[Federal Register Volume 88, Number 12 (Thursday, January 19, 2023)]
[Rules and Regulations]
[Pages 3548-3627]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-00702]



[[Page 3547]]

Vol. 88

Thursday,

No. 12

January 19, 2023

Part III





 Department of Agriculture





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 7 CFR Part 205





National Organic Program (NOP); Strengthening Organic Enforcement; 
Final Rule

  Federal Register / Vol. 88 , No. 12 / Thursday, January 19, 2023 / 
Rules and Regulations  

[[Page 3548]]


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DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 205

[Doc. No. AMS-NOP-17-0065; NOP-17-02]
RIN 0581-AD09


National Organic Program (NOP); Strengthening Organic Enforcement

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Final rule.

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SUMMARY: This rulemaking amends the United States Department of 
Agriculture (USDA) organic regulations to strengthen oversight and 
enforcement of the production, handling, and sale of organic 
agricultural products. The amendments protect integrity in the organic 
supply chain and build consumer and industry trust in the USDA organic 
label by strengthening organic control systems, improving farm to 
market traceability, and providing robust enforcement of the USDA 
organic regulations. Topics addressed in this rulemaking include: 
applicability of the regulations and exemptions from organic 
certification; National Organic Program Import Certificates; 
recordkeeping and product traceability; certifying agent personnel 
qualifications and training; standardized certificates of organic 
operation; unannounced on-site inspections of certified operations; 
oversight of certification activities; foreign conformity assessment 
systems; certification of producer group operations; labeling of 
nonretail containers; annual update requirements for certified 
operations; compliance and appeals processes; and calculating organic 
content of multi-ingredient products.

DATES: 
    Effective date: March 20, 2023
    Implementation date: March 19, 2024.

FOR FURTHER INFORMATION CONTACT: Jennifer Tucker, Ph.D., Deputy 
Administrator, National Organic Program. Telephone: 202-720-3252. 
Email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Executive Summary

    This rulemaking amends several sections of the USDA organic 
regulations, 7CFR part 205, to strengthen oversight of the production, 
handling, certification, marketing, and sale of organic agricultural 
products as established by the Organic Foods Production Act of 1990 
(OFPA, or ``the Act'').\1\ When implemented, this rulemaking will 
improve organic integrity across the organic supply chain, and benefit 
stakeholders throughout the organic industry. These amendments close 
gaps in the current regulations to build consistent certification 
practices to deter and detect organic fraud, and improve transparency 
and product traceability. In addition, the amendments will assure 
consumers that organic products meet a robust, consistent standard and 
reinforce the value of the organic label.
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    \1\ The Organic Foods Production Act of 1990, 7 U.S.C. 6501-
6524, is the statute from which the Agricultural Marketing Service 
derives authority to administer the NOP and authority to amend the 
regulations as describedin thisrulemaking. This document is 
available at: https://uscode.house.gov/view.xhtml?path=/prelim@title7/chapter94&edition=prelim
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    The need for this rulemaking is driven by organic market growth and 
increasingly complex organic supply chains. Today's organic market is 
characterized by long--and often global--supply chains where organic 
products are handled by many businesses before reaching the consumer. 
Often, these businesses are not certified organic--and therefore have 
no oversight from the USDA or USDA-accredited certifying agents. The 
absence of direct enforcement over some entities in the organic supply 
chain, in combination with price premiums for organic products, has 
created the opportunity for organic fraud. The amendments in this 
rulemaking are designed to mitigate the occurrence of organic fraud.
    The Agricultural Marketing Service (AMS) is confident in the 
integrity and value of the USDA organic seal. Consumers can trust the 
organic label due to a rigorous oversight system that operates 
globally. However, the challenges of modern organic supply chains 
demand action to strengthen enforcement and uphold the integrity of the 
USDA organic label.
    This rulemaking strengthens enforcement of the USDA organic 
regulations through several actions mandated by the Agriculture 
Improvement Act of 2018:
    1. Reduce the types of uncertified entities in the organic supply 
chain that operate without USDA oversight--including importers, certain 
brokers, and traders of organic products. This will safeguard organic 
product integrity and improve traceability.
    2. Require the use of NOP Import Certificates for all organic 
products entering the United States. This change expands the use of NOP 
Import Certificates to all organic products imported into the United 
States, improving the oversight and traceability of imported organic 
products.
    3. Clarify the NOP's authority to oversee certification activities, 
including the authority to act against an agent or office of a 
certifying agent. Additionally, certifying agents must notify the NOP 
upon opening a new office, which will allow the NOP to provide more 
effective and consistent oversight of certifying agents and their 
activities.
    Additionally, this rule includes several essential actions that 
work in alignment with the provisions above to further strengthen 
enforcement of the USDA organic regulations:
    1. Require that nonretail containers used to ship or store organic 
products are labeled with organic identity and are traceable to audit 
trail documentation. This information will clearly identify organic 
products, reduce the mishandling of organic products, and support 
traceability.
    2. Require certifying agents to conduct unannounced inspections of 
at least 5% of the operations they certify, complete mass-balance 
audits during annual on-site inspections, and verify traceability back 
to the previous certified operation in the supply chain during annual 
on-site inspections.
    3. Require certifying agents to issue standardized certificates of 
organic operation generated from the USDA's Organic Integrity Database 
(OID); this will simplify the verification of valid certificates of 
organic operation. Certifying agents must also keep accurate and 
current certified operation data in OID, which will further support 
verification of operations' certified status.
    4. Clarify how certified operations may submit changes to their 
organic system plan, with the goal of reducing paperwork burden for 
organic operations and certifying agents. This rule also builds 
consistency in certification practices by clarifying that certifying 
agents must conduct on-site inspections at least once per calendar 
year.
    5. Establish specific qualification and training requirements for 
certifying agent personnel, including inspectors and certification 
reviewers. Requiring that personnel meet minimum education and 
experience qualifications and requiring continuing education will 
ensure high-quality and consistent certification activities across all 
certifying agents.
    6. Clarify conditions for establishing, evaluating, and terminating 
equivalence determinations with foreign government organic programs, 
based on an

[[Page 3549]]

evaluation of their organic foreign conformity systems. This will 
ensure the compliance of organic products imported from countries that 
have organic trade arrangements or agreements with the United States.
    7. Clarify that the NOP may initiate enforcement action against any 
violator of the OFPA, including uncertified operations and responsibly 
connected parties; clarify what actions may be appealed and by whom; 
and clarify NOP's appeal procedures and options for mediation 
(alternative dispute resolution).
    8. Specify certification requirements for producer group 
operations, to provide consistent, enforceable standards and ensure 
compliance with the USDA organic regulations. Producer groups must meet 
certain criteria to qualify for certification, and must use an internal 
control system to monitor compliance.
    9. Clarify the method of calculating the percentage of organic 
ingredients in a multi-ingredient product to promote consistent 
interpretation and application of the regulation.
    10. Require certified operations to develop and implement improved 
recordkeeping and organic fraud prevention processes and procedures; 
require certifying agents to conduct supply chain traceability audits 
and to develop and implement information-sharing processes.

Costs and Benefits

    AMS estimates the following costs and benefits of this rule:

                                      Costs and Benefits of SOE Rulemaking
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                                                      Average annual cost \a\             Total cost \b\
                                                 ---------------------------------------------------------------
                                                    3% Discount     7% Discount     3% Discount     7% Discount
                                                       rate            rate            rate            rate
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Domestic Costs..................................     $10,548,510      $7,884,601    $158,227,651    $118,269,011
Foreign Costs...................................       8,769,681       6,550,892     131,545,210      98,263,398
                                                 ---------------------------------------------------------------
    Total Costs.................................      19,318,191      14,435,494     289,772,861     216,532,409
                                                 ---------------------------------------------------------------
    Benefits....................................      32,944,812      24,272,099     494,172,179     364,081,491
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\a\ Estimated annual averages of the 15-year Net Present Value domestic costs discounted at 3 and 7 percent.
\b\ Estimated total domestic costs for affected industry in Net Present Value discounted at 3 and 7 percent.

Table of Contents

I. Executive Summary
II. Background
    A. Authority
    B. Purpose and Need for the Rule
    C. History
    D. Public Comment
    E. Terminology
    F. Does this action apply to me?
    G. Compliance Date
III. Overview of Amendments
    A. Applicability and Exemptions From Certification
    B. Imports to the United States
    C. Labeling of Nonretail Containers
    D. On-Site Inspections
    E. Certificates of Organic Operation
    F. Continuation of Certification
    G. Paperwork Submissions to the Administrator
    H. Personnel Training and Qualifications
    I. Oversight of Certification Activities
    J. Accepting Foreign Conformity Assessment Systems
    K. Compliance and Noncompliance Procedures
    L. Mediation
    M. Adverse Action Appeal Process
    N. Producer Group Operations
    O. Calculating the Percentage of Organically Produced 
Ingredients
    P. Supply Chain Traceability and Organic Fraud Prevention
    Q. Technical Corrections
    R. Additional Amendments Considered but Not Included in This 
Rule
IV. Regulatory Analyses
    A. Summary of Economic Analyses
    B. Regulatory Impact Analysis
    C. Executive Order 12988
    D. Paperwork Reduction Act
    E. Executive Order 13175
    F. Executive Order 13132
    G. Civil Rights Impact Analysis
    H. Related Documents

II. Background

A. Authority

    The Organic Foods Production Act of 1990 (OFPA) (7 U.S.C. 6501-
6524), authorizes the Agricultural Marketing Service (AMS) to establish 
and maintain national standards governing the marketing of organically 
produced agricultural products. AMS administers these standards through 
the National Organic Program (NOP). Final regulations implementing the 
NOP, also referred to as the USDA organic regulations, were published 
on December 21, 2000 (65 FR 80548) and became effective on October 21, 
2002.\2\ Through these regulations, AMS oversees national standards for 
the production, handling, labeling, and sale of organically produced 
agricultural products.
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    \2\ 7 CFR part 205 National Organic Program; Final Rule. 
December 21, 2000. Available on the AMS website: https://www.federalregister.gov/documents/2000/12/21/00-32257/national-organic-program
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B. Purpose and Need for the Rule

    Since full implementation of the USDA organic regulations, the 
organic industry has experienced significant change. Both demand for 
and sales of organic products have risen steadily; total U.S. sales of 
organic products reached more than $63 billion in 2021.\3\ The number 
of businesses producing, handling, marketing, and selling organic 
products has also grown to meet consumer demand. Rapid growth has 
attracted many businesses to the USDA organic label and increased the 
complexity of global organic supply chains.
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    \3\ Organic Trade Association, Organic Industry Survey, 2022.
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    Complexity makes oversight and enforcement of the organic supply 
chains difficult because organic products are credence goods, which 
means that their organic attributes, or ``integrity,'' cannot be easily 
verified by consumers or businesses who buy organic products for use or 
resale. The elements needed to guarantee organic integrity--transparent 
supply chains, trusted interactions between businesses, and mechanisms 
to verify product legitimacy--are more difficult to achieve in the 
increasingly complex modern organic industry. This is further 
compounded by inconsistent interpretation and implementation of the 
USDA organic regulations, caused by a lack of clarity in some portions 
of the regulation.
    AMS is confident in the integrity and value of the USDA organic 
seal. Consumers can trust the organic label due to a rigorous oversight 
system that operates globally. However, the above challenges sometimes 
cause

[[Page 3550]]

mishandling of organic products, where integrity is compromised due to 
improper handling. Additionally, high demand for organic products, the 
absence of direct enforcement over some entities in the organic supply 
chain, and organic price premiums increase the opportunity and 
incentive for organic fraud (when nonorganic products are deceptively 
represented as organic).
    This rule addresses these risks and challenges by expanding 
oversight to higher-risk portions of organic supply chains, requiring 
organic operations to implement traceability and verification best 
practices, and clarifying oversight and enforcement practices to ensure 
more consistent implementation by certifying agents. This rule will 
help prevent loss of organic integrity--which can occur both through 
unintentional mishandling of organic products, and intentional fraud 
meant to deceive--and strengthen the trust consumers, farmers, and 
businesses have in the USDA organic label.
Mishandling of Organic Products and Complex Supply Chains
    One of the most common risks to the integrity of an organic product 
is mishandling--when an entity unintentionally compromises the unique 
attributes that make a product organic. Once organic integrity is 
compromised, that product can no longer be sold as organic, and both 
its unique attributes and price premium are forfeit. Mishandling can 
occur at any point in a supply chain, including production, handling, 
transport, storage, sale, and processing. Examples of mishandling that 
can cause a loss of integrity include exposure to pesticides, 
fertilizers, fumigants, or cleaning agents that are not permitted in 
organic production; mixing (``commingling'') of organic and nonorganic 
products; relabeling or repackaging with incorrect identification; and 
inability to demonstrate organic status due to poor or incomplete 
information in records or transaction paperwork. The likelihood of such 
mishandling is greater in long, complex supply chains where many 
businesses, including businesses not certified organic, handle and sell 
organic products.
    When the organic regulations were published in 2000, organic 
products were marketed mostly locally or regionally, and supply chains 
tended to be short and transparent; for example, farm to wholesale to 
retail to consumer. Demand and sales have grown considerably since 
then. This significant market growth has attracted more producers, 
handlers, product suppliers, importers, brokers, distributors, and 
others to the organic market. Consider the example of an organic egg 
supply chain in the United States, beginning with the production of 
certified organic corn and ending with the sale of eggs to the 
consumer. This demonstrates the typical entities and transactions in an 
organic supply chain under the existing regulations:
     A certified organic farm produces organic corn.
     The corn is transported via an uncertified truck to a 
local grain elevator, where it is aggregated with other organic corn 
from nearby producers.
     An uncertified commodity trader buys the corn.
     The corn is transported via uncertified truck to an 
uncertified storage facility; both transport and storage are 
subcontracted and are not owned by the commodity trader.
     The commodity trader sells the corn to a certified organic 
grain supplier; the two parties remain anonymous because they use an 
uncertified broker to facilitate the transaction.
     The corn is transported via uncertified rail and river 
barge to the grain supplier; it is transloaded and stored temporarily 
several times before being delivered to the certified grain supplier.
     The certified organic grain supplier stores the corn and 
combines it with imported organic corn purchased from an importer via 
an uncertified broker.
     The certified grain supplier sells the corn to a certified 
organic feed processer; the corn is transported via an uncertified 
truck.
     The certified processer combines the corn with several 
other ingredients to create organic chicken feed.
     The certified processer sells the feed to a certified 
organic egg producer and transports it via an uncertified truck.
     The certified organic egg producer sells organic eggs to 
an uncertified distributor.
     The uncertified distributor sells the organic eggs to a 
retailer prior to final sale to the consumer.
    This example illustrates the supply chain for a single ingredient--
organic feed corn. The supply chain for the organic eggs at the end of 
this example is even more complex because it includes other ingredients 
that go into the chicken feed (e.g., soybean meal, oats, wheat, seed 
oils). Many of these ingredients are sourced both domestically and 
internationally. Each ingredient has its own unique supply chain; 
together they create a complex web converging on a single organic 
product. It is largely because of this complexity that this rule 
introduces more specific traceability, verification, oversight, and 
enforcement practices for high-risk portions of organic supply chains.
Organic Fraud
    In addition to mishandling, a growing risk to organic integrity is 
fraud--the deceptive representation, sale, or labeling of nonorganic 
agricultural products as organic. High demand for organic products, the 
absence of direct enforcement over some entities in the organic supply 
chain, and organic price premiums have increased the opportunity and 
incentive for organic fraud. Both NOP and organic stakeholders have 
uncovered organic fraud in organic supply chains, particularly in 
organic grain and oilseed supply chains. Because such supply chains are 
complex and involve multiple changes in ownership of high demand 
products, the incentive for fraud is high. Federal investigations show 
that organic grain and oilseed fraud can lead to tens of millions of 
dollars in fraudulent sales within just a few months. The following 
examples highlight some of the types of organic fraud that this rule 
seeks to prevent. The examples also demonstrate the magnitude of total 
organic fraud and how this rule's additional oversight and enforcement 
mechanisms will reduce fraud.
     In 2019, four individuals were sentenced to prison terms 
for their roles in an organic grain fraud ring. The charges were 
brought by the U.S. Attorney's Office for the Northern District of 
Iowa. All four were sentenced to prison terms. The lead defendant, who 
was sentenced to more than ten years, pled guilty to defrauding 
customers in a scheme involving at least $142 million in nonorganic 
grains sold as organic. The lead defendant sold fraudulent grain to 
customers over a period of seven years, claiming the product was 
organically grown in Nebraska and Missouri.\4\ This rule includes more 
robust traceability and verification practices that would have helped 
identify and stop this type of fraud earlier, preventing further sale 
of the fraudulent products and reducing the impact of the fraud.
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    \4\ https://www.justice.gov/usao-ndia/pr/field-schemes-fraud-results-over-decade-federal-prison-leader-largest-organic-fraud.
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     In February 2020, a federal grand jury indicted an 
individual in South Dakota for allegedly selling $71 million of 
nonorganic grains and oilseeds falsely labeled organic between 2012 and

[[Page 3551]]

2018.\5\ The defendant pled guilty and was sentenced in 2021 to 51 
months in federal prison. He was also ordered to pay more than $15 
million in restitution. The fraud ring spanned multiple states. After 
NOP revoked the business' organic certifications, the responsible 
parties established new brokerage firms to continue their fraud. Under 
the current organic regulations, these brokerages did not require 
organic certification and NOP had no oversight of their activities. 
This rule will require the certification and oversight of brokers like 
those involved in this case. This would allow the NOP to identify and 
prevent the fraud, minimizing damage to the U.S. market.
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    \5\ https://www.wisfarmer.com/story/news/2020/02/18/south-dakota-man-indicted-71-million-organics-fraud/4801207002/. https://www.justice.gov/usao-sd/pr/florida-man-sentenced-conspiracy-commit-wire-fraud-and-money-laundering.
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     In 2017, an investigation revealed three shipments of 
imported ``organic'' corn and soybeans--each weighing between 36 and 46 
million pounds--were fraudulently labeled as organic. The associated 
transaction records indicated that all three shipments originated from 
producers in the Black Sea region that were not certified organic, and 
that the shipments were originally sold at lower conventional prices. 
In one case, a shipment of soybeans had been fumigated with aluminum 
phosphide, which is prohibited for use in organic production and 
handling. By the time this fraud was discovered, about 21 million 
pounds of this same shipment of soybeans had already been distributed--
primary to organic producers as livestock feed.\6\ This rule will 
require the use of NOP Import Certificates to verify the source and 
integrity of organic imports, which will help detect and prevent 
fraudulently labeled imports, such as those in this example, from 
entering domestic supply chains.
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    \6\ https://www.washingtonpost.com/business/economy/the-labels-said-organic-but-these-massive-imports-of-corn-and-soybeans-werent/2017/05/12/6d165984-2b76-11e7-a616-d7c8a68c1a66_story.html.
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     In July 2022, a Minnesota farmer was indicted for growing 
and selling fraudulent organic grains worth more than $46 million. The 
farmer was certified organic but was growing grains with synthetic 
fertilizers and pesticides in violation of the USDA organic 
regulations. He sold this conventional grain (both what he produced 
conventionally as well as conventional grain he purchased) as organic, 
fraudulently presenting his certificate of organic operation to claim 
the grain was organic and withholding the grain's true status from 
buyers.\7\ This rule includes more robust traceability and verification 
practices that would have helped identify and stop this type of fraud 
earlier, preventing further sale of the fraudulent products and 
reducing the impact of the fraud.
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    \7\ https://www.justice.gov/usao-mn/pr/cottonwood-county-farmer-charged-46-million-organic-grain-fraud-scheme.
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    In several of the above examples, fraudulent livestock feed was 
sold to certified organic livestock producers, magnifying the effects 
of the fraud. NOP continues to investigate complaints and multiple 
cases of organic fraud at the production and handling levels. These 
examples demonstrate the magnitude of fraud that NOP intercepts with 
current oversight and enforcement techniques. SOE will significantly 
bolster the oversight and enforcement mechanisms that NOP, certifying 
agents, and operations have at their disposal. In the fraud cases 
discussed above, these mechanisms would have allowed earlier fraud 
detection and more effective enforcement action and would have greatly 
reduced or even prevented the fraud.
Patterns in USDA Organic Certification and Organic Imports
    The scope and distribution of potential organic fraud can also be 
seen in changes in the number of operations certified to the USDA 
organic standards and changes in the amount of organic imports from 
certain regions. Two recent NOP efforts show both the potential type 
and magnitude of fraud in the marketplace; more importantly, they also 
demonstrate the potential of improved oversight and enforcement 
mechanisms.
    In 2018 and 2019, NOP began making changes to improve oversight of 
organic imports, especially grain and oilseed imports from the Black 
Sea region. NOP conducted farm-level yield analysis to compare expected 
and actual yield, supply chain research to better understand the roles 
and relationships of high-risk entities, and targeted import 
surveillance to investigate credible reports of suspected fraud. As a 
result of this heightened oversight and enforcement action, at least 
180 operations (60 percent) in the Black Sea region have lost their 
organic certification. In 2016, imports from the Black Sea region 
represented 49 percent of the total dollar value of imported organic 
grain and oilseeds (including corn, soybeans, wheat, barley, 
sunflowers, flaxseed, and peas). In 2018, imports of these grains and 
oilseeds from the region had dropped to 21 percent of the total dollar 
value. The steep drop in organic certification and downward supply 
trend in the Black Sea region give an indication of the magnitude and 
type of fraud, as well as the success of stronger oversight and 
enforcement strategy. Despite this enforcement success, key gaps in 
oversight remain, such as uncertified entities in import supply chains 
and non-mandatory use of NOP Import Certificates. This rule will help 
close these gaps and bolster NOP's ability to detect and prevent 
fraudulent organic imports.
    In January 2021, AMS announced it would end its U.S.-India organic 
recognition, which had allowed India's Agricultural and Processed Food 
Products Export Development Authority (APEDA) to accredit certifying 
agents to provide USDA organic certification in India. AMS ended this 
recognition because NOP audits consistently found India's organic 
control system to be insufficient to protect the integrity of the USDA 
organic seal. In late 2020, prior to the end of U.S.-India recognition, 
there were 4,023 operations certified to the USDA organic standard in 
India. Operations formerly certified by AEDPA-accredited certifying 
agents were given an 18-month transition period to become certified by 
a USDA-accredited certifying agent. Since the end of the transition 
period in July 2022, only 1,471 operations in India remain certified to 
the USDA organic standard. Because failure to become recertified may 
indicate an inability to comply with the USDA organic regulations, this 
significant (63 percent) drop in the number of certified operations may 
indicate the general volume of noncompliant activity (including 
mishandling and fraud) that may have been taking place under the former 
recognition. Additionally, following the end of the U.S. -India 
recognition, imports of certified organic products from India has 
dropped from an average per quarter value of $15.6 million to $9.4 
million, a 39 percent decrease. This drop in import value suggests that 
a significant number of organic imports from India may not have been 
fully compliant with the USDA organic standard. The end of the U.S.-
India recognition demonstrates both the magnitude of potential fraud in 
the market, and how more effective oversight (in this case, 
certification only by USDA-accredited certifying agents) can 
successfully safeguard the integrity of the USDA organic label. Despite 
this success, there are still gaps in the oversight of foreign-
accredited certifying agents and imports from these countries.

[[Page 3552]]

This rule will allow NOP to more fully implement its oversight 
authority by codifying specific procedures for evaluating, accepting, 
and continuing equivalency or recognition with foreign organic 
programs.
    These examples demonstrate how applying oversight and enforcement 
best practices can reduce organic fraud. SOE will reduce fraud by 
codifying best practices in critical areas--exemptions from 
certification, import oversight, traceability, recordkeeping, 
inspections and audits, oversight of certifying agents, and assessment 
of organic trade partners. Additionally, the examples above only show 
the positive results of improved oversight and enforcement at the 
federal level; SOE will build upon this success by requiring certifying 
agents and organic operations to use similar techniques. This means 
proven oversight and enforcement techniques will be deployed closer to 
where fraud occurs, which will facilitate earlier detection, stop more 
fraud before it cascades further into supply chains, and more directly 
deter fraudulent actors. Because this rule codifies best practices and 
requires key parties in organic supply chains use these practices, AMS 
expects that SOE's benefits will exceed those demonstrated in the 
examples above.

C. History

    In response to their experiences in the organic system, 
stakeholders have called for the NOP to take steps to improve oversight 
of organic systems and enforcement of the USDA organic regulations. 
Commonly cited areas for improvement include certification of excluded 
handlers, organic import oversight, fraud prevention, organic trade 
arrangements, and organic inspector qualifications. Public discussions 
on many topics included in this rule occurred during multiple National 
Organic Standards Board (NOSB) meetings.\8\
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    \8\ The April 2021 NOSB meeting is the most recent example of a 
public discussion to address fraud concerns in the organic supply 
chain. A discussion document, meeting transcripts, and public 
comments are available at https://www.ams.usda.gov/event/national-organic-standards-board-nosb-meeting-crystal-city-va-0.
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    This rule seeks to strengthen enforcement of the USDA organic 
regulations and protect the integrity of the organic label by (1) 
strengthening organic control systems; (2) improving organic import 
oversight; (3) clarifying organic certification standards; and (4) 
enhancing supply chain traceability. AMS identified the need for these 
changes through:
     Direct experience in administering the NOP, particularly 
complaint investigations and audits of accredited certifying agents;
     The Agriculture Improvement Act of 2018,\9\ which amended 
the OFPA.
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    \9\ The Agriculture Improvement Act of 2018, Public Law No: 115-
334, is available at: https://www.congress.gov/115/plaws/publ334/PLAW-115publ334.pdf.
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     Recommendations of a 2017 Office of Inspector General 
report; \10\
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    \10\ USDA Office of Inspector General Audit Report 01601-0001-
21: National Organic Program International Trade Arrangements and 
Agreements. September 2017: https://www.usda.gov/sites/default/files/01601-0001-21.pdf.
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     Recommendations of the NOP's federal advisory committee, 
the National Organic Standards Board (NOSB); and
     Industry stakeholder and consumer feedback.
    AMS expects the amendments will bring more effective oversight and 
enforcement, improve organic integrity and product traceability, 
clarify existing standards to ensure fair competition, bolster consumer 
trust in the organic label, reduce organic fraud, and support continued 
industry growth. Information about each amendment is described in more 
detail below.

D. Public Comment

    AMS published the Strengthening Organic Enforcement proposed rule 
on August 5, 2020, opening a 60-day public comment period. AMS received 
more than 1,500 public comments from a variety of stakeholders, 
including certifying agents, certified organic producers and handlers, 
uncertified handlers, retailers, organic inspectors, trade 
associations, organic advocates, scientific organizations, government 
organizations, and consumers. The majority of public comments supported 
the proposed amendments and agreed that the rule is needed to improve 
oversight and enforcement, drive consistent implementation of the 
organic regulations, and reduce organic fraud.
    Many stakeholders provided meaningful feedback about the proposed 
policy revisions, including recommendations to improve the rule through 
greater specificity and clarity. Others discussed how the proposed 
amendments would affect them or suggested alternatives to the proposed 
policies. Popular topics of discussion included the need for 
certification; excluded handlers; exemptions from certification; 
implementation of the mandatory NOP Import Certificate requirements; 
supply chain traceability audits; recordkeeping and verification 
requirements; fraud prevention plans for certified operations; 
oversight of producer groups; qualifications and training requirements 
for certifying agent personnel; labeling of nonretail containers; and 
unannounced inspections.
    Some comments also discussed the proposed implementation timeframe 
of one year after publication of the final rule. Some comments asked 
AMS to implement the rule immediately, while others agreed that a one-
year timeframe is reasonable and gives stakeholders time to comply with 
the new requirements. A few comments noted that some parts of the rule 
may require more than one year to implement and asked AMS to consider 
this in the final rule. Few comments addressed the costs and benefits 
of the rule in detail, but many comments noted in general that the 
costs of the rule are acceptable and outweighed by the benefits.
    AMS took these public comments into consideration when revising the 
policy, implementation timeframe, and cost-benefit analysis of this 
rulemaking. For more information on the comments received and AMS's 
response to specific comments, refer to ``III. Overview of 
Amendments.''

E. Terminology

    Throughout this rule, AMS refers to four concepts--organic 
integrity, organic fraud, audit trails, and supply chain traceability--
which are integral to the purpose of this rule. AMS is explaining these 
concepts upfront to assist reader understanding:
     Organic integrity: The unique attributes that make a 
product organic and define its status as organic. A product that fully 
complies with the USDA organic regulations has integrity, and its 
organic qualities have not been compromised.
     Organic fraud: Deceptive representation, sale, or labeling 
of nonorganic agricultural products or ingredients as ``100 percent 
organic,'' ``organic,'' or ``made with organic (specified ingredients 
or food group(s))'' (7 CFR 205.2).
     Audit trail: Documentation that is sufficient to determine 
the source, transfer of ownership, and transportation of any 
agricultural product labeled as ``100 percent organic,'' the organic 
ingredients of any agricultural product labeled as ``organic'' or 
``made with organic (specified ingredients)'' or the organic 
ingredients of any agricultural product containing less than 70 percent 
organic ingredients identified as organic in an ingredients statement 
(7 CFR 205.2).

[[Page 3553]]

     Supply chain traceability: The ability to identify and 
track the movement, sale, custody, handling, and organic status of an 
agricultural product along a supply chain. Supply chain traceability 
audits are used to verify an agricultural product's compliance with the 
USDA organic regulations.

F. Does this action apply to me?

    You may be affected by this action if you are engaged in the 
organic industry. Potentially affected entities may include, but are 
not limited to, the following:
     Individuals or business entities that are considering 
organic certification;
     Existing production and handling operations that are 
currently certified organic under the USDA organic regulations;
     Brokers, traders, and importers of organic products that 
are not currently certified under the USDA organic regulations;
     Operations that use non-retail containers for shipping or 
storing organic products;
     Retailers that sell organic products;
     Operations that receive or review certificates of organic 
operation to verify compliance with USDA organic regulations;
     USDA-accredited certifying agents, inspectors, and 
certification review personnel;
     Operations that import organic products into the United 
States; and/or
     Operations that export organic products to the United 
States and the corresponding certifying agents.
    This list is not exhaustive but identifies key entities likely to 
be affected by this action. Other types of entities may also be 
affected. To determine whether you or your business may be affected by 
this action, you should carefully examine the regulatory text and 
discussion below.

G. Compliance Date

    AMS is establishing a compliance date for this final rule of March 
19, 2024, or 12 months after the effective date of this final rule. 
This means that all entities affected by this rule, including certified 
operations and certifying agents, must comply with the provisions of 
this final rule by this date. This also means that operations requiring 
organic certification because of this final rule must be certified by 
the compliance date. AMS is setting this compliance date to allow 
affected entities time to read and understand this final rule, obtain 
organic certification if needed, and prepare for and implement other 
changes in this final rule.

