Strengthening Organic Enforcement Frequently Asked Questions

Topics

General Questions
Organic Certification and How to Get Certified
Exemptions
Organic Imports and Import Certificates
For Customs Brokers: Import Procedures
Sector-Specific Questions

General Questions

Q1. What is the Strengthening Organic Enforcement (SOE) final rule and how do I learn about it?

The SOE rulemaking updates the USDA organic regulations to strengthen oversight of the production, handling, and sale of organic products. The final rule published in the Federal Register on January 19, 2023. The rule was fully implemented on March 19, 2024.

Potentially impacted businesses should read the rule to determine how it may affect them. To learn more, access the final rule, related documents, training materials and other resources:

Q2. When am I required to comply with the SOE final rule regulatory updates?

The SOE final rule implementation period ended on March 19, 2024. Farms, businesses and other entities working in organic supply chains are now required to comply with the new regulations. We understand that not all operations that must be certified completed the certification process before the March deadline. We will take into account the progress an operation has made against that goal when considering enforcement action. Entities that need to get certified under the rule need to apply for certification to avoid penalties under the Organic Foods Production Act (OFPA).

Q3. What are the different types of certificates associated with organic products?

  • Operation certificate: An organic operation certificate is the documentation that indicates a farm or business is certified as an organic operation under the USDA or equivalent organic regulations. The operation certificate allows that farm or business to sell, label, or market its products as organic. Organic operation certificates are issued by certifiers out of the Organic Integrity Database and contain a 10-digit NOP identification number.
  • NOP Import Certificate: An NOP Import Certificate must be associated with certified organic products imported to the United States. Prior to the March 19, 2024, implementation date, the NOP Import Certificate was issued in paper form and was optional in many cases. With SOE implementation, an NOP Import Certificate must be issued electronically for any certified organic shipment entering the United States. NOP Import Certificates must be issued from the Organic Integrity Database by the certifier of the exporter. These certificates must be issued prior to the date of export and contain a 21-character (19 numbers and 2 dashes) identifier.

Organic Certification and How to Get Certified

Q4. Who needs to be certified?

Except for exempt operations, any operation that produces or handles organic agricultural products must be certified. In general, handle means to “sell, process, or package” organic products. The definition of handle also includes the following activities where there may be physical contact with agricultural products: combining, aggregating, culling, conditioning, treating, packing, containerizing, repackaging, labeling, storing, receiving or loading. Handling also includes the following activities where there may not be physical contact with the product: selling, trading, facilitating sale or trade, importing and exporting. This list of handling activities is not exhaustive.

This means that most entities doing business in organic trade need to be certified: there are very few exceptions to this. Further, a buyer may contractually require organic certification for its suppliers or handlers, even if the entities are legally exempt under the rule. We encourage certification of all entities working in organic trade.

Q5. How do I get certified?

There are five basic steps for organic certification under the USDA organic regulations. The time needed to complete the organic certification process varies based on the business size and complexity, as well as the selected certifier.

  1. Choose a USDA-accredited certifier and apply for organic certification:

    Certifying agents, or certifiers, are authorized by the USDA to certify your business as organic. The first step to certification is to choose a certifying agent that fits your needs. You may wish to contact multiple certifiers to find one with expertise in your line of business.

    Your certifier will provide an application and fee schedule. You will also need to write an Organic System Plan (OSP) describing how your business practices meet organic standards. In it, you explain how your business operations and systems comply with the rules. In many areas, the organic regulations allow for multiple approaches to achieve compliance.
  1. Application Review

    Your certifier will review your application. If your application is complete and your OSP meets the organic standards, the certifier will schedule an inspection.
  1. Onsite Inspection

    An inspector representing your certifier will visit your business to assess your organic practices and assess whether your organic practices match your OSP.
  1. Review

    Your certifier will review the inspection report and determine your compliance with the organic standards. You may need to make some changes if you do not fully meet the requirements.
  1. Certifier Decision

    If you are fully compliant with the regulations, your certifier will issue you an organic operation certificate. To maintain organic certification, your certified organic business will go through an annual review and inspection process.

