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By Christie Badger, Independent Organic Inspector & Consultant
With the publication of the Strengthening Organic Enforcement (SOE) final rule on January 18, 2023, the USDA National Organic Program (NOP) published the most significant update to the organic regulations since the publication of the original Organic Food Production Act (OFPA) in 1990. SOE is aimed at protecting organic integrity and bolstering consumer confidence in organic sales in light of an organic landscape that has changed dramatically in the past twenty years. The rule has an implementation date of March 19, 2024.
According to the press release (https://www.usda.gov/media/press-releases/2023/01/18/usda-publishes-strengthening-organic-enforcement-final-rule#:~:text=What%20does%20the%20rule%20do,enforcement%20of%20the%20organic%20regulations) published on usda.gov, the new rule accomplishes its aims by “supporting strong organic control systems, improving farm to market traceability, increasing import oversight authority, and providing robust enforcement of the organic regulations.” The release lists key updates to include:
On a webinar introducing the new rule on February 21, 2023, Deputy Administrator Jenny Tucker was quick to point out that the new provisions work with existing regulations, layering, supplementing, and modifying the existing body of regulations. She also noted that there are a lot of components to the rule, and then provided a focus on four overarching goals, which we will focus on here, as follows:
Reducing the number of uncertified entities
Through the expansion of the definitions of handle, the rule requires more businesses in the organic supply chain to be certified.
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.
During the comment period, there were many suggestions for what should be included in the definition of handle, and while many of the suggestions were included, many were not. That being said, the NOP addresses this in the explanatory text, noting:
The definition of handle is not an exhaustive list of activities that must be certified. There may be additional activities not listed in the definition that are similar to the listed activities and require certification, or different words or synonyms for the same or similar activities. The absence of a specific term in the definition of handle does not mean the activity is not handling or that an operation conducting this activity does not need certification.
And therein lies the rub. While many of the suggested activities to be included in the definition are addressed in different areas throughout the explanatory text, some are not. Unfortunately, the NOP did not, in all cases, address the process by which it decided which of suggested activities would be included in the definition and which would not. This is one of the areas where stakeholders will most likely be referencing the explanatory text a great deal and will most likely lead to additional clarifications that need to be made.
How will this affect your business? Perhaps the biggest takeaway here is to take a close look at your supply chains. Many businesses that did not previously require certification will now need to get certified, including supply chain intermediaries, such as traders, commodity brokers, and importers. In addition, those producing organic products will want to ensure that their suppliers are appropriately certified to maintain the organic status of their products.
Limited exemptions are outlined in the rule, as follows:
That being said, there are many nuances and caveats within these limitations, and a close reading of the rule is required to begin to try to understand them. For example, an operation with annual sales of less than $5,000 does not require certification; however, producers claiming this exemption must not represent the agricultural products they produce as certified organic, must not use the USDA organic seal, and products produced or processed by these exempt operations must not be identified or represented as organic in a product processed by another operation.
When it comes to the exemption for retail establishments, one must first ensure that the business meets the designation as a “retail establishment.”
The regulations define retail establishment to include a range of transaction modes for selling to consumers that commonly occur in the modern marketplace. Retail establishment includes 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.
However, don’t forget to “read the fine print.” While “mail-order” and “delivery service” are included on the list, the explanatory text provides further detail. “Retail establishments may use virtual transactions for sales, but they must also have a physical location for consumers to purchase products.” In addition, it is clearly stated that “businesses which sell to other businesses (wholesale) do not qualify as retail establishments.” Only operations that qualify as “retail establishments” are eligible for the retailer exemptions.
When it comes to shipping and handling operations, as well as distributors, it’s all about the packaging. If the product being “handled” is “enclosed in sealed, tamper-evident packages or containers that are labeled for retail sale prior to being received or acquired by the operations; and remain in the same sealed, tamper-evident packages or containers that are labeled for retail sale and are not otherwise handled while in the control of the operation,” the operation may qualify as exempt from certification. Unfortunately, the definition of “sealed, tamper-evidence packages or containers” was not provided within the rule or in the explanatory text.