III. Overview of Amendments

A. Applicability and Exemptions From Certification

    The table below includes the regulatory provisions related to this 
section of the rule. A discussion of the policy follows.

 
------------------------------------------------------------------------
                  Section                       Final regulatory text
------------------------------------------------------------------------
205.2.....................................  Terms Defined.
                                            Definitions for Handle,
                                             Handler, Handling
                                             operation, and Retail
                                             establishment.
205.100...................................  What has to be certified.
                                            Paragraph (a).
205.101...................................  Exemptions from
                                             certification.
                                            Entire section.
205.310...................................  Agricultural products
                                             produced or processed by an
                                             exempt operation.
                                            Paragraphs (a) and (b).
------------------------------------------------------------------------

    The USDA organic regulations require organic certification of 
businesses that sell, process, or package organic agricultural products 
as handling operations. This rulemaking clarifies that most operations 
that operate in the middle of organic supply chains must be certified 
organic. This may include entities that sell, trade, distribute, or 
import organic products. The activities of these operations may affect 
organic integrity; therefore, certification is necessary to assure 
consumers that organically produced products meet a consistent 
standard. In addition to clarifying who needs certification, this 
rulemaking also provides limited exemptions to organic certification 
for certain entities and activities that present a low risk to organic 
integrity.
    This action may affect noncertified operations that handle organic 
products, sell organic products, or facilitate the sale or trade of 
organic products on behalf of a seller or oneself; certified organic 
operations; organic inspectors; and certifying agents. Readers should 
carefully examine the regulatory text and policy discussion to 
determine if they are affected.
Background
    The organic market has grown considerably since the USDA organic 
regulations took effect in 2002. The Organic Trade Association reports 
that total U.S. organic sales grew from $3.4 billion in 1997 to $61.9 
billion in 2020.\11\ This growth has created increasingly complex 
organic supply chains as additional domestic and international 
businesses choose to produce and sell organic products for the U.S. 
market. Some segments of organic supply chains remain uncertified under 
current regulation, creating gaps in oversight, increasing the 
opportunity for fraud, and complicating enforcement by the USDA and its 
enforcement partners.
---------------------------------------------------------------------------

    \11\ Organic Trade Association, Organic Industry Survey, 2018-
2021
---------------------------------------------------------------------------

    Oversight and enforcement of organic supply chains are challenging 
because organic products are credence goods, which means that their 
organic attributes, or ``integrity,'' cannot be easily verified by an 
individual. Guaranteeing organic integrity requires transparent supply 
chains, trusted interactions between businesses, and mechanisms to 
verify product legitimacy. This is best accomplished via certification, 
which requires operations to follow traceability and verification 
practices, and provides regular oversight in the form of audits and 
annual inspection. This rulemaking broadens the scope of who must be 
certified, opening more of the organic supply chain to oversight and 
mitigating the risks of noncertified businesses handling organic 
product.
    OFPA authorizes the USDA to regulate and enforce the production, 
handling, and sale of organic products (7 U.S.C. 6503). This includes 
activity within organic supply chains, from production through final 
sale to the

[[Page 3554]]

consumer.\12\ AMS is exercising its authority to regulate entities in 
organic supply chains by requiring certification of some types of 
currently noncertified operations. This action is mandated by the 2018 
Farm Bill, which states that the USDA must ``issue regulations to limit 
the type of organic operations that are excluded from certification 
under section 205.101'' of the organic regulations.\13\ This rulemaking 
supports the OFPA's purpose ``to assure consumers that organically 
produced products meet a consistent standard (7 U.S.C. 6506(a)(11)).''
---------------------------------------------------------------------------

    \12\ OFPA and the USDA organic regulations do not provide 
authority to regulate the transport of organic agricultural 
products.
    \13\ See section 10104(a) of the Agriculture Improvement Act of 
2018, Public Law No: 115-334, available at: https://www.congress.gov/115/plaws/publ334/PLAW-115publ334.pdf,
---------------------------------------------------------------------------

Who needs to be certified?
    Section 205.100(a) of the organic regulations states that any 
operation that produces or handles organic agricultural products must 
be certified organic. This means that operations conducting activities 
described in the definition of handle must be certified organic and 
must follow all applicable portions of the OFPA and the USDA organic 
regulations. In general, handle means to ``sell, process, or package'' 
organic agricultural products. Limited exemptions for operations that 
handle organic agricultural products are described in Sec.  205.101(a)-
(h).
    The definition of handle includes the term processing, which is 
defined in Sec.  205.2.\14\ Operations that process organic 
agricultural products must be certified. Handle further explains what 
to ``sell'' and ``package'' mean by including additional examples of 
handling activities. The examples represent typical supply chain 
activities that may affect organic integrity. This includes activities 
where there is physical contact with agricultural products, such as 
combining, aggregating, culling, conditioning, treating, packing, 
containerizing, repackaging, labeling, storing, receiving, or 
loading.\15\ Examples of operations that often conduct these activities 
may include grain elevators; bulk grain handlers; warehouses that cull, 
label, or repackage; central bakeries or kitchens that serve grocery 
chains; or ports of entry.
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    \14\ 7 CFR 205.2 Processing. Cooking, baking, curing, heating, 
drying, mixing, grinding, churning, separating, extracting, 
slaughtering, cutting, fermenting, distilling, eviscerating, 
preserving, dehydrating, freezing, chilling, or otherwise 
manufacturing and includes the packaging, canning, jarring, or 
otherwise enclosing food in a container.
    \15\ The regulations at Sec.  205.2 define ``label'' and 
``labeling'' to explain the type and location of information 
covered. Labeling as a handling activity refers to the act of 
applying a label to a product with an organic claim; applying other 
types of labels, such as for inventory or information accompanying a 
product, may not need certification.
---------------------------------------------------------------------------

    Handle also includes activities where there may not be physical 
contact with agricultural products, such as selling, trading, 
facilitating sale or trade on behalf of a seller or oneself, importing 
to the United States, or exporting from a foreign country for sale in 
the United States. These activities are included in the definition of 
handle because they have the potential to affect organic integrity. 
Operations that conduct these activities must be certified (unless 
exempt per Sec.  205.101). Examples of operations that often conduct 
these activities may include sales brokers, commodity traders, 
ingredient sourcers, importers, or exporters.
    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.
What are the certification requirements for handlers?
    All certified organic operations must follow the portions of the 
USDA organic regulations that apply to activities they conduct. 
Conversely, some portions of the regulation will not apply to every 
operation (e.g., a certified operation that only produces crops does 
not have to follow the livestock requirements of subpart C). Similarly, 
the scope of a handling operation's certification only covers the 
activities it conducts. For example, the OSP of a certified importer 
would likely describe the operation's system to maintain transaction 
records and audit trails, verify suppliers and NOP Import Certificates, 
and verify traceability. On-site inspection of such an operation would 
likely focus on a records review and evaluation, rather than evaluation 
of physical facilities.
    Contractors are sometimes used in the organic industry to provide 
services to certified operations. Contractors that qualify for an 
exemption per Sec.  205.101(a)-(f) do not need to be certified. Any 
contractor performing handling activities on behalf of an operation 
must be certified or described in the OSP of a certified operation.
    It is common for some operations to handle both organic and 
nonorganic agricultural products (i.e., a split operation). For a split 
operation, only the portion(s) of the operation that produces or 
handles organic agricultural products must be certified. If a portion 
of an operation qualifies for an exemption from certification described 
in Sec.  205.101(a)-(h), only that portion may be exempt, and the 
remainder of the operation must be certified if it produces or handles 
organic agricultural products. For example, a grocery store chain's 
retail locations may be exempt under Sec.  205.101(b) or (c), but its 
importing and some distribution activities would likely need to be 
certified.
Organic Agricultural Products Received From an Exempt Operation
    Agricultural products produced or processed on an exempt operation 
must follow all requirements of Sec.  205.310. This means that an 
operation receiving products produced or processed by an exempt 
operation cannot represent the products as certified organic, cannot 
display the USDA organic seal on the products, and cannot use the 
products as organic ingredients in a product produced by the receiving 
operation. In effect, product received and then processed by an exempt 
operation loses its certified organic status and cannot be represented 
as organic.
    However, exempt operations may perform limited handling of 
certified organic products, as described in each exemption at Sec.  
205.101; i.e., if an exempt operation handles certified organic 
products in a manner consistent with its applicable exemption, the 
products maintain their organic status. This means, for example, that 
an exempt warehouse may receive, store, and prepare for shipment 
packaged certified organic products. Conversely, if this warehouse 
opens or relabels such packaged products, then the certified organic 
status of the products is lost, and an operation receiving these 
products must not represent them as certified organic.
    The USDA organic regulations require certified operations to 
implement recordkeeping and verification practices that ensure the 
integrity of organic agricultural products they receive, including 
products received from exempt or uncertified operations. Records must 
trace organic products back through any exempt operations to the last 
certified operation in the supply chain, and operations must verify 
their suppliers, including exempt operations. See Sec. Sec.  
205.103(b)(2) and 205.201(a)(3) in the section on Supply Chain 
Traceability and Fraud Prevention later in this rule.

[[Page 3555]]

Exemptions From Certification
    The USDA organic regulations require certification of any operation 
that produces or handles organic agricultural products (Sec.  
205.100(a)). However, the regulations provide limited exemptions to 
certain types of operations that conduct low-risk activities, and are 
therefore less likely to compromise organic integrity of the 
agricultural products they handle. These exemptions, and the conditions 
that must be met to qualify for each, are described in Sec.  205.101.
    The USDA organic regulations formerly used the terms ``exemption'' 
and ``exclusion'' to describe activities that do not require organic 
certification. This final rule removes use of the term ``exclusion'' 
from Sec.  205.101 and throughout the organic regulation to reduce 
confusion and misinterpretation about who needs to be certified. The 
term ``exemption'' is now used exclusively to describe activities that 
do not require organic certification. Previous ``exclusions'' listed 
under former Sec.  205.101(b) have been modified and are now listed 
under current Sec.  205.101.
Responsibilities of Exempt Operations
    Operations described in Sec.  205.101 are exempt from the 
requirement to be certified organic under subpart E. However, these 
exempt operations must still follow all other applicable portions of 
the organic regulations, including the production and handling 
requirements of subpart C. For example, a very small vegetable farm may 
be exempt from certification per Sec.  205.101(a); this means the farm 
does not have to be certified and inspected annually, and does not have 
to develop and submit an organic system plan. However, the farm must 
follow the other organic production and handling requirements of 
subpart C, including soil and fertility practices, crop rotation, weed 
management, and seed use practices. Exempt operations must also comply 
with Sec.  205.272 and practices to prevent commingling and contact 
with prohibited substances.
    Exempt operations must also follow the applicable labeling 
requirements of subpart D. Critically, this means exempt operations 
must not represent the agricultural products they produce or process as 
certified organic and must not use the USDA organic seal. Additionally, 
agricultural products produced or processed by an exempt operation must 
not be identified or represented as organic in a product processed by 
another operation (See Sec.  205.310, Agricultural products produced or 
processed on an exempt operation). Additionally, exempt operations are 
only permitted to perform the limited handling activities described in 
the applicable exemption; any handling outside of that described in the 
exemption may result in loss of organic status of products.
    Operations that qualify for an exemption may voluntarily choose to 
become certified. By becoming certified, the operation may market the 
products it produces and processes as certified organic, display the 
USDA organic seal on its products, and represent these products as 
ingredients for use in other organic products.
    Like certified operations, exempt operations are subject to 
penalties for violating the OFPA and the organic regulations. Section 
205.100(c) of the organic regulations states that any person or 
responsibly connected person--including exempt operations--that 
knowingly sells or labels a product as organic, except in accordance 
with the Act, shall be subject to a civil penalty as specified in 7 CFR 
3.91(b)(1)(xxxvi).\16\
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    \16\ 7 CFR 3.91(b)(xxxvi): Civil penalty for knowingly labeling 
or selling a product as organic except in accordance with the 
Organic Foods Production Act of 1990, codified at 7 U.S.C. 6519(c). 
As of the publication of this rule the civil penalty amount is a 
maximum of $20,130 per violation.
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Recordkeeping by Exempt Operations
    Like certified operations, exempt operations play a critical role 
in maintaining the integrity of organic products as they travel from 
production to consumer. Therefore, exempt operations must maintain 
records of the organic products they produce and handle, including 
records that: demonstrate that agricultural products identified as 
organic were organically produced and handled; and verify quantities of 
organic agricultural products received and shipped or sold. Such 
records are necessary to maintain an audit trail for organic products; 
this will facilitate many other provisions of this rule, including 
supply chain traceability audits (Sec.  205.501(a)(21)), recordkeeping 
by certified operations (Sec.  205.103), on-site inspections (Sec.  
205.403(d)), and fraud prevention plans (Sec.  205.201(a)(3)). Retail 
establishments that do not process agricultural products (see 
definition for Handle at Sec.  205.2 and exemption from certification 
at Sec.  205.101(b)) do not need to maintain such records. Exempt 
handlers must have required records available and must show those 
records to a representative of the Secretary upon request. Failure to 
produce compliant records may lead to enforcement action.
Small Producers and Handlers
    Small organic producers and handlers are exempt from certification 
at Sec.  205.101(a). This exemption is limited to producers and 
handlers with gross agricultural income from organic sales of no more 
than $5,000 annually. These operations are exempt from certification 
under subpart E and from submitting an organic system plan, but must 
follow all applicable organic production and handling requirements of 
subpart C and labeling requirements of subpart D. This includes the 
requirements to prevent commingling and prevention of contact with 
prohibited substances (Sec.  205.272).
    Such operations must not represent the agricultural products they 
produce or process as certified organic and must not use the USDA 
organic seal. Agricultural products produced or processed by these 
exempt operations must not be identified or represented as organic in a 
product processed by another operation (see Sec.  205.310).
Retail Establishments
    Retail businesses that handle organic agricultural products and 
sell directly to consumers may be exempt from certification. To qualify 
for an exemption, the operation must be a retail establishment and meet 
the conditions for the exemptions in Sec.  205.101(b) and (c).
    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. Retail is commonly described as 
selling directly to consumers, end-users, or the public. The definition 
for retail establishment aligns with that concept. Businesses which 
sell to other businesses (wholesale) do not qualify as retail 
establishments. Retail establishments may use virtual transactions for 
sales, but they must also have a physical location for consumers to 
purchase products.
    Only operations that are retail establishments are eligible for the 
retailer exemptions. The definitions for handler and handling operation 
do not include final retailers of agricultural products that do not 
process agricultural products. This exemption from certification is 
also reinforced at section 205.101(b), which exempts retail 
establishments that sell, but do not

[[Page 3556]]

process, organic agricultural products to consumers.
    Section 205.101(c) exempts retail establishments that process 
certified organic agricultural products at the point of sale to the 
consumer. Distributors or brand name owners that do not qualify as 
retail establishments should review the exemptions from certification 
at Sec.  205.101(e) and (f), as those may apply to their activities.
Retail Operations That Don't Process
    Retail establishments that do not process agricultural products are 
not handlers or handling operations and may be exempt from 
certification under Sec.  205.101(b). The OFPA and Sec.  205.2 define 
processing as cooking, baking, heating, drying, mixing, grinding 
churning, separating, extracting, cutting, fermenting, eviscerating, 
pre-serving, dehydrating, freezing, or otherwise manufacturing, and 
includes the packaging, canning jarring, or otherwise enclosing food in 
a container. A retail establishment that is not processing may do other 
handling activities without certification. This could include, for 
example, removing produce from shipping boxes and washing and 
transferring product to display cases or opening bags of oats and 
transferring contents to bulk food dispensers. Although a retailer 
performing such handling activities may be exempt from certification, 
all retail establishments must comply with Sec.  205.272, which 
requires measures to prevent commingling of organic products and 
contact with prohibited substances.
    Retail establishments that do not process ``100% organic'' and 
``organic'' unpackaged products may use the USDA organic seal and/or 
seal of the certifying agent in retail labeling and display of these 
unpackaged products (Sec.  205.308). Retail establishments that do not 
process ``made with organic. . .'' unpackaged products may use that 
claim in retail labeling and displays (Sec.  205.309).
Retail Establishments That Process
    Retail establishments that process organic agricultural products 
may be exempt from certification under Sec.  205.101(c). To qualify for 
this exemption, a retail establishment must process organic products at 
the point of final sale to the consumer. This means that the products 
must be processed and sold in the same physical location. This could 
include repackaging bulk containers of organic product into individual 
units for retail sale within an individual grocery store or a retail 
establishment that prepares ready-to-eat meals and sells them online to 
consumers from the processing location.
    Per Sec.  205.310, organic agricultural products that are processed 
by exempt retail establishments (such as in the examples above) must 
not be sold, labeled or represented as ``certified'' organic, must not 
display the USDA seal or identify the certifying agent, and must not be 
used by another operation as ingredients in a certified organic 
product. Only retail establishments that are certified organic may use 
the USDA organic seal (or make certified organic claims) on products 
they process.
    This exemption does not cover retail establishments that sell 
organic products to consumers which are processed at a location 
separate from the point of sale. This could include, for example, an 
online retailer that sells products processed at an uncertified 
facility or a central processing facility that prepares food sold in 
bakery and deli sections of grocery stores. In these scenarios, the 
processing facility is not co-located in the same physical location as 
the point of sale and the retail establishment exemption does not cover 
separate processing facilities. The processors would need to be 
separately certified in order for a retail establishment to sell their 
products as organic.
    In addition, this exemption does not cover retailers that process 
and sell to consumers only via virtual transactions. ``Virtual 
transaction'' describes any form of transaction that does not occur in-
person (e.g., telephone, mail-order, and/or online sales). Retailers 
that process and sell to consumers virtually without having a physical 
location for retail sales must be certified. These businesses do not 
meet the definition for retail establishment, and, by extension, the 
conditions for exemption from certification.
    All exempt retail establishments must comply with the requirements 
of Sec.  205.272, which describes handling requirements to prevent 
commingling and contact with prohibited substances. In addition, exempt 
retail establishments that process organic products must follow the 
labeling provisions specified in Sec.  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. Exempt handlers must 
have these records available and must show them to a representative of 
the Secretary upon request (7 U.S.C. 6519(a)(1)). Failure to produce 
compliant records may lead to enforcement action.
Operations That Handle Only Products With Less Than 70 Percent Organic 
Ingredients
    Section 205.101(d) exempts from certification operations that only 
handle agricultural products with less than 70 percent organically 
produced ingredients, and operations that only identify organic 
ingredients on the product informational panel. This exemption is not 
new policy. It combines two existing exemptions: operations that handle 
products with less than 70 percent organic ingredients (former Sec.  
205.101(a)(3)) and operations that handle products that only identify 
organic ingredients on the information panel (former Sec.  
205.101(a)(4)). AMS combined these exemptions because they cover 
operations that handle products in the same labeling category (per 
Sec.  205.305), and because these operations must follow identical use 
and labeling requirements. Operations that qualify for this exemption 
are exempt from certification under subpart E and from submitting an 
organic system plan, but must follow all applicable organic production 
and handling requirements of subpart C and labeling requirements of 
subpart D. This includes the labeling requirements for products with 
less than 70 percent organic content (Sec.  205.305) and the 
requirements to prevent commingling and prevention of contact with 
prohibited substances (Sec.  205.272).
    Handlers covered under this exemption must have the records 
required by Sec.  205.101(i) available and show them to a 
representative of the Secretary upon request (7 U.S.C. 6519(a)(1)). 
Failure to produce compliant records may lead to enforcement action. 
Such operations must not represent the agricultural products they 
produce or process as certified organic and must not use the USDA 
organic seal. Agricultural products produced or processed by these 
exempt operations must not be identified or represented as organic in a 
product processed by another operation (see Sec.  205.310).
Storing or Selling Packaged Organic Products
    The movement of packaged and sealed organic products through the 
supply chain is a lower-risk activity. Packaged products are less 
likely to be commingled, exposed to contaminants, or tampered with, and 
alterations are easier to detect. Handling operations that sell, 
distribute, or store packaged organic agricultural products may be 
exempt from organic certification. Two exemptions, at Sec.  205.101(e) 
and (f),

[[Page 3557]]

apply to limited handling activities involving only organic 
agricultural products that are in sealed, tamper-evident packaging or 
containers. The key distinctions between these exemptions are that 
205.101(f) covers operations that buy and sell, in addition to 
receiving, storing and/or preparing for shipment, and that 205.101(f) 
covers only retail-packaged products versus packaged products that are 
not in final retail packaging. Tamper-evident packaging or container 
means that the contents are sealed in a manner where an attempt to 
break the seal, access the contents, or reclose the package would be 
obvious. These exemptions cover only the specified handling activities. 
These exemptions do not, for example, cover buying, selling, receiving, 
storing, or loading of unpackaged products; those activities require 
certification.
    The exemption at Sec.  205.101(e) is intended primarily for storage 
and warehouse facilities. Section 205.101(e) applies to handlers that 
are only receiving, storing and/or preparing for shipment products that 
are received in and remain in sealed, tamper-evident packaging until 
the products leave their custody. This allowance may cover, for 
example, warehouses and storage facilities, including some cold storage 
facilities that only receive and store packaged products and prepare 
them for shipment to another entity. Examples of tamper-evident 
packaging include produce boxes with ``DO NOT TAMPER WITH'' tape placed 
across the box flaps, sealed bulk bags of flour, or sealed drums and 
totes of olive oil. Storage facilities or warehouses that receive 
products that are not in sealed, tamper-evident packaging must be 
certified.
    The exemption at Sec.  205.101(f) is intended primarily for 
distributors. Section 205.101(f) applies to handlers that only buy, 
sell, receive, store and/or prepare for shipment retail-packaged 
organic agricultural products. This allowance may cover, for example, 
some distributors, brand name owners, and sales brokers that purchase 
and/or receive products in their finished retail packaging. Products 
must be received in and remain in the final retail packaging without 
alteration throughout their custody. This exemption does not apply to 
sales brokers, traders, or other handlers that buy and sell products 
that are not in their final retail packaging.
    Preparing for shipment is an activity that is covered under both 
exemptions at Sec.  205.101(e) and (f). This may include various tasks 
that must be performed with the sealed, tamper-evident packaging 
remaining intact and without altering product contents or any retail 
labeling. Examples of preparing for shipment include putting packaged 
products into shipping containers, applying internal tracking numbers, 
shrink-wrapping shipping cartons to a pallet, breaking down pallets of 
fully packaged products, adding protective packaging to nonretail 
containers or retail displays of organic products, packing individual 
packaged products onto a shipping pallet, loading/unloading packaged 
products onto or from transport vehicles, and placing individual retail 
packages into a retail display which the certifying agent of the last 
certified handling operation has verified as compliant.
    Handlers that qualify for an exemption at Sec.  205.101(e) or (f) 
must use practices for preventing commingling and contamination of 
organic products, in compliance with Sec.  205.272. In addition, exempt 
handlers must have records available and must show those records to a 
representative of the Secretary upon request, to show that organic 
products are organically produced and handled and to verify quantities 
of organic product received and shipped or sold. Failure to produce 
compliant records may lead to enforcement action.
Customs Brokers
    Section 205.101(g) exempts Customs brokers from organic 
certification. Customs brokers facilitate the entry of products into 
the United States by helping meet import documentation and filing 
requirements and by acting as intermediaries between importers and the 
U.S. government. Customs brokers do not take ownership or physical 
possession of organic products and their actions present minimal risk 
to organic integrity. They are often distinct from sales or commodity 
brokers, who sell or facilitate the sale of organic products--those 
operations must be certified if they handle organic products. Customs 
brokers also play a critical role by filing NOP Import Certificate data 
in the U.S. Custom and Border Protection's (CBP) Automated Commercial 
Environment (ACE) import entry system.
    This exemption is limited to Customs brokers as defined by 19 CFR 
111.1: ``a person who is licensed under this part to transact customs 
business on behalf of others.'' Customs business is further defined in 
19 CFR 111.1 and includes ``activities involving transactions with CBP 
[U.S. Customs and Border Protection] concerning the entry and 
admissibility of merchandise . . . payment of duties, taxes, or other 
charges . . . the preparation . . . of documents in any format and the 
electronic transmission of documents . . . intended to be filed with 
CBP in furtherance of any other customs business activity . . . '' \17\
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    \17\ See 19 CFR 111.1 for complete definitions of Customs broker 
and Customs business: https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=ab6e30d35ef538ce07bc8021d6e1d4c3&mc=true&n=sp19.1.111.a&r=SUBPART&ty=HTML#se19.1.111_11.
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    To qualify for this exemption, Customs brokers must only conduct 
customs business. If a Customs broker conducts any additional activity 
within the definition of handle--such as selling, importing, or 
trading--the Customs broker must be certified.
Logistics Brokers
    Section 205.101(h) exempts from certification operations that only 
arrange for the shipping, storing, transport, or movement of organic 
agricultural products. Sometimes known as ``logistics brokers,'' these 
operations facilitate the movement and storage of agricultural products 
by connecting a consigner (or consignee) with a carrier who can 
transport/store the products. Logistics brokers do not take ownership 
or physical possession of organic products. The activities they conduct 
present minimal risk to organic integrity because they only secure 
transport/storage to meet the needs of a third party who owns or is 
responsible for the agricultural product.
    This exemption is limited to operations that only arrange for the 
shipping, storing, transport, or movement of agricultural products and 
do not conduct any other activity in the definition of handle. If such 
an operation conducts other handling activities--such as selling, 
importing, or trading--the operation must be certified.
Transport
    Transport of agricultural products alone is not a handling activity 
and does not require certification (see definitions of handle in 7 CFR 
205.2 and 7 U.S.C. 2502(8)). Transport generally refers to the movement 
of products in commerce. Examples of activities which are 
transportation and do not require certification include: moving organic 
hay or milk from a certified producer to a certified organic buyer or 
certified processing facility, moving organic grain or organic 
livestock from certified organic farms to a certified handling or 
slaughter facility, and food delivery services transporting prepared 
foods from a retail establishment to a consumer.
    Any activities other than the movement of product on a 
transportation vehicle or moving products between transportation

[[Page 3558]]

vehicles (transloading) are handling and require certification. 
Handling activities which are adjacent to transport require 
certification unless they are covered by exemptions 205.101(e) or (f) 
for packaged products. Examples of adjacent activities which do not 
qualify as transport include combining, splitting, containerizing, 
packing/repacking, treating, sorting, opening, enclosing, or labeling/
relabeling. In addition, loading or unloading of unpackaged products 
into or from a storage facility is not a form of transportation; this 
activity must be certified.
    Certified operations are responsible for verifying that products 
handled by uncertified entities in their supply chain remain in 
compliance with the organic regulations. This includes verifying 
organic products transported by an uncertified transporter. A certified 
operation needs to describe procedures for verifying suppliers in the 
supply chain and the organic status of products received (Sec.  
205.201(a)(3)). In addition, certified operations must maintain records 
back to last certified operation, which may encompass uncertified 
operations that fall between certified entities (Sec.  205.103(b)(2)). 
The certified organic operation responsible for the organic products 
that are transported must: maintain records, for the audit trail and 
traceability, in sufficient detail as to be readily understood and 
audited; demonstrate prevention of commingling and contamination during 
transportation (Sec.  205.272); fully describe the transportation 
practices in the organic system plan; and ensure that the 
transportation records for organic products are available for 
inspection. Certified operations that load or receive products from 
uncertified transporters can verify prevention of contamination/contact 
with prohibited substances through, for example, affidavits or other 
documentation of vehicle clean out.
Summary of Changes to the Final Rule
    AMS made several revisions to the proposed regulatory text when 
writing this rulemaking. Changes to the rulemaking are discussed below. 
This is then followed by responses to specific themes from public 
comment.
     AMS revised the definition of handle to include additional 
examples of activities that require organic certification. AMS added 
these activities in response to public comments, which asked for 
additional clarity about who must be certified. The additional 
activities in the definition more clearly indicate activities that 
require certification and will help businesses determine whether they 
need organic certification.
     AMS simplified the term handler and removed ``except for 
operations that are exempt from certification'' and ``or a portion of 
[an operation]'' from handling operation. These phrases are redundant 
because they are explained in Sec.  205.100--What has to be certified. 
AMS also added ``except final retailers of agricultural products that 
do not process agricultural products'' to both definitions. This 
clarifies that certain final retailers are not handlers or handling 
operations and aligns the definitions with OFPA. The two definitions 
are now mostly synonymous, differing only in their reference to either 
a person or an operation.
     The proposed rule would have replaced the defined term 
retail food establishment with the updated term retail operation, which 
focused on the key activities of retailers, notably those selling 
``directly to final consumers.'' Many public comments noted that the 
proposed phrase ``direct to final consumers'' was imprecise and would 
not be interpreted consistently by stakeholders. These comments also 
indicated that stakeholders are familiar with the meaning of the 
original defined term retail food establishment and how to apply it. 
Therefore, this final rule uses the defined term retail establishment, 
which has language very similar to the original retail food 
establishment, to ensure consistent stakeholder understanding. This 
final defined term removes the word ``food'' because retailers 
sometimes sell non-food items; it also avoids the potentially confusing 
phrase ``directly to final consumers.'' Finally, this definition for 
retail establishment adds more examples of types of retail 
establishments to help stakeholders determine whether they are a retail 
establishment.
     AMS removed ``or a portion of an operation'' from the 
descriptions of each exemption; this language was redundant because it 
is included in Sec.  205.100--What has to be certified.
     AMS removed references to Sec.  205.272 because they are 
redundant to the reference to subpart C in the introductory paragraph 
of Sec.  205.101.
     In the introductory paragraph of Sec.  205.101, AMS 
replaced references to Sec.  205.310 with a reference to subpart D. 
This more broadly references the labeling requirements exempt 
operations must follow, including use of the USDA seal and labeling in 
retail environments.
     In Sec.  205.101(b), AMS removed ``sells'' to clarify that 
retail establishments may also perform some handling (not just selling) 
in the regular course of business.
     In Sec.  205.101(c), AMS removed the reference to 
agricultural products ``previously labeled for retail sale'' and 
replaced it with the statement ``certified under this part'' to clarify 
that retailers may process certified organic products regardless of 
whether the products are labeled for retail sale or for other use 
(e.g., organic products labeled for food service).
     AMS revised Sec.  205.101(e) to exempt only storage of 
products sealed in tamper-evident packaging. Storage of unpackaged 
organic products is a high-risk activity that requires certification to 
maintain integrity. Sealed, tamper-evident packaging makes organic 
products less susceptible to fraud and mishandling and helps maintain 
organic integrity during storage and handling by uncertified 
operations.
     AMS added new paragraph (f) in Sec.  205.101 to exempt the 
sale of retail products sealed in tamper-evident packaging. Sale of 
this type of packaged retail products presents little risk to organic 
integrity, and operations storing and selling these products do not 
require organic certification.
     AMS added new paragraphs (g) and (h) to Sec.  205.101 to 
exempt Customs brokers and logistics brokers because these operations 
only facilitate entry of imports into the United States, and their 
activities do not present a risk to organic integrity.
     AMS removed recordkeeping requirements from specific 
exemptions and replaced them with a general ``Recordkeeping by exempt 
operations'' paragraph at Sec.  205.101(i).
     AMS revised Sec.  205.310 to remove ``or excluded'' and 
replaced ``handled'' with ``processed'' to more clearly indicate that 
products processed by an exempt operation must not be used as an 
ingredient in an organic product processed by others.
Summary of Public Comment
    AMS received many public comments from stakeholders across the 
organic industry discussing this section of the proposed rule. The 
majority of comments generally supported AMS's proposed revisions and 
agreed that the organic regulations must clearly indicate who needs to 
be certified and reduce the types of uncertified operations in organic 
supply chain. Many commenters requested further clarification of the 
proposed changes, particularly about the need for organic certification 
and exemptions from certification.

