Final Rule available at: www.ams.usda.gov/rules-regulations/strengthening-organic-enforcement

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Strengthening Organic Enforcement(SOE)

Final Rule Primers
 

Strengthening Organic Enforcement: Table of Contents for Final Primers

Doc # Primer Title Master 

Document Page

01 Who Needs to Be Certified? 3

02 Improving Traceability and Preventing Organic Fraud 7

03 Import Certificates 11

04 Certificates of Organic Operation and the Organic Integrity Database 16 

05 On-Site Inspections and Continuation of Certification 20

06 Nonretail Labeling and Calculating Percent Organic 24

07 Personnel Training and Qualifications 28

08 Compliance, Mediation, and Appeals 33 

09 Producer Groups, Satellite Offices, and Equivalency 40

10 Quick Guide: SOE CFR Reference Changes 47
Page 1 of 4

Strengthening Organic Enforcement: Who Needs to Be Certified?

SOE’s biggest change is that more operations in the organic supply chain will need to be certified organic. These changes are described in 

SOE section A.—Applicability and Exemptions from Certification. This document pairs a condensed version of the relevant regulatory text with a 

plain-language description of what the change means. Bolded text in the table below indicates a key concept. 

General Comments from the National Organic Program: We strongly encourage certification of all businesses engaged in organic. It benefits 

the organic sector to have as many businesses certified as possible along a supply chain. There are many business benefits for being certified, 

and more and more buyers expect it to do business in organic. As a program, we need to protect the integrity of the entire supply chain – this is 

facilitated by having a certifier overseeing each business along that chain. Having everyone certified helps us oversee the sector from farm to 

market.

A. Applicability and Exemptions from Certification

Section Condensed Regulatory Text Key Takeaways

205.100

(a)

WHAT HAS TO BE CERTIFIED.

Except for...exempt operations...each operation...that 

produces or handles [organic] agricultural products must be 

certified.

Who needs to be certified? Anyone that produces or handles

organic products. To produce means to grow or raise...but what 

does handle mean?
Page 2 of 4

Section Condensed Regulatory Text Key Takeaways

205.2 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.

Handle means many things! In general, operations that do these 

things must be certified. 

SOE adds more specific activities to “handle,” including trade, 

facilitate sale (broker), import, and export. Even businesses that 

don’t physically handle products may still need to be certified

if they conduct one of these activities.

205.101 EXEMPTIONS FROM CERTIFICATION

[Operations listed in] this section are exempt from 

certification...and from submitting an organic system 

plan...but must comply with the applicable organic 

production and handling requirements...[and]...applicable 

labeling requirements. 

NOTE: SOE thoroughly revises and reorganizes § 205.101. Former 

references to specific paragraphs may no longer be valid!

Not every operation that does these things must be certified. 

Reasonable exemptions to certification are allowed for 

operations with low-risk activities. These operations don’t need to 

be certified, but they must still follow the rules for producing 

and handling organic products.

SOE = narrower exemptions = more certified operations

205.101

(a)

A production or handling operation that sells agricultural 

products as “organic” but whose gross agricultural income 

from organic sales totals $5,000 or less annually.

This exempts very small farms and businesses from certification.

No change in policy.
Page 3 of 4

Section Condensed Regulatory Text Key Takeaways

205.101

(b)

EXEMPTIONS FROM CERTIFICATION, cont.

A retail establishment that does not process organically 

produced agricultural products.

This exempts most retailers (like grocery stores) that sell organic 

products. No change in policy.

205.101

(c)

A retail establishment that processes, at the point of final 

sale, [organic] agricultural products... 

This exempts a broader range of retailers from certification 

(including restaurants and stores that cook or prepare food). 

Online retailers that process but don’t have a physical location 

where they sell products must be certified. 

205.101

(d) 

A handling operation that only handles agricultural products 

that contain less than 70 percent organic ingredients...or 

that only identifies organic ingredients on the information 

panel.

This exempts processors that make products with lower amounts 

of organic ingredients (e.g., “made with organic...”). No change in 

policy. 

205.101

(e)

An operation that only receives [or] stores organic...products 

that [are] enclosed in sealed, tamper-evident packages or 

containers...[and] remain in the same...packages... 

This exempts warehouses and storage operations that only store 

packaged organic products. This includes both retail and nonretail 

packaging. Operations that store bulk or unpackaged products 

must be certified. 

205.101

(f)

An operation that only buys, sells...[or] stores...organic...

products...labeled for retail sale that [are] enclosed in 

sealed, tamper-evident packages or containers [and] remain 

in the same sealed, tamper-evident packages or containers... 

This exempts wholesalers that only sell retail-packaged products.

Wholesalers that sell bulk products or nonretail-packaged 

products must be certified. 
Page 4 of 4

Section Condensed Regulatory Text Key Takeaways

205.101

(g)

A Customs broker (per 19 CFR 111.1) that only conducts 

customs business...

This exempts CBP-licensed Customs brokers. These operations 

file import paperwork, but don’t touch or handle products.

205.101

(h)

An operation that only arranges for the shipping, storing, 

transport, or movement of organic agricultural products...

This exempts logistics brokers—businesses that connect 

operations with carriers and storage facilities for a fee. 

N/A TRANSPORT Businesses that strictly transport organic products do not require 

organic certification.

Transport is not included in the regulatory or statutory 

definition of handle. SOE requires that certified operations use 

audit trails and traceability to verify that uncertified transporters 

don’t compromise integrity. 
Page 1 of 4

Strengthening Organic Enforcement: 

Improving Traceability and Preventing Organic Fraud

One of SOE’s primary goals is to continuously improve the oversight of organic integrity within increasingly complex supply chains. Organic 

integrity can be lost due to both fraud and accidental mishandling. Section P—Supply Chain Traceability and Organic Fraud Prevention—makes 

several important changes that protect against both. It ensures organic products can be traced all the way back from retail to production. This 

document pairs condensed regulatory text with a plain-language description of what the change means. Bolded text in the table below 

indicates a key concept. 

General Comments from the National Organic Program: The provisions on traceability and fraud prevention work together to protect the 

organic integrity of the entire supply chain. Along with the Applicability and Exceptions from Certification section, these provisions outline 

actions required by both certifiers and operations to enable full supply chain traceability. The rule encourages risk-based approaches to these

processes to be sound and sensible, while also effectively protecting the market. 

P. Supply Chain Traceability and Organic Fraud Prevention

Section Condensed Regulatory Text Key Takeaways

205.2 DEFINITIONS

Organic fraud. Deceptive representation, sale, or labeling of 

nonorganic agricultural products or ingredients as ... organic.

Organic fraud was not previously defined in regulatory text. 

Defining it helps the industry understand what the rule is

intended to prevent.

205.103

(b)(2)

RECORDKEEPING

Fully disclose all activities and transactions of the certified 

operation, in sufficient detail as to be readily understood and 

audited; records must span the time of purchase or 

acquisition, through production, to sale or transport and be 

traceable back to the last certified operation;

This section describes additional recordkeeping responsibilities 

of certified operations. SOE adds the bolded clause to ensure 

that traceability is maintained within an operation and back 

to the last certified operation. These key elements are 

required to conduct full supply chain traceability audits. 
Page 2 of 4

Section Condensed Regulatory Text Key Takeaways

When using a noncertified intermediary (e.g., an exempt

wholesaler or shipping company), certified operations will need 

records showing both the last certified operation to possess 

or handle the product, and that organic integrity was 

maintained by the noncertified intermediary.

This provision further highlights the importance of having 

entities certified across the supply chain. 

205.103

(b)(3)

[Such records must] Include audit trail documentation ... and

identify agricultural products on these records as “100% 

organic,” “organic,” or “made with organic...”

This specifies that certified operations must keep audit trail 

records—i.e., transactional or external records, and that these 

records must identify products as organic. 

This is a new paragraph. Former paragraphs (3) and (4) move 

down to (4) and (5), respectively.