Finally, customs brokers that do not take ownership or physical possession of organic products are exempt from certification.
While the rule does allow limited exemptions from certification for what are being called “low-risk” operations, the exemption only applies to certification. Handling and recordkeeping requirements remain in place for these operations. Exempt operations must comply with the requirements of § 205.272, which describes handling requirements to prevent commingling and contact with prohibited substances. In addition, they must follow the labeling provisions specified in § 205.310 and maintain records to (1) demonstrate that agricultural products identified as organic were organically produced and handled; and (2) verify quantities received, sold, or produced from such agricultural products.
Transportation Concerns: Many commenters raised transportation concerns. What it comes down to is two-fold—one, the Agricultural Marketing Service (AMS) stating that “OFPA and the USDA organic regulations do not provide authority to regulate the transport of organic agricultural products,” and two, “AMS is defining the need for certification based on activities performed, not type of business.” Therefore, determining whether or not a rail car company or trucking company or milk truck needs to be certified is not the point; determining whether or not the activity they are performing needs certification is the real question. The devil is in the details indeed.
Specifically, AMS had this to say about milk haulers:
AMS is defining the need for certification based on activities performed, not type of business, because this will ensure that businesses conducting high-risk activities require certification (and conversely that businesses that conduct low-risk activities remain exempt). A milk hauler would be exempt from certification if they only transport organic milk (e.g., move milk from a dairy to a processor) but do not otherwise handle the milk (e.g., process or package loads of milk). Transport alone does not require certification.
On the February 21, SOE Introduction webinar, Dr. Jenny Tucker stated several times, “Here at the Program, we have a big bias toward being certified.” She noted that not being certified may restrict your business from being nimble in the marketplace and being able to shift your focus as needed. She further noted that being certified lowers the work businesses have to do to provide paperwork when a supply-chain audit happens. She encouraged businesses to weigh the business activities in light of the rule, noting, “We want as many entities to be certified as possible across the supply chain to protect farm to market traceability.”
Requiring the use of organic import certificates
The new rule requires the use of electronic NOP import certificates for all products being imported into the United States. Import certificates will be generated in the Organic Integrity Database (OID), by the certifier of the exporter to the United States. The OID is the database launched in 2015 by the NOP to provide information on current and former certified organic operations publicly available online.
There are two main points of focus. First, what this means for exporters to the US who live in a country that does not have an equivalency agreement with the US? And second, how exactly does the electronic import certificate work?
The NOP has been very clear that they will be working with governments of countries that do have an equivalency agreement with the US to allow information on certified operations to be entered into a new section (not yet created) of the OID called GLOBAL. This will allow the certifiers of these operations to provide the import certificates, as required. But what about countries that do not have equivalency agreements? Those exporters are going to need to get certified.
As far as how exactly the electronic import certificates will work, there are a few details that need to be understood before we can begin to take in the full picture. First, certifiers have up to 10 days after the shipment reaches the US port to issue the import certificate. After the certificate is issued out of the OID, the information must be entered into the Customs and Border Protection’s (CBP) Automated Commercial Environment (ACE) system. ACE is the system through which the trade community reports imports and exports and the government determines admissibility. While some are asking the question how CBP can determine admissibility 10 days after the shipment reaches the US port, this timeline is set by CBP.
During the introductory webinar for the rule, Dr. Tucker stated that the import certificate provides traceability to the port of entry and provides an auditable record trail. In their comments on the proposed rule, (https://www.nationalorganiccoalition.org/blog/2020/10/6/noc-comments-on-far-reaching-proposed-changes-to-usda-organic-regs?rq=SOE the National Organic Coalition (NOC) raised serious concerns regarding the 10-day period:
Allowing importers 10 days to file the electronic certificate after the shipment has reached a U.S. port could mean the difference between preventing fraudulent products from entering the U.S. and having to try to retrieve them once they have entered commerce. Furthermore, if the information in the import certificate is insufficiently verified or up to date, the certificate provides a false sense of confidence in the organic status of the product. These proposed regulations do not sufficiently prevent conventionally produced imports from being fraudulently represented and sold as organic. Fraudulent import certificates could exacerbate challenges if it leads to a false sense of confidence.