[[Page 3559]]

Revised Definitions
    The revised definition of handle was discussed in many comments. 
Some commenters requested expanding the definition to include terms 
such as ``port,'' ``transload,'' and ``brand owner'' to the regulatory 
text. Commenters also requested specific distinctions be made between 
``transport'' and ``transload,'' noting current inconsistency in how 
these are interpreted by the industry.
    Some comments discussed further clarification needed, including how 
``cold storage'' fits into the rule. Other comments requested to 
further clarify handle by better defining ``split.'' Another commenter 
requested clarification for operations that repackage or repurpose 
certified organic products for on-site sale (e.g., delis). A few 
commenters also requested AMS discuss virtual transactions more 
clearly.
    In response to AMS's request for additional activities that may 
need to be certified, commenters suggested the following be added to 
the definition of handle: split, open, close, sort, combine, 
consolidate, aggregate, enclose, condition, treat, size, grade, 
transload, brand ownership, private label, import, export, commingle, 
transport, and deliver.
Exemptions
    Certification of and exemption for brokers was frequently discussed 
in comments. Many commenters requested that brokering activities be 
exempt, with some requesting broad exemptions for all brokers and 
others favoring exemptions for certain brokering activities. These 
comments explained that exemptions are warranted because brokers 
typically do not take physical possession of the products. Many 
commenters also stated that all brokering activity should be certified, 
regardless of physical or financial possession.
    Several comments requested changes or clarifications to the 
exemption for operations with organic sales of less than $5,000, 
although the proposed rule did not revise existing policy. Most of 
these comments wrote in support of this exemption, though some proposed 
changes such as raising the maximum receipts to $10,000 while still 
maintaining exempt status.
    In general, some comments requested fewer exemptions, and asked AMS 
to implement a transition period for operations that would require 
certification under the rulemaking. Further comments wrote that 
operations that sell direct to consumers should be eligible for 
exemption. Several comments requested that storage facilities which 
only receive product packaged by a certified operation be exempt. One 
comment requested that products, not operations, be eligible for 
exemption because operations can interact with organic and non-organic 
products.
    Some comments also requested clarification about private label 
brands. There was no clear consensus among comments about the need to 
certify such operations. Many comments stated that these operations 
must be certified, and that doing so would improve traceability and 
integrity. Others requested that private labels be exempt to avoid 
additional costs and labeling inconsistencies. Further comments 
requested that ``private label'' be added to the definition of ``retail 
establishment'' because retail brands often sell private-labeled 
product.
    Comments disagreed about the specific requirements exempt 
operations must follow. Some comments argued for more specific 
regulatory requirements for exempt operations (i.e., clarify what 
exempt operations can and cannot do). Many comments discussed the use 
of the USDA organic label by exempt operations, stating that exempt 
operations should not be permitted to use the certified organic label. 
They requested that whenever the organic label is used, the business 
must be certified.
Transport
    Many comments requested specific exemptions for most transportation 
of organic products. Specifically, several comments requested that milk 
hauling and transportation between two certified operations should be 
exempt from certification. While the majority of comments requested 
these types of transportation be exempt, some comments disagreed, 
requesting limits on transportation exemptions. Other comments 
requested clarification for whether third-party delivery services that 
restaurants use are exempt. Finally, some comments also asked AMS to 
clarify whether transloading activities need to be certified.
Recordkeeping and Compliance
    Some comments were concerned with verifying exempt operations 
compliance. Several commenters suggested requiring universal use of 
affidavits when doing business with exempt operations. Another 
suggested utilizing invoices to track compliance using mass-balance 
audits.
    Many comments addressed recordkeeping. Several comments requested 
modifying recordkeeping requirements to require exempt operations to 
maintain records for five years to align requirements for certified and 
exempt operations. Other comments wrote that the recordkeeping 
requirements are burdensome for exempt businesses and asked AMS to not 
require certain recordkeeping practices.
Responses to Public Comment
Definition of Handle
    (Comment) AMS received many comments about the definition of handle 
and activities that should or should not require certification. 
Comments discussed a wide range of activities spanning all segments of 
the supply chain and suggested many additional activities to include in 
the definition of handle, including to split, open, close, sort, 
combine, consolidate, aggregate, enclose, condition, treat, size, 
grade, transload, brand ownership, private label, import, export, 
commingle, transport, and deliver. Conversely, comments also provided 
examples of activities that should not require certification, including 
storing packaged products, transporting, delivering, repackaging or 
splitting cases of retail-packaged products, loading, receiving, 
brokering, selling or trading packaged products, selling retail 
products, or labeling for inventory purposes.
    (Response) AMS agrees that some of the activities presented by 
commenters require certification and has added more examples to the 
definition of handle to help clarify who and what activities must be 
certified. 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 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. More specific responses to certain activities are 
discussed below.
    (Comment) Several comments noted the difference between the 
definitions of handler and handling operation and asked AMS to either 
clarify this difference, or harmonize the two definitions.
    (Response) AMS simplified handler and removed ``except for 
operations that are exempt from certification'' and ``or a portion of 
[an operation]'' from handling operation. These phrases are redundant 
because they are explained in Sec.  205.100--What has to be certified. 
AMS also added ``except final retailers

[[Page 3560]]

of agricultural products that do not process agricultural products'' to 
both definitions. This clarifies that certain final retailers are not 
handlers or handling operations, and aligns the definitions with OFPA. 
The two definitions are now mostly synonymous, differing only in their 
reference to either a person or an operation.
    (Comment) Several comments asked AMS to include importing and 
exporting to the definition of handle, noting that the mandatory use of 
NOP Import Certificates requires certification of importers and 
exporters.
    (Response) AMS agrees with these comments and has added importing 
to the United States and exporting for sale in the United States to the 
definition to help clarify that these activities require certification, 
and to support the mandatory use of NOP Import Certificates described 
in Section 2 of this rule, Imports to the United States.
    (Comment) Commenters questioned the inclusion of ``facilitating 
sale or trade'' in the definition for handle. The comments explained 
that the meaning is vague and too broad and would result in customs 
brokers, freight forwarders, sales brokers, and administrative 
activities requiring certification.
    (Response) The original definition for handle covered many 
activities in the supply chain, from post-production to retail sale. 
The updated definition is specific about which activities are included 
in ``sell, process or package.'' However, the list of activities is not 
exhaustive and does not capture all activities that may be considered 
as selling, processing, or packaging an agricultural product. AMS 
included ``facilitating sale or trade on behalf of a seller or 
oneself'' as a general category to capture activities which are 
integral to selling a product and may be known by various names. The 
definition for handle includes handling activities that fall under 
AMS's authority, although sometimes certain activities listed in handle 
may not require certification. For example, entities that perform lower 
risk activities--such as Customs brokers, logistics providers (e.g., 
freight forwarders), and limited handling of packaged products--may be 
exempt from certification (see Sec.  205.101(e)--(h)).
Retail
    (Comment) AMS received comments requesting clarification regarding 
whether distribution centers and transport vehicles associated with a 
retail establishment are exempt from certification. Some commenters 
requested that off-site warehouses and distribution centers not be 
exempt unless they meet proposed Sec.  205.101(e). According to 
commenters, this clarification is needed to ensure that distribution 
centers do not avoid certification by claiming to be an exempt retail 
establishment.
    (Response) A warehouse or distribution center associated with a 
retail establishment is only exempt if it meets the criteria described 
in Sec.  205.101(e) or (f). Transport vehicles associated with a retail 
establishment do not require certification if they only transport and 
do not handle organic agricultural products per Sec.  205.2.
    (Comment) AMS received comments asking whether virtual transactions 
with a final consumer are exempt from certification. Although a few 
comments asked NOP to either exempt or require certification of this 
activity, most comments did not give an opinion and only asked NOP for 
clarification.
    (Response) AMS has provided additional clarification by noting that 
only businesses that meet the definition for retail establishment are 
exempt under Sec.  205.101(b) and (c). Virtual businesses that only 
sell retail packaged products to consumers, but do not qualify as 
retail establishments, may be exempt from certification if they meet 
the criteria of Sec.  205.101(f). AMS provides further detail in the 
``Retail establishments'' section of the preamble.
    (Comment) Comments noted that the proposed definition of retail 
operation did not include the list of examples that was provided in the 
preamble, and asked AMS to add them to the definition.
    (Response) AMS agrees that the examples help clarify the definition 
and has added them to the final definition of retail establishment.
    (Comment) Comments requested revising the exemption for retailers 
that process by not limiting this to processing only products that were 
previously labeled for retail sale. Comments indicated that retailers 
commonly source products labeled for food service.
    (Response) AMS has removed that qualification from Sec.  205.101(c) 
to clarify that exempt retail establishments may process certified 
organic products regardless of whether the products are labeled for 
retail sale.
    (Comment) AMS received comments asking about the status of food 
delivery services, specifically those affiliated with or serving retail 
operations. Although a few comments asked NOP to either exempt or 
require certification of this activity, most comments did not give an 
opinion and only asked NOP for clarification.
    (Response) Services which deliver products from a retail 
establishment to a consumer may not require certification. A service 
which delivers product from the retailer to the consumer after final 
sale and does not engage in handling is transport and does not require 
certification.
    (Comment) Comments requested clearer guidance on what handling 
activities retail operations could engage in and remain exempt. 
Comments explained that the exemption for retailers that only sell and 
retailers that process creates uncertainty for the many retail 
operations that sell and handle. A few comments gave specific examples 
of activities that exempt retail establishments should be allowed to 
conduct, including removing/unpacking products, washing and 
transferring products to retail displays, and breaking down master 
cases of individual packaged products. However, most comments did not 
give an opinion and only asked NOP for clarification.
    (Response) AMS has revised the definitions of handler and handling 
operation to exclude retailers that do not process organic agricultural 
products; these operations may not require certification. This is 
reinforced by the exemption for retailers that handle but do not 
process at Sec.  205.101(b), which acknowledges that exempt retail 
establishments may perform some handling activities. AMS has also 
revised the definition for handle to be more specific about the types 
of activities included. The additional description will help to clarify 
the differences and overlap in handling and processing activities.
    (Comment) Comments asked to clarify the meaning of ``point of 
sale'' in reference to virtual transactions for retailers. There was a 
suggestion to allow virtual transactions only when the sale occurs from 
a brick-and-mortar retail location, to prohibit retailers that sell 
only via an online platform.
    (Response) The definition for retail establishment allows for 
virtual retail transactions. For a retail establishment to be exempt, 
the sales must occur at the same location as the processing, and there 
must also be a physical location for consumers to purchase products.
Storage
    (Comment) AMS received comments stating that storage of unpackaged 
or bulk organic products is high-risk and should require certification. 
They also noted that the proposed rule eliminated the distinction 
between packaged and unpackaged product relating to receiving, storing, 
and loading activities; this could allow high-risk operations

[[Page 3561]]

such as grain elevators and ports of entry to be exempt from 
certification. Some comments requested AMS only exempt the storage of 
sealed, tamper-evident packaged products.
    (Response) AMS has revised the exemption at Sec.  205.101(e) to 
exempt only operations that store, receive, and prepare for shipment 
organic products in sealed, tamper-evident packages. Products must 
remain in their packages and the exempt operation must not handle the 
product beyond storing, loading, and preparing for shipment. Operations 
that store bulk products or products not packaged in sealed, tamper-
evident packaging must be certified.
    AMS made this change because the proposed rule would have exempted 
operations that store unpackaged or bulk organic products. Many public 
comments noted that storage of unpackaged organic products is a high-
risk activity that requires certification to maintain integrity. AMS 
agrees that storage of unpackaged products is a high-risk activity. 
Lack of sealed or protective packaging increases the likelihood of 
contamination with prohibited materials (e.g., pesticides and 
fumigants), commingling with nonorganic products, and 
misidentification. These risks are especially great in high-activity 
areas, and storage of unpackaged products requires additional care and 
oversight to ensure organic integrity is maintained. Therefore, AMS is 
requiring certification of operations that store unpackaged products. 
Conversely, because packaging reduces the risk of contamination, 
commingling, and misidentification, AMS is granting an exemption from 
certification for operations that only store packaged products that are 
sealed upon arrival and remain in their packaging.
    AMS has narrowed the exemption to include only operations that 
store, receive, and/or prepare for shipment organic products in sealed, 
tamper-evident packaging. Sealed, tamper-evident packaging makes 
organic products less susceptible to fraud and mishandling and helps 
maintain organic integrity during storage and handling by uncertified 
operations.
    (Comment) Commenters requested AMS exempt from certification 
activities where packaged product remains in its container, such as 
breaking up pallets of packaged organic products that remain in its 
original inner packaging, or placing such products into a retail 
display.
    (Response) Section 205.101(e) and (f) exempt operations that 
receive, store, and prepare for shipment organic products enclosed in 
sealed, tamper-evident packages or containers. Preparing for shipment 
may include various tasks that must be performed with the sealed, 
tamper-evident packaging remaining intact and without altering product 
contents or any retail labeling. Examples of preparing for shipment 
include putting packaged products into shipping containers, applying 
internal tracking numbers, shrink-wrapping shipping cartons to a 
pallet, breaking down pallets of fully packaged products, adding 
protective packaging to nonretail containers or retail displays of 
organic products, packing individual packaged products onto a shipping 
pallet, placing individual retail packages into a retail display, and 
loading/unloading packaged products onto or from transport vehicles.
    (Comment) Several comments asked if cold storage of organic 
agricultural products is exempt from certification, pointing to the 
inclusion of ``chilling'' in the definition of processing.
    (Response) Cold storage of organic agricultural products may be 
exempt from organic certification if the activity meets the criteria of 
Sec.  205.101(e), i.e., only sealed, tamper-proof packaged organic 
products are stored. The act of cooling packaged organic products is a 
common low-risk storage activity that is different from ``chilling'' 
performed as part of organic product processing.
    (Comment) Several commenters requested that AMS remove the verb 
``loads'' from proposed Sec.  205.101(e) for operations that storage 
organic products, arguing that ``load'' could be conflated with 
handling activities such as placing or packaging bulk products into 
containers.
    (Response) AMS uses ``prepare for shipment'' in exemptions at Sec.  
205.101(e)-(f) to clarify that these exempt operations may not perform 
activities such as packaging or loading bulk products into containers. 
Prepare for shipment means that these operations may move products into 
or onto a mode of transport, provided that the products are packaged 
per Sec.  205.101(e)-(f).
    (Comment) One commenter asked AMS to require certification of 
storage facilities that store both organic and nonorganic agricultural 
products. They argue that such ``split'' storage operations are a known 
source of contamination and commingling, and that certification is 
necessary to prevent this.
    (Response) This rulemaking addresses the risks of contamination and 
commingling by split storage operations by (1) requiring the 
certification of operations that handle unpackaged organic products and 
(2) limiting the exemption for storage operations to only those that 
handle sealed, tamper-proof packaged organic products. AMS believes 
these changes will mitigate the risks of split operations.
    Additionally, Sec.  205.100(a) states that ``each operation or 
portion of an operation'' that handles organic agricultural products 
must be certified. Similarly, the exemption at Sec.  205.101(e), which 
allows storage of packaged organic products without certification, 
would be limited to only the portions of an operation that meet the 
narrow criteria of this exemption. This means that a portion of a split 
operation that stores unpackaged organic products needs to be 
certified.
Transport
    (Comment) Commenters requested that AMS explicitly state what 
transportation activities are exempt from certification. They also 
noted that the regulatory text and preamble lack a specific exemption 
for transport of agricultural products.
    (Response) The OFPA provides AMS authority to regulate the handling 
(i.e., selling, processing, or packaging) of organic agricultural 
products; however, transportation activities are not included in this 
authority. Transport is generally described as the movement of products 
in commerce. Based on the OFPA, transport of organic agricultural 
products does not need to be certified; however, any handling 
activities that occur during transport must be. See the definition of 
handle for examples of activities that may require certification.
    (Comment) AMS received several comments asking if milk haulers will 
require organic certification. Most comments requested only 
clarification on this topic, but several specifically requested that 
milk haulers be exempted from certification.
    (Response) 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.
    (Comment) AMS received comments requesting that the transport 
exemption be limited to transport from one certified operator to 
another, or to a

[[Page 3562]]

final retailer, to ensure traceability of product throughout supply 
chains.
    (Response) AMS is not restricting transport of organic agricultural 
products from one certified operation to another. This rule ensures 
traceability via other means: certified operations must maintain audit 
trail documentation for products they produce or handle (Sec.  
205.103(b)(3)) and keep records to trace organic products received back 
to the last certified operation in the supply chain (Sec.  
205.103(b)(2)). This means that certified operations must ensure 
traceability of products transported by uncertified operations, 
including if several uncertified transporters are used in sequence.
    (Comment) Many comments discussed transloading organic agricultural 
products and asked AMS to clarify if this activity requires 
certification.
    (Response) Transloading is commonly defined as the movement of 
agricultural products between modes of transport. AMS does not have the 
authority to regulate transport. Therefore, transloading strictly 
between modes of transportation does not need to be certified.
    However, transloading is sometimes used to describe the movement of 
agricultural products from storage to transport or transport to 
storage. AMS considers these activities to be loading and receiving 
(see Sec.  205.2 and the definition of handle). Moving unpackaged 
organic agricultural products from storage to transport, or from 
transport to storage, requires certification. If the organic 
agricultural products are enclosed in sealed, tamper-proof containers 
or packages, then loading and receiving is exempt from certification.
Small Operations
    (Comment) Several comments discussed the exemption for small 
operations at Sec.  205.101(a). A few commenters asked AMS to clarify 
if the exemption applies to both production and handling operations. 
Others requested that AMS allow ingredients produced or processed by 
such exempt operations to be used as certified organic ingredients 
produced by other operations. One commenter requested AMS increase the 
gross sales limit of $5,000.
    (Response) This rulemaking does not modify current policy regarding 
the exemption for small operations. Section 205.101(a) exempts 
operations that produce or handle agricultural products as ``organic'' 
but whose gross agricultural income from organic sales totals $5,000 or 
less annually. However, these operations must not sell, label, or 
represent agricultural products they produce or process as certified 
organic, and such products must not be used as certified organic 
ingredients in products processed by another operation (see Sec.  
205.310). Additionally, the $5,000 gross sales threshold is set by the 
OFPA, and AMS does not have authority to increase this limit.
Selling and Representing
    (Comment) Many comments requested that AMS provide exemptions for 
operations that do not physically handle or contact organic 
agricultural products, arguing that such operations do not threaten 
organic integrity.
    (Response) AMS disagrees with commenters' claim that lack of 
physical contact equals low risk. Organic integrity depends on 
oversight and transparency across the entire organic supply chain--
including some operations that may never physically contact organic 
products. The need for certification is based on risk and this rule 
requires certification of high-risk operations such as importers, 
traders, and others that facilitate the sale of organic products. 
Although these operations may not physically contact organic products, 
they control critical events along organic supply chains where organic 
integrity can be compromised, including purchase, sale, transport, 
storage, and combining or splitting products. For example, an importer, 
broker, or trader could unintentionally compromise the integrity of 
organic products they buy or sell by not seeking or keeping records to 
demonstrate traceability and verify organic integrity. Without these 
records, there is no way to verify that a product was properly handled 
by the multiple physical handlers in a supply chain. A breach of 
integrity could go unreported, and the importer or trader would 
unintentionally sell a product that has lost its organic status and 
integrity. Similarly, brokers and traders could mistakenly direct 
contracted storage facilities and transporters to perform activities 
that compromise organic integrity, such as directing a storage facility 
to fumigate a container of organic wheat or directing a transporter to 
combine loads of organic and nonorganic corn.
    Additionally, because importers, brokers, traders and others that 
facilitate sales have direct financial interest in the transaction of 
organic products, they have the incentive and opportunity to commit 
fraud. For example, an operation could falsify records to claim that a 
nonorganic product is certified organic, or direct a contracted storage 
facility or transporter to mix organic and nonorganic products, and 
then claim the entire load is organic. NOP has investigated many 
notable cases of fraud committed by uncertified operations that did not 
physically contact the products in question (see the discussion on 
fraud under ``Purpose and Need for the Rule'').
    The risk of both unintentional breach of integrity and fraud has 
grown with the organic market as supply chains increase in complexity 
and more uncertified parties affect control of organic products and 
their transaction. Requiring certification based on risk ensures 
traceability, verification, accountability, and oversight at the most 
critical points of the supply chain, including the activities of 
brokers, traders, importers, and others who facilitate sale but may not 
physically contact organic products. The rule also provides reasonable 
exemptions for low-risk operations to reduce cost and administrative 
burden to the industry.
    (Comment) Many comments discussed private labeling and brand 
ownership of organic products. Opinions differed about the need to 
certify these operations. Some commenters argued that requiring 
certification of these operations would improve transparency and 
traceability of products, while others claimed that doing so would be 
unnecessary and create potential problems with labeling and 
traceability.
    (Response) ``Brand owners'' or operations that sell or distribute 
organic products produced by another operation on their behalf may be 
exempt from certification if they meet the criteria of Sec.  
205.101(f). This exemption allows the buying, selling, receiving, 
storing, and preparing for shipment of organic products that are 
packaged for retail sale. The products must be sealed in tamper-evident 
packaging ready for retail sale, and the operation must not open or 
otherwise handle the retail packages. Private labeling operations that 
process organic agricultural products must be certified.
    (Comment) Commenters asked AMS to clarify if sales brokers need to 
be certified, including businesses that buy or sell only packaged 
organic products.
    (Response) Operations that sell, trade, or facilitate sale or trade 
of organic agricultural products on behalf of a seller or oneself must 
be certified. However, AMS is providing an exemption for operations 
that only buy, sell, receive, store, or prepare for shipment organic 
products packaged for retail sale (Sec.  205.101(f)). The products must 
be sealed in tamper-evident

[[Page 3563]]

packaging labeled for retail sale, and the operation must not open or 
otherwise handle the retail packages. Sale of organic products not 
packaged for retail sale (e.g., bulk; unpackaged; packaged for 
nonretail sale; unsealed, non-tamper-evident packaging) must be 
certified.
Supply Chain Logistics
    (Comment) Many comments asked AMS to provide a specific exemption 
for Customs brokers licensed by U.S. Customs and Border Protection, 
arguing that these operations only facilitate entry of imports into the 
United States, and that their activities do not present a risk to 
organic integrity.
    (Response) AMS agrees that the activities of Customs brokers do not 
threaten organic integrity. Therefore, Sec.  205.101(g) exempts from 
certification licensed Customs brokers that only conduct Customs 
business per 19 CFR 111.1. This exemption is limited to Customs 
business; other activities conducted by a Customs broker that fall 
within the definition of handle--including selling, importing, or 
trading organic agricultural products--may require certification.
    (Comment) Several comments asked AMS to clarify if businesses that 
facilitate the storage and transport of organic agricultural products, 
such as logistics brokers and freight forwarders, require 
certification.
    (Response) Logistics brokers, freight forwarders, and other 
businesses that facilitate storage and transport of agricultural 
products may be exempt if they meet the criteria of Sec. Sec.  
205.101(e) or (h). These exemptions only apply to operations that 
conduct or facilitate specific shipping, storing, or transport 
activities. This may include logistics brokers or freight forwarders 
who do not take ownership or physical possession of organic products 
and only provide a service by connecting a consigner (or consignee) 
with a carrier who transports/stores the products. Additionally, 
transport of organic agricultural products does not require 
certification if the transport operation does not handle the products 
(see definition of handle in Sec.  205.2). Other handling activities--
such as selling, importing, or trading--must be certified.
    (Comment) Many commenters responded to AMS's request for comment 
about ports of entry. Most commenters agreed that the activities of 
ports--such as loading, storing, receiving, combining, and splitting--
must be certified if unpackaged products are being handled. Comments 
stated that handling of unpackaged goods at ports should be certified 
because ports conduct physical activities that can compromise organic 
integrity. Ports unload, move, split, combine, and store both organic 
and nonorganic products, increasing the risk of commingling organic and 
nonorganic products, and the risk of contamination with substances not 
allowed in organic handling. In contrast, several comments from trade 
associations state that requiring certification of port activities may 
cause delays, increase costs, and may have limited positive impacts on 
organic integrity. Several comments asked AMS for more clarification 
about the need for ports of entry to be certified.
    (Response) Ports of entry must be certified if the activities they 
conduct meet the definition of handle and do not clearly fit an 
exemption at Sec.  205.101(a)-(h).
Recordkeeping and Verification
    (Comment) Several comments noted that proposed Sec.  205.101 did 
not clearly explain the requirements and recordkeeping practices each 
exempt operation must follow. A few comments also asked AMS to increase 
the recordkeeping requirement for exempt operations to five years to be 
consistent with requirements for certified operations.
    (Response) AMS has revised Sec.  205.101 to clarify the 
requirements and recordkeeping practices that exempt operations must 
follow. Specific references to individual requirements are removed from 
each exemption, and the introductory paragraph explains universally 
that all exempt operations must follow the applicable production, 
handling, and labeling requirements of subparts C and D. The preamble 
further explains with specific examples of requirements exempt 
operations may have to follow.
    AMS has also removed recordkeeping requirements from individual 
exemptions and replaced them with a single, consistent recordkeeping 
requirement that applies universally to most exempt operations. AMS 
retained the requirements for exempt operations to maintain records for 
at least three years because there was not a compelling reason for 
increasing that timeframe without prior notice.
    (Comment) AMS received several comments asking who is responsible 
for verifying exempt operations' compliance with the organic 
regulations.
    (Response) Certified operations are responsible for verifying the 
compliance of the certified organic products they receive, including 
those received from exempt operations. Section 205.201(a)(3) requires a 
certified operation's OSP to include monitoring practices and 
procedures to verify suppliers (including exempt suppliers) and the 
organic status of products they receive. AMS is not prescribing how 
certified operations should verify suppliers and products; this 
provides flexibility for operations to develop and implement practices 
that best suit their business and the products they handle.

B. Imports to the United States

    The table below includes the regulatory text related to this 
section of the rule. A discussion of the policy follows.

------------------------------------------------------------------------
                  Section                       Final regulatory text
------------------------------------------------------------------------
205.2.....................................  Terms Defined.
                                            Definitions for Organic
                                             exporter and Organic
                                             importer.
205.273...................................  Imports to the United
                                             States.
                                            Entire section.
205.300...................................  Use of the term,
                                             ``organic.''
                                            Paragraph (c).
------------------------------------------------------------------------

Purpose, Scope, and Authority
    AMS is amending the USDA organic regulations by adding a new 
section (205.273) requiring the use of the National Organic Program 
Import Certificate (``NOP Import Certificate''). The NOP Import 
Certificate is a transaction certificate, or data set, that contains 
detailed information about the quantity and origin of organic product 
being imported into the United States. Any organic agricultural product 
imported to the United States must be associated with a valid NOP 
Import Certificate, generated by the certifying agent of the final 
certified exporter sending the product to the United States.