Businesses located outside of the United States must be certified in one of the following ways to do business in the U.S. organic market:

  • Certified to the USDA organic regulations using the process above.
  • Certified to a trade partner’s organic standard – The U.S. has established organic equivalence arrangements with Canada, Japan, Korea, Switzerland, Taiwan, the United Kingdom and the European Union (includes all member countries). Equivalence arrangements allow the trade of organic products between partner countries.
  • Certified to the USDA organic regulations by a certifier accredited by an authorized foreign government – The U.S. has established recognition agreements with Israel and New Zealand. Recognition agreements allow a foreign government to accredit certifying agents in that country to the USDA organic standards.

Businesses may visit our international trade web page for more information on how to get certified to one of our trade partner’s organic standards.

Q6. I am selling organic products to another business. Do I need to make sure my buyer is certified organic?

In general, sellers of organic product are not responsible for the certification status of their buyers. This is because some buyers – like restaurants and retail establishments – may be exempt under the rule. Sellers, however, must confirm the organic certification status of their suppliers. The GLOBAL INTEGRITY database provides up-to-date information on the status of businesses certified to the USDA or a trade partner’s organic standards.

As part of our risk-based approach to oversight, NOP will investigate reports of uncertified entities doing business in organic trade.

Q7. My certifier (or my buyer’s certifier) is asking for a lot of information. Is this normal?

The organic certification process is designed to be decentralized, and certifiers are responsible and accountable for operation-level compliance. This means NOP cannot provide feedback about why a certifying agent or a customer’s certifying agent is requiring a business to complete a specific form or submit specific documentation. Certifying agents are responsible for verifying that the operations they certify comply with all parts of the USDA organic regulations that apply to that business’ specific activities. Because the activities of organic businesses vary widely, certifiers may need to request information from operations and the businesses in that operation’s supply chain to determine which requirements are applicable and subsequently verify compliance with those requirements.

If it is unclear why a certifying agent is requiring the submission or completion of certain documentation, ask the certifying agent to explain why the information is needed. Businesses are responsible for demonstrating how they are complying with the rules - and there may be multiple ways to comply. Once you understand what the certifier is looking for and why (what part of the regulations they are addressing), you may be able to demonstrate your compliance using an approach that aligns with your specific business operations and systems for ensuring organic integrity. Reading the rule will help you in explaining how your approach is compliant. This gives you agency in this process.

Q8. What must be included on nonretail container labels?

Nonretail containers used to ship or store organic products must be clearly labeled with a statement that identifies the product as organic. Clearly visible organic identification alerts handlers that the contents of the nonretail container may require special care, thus reducing accidental mishandling of the product, like treatment with a prohibited substance or commingling with conventional product during transport and storage. Operations may use abbreviations or acronyms to identify products as organic, provided that they are clear and easily understood. This provides flexibility for operations to meet the requirements of § 205.307(a)(1) and makes it easier to label containers with limited space or containers that are difficult to label due to their size, shape, material, or use.

Nonretail containers must also be clearly labeled with information that links the container to audit trail documentation (see § 205.2 for definition of audit trail). This could be a production lot number, shipping identification, or other unique information that handlers can use to trace the container to its associated audit trail documentation. This creates a clear link between container and audit trail and minimizes the size of labels by allowing some information to be listed in associated documentation, instead of directly on the nonretail container label. Operations may use temporary labels or signage to meet the requirements of § 205.307(a). This provides additional flexibility for containers that may be difficult to label due to size, shape, material, or use.

When developing or updating their Organic System Plan (OSP), operations seeking certification can propose to their certifiers the labeling solutions they believe to be compliant based on their understanding of SOE requirements and knowledge of their own operation.

Q9. How do I develop a fraud prevention plan?

The SOE final rule requires that all certified operations maintain and implement practices to verify the organic status of suppliers and products in their supply chain and to prevent organic fraud. Collectively, these practices are often called “fraud prevention plans.” The fraud prevention plan must be included in an operation's Organic System Plan (OSP).