205.201

(a)(3)

ORGANIC PRODUCTION AND HANDLING SYSTEM PLAN

... must include a description of the monitoring practices and 

procedures to verify suppliers in the supply chain and organic 

status of agricultural products received, and to prevent 

organic fraud ... as appropriate to the certified operation’s 

activities, scope, and complexity; 

This requires certified operations to add a “fraud prevention 

plan” (FPP) to their OSP. The rule allows for flexibility with 

respect to how the FPP is modified for different supply chain 

environments in a sound and sensible way. For example, a 

granola producer combining many organic ingredients will 

need a FPP that is more complex than a vegetable farm selling 

to local vendors. FPPs are an industry best practice.

205.501

(a)(10)

REQUIREMENTS FOR ACCREDITATION

[Certifying agents must] Maintain strict confidentiality with 

respect to its clients ... except:

SOE requires that certifying agents share information with 

each other to assist with compliance and enforcement. This is 
Page 3 of 4

Section Condensed Regulatory Text Key Takeaways

(ii) For enforcement purposes, certifying agents must

exchange any compliance-related information that is

credibly needed to certify, decertify, or investigate an

operation, including for the purpose of verifying supply chain

traceability and audit trail documentation; and

(iii) ... all of the certifying agents that are involved in the

exchange still have a duty to preserve the confidentiality of

[proprietary] information.

necessary to conduct supply chain traceability audits and verify 

integrity of products traveling across supply chains. 

If shared information is sensitive or proprietary, the certifying 

agent must maintain its confidentiality, even after sharing it.

205.501

(a)(13)

Accept the certification decisions made by another certifying 

agent... provide information to other certifying agents to 

ensure organic integrity or to enforce organic regulations, 

including to verify supply chain integrity, authenticate the 

organic status of certified products, and conduct 

investigations;

205.501

(a)(21)

Conduct risk-based supply chain traceability audits ... and 

share audit findings with other certifying agents as needed to 

determine compliance. 

SOE requires certifying agents to conduct risk-based supply 

chain traceability audits to trace products across multiple links 

in a supply chain. Traceability between operations is a key 

element of modern supply chain and product verification.

This is a new paragraph. Former paragraph (a)(21) is now 

(a)(23).

205.2 Supply chain traceability audit. The process of identifying and 

tracking the movement, sale, custody, handling, and organic 

status of an agricultural product along a supply chain to verify 

SOE adds supply chain traceability audit to clarify the scope

and objective of this certifier requirement. The requirements in

501(a)(21) give certifiers flexibility to choose how they conduct 

audits to verify compliance.
Page 4 of 4

Section Condensed Regulatory Text Key Takeaways

the agricultural product’s compliance with [the organic 

regulations]

205.504

(b)(4)

A copy of the procedures to be used for sharing information 

with other certifying agents and for maintaining the 

confidentiality of any business-related information...

Certifying agents must have written procedures and criteria

for conducting risk-based supply chain audits. This will allow 

NOP to audit certifiers and assess how certifiers are 

implementing this supply chain traceability requirements.

This is a new paragraph. 

205.504

(b)(7)

A copy of the criteria to identify high-risk operations and 

agricultural products for supply chain traceability audits; and 

procedures to conduct risk-based supply chain traceability 

audits.
Page 1 of 5

Strengthening Organic Enforcement: Import Certificates

NOP Import Certificates are a key part of Strengthening Organic Enforcement’s (SOE) integrated strategy. By providing an auditable record trail 

of the import process, Import Certificates support traceability and verification of organic integrity. The data collected in Import Certificates will 

also allow NOP to monitor market trends, surveil imports, and detect and prevent fraud. This document pairs condensed regulatory text from 

section B—Imports to the United States—with a plain-language description of what the change means. Bolded text in the table below indicates 

a key concept. 

General Comments from the National Organic Program: Organic import certificates provide critical data allowing USDA to see what organic 

products are coming into the country and from where. This will help guide future surveillance work. Further, invalid certificate numbers will be 

flagged, allowing us to follow-up quickly with importers. It is critical that certifiers overseeing exporters sending product to the U.S. have 

effective organic control system for verifying the integrity of organic products and claims. 

B. Imports to the United States

Section Condensed Regulatory Text Key Takeaways

205.2 DEFINITION

Organic exporter. The final certified exporter of the organic 

agricultural product, who facilitates the trade of, consigns, or 

arranges for the transport/shipping of the organic agricultural 

product from a foreign country to the United States.

Organic exporters to the U.S. must be certified. They export 

the product and therefore must have their certifier approve and 

generate an Import Certificate.

205.2 DEFINITION

Organic importer. 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.

Organic importers must be certified. They import the product

and must verify its integrity. They also check that the import 

matches the Import Certificate. 
Page 2 of 5

Section Condensed Regulatory Text Key Takeaways

205.273 Imports to the United States. This section is entirely new.

205.273 Each shipment of organic agricultural products imported into 

the United States must be certified pursuant to subpart E of 

this part, labeled pursuant to subpart D of this part, be declared 

as organic to U.S. Customs and Border Protection, and be 

associated with valid NOP Import Certificate data. 

SCOPE of the NOP Import Certificate:

• What can be imported? Products certified to the USDA

organic standard or equivalent under a trade arrangement.

• When is an Import Certificate needed? For any organic

agricultural product imported into the U.S., regardless of

country of origin.

• What needs an Import Certificate? Each shipment of

organic agricultural product needs to be associated with an

NOP Import Certificate.

205.273

(a)

Persons exporting organic agricultural products to the United 

States must request an NOP Import Certificate from a 

certifying agent prior to their export. Only certifying agents 

accredited by the USDA or foreign certifying agents authorized 

under an organic trade arrangement may issue an NOP Import 

Certificate.

NOP Import Certificate PROCESS: 

• The certified exporter to the U.S. sends export shipment

data to their certifier and requests an Import Certificate.

The certifier verifies the information and issues the Import

Certificate from the USDA Organic Integrity Database

(INTEGRITY).

• The certifier who issues the NOP Import Certificate must be

accredited either by USDA or by another government under

a trade arrangement.

205.273

(b)

The certifying agent must review an NOP Import Certificate 

request and determine whether the export complies with the 

USDA organic regulations. The certifying agent must have and 

implement a documented organic control system for intaking 

and approving or rejecting the validity of an NOP Import 

Certificate request. The certifying agent shall issue the NOP 

PROCESS continued...

• The exporter’s certifier reviews the Import Certificate

request and determines if the shipment is compliant.

• Once the approved, the certifier generates an Import

Certificate in INTEGRITY.
Page 3 of 5

Section Condensed Regulatory Text Key Takeaways

Import Certificate through the Organic Integrity Database

only if the export complies with the USDA organic regulations.

• The certifier then gives the Import Certificate (or data) to

the exporter, who gives it to the importer. A physical copy

does not need to accompany a shipment. Electronic

transfer of records is already common in the industry.

• If the certifier’s control system provides sufficient oversight

to allow it, a certifier may issue one Import Certificate for

multiple shipments in a given timeframe or volume of

product.

205.273

(c)

Each compliant organic import must be declared as organic to 

U.S. Customs and Border Protection by entering NOP Import 

Certificate data into the U.S. Customs and Border Protection’s 

Automated Commercial Environment system. Organic imports 

must be clearly identified and marked as organic on all 

import documents including but not limited to invoices, 

packing lists, bills of lading, and U.S. Customs and Border 

Protection entry data. Only NOP Import Certificate data 

generated by the Organic Integrity Database are valid.

PROCESS continued...

• A Customs broker uploads the Import Certificate data into

ACE. If the importer is a licensed Customs broker, they may

upload the data themselves.

• “Clearly identified and marked as organic” is a reference to

SOE’s updated labeling and recordkeeping requirements.

This reinforces that clear organic identification in records is

necessary for traceability and product verification.

205.273

(d) 

Upon receiving a shipment...the organic importer must ensure 

the import is accompanied by accurate NOP Import 

Certificate data and must verify that the shipment has had no 

contact with prohibited substances...or exposure to ionizing 

radiation... since export. The organic importer must have a 

documented organic control system to conduct this 

verification.

PROCESS continued...

• The importer verifies compliance of the import. This

includes verifying that the shipment has a valid Import

Certificate and has not been fumigated or irradiated.

• Other types of verification may be necessary depending on

the product and country of origin.
Page 4 of 5

Section Condensed Regulatory Text Key Takeaways

205.300

(c)

Products produced in a foreign country and exported for sale in 

the United States must be certified pursuant to subpart E of this 

part, labeled pursuant to this subpart D, and must comply with 

the requirements in § 205.273.