[[Page 3564]]

    The purpose of the NOP Import Certificate is to document the 
organic status and quantity of imported organic products as they travel 
from a certified organic exporter in a foreign country to a certified 
organic importer in the United States. The NOP Import Certificate 
ensures an auditable business transaction by documenting that the 
products in the shipment are organic and may be sold, represented, and 
distributed as organic within the United States.
    The mandatory use of NOP Import Certificates is authorized by the 
Organic Foods Production Act (OFPA), as amended by the ``2018 Farm 
Bill''.\18\ The OFPA specifies what information an NOP Import 
Certificate must include (7 U.S.C. 6502(13)) and also stipulates that 
the NOP Import Certificate must ``be available as an electronic 
record'' and captured in a tracking system maintained by the U.S. 
Government (7 U.S.C. 6514(d)). The OFPA also provides the Secretary 
with broad authority to establish appropriate and adequate enforcement 
procedures and any other requirements that the Secretary may determine 
to be necessary (7 U.S.C. 6506).
---------------------------------------------------------------------------

    \18\ See sections 10104(b)(3) and 10104(c) of the Agriculture 
Improvement Act of 2018, Public Law 115-334. Available at: https://www.congress.gov/115/plaws/publ334/PLAW-115publ334.pdf.
---------------------------------------------------------------------------

    The NOP Import Certificate must be presented to U.S. Customs and 
Border Protection (CBP) through the CBP Automated Commercial 
Environment (ACE). The use of this standardized electronic format will 
ensure consistency in data for auditing, surveillance, and enforcement 
purposes. The OFPA, as amended by the 2018 Farm Bill, states that AMS 
must establish a system of tracking NOP Import Certificates, and that 
AMS ``may integrate the system into any existing information tracking 
systems for imports of agricultural products'' (7 U.S.C. 6514(d) and 
6522(c)).\19\
---------------------------------------------------------------------------

    \19\ See section 10104(c) of the Agriculture Improvement Act of 
2018, Public Law 115-334. Available at: https://www.congress.gov/115/plaws/publ334/PLAW-115publ334.pdf.
---------------------------------------------------------------------------

    Because the OFPA enables AMS to access information available in ACE 
(7 U.S.C. 6521(c)), AMS is using ACE to accept NOP Import Certificate 
data.\20\ ACE is an automated and electronic system for processing 
commercial trade data. It is the primary system through which the 
global trade community files information about imports and exports so 
that admissibility into the United States may be determined by 
government agencies (including AMS) to ensure compliance.
---------------------------------------------------------------------------

    \20\ See sections 10104(h) and (j) of the Agriculture 
Improvement Act of 2018, Public Law115-334. Available at: https://www.congress.gov/115/plaws/publ334/PLAW-115publ334.pdf.
---------------------------------------------------------------------------

    The data to be entered into ACE include fields for the information 
needed to meet the requirements of an NOP Import Certificate as defined 
in the OFPA: origin; destination; the certifying agent issuing the NOP 
Import Certificate; harmonized tariff code, when applicable; total 
weight; and the organic standard the product was certified to (7 U.S.C. 
6502(13)). For the purposes of uploading and tracking NOP Import 
Certificates, the data must be available as an electronic format to 
meet the requirements of the OFPA (7 U.S.C. 6514(d)(1)).
    Both the OFPA and the USDA organic regulations require certified 
operations to maintain and make available to the Secretary records that 
concern the production, harvesting, and handling of agricultural 
products that are or that are intended to be sold, labeled, or 
represented as organic. This includes sufficient records to provide an 
audit trail to determine the source, type and quantity, transfer of 
ownership, and transportation of any agricultural product labeled as 
organic. Likewise, both the OFPA and the USDA organic regulations 
require certifying agents to maintain and make available to the 
Secretary records concerning its activities.
    This policy also aligns with international guidelines and norms 
related to organic oversight. NOP considered international standards 
established by the Codex Alimentarius Commission (Codex) \21\ and norms 
published by the International Federation of Organic Agriculture 
Movements (IFOAM).\22\ Both provide for and support the use of 
transaction shipment certificates such as the NOP Import Certificate.
---------------------------------------------------------------------------

    \21\ Section 7 of the Codex Guidelines for the Production, 
Processing, Labelling and Marketing of Organically Produced Foods 
recommends imported organic products to be marketed only where the 
competent authority or designated body in the exporting country has 
issued a certificate of inspection stating that the lot designated 
in the certificate was obtained within an organic system of 
production, preparation, marketing, and inspection.
    \22\ IFOAM Norms define a transaction certificate as a 
``document issued by a certification body or by the operator, 
declaring that a specified lot or consignment of goods is 
certified.''
---------------------------------------------------------------------------

Change From Current Policy
    NOP Import Certificates are currently only used for organic 
products imported from countries with which AMS has an equivalence 
determination. The USDA has established equivalence determinations with 
Canada, the European Union, Switzerland, Japan, South Korea, Taiwan, 
and the United Kingdom. Organic imports from Canada are accompanied by 
an organic certificate that includes an attestation statement that the 
products comply with the terms of the United States-Canada Organic 
Equivalency Arrangement. Organic imports from the European Union, 
Switzerland, Japan, South Korea, Taiwan, and the United Kingdom are 
accompanied by an NOP Import Certificate. The certifying agent of the 
exporter evaluates the request for an NOP Import Certificate, and upon 
verification of the organic shipment, completes and issues an NOP 
Import Certificate. Form NOP 2110-1 is currently used for this purpose.
    In the past, AMS has not required NOP Import Certificates for 
organic exports from countries with which the United States does not 
have an organic equivalence determination. The rulemaking changes this 
to make the use of NOP Import Certificates mandatory, regardless of an 
imported product's country of origin or if that country has an 
equivalency determination with USDA. Specifically, this rulemaking 
requires that all imported products intended to be sold, represented, 
labeled, or marketed as organic in the United States must be declared 
as organic to U.S. Customs and Border Protection (CBP), using an NOP 
Import Certificate.
Alignment of Policy With U.S. Customs and Border Protection Policies 
and Systems
    The OFPA, as amended by the 2018 Farm Bill, requires the 
establishment of an Organic Agricultural Product Imports Interagency 
Working Group, consisting of members of both the USDA and CBP (see 7 
U.S.C. 6521a).\23\ The mandatory use of NOP Import Certificates 
supports the working group's goal to ensure the compliance of organic 
agricultural products imported into the United States.
---------------------------------------------------------------------------

    \23\ See section 10104(i) of the Agriculture Improvement Act of 
2018, Public Law No: 115-334. Available at: https://www.congress.gov/115/plaws/publ334/PLAW-115publ334.pdf.
---------------------------------------------------------------------------

    Under this policy, AMS and CBP will collaborate to verify that 
imported organic products are associated with NOP Import Certificates. 
In April 2020, the electronic version of the NOP Import Certificate was 
deployed in ACE as an optional filing step for organic imports. The use 
of the electronic NOP Import Certificate will be mandatory once this 
rule is fully implemented.
    NOP Import Certificates will be required for any commodity imported 
into the United States that is being

[[Page 3565]]

manifested, sold, marketed, or labeled organic. NOP Import Certificates 
are required for organic commodities regardless of value or size and is 
not applicable for any di Minimis exemptions under current CBP 
regulations.
Generating the NOP Import Certificate
    This section describes how the NOP Import Certificate data are 
generated. NOP Import Certificates must be generated using the USDA's 
Organic Integrity Database. By the time the rule is fully implemented, 
both USDA-accredited certifying agents and organic certifying agents 
accredited by countries with which USDA holds an organic trade 
arrangement or agreement (equivalence determination or recognition 
arrangement) will have access to the Organic Integrity Database to 
generate NOP Import Certificates. Only the Organic Integrity Database 
can be used to generate valid NOP Import Certificates, and only 
accredited organic certifying agents (USDA or under an organic trade 
arrangement or agreement) are authorized to use the Organic Integrity 
Database.
Where does the data for the NOP Import Certificate come from?
    The data for the NOP Import Certificate is generated in the Organic 
Integrity Database by the certifying agent of the exporter. The 
exporter is responsible for facilitating the trading, selling, 
consigning, shipping, or exporting of organic product from a foreign 
country to the United States. An organic exporter must be certified 
organic by certifying agents accredited by the USDA or certifying 
agents authorized by a trade arrangement or agreement. Organic 
exporters may be the final physical handler of organic products within 
a foreign country, or they may be the entities that facilitate, sell, 
or arrange the sale of organic products shipped to the United States.
    This exporter is responsible for verifying that the organic product 
complies with organic standards. This includes, but is not limited to, 
verifying that the import has not been exposed to a prohibited 
substance, treated with a prohibited substance as a result of 
fumigation or treated with ionizing radiation at any point in the 
products' movements across country borders.
How does the certifying agent evaluate the request for an NOP Import 
Certificate?
    The certifying agent determines the format of the NOP Import 
Certificate request from the certified operation, based on the data 
required for the Organic Integrity Database to generate the NOP Import 
Certificate. The request for an NOP Import Certificate must include all 
information required by the organic exporter's certifying agent to 
complete the NOP Import Certificate. The certifying agent is required 
to confirm the authenticity of the organic products covered by the NOP 
Import Certificate using control systems it designs for this purpose. 
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 is responsible for ensuring that the issued 
NOP Import Certificate is only associated with an amount of product 
that has been verified to be certified organic. The certifying agent 
has the authority to determine whether it will issue an NOP Import 
Certificate for a specific shipment, or for a specific timeframe (e.g., 
weekly, monthly, season) and amount or volume ceiling. This 
determination is to be based on the capacity and control systems of 
both the certifying agent and the certified operation. There is no 
limit on the length of timeframe a certifying agent chooses. However, 
the certifying agent must choose a timeframe that is appropriate to 
their administrative capacity and documented control system and allows 
them to verify the integrity of the specific type and volume of import.
    Once the certifying agent verifies the authenticity of the organic 
export, the certifying agent enters or uploads the information needed 
into the Organic Integrity Database. Each NOP Import Certificate must 
be associated with a certified organic operation listed in the 
database, identified by a 10-digit code. The Organic Integrity Database 
will generate a unique NOP Import Certificate that includes both the 
10-digit identifier for the operation and a unique numerical identifier 
for the NOP Import Certificate. The certifying agent will provide the 
NOP Import Certificate, or data set with the NOP Import Certificate 
number, back to the certified organic exporter requesting the NOP 
Import Certificate. The certifying agent can cancel or void a NOP 
Import Certificate in the Organic Integrity Database at any time.
Transmitting the NOP Import Certificate From Exporter to Importer
    The certified organic exporter provides the NOP Import Certificate 
to the U.S. importer, who provides it to the specific entity 
responsible for entering import information into the ACE system. This 
is typically an importer or designated Customs broker. The NOP Import 
Certificate data can be sent either electronically or via paper. The 
U.S. importer or Customs broker enters the NOP Import Certificate data 
into ACE as part of its standard import filing process; this process is 
governed by timelines determined by CBP. Organic certifying agents will 
not have access to ACE; this activity is done by the importer or its 
Customs broker, using the NOP Import Certificate data provided by the 
certifying agent to the exporter.
    As the certified organic product itself moves from the exporting 
country into the United States, all entry documentation including, but 
not limited to bills of lading, bills of sale, commercial invoices, and 
packing lists must clearly state that the product is organic. Exporting 
and importing operations must maintain records required under Sec.  
205.103. CBP may hold shipments at the border to address health and 
safety issues or violations of U.S. trade laws with a specific 
commodity or shipment.
Importer Responsibilities
    Upon receiving a shipment, an organic importer must verify that the 
organic product(s) comply with the USDA organic regulations. This 
includes ensuring that an NOP Import Certificate is associated with the 
product received. It also includes verifying that the import has not 
been treated with a prohibited substance as a result of fumigation or 
treated with ionizing radiation at any point in the products' movements 
across borders. Verification may take many forms, depending on the 
documentation provided, and country and commodity. The importer must 
have an organic control system that documents how this verification is 
conducted to protect the organic integrity of imported product. This 
control system is reviewed by the importer's certifying agent.
    Both the organic exporter and U.S. organic importer must maintain 
records of NOP Import Certificates, and these records must be available 
for inspection by the NOP and certifying agents in accordance with 
Sec.  205.103. Certifying agents that are overseeing imports of organic 
products into the United States must have a system for ensuring that 
operations receiving organic product are receiving and maintaining NOP 
Import Certificates, and that they are not accepting more product from 
any providers than is authorized by NOP Import Certificates.

[[Page 3566]]

Connecting NOP Import Certificate With ACE Import Data
    Once NOP Import Certificate Data is entered into ACE, the data are 
transmitted to AMS for analysis, surveillance, and enforcement. AMS 
will align and validate the data generated in ACE with the original NOP 
Import Certificate entered into the Organic Integrity Database. This 
will connect the data about the actual imported product back to the 
data about the corresponding authorized export, aligning both sides of 
the transaction. This alignment will allow for the identification of 
any anomalies or indicators of fraud, such as: NOP Import Certificates 
in ACE that were not authorized (do not have a valid certificate 
number) by a certifying agent in the Organic Integrity Database (e.g., 
fraudulent certificates); volumes of product entered in ACE that exceed 
those authorized in the Organic Integrity Database; and/or entries into 
ACE that are associated with an operation that is no longer certified. 
This type of automated data-driven surveillance is a common approach in 
trade oversight.
Timing of the NOP Import Certificate
    The timing of the NOP Import Certificate data entry into ACE must 
comply with current CBP import filing requirements for Partner 
Government Agencies. The certified organic exporter must time the NOP 
Import Certificate request in such a way that the certifying agent has 
time to consider the request and generate the NOP Import Certificate, 
and the exporter has time to deliver it to the importer or Customs 
broker before the CBP filing requirements for the product.
    Requiring an NOP Import Certificate provides trackable and 
auditable verification that organic products comply with the USDA 
organic regulations. This requirement will also support investigations 
if noncompliant products are exported and misrepresented as organic for 
sale in the United States. Given that the Organic Integrity Database 
will be the definitive tool for generating NOP Import Certificates, 
additional guidelines on data entry to generate NOP Import Certificates 
will be provided through that system.
Summary of Changes to the Final Rule
    AMS made several changes to the regulatory text of the SOE proposed 
rule when writing this final rule. Changes to the final rule are 
discussed below and are followed by responses to specific themes from 
public comment.
     AMS removed ``owner'' from the definition of organic 
exporter, added ``certified'' before ``exporter,'' and ``to the United 
States'' after ``from a foreign country.'' This clarifies that the 
organic exporter must be certified, and that the organic exporter may 
be the final physical handler of organic products within a foreign 
country, or they may be the entities that facilitate, sell, or arrange 
the sale of organic products shipped to the United States. This was 
done to clarify questions about ``who needs to be certified'' received 
during public comment.
     AMS removed ``of record'' from the definition of organic 
importer and added a statement that the organic importer is responsible 
for entering NOP Import Certificate data into ACE. This addresses 
public commenters' request to clarify the role of the organic importer 
and the person responsible for entering data into ACE.
     AMS removed ``through a U.S. Port of Entry,'' as all 
imports must enter through such a Port, so the phrase is not needed.
     AMS removed references to ``or equivalent data source'' 
and ``NOP Form 2110-1'' throughout Sec.  205.273 and clarified that the 
Organic Integrity Database must be used to issue NOP Import 
Certificates. AMS has determined that the Organic Integrity Database 
will be the only data source for NOP Import Certificates because it is 
a preexisting, proven tool that meets U.S. government security 
requirements, and already accepts data in multiple different forms to 
accommodate data inputs from other systems. The Organic Integrity 
Database is already used and understood by certifying agents, including 
many accredited by both the USDA and trade partner countries. It is a 
system that accepts data in multiple forms, that any government can 
engage with, and that minimizes onboarding time and learning curve. 
Using the Organic Integrity Database as a single source of 
certification and import data, while allowing multiple data upload 
methods, will provide secure access to import data that facilitates the 
use of NOP Import Certificates.
     AMS clarified that certifying agents may issue NOP Import 
Certificates for a specific timeframe, if appropriate, not limited to a 
single transaction. This addresses public commenters' concerns about 
generating NOP Import Certificates for multiple shipments in short 
timeframes (e.g., multiple shipments of fresh produce across the 
border). This change allows certifying agents to determine whether they 
will issue an NOP Import Certificate for a specific shipment or for a 
specific timeframe (e.g., weekly, monthly, seasonally) and amount or 
volume ceiling. Because certifiers conduct certification activities on 
a one-year cycle, it is expected that import certificates are unlikely 
to exceed one year in duration. The certifying agent must choose a 
timeframe that is appropriate to their administrative capacity and 
documented control system, and allows them to verify the integrity of 
the specific type and volume of import.
     AMS clarified the requirement that certifying agents must 
have and implement a documented organic control system for intaking and 
approving or rejecting NOP Import Certificates. This ensures that 
certifying agents have auditable processes and procedures that NOP can 
audit to assess certifying agents' ability to generate and approve NOP 
Import Certificates.
     AMS removed the requirement that certifying agents must 
issue NOP Import Certificates within 30 days. This avoids any timing 
discrepancy between NOP Import Certificate data entry and CBP import 
filing requirements. AMS does not have authority to change CBP entry 
requirements. The timing of the NOP Import Certificate data entry into 
ACE must comply with current CBP import filing requirements for Partner 
Government Agencies.
     AMS clarified that organic importers must have a 
documented organic control system to verify NOP Import Certificates and 
verify no contact with prohibited substances or exposure to ionizing 
radiation. This is necessary to ensure that organic importers have 
auditable processes and procedures that certifying agents can review to 
assess importers' ability to verify NOP Import Certificates and verify 
the integrity of imported organic products.
     AMS clarified that organic importers must verify that the 
NOP Import Certificate data accurately reflects the shipment, which may 
include verification of quantities and types of product specified on 
the NOP Import Certificate. This requirement more clearly states the 
organic importer's responsibility in assessing and ensuring the 
integrity of imported products, providing an additional layer of 
oversight at a critical juncture in organic supply chains.
Summary of Public Comment
    The majority of public comments were strongly in support of AMS's 
proposed mandatory use of NOP Import Certificates. Many comments 
discussed or recommended changes to the NOP Import Certificate process, 
including the timing of NOP Import Certificates, ACE data entry, how 
the certificate should travel with the import, certifying agent

[[Page 3567]]

role and capacity, and how the NOP Import Certificate would function 
within organic trade arrangements and agreements.
    Comments frequently asked AMS to clarify if NOP Import Certificates 
can be issued before or after shipment. They also noted that the 
proposed 30-day requirement to issue NOP Import Certificates does not 
align with the 10-day ACE entry deadline noted in the preamble. Some 
comments requested that AMS allow up to 30 days to enter NOP Import 
Certificate data into ACE, while others recommended 10 days or less to 
help reduce fraud.
    Many comments asked AMS to clarify if an NOP Import Certificate 
must ``accompany'' an import or be ``associated with'' an import. 
Several comments requested that AMS require imports be ``accompanied'' 
by an NOP Import Certificate and that the certificate travel with the 
import and be presented at entry into the United States, claiming that 
this would help prevent fraudulent organic products from entering the 
U.S. market. Others stated a preference to allow NOP Import 
Certificates to ``be associated'' with shipments, noting that this 
flexibility is needed to match the frequency and pace of land imports 
via truck and rail.
    Several comments noted that issuing NOP Import Certificates for 
individual shipments would be difficult for high-volume, high-frequency 
imports, especially those from Canada and Mexico. These comments asked 
AMS to consider allowing certifying agents to issue NOP Import 
Certificates that cover a specific time period (e.g., quarterly), 
product type, and volume. Comments argued this would reduce 
administrative burden and cost to both certified operations and 
certifying agents. A few comments also claimed that some certifying 
agents may not have the administrative capacity or technical expertise 
to issue and verify NOP Import Certificates as proposed.
    A few comments asked AMS to clarify the definitions and roles of 
exporters and importers, noting that it is not clear who is responsible 
for requesting NOP Import Certificates, verifying them upon import, and 
entering data into ACE. Some comments also asked AMS to further define 
``equivalent data.''
    Finally, some comments requested clarification about the general 
applicability and use of NOP Import Certificates, including their use 
for very small or infrequent shipments, use by exporters in a country 
AMS has a trade arrangement or agreement with, use of electronic vs. 
paper certificates, and use in trade between two foreign countries.
Responses to Public Comment
Timing of NOP Import Certificates
    (Comment) AMS received many comments concerning the 30-day time 
frame for certifying agents to review and issue NOP Import 
Certificates. Commenters stated that the 30-day timeframe will 
negatively impact imports of perishable organic product from Canada and 
Mexico that require a rapid import process.
    Other commenters stated that the 30-calendar-day timeframe for 
certifying agents to review and issue NOP Import Certificates does not 
align with the existing 10-day requirement to upload the NOP Import 
Certificate data into the ACE system. Others requested that the 10-day 
requirement for organic exporters to enter data from an NOP Import 
Certificates or equivalent into ACE align with the proposed 30-day 
requirement for certifying agents to issue an NOP Import Certificate or 
equivalent. Commenters also requested that the 10-day timeframe to 
enter NOP Import Certificate data be reduced to prevent organic fraud.
    More broadly, AMS received comments asking if NOP Import 
Certificates can be issued both before and after shipment. 
Additionally, commenters asked If NOP Import Certificates could be 
issued after the shipment of organic product has already entered the 
United States.
    (Response) The timing of the NOP Import Certificate data entry into 
ACE must comply with current CBP import filing requirements for Partner 
Government Agencies. AMS does not have authority to change CBP entry 
requirements.
    The certified organic exporter must time the NOP Import Certificate 
request in such a way that the certifying agent has time to consider 
the request and generate the NOP Import Certificate, and the exporter 
has time to deliver it to the importer or Customs broker before the CBP 
filing requirements for the product.
    To address the problem of generating NOP Import Certificates for 
multiple shipments in short timeframes (e.g., multiple shipments of 
fresh produce across the border), AMS is granting the certifying agent 
the authority to determine whether it will issue an NOP Import 
Certificate for a specific shipment, or for a specific timeframe (e.g., 
weekly, monthly, season) and amount or volume ceiling. The certifying 
agent is responsible for ensuring that the issued NOP Import 
Certificate is only associated with an amount of product that has been 
verified to be certified organic.
Associated vs. Accompanying
    (Comment) Several commenters noted that proposed Sec.  205.273(d) 
states that the organic importer of record must ensure that the 
shipment is accompanied by a verified NOP Import Certificate. This 
conflicts with the preamble which states that shipments of organic 
product must be associated with a valid NOP Import Certificate.
    (Response) To clarify the requirement, AMS has removed the term 
accompanied from the rule. The NOP Import Certificate must be 
associated with a shipment. This revision accurately describes AMS's 
intent that organic shipments are associated with, and not accompanied 
by, a valid NOP Import Certificate at the time of entry into the United 
States.
    (Comment) Commenters requested that the term associated, located in 
the preamble text, be changed to accompany and that AMS require NOP 
Import Certificates to be available upon entry to the United States, to 
prevent fraud in the organic market.
    (Response) USDA is requiring that all organic exports to the United 
States be associated with a valid NOP Import Certificate. By requiring 
organic imports to be associated with, and not accompanied by, an NOP 
Import Certificate, USDA will have access to the import data without 
restricting or slowing import and trade of organic products.
Certifying Agent Capacity
    (Comment) AMS received several comments highlighting that organic 
certifying agents lack the capacity to issue the number of NOP Import 
Certificates that would be required under the proposed rule at one per 
shipment. Comments specifically referenced the high-volume of organic 
products coming by truck and rail from Mexico and Canada.
    (Response) It is the certifying agent's responsibility to ensure 
that the exporting operation has the capacity to produce or handle the 
product covered by the NOP Import Certificate. When a certifying agent 
issues a NOP Import Certificate, it is validating that the product is 
truly organic; therefore, it must have adequate control systems to 
verify these claims.
    To address the problem of generating NOP Import Certificates for 
multiple shipments in short timeframes (e.g., multiple shipments of 
fresh produce across the border), AMS is granting the certifying agent 
the authority to determine whether it will issue an NOP Import 
Certificate for a specific shipment, or for a specific timeframe

[[Page 3568]]

(e.g., weekly, monthly, season) and amount or volume ceiling. The 
certifying agent is responsible for ensuring that the issued NOP Import 
Certificate is only associated with an amount of product that has been 
verified to be certified organic.
    (Comment) AMS received several comments that recommended a 
staggered implementation timeline for the NOP Import Certificate 
requirement to ensure certifying agents have the administrative 
capacity to process additional NOP Import Certificates. Several 
comments also expressed concern about the increased cost associated 
with issuing NOP Import Certificates. Comments noted that certifying 
agents would need to hire and train additional technical staff to 
comply with the proposed requirements for NOP Import Certificates.
    (Response) Under the current USDA organic regulations, certifying 
agents are not allowed to provide certification services that are 
outside its administrative capacity. While a reasonable implementation 
period is being provided to fully update the Organic Integrity Database 
to generate NOP Import Certificates, certifying agents are not to issue 
any NOP Import Certificates without having adequate expertise and 
staffing to verify the organic status of products it oversees under the 
organic program.
    (Comment) Commenters asked how certifying agents will verify 
whether a shipment is compliant with the USDA organic regulations based 
on an NOP Import Certificate.
    (Response) Certifying agents that are overseeing exports of organic 
products to the United States must have and implement a documented 
organic control system for intaking and then approving or rejecting an 
NOP Import Certificate request. The certifying agent is responsible for 
ensuring that the issued NOP Import Certificate is only associated with 
an amount of product that has been verified to be certified organic. 
Certifying agents that are overseeing importers of organic products 
into the United States must have a system for ensuring that operations 
receiving organic product are receiving and maintaining NOP Import 
Certificates, ensuring that importers have met the requirements of this 
section, and that they are not accepting more product from any 
providers than is authorized by NOP Import Certificates.
General Applicability
    (Comment) AMS received comments asking if NOP Import Certificates 
would be required for small, retail, and mixed shipments of organic 
product imported into the United States.
    (Response) NOP import Certificates will be required for any 
commodity imported into the United States that is being manifested, 
sold, marketed, or labeled organic. NOP Import Certificates are 
required for organic commodities regardless of value or size and is not 
applicable for any de minimis exemptions under current CBP regulations. 
A very limited number of exemptions will be allowed for items such as, 
but not limited to, food donations, non-retail samples, and 
humanitarian efforts.
    (Comment) Commenters asked if NOP Form 2110-1, NOP Import 
Certificate, is mandatory and whether a paper copy would be permitted. 
Commenters also asked if certifying agents would issue physical or 
digital copies of NOP-2110-1 to operations.
    (Response) Only the NOP Import Certificate and its associated data, 
generated from the Organic Integrity Database, is a valid NOP Import 
Certificate. Either a paper-based or electronic NOP Import Certificate 
may be used. Certifying agents will determine the format it will use to 
provide the exporter with the NOP Import Certificate data.
ACE Data Entry
    (Comment) We received comments requesting AMS clarify the 
definition of ``equivalent data source'' by providing additional text 
in Sec.  205.273(e). Commenters requested the requirement explicitly 
state that USDA is the sole authority that determines equivalent data 
sources.
    (Response) In the final rule, we have removed the term ``equivalent 
data source.'' All NOP Import Certificates will be generated using the 
Organic Integrity Database. AMS provides multiple ways to upload or 
enter data into the Organic Integrity Database. We have determined it 
will be the only data source for NOP Import Certificates because it is 
a preexisting, proven tool that meets U.S. government security 
requirements, and a centralized system is needed to facilitate supply 
chain traceability and to assess authorized import certificate data 
against actual import data generated by CBP and reported back to AMS. 
The Organic Integrity Database allows data submittals in multiple 
formats, such as direct data entry, data spreadsheet uploads, and 
automated programming interfaces. A data dictionary is also public, 
allowing external parties to easily map their own systems and data 
exports to the tool. The Organic Integrity Database is already used and 
understood by certifying agents, including many accredited by both the 
USDA and trade partner countries. It is a system that any government 
can engage with that minimizes onboarding time and learning curve. 
Using the Organic Integrity Database as a single source of 
certification and import data, while allowing multiple data upload 
methods, will provide secure access to import data that facilitates the 
use of NOP Import Certificates.
    (Comment) We received a number of comments about the respective 
roles of the exporter and importer with respect to the NOP Import 
Certificate. Several comments stated that the organic exporter does not 
have access to the CBP ACE system and is not the party that would enter 
the required data into ACE. Commenters recommended that the importer of 
record be the entity responsible for entering data into ACE. Comments 
stated that the proposed definition of organic importer of record is 
unclear and does not reliably identify the party capable of ensuring 
each shipment is associated with an NOP Import Certificate.
    (Response) NOP Import Certificates must be generated by the 
certified organic exporter's certifying agent, using the USDA's Organic 
Integrity Database. Only the Organic Integrity Database can be used to 
generate valid NOP Import Certificates, and only accredited organic 
certifying agents (USDA or under an organic trade arrangement or 
agreement) are authorized to use the Organic Integrity Database.
    Once the NOP Import Certificate is generated in the Organic 
Integrity Database, the exporter's certifying agent provides the NOP 
Import Certificate, or data set with the NOP Import Certificate number, 
back to the certified organic exporter who requested the NOP Import 
Certificate. The certified organic exporter then provides the NOP 
Import Certificate to the U.S. importer or buyer, who provides it to 
the specific entity responsible for entering import information into 
the ACE system. This is typically an importer or designated Customs 
broker. That importer or Customs broker enters the NOP Import 
Certificate data into the ACE system as part of its standard import 
filing processes, including the Entry Summary Process. Organic 
certifying agents will not have access to ACE; this activity is done by 
the importer or its Customs broker, using the NOP Import Certificate 
data provided by the certifying agent to the exporter.
    (Comment) Commenters asked how imported organic product would be 
identified in ACE without an organic

[[Page 3569]]

Harmonized Tariff Schedule (HTS) code.
    (Response) The NOP Import Certificate in ACE has been programmed to 
enable NOP Import Certificate entry for a wide range of products, 
including agricultural products and textiles, not just those with an 
organic HTS code. An organic HTS code is not required to upload NOP 
Import Certificate data into ACE.
Trade Arrangements and Agreements
    (Comment) AMS received comments requesting that foreign-based 
certifying agents operating under recognition arrangements be required 
to list organic operations in the Organic Integrity Database. As noted 
by commenters, the absence of that data makes it difficult for 
organizations to verify the certification status of foreign-certified 
operations.
    (Response) AMS is changing access to the Organic Integrity Database 
to include organic certifying agents and operations operating under 
organic trade arrangements or agreements, such as equivalency and 
recognition arrangements. Certified organic operations covered under 
trade arrangements or agreements will need to be listed in the Organic 
Integrity Database by their certifying agents for the certifying agents 
to be able to generate NOP Import Certificate for valid products 
entering the United States as organic.
    (Comment) We received comments asking how NOP Import Certificates 
would apply to trade of organic products under, and outside of, an 
equivalency arrangement. Additionally, commenters requested more 
information about how NOP Import Certificates would apply to NOP-
certified products traded between foreign countries.
    (Response) The NOP Organic Import Certificate is required for any 
product imported into the United States that is being manifested, sold, 
marketed, or labeled organic, regardless of the product's country of 
origin or if that country has an equivalency determination with USDA. 
Organic products imported from any country with which AMS has an 
equivalency determination must follow the same NOP Import Certificate 
requirements outlined in this rule. Other countries may also have their 
own unique filing requirements for organic products coming into their 
countries; organic businesses need to consult with their supply chains 
to determine those requirements.

C. Labeling of Nonretail Containers

    The table below includes the regulatory text related to this 
section of the rule. A discussion of the policy follows.

