mushroom producers with the rules specified in the Regulation is March 22, 2027. To better understand the process of publishing the organic mushroom production rules according to USDA NOP, we recommend that you review the link provided and confirm the information with your certifying agent. In addition, you may read our content article on organic mushroom production.
§ 205.2 Terms
During the Strengthening Organic Enforcement process, some terms were updated. In order to increase consumer confidence in organic products and to better understand the subject of exemption from certification, definitions such as Handle, Handler were updated so that institutions know their boundaries. For example:
Handle: To sell, process, or package agricultural products, including but not limited to trading, facilitating sale or trade on behalf of a seller or oneself, importing to the United States, exporting for sale in the United States, combining, aggregating, culling, conditioning, treating, packing, containerizing, repackaging, labeling, storing, receiving, or loading.
From the time a product is produced, as it moves along the supply chain, in order to ensure that its organic status is not compromised, this renewed definition has been broadened and also includes activities present in the modern industry.
Handler: Any person that handles agricultural products, except final retailers of agricultural products that do not process agricultural products.
Handling operation: Any operation that handles agricultural products, except final retailers of agricultural products that do not process agricultural products.
Retail establishment: Restaurants, delicatessens, bakeries, grocery stores, or any retail business with a restaurant, delicatessen, bakery, salad bar, bulk food self-service station, or other eat-in, carry-out, mail-order, or delivery service of raw or processed agricultural products.
The term retail food establishment has been renamed as retail establishment, and its definition has been expanded to include sales methods commonly used in the modern market. In today’s age of electronic and internet commerce, it is also intended to include direct-to-consumer sales names.
§ 205.101 Exemptions from Certification
Before the Strengthening Organic Enforcement (SOE), this article was entitled ‘Exemptions and exclusions from certification’; the word exclusions has been removed, and it has been updated as ‘Exemptions from certification.’
Operations listed in § 205.101 (a) through (h) are exempt from certification under subpart E of this part and from submitting ‘organic system plan-OSP’ for acceptance or approval under § 205.201 but must comply with the applicable organic production and handling requirements of subpart C, the applicable labeling requirements of Subpart D, and all requirements described in 205.101.
On the other hand; exempted activities are not completely risk-free. To address this risk, certified operations must include the monitoring of exempt activities in their organic system plans. The certifying agent will also assess the risk of exempt operations in the supply chain. Generally, certification exemption is possible for operations under the supervision of the main company, where it is ensured that the organic integrity of the products will not be affected. If necessary, depending on the risk assessment, the certifying agent will also inspect these activities.
Regarding exempt operations, we strongly recommend that you carefully read the other relevant Regulation articles and follow the information provided by your certifying agent. (§ 205.101 (i): Recordkeeping of exempt operations, § 205.310: Labeling rules for agricultural products produced or processed at an exempt operation)
§ 205.105 Allowed and prohibited substances, methods, and ingredients in organic production and handling
Unlike other Regulations, USDA-NOP lists not only permitted but also prohibited substances, methods, and ingredients. These lists are included within USDA-NOP 7 CFR Part205, and there are no additional regulations or annexes where they are listed.
Also unlike other Regulations, hanbook documents have been prepared to help assess the compliance of substances, methods, and ingredients intended to be used in organic production with USDA NOP. You may find detailed information on this topic in our content articles prepared on Plant Protection and Fertilizer materials. The most critical issue is that not only the active ingredients of substances to be allowed but also the inert ingredients must comply with United States laws.
§ 205.201 Organic Production and Handling System Plan—OSP
With the Strengthening Organic Enforcement, an important requirement added to the OSP is the ‘organic fraud prevention plan.’ Accordingly, § 205.201-a/3:
The organic production or handling system plan must include a description of the monitoring activities and procedures to be carried out and maintained, including the frequencies with which they will be performed, in order to verify that the Plan is being effectively implemented. This must include a description of the monitoring activities and procedures, appropriate to the certified operation’s activities, scope, and complexity, for verifying the organic status of suppliers and agricultural products received in the supply chain, and for preventing organic fraud.
Organic fraud: Deceptive representation, sale, or labeling of nonorganic agricultural products or ingredients as “100 percent organic,” “organic,” or “made with organic (specified ingredients or food group(s)).”
Another important requirement added to the OSP is the description of the internal control system in group operations. Please review § 205.201-c. We also recommend that you evaluate our content article on group operations.
§ 205.202 Land Requirements
This is one of the most important aspects that distinguish USDA-NOP from other regulations. During the transition period, no prohibited input should be applied to the land, and the land must be managed in accordance with the regulation for a period of 3 years. There are no transition categories; products can be sold conventionally in the first two years. Products can be sold as organic once the 3-year period is completed, if the products are suitable for organic certification according to NOP.
§ 205.273 Imports to the United States
With the Strengthening Organic Enforcement, the ‘NOP import certificate’ has become mandatory, regardless of the country of origin. The NOP import certificate, also known as the ‘transaction certificate,’ provides information about the origin and quantity of the product. It guarantees that the product specified is organic and can be marketed and presented as organic. The NOP import certificate is issued electronically through the Organic Integrity Database.
§ 205.301 Product Composition
USDA-NOP has 4 labeling categories. These are:
- 100% organic: A raw or processed agricultural product sold, labeled, or represented as “100 percent organic” must contain 100 percent organically produced ingredients.
- Organic: A raw or processed agricultural product sold, labeled, or represented as “organic” must contain not less than 95 percent organically produced raw or processed agricultural products.
- Made with organic: Must contain at least 70 percent, by weight or fluid volume excluding water and salt, of ingredients produced and processed in compliance with the requirements of Subpart C.
- Produced with less than 70 percent organic products: Multiingredient agricultural product sold, labeled, or represented as “made with organic (specified ingredients or food group(s))” must contain at least 70 percent organically produced ingredients which are produced and handled pursuant to requirements in subpart C of NOP Regulation.
According to USDA-NOP, detailed labeling rules can be found in 7 CFR Part205, Subpart D—Labels, Labeling, and Market Information.