The scale of the fraud prevention plan varies based on the activities, scope, and complexity of the operation. For example, a producer who does not handle another operation's organic products has a lower risk of experiencing organic fraud. Such a producer may develop a simple fraud prevention plan that includes checks on the organic status of its inputs and seed.

By contrast, a processor that receives many organic ingredients from many suppliers may be at higher risk of experiencing organic fraud. Such a producer should develop a fraud prevention plan that describes detailed practices to detect, prevent, minimize, and mitigate organic fraud risks throughout its supply chains. Operations should work with certifiers to identify potential organic fraud risks and implement plans to address those risks.

Exemptions 

Q10. What operations or activities are exempt from organic certification under SOE?

The organic rule provides limited exemptions for some operations conducting certain low-risk activities. Exempt entities and activities include:

  • Operations that sell $5,000 or less in organic products each year.
  • Retail establishments that sell direct to consumers and do not process organic products.
  • Retail establishments that sell direct to consumers and only process organic products at the final point of sale. Common retail establishment examples include restaurants, bakeries, grocery stores, delicatessens, salad bars and other stores that cook or prepare food.
  • Handling operations that only handle products containing less than 70 percent organic ingredients, or products that only identify organic ingredients on the information panel.
  • Operations that only receive, store and/or prepare for shipping, and do not otherwise handle, import or export:  Organic products that are received and remain in the same sealed, tamper-evident packaging; OR Organic products received that are already labeled for retail sale.
  • Operations that only buy and sell, and do not otherwise handle, import or export organic products received that are already labeled for retail sale.
  • Customs brokers who only conduct customs business activities for organic products but don’t otherwise handle them.

Importing and exporting are NOT exempt activities under SOE. One of the primary points of the rule is to create a “certification handshake” across the border – so there is a certified exporter to the U.S. and a certified importer into the U.S. The NOP Import Certificate provides traceability to the port of entry and ensures an auditable record trail to effectively trace imports back to exporters.

Transport is not included in the regulatory or statutory definition of handle. Businesses that strictly transport organic products are exempt from the organic certification requirement. However, traceability between operations is a key element of modern supply chain and product verification. As such, SOE requires that certified operations maintain records for the audit trail and traceability of the product and demonstrate that uncertified transport activities do not compromise the organic status of the transported product.

Q11. Can NOP confirm my status as an exempt operation?

The NOP is not able to respond to business-specific questions or scenarios about whether specific entities need to be certified, because businesses are so different – the rule is written to help businesses analyze their own activities to assess the need for certification, and how to implement its requirements. For example, whether a facility must be certified or not depends highly on the type of activities and products it handles.

Similarly, we cannot provide letters confirming exemption status. We encourage any business that determines itself to be exempt to have documentation readily available to support this claim for when it is requested by the NOP, a certifier, or a buyer.

Q12. If I am exempt, what are my responsibilities under SOE?

Operations that are exempt from organic certification must still follow the rules for producing and handling organic products. That means they are not allowed to expose organic products in any way to prohibited substances. When shipping, storing, or transporting, they must maintain separation between organic and conventional (non-organic) products.

In addition, exempt operations are required to maintain and be able to provide records justifying its exempt status, as well as documentation verifying the organic status of any handled product. Records must provide traceability back to the previously certified entity in the supply chain and may include invoices, shipping records, certificates, bills of lading, and other documentation deemed necessary by the buyer or the buyer’s certifier to verify organic integrity. The types of records required will depend on the type of business and the associated supply chain relationships.

Traceability between operations and across the border is a key to product verification. Uncertified (exempt) operations present a higher risk for maintaining the organic integrity of products handled. Getting certified lowers your risk when contacted for records about your suppliers during supply chain traceability exercises.

Organic Imports and Import Certificates

Q13. Do importers need to be certified?

Yes, importers of organic products need to be certified. Importing is NOT an exempt category of activity under the rule. SOE defines organic importer as “The operation responsible for accepting imported organic agricultural products within the United States and ensuring NOP Import Certificate data are entered into the U.S. Customs and Border Protection import system of record.”