This general labeling requirement in subpart D (Labels, 

Labeling, and Market Information) now includes a crossreference to NOP Import Certificates. 
Page 5 of 5
Page 1 of 4

Strengthening Organic Enforcement: Certificates of Organic Operation and 

the Organic Integrity Database

The Strengthening Organic Enforcement (SOE) final rule updates how information about organic operations is generated and shared. The rule 

requires that certifiers: 

• Generate standardized certificates of organic operation using USDA’s Organic Integrity Database (INTEGRITY); and

• Maintain up-to-date operation profiles in INTEGRITY.

These updates support organic integrity by giving certifiers and operations access to consistent and high-quality information that they use to 

validate organic products, ingredients, and supply chain operations. Uniform certificates of operation will also reduce confusion across the 

organic industry and deter fraud.

This document combines regulatory text from three sections (E. Certificates of Organic Operation, G. Paperwork Submissions to the 

Administrator, and K. Compliance and Noncompliance Procedures) with a plain-language description of what the changes mean. Bolded text in 

the table below indicates a key concept. 

General Comments from the National Organic Program: The Organic Integrity Database (INTEGRITY) is a globally respected database that 

plays a central role in organic market development and oversight. These provisions maximize the use of INTEGRITY as a definitive source of 

data and certificates for organic trade. The provisions also remove some reporting requirements for certifiers, to balance the added update 

requirements to INTEGRITY. We expect that standardizing the operation-level certificate through INTEGRITY will both deter fraud and increase 

the regularity of reporting. Certifiers can still issue addenda to the standard operation certificate if they wish to. 

E. Certificates of Organic Operation

Section Regulatory Text Key Takeaways

205.2 Terms defined.
Page 2 of 4

Section Regulatory Text Key Takeaways

205.2 Organic Integrity Database. The National Organic Program's 

electronic, web-based reporting tool for the submission of 

data, completion of certificates of organic operation, and 

other information, or the tool’s successors.

This is a newly defined term that explains the core functions of 

INTEGRITY—including that certificates of organic operation 

must be generated in INTEGRITY.

205.404 Granting certification.

205.404

(b)

The certifying agent must issue a certificate of organic 

operation. The certificate of organic operation must be 

generated from the Organic Integrity Database and may be 

provided to certified operations electronically.

Certifiers can no longer create certificates of organic operation 

using their own formats. Generating certificates in INTEGRITY 

will ensure consistent formatting and information, making it 

easier for certifiers and operations to verify suppliers, products, 

and ingredients. Certifiers can provide either electronic or 

paper copies to operations.

205.404 

(c)

[Redesignate former § 205.404(c) as (d) and add new 

paragraph (c) on certificate addenda.]

In addition to the certificate of organic operation provided for in 

paragraph (b) of this section, a certifying agent may issue its 

own addenda to the certificate of organic operation. If issued, 

any addenda must include:

(1) Name, address, and contact information for the certified

operation;

(2) The certified operation's unique ID number/code that

corresponds to the certified operation's ID number/code in the

Organic Integrity Database;

(3) A link to the Organic Integrity Database or a link to the

certified operation's profile in the Organic Integrity Database,

along with a statement, “You may verify the certification of this

Paragraph (c) on certificate addenda is new. Former paragraph 

(c) is moved down to (d). Issuing an addendum is optional.

Addenda can provide additional useful information about the

operation that is not included in the certificate of operation.

If an addendum is issued, certain mandatory information must 

be included on the addendum to make it clear how someone 

can verify the operation’s status. Specifically, the addendum 

must connect back to the operation profile in INTEGRITY and 

must have a clear statement that the operation’s status can be 

verified in INTEGRITY. 

A certifier may generate addenda in INTEGRITY, or they may 

generate addenda using their own system.
Page 3 of 4

Section Regulatory Text Key Takeaways

operation at the Organic Integrity Database,” or a similar 

statement;

(4) Name, address, and contact information of the certifying

agent; and

(5) “Addendum issue date.”

This is a new paragraph. 

G. Paperwork Submissions to the Administrator

Section Regulatory Text Key Takeaways

205.405 Denial of certification.

205.405 

(c)(3)

[Remove paragraph (c)(3)] SOE removes former paragraph (c)(3), which required a 

certifier to notify NOP when they took corrective actions on a 

notice of noncompliance issued to an operation. The INTEGRITY 

data requirements below make these notifications redundant.

205.501 General requirements for accreditation.

205.501 

(a)(15)

Maintain current and accurate data in the Organic Integrity 

Database for each operation which it certifies;

This replaces the former requirement to send NOP copies of 

denials of certification and notifications of noncompliance,

noncompliance correction, proposed suspension or revocation, 

and suspension or revocation. It also removes the requirement 

to provide NOP a list of certified operations each year.

Instead, operations must keep current and accurate operation 

data in INTEGRITY, including information about the 

certification status of the operation. 
Page 4 of 4

Section Regulatory Text Key Takeaways

INTEGRITY will specify what types of information is required.

Some of this information will be public (such as certification 

status and areas of operation) and other types of information 

will only be available to NOP and certifiers (such as acreage).

K. Compliance and Noncompliance Procedures

Section Regulatory Text Key Takeaways

205.662 Noncompliance procedure for certified operations.

205.662 

(e)(3)

Within 3 business days of issuing a notification of suspension 

or revocation, or the effective date of an operation’s surrender, 

the certifying agent must update the operation’s status in the 

Organic Integrity Database.

Note: This primer only covers part of section K; this section 

makes additional changes to compliance/noncompliance 

procedure!

Certifiers must update INTEGRITY with changes in an 

operation’s certification status within 3 business days. This 

will ensure that other operations and certifiers are promptly 

made aware of the change.

This is a new paragraph.
Page 1 of 4

Strengthening Organic Enforcement: On-Site Inspections and 

Continuation of Certification

SOE requires that all certifiers conduct a minimum number of unannounced inspections per year; this was previously required through a 

certifier Instruction in the NOP Handbook, but is now codified in the regulations. Additionally, the rule requires that certifiers complete annual 

on-site inspections at least once per calendar year, during which certifiers must perform mass-balance audits and verify product traceability.

This document combines regulatory text from two sections (D. On-Site Inspections and F. Continuation of Certification) with a plain-language 

description of what the changes mean. The bolded text in the table below indicates a key concept. 

General Comments from the National Organic Program: Every certified organic farm and business is inspected at least once a year by a 

qualified organic inspector. These inspections assess the operation’s compliance and determines if they are following their approved Organic 

System Plan. These SOE provisions clarify how these inspections are done. The rules also mandate that certifiers cannot certify operations that 

they cannot access for unannounced inspections. 

D. On-Site Inspections

Section Regulatory Text Key Takeaways

205.2 Terms defined.

205.2 Unannounced inspection. The act of examining and evaluating 

all or a portion of the production or handling activities of a 

certified operation without advance notice to determine 

compliance with the Act and the regulations in this part.

An unannounced inspection can include a full operation or be 

limited to a portion of an operation or an operation’s 

activities, allowing certifiers to use unannounced inspections 

as a risk-based tool to target specific areas, activities, or times 

of the year. 
Page 2 of 4

Section Regulatory Text Key Takeaways

Unannounced inspections aren’t scheduled like full annual 

inspections. However, certifiers may give up to four hours prior 

notice to ensure the operation is accessible and safe to visit.

205.403 On-site inspections

205.403 

(b)

[SOE adds this new paragraph on unannounced inspections. 

Former paragraphs (b) – (e) shift down one each to (c) – (f).] 

Unannounced inspections. 

(1) A certifying agent must, on an annual basis, conduct

unannounced inspections of a minimum of five percent of

the operations it certifies, rounded up to the nearest whole

number.

(2) Certifying agents must be able to conduct unannounced

inspections of any operation they certify and must not accept 

applications or continue certification with operations located in 

areas where they are unable to conduct unannounced 

inspections.

Certifiers must complete a minimum number of unannounced 

inspections per year. Operations may be randomly selected or

selected in response to high risk, investigations, or other 

criteria. 