Further, certifiers may issue import certificates to cover single shipments, multiple shipments, or a time period (with no limit specified within the final rule). Dr. Tucker provided further details on this, explaining that for a crop produced in a narrow timeframe and exported to the US, a certifier can do a yield analysis and may issue an import certificate that covers the volume that can be credibly produced. She further emphasized that certifiers will be at risk of losing their accreditation if they are found to be issue an import certificate that is not under organic control. Therefore, certifiers will need to focus on evolving their organic control systems to ensure they only generate import certificates for validated organic products.
Although Dr. Tucker provided the example of a crop that is produced within a narrow timeframe, it is important to understand that the new rule does not specify a timeframe. And, while she was quick to point out that certifiers would need to evolve their organic control systems to ensure organic integrity is maintained, the new rule is silent on how the NOP will update and change practices to catch up to the new challenges within the organic supply chain.
Strengthening recordkeeping and supply chain traceability
The new rule both emphasizes and codifies existing and new recordkeeping requirements, as well as supply chain traceability requirements for both certified operations and certifiers.
Certified operations must maintain records that trace products back to the last certified operation. With this requirement, the mandate for so many intermediaries in the supply chain to seek certification becomes a benefit for supply chain traceability. Operations must also document the monitoring practices used to prevent fraud and verify suppliers and products. While this may sound like more paperwork on top of paperwork, for most family farms, it should not be much more than what should already be happening. Currently, when working with uncertified brokers, producers should already be obtaining certificates for purchased products. In addition, documenting the “monitoring practices used to prevent fraud and verify suppliers and products” may be as simple as developing a standard operating procedure (SOP) that is documented and can be referenced.
The rule requires certified operations to clearly identify products as organic on records and labels. As an independent organic inspector, I can say that this may be one of the easiest changes to make, but one of the hardest for producers to remember. Producer must train themselves to identify their products on invoices, other records, and labels as “organic,” rather than assume that people will know the product is organic because there is an organic certificate accompanying the invoice or label.
Finally, the rule codifies that certified organic operations must submit updates to organic system plans (OSPs) during certification renewal. Over the past several years, it has become a more common practice for certifiers to only require OSP updates to those section of the OSP that would have changes from the previous year with the annual update paperwork rather than requiring the entirely new OSP submission.
Certifiers are required to describe the procedures used to identify operations and products at high risk for organic fraud. In addition to certifiers, commenters to the proposed rule called on the NOP to adopt criteria for risk-based accreditation oversight based on the NOSB recommendation (https://www.ams.usda.gov/sites/default/files/media/CACSRiskBasedAccreditationOct2018Rec.pdf) on this topic from October 2018, calling for the NOP to share information with other accreditors to flag risky certifiers and operations in the organic supply chain. For example, the NOP should give additional scrutiny to a certifier whose accreditation has been revoked by a nation with which the U.S. has an organic equivalency arrangement and should work closely with other accreditation bodies operating in the region where fraud has been found. This was not included in the final rule. In addition to risk-based analysis, certifiers are required to conduct supply chain traceability audits to verify the compliance and chain-of-custody of high-risk commodities and operations, and share compliance-related information about certified operations with other certifiers.
Certifiers already have a reference for this work from the Accredited Certifiers Association (ACA) Best Practices (https://www.accreditedcertifiers.org/aca-working-groups-frequently-asked-questions). The ACA is a certifier-member organization that lists as its mission, “To ensure consistent implementation of USDA Organic Regulations through collaboration and education of accredited certification Agencies.” Through collaborative efforts of working groups, the ACA brings together the knowledgeable body of certification professionals to articulate Best Practices or other communications relevant to organic certification. “ACA Best Practice documents provide recommendations for consistent implementation of the organic regulations. They are not binding for ACA members; however, they offer a framework for consistent interpretation. Adherence to ACA Best Practices is encouraged for all ACA members and accredited certifiers.”