Traceability and accountability were key drivers in developing the SOE rule. It is important that we create a certification handshake across the border so that there is a certified exporter to the U.S. and a certified importer into the U.S. That importer does not have to be located in the United States under the rule, but they do need to be certified - regardless of packaging used. Organic certification is the only way to provide that verification.

Q14. How do I get an NOP Import Certificate?

With very few exceptions, imports of organic agricultural products into the U.S. must be associated with an NOP Import Certificate for all shipments with a departure date after March 19, 2024.

NOP Import Certificates are generated by certifiers in the Organic Integrity Database, using requests provided by certified exporters of organic product to the United States. Certifiers then provide key information, such as the certificate number, back to the exporter to the U.S, who then shares the information with the importer. Certifiers may generate certificates for a single import, or for the duration of a period of time (e.g., to cover multiple shipments during one growing season). If a time-based certificate is used, then the initial maximum timeframe is 12 months, with the option to extend the certificate’s validity for an additional 6 months. It is optional for exporters (via their certifiers) to indicate lot numbers on an import certificate.

The regulations require the exporter to request an NOP Import Certificate from its certifier prior to export. When requesting an import certificate, exporters should consider the time a certifier needs to generate the certificate. Certifiers must issue the import certificate before the shipment departs the country of origin, and within a timeframe that allows the exporter to deliver the import certificate to the importer or customs broker before the U.S. Customs and Border Protection filing requirements, which is typically prior to movement of cargo. Certifiers cannot backdate the certificates. Certifiers need time to verify the authenticity of the organic product, so if you are an importer or exporter, you need to include time for this process.

As of March 19, 2024, the legacy paper Import Certificate form (NOP 2110-1) was transitioned to a fully electronic format which is now filled out and issued in the Organic Integrity Database (OID). Forms must be generated by an accredited certifying agent in OID.

For additional background, review the Advisory from Customs and Border Protection, dated March 19, 2024.

Q15. How do Harmonized Tariff Schedule (HTS) Codes relate to the NOP Import Certificate?

U.S. Customs and Border Protection (CBP) uses the Harmonized Tariff Schedule (HTS) of the United States to help determine customs duties to be paid on imports into the country. The HTS is a classification system that sets out the tariff rates and statistical categories for all merchandise imported into the United States. The HTS provides 6-10-digit codes to identify the imported commodities. CBP uses these HTS codes as identifiers in its Automated Commercial Environment (ACE), the system used to automate commercial trade processing at U.S. borders.

Likewise, NOP Import Certificate use HTS codes to identify organic imports. When completing the NOP Import Certificate, certifiers must use the full 10-digit HTS code. There are many commodities that do not have organic HTS codes. If there is no organic HTS code, a conventional HTS code for the same product should be used on the NOP Import Certificate. HTS codes can be found on the U.S. International Trade Commission website.

One electronic NOP Import Certificate must be issued for each commodity or HTS code. Separate NOP Import Certificates are required when multiple commodities (e.g., blueberries and strawberries) or multiple HTS codes are within the same shipment. However, one NOP Import Certificate can be used for the same commodity or HTS code that is being shipped in multiple package sizes. If products have different names, but share the same HTS code, only one import certificate is needed.

Q16. How do I know what goes on the NOP Import Certificate form?

Some businesses have asked questions about what goes in the different boxes on the NOP Import Certificate form. Certifiers electronically complete the NOP Import Certificate in the Organic Integrity Database, using information provided by exporters to the U.S. The purpose of the form is to provide information that enables certifiers and the National Organic Program to effectively trace imports back to exporters, to help support cross-border connections – and be able to more quickly and effectively follow up along supply chains to verify the integrity of organic shipments. As such, businesses should consult with their supply chains and certifiers to determine how best to complete the individual boxes on the form itself to best support that traceability.

Q17. What’s the difference between the Organic Integrity Database (INTEGRITY) and GLOBAL?

The Organic Integrity Database (INTEGRITY) is a comprehensive list of USDA-certified organic operations. The system contains up-to-date information about certified operations that may or may not sell organic agricultural products. USDA-accredited certifiers regularly update information in INTEGRITY on the operations they certify as organic.