The ability to conduct an unannounced inspection is considered 

part of a certifier’s administrative capacity: if a certifier cannot 

conduct an unannounced inspection due to geography, 

logistics, staffing, security, or other reasons, then they cannot 

certify that operation. 

205.403 

(d)(4)

[Add mass-balance requirements to “Verification of 

Information,” formerly § 205.403(c).]

An on-site inspection of an operation must verify:

Mass-balances, in that quantities of organic product and 

ingredients produced or purchased account for organic 

product and ingredients used, stored, sold, or transported.

During full annual on-site inspections, certifiers must perform 

mass-balance or “in-out” audits to confirm that inputs match 

outputs. This is an effective way to detect and discourage fraud. 

For example, if a manufacturer’s records show they are 

producing more organic product than the volume of organic

ingredients they purchase would suggest, this is a flag that they 

might be fraudulently using nonorganic ingredients.
Page 3 of 4

Section Regulatory Text Key Takeaways

205.403 

(d)(5) 

[Add traceability requirements to “Verification of Information,” 

formerly § 205.403(c).]

An on-site inspection of an operation must verify:

That organic products and ingredients are traceable by the 

operation from the time of purchase or acquisition through 

production to sale or transport; and that the certifying agent 

can verify compliance back to the last certified operation.

Certifiers must verify traceability within an operation and 

traceability to their certified supplier(s). 

This pairs with an operation’s traceability and audit trail 

documentation requirements in § 205.103(b)(2) and (3) (see

the primer on Supply Chain Traceability and Organic Fraud 

Prevention). Certifiers must evaluate how operations 

maintain traceability.

F. Continuation of Certification

Section Regulatory Text Key Takeaways

205.406 Continuation of certification

205.406 

(a) 

To continue certification, a certified operation must annually ...

submit the following information to the certifying agent:

(1) A summary statement, supported by documentation,

detailing any ... changes to... the organic system plan...

(2) Any additions or deletions to the previous year's organic

system plan...

(3) Any additions to or deletions from the information required

pursuant to § 205.401(b); and

(4) Other information as deemed necessary ... to determine

compliance with the Act and the regulations...

Reduces paperwork by eliminating the need to annually 

submit:

• A full, updated copy of the OSP

• Updates on the correction of minor noncompliances

(operations must already do this is as part of

noncompliance procedure at § 205.662(a)(3) and

certification procedure at § 205.404(a)).
Page 4 of 4

Section Regulatory Text Key Takeaways

205.406 

(b)

The certifying agent must arrange and conduct an on-site 

inspection, pursuant to § 205.403, of the certified operation at 

least once per calendar year. 

Ensures that all operations are inspected annually. The 

previous requirement was sometimes interpreted to allow up to 

an additional 6 months (18 months total) between inspections.

Certifiers can schedule annual on-site inspections at a time 

when they are best able to observe and evaluate the 

operation’s activities (e.g., the growing season).

If a certifier cannot complete a full annual inspection due to an 

emergency or other condition, they are to conduct follow-up 

inspections to determine the operation’s compliance.
Page 1 of 4

Strengthening Organic Enforcement: Nonretail Labeling and 

Calculating Percent Organic

SOE requires that operations label nonretail containers with critical information that will help prevent contamination and comingling and 

support traceability and verification. SOE also clarifies how to calculate the percentage of organic ingredients in multi-ingredient products.

This document combines sections C. Labeling of Nonretail Containers and O. Calculating the Percentage of Organically Produced Ingredients

with a plain-language description of what the change means. The bolded text in the table below indicates a key concept. 

General Comments from the National Organic Program: The emergence of longer and more complex supply chains has highlighted the need 

for more tools as organic goods travel from farm to market. This section of the rule outlines risk-based requirements that protect organic 

integrity, decrease the risk of comingling, and facilitate organic verification traceability in real time. The section on calculating organic 

ingredients completed our work on a long-standing Draft Guidance document that has been of interest to the organic community. 

C. Labeling of Nonretail Containers

Section Regulatory Text Key Takeaways

205.2 [For context only; SOE does not change this term]

Nonretail container. Any container used for shipping 

or storage of an agricultural product that is not used in 

the retail display or sale of the product.

Nonretail containers are defined in § 205.2 and may include: 

• Produce boxes, totes, bulk containers, bulk bags, flexible bulk

containers, harvest crates and bins;

• Boxes, crates, cartons, and master cases of wholesale packaged

products; and

• Trailers, tanks, railcars, shipping containers, vessels, cargo holds,

freighters, barges, grain elevators, silos, grain bins, or other

methods of bulk transport or storage.

205.307 Labeling of nonretail containers
Page 2 of 4

Section Regulatory Text Key Takeaways

205.307 

(a)

Nonretail containers used to ship or store certified 

organic agricultural products must display: 

AMS adopts a risk-based approach by only requiring the most critical 

information on nonretail container labels: organic identification and 

information that links the container to audit trail documentation. This 

reduces administrative burden and cost to operations while still 

protecting organic integrity.

205.307 

(a)(1)

Identification of the product as organic; and Clear identification reduces the likelihood of accidental contamination 

or commingling. “Organic identification” can be anything that allows 

someone to clearly and immediately identify the contents as 

organic, such as a short statement, “organic,” an abbreviation, an 

acronym, or a USDA seal. Operations may use temporary signs or 

labels for containers that are difficult to label due to size, shape, 

material, etc.

205.307 

(a)(2)

The production lot number, shipping identification, or 

other unique information that links the container to 

audit trail documentation.

Linking a container to audit trail documentation reduces information 

on labels without sacrificing the ability to trace or verify products. 

Audit trail documentation allows someone to determine the source, 

transfer of ownership, and transport of a product.

Operations may include additional information on labels such as special 

handling instructions, operation or certifier names, and contact 

information.

205.307 

(b)

Audit trail documentation for nonretail containers 

must identify the last certified operation that 

handled the agricultural product.

This reinforces an SOE recordkeeping requirement to trace back to the 

last certified operation in a supply chain. (See § 205.103(b)(2) and the 

primer on “Supply Chain Traceability and Organic Fraud Prevention”)

205.307 

(c)

Paragraph (a)(1) of this section does not apply to 

nonretail containers used to ship or store agricultural 

This avoids duplicative labeling. Master cases, pallets, or other 

containers don’t need additional organic identification if the retail 
Page 3 of 4

Section Regulatory Text Key Takeaways

products packaged for retail sale with organic 

identification visible on the retail label.

packages they hold indicate the products are organic (for example, if the 

USDA organic seal is visible). These types of containers must still 

include information linking back to audit trail documentation.

O. Calculating the Percentage of Organically Produced Ingredients

Section Regulatory Text Key Takeaways

205.302 Calculating the percentage of organically produced ingredients.

205.302 

(a)(1)

Dividing the total net weight of the combined organic 

ingredients at formulation by the total weight of all 

ingredients of the product at formulation. Water and salt 

added as ingredients at formulation are excluded from the 

calculation. 

The regulation previously used “weight of the finished product.” 

This did not account for water loss from ingredients such as fruit 

during baking or other processing. Operations must now 

calculate the percentage of organic content based on the 

weight of all ingredients before processing. Consistent with 

current policy, salt and water are not included in calculations.

205.302 

(a)(2)

Dividing the total fluid volume of the combined organic 

ingredients at formulation by the total fluid volume of all 

ingredients of the product at formulation if the product and 

ingredients are liquid. Water and salt added as ingredients at 

formulation are excluded from the calculation. If the liquid 

product is identified on the principal display panel or 

information panel as being reconstituted from concentrates, the 

calculation should be made based on single-strength 

concentrations of all ingredients.

For consistency, calculating based on the weight of all 

ingredients at formulation carries through to liquid products. 
Page 4 of 4

Section Regulatory Text Key Takeaways

205.302 

(a)(3)

For products containing organically produced ingredients in 

both solid and liquid form, dividing the combined net weight of 

the solid organic ingredients and the net weight of the liquid 

organic ingredients at formulation by the total weight of all 

ingredients of the product at formulation. Water and salt added 

as ingredients at formulation are excluded from the calculation.

For consistency, calculating based on the weight of all 

ingredients at formulation carries through to products that 

contain both liquid and solid ingredients. 