Several Best Practices (https://www.accreditedcertifiers.org/https-www-accreditedcertifiers-org-policy-advocacy) have been developed that address the requirements established by the final SOE rule. In November 2019, the ACA produced a best practice document for certifiers titled ACA Guidance for Risk Assessment and Follow Up. In April 2018, the best practice document titled ACA Best Practices for Verifying Traceability in the Supply Chain Revised was published. And in April 2020, the best practice document for certifiers titled ACA Best Practices for Cross Agency Investigations was published.
Finally, the final rule requires certifiers to keep operation data for all certified entities updated in the Organic Integrity Database, including acreage data. While acreage data will not be recorded at the level of crop production, the reporting of acreage data will allow for mass balance audit exercises to support the verification of specific organic products.
Strengthening oversight of accredited certifiers
The final rule codifies many of the practices that most, but not all, certifiers are already doing, such as:
Other regulatory changes worth mentioning
Codifies organic equivalence determination procedures:
USDA organic regulations formerly addressed USDA's authority to make equivalence determinations in general terms under § 205.500(c), but did not describe the criteria, scope, and other parameters to establish, oversee, or terminate such equivalence determinations, which are critical to the enforcement of organic imports. This new § 205.511 does not change current policy or add any new requirements. It codifies existing practices and clarifies the procedures followed when determining organic equivalence, which strengthens oversight and enforcement capacity of organic imports by supporting the government’s authority to reassess, continue, and terminate equivalence determinations, as necessary. Without this clear implementation of Federal authority in the USDA organic regulations, the government could face challenges establishing and enforcing terms under current and future equivalence determinations that are critical to ensuring the integrity of imported organic products.
Clarifies mediation and appeals processes and procedures for resolving noncompliance issues:
AMS revised § 205.663 to improve the general readability of this section and to more clearly explain how mediation may be used in noncompliance procedures.
Standardizes certificates of organic operations:
Requires certifying agents to issue standardized certificates of organic operation generated from the USDA’s publicly available Organic Integrity Database (OID).
Strengthens oversight of certifier “satellite offices”:
To support the consistent application of the organic regulations across all certifying agents, § 205.501(a)(22) requires certifying agents to notify AMS within 90 calendar days of the opening of any office performing certification activities.
Notification of a new office opening must include basic information to support effective oversight of the certification office, including the countries serviced, location and nature of the certification activities, and the qualifications of the personnel that will provide the certification activities. Information on the location of new offices allows AMS to efficiently use personnel and travel resources to schedule on-site audits, and to be precise in any adverse action that may affect only a portion of certifying agent’s accreditation, e.g., a certification office or activities in a specific country or region. Information on the types of certification activities being conducted allows AMS to better evaluate the need for additional oversight; for instance, a new office located in a high-risk area with a history of organic fraud may require additional oversight.
Clarifies how to calculate the percentage of organic ingredients in multi-ingredient products:
AMS replaced the parenthetical statements “(excluding water and salt)” with the single statement “Water and salt added as ingredients at formulation are excluded from the calculation.” This more clearly states NOP’s intent and will result in more consistent calculation of organic content across the industry.
Let’s be clear—this new rule is a monster. While the actual regulations account for approximately 10% of the published document, the explanatory text, sometimes referred to as the preamble, is a must read when striving to understand all of the nuances of the rule. Dr. Tucker repeatedly emphasizes the need to read the rule (https://www.ams.usda.gov/rules-regulations/strengthening-organic-enforcement) when speaking about it, and its good advice.
Christie Badger is an independent organic inspector & consultant, and can be reached at 570.975.9548 or by email: email@example.com