----------------------------------------------------------------------------------------------------------------
                       Section                                           Final regulatory text
----------------------------------------------------------------------------------------------------------------
205.307.............................................  Labeling of nonretail containers.
                                                      Paragraphs (a) through (c).
----------------------------------------------------------------------------------------------------------------

    Accurate labeling of non-retail containers used to ship or store 
organic products is critical to organic integrity. Proper labeling 
reduces misidentification and mishandling, facilitates traceability and 
product verification, reduces the potential for organic fraud, and 
allows accurate identification of organic product by customs officials 
and transportation agents.
    Therefore, this rulemaking requires that all nonretail container 
labels must identify contents as organic and include information 
linking the container to audit trail documentation. Additionally, audit 
trail documentation associated with a nonretail container must identify 
the last certified operation that handled the product. Affected 
entities may include but are not limited to: certified and noncertified 
operations that store and transport organic product in nonretail 
containers; certifying agents; and inspectors.
Background
    The organic regulations previously only required a production lot 
number on nonretail containers labels used to ship or store organic 
product. Other information--such as identification of the product as 
organic, and special handling instructions--were optional, but not 
required on nonretail container labels. Based on the NOP's experience 
enforcing the organic regulations, this lack of information created 
gaps in the organic chain of custody, complicated the verification of 
organic integrity, and increased the likelihood of organic fraud.
    To reduce the prevalence of organic fraud and increase oversight of 
organic supply chains, nonretail containers are now required to be 
marked with a statement identifying the product as organic and must 
include unique information that will link the nonretail containers to 
audit trail documentation. Unique identifying information could include 
lot numbers, shipping information, or a unique identifier for that 
shipment. Accurate labeling will identify contents as organic as a 
container moves through the supply chain; this will reduce mishandling 
and help maintain an audit trail and improve traceability.
Nonretail Containers: Description and Use
    Nonretail containers are defined under Sec.  205.2 of the USDA 
organic regulations as ``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 used to ship or store either 
packaged or unpackaged organic products, and may include the following:
     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.
    Nonretail containers are not used to display organic products for 
sale to the consumer at retail establishments. Packages that display 
organic products for retail sale to the consumer must be labeled 
according to Sec. Sec.  205.303 and 205.306.
What must be included on nonretail container labels?
    Nonretail containers used to ship or store organic products must be 
clearly labeled with a statement that identifies the product as 
organic. Clearly visible organic identification alerts handlers that 
the contents of the nonretail container may require special care, thus 
reducing accidental mishandling of the product, such as treatment with 
a prohibited substance or commingling with conventional product during 
transport and storage. Operations may use abbreviations or acronyms to 
identify products as organic, provided that they are clear and easily 
understood. This provides flexibility for

[[Page 3570]]

operations to meet the requirements of Sec.  205.307(a)(1) and makes it 
easier to label containers with limited space or containers that are 
difficult to label due to their size, shape, material, or use.
    Nonretail containers must also be clearly labeled with information 
that links the container to audit trail documentation (see Sec.  205.2 
for definition of audit trail). This could be a production lot number, 
shipping identification, or other unique information that handlers can 
use to trace the container to its associated audit trail documentation. 
This creates a clear link between container and audit trail and 
minimizes the size of labels by allowing some information to be listed 
in associated documentation, instead of directly on the nonretail 
container label.
    Operations may use temporary labels or signage to meet the 
requirements of Sec.  205.307(a). This provides additional flexibility 
for containers that may be difficult to label due to size, shape, 
material, or use.
    Revisions to Sec.  205.307 do not limit the information that can be 
on a nonretail label. This gives operations the flexibility to include 
details they deem critical to the integrity of specific products. For 
example, an operation may opt to include special handling instructions, 
the USDA organic seal for qualifying products, the operation or 
certifying agent name, or contact information on the nonretail label.
Nonretail Containers and Audit Trail Documentation
    Nonretail containers used to ship or store organic products must be 
labeled with information that links the container to audit trail 
documentation (Sec.  205.307(a)(2)). Such documentation must be 
sufficient to determine the source, transfer of ownership, and 
transportation of the product (see definition of audit trail in Sec.  
205.2) and must identify the last certified operation that handled the 
product (Sec.  205.307(b)).
    Listing the last certified organic operation provides a point of 
contact to verify the organic status of a product and supports 
operations' traceability, recordkeeping, and fraud prevention 
requirements (Sec. Sec.  205.103(b)(2)-(3) and 205.201(a)(3)). It also 
supports on-site inspections and supply chain traceability audits 
conducted by certifying agents (Sec. Sec.  205.403(d)(5) and 
205.501(a)(21)) by ensuring good recordkeeping of the critical 
transfers between certified operations.
Exception to Organic Identification on Nonretail Containers
    Nonretail containers used to ship or store agricultural products 
packaged for retail sale with organic identification visible on the 
retail label are not required to identify product as organic per Sec.  
205.307(a)(1). Examples include master cases and pallets where the 
organic identification (e.g., the USDA organic seal) of individual 
retail units is visible. These are exempt from Sec.  205.307(a)(1) 
because the organic identification is visible on the retail label.
    These types of nonretail containers are only excepted from the 
requirements of Sec.  205.307(a)(1). All nonretail containers must be 
linked or traceable to audit trail documentation per Sec.  
205.307(a)(2); this ensures traceability of the product in the 
containers and supports organic integrity during transport, storage, 
and handling.
Summary of Changes to the Final Rule
    AMS made several changes to the regulatory text of the SOE proposed 
rule when writing this final rule. Changes to the proposed rule are 
discussed below and are followed by specific themes from public 
comment.
     AMS simplified the requirement to list full organic 
identification (e.g., ``100 percent organic,'' or ``made with organic . 
. .'') to ``identification of product as organic,'' which provides more 
flexibility to operations and shortens the organic identification 
statement without changing the statement's intent or its utility as 
immediate and clear identification of nonretail containers. This change 
was made in response to public comment.
     AMS revised the requirement to list production lot numbers 
or shipping identification. This information is now used to link a 
container to audit trail documentation. To reduce administrative burden 
and cost to operations, AMS is only requiring the most critical 
information on nonretail container labels: organic identification and 
information that links the container to audit trail documentation. This 
maintains traceability and integrity by requiring nonretail containers 
to be linked to audit trail documentation, which must identify the last 
certified operation that handled the product and must be sufficient to 
determine the source, transfer of ownership, and transportation of the 
product.
     AMS removed the requirement to identify the product's 
certifying agent on nonretail labels because this information may be 
included in audit trail documentation linked to nonretail containers. 
Removing this requirement limits information on nonretail labels to the 
most critical information, thereby reducing cost and burden without 
sacrificing integrity.
     AMS added a requirement that audit trail documentation 
associated with a nonretail container must identify the last certified 
operation that handled the product. This allows operations to verify 
the source of organic products they receive and provides a record trail 
that certifying agents can use to conduct full supply chain 
traceability audits and verify organic status.
     The final rule no longer requires organic identification 
on nonretail containers of retail-labeled products. This avoids undue 
administrative burden, cost, and redundant information when organic 
identification is already visible on the products' retail labels.
     AMS removed the list of optional information that may be 
listed on nonretail container labels. This list is not necessary 
because operations may optionally include any additional information on 
nonretail labels if they wish.
Summary of Public Comment
    Public comments strongly supported mandatory organic identification 
on nonretail container labels. However, many comments requested the 
flexibility to use alternatives like abbreviations and common names. 
Commenters stated that the proposed rule's requirement to use specific 
(and sometimes lengthy) statements would add cost and be difficult to 
apply to containers with limited space. Commenters also requested that 
AMS require generic product names--e.g., ``organic tomatoes''--on 
labels, claiming that this information is needed to quickly identify 
the contents of nonretail containers.
    Other commenters requested AMS mandate additional information on 
large nonretail container labels to include country of origin, special 
handling instructions, and the USDA organic seal. Additionally, 
comments pointed out that nonretail labels should not be limited to the 
information explicitly listed in Sec.  205.307, and requested that NOP 
allow operations to include other types of information on labels.
Responses to Public Comment
    (Comment) We received comments requesting AMS require all nonretail 
containers display the information described in Sec.  205.307, 
regardless of size or type (i.e., not allow exceptions for large 
nonretail containers used for transport or storage). Additionally, 
commenters noted that there was no definition or description outlining 
what type of containers would be exempt from the labeling requirements.

[[Page 3571]]

    (Response) All nonretail containers of organic products must be 
labeled with information that links the container to audit trail 
documentation, regardless of size, shape, or use. This ensures 
information needed to verify and trace the product is available to 
those handling the product. Only nonretail containers used to ship or 
store agricultural products packaged for retail sale with organic 
identification visible on the retail label are excepted from the 
requirements of Sec.  205.307(a)(1).
    (Comment) Commenters requested the name and contact information of 
the certified operation be a mandatory field on all nonretail container 
labels because a certifying agent name alone is not sufficient to match 
a physical product to an organic certificate. Other commenters also 
requested that the operation's address or the NOP operation ID also be 
included.
    (Response) AMS is 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. Traceability and 
integrity are maintained by requiring nonretail containers be linked to 
audit trail documentation, which must identify the last certified 
operation that handled the product. Audit trail documentation must be 
sufficient to determine the source, transfer of ownership, and 
transportation of the product (see audit trail in Sec.  205.2).
    (Comment) We received comments requesting that listing the 
certifying agent be optional because it was redundant for master cases 
of retail-packaged product and added to the cost of the label.
    (Response) AMS does not require listing the certifying agent on 
nonretail container labels. Such information may be listed in audit 
trail documentation; operations may choose to do this to verify organic 
status of the product or determine the source, transfer of ownership, 
and transportation of the product. Section 205.307(c) excepts nonretail 
containers of retail-packaged products from listing organic 
identification if the retail packages clearly identify the product as 
organic.
    (Comment) AMS received comments noting both disagreement and 
confusion regarding which operation/certifying agent pair is required 
to be on the nonretail label. Commenters stated that the proposed 
revision (``producer of the product, or . . . the last handler that 
processed the product'') may not indicate the appropriate operation for 
verification purposes or in private labeling scenarios.
    (Response) Section 205.307(b) requires that a nonretail container's 
audit trail documentation identify the last certified operation that 
handled the product. The certifying agent that certified this handler 
may be listed in audit trail documentation; operations may choose to do 
this to verify organic status of the product or determine the source, 
transfer of ownership, and transportation of the product.
    (Comment) We received comments stating that special handling 
instructions are critical to the integrity of organic products in the 
supply chain and requested that AMS make this information mandatory on 
all labels. Commenters also inquired about what special handling 
instructions should include.
    (Response) We are not requiring special handling instructions on 
nonretail container labels; this reduces administrative burden and cost 
to operations without risking integrity. Operations may include special 
handling instructions (or other information) on nonretail containers if 
they deem it necessary.
    (Comment) AMS received comments requesting the mandatory use of 
tamper-evident seals on nonretail containers. Commenters argue that 
tamper-evident seals may help prevent fraud and mishandling of organic 
product.
    (Response) AMS is not requiring tamper-evident seals on nonretail 
containers; this avoids potential undue administrative burden and costs 
to operations. Operations may use tamper-evident seals on nonretail 
containers if they deem it necessary.

D. On-Site Inspections

    The table below includes the regulatory text related to this 
section of the rule. A discussion of the policy follows.

----------------------------------------------------------------------------------------------------------------
                       Section                                           Final regulatory text
----------------------------------------------------------------------------------------------------------------
205.2...............................................  Terms defined.
                                                      Definition for Unannounced inspection.
205.403.............................................  On-site inspections.
                                                      Paragraphs (b)(1) and (2) and (d)(4) and (5).
----------------------------------------------------------------------------------------------------------------

    On-site inspections of certified organic operations are a 
critically important tool used to verify an operation's compliance with 
the Act and the organic regulations. This rulemaking strengthens the 
utility of on-site inspections by requiring that certifying agents:
     Conduct a minimum number of unannounced inspections each 
year.
     Conduct mass-balance audits during on-site inspections.
     Verify traceability of product and ingredients within an 
operation during on-site inspections.
     Verify traceability of product in an operation's supply 
chain back to the last certified operation during on-site inspections.
    These requirements will strengthen organic integrity and supply 
chain traceability by requiring the use of proven best practices during 
inspection of organic production and handling. Entities affected by 
this policy may include certifying agents, certified operations, and 
operations applying for certification. Organic stakeholders should 
carefully examine the regulatory text and policy discussion below.
Unannounced Inspections--Background
    Unannounced inspections are an effective and useful tool to ensure 
compliance across certified operations and bolster consumer trust in 
the organic label. NOP previously issued an instruction (NOP 
Instruction 2609) on unannounced inspections, which recommends that 
certifying agents conduct unannounced inspections of five percent of 
their total certified operations per year as a tool for ensuring 
compliance with the regulations.\24\ This NOP instruction was supported 
by a recommendation made by the NOSB in December 2011.\25\ The organic 
regulations previously allowed for, but did not require, unannounced 
inspections, leaving this to the discretion of the certifying agent.

[[Page 3572]]

Therefore, AMS has codified the requirement for certifying agents to 
conduct a minimum number of unannounced inspections annually of 
certified operations.
---------------------------------------------------------------------------

    \24\ NOP 2609, Instruction, Unannounced Inspections. September 
12, 2012. Available in the NOP Program Handbook: https://www.ams.usda.gov/sites/default/files/media/2609.pdf.
    \25\ NOSB Recommendation, Unannounced Inspections. December 2, 
2011. Available on the AMS website: https://www.ams.usda.gov/sites/default/files/media/NOP%20CACC%20Final%20Rec%20on%20Unannounced%20Inspections.pdf.
---------------------------------------------------------------------------

Use of Unannounced Inspections
    To clarify the difference between unannounced inspections and full 
annual inspections, AMS is defining the term unannounced inspection as 
``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.'' \26\ Note that unannounced inspections are different 
from a full annual inspection because the scope of the inspection may 
be limited to a portion of the operation or the operation's activities, 
and certifying agents must conduct the inspection without advance 
notice.
---------------------------------------------------------------------------

    \26\ Compare to the definition of inspection at 7 CFR 205.2: The 
act of examining and evaluating the production or handling operation 
of an applicant for certification or certified operation to 
determine compliance with the Act and the regulations in this part.
---------------------------------------------------------------------------

Scope of Unannounced Inspections
    Relative to a full annual on-site inspection, an unannounced 
inspection may be limited in scope, depth, and breadth and may cover 
only a portion of the operation or the operation's activities, such as 
parcels, facilities, products, or a review of records. This allows 
unannounced inspections to be used as a risk-based tool to address 
specific needs, such as investigation of a complaint or high-risk area. 
Inspectors may conduct sampling during an unannounced inspection. 
Samples collected may count towards the number of samples a certifying 
agent must collect annually per Sec.  205.670(d) of the organic 
regulations. Sample collection alone, however, does not qualify as an 
unannounced inspection.
    When unannounced inspections are limited in scope, they are not 
required to follow the requirements of Sec.  205.403(c)(2), (d), or 
(e). This means unannounced inspections:
     May be conducted when an authorized representative of the 
operation is not present and the inspector is not trespassing.
     May be conducted at any time of year.
     Do not have to verify all areas or activities of the 
operation like a full, annual inspection.
     Do not have to include an exit interview with an 
authorized representative of the operation.
    An unannounced inspection may fulfill the requirement for a full 
annual on-site inspection, provided that the inspector meets all 
requirements for an annual on-site inspection per Sec.  205.403. This 
includes meeting the timing, scope, exit interview and documentation 
requirements for annual inspections. The exception is that the 
inspection would not be scheduled in advance with the operation's 
awareness. If an unannounced inspection will serve as the annual 
inspection, an authorized representative must be present.
Selecting Operations for Unannounced Inspections
    To maximize the effectiveness of unannounced inspections, 
certifying agents are encouraged to select operations from a range of 
different production and handling types, products, and locations. 
Operations may be selected randomly, by risk, in response to a 
complaint or investigation, or other criteria. The number of 
unannounced inspections to be conducted annually should be calculated 
by rounding up to the nearest whole number, so that certifying agents 
with very few certified operations (e.g., under 20 operations) are 
still required to conduct at least one unannounced inspection per year.
Planning and Scheduling Unannounced Inspections
    Unannounced inspections should be conducted without advance notice 
to the operation. However, some unannounced inspections may require 
advance notice (e.g., to ensure that portions of an operation are 
accessible or safe to access). Therefore, a certifying agent may notify 
an operation up to four hours prior to the inspector arriving onsite. 
As a best practice, certifying agents are encouraged to disclose their 
process for unannounced inspections, including a policy on inspector 
access to certified operations, and to train inspectors to prevent 
trespassing or breaking laws when accessing an operation. An 
operation's refusal to allow an inspector access to any portion of the 
operation is a violation of Sec.  205.403 and warrants a notification 
of noncompliance.
    Following an unannounced inspection, an inspection report must be 
written by the inspector and reviewed by the certifying agent. The 
results of the inspection must be communicated to the inspected 
operation per Sec.  205.403(f) and the certifying agent's internal 
protocols.
Certifying Agent Ability To Conduct Unannounced Inspections
    Certifying agents must be able to conduct unannounced inspections 
of any operation they certify. Therefore, AMS requires that certifying 
agents only accept applications for certification or continue 
certification from operations for which the certifying agent is able to 
conduct unannounced inspections. To ensure consistency, transparency, 
and accountability, certifying agents are expected to describe the 
areas where they operate in the written materials they provide to both 
applicants and certified operations, and review the locations of all 
operations during their application review or annual review.
    A certifying agent that cannot conduct unannounced inspections in 
an applicant's or certified operation's location due to logistical 
challenges, staffing, security, or other reasons, is considered to not 
have the administrative capacity for certification activities in that 
area, consistent with Sec.  205.501(a)(19). In this case, the 
certifying agent must document the specific reasons it does not have 
the administrative capacity to certify in that area, and must inform 
the applicant or certified operation to seek certification from another 
certifying agent. If new certification is not obtained, the operation's 
certification would be suspended/revoked. This process is similar to 
the current procedures used when a certifying agent surrenders its 
accreditation or is suspended/revoked.
    For additional information about unannounced inspections, 
certifying agents may refer to NOP Instruction 2609.
Mass-Balance and Traceability Audits During On-Site Inspections
    Traceability of organic products is critical to verification of 
organic integrity. Therefore, AMS requires that certifying agents 
verify quantities and traceability of organic products produced or 
handled by an operation through mass-balance and traceability audits. 
Audit tools are the premier methods to verify organic integrity. The 
importance of audits has increased because transaction certificates, 
which certifying agents relied upon in the past to verify the organic 
status of specific loads or sales or organic products, are neither 
required by the USDA organic regulations nor universally issued by 
certifying agents.
Mass-Balance Audits
    During on-site inspections, certifying agents must verify that the 
quantities of organic product and ingredients

[[Page 3573]]

produced or purchased by an operation accounts for organic products and 
ingredients used, stored, sold, or transported by the operation (Sec.  
205.403(d)(4)). Commonly known as a ``mass-balance'' or ``in-out'' 
audit, this verification is an effective method of detecting and 
discouraging organic fraud.
    Mass-balances may be performed on products that are produced on an 
operation, but then used or stored on-site and not sold (e.g., silage 
produced on-site as feed for dairy animals). Mass-balance covers 
quantities of agricultural products; other quantitative assessments 
such as dry matter intake and stocking rate verification are not mass-
balances. To conduct these mass-balance audits, certifying agents may 
choose a sub-set of products based on risk or other factors. With 
respect to multi-ingredient products, certifying agents may choose a 
single ingredient or multiple ingredients to mass-balance. When a 
single ingredient is selected, a best practice is to choose an 
ingredient that is high-risk or used in several products.
    Mass-balances do not replace the recommended best practice of also 
conducting yield analyses at producer operations. Yield analysis looks 
at whether harvested quantities are consistent with expected yields. 
This is an important tool to assess the potential for commingling of 
noncertified/nonorganic products with organic products.
Traceability Audits
    Successful traceability within organic supply chains requires three 
basic elements: (1) traceability within a single operation; (2) 
traceability one step back from an operation in a supply chain; and (3) 
traceability by a third party along an entire supply chain, source to 
consumer.
    Therefore, during all annual inspections certifying agents must 
verify the traceability of organic product both within an operation and 
verify traceability back to an operation's suppliers (Sec.  
205.403(d)(5)).\27\ This means that a certifying agent must verify that 
an operation can trace the products it produces or handles during the 
full time the operation possesses those products, from time of purchase 
or acquisition, through production, to sale or transport. This includes 
ingredients or products that the operation handles but may not own.
---------------------------------------------------------------------------

    \27\ The third traceability element, traceability along an 
entire supply chain, is addressed in 7 CFR 205.501(a)(21), and 
discussed in this rulemaking in Section P, Supply Chain Traceability 
and Organic Fraud Prevention.
---------------------------------------------------------------------------

    Additionally, certifying agents must verify the traceability of 
products from an operation's suppliers (Sec.  205.403(d)(5)). Because 
supply chains sometimes include operations that are not certified, 
certifying agents must verify compliance of organic products back to 
the last USDA-certified organic operation. Certifying agents may verify 
compliance back to the last certified operation by inspecting and 
verifying audit trail documentation and other records kept by the 
certified operation being inspected. This will ensure oversight of the 
critical linkages between certified operations and support full 
traceability and verification of organic products across supply chains.
    Certifying agents must also conduct supply traceability chain 
audits when circumstances meet criteria defined by the certifying agent 
(Sec. Sec.  205.501(a)(21) and 205.504(b)(7)). These audits would not 
be performed at every annual inspection.
Responses to Public Comment
Virtual/Remote Inspections
    (Comment) Several public comments noted that during the COVID-19 
pandemic, virtual inspections, or sometimes a hybrid of virtual an on-
site inspection, were temporarily used by certifying agents. Several 
comments asked if AMS intends to allow the use of virtual inspections 
for operations that have a demonstrated history of compliance or are at 
low risk of organic fraud.
    (Response) Virtual and/or remote inspections were not included in 
the SOE proposed rule and AMS is therefore not setting specific policy 
related to virtual or remote inspections. The final regulations provide 
flexibility so that AMS may consider virtual inspection policy options 
in the future.
Unannounced Inspections
    (Comment) Several comments asked AMS to increase the minimum number 
of operations that must receive unannounced inspections beyond the five 
percent AMS proposed.
    (Response) AMS is finalizing the proposed requirement that 
certifying agents must conduct unannounced inspections of at least five 
percent of the operations they certify. This is consistent with a 2011 
NOSB recommendation and a current NOP Instruction document. AMS chose 
this percentage because the majority of USDA-accredited certifying 
agents currently complete unannounced inspections at this 
frequency.\28\ Because most certifying agents are already completing 
unannounced inspections at this level, this percent should be tenable 
for certifying agents, regardless of size. To justify a higher 
percentage, AMS would require additional information, industry 
feedback, and data to assess the potential impact. Comments did not 
provide justification or data to support a higher inspection 
percentage. However, certifying agents may choose to conduct a higher 
percentage of unannounced inspections to supplement their oversight and 
enforcement of certified operations.
---------------------------------------------------------------------------

    \28\ 42 of the 49 USDA-accredited certifying agents the NOP 
audited in calendar years 2018 and 2019 completed unannounced 
inspections for 5% of the operations they certify.
---------------------------------------------------------------------------

    (Comment) Some public comments asked if AMS intends to publish 
criteria for initiating or using unannounced inspections.
    (Response) AMS is not adding criteria for using or initiating 
unannounced inspections to the regulations. Unannounced inspections may 
be triggered and selected by a variety of factors, including at random 
and in response to complaints or investigations. The regulations 
provide certifying agents flexibility to use unannounced inspections 
when and where they are most effective.
Mass-Balances
    (Comment) Several public comments asked if AMS is requiring one 
mass-balance per certification scope (i.e., crops, livestock, handling, 
wild crops) of an operation.
    (Response) The regulatory text provides certifying agents the 
flexibility to determine where such audits are most needed within a 
single inspection.
    (Comment) Some comments asked AMS if mass-balances should be 
performed for single-ingredient or multi-ingredient products, and if 
mass-balances for multi-ingredient products must balance all 
ingredients in the product.
    (Response) The final regulatory text provides certifying agents 
flexibility to perform mass-balance audits of both single- and multi-
ingredient products. For multi-ingredient products, the certifying 
agent may choose to mass-balance one or more of the ingredients.

E. Certificates of Organic Operation

    The table below includes the regulatory text related to this 
section of the rule. A discussion of the policy follows.

[[Page 3574]]



------------------------------------------------------------------------
                  Section                       Final regulatory text
------------------------------------------------------------------------
205.2.....................................  Terms defined.
                                            Definition for Organic
                                             Integrity Database.
205.404...................................  Granting certification.
                                            Paragraphs (b) and (c).
------------------------------------------------------------------------

    Certificates of organic operation are an important tool used by 
organic stakeholders to communicate information about certified 
operations. Certifying agents must generate certificates of organic 
operation electronically using the Organic Integrity Database. 
Standardized, electronic certificates maintained in a publicly 
accessible database will help to deter and prevent the use of 
fraudulent certificates of organic operation. This requirement also 
ensures that certificates of organic operation have consistent 
information and format, allowing certifying agents and buyers of 
organic products to readily validate certificates of organic operation. 
Certifying agents may add their unique addenda to certificates of 
organic operation to provide additional details about the certified 
operation.
    Affected entities may include certifying agents, applicants for 
USDA accreditation, certified operations and entities seeking to 
validate the certification status of an organic operation. Readers 
should carefully examine the regulatory text and discussion below to 
determine if they are affected by this action.
Background
    AMS accredits nearly 80 certifying agents; only a few currently 
create certificates of organic operation using the Organic Integrity 
Database. As a result, more than 70 distinct formats of certificates of 
organic operation exist in the market. This variation increases the 
likelihood of alteration and organic fraud. In addition, AMS 
consistently cites noncompliances for certifying agents who do not 
include all of the required information on their certificates of 
organic operation. Of the 49 USDA-accredited certifying agents audited 
by the NOP in calendar years 2018 and 2019, 16 were cited for issuing 
certificates of organic operation not consistent with USDA organic 
regulations and instruction. The use of a uniform certificate of 
organic operation generated through the Organic Integrity Database 
eliminates these inconsistencies and helps avoid noncompliances.
    The requirement for uniform certificates of organic operation 
supports OFPA's purpose to facilitate interstate commerce of organic 
foods (7 U.S.C. 6501(3)). This rulemaking also addresses a 2005 NOSB 
recommendation to standardize information on certificates of organic 
operation and require certifying agents to issue and maintain 
certificates of organic operation from a common database.\29\
---------------------------------------------------------------------------

    \29\ NOSB Recommendation: Information on Certificates of Organic 
Operation: https://www.ams.usda.gov/sites/default/files/media/NOSB%20Rec%20Standardize%20Organic%20Certifications%20Certificates.pdf.
---------------------------------------------------------------------------

Organic Integrity Database and Certificates of Organic Operation
    The certificate of organic operation communicates information about 
the organic certification of an operation. This rulemaking requires 
certifying agents to provide uniform certificates of organic operation 
that are electronically generated from the Organic Integrity Database.
    AMS defines the term Organic Integrity Database in Sec.  205.2 as 
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 its successors. The Organic 
Integrity Database may also be referred to as the OID or INTEGRITY. AMS 
is responsible for the functionality of the Organic Integrity Database 
and ensuring consistent content and styles of all certificates of 
organic operation. The general public can view information in the 
Organic Integrity Database online at: https://organic.ams.usda.gov/integrity/
Generating Certificates of Organic Operation in the Organic Integrity 
Database
    Section 205.404(b) requires certifying agents to generate 
certificates of organic operation in the Organic Integrity Database, 
making it easier for the certificates to be accessed online by relevant 
stakeholders in the organic supply chain (e.g., other certifying 
agents, inspectors). Section 205.501(a)(15) requires certifying agents 
to maintain current and accurate data on operations they certify in the 
Organic Integrity Database. Together, sections 205.404(b) and 
205.501(a)(15) require certifying agents to input and maintain accurate 
data on the operations they certify, and to generate certificates of 
organic operation using the Organic Integrity Database. This applies to 
all USDA-accredited certifying agents whether foreign- or domestic-
based.
    Certificates of organic operation generated in the Organic 
Integrity Database include the required information that stakeholders 
need to verify organic status of an operation. Users can also access 
the database to see if an operation's organic certification has been 
suspended, revoked, or surrendered. In addition to strengthening 
organic integrity, standardized certificate format and data fields 
facilitate and simplify verification of products, ingredients, and 
suppliers. The Operation Profile feature in the Organic Integrity 
Database also lists the generic products and services offered by an 
operation. The accessibility and security of this data will reduce 
administrative burden on certified operations that purchase organic 
products and ingredients, as well as certifying agents and inspectors 
who monitor compliance.
    Certifying agents can continue using the data submission template 
and the web-based form to upload the required data fields into the 
Organic Integrity Database. Additionally, certifying agents can 
transfer data from in-house databases to the Organic Integrity Database 
using an Application Programing Interface (API) to reduce duplicative 
data entry. AMS provides a data submission API guide for certifying 
agents on the Organic Integrity Database's User Resources page.
Addenda to Certificates of Organic Operation
    Some certifying agents use certificate addenda to supplement the 
information on certificates of organic operation with more details 
about an operation and the products it is certified to produce and/or 
handle. Certificate addenda may be generated and maintained in the 
Organic Integrity Database or by certifying agents' databases. The 
rulemaking allows certifying agents to continue providing their own 
certification addenda to communicate additional information about an 
operation's certification in a different format than certificates 
generated by the Organic Integrity Database. For example, an addendum 
may include information about an operation's certification to

[[Page 3575]]

various international organic standards or the brand names of products 
that the operation produces and/or handles that are not included on the 
certificate of organic operation. Certificate addenda may be issued 
only for a certified operation at an approved location(s).
    Section 205.404(c) requires five elements to be on any organic 
certificate addenda issued by certifying agents to deter organic fraud 
and provide consistency across certifying agents. Primarily, the 
addendum requirements are intended to ensure that someone viewing the 
document is aware that certification may be verified in the Organic 
Integrity Database. The accuracy of information on addenda, such as 
products and labeling categories, may also be verified in the Organic 
Integrity Database (see Operation Profiles). In summary, an addendum 
must identify the name, location, and contact information of the 
operation and certifying agent; an operation's unique operation ID from 
the Organic Integrity Database; addendum issue date; a link to the 
operation's certificate or profile in the Organic Integrity Database; 
and a statement citing the Organic Integrity Database for certificate 
verification. Certifying agents may include other data in addition to 
the mandatory elements on certificate addenda.
Summary of Changes to the Final Rule
    AMS revised Sec.  205.2 to replace the name of the proposed term 
``INTEGRITY'' with ``the Organic Integrity Database.'' Additionally, 
AMS did not include proposed Sec.  205.404(c)(6) which would have 
required expiration dates on certificate addenda. Many public comments 
noted that an addenda expiration date could cause confusion, as it 
could be mistakenly interpreted as expiration of an operation's 
certification. Organic certification does not expire; it continues 
until surrendered, suspended, or revoked--see Sec.  205.404(d). 
Further, several public comments noted that addenda expiration dates 
would increase workload for certifying agents, as they would need to 
update addenda expiration dates even if there are no other changes to a 
certificate of organic operation. AMS agrees with public comments and 
is not finalizing the requirement for addenda expiration dates. This 
will also encourage stakeholders to adopt the best practice of 
verifying certification status in the Organic Integrity Database, as 
this tool will include the most up-to-date operation and certification 
information (see Sec.  205.201(a)(15)).
Summary of Public Comments
    Comments generally supported requirements to including uniform 
information on certificates of organic operation, noting that this 
would reduce inconsistencies across the industry on what information is 
collected and maintained. Comments expressed concern about using the 
Organic Integrity Database to generate the certificate files and some 
argued that the proposed changes would instead hinder the process for 
certificate generation, rather than streamlining it. Some certifying 
agents noted that they would be more comfortable and efficient using 
their proprietary databases to generate certificate information and 
that using the Organic Integrity Database would be additional work to 
enter duplicative data. Comments requested a method for certifying 
agents to easily upload or transfer their existing data into the 
Organic Integrity Database, and to generate a certificate of organic 
operation. In addition, comments generally opposed including an 
expiration date on certificates of organic operation because a 
certificate expiration date could be conflated with an operation's 
certification status.
Responses to Public Comment
    (Comment) Comments requested that NOP change the name of the 
proposed term INTEGRITY to Organic Integrity Database. Commenters 
stated that referring to the database's nickname is not descriptive 
enough and could lead to confusion between the concept of organic 
integrity and the database.
    (Response) AMS has revised Sec.  205.2 to use the term Organic 
Integrity Database to reduce the possibility of stakeholder confusion 
by using the full name of the database.
    (Comment) Certifying agents stated that entering operation data 
into their own databases and the Organic Integrity Database is 
duplicative work and would be a financial and administrative burden 
because it will require administrative staff to update both databases. 
Commenters also expressed concern about whether the Organic Integrity 
Database would have the functionality and capacity to withstand the 
number of people who would need to access it regularly, if the Organic 
Integrity Database is also used to generate certificates of organic 
operation.
    (Response) AMS provides tools for uploading data (data submission 
template) and transferring data (via an API) into the Organic Integrity 
Database to reduce duplication. Please see the data submission API 
guide for certifying agents on the Organic Integrity Database's User 
Resources page. In addition, generating certificates pulls from the 
mandatory data that certifying agents must enter into the Organic 
Integrity Database to comply with Sec.  205.501(a)(15). Section 
205.501(a)(15) requires certifiers to enter data into the Organic 
Integrity Database and states certifying agents must ``Maintain current 
and accurate data in the Organic Integrity Database for each operation 
which it certifies.'' Certificate generation does not require 
additional data. AMS is prepared for the increased usage of the Organic 
Integrity Database as a result of the rulemaking and will offer 
outreach to certifying agents to support technology integration.
    (Comment) AMS received comments requesting clarification on whether 
the rule requires operations to receive certificates of organic 
operation electronically--noting that many operations prefer (or can 
only receive) paper certificates.
    (Response) Section 205.404(b) states that an organic certificate 
may be provided to operations electronically--however, this step occurs 
after a certificate has been generated electronically and does not 
affect how a certifying agent transmits certificates to an operation. 
Anyone may print a certificate from the Organic Integrity Database as 
needed.