205.302 

(b) – (c)

Paragraphs (b) and (c) are unchanged.
Page 1 of 5

Strengthening Organic Enforcement: Personnel Training and Qualifications

This section of SOE more clearly lists qualifications for organic inspectors and certification reviewers, including specific knowledge, skills, 

expertise, training, and experience requirements. It also requires that certifiers evaluate the performance of inspectors in the field (witness 

audits). Because inspectors and certifiers are the first lines of defense against fraud, these requirements will protect the integrity of the organic 

label across entire supply chains. 

This document combines regulatory text from section H. Personnel Training and Qualifications with a plain-language description of what the 

change means. The bolded text in the table below indicates a key concept. 

General Comments from the National Organic Program: Organic is a process standard, and process standards are ultimately people 

standards – we need qualified professionals in a range of organic certification jobs. These rule provisions boost confidence for certified 

operations that well-trained and experienced professionals are visiting their farms and businesses and reviewing their plans and records.

H. Personnel Training and Qualifications

Section Regulatory Text Key Takeaways

205.2 Terms defined.

205.2 Certification review. The act of reviewing and evaluating a 

certified operation or applicant for certification and 

determining compliance or ability to comply with the USDA 

organic regulations. This does not include performing an 

inspection.

Along with the existing definition of inspection, this term 

describes who these requirements apply to. Anyone who 

performs an inspection or certification review must meet the 

criteria. 

205.501 General requirements for accreditation.

205.501 

(a)(4)

Continuously use a sufficient number of qualified and 

adequately trained personnel, including inspectors and 

Paragraphs under (a)(4) cover training and qualifications for 

both inspectors and certification reviewers. SOE adds 
Page 2 of 5

Section Regulatory Text Key Takeaways

certification review personnel, to comply with and implement 

the USDA organic standards.

“continuously” and “qualified” to communicate the 

requirements for certifier personnel more clearly.

(a)(4)(i) Certifying agents must demonstrate that all inspectors, 

including staff, volunteers, and contractors, have the 

relevant knowledge, skills, and experience required to 

inspect operations of the scope and complexity assigned and 

to evaluate compliance with the applicable [USDA regulations].

Paragraphs under (a)(4)(i) cover inspectors. An inspector’s

knowledge, skills, and experience must fit the scope and 

complexity of the operations they will inspect. For example, 

crop operations may require different knowledge, skills, and 

experience than a dairy operation or food manufacturer.

(A) Certifying agents must demonstrate that inspectors

continuously maintain adequate knowledge and skills about

the current USDA organic standards, production and handling

practices, certification and inspection, import and/or export

requirements, traceability audits, mass-balance audits, written

and oral communication skills, sample collection, investigation

techniques, and preparation of technically accurate inspection

documents.

This paragraph describes the knowledge and skills that all 

inspectors must have. To reinforce other parts of SOE, this 

includes specific skills related to importing and exporting, 

traceability audits, and mass-balance audits.

(B) All inspectors must demonstrate successful completion of

training that is relevant to inspection. Inspectors with less than

one year of inspection experience must complete at least 50

hours of training within their first year and prior to performing

inspections independently. Inspectors with one or more years

of inspection experience must annually complete at least 10

hours of training if inspecting one area of operation (as defined

at § 205.2) and an additional 5 hours of training for each

additional area of operation inspected.

This paragraph focuses on training relevant to inspection.

SOE requires annual training that scales to experience and the 

types of operations an inspector inspects.

For example, an inspector who inspects crop, livestock, and wild 

crop operations (i.e., three “scopes” or areas of operation) must 

complete at least 20 hours of training annually. 
Page 3 of 5

Section Regulatory Text Key Takeaways

(C) Certifying agents must demonstrate that inspectors have a

minimum of 2,000 hours of experience relevant to the scope

and complexity of operations they will inspect before assigning

initial inspection responsibilities.

All inspectors must have an equivalent of one year of relevant 

experience before inspecting operations independently. This 

can include education, training, work on a farm or ranch, 

internships, apprenticeships, volunteer work, and more.

(a)(4)(ii) Certifying agents must demonstrate that all certification 

review personnel, including staff, volunteers, or contractors, 

have the knowledge, skills, and experience required to perform 

certification review of operations of the scope and complexity 

assigned and to evaluate compliance with the applicable 

regulations of this part.

Paragraphs under (a)(4)(ii) cover certification reviewers. Like 

inspectors, certification reviewers must have knowledge, skills, 

and experience appropriate for the scope and complexity of 

operations they review.

(A) Certifying agents must demonstrate that all certification

review personnel continuously maintain adequate knowledge

and skills in the current USDA organic standards, certification

and compliance processes, traceability audits, mass-balance

audits, and practices applicable to the type, volume, and range

of review activities assigned.

Like certifiers, certification reviewers must also have the

knowledge and skills required to review an operation’s 

compliance. The specific skills are a little different than 

inspectors because they perform different duties (e.g., 

certification reviewers typically don’t need to know how to 

collect samples).

(B) All certification review personnel must demonstrate

successful completion of training that is relevant to

certification review. Certification review personnel with less

than one year of certification review experience must complete

at least 50 hours of training within their first year performing

certification review. Certification review personnel with one or

more years of certification review experience must annually

complete at least 10 hours of training if conducting

certification review related to one area of operation and an

Certification reviewers must complete the same amount of 

annual training as inspectors.
Page 4 of 5

Section Regulatory Text Key Takeaways

additional 5 hours of training for each additional area of 

operation.

(a)(4)(iii) Certifying agents must maintain current training

requirements, training procedures, and training records for 

all inspectors and certification review personnel.

Keeping records and other information allows NOP to evaluate 

a certifier’s compliance during audits.

(a)(5) Demonstrate that all persons with inspection or certification 

review responsibilities have sufficient expertise in organic 

production or handling techniques to successfully perform 

the duties assigned. Sufficient expertise must include 

knowledge of certification to USDA organic standards and 

evidence of education, training, or professional experience in 

the fields of agriculture, science, or organic production and 

handling that relates to assigned duties.

In addition to general knowledge and skill, inspectors and 

certification reviewers must also demonstrate expertise 

specific to organic production and handling This can be 

gained through education, professional experience in 

agriculture or science, or direct experience working on a farm or 

in a handling facility.

(a)(6) Conduct an annual performance evaluation of all persons 

who conduct inspections, certification review, or implement 

measures to correct any deficiencies in certification services.

Certifiers must annually review the performance of all 

inspectors and certification reviewers.

(i) Witness inspections—certifying agents must ensure that

each inspector is evaluated while performing an inspection

at least once every three years, or more frequently if warranted.

Inspectors with less than three years of inspection experience

must undergo a witness inspection annually. Witness

inspections must be performed by certifying agent personnel

who are qualified to evaluate inspectors.

Certifiers must evaluate inspectors during inspections. The 

frequency of these witness audits is scaled to the inspector’s 

experience and performance. 
Page 5 of 5

Section Regulatory Text Key Takeaways

(ii) Certifying agents must maintain documented policies,

procedures, and records for annual performance evaluations

and witness inspections.

Keeping records and documenting policies allows NOP to 

evaluate a certifier’s compliance during audits. 
Page 1 of 7

Strengthening Organic Enforcement: Compliance, Mediation, and Appeals

SOE includes many mechanisms that prevent organic fraud and mishandling before it happens (e.g., certification of more businesses in supply 

chains, NOP Import Certificates, improved recordkeeping and traceability). The rule also updates the processes and procedures for handling 

noncompliance after it occurs. Key changes include clearer authority to strengthen enforcement against uncertified operations, updates to 

promote the use of mediation as an alternate dispute resolution method, and revisions to the appeals process. 

This document discusses sections K. Compliance and Noncompliance Procedures, L. Mediation, and M. Adverse Action Appeal Process. 

Regulatory text is paired with a plain-language description of what the change means. The bolded text indicates a key concept. 

General Comments from the National Organic Program: Over the past several years, AMS has introduced new appeals processes and 

enforcement procedures that stress alternative dispute resolution solutions that bring operations into compliance more quickly than the 

traditional noncompliance escalation steps. SOE integrates many of these processes into the regulations. The updates also clarify NOP’s ability

to enforce against uncertified operations through formal administrative law processes. 