The Global Organic Integrity Database (GLOBAL) expands the Organic Integrity Database with two modules. The Trade Partner module allows international certifiers to report on farms and businesses certified under organic trade arrangements (equivalence and recognition). The Import Certificate module allows USDA-accredited certifiers and our trade partner certifiers to generate electronic import certificates for organic products being imported to the United States.

The system, referred to as GLOBAL INTEGRITY, is viewable to certifiers, trade, and the general public. Only USDA and certifiers can add or edit information in the system and view import certificate information. Import certificate information is not visible to the public.

Q18. How do organic trading partners generate NOP Import Certificates?

Organic products imported to the U.S. under an organic trade arrangement and certified to a trade partner’s equivalent standard are covered by the SOE rule and must also be associated with an NOP Import Certificate. Certifiers overseeing exporters that want to send products to the United States under an organic trade arrangement generate NOP Import Certificates using the GLOBAL INTEGRITY module in the Organic Integrity Database.

To access GLOBAL INTEGRITY, click Trade Partners in the web page top menu. The dropdown list shows separate options for each trade partner’s organic standard and the countries it covers. Once an operation is listed in GLOBAL INTEGRITY, the certifier is able to generate an Import Certificate from the system after verifying the authenticity of the product being exported to the U.S.

Q19. Can a NOP Import Certificate be revised after it has been issued?

The certifier who generated the original NOP Import Certificate is allowed to revise certain import certificate fields after the certificate is issued, including the end date, net weight, number of containers, lot numbers (or other shipment identifier), and remarks. The product quantity information can be regularly updated on a certificate that is valid for an extended period of time to make sure the certificate information is as accurate as possible. If other minor changes with the shipment occur after the certificate is issued, it is not necessary to revise the certificate, as long as the issuing certifier has verified the product’s compliance. However, if the importer requests a new NOP Import Certificate from the exporter, the certifier will need to generate a new one, provided the product is verified as compliant.

If more significant changes to the shipment occur after the certificate is issued – like changes to the volume or to the actual product being imported – then the certifier should update the certificate or invalidate it and issue a new one. While the certificate itself cannot be canceled, it can be invalidated by changing the end date to the current date and allowing the certificate to become invalid overnight.

NOP recommends that certifiers include an explanation in the remarks field explaining what changes were made and why they were needed each time a certificate is revised. NOP will receive data each time an NOP Import Certificate is used.

Q20. What happens with shipments in transit to the U.S. prior to March 19, 2024?

The rule implementation date of March 19, 2024, marks the date on which all departing exports must have an approved NOP Import Certificate. Products shipped from the exporter before March 19, 2024, may arrive after the implementation date without the certificate. These products are considered in the stream of commerce. Organic products shipped and filed with U.S. Customs and Border Protection after the SOE implementation date must have an NOP Import Certificate.

Q21. What does not need an NOP Import Certificate?

Food and fiber certified to the USDA organic regulations or to a trade partner’s organic standards are covered by the NOP Import Certificate requirement. In some specific and limited situations, imports may not require an NOP Import Certificate. Examples include:

  • Substances used as inputs in organic production and handling systems that are not required to be certified, like fertilizers, pest control materials, or sanitizers. These inputs are reviewed by certifiers and Material Review Organizations.
  • Aquaculture products that are certified organic under another government’s organic regulations may be sold as organic in the United States but may not refer to USDA organic certification or use the seal. There are currently no USDA organic standards for aquaculture or wild fish products. As such, aquaculture is outside the scope of the USDA organic regulations, making it also outside the scope of SOE and the NOP Import Certificate requirement.
  • Products that have certified organic ingredients, but that are not certified as an end product (examples: uncertified clothing made with organic textiles/cotton; wood utensils, or personal care products not certified to USDA standards, but which include certified ingredients) are outside of the scope of the USDA’s organic regulations. NOP Import certificates are not available for textiles certified to GOTS. More on organic textiles.  More on personal care products.
  • Shipments that transition through the United States but do not enter the U.S. stream of commerce. For example, a product sold from Canada to Mexico that is transloaded in the United States (typically in a customs-bonded warehouse) does not require an NOP Import Certificate.
  • This is a risk-based regulation that focuses on commercial organic imports to the U.S. As such, online retail sales to individual consumers (not to operations or businesses) for personal consumption only do not have an NOP Import Certificate at this time. The product(s) must be certified to the USDA organic standards or to a standard that has been determined to be equivalent. This exception only applies to individual consumers, not businesses.