F. Continuation of Certification

    The table below includes the regulatory text related to this 
section of the rule. A discussion of the policy follows.

----------------------------------------------------------------------------------------------------------------
                       Section                                           Final regulatory text
----------------------------------------------------------------------------------------------------------------
205.406.............................................  Continuation of certification.
                                                      Paragraphs (a) and (b).
----------------------------------------------------------------------------------------------------------------

    AMS has amended Sec.  205.406 to clarify the annual update 
requirements for organic system plans (OSP) and to specify that 
certifying agents are required to conduct inspections of operations 
they certify at least once per

[[Page 3576]]

calendar year. These changes maintain requirements for certified 
operations to provide certifying agents with updated and accurate 
information about their organic activities while eliminating 
duplicative work, and will strengthen oversight of organic operations 
through regular and timely inspection. Affected entities may include, 
but are not limited to certifying agents, certified organic operations, 
and operations seeking organic certification. You should carefully 
examine the regulatory text to determine if you or your organization 
may be affected by this action.
Annual Updates of Organic System Plans
    Previously, the organic regulations required certified operations 
to submit an updated OSP in its entirety as part of annual 
certification renewal. Certifying agents implemented this 
inconsistently: some required certified operations submit an entire OSP 
every year, while others required operations only to submit revisions 
to their OSP. To clarify OSP requirements, this rulemaking revises 
Sec.  205.406(a) to allow certified organic operations to only submit 
sections of its OSP that have changed to its certifying agent.
    Additionally, the rulemaking removes previous paragraph Sec.  
205.406(a)(3), which required that certified operations provide, along 
with its annual update, an update on the correction of minor 
noncompliances previously identified by the certifying agent as 
requiring correction for continued certification. This requirement was 
duplicative and unnecessary, as certifying agents (when issuing a 
notice of noncompliance) must specify a date by which a certified 
operation must rebut or correct noncompliances (Sec. Sec.  
205.662(a)(3) and 205.404(a)). Removal of this requirement reduces 
paperwork, simplifies the certification process, and ensures that 
noncompliances are resolved according to the deadline in the notice, 
rather than waiting until the next certification cycle.
    The NOP previously described this approach in published certifying 
agent Instructions (NOP 2615 and NOP 2601).\30\ This change is 
necessary to ensure legal enforceability, consistent practices between 
certifying agents, and reduce the paperwork burden of organic 
certification. This will not impact the requirements for certified 
operations to maintain an updated OSP or the requirement for an 
operation to notify its certifying agent of operational changes that 
may affect its compliance with organic regulations (Sec.  205.400(f)). 
Further, the on-site inspection of an organic operation must verify 
that the entire OSP is implemented as described.
---------------------------------------------------------------------------

    \30\ NOP 2601 The Organic Certification Process, December 16, 
2013: https://www.ams.usda.gov/sites/default/files/media/2601.pdf; 
NOP 2615 Organic System Plans, Organic System Plan Updates, and 
Notification of Changes, December 16, 2013: https://www.ams.usda.gov/sites/default/files/media/2615.pdf.
---------------------------------------------------------------------------

Frequency and Scheduling for Annual Inspections
    Annual inspection cycles are essential to vigilant oversight of 
organic operations. Inconsistent interpretation of previous Sec.  
205.406 regarding inspection timing sometimes resulted in inspection 
frequencies longer than the annual timeframe specified in OFPA (7 
U.S.C. 6506(a)(5)). For example, former Sec.  205.406(b) was sometimes 
interpreted to mean that an operation may be inspected once every 18 
months on an ongoing basis (i.e., two inspections over a 36-month 
period compared to three inspections if conducted annually). To clarify 
frequency of on-site inspection, this rulemaking revises Sec.  
205.406(b) to simplify the regulatory text and clearly state that 
inspections are to be conducted at least once per calendar year.
    Revised paragraph (b) clarifies that all certified operations must 
be inspected at least once in a calendar year, regardless of (1) when 
the certified operation was last inspected and (2) when, or if, the 
certified operation provided its annual updates. This revision allows 
certifying agents flexibility to conduct on-site inspections at any 
time during the year (essential for verifying activities throughout the 
growing season, for example) to ensure that an inspection is conducted 
every single calendar year. Additional inspections may be needed to 
inspect all portions of an operation to assess full compliance of an 
operation (e.g., during and outside the grazing season for livestock 
operations). This requirement does not replace the need for additional 
unannounced inspections.
Summary of Changes to the Final Rule
    AMS did not make any revisions to the proposed regulatory text. The 
policy continues unchanged in this final rule.
Summary of Public Comment
    Public comments largely supported changes made in the proposed 
rule, citing support for reduced paperwork, increased flexibility, and 
clear enforceability to uphold organic integrity. Some comments 
questioned the need for the proposed changes, citing that the work of 
updating an entire OSP is not significantly greater than updating 
portions of it.
    Several comments supported revisions to section 205.406(b), which 
now requires certifying agents to conduct on-site inspection once per 
calendar year. However, commenters requested additional flexibility 
regarding annual inspections requirements in the face of extreme 
circumstances that may render an in-person inspection unsafe or 
unfeasible for the inspector or operation. These comments cite the 
COVID-19 pandemic as an example.
    Other comments were generally in support of the flexibility that 
the revisions provide, particularly allowing inspections to occur when 
seasonally appropriate (and potentially reducing certifying agents' 
need to request additional inspections). However, a few commenters 
noted that the calendar year restriction may cause inspections to occur 
one closely after another, depending on the type of operation and 
harvest timeline.

Responses to Public Comment

    (Comment) AMS received comments stating that the revisions to OSP 
submission requirements could lead to inconsistent information across 
certifying agent databases and the Organic Integrity Database.
    (Response) All certifying agents are now required to maintain 
updated information on operations they certify in the Organic Integrity 
Database. This requirement will eliminate inconsistencies.
    (Comment) Comments asked if certifying agents can still request 
full updated OSPs from operations they certify, should the certifying 
agent deem the proposed changes significant.
    (Response) The rulemaking does not change or limit the ability of 
certifying agents to request information, including a full OSP, that is 
needed to determine an operation's compliance with the organic 
regulations. Paragraph 205.406(a)(4) of the regulations requires 
operations to provide certifying agents information that they deem 
necessary to determine compliance with organic regulations.
    (Comment) We received comments requesting more flexibility 
regarding annual inspections (e.g., allowing the issuance of temporary 
variances, or allowing for virtual inspections) in the face of extreme 
circumstances that may render an in-person inspection unsafe or 
unfeasible for the inspector or operation.
    (Response) AMS acknowledges that extreme circumstances may prevent 
a certifying agent from completing an on-site inspection once per 
calendar year. In such cases, the certifying agent may

[[Page 3577]]

delay inspection, but the delay should be minimized and explained in 
the certifying agent's inspection report and records. A certifying 
agent's inability to consistently inspect operations annually due to 
access, safety, extreme weather, or other issues is a failure to carry 
out inspection requirements and does not fulfill the general 
requirements for accreditation (Sec.  205.501(a)(3)). When the 
certifying agent is unable to provide adequate oversight and 
enforcement, the certifying agent should not continue to certify the 
operation.
    (Comment) AMS received comments proposing an inspection window 
anywhere between 7 and 17 months apart rather than 18 months, thus 
allowing inspectors to conduct inspections when seasonally appropriate.
    (Response) The rulemaking establishes a minimum frequency for on-
site inspections--at least once per calendar year--to ensure all 
certified operations meet OFPA's requirement for annual inspection. If 
the certifying agent is unable to complete a full inspection during a 
time when land, facilities, and activities that demonstrate compliance 
can be observed (see Sec.  205.403(c)(2)), then the certifying agent 
may conduct additional on-site inspections, as allowed in Sec.  
205.403(a)(3)(i), to cover unobserved portions and ensure compliance 
with Sec.  205.403.

G. Paperwork Submissions to the Administrator

    The table below includes the regulatory text related to this 
section of the rule. A discussion of the policy follows.

----------------------------------------------------------------------------------------------------------------
                       Section                                           Final regulatory text
----------------------------------------------------------------------------------------------------------------
205.501.............................................  General requirements for accreditation.
                                                      Paragraph (a)(15).
----------------------------------------------------------------------------------------------------------------

    Accurate and current information about certified operations is 
critical for commerce and oversight in the organic sector. This 
rulemaking supports accessible and updated data on organic operations 
by requiring certifying agents to maintain current data on all 
operations they certify in the Organic Integrity Database. Certifying 
agents and certified operations may be affected by these requirements. 
Readers should carefully review the regulations and policy discussion 
to determine whether they must comply.
Background
    The organic industry, including certifying agents, certified 
operations, consumers, AMS, and other regulatory agencies use the 
Organic Integrity Database to confirm the certification status of 
operations, organic status of products, find contact or product 
information for specific operations, and obtain data points for 
investigation and enforcement actions. Timely updates to maintain data 
on an operation's current status, including certified products and 
acreage, is necessary for efficient business transactions and informed 
oversight. The availability of operation data also reduces the time 
spent by certifying agents and by AMS responding to inquiries about 
specific operations because interested parties can independently access 
the information they need.
Mandatory Reporting in Organic Integrity Database
    Certifying agents are required to provide and maintain current 
mandatory data on operations in the Organic Integrity Database. The 
required data fields are listed in the INTEGRITY Data Dictionary and 
defined in the Glossary of Terms which can be accessed at https://organic.ams.usda.gov/Integrity/About.aspx. Some of the data in the 
Organic Integrity Database is publicly accessible. Examples of 
mandatory, public data fields include: certification status, scope(s) 
of certification (e.g., crops, livestock, handling, wild-crop), and the 
organic commodities produced or handled by the operation. This 
information is essential for certifying agents and operations to verify 
the organic status of operations and products and supports efficient 
business transactions. Organic acreage is an example of mandatory data 
that will not be publicly available in the Organic Integrity Database.
Update Frequency
    Certifying agents are to establish processes for updating data in 
the Organic Integrity Database in a manner that keeps information 
current about their certified operations. This is needed to support the 
industry's reliance on the Organic Integrity Database for current and 
accurate information about individual operations. Certifying agents are 
required in Sec.  205.662(e)(3) to update the Organic Integrity 
Database within 72 hours of an operation's suspension, revocation or 
surrender of certification.
    This rule removes the requirement for certifying agents to provide 
notices of denial of certification to the Administrator following the 
issuance of a notice of noncompliance to an applicant for certification 
(formerly Sec.  205.405(c)). In addition, the rule removes the 
requirement for submission of any notices of denial of certification, 
notifications of noncompliance, notification of noncompliance 
correction, notification of proposed suspension or revocation, or 
notification of suspension or revocation (formerly Sec.  
205.501(a)(15)(i)). Also, the rule removes the annual requirement for 
certifying agents to submit, by January 2, an annual list of operations 
certified during the preceding year (formerly Sec.  
205.501(a)(15)(ii)). Certifying agents' adherence to noncompliance 
procedures in the regulations are evaluated during NOP audits, review 
of appeal cases and relevant complaints. The requirement for certifying 
agents to list operations in the Organic Integrity Database and their 
corresponding certification status makes the paperwork submission 
requirements unnecessary.
Summary of Changes to the Final Rule
    AMS renamed the term INTEGRITY in Sec.  205.501(a)(15) to the 
Organic Integrity Database.
Summary of Public Comment
    Comments were largely in support of the proposed revisions, citing 
that the changes remove an unnecessary and redundant step from 
certifying agents' day-to-day operations. Commenters also noted that 
codifying global use of the Organic Integrity Database and maintaining 
``accurate and current'' data are both critical to ensuring organic 
integrity. Commenters noted that the regulatory text does not explain 
how often certifying agents should update operation data.
Responses to Public Comment
    (Comment) Comments requested that AMS require certifying agents to 
upload and maintain data in the Organic Integrity Database on 
operations that are no longer certified, were denied certification, or 
withdrew certification with adverse actions on record.
    (Response) The Organic Integrity Database can identify applicants 
for certification that were denied or

[[Page 3578]]

withdrew from certification. AMS encourages certifying agents to enter 
those operations into the Organic Integrity Database, however, this is 
not a required reporting element. The Organic Integrity Database 
includes all operations which are no longer certified because they are 
suspended, revoked, or surrendered.
    (Comment) Comments noted that the rule does not describe the data 
fields that certifying agents are required to complete in the Organic 
Integrity Database.
    (Response) The Data Dictionary provides a list of all data fields 
for the Organic Integrity Database (https://organic.ams.usda.gov/Integrity/About.aspx). The Data Dictionary will be updated upon 
implementation of this rulemaking to make all current fields mandatory. 
AMS may add more mandatory fields in the future based on industry and 
NOP needs.
    (Comment) Comments requested that certifying agents be required to 
update the Organic Integrity Database within 72 hours of any changes to 
crops, products, acreage, or certification status.
    (Response) The rule does not require certifying agents to update 
all required data fields within a certain timeframe, as certifiers need 
flexibility to create their own systems for updating and maintaining 
current data in the Organic Integrity Database. However, AMS does 
require certifying agents to update certain data fields within a 
specified timeframe. For example, Sec.  205.662(e)(3) requires 
certifying agents to update the Organic Integrity Database with changes 
to an operations certification status within 3 business days. The Data 
Quality Minimum Standards and Best Practices provides recommendations 
for the minimum frequency to update specific data fields in the Organic 
Integrity Database.\31\
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    \31\ Available in the Organic Integrity Database: https://organic.ams.usda.gov/integrity/About.aspx.
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H. Personnel Training and Qualifications

    The table below includes the regulatory text related to this 
section of the rule. A discussion of the policy follows.

----------------------------------------------------------------------------------------------------------------
                       Section                                           Final regulatory text
----------------------------------------------------------------------------------------------------------------
205.2...............................................  Terms defined.
                                                      Definition for Certification review.
205.501.............................................  General requirements for accreditation.
                                                      Paragraphs (a)(4), (5), and (6).
----------------------------------------------------------------------------------------------------------------

    The USDA organic regulations require that certifying agents use a 
sufficient number of trained and qualified inspectors and certification 
review personnel with expertise in organic production and handling. 
This rulemaking enhances existing requirements with detail about the 
qualifications that organic inspectors and certification reviewers must 
have in order to work for certifying agents. By clarifying the 
necessary technical skills, qualifications, and knowledge needed to 
conduct organic inspections and certification review, AMS ensures that 
inspectors and certification reviewers are better prepared to verify 
organic compliance, which further strengthens organic integrity across 
all levels of the supply chain and upholds confidence in the organic 
label among consumers.
    The rule adds new requirements for certifying agents, inspectors, 
and certification personnel:
     Certifying agents must verify that all inspectors and 
certification personnel they contract with or hire have the minimum 
required training, skills, and knowledge.
     Inspectors and certification personnel must meet a minimum 
baseline of knowledge, skills, and experience before beginning 
inspection or certification review activities.
     Inspectors and certification personnel must meet annual 
training requirements to continue inspection or certification review 
activities.
     Certifying agents must conduct periodic observations of 
inspectors during inspections (``witness inspections'') as a part of 
their annual evaluation activities.
     Certifying agents must maintain policies, procedures, and 
records regarding inspector and certification review personnel training 
and evaluation.
    The provisions in this chapter affect current and potential organic 
inspectors, certification review personnel, and certifying agents who 
employ or contract with inspectors or certification review personnel. 
Some provisions apply directly to certifying agents' hiring and 
evaluation processes. Others clarify the amount of training inspectors 
are required to do to maintain compliance to the organic regulations. 
The following discussion provides further detail on the provisions and 
AMS's responses to comments received on the proposed rule.
Background
    To continue certification, a certified organic operation must 
undergo an on-site inspection at least once a year. Organic inspectors 
visit certified organic operations to thoroughly investigate the 
operation's processes, facilities, and records. Inspections vary by 
type and complexity of operation, but generally an inspector will 
review fields to investigate pest management, soil fertility 
management, buffer zones, and other production techniques; inspect 
storage and preparation areas for evidence of commingling or 
contamination with substances prohibited in organic; review records and 
invoices; conduct mass-balance, traceability, and yield analyses; and 
interview a representative of the operation. The inspector may also 
collect samples to test for pesticide residues. The inspector then 
prepares an inspection report that the certifying agent uses to 
evaluate the operation's compliance with the organic regulations. In 
addition to regular, once-a-year scheduled inspections, organic 
inspectors also conduct unannounced inspections, which are conducted 
without advance notice and are often used to target a more limited, but 
higher-risk, portion of an operation to ensure compliance (see the 
``On-Site Inspections'' portion of this rule for more detail).
    Organic inspectors and review staff are therefore the most direct 
form of enforcement and verification because they inspect certified 
organic operations onsite and report their findings to certifying 
agents. Persons performing certification review activities also ensure 
organic integrity by reviewing these inspection reports along with 
organic system plans, inputs, and other certification documents that 
are used to determine compliance with the organic regulations and grant 
continued certification. The role as inspectors and

[[Page 3579]]

reviewers has only grown more critical as organic operations and supply 
chains become more complex and diverse.
    Inspection and certification review are complex professions that 
require detailed and highly specialized knowledge of organic regulation 
and agricultural practices and strong observation, communication, and 
investigation skills. Without highly qualified inspectors and 
certification review personnel, loss of organic integrity--either 
unintentional or fraudulent--would go unnoticed and the organic 
certification system would fail. Therefore, these personnel must adhere 
to consistent standards of knowledge, skill, and experience, relevant 
to the scope and complexity of the organic operations they inspect and 
review. Consistent standards will ensure effective oversight and review 
of organic operations, catching and preventing mishandling and fraud at 
critical points in the organic supply chain.
    The rapidly increased complexity and scale of the organic market 
has multiplied opportunities for mishandling of organic products and 
fraud, especially as supply chains for organic products increasingly 
depend on imported goods. In its February 2018 recommendation, the NOSB 
referenced ``well-publicized incidents of proven fraudulent imports in 
the last year'' as a compelling reason to ensure the industry has 
``qualified inspectors experienced in a broad range of operations 
diverse in scope and scale.'' \32\ For example, a May 2017 Washington 
Post investigation found that millions of pounds of imported corn, 
soybeans, and ginger had been fraudulently labeled organic, and 
inconsistent inspection practices were partly to blame.\33\ 
Additionally, public comments from accredited certifying agents and 
organic inspector associations agreed that minimum training and 
qualification requirements for inspectors are necessary to detect 
breach of organic integrity and fraud. AMS recognizes that in a diverse 
market where operations can choose their own certifiers, one critical 
element of protecting organic integrity and preventing fraud is 
ensuring that all organic inspectors and reviewers are held to the same 
high standards of training and experience.
---------------------------------------------------------------------------

    \32\ NOSB Formal Recommendation, Inspector Qualifications and 
Training, May 29, 2018: https://www.ams.usda.gov/sites/default/files/media/CACSInspectorQualificationsRec.pdf.
    \33\ Peter Whoriskey, ``The labels said `organic.' But these 
massive imports of corn and soybeans weren't.'' Washington Post. May 
12, 2017. https://www.washingtonpost.com/business/economy/the-labels-said-organic-but-these-massive-imports-of-corn-and-soybeans-werent/2017/05/12/6d165984-2b76-11e7-a616-d7c8a68c1a66_story.html?utm_term=.97e7f3942427&itid=lk_inline_manual_
7.
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    The regulations previously lacked specific detail about 
qualifications, experience, and continual training for inspectors and 
certification reviewers. Certifying agents currently set their own 
policies and minimum qualifications to hire inspectors and reviewers, 
creating inconsistency in on-site inspection and certification review. 
Further, many inspectors are independent contractors who are 
responsible for establishing and maintaining their own knowledge base. 
This diversity of background and training creates an inconsistent 
baseline of knowledge and skill.
    In 2012, NOP issued a memo to clarify that all inspectors and 
reviewers, whether staff or independent contractors, must possess the 
expertise and qualifications needed to evaluate compliance with the 
USDA organic standards.\34\ Additionally, the NOSB provided 
recommendations in 2018 to address the need for specific qualification 
and training requirements for inspectors and persons performing 
certification review.\35\ This rulemaking codifies the general policy 
in the 2012 memo and addresses the NOSB recommendations by describing 
baseline qualifications for certifying agent personnel.
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    \34\ NOP Memo: Criteria and Qualifications for Organic 
Inspectors; April 2012: https://www.ams.usda.gov/sites/default/files/media/NOP-Notice-OrganicInspectorCriteria.pdf.
    \35\ NOSB Formal Recommendation, Inspector Qualifications and 
Training, May 29, 2018: https://www.ams.usda.gov/sites/default/files/media/CACSInspectorQualificationsRec.pdf.
---------------------------------------------------------------------------

    To clarify the portions of this policy that apply to certification 
review personnel, AMS defines the term certification review as ``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.'' The term does not encompass performing an 
inspection, which is separately defined in Sec.  205.2.\36\ Examples of 
certification review includes reviewing applications for certification, 
reviewing certification documents, evaluating qualifications for 
certification, making recommendations concerning certification, or 
making certification decisions and implementing measures to correct any 
deficiencies in certification services. Establishing baseline 
qualifications for the personnel conducting these activities will lead 
to greater consistency in certification review and decision.
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    \36\ Sec.  205.2 Inspection. The act of examining and evaluating 
the production or handling operation of an applicant for 
certification or certified operation to determine compliance with 
the Act and the regulations in this part.
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General Requirements
    Section 205.501(a)(4) requires that certifying agents 
``continuously use a sufficient number of qualified and adequately 
trained personnel'' to implement and comply with the organic 
regulations. Certifying agents must maintain adequate staffing levels 
and the range of expertise needed to perform the full range of 
certification activities, including inspection and certification 
review. This includes maintaining an inspection staff to timely 
complete initial on-site inspections, annual inspections for all 
operations it certifies, unannounced inspections on a minimum of 5 
percent of the operations it certifies annually (see Sec.  205.403(b)), 
and any other inspections needed to ensure compliance with the 
regulations.
    Certifying agents sometimes use contracted or volunteer personnel 
(i.e., persons not directly employed by the certifying agent) to 
inspect operations or complete certification review. Therefore, 
certifying agents must ensure that all inspectors and certification 
review personnel--including staff, contractors, and volunteers--meet 
the requirements of Sec.  205.501(a)(4)-(6). This means that any person 
performing inspection or certification review activities must meet 
these requirements, regardless of their work or contractual 
relationship with the certifying agent. This ensures consistent 
inspection and certification review by all certifying agents.
Knowledge, Skill, and Expertise
    Certifying agents must demonstrate that all personnel they use to 
conduct inspection and certification review continuously maintain 
knowledge and skills that qualify them to perform duties as assigned 
(Sec.  205.501(a)(4)(i)(A) and (a)(4)(ii)(A)). These paragraphs detail 
the minimum knowledge and skills that inspectors and certification 
reviewers must have. Because inspectors and certification reviewers 
perform different functions, each must meet different baseline 
criteria, although there is some overlap, such as knowledge and skill 
of the organic regulations, traceability audits, and mass-balance 
audits. Certifying agents must demonstrate, as part of their 
accreditation process, that any inspectors or certification reviewers 
they use have sufficient knowledge in organic standards and practices 
to successfully understand, verify, and document an operation's 
compliance or noncompliance with the organic regulations.

[[Page 3580]]

    The requirements in the rulemaking are based on NOSB 
recommendations, public comments, and the NOP's own experience auditing 
certifying agents. AMS chose these specific skills because they are 
essential to inspection and certification review. These requirements 
will ensure that inspectors and certification review personnel can 
accurately interpret the regulations and standards, and consistently 
apply critical skills when inspecting and assessing compliance. This 
will address the current regulation's lack of specific qualifications, 
experience, and continual training for inspectors and reviewers.
    Certifying agents must also demonstrate the expertise of all 
personnel they use to conduct inspection and certification review 
(Sec.  205.501(a)(5)). Critically, this means all inspection and review 
personnel must have expertise in knowledge of certification to the USDA 
organic standards. Certifying agents must also demonstrate their 
personnel must have education, training, or professional experience in 
the fields of agriculture, science, or organic production and handling 
that relates to assigned duties. This requirement to demonstrate 
expertise will facilitate more robust accreditation audits of 
certifying agents and ensure more consistent oversight of certifying 
agents. Together with the above knowledge and skills, this requirement 
to maintain adequate expertise will also promote development of a 
uniform, high-quality base of organic inspectors and certification 
reviewers.
Training
    Organic inspectors and certification reviewers must complete 
regular training relevant to their duties. Training may include 
courses, webinars, training sessions, field days, seminars, 
conferences, shadowing other inspectors on their inspections, and 
directed readings on relevant topics. Certifying agents may determine 
if specific trainings fulfill the requirements. Relevant training 
courses available on the Organic Integrity Learning Center (OILC) may 
also meet the annual training requirements. When the minimum training 
hours are completed, certifying agents must still ensure that each 
inspector and certification reviewer has the training that is 
sufficient to competently perform assigned inspections or duties.
    Sections 205.501(a)(4)(i)(B) and 205.501(a)(4)(ii)(B) require 
inspectors and certification review personnel with less than one year 
of experience to complete at least 50 hours of training on USDA organic 
standards, inspection protocols, and organic production and handling 
practices. This requirement will help ensure new inspectors and 
certification review personnel are adequately prepared for their 
duties. The proposed rule had included a lower number of hours across 
all staff, new and experienced. Commenters suggested that less-
experienced staff require more hours of training than existing staff. 
AMS agrees with public comments and has raised the initial training 
requirement for less-experienced staff to 50 hours, which is a 
reasonable balance that aligns with industry best practice and will 
ensure staff are adequately prepared to perform inspection and 
certification duties.
    Onboarding for new inspectors or certification reviewers hired by 
certifying agents may count towards the 50-hour requirement, as can 
other qualifying training they complete in their first year performing 
inspection or certification review duties. Any onboarding that counts 
towards the training would need to be technical rather than 
administrative to qualify as relevant training. New inspectors must 
complete the 50 hours of training, at minimum, before they conduct 
inspections independently. This allows new inspectors to gain practical 
training through shadow inspections. Training requirements apply 
equally to inspectors who are hired as employees and contractors of 
certifying agents; initial training received must sufficiently address 
the scope and complexity of work these personnel encounter when 
performing their duties.
    Sections 205.501(a)(4)(i)(B) and 205.501(a)(4)(ii)(B) detail 
training requirements for inspectors and certification reviewers with 
more than one year of experience. Inspectors and certification 
reviewers must complete relevant ongoing training appropriate to their 
existing skills, expertise, and scope of work. The annual minimum is 10 
hours per year for personnel inspecting or reviewing one area of 
operation (i.e., crops, wild crops, livestock, and handling). Five 
additional hours of annual training are required for each additional 
scope or area of operation. For example, an inspector who only inspects 
crop operations (i.e., a single area of operation) must complete at 
least 10 hours of annual training; an inspector who inspects crop, 
livestock, and wild crop operations (i.e., three areas of operation) 
must complete at least 20 hours of training annually. Because there are 
four scopes of certification in the USDA organic regulation (crops, 
livestock, handling, and wild crops), the maximum number of training 
hours an inspector would be required to complete annually would be 25 
hours (10 hours of training for the first scope of certification, plus 
5 hours for each of the additional 3 scopes of certification).
    AMS chose these training requirements based on review of public 
comment and review of established industry norms. AMS agrees with 
public comments that new inspectors will require more robust initial 
training and certifying agent personnel may require more or less annual 
training depending on how many areas of operation they inspect or 
review. Therefore, relative to the proposed rule, AMS is requiring 50 
hours of training for new personnel, and 10 hours plus 5 hours per 
additional area of operation for more experienced inspectors.
    AMS chose the 50-hour requirement for new inspectors because it 
aligns with industry best practice. Some certifying agents commented 
that the proposed 20-hour requirement for new inspectors was adequate, 
while others maintained that 75-100 hours was necessary; 50 hours is a 
median within that range. The 50-hour requirement also aligns closely 
with the Accredited Certifier's Association's ``Guidance on Organic 
Inspector Qualifications,'' which recommends initial inspector training 
that totals 43-46 hours plus several mentored inspections and monitored 
reports.\37\ Finally, many certifying agents currently require new 
inspectors to complete the International Organic Inspector 
Association's (IOIA) basic training, a 5-day course requiring 
approximately 40 hours to complete,\38\ plus additional field 
observation and training that together total to 50 hours of training.
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    \37\ ``Guidance on Organic Inspector Qualifications,'' 
Accredited Certifiers Association, Inc., February, 2018, https://www.accreditedcertifiers.org/wp-content/uploads/2018/02/ACA-Guidance-on-Inspector-Qualifications-with-IOIA-Evaluation-Checklist.pdf.
    \38\ IOIA Basic Training: https://www.ioia.net/training-program-overview/.
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    AMS chose an annual training requirement of 10 hours plus 5 hours 
per additional scope for more experienced inspectors because it is 
consistent with standards established by other agencies or 
organizations (e.g., Preventive Controls Qualified Individuals per 2011 
Food Safety Modernization Act, ISO 9001 Global Certified Lead Auditor), 
and because it increases flexibility by allowing more or less total 
annual training hours based on the areas of operations inspected or 
reviewed. These requirements will ensure that inspectors and reviewers 
receive annual training that is