K. Compliance and Noncompliance Procedures

Section Regulatory Text Key Takeaways

205.660 Compliance—General.

205.660 

(c)

Note: This is a new paragraph! Former paragraphs (c) and (d) are

now (d) and (e), respectively. 

The Program Manager may initiate enforcement action against 

any person who sells, labels, or...implies...[a] product 

is...organic, if the product was produced or handled in violation 

of the OFPA or the regulations in this part.

The change clearly states NOP’s authority to take 

enforcement action against uncertified operations or 

individuals that falsely represent conventional products as 

organic.
Page 2 of 7

Section Regulatory Text Key Takeaways

205.661 Investigation. Changing the title of § 206.661 more clearly states that NOP has 

authority to investigate uncertified operations (not just 

certified operations) for violations of OFPA and the regulations.

205.100 What has to be certified.

(c) Any person or responsibly connected person that...

[knowingly sells fraudulent organic products or makes false 

claims is subject to civil penalties, fines, or imprisonment]

SOE clarifies that the penalties for organic fraud apply to 

responsibly connected persons who created or perpetuated 

the fraud.

205.662 Noncompliance procedure for certified operations.

(e)(3) Within 3 business days of issuing a notification of suspension

or revocation, or the effective date of an operation’s surrender, 

the certifying agent must update the operation’s status in the 

Organic Integrity Database.

Certifiers provide a specific timeframe by which certifiers must

report critical changes in operation status (i.e., status 

changes that could affect the integrity of products that another 

operation buys or receives) by updating INTEGRITY.

(f)(1) A certified operation or a person responsibly connected with 

an operation whose certification has been suspended may... 

submit a request...for reinstatement of its certification, or 

submit a request for eligibility to be certified...

A person responsibly connected to a suspended operation 

may lose eligibility to be certified. Just like an operation, this

responsibly connected person must apply though NOP to review 

their eligibility for certification.

(g)(1) [In addition to suspension or revocation, any certified operation 

that] knowingly sells or labels a product as organic, except in 

accordance with the Act, shall be subject to a civil penalty of not 

more than the amount specified in 7 CFR 3.91(b)(1)(xxxvi) per 

violation.

Civil penalties have generally been used mostly with uncertified 

operations. This clarifies that certified operations may also be 

fined in addition to losing their certification. This change 

explicitly notes that certified more precisely cites the maximum 

civil penalty for violations.
Page 3 of 7

L. Mediation

Section Regulatory Text Key Takeaways

205.663 Mediation. § 205.663 has been divided into subparagraphs for clarity.

(a) A certifying agent must submit with its administrative 

policies and procedures: decision criteria for acceptance of 

mediation, and a process for identifying personnel conducting 

mediation and setting up mediation sessions per 

§ 205.504(b)(8).

Certifying agents must include mediation criteria and 

procedures in their administrative policies and procedures. 

This is needed to fulfill due process requirements under the 

Administrative Procedures Act (APA) when cases proceed 

through an administrative law process. 

(b) A certified operation or applicant for certification may request 

mediation to resolve a denial of certification or proposed 

suspension or proposed revocation of certification issued by a 

certifying agent or State organic program. 

This codifies that mediation is an available method of 

alternative dispute resolution to resolve noncompliances 

before an operation or certifying agent appeals to AMS. 

(b)(1) A certified operation or applicant for certification must submit 

any request for mediation in writing... within 30 calendar

days of receipt of the notice of proposed suspension or 

proposed revocation of certification or denial of certification. 

Clarifies the timeline to submit a request for mediation. 30 days 

aligns with the timeframe provided to submit an appeal of a 

proposed adverse action.

(b)(2) A certifying agent or State organic program may accept or reject 

a request for mediation based on the decision criteria required 

in paragraph (a) of this section. Certifying agents must 

document these criteria. and how the certifying agent applied 

the criteria to the request.

Decision criteria for accepting or rejecting mediation must be 

fair and not arbitrary. The agent must be able to document 

how standard criteria were used to make a specific acceptance 

or rejection decision.

(b)(3) If a certifying agent rejects a mediation request, it must provide 

this rejection, and the justification for the rejection, in writing to 

the applicant for certification or certified operation. The 

rejection must include the right to request an appeal, pursuant 

SOE adds a reference to the updated appeals process in 

§ 205.681 to clarify what steps the certifier and operation should

take following rejection of a mediation request.
Page 4 of 7

Section Regulatory Text Key Takeaways

to § 205.681, within 30 calendar days of the date of receipt of 

the written notification of rejection of the request for mediation.

(b)(4) (4) When an operation appeals a rejection of mediation, the

adverse action which is contested must not be finalized

during the appeal proceeding.

The rule clarifies that the adverse action being contested cannot 

be finalized during the appeal proceeding. This clarification 

supports the right to due process.

(c) Both parties must agree on the person conducting the 

mediation.

This is required for both formal and informal mediation.

(d) If a State organic program is in effect, the parties must follow

the mediation procedures established in the State organic 

program and approved by the Secretary.

All parties must follow any additional mediation requirements 

of a State organic program. 

(e) The parties to the mediation have a maximum of 30 calendar 

days to reach an agreement from the start of mediation. 

Successful mediation results in a settlement agreement agreed 

to in writing by both the certifying agent and the certified 

operation. If mediation is unsuccessful, the applicant for 

certification or certified operation has 30 calendar days from 

receipt of a written notice of termination of mediation to appeal

the denial of certification or proposed suspension or revocation 

pursuant to §205.681.

Clarifies that the 30 days starts when mediation starts. This 

paragraph also clarifies what the successful outcome of 

mediation looks like: the goal of mediation is to reach a 

settlement agreement that leads to compliance (either by

exiting the market or coming into compliance). 

205.663 

(f)

Any settlement agreement reached through mediation must 

comply with the Act and the regulations in this part. The 

Program Manager may review any mediated settlement 

agreement for conformity to the Act and the regulations in this 

part and may reject any agreement or provision not in 

conformance with the Act or the regulations in this part.

Clarifies that NOP, not the Secretary, may review mediated 

settlement agreements.
Page 5 of 7

Section Regulatory Text Key Takeaways

205.663 

(g) 

The Program Manager may propose mediation and enter into a 

settlement agreement at any time to resolve any adverse action 

notice.

Clarifies that NOP may use mediation as part of its oversight, 

compliance, and enforcement activities. 

205.504 Evidence of expertise and ability. [certifying agents]

A private or governmental entity seeking accreditation...must 

submit...documents and information to demonstrate its 

expertise in organic production or handling techniques [and] its 

ability to fully comply with and implement...205.661 through 

205.663... 

Certifiers must include mediation criteria and procedures in the 

information that they provide to demonstrate their ability to 

comply with the organic regulations.

(b)(8) Administrative policies and procedures. (8) A copy of reasonable 

decision criteria for acceptance of mediation, and a process for 

identifying personnel conducting mediation and setting up 

mediation.

M. Adverse Action Appeals Process

Section Regulatory Text Key Takeaways

205.2 Terms defined.

205.2 Adverse action. A noncompliance decision that adversely affects 

certification, accreditation, or a person subject to the Act, 

including a proposed suspension or revocation; a denial of 

certification, accreditation, or reinstatement; a cease and desist 

notice; or a civil penalty.

Adverse action is a newly defined term that replaces 

noncompliance decision throughout the appeals sections of the 

regulation. It clarifies what specific types of notices are 

appealable.

205.680 Adverse Action Appeal Process—General.
Page 6 of 7

Section Regulatory Text Key Takeaways

(d) Persons subject to the Act who believe they are adversely 

affected by an adverse action... may request mediation as 

provided in § 205.663.

New paragraph! Former (d) is redesignated as (f).

Cross-reference to mediation as an appropriate course of action 

to resolve an adverse action before a party appeals.

(e) All appeals must comply with the procedural requirements in 

§ 205.681(c) and (d).

New paragraph! Former (e) is redesignated as (g).

Cross-reference to appeals filing requirements.

205.681 Adverse Action Appeals Process—Appeals.

(a) Adverse actions by certifying agents. An applicant for 

certification may appeal... 