For Customs Brokers: Import Procedures

Q22. I am a customs broker. Do I need to be certified?

Under SOE, customs brokers are exempt from the requirement of organic certification if they do not take ownership or physical possession of organic products, and they meet the definition of a customs broker per 19 CFR 111.1. To qualify for this exemption, customs brokers must only conduct customs business. If a customs broker conducts any additional activities within the definition of handle – such as selling, importing, or trading organic agricultural products – the customs broker may need to be certified to conduct those additional activities.

Q23. What responsibilities do customs brokers have with the NOP Import Certificate?

The NOP Import Certificate – more specifically, the 21-character NOP Import Certificate number (19 digits and two dashes) – is the primary information customs brokers need for imported organic products. This import certificate and number can only be issued from the USDA Organic Integrity Database by the organic certifier overseeing a certified organic exporter to the United States. The exporter then provides the NOP Import Certificate information to the importer, who must include it in the filing paperwork they submit to the customs broker.

Providing the NOP Import Certificate number to the customs broker – in lieu of a physical or electronic document – meets the organic requirements for having an import certificate associated with your shipment. The customs broker uses the import certificate number to complete paperwork for organic commodities imported to the U.S.

Customs brokers are not responsible for making sure the importer whose entry paperwork they file in ACE is certified. If the NOP determines that an importer of organic products is not certified, the program will pursue this potential violation further.

Customs brokers are not required to maintain copies of the NOP Import Certificate for completed shipments. Importers are required to maintain copies of the NOP Import Certificate associated with their shipments as part of recordkeeping requirements.

Q24. As a customs broker, how do I file NOP Import Certificate information?

The NOP import certificate must be filed in U.S. Customs and Border Protection’s (CBP) Automated Commercial Environment (ACE) as part of the entry package used to file other Partner Government Agency requirements that apply.

A separate organic import certificate is needed for each individual HTS code of organic products being imported. The organic certificate will be provided to the exporter to the U.S. by its organic certifier, which is usually located in the foreign country. Some organic import certificates will be effective for an extended time frame, so you will be able to use those certificates for more than one entry.

When filing an electronic NOP Import Certificate in ACE, select the OR2 option when prompted. You only need to input the 21-character electronic import certificate number. In the rare instance you receive a legacy paper certificate for ACE filing - that does not contain a 21-digit certificate number format (which has been replaced by the new electronic format as of 3/19/24), you will use the OR 1 option in ACE. There is no requirement to upload the import certificate to the ACE Document Image System (DIS).

There are two possible flags in the ACE system that could apply to organic products. They include:

  • AM 7 warning flag: This flag means that the HTS code you entered MAY be subject to AMS organic import certificate filing. These are products that could be organic but don’t have an organic HTS code. SOE requires that the paperwork and shipping containers used for organic imports clearly identify the products as organic, so if there is no indication of an organic claim in the filing package, the customs broker is not responsible for doing further investigation to reconfirm the product status. If the product is not organic, it can be disclaimed.
  • AM 8 warning flag: This flag means that the HTS code entered is for an organic product, and you MUST file an NOP Import Certificate in the system.

Sector-Specific FAQs

Q25. What do retail distribution centers need to know about SOE?

While retail stores are exempt based on the rule, many retail distribution centers, particularly those handling produce, are NOT exempt due to the nature of their handling activities. Distribution centers that conduct handling activities like combining, treating, packing, repackaging, and labeling of organic products must be certified.