[[Page 3581]]

appropriate for the level and scope of their duties.
    In certain cases, certifying agents may not be able to prescribe 
specific training to contracted inspectors or certification review 
personnel. However, certifying agents must use a sufficient number of 
qualified and trained personnel (Sec.  205.501(a)(4)) and demonstrate 
that all persons with inspection and certification review 
responsibilities have expertise in organic production and handling 
(Sec.  205.501(a)(5). This means that certifying agents must ensure any 
contractor used to conduct inspection or certification review 
activities meets the training requirements described in the regulation.
Experience
    In addition to training, Sec.  205.501(a)(4)(i)(C) requires that 
certifying agents demonstrate that the inspectors they use have 
experience that prepares them to conduct their assigned duties. 
Certifying agents must demonstrate that inspectors have at least 2,000 
hours of relevant experience that prepares them for the areas of 
operation they will be assigned (i.e., crops, livestock, handling, or 
wild crops). Both this baseline experience requirement and the 50-hour 
training requirement must be met before inspectors can independently 
inspect organic operations. An experienced inspector may advance to 
inspect more complex operations based on performance.
    The proposed rule specified one year of experience. This was 
consistent with the 2018 NOSB recommendation and generally supported by 
public comments. However, because public comments noted that ``one 
year'' is unclear and can be interpreted differently, AMS has chosen a 
more specific 2,000-hour requirement. This is equivalent to one year of 
full-time work (accounting for vacation and time off) and expands the 
pool of qualifying experiences because the hours can be obtained across 
multiple years, from one or more jobs, internships, or other qualifying 
activities.
    Eligible types of experience include but are not limited to: work 
on a farm or ranch; agricultural extension work; agricultural 
education; internships; apprenticeships; experiential education; 4-H; 
Future Farmers of America; other inspection or auditing work; 
management of an organic food handling operation; food processing 
research; or natural resource management work. Qualifying experience is 
not restricted to paid work, and may include volunteer work or 
education.
    This minimum experience requirement is supported by Sec.  
205.501(a)(5), which requires that certifying agents demonstrate that 
all persons with inspection or certification review responsibilities 
have education, training, or professional experience that relates to 
the duties they will perform.
Field Evaluation of Inspectors
    Section 205.501(a)(6) requires certifying agents to ensure that 
every inspector they use is evaluated while performing an inspection at 
least every three years. Inspectors with less than three years of 
organic inspection experience must be evaluated every year. The 
regulatory text refers to observing an inspector while they are 
inspecting an operation as a ``witness inspection.'' This term is used 
by the International Standards Organization to refer to observations of 
inspections to ensure proper adherence to inspection procedures and the 
standards to which the inspection is being made.
    The rulemaking's field evaluation requirements are consistent with 
a 2016 NOSB proposal and accepted industry guidance from the Accredited 
Certifiers Association.\39\ In addition, public comments supported this 
evaluation frequency, including annual evaluations for inspectors with 
less than three years of inspection experience. The rulemaking is 
therefore aligned with industry best practice, and will ensure that the 
performance of all inspectors is consistently monitored and evaluated 
by certifying agents.
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    \39\ ``Personnel Performance Evaluations of Inspectors'' 
proposal, December 13, 2016: https://www.ams.usda.gov/sites/default/files/media/CACSInspectorsProposal.pdf.
    The Accredited Certifiers Association, Inc. is a 501(c)(3) non-
profit educational organization created to benefit the accredited 
organic certifying agent community and the organic industry: https://www.accreditedcertifiers.org/.
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    The above requirement is a minimum and certifying agents have the 
option of conducting witness inspections more frequently than the above 
guidelines to verify an inspector's ability to successfully conduct 
inspection duties. For example, certifying agents may decide to conduct 
additional witness inspections if there is a sudden change in the 
complexity of an operation being inspected, or if inspection reports 
show deficiencies in an inspector's skill or knowledge.
    To ease the burden on certifying agents and inspectors, certifying 
agents may share witness inspection reports with each other, but each 
certifying agent must demonstrate that they have evaluated each 
inspector's performance in accordance with their own internal personnel 
policies and procedures. Certifying agents may use employees or 
contractors to perform the witness inspections, provided they are 
qualified to perform such duties (e.g., a witness inspection for a 
diversified crop operation should be overseen by an evaluator with 
adequate experience in inspecting diversified crop operations). A key 
indicator of an individual's qualifications to conduct witness 
inspections is whether that person can perform the type of inspections 
they are evaluating.
    To ensure that witness inspections are effective and consistent, 
certifying agents must maintain procedures for conducting and 
documenting them, and maintain records of all witness inspections of 
inspectors they have conducted (Sec.  205.501(a)(6)(ii)). These records 
may include a quantitative or qualitative evaluation of the inspector, 
along with details on where, when, by whom, and on what area of 
operation the inspection was conducted. This requirement will 
facilitate more robust accreditation audits and ensure more consistent 
oversight of certifying agents.
    Witness inspections are intended as one tool to help certifying 
agents maintain, evaluate and improve inspector quality, but certifying 
agents are also expected to take corrective action appropriate to 
remedying gaps and deficiencies in knowledge and skills. For example, 
if a witness inspection identifies problems with an inspector's report 
writing, then a desk audit of additional inspection reports may be 
appropriate to address any shortcomings. Conversely, if an inspector 
misses a significant noncompliance while inspecting an operation, the 
certifying agent may decide to conduct a follow-up witness inspection 
of the inspector.
Summary of Changes to the Final Rule
    AMS made several changes to the proposed regulatory text when 
writing this final rule. Changes to the final rule are discussed below 
and are followed by responses to specific themes from public comment.
     In Sec.  205.501(a)(4)(i) and (a)(4)(ii), AMS changed 
``scale'' to ``complexity'' because public comments noted that scale 
does not always equate to greater complexity. AMS agrees with public 
comments and included ``complexity'' in the rulemaking to highlight its 
importance in determining appropriate qualifications for inspectors and 
reviewers.
     In Sec.  205.501(a)(4)(i)(A) and (a)(4)(ii)(A), AMS 
replaced ``auditing'' with ``traceability audits'' and ``mass-balance 
audits.'' This addresses public

[[Page 3582]]

comments that requested additional specificity about the meaning of 
``audit.'' The new language more closely aligns with accepted and well-
understood industry terminology and more clearly describes the 
knowledge and skills that certifying agents must ensure their 
inspectors and reviewers possess.
     AMS revised the proposed annual training requirement of 20 
hours in Sec.  205.501(4)(i)(B) and (4)(ii)(B). Inspectors and 
reviewers must complete a baseline of 10 hours of training, plus an 
additional 5 hours for each additional area of operation they inspect 
or review. Inspectors and reviewers with less than one year of 
inspection experience must complete 50 hours of training within their 
first year. This revised requirement is consistent with established 
industry training standards but is also more flexible because it allows 
for more or less total annual training hours based on the experience of 
the inspector or reviewer and the areas of operations they inspect or 
review. This requirement will ensure that inspectors and reviewers 
receive annual training that is appropriate for the level and scope of 
their duties.
     AMS updated proposed Sec.  205.501(a)(4)(i)(C) from 
``field-based experience related to both the scope and scale of 
operations they will inspect'' to ``experience relevant to the scope 
and complexity of operations they will inspect.'' We removed ``field-
based'' because that term was unclear and could be interpreted too 
narrowly. Using ``scope and complexity'' focuses the requirement on 
experience relevant to the type of inspections to be performed.
     AMS changed the one-year experience requirement in Sec.  
205.501(a)(4)(i)(C) to 2,000 hours in response to comments that 
requested more specificity and a clear metric for verifying compliance. 
A 2,000-hour requirement is clearer, will promote consistent 
implementation among certifying agents, will allow inspectors to 
combine qualifying experience from more than one activity, and was 
supported by public comments.
     In Sec.  205.501(a)(6), AMS added ``witness inspection'' 
to refer to certifying agents observing inspectors as they inspect an 
operation. This change aligns with industry and international 
convention and more clearly describes the requirement.
     AMS revised Sec.  205.501(a)(6) to clarify that certifying 
agents must conduct annual witness inspections of inspectors with fewer 
than three years of experience. This change is consistent with industry 
best practice and will ensure that the performance of new inspectors is 
consistently monitored and evaluated by certifying agents.
Summary of Public Comment
    Many public comments focused on the proposed number of required 
hours of continuing education, with a mix of comments that believed 
that 20 hours annually is sufficient, and others arguing that 20 hours 
would not be sufficient. A few comments requested flexibility in how 
inspectors meet the education requirements, suggesting that added 
flexibility would help them complete the education more easily and 
reduce costs for certifying agents.
    Some comments expressed concern that the proposed requirement of 
one-year of field-based experience was restrictive, and that the 
proposed rule was not specific enough about what types of experience 
would qualify. AMS also received several comments noting that using 
years as a metric is not an adequate measure for experience; several 
comments suggested a minimum number of hours per year as an 
alternative.
    Several comments discussed inspector evaluations, with most of 
these comments supporting in-person evaluations once every three years, 
and others recommending more frequent evaluations for new or 
inexperienced inspectors.
Responses to Public Comment
Specified Additional Knowledge, Skills, and Experience
    (Comment) One comment stated that labor laws prevent certifying 
agents from requiring contract inspectors to undertake specific 
training.
    (Response) The regulations do not require contract inspectors to 
complete training specified by certifying agents; however, certifying 
agents must demonstrate that all inspectors, including contract 
inspectors, complete training that is relevant to inspection. 
Certifying agents can recommend or offer courses to contract 
inspectors, but may not be able to require completion of specific 
training courses. Certifying agents should review inspector training 
logs or other records to ensure that the inspector has completed the 
required number of hours and that the training is appropriate to 
inspectors' skill and role.
    (Comment) Comments expressed concern that a list of skills, 
knowledge, and experience detailed in Sec.  205.501(a)(4)(i)(A) may 
limit the pool of organic inspectors, and thus limit the capacity of 
certifying agents to inspect operations. Comments stated that specific 
qualifications should be based on the scope of inspections performed by 
individual inspectors.
    (Response) The list of qualifications specified in this section are 
not unique to any specific type of organic operation, but are important 
for all inspection and certification review activities, regardless of 
area of operation. All inspectors must meet the general qualifications 
listed in Sec.  205.501(a)(4)(i)(A). Specific qualifications should be 
based on the scope of inspections performed--Sec.  205.501(a)(4) 
requires certifying agents to demonstrate that inspectors have 
qualifications to inspect the scope and complexity of the operations 
assigned.
    (Comment) Comments recommended including recordkeeping, mass-
balance audits, traceability/trace-back audits, DMI calculations, 
biosecurity, cultural training, and internal control systems for 
producer groups as areas where inspectors must demonstrate adequate 
knowledge and skills.
    (Response) AMS expanded the list of qualifications in the 
rulemaking to include mass-balance audits and traceability audits. 
These additions support changes to the USDA organic regulations for 
supply chain traceability and on-site inspections as a result of this 
rulemaking. DMI calculations, biosecurity, and internal control systems 
for producer groups are specific to particular types of operations, and 
AMS is not mandating these topics for general organic inspector 
qualifications. Although knowledge of recordkeeping is not explicitly 
included, some certifying agent personnel may need this knowledge if it 
pertains to their duties (e.g., personnel who conduct supply chain 
traceability audits).
    (Comment) Comments recommended requiring special qualifications or 
experience for inspectors who inspect high-risk operations, including 
special training requirements for producer group operations.
    (Response) AMS is not including special training requirements for 
inspectors of high-risk operations or producer group operations. 
Section 205.501(a)(4)(i) requires certifying agents to demonstrate that 
their inspectors are qualified to inspect the operations of the scope 
and complexity assigned. If an inspector is to inspect high-risk 
operations or producer groups, then they must be qualified to inspect 
those types of operations.
    (Comment) Comments recommended clarifying that import/export skills 
are needed only if relevant, as not all certifying agents deal with 
import or export of organic products.
    (Response) AMS is keeping import/export requirements in the 
knowledge

[[Page 3583]]

areas required for all inspectors. Because this rule requires an NOP 
Import Certificate for each organic shipment imported to the United 
States, all inspectors must have knowledge of import and/or export 
requirements and how they are implemented. Inspectors who regularly 
inspect importing or exporting operations, or operations adjacent in 
the supply chain, may require more advanced import/export expertise.
Training Requirements
    (Comment) Some comments stated that an annual training requirement 
violates labor laws regarding contractors. Commenters claimed 
certifying agents cannot provide the training to contract inspectors, 
so these inspectors will need to pay for the training, which could lead 
to higher inspection fees.
    (Response) All inspectors must meet the hourly annual requirements 
for training that is relevant to their inspection work. While 
certifying agents cannot require inspectors to complete trainings, 
certifying agents must ensure all contract inspectors they use meet the 
training requirement. The rulemaking adds clarifying detail to existing 
training requirements to ensure consistent implementation by certifying 
agents. In addition, there are various trainings available for free, 
such as the online Organic Integrity Learning Center, which offers 33 
courses averaging 3-4 hours per course. Additional no-cost resources 
that could qualify for training include resources published by 
universities, the USDA, or other organic experts (e.g., plant 
identification databases, university extension courses, recorded 
lectures, informational web pages) and organic farming conferences. 
Furthermore, certifying agents commonly offer no-cost activities that 
can count as training, such as updates to inspection procedure, 
overviews of changes in organic regulation, supervised inspections, or 
field visits. Because of the wide availability of no-cost training, and 
because the rule's hourly training requirement is consistent with what 
the industry already practices, AMS does not believe this requirement 
will result in additional costs for inspectors beyond what is accounted 
for the in the rule's economic analysis, or affect the cost of 
inspection.
    (Comment) Comments stated that the number of required training 
hours should depend on how many different types of operations are 
inspected by a particular inspector.
    (Response) AMS revised the training hour requirements in the 
rulemaking based on the types of operations inspected--see Sec.  
205.501(a)(4)(i)(B) and (a)(4)(ii)(B).
    (Comment) Comments showed concern that a specific numerical 
training requirement is not appropriate. They stated that the required 
content in the training is critical, not the number of training hours.
    (Response) The annual training minimum is required to ensure the 
regulation's specified knowledge, skills, and experience requirements 
are effectively implemented. Establishing a minimum number of training 
hours sets a clear baseline for inspector and certification reviewer 
knowledge that promotes consistent implementation of the regulation by 
certifying agents.
Experience Requirements
    (Comment) Comments opposed the requirement that inspectors have one 
year of field-based experience, asserting it was difficult to interpret 
and may limit the pool of potential inspectors.
    (Response) AMS agrees that the proposed use of ``field-based'' 
experience may be interpreted narrowly (e.g., only farming and organic 
inspection experience) and that this may limit the pool of potential 
new organic inspectors. The final rule is updated to reference 
``relevant'' rather than ``field-based'' experience. This change 
supports the use of a broader pool of qualified candidates, such as 
persons with auditing or food handling experience.
    (Comment) Comments recommended changing the proposed requirement 
for one year of experience to a specific number of hours of related 
experience.
    (Response) AMS incorporated this recommendation into the final 
rule. Inspectors are required to have at least 2,000 hours of relevant 
experience prior to conducting their first inspection. This is 
equivalent to one year of full-time work, and can be obtained across 
multiple years, from one or more jobs, internships, or other qualifying 
activities. This clarifies the requirement and expands the pool of 
qualifying experiences across an individual's career and education.
    (Comment) Comments recommended AMS adopt a ``mentoring and 
evaluation system'' for inspectors in lieu of a one-year field-based 
experience requirement because the proposed requirement was vague. 
Comments stated requiring experience based on scope and scale was seen 
as overly prescriptive and would limit the pool of qualified 
inspectors.
    (Response) The rulemaking does not codify an inspector mentoring 
program. However, a mentorship program may be used by a certifying 
agent to improve the quality and proficiency of their inspectors. 
Mentorships may also count towards the 2,000-hour minimum experience 
requirement, provided that the certifying agent can demonstrate that 
the mentorship provided experience relevant to inspection.
Field Evaluation of Inspectors/Witness Inspections
    (Comment) Several comments recommended that witness inspections 
occur more frequently than once every three years, or that NOP issue 
guidance for how to determine when witness inspections should be more 
frequent.
    (Response) Certifying agents may conduct witness audits more 
frequently than once every three years ``if warranted.'' However, 
certifying agents must also maintain documented policies, procedures, 
and records for annual performance evaluations and witness inspections 
(Sec.  205.501(a)(6)). This means that a certifying agent may choose to 
conduct witness inspections more frequently than required by the 
regulation (e.g., to monitor inspectors with performance issues), but 
that the reason for more frequent witness audits should be justified 
and documented in the certifying agent's policies and procedures.
    Additionally, AMS increased the frequency of witness inspections 
for inspectors with less than three years of experience from once per 
three years to annually. This change was made to ensure that the 
performance of new inspectors is consistently monitored and evaluated 
by certifying agents.
    (Comment) Comments recommended allowing virtual or remote witness 
inspections.
    (Response) Virtual and/or remote witness inspections were not 
included in the SOE proposed rule and AMS is therefore not setting 
specific policy related to virtual or remote witness inspections. The 
final regulations provide flexibility so that AMS may consider virtual 
witness inspection policy options in the future.
    (Comment) Comments recommend allowing certifying agents to share 
inspector evaluation reports with other certifying agents following 
witness inspections.
    (Response) AMS has addressed this recommendation in the rulemaking. 
Certifying agents may share witness inspections reports with each 
other. However, certifying agents using an inspector performance 
evaluation or witness inspection report from another certifying must 
demonstrate that they have evaluated the inspector's performance in 
accordance with their

[[Page 3584]]

own internal personnel policies and procedures.
    (Comment) Several comments expressed concern that the proposed 
language would not allow contractors of a certifying agent to perform 
witness inspections.
    (Response) Certifying agents may use contractors to perform witness 
inspections. However, the contracted personnel performing the witness 
inspection must be qualified to evaluate the inspector (Sec.  
205.501(a)(6)(i)).
    (Comment) One comment stated that new inspectors should be shadowed 
on 10 inspections during their first year, in addition to the proposed 
20-hour training requirement.
    (Response) AMS has not included this recommendation in the 
rulemaking. Witness inspections will assess inspectors as they perform 
their duties, with more frequent witness inspections of less 
experienced inspectors. Comments did not demonstrate the benefit of 
shadowing, although certifying agents may use this method if it is 
documented in their policies and procedures for witness inspections.

I. Oversight of Certification Activities

    The table below includes the regulatory text related to this 
section of the rule. A discussion of the policy follows.

----------------------------------------------------------------------------------------------------------------
                       Section                                           Final regulatory text
----------------------------------------------------------------------------------------------------------------
205.2...............................................  Terms defined.
                                                      Definition for Certification activity and Certification
                                                       office.
205.501.............................................  General requirements for accreditation.
                                                      Paragraph (a)(22).
205.665.............................................  Noncompliance procedure for certifying agents.
                                                      Paragraph (a).
----------------------------------------------------------------------------------------------------------------

    This rulemaking revises the USDA organic regulations at Sec. Sec.  
205.2, 205.501(a)(22) and 205.665(a) to clarify AMS's authority to 
oversee the activities of certifying agents. Certifying agents must 
notify AMS when opening any certification office that conducts 
certification activities. In addition, this rulemaking clarifies that 
AMS may issue notices of noncompliance to certifying agents based on 
the certification activities of a party working on behalf of a 
certifying agent.
    Certifying agents, applicants for accreditation, and certified 
operations may be affected by these requirements. Readers should 
carefully review the regulations and policy discussion to determine if 
they may be affected by this action.
Background
    Certifying agents commonly have multiple offices to ensure they 
provide adequate services to their clients. However, certifying agents 
sometimes open new certification offices without reporting this to AMS. 
Some certification offices operate independently and in different 
countries or regions than a certifying agent's main office. AMS cannot 
provide oversight (regular audits and reviews) or enforcement of 
offices of which it is not aware. This can lead to inconsistent 
application and enforcement of the regulations across certifying 
agents. To address these gaps in oversight, the 2018 Farm Bill amended 
OFPA to require certifying agents to report new certification offices 
to AMS within 90 days of opening.\40\
---------------------------------------------------------------------------

    \40\ See section 10104(d) of the Agriculture Improvement Act of 
2018, Public Law No: 115-334, available at: https://www.congress.gov/115/plaws/publ334/PLAW-115publ334.pdf (7 U.S.C. 
6515(j)).
---------------------------------------------------------------------------

    AMS also needs clear authority to initiate enforcement against 
parties acting on behalf of a certifying agent (e.g., a subcontractor) 
or individual certification offices. The use of subcontractors is 
common in the organic industry and effective enforcement depends on 
oversight of all persons involved in the certification of organic 
operations. Uncertainty about whether AMS can target a certification 
office or contractor for enforcement action interferes with precise and 
expedited enforcement. Therefore, AMS revised the organic regulations 
to clarify that entities acting on behalf of a certifying agent are 
subject to oversight and enforcement.
90-Day Notification of New Certification Offices
    To support the consistent application of the organic regulations 
across all certifying agents, Sec.  205.501(a)(22) requires certifying 
agents to notify AMS within 90 calendar days of the opening of any 
office performing certification activities. A certification office is 
defined as any site or facility where certification activities take 
place, except for activities that take place at certified operations or 
other specialized facilities, such as inspection, sampling, and 
testing. This notification requirement applies to any facility or 
location that meets the definition of certification office, regardless 
of how the office is classified by a certifying agent (e.g., 
``central'' vs. ``satellite'' offices).
    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.
Authority To Issue Notices of Noncompliance
    AMS is clarifying its authority to issue notices of noncompliance 
to certifying agents based on the activities of persons acting on 
behalf of a certifying agent, the activities of a certification office, 
or the activities in a specific country. AMS added the term 
certification activity to Sec.  205.2 of the organic regulations to 
define activities that are essential to the function of a certifying 
agent and therefore subject to NOP oversight. Certification activity is 
any business conducted by a certifying agent, or by a person acting on 
behalf of a certifying agent (e.g., a specific office operating in 
specific countries, or a subcontractor or subcontractor organization). 
Any business activity conducted by a certifying agent as it implements 
the USDA organic regulations is considered a certification activity, 
including review, inspection, and certification of organic operations. 
The definition includes a non-exhaustive list of certification 
activities that fall under AMS oversight authority.

[[Page 3585]]

    AMS's authority to initiate enforcement action for a portion of a 
certifying agent's operation is reinforced in Sec.  205.665(a)(1). This 
states that AMS may send notifications of noncompliance to a certifying 
agent based upon review of the certification activities of:
     A person acting on behalf of the certifying agent or
     A certification office.
    This means that AMS may issue notices of noncompliance to a 
certifying agent based on the activity of certifying agent 
subcontractors, or an individual certification office(s) that may be in 
a different location from the certifying agent's main office. Further, 
AMS may suspend or revoke a portion of accreditation for activities in 
a specific certification office, country, or region.
Summary of Changes to the Final Rule
    AMS made no changes to the proposed regulatory text in Sec. Sec.  
205.2, 205.501(a)(22), and 205.665(a) with respect to oversight of 
certification activities and has finalized the proposed requirements.
Summary of Public Comment
    The majority of public comments supported AMS's proposed 
clarification. Commenters were primarily concerned that the proposed 
definition of certification office would subject remote staff and home 
offices to NOP audits. Commenters stated that NOP audits of home 
offices and remote workers does not align with NOP's intent for adding 
the term certification office. Comments suggested excluding home 
offices and telework locations from the definition for certification 
office, and some explained that certifying offices which solely operate 
virtually should qualify as a certification office and individual 
workers working remotely on a temporary basis should not be subject to 
NOP audits.
    Commenters were also concerned that the 90-day timeframe for 
certifying agents to notify AMS of new offices conducting certification 
activities is too long.
Responses to Public Comment
Definition of Certification Office
    (Comment) AMS received comments requesting that the definition of 
certification office exclude home offices and remote workers. 
Commenters asserted that if home offices for remote staff are included 
in the definition of certification offices, they will be subject to 
audits, which would be unreasonable.
    (Response) Home offices are not excluded in the definition of 
certification office because some certifying agents may maintain home 
offices as their primary location or certification office from which 
they conduct certification activities.
90-Day Notification of New Offices
    (Comment) We received comments stating that the 90-day timeframe 
for certifying agents to notify AMS of new offices conducting 
certification activities is too long. Some suggested that timeframes of 
30 or 45 days would be more appropriate.
    (Response) The 2018 Farm Bill established the 90-day timeframe. 
Section 10104 (j) of the 2018 Farm Bill and 7 U.S.C. 6515(j) state 
``Not later than 90 days after the date on which a new certifying 
office performing certification activities opens, an accredited 
certifying agent shall notify the Secretary of the opening.'' While 
certifying agents may choose to notify AMS earlier, AMS is retaining 
the 90-day notification requirement in the organic regulations.
    (Comment) Commenters asked what office types (e.g., satellite 
offices or main offices) would require a certifying agent to notify 
AMS.
    (Response) Certifying agents must notify AMS of the opening of any 
type of office where certification activities take place. This 
requirement for notification is based on the activities of an office 
not the type.

J. Accepting Foreign Conformity Assessment Systems

    The table below includes the regulatory text related to this 
section of the rule. A discussion of the policy follows.

----------------------------------------------------------------------------------------------------------------
                       Section                                           Final regulatory text
----------------------------------------------------------------------------------------------------------------
205.2...............................................  Terms defined.
                                                      Definitions for Conformity assessment system and Technical
                                                       requirements.
205.511.............................................  Accepting foreign conformity assessment systems.
                                                      Entire section.
----------------------------------------------------------------------------------------------------------------

    AMS has added a new section to the USDA organic regulations, Sec.  
205.511, on accepting foreign conformity assessment systems that 
oversee organic certification in foreign countries. Section 205.511 
replaces former Sec.  205.500(c).
    Affected entities may include, but are not limited to:
     Trade partners who have established an organic equivalence 
determination or are interested in establishing an equivalence 
determination with the United States.
     Foreign certifying agents and certified operations not 
accredited or certified by the USDA.
     Foreign organic producers who export products to the 
United States.
    The above list is a general description of entities likely to be 
affected by this action. Other types of entities could also be 
affected. You should carefully examine the regulatory text to determine 
if you or your organization may be affected by this action.
Background
    The OFPA, under 7 U.S.C. 6505(b), allows imported organic products 
to be sold or labeled in the United States as organically produced if 
the Secretary determines that the products have been produced and 
handled under an organic certification program with requirements and 
oversight determined to be at least equivalent to those described in 
the OFPA. Under this authority, the U.S. government, including the USDA 
and the U.S. Trade Representative, work closely together to implement 
processes that determine the equivalence of foreign organic 
certification programs and then negotiate an arrangement or agreement 
as appropriate.
    USDA organic regulations formerly addressed USDA's authority to 
make equivalence determinations in general terms under Sec.  
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 Sec.  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

[[Page 3586]]

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.
Definitions
    The rulemaking adds two new terms in Sec.  205.2: conformity 
assessment system and technical requirements. These terms are defined 
to ensure that the process and requirements described in Sec.  205.511 
are clear. The rulemaking defines conformity assessment system as all 
activities, including oversight, accreditation, compliance review, and 
enforcement, undertaken by a government to ensure that the applicable 
technical requirements for the production and handling of organic 
agricultural products are fully and consistently applied. The 
rulemaking defines technical requirements as a system of relevant laws, 
regulations, regulatory practices, standards, policies, and procedures 
that address the certification, production, and handling of organic 
agricultural products.
Foreign Product Certification
    Section 205.511(a) describes the U.S. government's authority under 
OFPA to make equivalence determinations and explains the conditions in 
which foreign-produced product can be labeled and sold as organic in 
the United States.
Equivalency Determination Request
    Section 205.511(b) describes the process used by the U.S. 
government and other foreign governments for initiating a request for 
an equivalence determination. Since there are several factors that may 
impact whether the U.S. government moves forward to review an 
equivalence determination request (e.g., agency resources, capacity to 
oversee the potential trade arrangement or agreement, relative benefits 
for the U.S. organic sector), this section clarifies that the U.S. 
government will determine if it can proceed with the evaluation process 
on a case-by-case basis.
Equivalency Reviews and Reassessments
    Section 205.511(d) lays out the current process that AMS and other 
foreign governments use to monitor equivalence determinations that have 
been made. The section provides some flexibility in the timing of 
reviews to accommodate unavoidable factors in both countries that can 
impact timing (e.g., federal budgets, election cycles, growing 
seasons).
Equivalence Termination Procedures
    Section 205.511(e) describes the conditions under which the U.S. 
government may terminate equivalence determinations. These conditions 
for termination are commonly accepted among countries that maintain 
equivalence determinations and are based upon the core concepts 
underlying equivalence. The U.S. government must be able to terminate 
equivalence determinations under these conditions in order to fulfill 
its statutory obligation to assure that organic products sold in the 
United States are compliant with OFPA and the USDA organic regulations 
and maintain a level playing field for U.S. farms and businesses.
    In addition to the conditions described in Sec.  205.511(e), the 
U.S. government may also terminate an equivalence determination ``for 
other good cause.'' This includes risks that may negatively affect the 
integrity of organic products imported from a country with which the 
U.S. government has an equivalence determination, policy changes, or 
resource constraints that impact either government. Examples include:
     Repeated cases of organic fraud that are not corrected by 
a foreign government;
     Increasing levels of organic fraud that a foreign 
government is unable or unwilling to address;
     Political instability, safety concerns, or limitations on 
access that make it impossible for USDA to travel to and assess a 
foreign government's equivalence determination;
     Reduction in funding or other resources that compromises a 
foreign government's or USDA's ability to operate its organic program 
and oversee the equivalence determination; or
     Changes in a foreign government's unilateral equivalence 
determination with the USDA that may restrict domestic producers' 
access to foreign markets.
    In all cases, the U.S. government would provide notice and 
justification to the foreign government prior to termination, and give 
notice to affected organic stakeholders along with a reasonable 
timeline to transition.
Summary of Changes to the Final Rule
    AMS made several revisions to the proposed regulatory text when 
writing this final rule. Changes to the proposed rule are discussed 
below and are followed by responses to specific themes from public 
comment.
     AMS added ``oversight, accreditation, compliance review, 
and enforcement'' to the definition of conformity assessment system to 
clarify the scope of the assessment of a foreign organic certification 
system's eligibility for an equivalence determination.
     AMS added ``standards, policies'' and ``certification'' to 
the definition of technical requirements to clarify the scope of this 
term and to ensure that the definition covers all parts of a country's 
framework for regulating organic products.
     AMS corrected the syntax of Sec.  205.511(a) and (b) to 
state that foreign product ``may be sold, labeled, or represented in 
the United States as organically produced.'' This accurately reflects 
the intent to allow foreign organic product to be exported to the 
United States and sold as organic, but does not allow foreign organic 
product to be labeled as domestically produced in the United States.
     AMS removed the reference to a two-year review cycle in 
Sec.  205.511(d) and replaced with a statement explaining how AMS will 
determine the timing and scope of reviews of equivalence 
determinations. This gives AMS the flexibility to determine timelines 
for audits and reassessments of equivalence determinations, and allows 
AMS to accommodate unavoidable factors when scheduling audits and 
reassessments of equivalence determinations.
Summary of Public Comment
    Public comments showed overall support for codifying AMS's existing 
practices for determining organic equivalence, agreeing that the 
proposed updates would strengthen the integrity of imported organic 
products.
    Several of these comments largely focused on how the specifics of 
the proposed Sec.  205.511 would improve the transparency and oversight 
of equivalence determinations and recognition agreements. Some of these 
comments recommended requiring certified foreign operations to be 
listed in the Organic Integrity Database and for NOP to investigate any 
countries with equivalence determinations found to be noncompliant. 
Some comments expressed opinions in opposition to some existing trade 
arrangements, and/or suggested that USDA not allow equivalence 
determinations and require direct certification via USDA-accredited 
certifying agents instead. Some comments were also uncertain the 
proposed requirements of Sec.  205.511 apply to recognition agreements.
    Several comments expressed concern that the proposed Sec.  
205.511(a) and (b)