SOE changes the title of this paragraph from “Certification 

appeals” to “Adverse actions by certifying agents” to better 

distinguish it from adverse actions by the NOP.

(a)(2) If the Administrator or State organic program denies an appeal, 

a formal administrative proceeding will be initiated to deny, 

suspend, or revoke the certification unless the parties resolve 

the issues through settlement, or the appellant waives or 

does not timely request a hearing... 

SOE clarifies that denial of an operation’s appeal does not 

always result in a formal administrative hearing. The affected 

parties may choose to accept a settlement or waive or decline 

a hearing. If a hearing is waived or not requested, the certifier

issues the adverse action without a formal proceeding. This is 

an important change in the default from “Hearing” to “no 

Hearing unless requested.”

(b) Adverse actions by the NOP Program Manager. A person 

affected by an adverse action, as defined by § 205.2, issued by 

the NOP Program Manager, may appeal to the Administrator. 

This section updates the outcomes that may follow an appeal. 

The regulations formerly only addressed the continuance or 

denial of accreditation. SOE adds that if an appeal is sustained: 

• An operation may continue certification, and

• Civil penalties and cease-and-desist notices are

withdrawn.

If an appeal is denied: 

(b)(1) (1) If the Administrator sustains an appeal, an applicant will be

issued accreditation, a certifying agent will continue its

accreditation, or an operation will continue its certification,

a civil penalty will be withdrawn and a cease-and-desist

notice will be withdrawn, as applicable to the operation.
Page 7 of 7

Section Regulatory Text Key Takeaways

(b)(2) If the Administrator denies an appeal, a formal administrative 

proceeding will be initiated to deny, suspend, or revoke the 

accreditation or certification and/or levy civil penalties unless 

the parties resolve the issues through settlement, the appellant 

waives a hearing, or the appellant does not timely request a 

hearing...

• IF the appellant wants to further contest the notice,

he/she must timely request a formal hearing.

• Civil penalties may be levied during the Hearing process

• The parties may resolve the matter through settlement

before a Hearing

(c) Filing period. An appeal must be filed in writing within the time 

period provided in the letter of notification or within 30 days... 

An adverse action will become final and nonappealable unless 

an appeal is timely filed.

SOE updates this paragraph to remove “noncompliance 

decision” and use “adverse action,” It also clarifies that an 

adverse action becomes final unless an appeal is timely filed. 

(d)(1) Appeals to the Administrator and Requests for Hearing must be 

filed in writing and addressed to: 1400 Independence Ave., [etc.] 

... or electronic transmission, NOPAppeals@usda.gov

SOE adds an email address where appeals may be sent 

electronically. 

(d)(3) All appeals must include a copy of the adverse action and a 

statement of the appellant's reasons for believing that the 

action was not proper...

The regulation now uses the new term adverse action to 

encompass the decisions an appellant may appeal.
 

 

 

Strengthening Organic Enforcement: 

Producer Groups, Satellite Offices, and Equivalency 

Sensible oversight of the global organic supply protects organic integrity. In addition to the NOP Import Certificate, SOE introduces several 

mechanisms that safeguard the integrity of imported products. The rule codifies standards for producer groups, a type of certification 

commonly used in other countries to produce favorites like coffee and bananas. SOE clarifies the USDA’s authority to enforce the activities of 

individual certification offices in other countries. Finally, SOE also codifies how the USDA determines if another country’s organic standard is 

equivalent to the USDA organic standard, allowing that country’s organic products to be sold in America. 

This document discusses sections N. Producer Group Operations, I. Oversight of Certification Activities, and J. Accepting Foreign Conformity 

Assessment Systems. Condensed regulatory text is paired with a plain-language description. Bolded text indicates a key concept. 

General Comments from the National Organic Program: The Strengthening Organic Enforcement (SOE) rule includes many provisions that 

address different topics, but that work together to create an inter-connected, systematic network of organic control systems at different 

oversight levels. These control systems protect the organic market from the level of a two-acre farm, to a country-specific certifier office, to 

another government’s organic program. 

N. Producer Group Operations

Section Regulatory Text Key Takeaways 

205.2 Terms defined. 

Producer group operation. A producer, organized as a person, 

consisting of producer group members and production units 

in geographic proximity governed by an internal control system 

under one organic system plan and certification. 

A group of individual farmers that are collectively certified 

under one organic certificate. 

Page 1 of 7
 

 

 

 

 

Section Regulatory Text Key Takeaways 

Producer group member. An individual engaged in the activity 

of producing or harvesting agricultural products as a member of 

a producer group operation. 

A member is a single farmer within a producer group. 

Producer group production unit. A defined subgroup of 

producer group members in geographic proximity within a 

single producer group operation that use shared practices and 

resources to produce similar agricultural products. 

A production unit is a collection of members in the same area 

that produce the same commodity. A producer group can have 

several production units, or just one. 

Internal control system (ICS). An internal quality management 

system that establishes and governs the review, monitoring, 

training, and inspection of the producer group operation, 

and the procurement and distribution of shared production and 

handling inputs and resources, to maintain compliance with the 

USDA organic regulations. 

The ICS is directly responsible for the compliance of the 

producer group. The ICS trains members but also inspects, 

monitors, and enforces members. In contrast, the certifier 

reviews the ICS and determines the ICS’s ability to ensure 

compliance with the regulations. 

205.400 General requirements for certification. 

(g) In addition to paragraphs (a) through (f) of this section, a 

producer group operation must: 

This section describes what it takes to be eligible for producer 

group certification under a single organic certificate. 

Certification of many individuals under a single organic 

certificate is possible because OFPA and the organic regulation 

use “person” as the basic regulatory unit. “Person” is defined in 

the regulations as “an individual, partnership, corporation, 

association, cooperative, or other entity.” 

(1) Be organized as a person; 

(2) Use centralized processing, distribution, and marketing facilities 

and systems; 

(3) Be organized into producer group production units; 

(4) Maintain an internal control system... 

(5) Ensure that all agricultural products sold, labeled, or 

represented as organic are produced only by producer group 

members using land and facilities within the certified operation; 

Page 2 of 7
 

 

 

Section Regulatory Text Key Takeaways 

(6) Ensure that producer group members do not sell, label, or 

represent their agricultural products as organic outside of the 

producer group operation unless they are individually certified; 

To be eligible for producer group certification, the group must 

follow specific organizational and procedural criteria, such 

as having an ICS, selling only through the producer group, 

providing certain data to certifying agents, conducting annual 

inspections of every member, and ensuring traceability. 

(7) Report to the certifying agent... [data about each member] 

(8) Conduct internal inspections of each producer group member... 

(9) Implement recordkeeping requirements to ensure traceability... 

(10) Implement procedures to ensure... complian[ce] with the USDA 

organic regulations and the Act; and 

(11) Address any other terms or conditions determined by the 

Administrator to be necessary... 

205.201 Organic production and handling system plan 

(c) ... [A] producer group operation’s organic system plan must 

describe its internal control system... 

Because the ICS is the cornerstone of producer group 

certification, the OSP must thoroughly describe how the ICS 

will maintain compliance with the organic regulations. 

Like other parts of an OSP, this information helps the ICS 

function well and helps certifiers assess compliance. Key 

areas of focus include the structure and function of both the ICS 

and the producer group, risk management, training, 

recordkeeping, traceability, monitoring, and inspection. 

(1) Define the organizational structure, roles, qualifications, and 

responsibilities of all personnel; 

(2) Identify producer group production units and locations; 

(3) Describe measures to protect against potential conflicts of 

interest... 

(4) Define geographic proximity criteria... 

(5) Describe procedures for accepting new members... 

(6) Describe characteristics of high-risk producer group members... 

(7) Describe [use and distribution of] shared resources... 

(8) Describe...training, education, and technical assistance... 

(9) Describe the system of records used to demonstrate 

compliance... 

Page 3 of 7
 

 

 

Section Regulatory Text Key Takeaways 

(10) Describe how internal monitoring, surveillance, inspection, 

sanctions, and auditing are used to assess compliance... 

205.403 On-site inspections. 

(a)(2) Inspections of producer group operation must: This section covers what certifiers must do when inspecting a 

producer group. Certifiers must: 

• Assess the ICS’s inspection of members

• Observe the ICS inspecting members

• Inspect a minimum number of members

• Inspect handling facilities

(i) Assess the internal control system’s compliance, [including] 

review of the internal inspections... 