Distribution centers that conduct limited handling activities like receiving, storing and/or preparing for shipping organic products that are received in, and remain in, sealed, tamper-evident packaging may be exempt from certification. However, there are many benefits of organic certification in terms of risk management. Certification provides more options for businesses that unexpectedly need to conduct unplanned handling activities, like splitting loads or storing unpackaged organic products. Uncertified businesses are prohibited from conducting most handling activities for organic products. Products handled by uncertified entities lose their organic status and cannot be sold, labeled, or otherwise represented as organic in the United States.

Q26. Are products labeled for foodservice use considered “labeled for retail sale”?

Products labeled for foodservice use may be considered “labeled for retail sale” within the meaning of
7 CFR 205.101(f), if the products are being directly provided to consumers. NOP considers a foodservice operation that directly provides food to consumers as included in the definition of “retail establishment” in 7 CFR 205.2.

A foodservice operation seeking to determine whether it can be considered exempt from certification under § 205.101(f) should note that the paragraph contains other requirements for exemption from certification, including that the products are enclosed in sealed, tamper-evident packages or containers that are labeled for retail sale prior to being received or acquired by that “retail establishment” and remain in those packages or containers while in control of the that same “retail establishment.”

Any retail establishment, foodservice operation, or other operation that is exempt under § 205.101(f) needs to comply with the recordkeeping and handling requirements for exempt operations in 7 CFR 205.101(i) and 205.272. The NOP will conduct mass balance and traceback audits to enforce the new organic integrity requirements, and exempt operations must be able to demonstrate their eligibility for an applicable exemption as well as their compliance with the handling and recordkeeping requirements.

Q27. How does SOE affect produce handlers?

Any operation considering claiming an exemption from organic certification should carefully review the activities that are prohibited by uncertified operations. The SOE rule notes that an exempt warehouse may “receive, store, and prepare for shipment packaged certified organic products [emphasis added] … If this warehouse opens or relabels such packaged products, then the certified organic status of the products is lost, and an operation receiving these products must not represent them as certified organic.”

In the context of the produce industry, a produce box or clamshell with holes to enable aeration and a tamper-proof seal would be considered “packaged” for the purpose of exempting the operation from organic certification. The SOE rule states: “Examples of tamper-evident packaging include produce boxes with “DO NOT TAMPER WITH” tape placed across the box flaps…” And further, “Tamper-evident packaging or container means that the contents are sealed in a manner where an attempt to break the seal, access the contents, or reclose the package would be obvious.” The uncertified produce handler would be required to ensure products packaged in this way are not exposed to prohibited substances.

If an uncertified (exempt) produce handling operation experiences a box breakage, causing the need to repack the products, the operation would not be able to complete the activities and retain the products’ organic status. The actions allowed by exempted operations are extremely limited – being uncertified would restrict the operation from doing many activities that are regularly encountered in daily produce activities.

The purpose of this provision is to protect organic integrity by not allowing an uncertified handler to complete higher risk handling activities, like splitting lots or repackaging goods. The goal is to reduce the risk that an uncertified operation might inadvertently or intentionally mix conventional and organic produce, compromising the organic integrity of the product.

Q28. How does SOE affect manufacturers that formulate feed additives and supplements and ingredients and processing aids containing agricultural ingredients?

A key focus of the Strengthening Organic Enforcement (SOE) rule is expanding oversight to higher-risk portions of organic supply chains; this includes requiring the certification of such entities as brokers, importers and exporters to the U.S., and other entities that are involved in longer complex supply chains.

Feed additives and feed supplements are evaluated and approved in accordance with 7 CFR 205.237(a) as synthetic substances allowed under §205.603 and nonsynthetic substances not prohibited under §205.604. The composition of the feed additives and feed supplements as containing more or less than 70 percent organic ingredients is not relevant. Therefore, §205.101(d) under SOE does not apply to the production of feed supplements or feed additives.

In terms of processing aids and ingredients, in addition to consulting §205.101(d), operations should consult §205.310(b).

Access these regulations.

Even if a manufacturer determines that certification is not required under the USDA organic regulations, more and more buyers are requiring it across the organic trade. The NOP encourages exempt businesses to apply for certification to support both consumer confidence and market expectations.