(ii) Conduct witness audits of internal control system inspectors... 

(iii) Individually inspect at least 1.4 times the square root or 2% of 

the total number of producer group members... 

(iv) Inspect each handling facility. 

I. Oversight of Certification Activities

Section Regulatory Text Key Takeaways 

205.2 Terms defined. 

Certification activity. Any business conducted by a certifying 

agent, or by a person acting on behalf of a certifying agent, 

including but not limited to: certification management; 

administration; application review; inspection planning; 

inspections; sampling; inspection report review; material 

review; label review; records retention; compliance review; 

investigating complaints and taking adverse actions; 

certification decisions; and issuing transaction certificates. 

This new term describes the scope of activities that certifiers 

perform and defines some of the activities that are subject to 

NOP oversight and enforcement. 

205.2 Certification office. Any site or facility where certification 

activities are conducted, except for certification activities that 

In combination with certification activities, this new term helps 

clarify that any office may be subject to NOP oversight and 

enforcement, whether it is a “central” or “satellite” office. 

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Section Regulatory Text Key Takeaways 

occur at certified operations or applicants for certification, such 

as inspections and sampling. 

205.501 General requirements for accreditation. 

(a)(22) Notify AMS not later than 90 calendar days after certification 

activities begin in a new certification office. ...[I]nclude the 

countries... the nature of the certification activities, and the 

qualifications of the personnel... 

Note: This paragraph is new and was a requirement in the 2018 

Farm Bill to help support NOP oversight of certifiers. 

Certifiers must notify NOP when they open a new 

certification office—also known as a “satellite office”—and 

must report information about the location, activities, and 

personnel. 

205.665 Noncompliance procedure for certifying agents. 

(a) (1) A written notification of noncompliance will be sent to the

certifying agent when...

(ii) The Program Manager determines that the certification

activities of the certifying agent, or any person performing 

certification activities on behalf of the certifying agent, are 

not compliant... 

(iii) The Program Manager determines that the certification

activities at a certification office, and/in specific countries, are

not compliant...

SOE reorganizes paragraph (a) and adds clearer language about 

when USDA may initiate enforcement action against a 

certifier. This means that USDA can take enforcement action 

based on the activity of subcontractors, an individual remote 

certification office or “satellite office,” or the activities within a 

specific country. 

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J. Assessing Foreign Conformity Assessment Systems

Section Regulatory Text Key Takeaways 

205.2 Terms defined. 

Technical requirements. A system of relevant laws, regulations, 

regulatory practices, standards, policies, and procedures 

that address... organic agricultural products. 

This is a new term for the standards that another government 

uses to describe and regulate organic production and handling. 

Conformity assessment system. All activities... undertaken by a 

government to ensure that the applicable technical 

requirements... are fully and consistently applied. 

How another government ensures compliance with their 

organic standards. 

205.511 Accepting foreign conformity assessment systems. New section! 

(a) ...Foreign product that is produced and handled under another 

country’s organic certification program may be sold, labeled, 

or represented in the United States as organically produced if 

the U.S. Government determines that such country’s organic 

certification program provides technical requirements and a 

conformity assessment system... that are at least equivalent 

to [U.S.] requirements. 

Organic products produced overseas can be sold in the U.S. if 

they are certified USDA organic OR if the products are certified 

under another government’s organic standard that is 

determined to be equivalent to USDA organic. 

Equivalent means that the other organic standard is similar 

enough to USDA organic that it’s considered interchangeable. It 

does not mean the standards are identical. 

(b) Countries desiring to establish eligibility of product certified 

under that country’s organic certification program...may 

request equivalence determinations from AMS... the 

requesting country must submit documentation that describes 

its technical requirements and conformity assessment system... 

A government can apply to request a determination of 

whether its organic standard is technically equivalent to the 

USDA organic standard. The government needs to provide all 

the information needed to assess technical equivalence. 

(c) AMS will describe the scope of an equivalence determination. 

(d) AMS will conduct regular reviews...to verify that the foreign 

[organic standard is] equivalent... and will determine if the 

IF the U.S. government determines the systems to be 

equivalent, AMS will regularly reevaluate the other 

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Section Regulatory Text Key Takeaways 

equivalence determination should be continued, amended, or 

terminated. AMS will determine the timing and scope of reviews 

and re-assessments... 

government’s organic standard—and their system and ability to 

enforce this standard—to see if it remains equivalent to USDA 

organic. The U.S. government may choose to continue, update, 

or end equivalence. 

(e) The U.S. Government may terminate equivalence... if AMS 

determines that the country’s technical requirements and/or 

conformity assessment program are no longer equivalent; if 

AMS determines that the foreign government’s organic control 

system is inadequate...; or for other good cause. 

Equivalence may end if the other government’s: 

• Organic standard is no longer similar to USDA’s organic

standard;

• System of oversight and enforcement is no longer similar

to USDA organic; or

• Ability to enforce the standard does not ensure integrity.

Page 7 of 7
May 2023

1 

Quick Guide: SOE CFR Reference Changes 

Purpose: The SOE rule significantly updated the USDA organic regulations. This document lists sections and/or 

paragraphs that the rule redesignated. For example, former paragraph 205.501(a)(21) is now paragraph (a)(23). It also 

lists new paragraphs and sections that SOE added. The table below lists these changes so that NOP can begin 

updating these references in NOP documents. 

Note: This table is a guide only. Please check the CFR when updating references in documents. If you are updating 

regulatory text, you must read the read final rule and the updated CFR. 

Former Reference New Reference Description of Change

205.2 205.2 Several revised and new definitions. See the CFR.

205.101 Significantly revised and reorganized. All references to 

paragraphs in 101 may need and update.

205.103(b)(3) 205.103(b)(4) (b)(3) redesignated as (b)(4)

205.103(b)(4) 205.103(b)(5) (b)(4) redesignated as (b)(5)

N/A 205.201(c) New paragraph on producer group OSPs.

N/A 205.273 New section on NOP Import Certificates.

205.307 205.307 Significantly revised and reorganized. Title of section and 

references to paragraphs in 307 will need an update.

N/A 205.400(g) New paragraph on producer group criteria.

N/A 205.403(a)(2) New paragraph on producer group inspections.

205.403(a)(2) 205.403(a)(3) (a)(2) redesignated as (a)(3)

N/A 205.403(b) New paragraph on unannounced inspections.

205.403(b) 205.403(c) Former paragraphs move up one letter. Paragraph (d) now also 

has new subparagraphs (1) and (2) on mass-balance and 

traceability.

205.403(c) 205.403(d)

205.403(d) 205.403(e)

205.403(e) 205.403(f)

N/A 205.404(c) New paragraph on organic certificate addenda.

205.404(c) 205.404(d) (c) redesignated as (d)

205.405(c)(3) Removed Remove paragraph about sending notices of approval or denial 

of certification to NOP.

205.500(c) 205.511 Replaced by new section on equivalency.

N/A 205.501(a)(21) New paragraph on traceability audits.

N/A 205.501(a)(22) New paragraph on new office notifications.

205.501(a)(21) 205.501(a)(23) (a)(21) redesignated as (a)(23)

N/A 205.504(b)(7) New paragraph on traceability audit procedures.

N/A 205.504(b)(8) New paragraph on mediation criteria.

N/A 205.511 New section on equivalency.

N/A 205.660(c) New paragraph on enforcement authority.

205.660(c) 205.660(d) (c) redesignated as (d)
May 2023

2 

Former Reference New Reference Description of Change

205.660(d) 205.660(e) (d) redesignated as (e)

205.661 205.661 Section title changed to “Investigation.”

N/A 205.662(e)(3) New paragraph on updating INTEGRITY.

205.663 205.663(a) – (g) Section on mediation revised and broken into paragraphs

205.665(a) 205.665(a) Paragraph revised and reorganized with additional 

subparagraphs.

N/A 205.680(d) New paragraph on mediation requests.

N/A 205.680(e) New paragraph on appeals procedure.

205.680(d) 205.680(f) (d) redesignated as (f)

205.680(e) 205.680(g) (e) redesignated as (g)