[[Page 3587]]

would allow organic products produced under foreign equivalence 
determinations to be sold as ``produced in the United States.'' Some 
comments pointed out that the two and five-year inspection timelines 
may conflict with other regulations.
Responses to Public Comment
Definition of Conformity Assessment Systems
    (Comment) AMS received comments requesting that several activities 
be included in the definition of conformity assessment systems. 
Commenters stated that it is critical to ensure that foreign 
governments have sufficient oversight, accreditation, compliance, and 
enforcement mechanisms in place to ensure that organic technical 
requirements are being enforced.
    (Response) The definition of conformity assessment systems has been 
modified from the proposed rule to include the following activities: 
oversight, accreditation, compliance review, and enforcement. The 
additional activities were added to the definition of conformity 
assessment systems to clarify the scope of the assessment of a foreign 
organic certification system's eligibility for an equivalence 
determination.
Definition of Technical Requirements
    (Comment) We received comments requesting that the definition of 
technical requirements include the terms standards, policies, and 
certification. Commenters stated that it was important that these terms 
be added to ensure that the definition covers all parts of a country's 
framework for regulating organic products.
    (Response) The terms standards, policies, and certification have 
been added to the definition of technical requirements. The new terms 
were added to ensure that the definition covers all parts of a 
country's framework for regulating organic products.
Labeling of Foreign Product Origin
    (Comment) Comments noted that Sec.  205.511(a) could be interpreted 
to allow labeling of foreign-produced organic product as ``produced in 
the United States.''
    (Response) The final rule corrects the syntax of Sec.  205.511(a) 
to state foreign organic product ``. . . may be sold, labeled, or 
represented in the United States as organically produced.'' This 
accurately reflects the intent to allow foreign organic product to be 
exported to the United States and sold as organic, but does not allow 
foreign organic product to be labeled as domestically produced in the 
United States.
Equivalence Reviews and Reassessments
    (Comment) We received comments requesting AMS clarify its timeline 
for audits and reassessments of equivalence determinations. 
Additionally, commenters noted the difference between proposed Sec.  
205.511(d), which requires a two-year midcycle review, and the proposed 
rule preamble, which states, ``The review cycles mirror ISO standards, 
which include a five-year reassessment cycle and mid-cycle reviews.''
    (Response) The final rule has been revised to allow AMS additional 
flexibility to determine timelines for audits and reassessments of 
equivalence determinations. The final rule replaces ``two-year cycle'' 
and ``five years'' with the phrase ``regular reviews and 
reassessments.'' The new regulatory language allows AMS to accommodate 
unavoidable factors when scheduling audits and reassessments of 
equivalence determinations.
    (Comment) AMS received comments asking if recognition agreements 
would be subject to AMS audits and reassessments per new Sec.  205.511.
    (Response) Recognition agreements will be subject to AMS audits and 
reassessments of equivalence per Sec.  205.511.
Equivalence Determination Procedures
    (Comment) We received comments requesting AMS describe in Sec.  
205.511(e) the criteria used to determine termination of an equivalence 
determination.
    (Response) Each equivalence determination is unique and is assessed 
using the general criteria described in Sec.  205.511. To ensure fair 
assessment of each unique equivalence determination, AMS has not 
codified specific criteria used to determine termination of 
equivalence.

K. Compliance and Noncompliance Procedures

    The table below includes the regulatory text related to this 
section of the rule. A discussion of the policy follows.

----------------------------------------------------------------------------------------------------------------
                       Section                                           Final regulatory text
----------------------------------------------------------------------------------------------------------------
205.660.............................................  General.
                                                      Paragraph (c).
205.661.............................................  Investigation.
                                                      Change section heading only.
205.100.............................................  What has to be certified.
                                                      Paragraph (c).
205.662.............................................  Noncompliance procedure for certified operations.
                                                      Paragraphs (e)(3), (f)(1), and (g)(1).
----------------------------------------------------------------------------------------------------------------

Authority To Pursue Enforcement Action Against Any OFPA Violator
    The NOP currently pursues enforcement actions against uncertified 
parties when AMS has evidence of OFPA violations. In 2021, more than 
half of the complaints received by the NOP alleging violations of OFPA 
involved uncertified operations representing products as organic. 
Continued AMS enforcement against uncertified operations is central to 
the effective administration of the OFPA.
    The rulemaking updates the USDA organic regulations by adding new 
paragraph (c) to Sec.  205.660, to clarify that the NOP Program Manager 
may initiate an enforcement action against any violator of OFPA, 
regardless of certification status. Consistent with the new paragraph 
(c) to Sec.  205.660, to clarify that the NOP Program Manager may 
initiate an enforcement action against any violator of the OFPA, AMS 
changed the title of Sec.  205.661 from ``Investigation of Certified 
Operations'' to ``Investigation.''
Enforcement Action Against Responsibly Connected Persons
    Person(s) responsibly connected to a violator of the OFPA may be 
complicit in the OFPA violation(s) because of their association to the 
violator. Because of this, the rulemaking clarifies at Sec. Sec.  
205.100 and 205.662 that any person who is responsibly connected to an 
operation that violates OFPA or the USDA organic regulations may be 
subject to a suspension of certification, civil penalties, or criminal 
charges and/

[[Page 3588]]

or may be ineligible to receive certification. This clarification 
strengthens AMS's enforcement capacity by ensuring that enforcement 
actions and penalties for violations of the OFPA extend to all 
accountable parties.
    Responsibly connected persons who are suspended or revoked may 
request to have their certification reinstated, if suspended, or their 
eligibility to become certified reinstated, if revoked. AMS has 
published guidance for Reinstating Suspended Operations (NOP 2605), 
which applies to both suspended and revoked operations that want to 
become certified again.\41\
---------------------------------------------------------------------------

    \41\ Instruction NOP 2605, Reinstating Suspended Operations: 
https://www.ams.usda.gov/sites/default/files/media/2605.pdf.
---------------------------------------------------------------------------

Timely Updates to the Organic Integrity Database
    Timely updates to the Organic Integrity Database (OID) are critical 
to inform other certifying agents, operations in the supply chain, and 
consumers when an operation is no longer certified and can help prevent 
noncompliant products from entering or continuing in the stream of 
commerce. At Sec.  205.662(e)(3) of the regulations, AMS requires 
certifying agents to provide timely updates on the status of an 
operation that has been suspended or revoked (or that has surrendered 
its organic certification). These updates should be viewable in the 
Organic Integrity Database within three business days of issuing a 
notification of suspension or revocation, or from the effective date of 
a surrender. This publicly available information helps businesses in 
the supply chain confirm that an operation from which they purchase or 
receive organic products has a valid organic certification.
    In most cases, the effective date of an operation's surrender means 
that the certifying agent has received notification from the operation 
and confirmed the surrender status. AMS recognizes that in some cases 
the effective date of the surrender may date prior to certifying agent 
confirmation of surrender and the Organic Integrity database updates 
will extend past the three-day window.
Federal Civil Penalty Inflation Adjustment
    Finally, AMS amended Sec.  205.662(g)(1) of the regulations to 
update the citation which specifies the maximum civil penalty amount 
for violations of the OFPA. Title 7 CFR 3.91(b)(1)(xxxvi) provides the 
civil penalty amount for each violation of OFPA. This amendment aligns 
with the Federal Civil Penalties Inflation Adjustment Act Improvements 
Act of 2015, Public Law 114-74, sec. 701.\42\
---------------------------------------------------------------------------

    \42\ https://www.govinfo.gov/content/pkg/PLAW-114publ74/html/PLAW-114publ74.htm. As of the publication of this rule the civil 
penalty amount is $20,130 per violation of OFPA occurring on or 
after February 15, 2022. The civil penalty amount will be adjusted 
in the future so readers should refer to 7 CFR 3.91(b)(1)(xxxvi) for 
the current amount.
---------------------------------------------------------------------------

Changes From Proposed to Final Rule
    AMS made one change to the proposed regulatory text when writing 
this final rule:
     Removed the phrase ``directly or indirectly'' from 
205.660(c) because its meaning was confusing. The intent of 205.660(c) 
is to clarify the scope of potential enforcement actions which may 
include blatant and subtle false labeling and representation of 
nonorganic products as organic.
    No other changes were made to the proposed regulatory text in 
Sec. Sec.  205.100(c), 205.660(c), 205.662(e)(3)), and 205.662(f)(1) 
and AMS has finalized the proposed requirements with respect to AMS's 
authority to enforce against any OFPA violator and all responsibly 
connected persons connected to a violator. AMS also made no changes to 
proposed requirement to timely update the Organic Integrity Database.
Summary of Public Comments
    In general, most public comments supported the proposed revisions 
to clarify AMS's authority to enforce against any violator of the OFPA 
and the organic regulations. Many comments also discussed the revisions 
in detail and offered recommendations or changes to the proposed 
policy.
    Many comments discussed the proposed three-day timeframe to submit 
updates to the Organic Integrity Database (Sec.  205.662(e)(3)). Some 
comments describe the requirement as too burdensome, while some support 
the three-day timeframe. Comments opposing the proposed requirement 
recommended alternatives ranging from 7 to 30 days. Other comments 
state that updates should be immediate, or made within 48 hours, so 
that noncompliant products do not continue in the stream of commerce.
    Several comments also claim that identifying and tracking all 
responsibly connected persons would be difficult, and requested more 
guidance on how this should be done. A few comments asked AMS if 
revocation of an operation's certification should also result in the 
revocation of all responsibly connected persons' certification.
    Some comments also asked AMS to clarify the phrase ``or submit a 
request for eligibility to be certified'' in Sec.  205.662(f)(1). A few 
comments also asked if this applies to persons responsibly connected to 
a suspended operation. One comment also asked if this section applies 
to revocation of certification.
Responses to Public Comment
Timely Updates to the Organic Integrity Database
    (Comment) AMS received comments that the three-day requirement to 
update the Organic Integrity Database is too burdensome. Commenters did 
not quantify negative impacts to certifying agents, nor did they 
clearly explain why this would be burdensome for certifying agents. 
Others supported the three-day timeframe or recommended that updates 
should be immediate or within 48 hours, so that noncompliant products 
do not continue in the stream of commerce. Other commenters recommended 
alternatives ranging from 7 to 30 days.
    (Response) Certifying agents will have a one-year implementation 
period before this requirement takes effect. During the implementation 
period, there is no fixed time frame for updating data in the Organic 
Integrity Database. This requirement is limited in scope and applies 
when an operation is suspended, revoked, or has surrendered organic 
certification. Public accessibility of an operation's correct 
certification status is essential for movement of products in organic 
supply chains. AMS believes that three days for certification status 
updates is adequate and supports organic verification across supply 
chains of different speeds. Extending the deadline beyond three days 
may interfere with the timely verification of an operation's accurate 
certification status. This is critical data and inaccurate information 
can delay legitimate transactions and fail to prevent sales of products 
from suspended or revoked operations. Further, AMS provides certifying 
agents with an API to upload data to the Organic Integrity Database, 
which reduces redundant or duplicative work for certifying agents.
Enforcing Against Responsibly Connected Persons
    (Comment) AMS received comments stating that identifying and 
tracking all responsibly connected persons would be difficult because 
these entities are not listed in the Organic Integrity

[[Page 3589]]

Database. Commenters requested guidance on how this should be 
accomplished.
    (Response) AMS is not specifying how certifying agents must 
identify responsibly connected persons, nor are we requiring 
responsibly connected persons to be listed and searchable as such in 
the Organic Integrity Database. Obtaining responsibly connected persons 
from organic system plans and/or identifying all known responsibly 
connected persons in adverse action letters are best practices that 
certifying agents should pursue.
Use of Term ``Indirectly'' in 205.660(c)
    (Comment) Commenters requested clarification of what is meant by a 
label or information which ``indirectly'' implies that product was 
produced with organic methods if product was produced in violation of 
the OFPA or the organic regulations.
    (Response) AMS removed the phrase ``directly or indirectly'' from 
205.660(c) because its meaning was confusing. The intent of 205.660(c) 
is to clarify the scope of potential enforcement actions which may 
include blatant and subtle false labeling and representation of 
nonorganic products as organic.
Civil Penalty Citation
    (Comment) For civil penalty fines, commenters requested AMS cite 
the regulation, not the amount, since the latter changes and becomes 
outdated.
    (Response) The proposed and final rules cite the regulation that 
sets the civil penalty amount.
Documented Delivery Confirmation
    (Comment) Commenters requested AMS allow ``documented delivery 
confirmation'' to accommodate electronic communication rather than only 
certified paper mail.
    (Response) AMS accepts that ``dated return receipts,'' which are 
required when certifying agents or NOP sends an adverse action notice 
to an operation, may include electronic communications. This means that 
the adverse action notices may be sent electronically to the recipient 
and delivery confirmation may include, for example, confirmation that 
an email has been delivered.

L. Mediation

    The table below includes the regulatory text related to this 
section of the rule. A discussion of the policy follows.

----------------------------------------------------------------------------------------------------------------
                       Section                                           Final regulatory text
----------------------------------------------------------------------------------------------------------------
205.504.............................................  Evidence of expertise and ability.
                                                      Introductory text and paragraph (b)(8).
205.663.............................................  Mediation.
                                                      Entire section.
----------------------------------------------------------------------------------------------------------------

Background
    AMS revised Sec.  205.663 to improve the general readability of 
this section and to more clearly explain how mediation may be used in 
noncompliance procedures. When successful, mediation is an efficient 
way to bring operations into compliance and resolve conflicts among 
certifying agents and operations. The USDA organic regulations require 
that certifying agents and State organic programs provide applicants 
for certification and certified operations the right to request 
mediation when they issue a denial of certification, notice of proposed 
suspension, or proposed revocation of certification (Sec. Sec.  
205.405(d) and 205.662(c)). Section 205.663 provides requirements for 
requesting mediation, responding to a mediation request, the time frame 
for reaching an agreement, and what happens when mediation is 
unsuccessful.
    The USDA organic regulations require certifying agents and State 
organic programs to notify operations of the option to request 
mediation as an alternative dispute resolution to resolve noncompliance 
findings that have led to a proposed suspension, revocation, or denial 
of certification. This will facilitate resolution of these issues 
before they escalate to an appeal to AMS or a State organic program.
Mediation Is a Collaborative Process
    The requirements for mediation support a process that is efficient 
and accessible to producers and handlers who want to resolve a denial 
of certification, proposed suspension, or revocation of certification. 
Mediation is a collaborative process between a certifying agent and an 
operation or applicant for certification. A successful mediation 
addresses the noncompliance(s) and leads to full compliance with the 
USDA organic regulations. To ensure that mediation is readily 
accessible, certifying agents and certified operations or applicants 
may engage in mediation without a third-party mediator, provided that 
all parties agree upon the person who will serve as the mediator.
Mediation Must Be Requested in Writing
    After a certifying agent issues a denial of certification, proposed 
suspension, or revocation of certification, a certified operation and 
certifying agent may discuss the option of mediation prior to receiving 
a request for mediation. However, for mediation to proceed as a form of 
alternative dispute resolution, an operation must request mediation in 
writing to the certifying agent. The request for mediation must be 
submitted to the certifying agent within 30 calendar days from the date 
of the proposed adverse action or denial of certification (Sec.  
205.663(b)(1)). This aligns with the length of time provided to submit 
an appeal of a proposed adverse action.
Mediation Acceptance Criteria
    A certifying agent determines whether to accept or reject a written 
request for mediation. Certifying agents must include mediation 
acceptance decision criteria as part of the administrative policies and 
procedures which certifying agents are required to submit to 
demonstrate their ability to comply with the certification program 
(Sec.  205.504(b)(8)). The mediation acceptance criteria must be fair 
and reasonable and not arbitrary. The criteria must be based on factors 
that will likely determine potential success or failure of the 
mediation process. The certifying agent must document how it applied 
the criteria to accept or reject requests for mediation. Parties to the 
mediation may develop conditions, such as cost, timeframes to reach a 
settlement agreement within the allowed maximum of 30 days, and any 
incremental steps, only after a certifying agent accepts a mediation 
request. A certifying agent must not impose any preconditions for the 
acceptance of mediation (i.e., the certifying agent cannot require that 
the operation take a specific action--other than submitting a written 
request for mediation--before it will consider mediation).

[[Page 3590]]

    If a certifying agent decides to reject a request for mediation, 
based on its criteria for acceptance of mediation, it must inform the 
operation in writing, with the justification for the rejection. That 
notification must explain that the operation has the right to appeal 
the rejection of mediation (Sec.  205.663(b)(3)). While an operation 
appeals a rejection of mediation, the proposed suspension or revocation 
which led to the request for mediation must not be finalized (Sec.  
205.663(b)(4)). The date that the notification is received by the 
operation is important because it starts the 30-day window for filing 
an appeal and may be used to determine whether an appeal has been 
timely filed. Likewise, when mediation is unsuccessful, the certifying 
agent must inform the operation in writing to document the start of the 
30-day window for filing an appeal. This means that certifying agents 
must send rejection and termination of mediation notices using a method 
with delivery confirmation.
Use of Settlement Agreements
    In accepting mediation, a certifying agent may also, at its 
discretion, offer a settlement agreement for an operation to consider 
(Sec.  205.663(e)). The outcome of successful mediation is a settlement 
agreement that brings an operation into compliance with the USDA 
organic regulations. A settlement agreement must clearly describe the 
corrective actions and timeframes for implementing corrective actions, 
and may impose additional actions (e.g., unannounced inspections, 
sampling for residue testing) to ensure the operation maintains 
compliance. A settlement agreement may also include a suspension of 
organic certification.
    A settlement offer may be useful when the corrective action(s) is 
clear and the noncompliance(s) is not recurrent. As part of the 
mediation, an operation may accept or reject the settlement agreement, 
negotiate the terms with the certifying agent, or request a mediator to 
try and reach a settlement agreement.
Use of a Third-Party Mediator
    This rule clarifies that mediation does not require a third-party 
mediator to reach a settlement agreement (Sec.  205.663(c)). The 
certifying agent and operation may agree that mediation will be between 
only those two parties. For example, mediation may consist of a phone 
call or series of phone calls between the operation and the certifying 
agent to discuss the terms of a settlement offer prior to signing the 
agreement.
    In some cases, the use of a third-party mediator may be 
appropriate, either because the operation initially requested this, or 
the operation rejected a settlement offer and then requested a 
mediator. To demonstrate their ability to comply with the certification 
program, each certifying agent must submit a process to identify a 
qualified mediator and set the time and location of mediation 
session(s), mediation format (in-person, video, phone), and mediation 
fees and payment (Sec.  205.504(b)(8)).
Role of the Program Manager
    The Program Manager does not require, manage, or otherwise 
participate in mediation between operations and certifying agents or 
State organic programs. The Program Manager may review an agreement 
that results from the mediation for conformity to the OFPA and the USDA 
organic regulations and reject any nonconforming provision or agreement 
(Sec.  205.663(f)). The Program Manager may direct the certifying agent 
or State organic program to revise any nonconforming provisions, and 
the operation would have a new opportunity to accept or reject the 
revised settlement agreement.
    Mediation under the USDA organic regulations is an alternative 
dispute resolution mechanism, conducted between a certified operation 
or applicant for certification and a certifying agent or State organic 
program. The Program Manager is not involved in determining the outcome 
of a mediation, notwithstanding his or her authority to review dispute 
resolution terms for conformity with the OFPA and the USDA organic 
regulations.
    This does not affect AMS's ability to carry out oversight, 
compliance, and enforcement activities on behalf of the Program 
Manager. For example, AMS may conduct informal mediation, at its 
discretion, and enter into mutually agreeable settlement agreements 
with parties that receive a proposed adverse action (Sec.  205.663(g)).
Changes From Proposed to Final Rule
    AMS made minor revisions to the proposed regulatory text when 
writing this final rule. Changes to the final rule are discussed below 
and are followed by specific themes from public comment.
     AMS added the words ``of receipt'' to Sec.  205.663(b)(3) 
and (e) so that the 30-day time frame for requesting an appeal when 
mediation is rejected or terminated provides adequate due process and 
aligns with the appeal filing time frame for other adverse action 
notices.
     AMS added a requirement for termination of mediation to be 
documented in a written notice so it is clear when an operation may 
exercise its right to file an appeal.
     AMS revised the introductory paragraph at Sec.  205.504 to 
include the cross-reference to Sec.  205.663 because certifying agents 
must submit mediation procedures as part of the evidence of their 
ability to comply with and implement mediation requirements.
     AMS relocated the requirement to submit mediation policies 
and procedures from Sec.  205.663(a) to Sec.  205.504(b), where 
requirements for certifying agents' policies and procedures are 
identified.
     AMS added a requirement that certifiers document the 
reason for denying mediation. If the rejection is appealed, this will 
allow the Administrator to determine whether the rejection was 
reasonable and consistent with the certifier's criteria for rejection.
     AMS added the word ``reasonable'' to Sec.  205.504(b)(8) 
to describe parameters for the criteria that certifiers must set for 
accepting mediation. This supports fair and consistent decisions on 
requests for mediation across certifying agents.
     AMS revised Sec.  205.663(e) to require that a settlement 
agreement be reached within 30 days from the start of mediation. This 
clarifies when the 30-day timeframe begins and supports timely 
resolution of compliance issues.
     AMS added a new provision at Sec.  205.663(b)(4) to 
clarify that an adverse action (e.g., proposed suspension or 
revocation) must not be finalized during the appeal proceeding. This 
clarification supports the right to adequate due process before an 
adverse action takes effect.
Responses to Public Comment
Settlement Agreements
    (Comment) Several commenters asked questions about the management 
of settlement agreements.
    (Response) AMS is not addressing questions about management of 
settlement agreements in this rule because they are beyond the scope of 
this rule. More information on settlement agreements is available 
through the Organic Integrity Learning Center and annual training for 
certifying agents.
Mediation
    (Comment) AMS received a comment stating certifying agents should 
be allowed to propose mediation and offer settlement agreements.
    (Response) The regulations do not prohibit a certifying agent from

[[Page 3591]]

informing an operation of its willingness to engage in mediation prior 
to an operation requesting mediation. In addition, the regulations do 
not prohibit a certifying agent from offering a settlement agreement as 
part of mediation to resolve an adverse action.
    (Comment) AMS received a comment to replace the terms ``mediation 
session'' with ``mediation'' to allow informal mediation at Sec.  
205.663(e).
    (Response) AMS replaced ``mediation session'' with ``mediation'' to 
account for informal mediation which may not use the same format as 
formal mediation.
    (Comment) AMS received a comment to change the deadline to submit a 
request for mediation from ``30 days from receipt'' to ``30 days from 
date of issue.''
    (Response) AMS is declining to make this change, in order to align 
with USDA's Office of Administrative Hearings and Appeals, which uses 
date of receipt and not date of issue. This practice preserves due 
process rights of operations being notified of adverse actions. AMS 
believes that the use of electronic communications and the availability 
of electronic delivery confirmation will make this requirement less 
burdensome.
    (Comment) Comments requested that AMS align language for timeframes 
for requesting mediation and requesting an appeal.
    (Response) AMS agrees that the timeframes for requesting mediation 
and requesting an appeal when mediation fails should be consistent. We 
changed Sec.  205.663(b)(3) to state that an operation has 30 days from 
receipt of the rejection of request for mediation to file an appeal. We 
also changed Sec.  205.663(e) to state that an operation has 30 days 
from receipt of a written notice of termination of mediation to file an 
appeal. These changes make the timeframes to file an appeal consistent 
whether mediation is rejected or terminated.
    (Comment) AMS received a comment that both parties agreeing on the 
person conducting mediation should only apply to formal mediation.
    (Response) AMS disagrees that consensus on the person conducting 
mediation should only apply for formal mediation. Informal mediation 
also requires that parties agree on who will facilitate the mediation, 
even when the parties to the mediation facilitate the process 
themselves.

M. Adverse Action Appeal Process

    The table below includes the regulatory text related to this 
section of the rule. A discussion of the policy follows.

----------------------------------------------------------------------------------------------------------------
                       Section                                           Final regulatory text
----------------------------------------------------------------------------------------------------------------
205.2...............................................  Terms defined.
                                                      Definition for Adverse action.
205.680.............................................  Adverse Action Appeal Process--General.
                                                      Entire section.
205.68..............................................  Adverse Action Appeal Process--Appeals.
                                                      Paragraphs (a), (a)(2), (b), (c), and (d)(1) and (2).
----------------------------------------------------------------------------------------------------------------

General Appeals
    AMS revised parts of the adverse action appeals process in 
Sec. Sec.  205.680 and 205.681. These changes clarify which actions can 
be appealed, recognize the use of alternative dispute resolution in 
lieu of a formal administrative proceeding to resolve an appeal, and 
reinforce that appeal submissions need to comply with the basic 
requirements in the regulations.
    The OFPA calls for an expedited appeals procedure that gives 
persons affected by a proposed adverse action the opportunity to appeal 
that action (7 U.S.C. 6520). All appealed adverse actions are 
expeditiously reviewed and decided in an unbiased manner by persons 
that are not involved in the initial decision to issue an adverse 
action. In December 2014, AMS issued guidance to explain how it 
administers the adverse action appeal process, the status of an 
appellant during an appeal, and the possible outcomes of an appeal in 
NOP 4011, Adverse Action Appeal Process.\43\
---------------------------------------------------------------------------

    \43\ NOP 4011, Adverse Action Appeal Process. December 23, 2011: 
https://www.ams.usda.gov/sites/default/files/media/4011.pdf.
---------------------------------------------------------------------------

    The original USDA organic regulations described how certified 
operations, accredited certifying agents, and applicants for 
certification or accreditation may appeal a noncompliance decision that 
would affect their certification or accreditation status or eligibility 
to become certified or accredited (Sec.  205.680(a)). The regulations 
explained when an appeal may be submitted, how it must be submitted, 
and what the appeal submission must contain. Specifically, appeals of 
noncompliance decisions of a certifying agent or NOP are appealable to 
the AMS Administrator, or to the State organic program if the appellant 
is in a State with an approved State organic program. A decision to 
sustain an appeal will result in a favorable action with respect to the 
appellant's certification or accreditation. Following a decision to 
deny an appeal, AMS will initiate a formal administrative proceeding 
(i.e., a hearing), unless the parties resolve the issue through 
settlement, or the appellant waives the hearing. If an appeal is not 
timely filed, the adverse action which led to the appeal will be final 
and cannot be appealed further.
Adverse Action Defined
    The new term adverse action clarifies which actions may be appealed 
under the USDA organic regulations. Adverse action replaces the use of 
``noncompliance decision'' throughout this section. Adverse action is 
defined as 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.
Option To Request Mediation or Appeal of an Adverse Action Issued by a 
Certifying Agent or State Organic Program
    When a certifying agent or State organic program issues a proposed 
suspension or revocation, operations have the option to request 
mediation or appeal the proposed adverse action. Mediation is covered 
in more detail in Sec.  205.663. The mediation process can be a viable 
path to resolve noncompliances that are correctable and are not willful 
or recurrent. If mediation is rejected or is not successful, the 
operation maintains the right to appeal. The time frame for filing an 
appeal is calculated from receipt of the notice of rejection or 
termination of mediation (Sec.  205.663(b)(3) and (e)).
Administrative Requirements
    Appeals must be properly filed as described in paragraphs (c) and 
(d) of Sec.  205.681. This means that an appeal must be:

[[Page 3592]]

     Filed in writing within the time period provided in the 
letter of notification or within 30 days from receipt of the 
notification, whichever occurs later.
     Sent to the correct physical or email address:
    [cir] 1400 Independence Ave. SW, Room 2642, Stop 0268, Washington, 
DC 20250.
    [cir] [email protected].
     Include a copy of the adverse action and explain why the 
adverse action is incorrect.
    An adverse action will become final and nonappealable unless an 
appeal is timely filed. Appeals will be considered ``filed'' on the 
date received by the Administrator or by the State organic program.
Denied Appeals
    AMS supports the use of alternative means, such as mediation and 
settlement agreements to expedite resolution of an adverse action 
dispute while preserving due process and avoiding prolonged formal 
proceedings. When an appeal is denied, AMS offers the appellant the 
option to waive further hearing. When an appellant waives a hearing, 
the appeal decision is final and takes effect. Failing to timely submit 
a request for hearing is regarded as a waiver of hearing. In some 
cases, when an appeal is denied, AMS may pursue a settlement agreement 
in lieu of initiating a formal administrative proceeding. AMS assesses 
the potential for a settlement agreement on a case-by-case basis and 
will exercise this option when a settlement may offer a viable route 
for the operation to come back into compliance or to exit the organic 
sector. Even when an appellant requests a hearing, AMS and the 
appellant may enter into a settlement agreement prior to the hearing. 
This provides flexibility to resolve appeals outside of a lengthy 
formal administrative process. The appellant reserves the right to an 
administrative hearing. Entering into a settlement agreement is an 
optional, not compulsory, alternative to a hearing.
Changes From Proposed to Final Rule
    AMS made several revisions to the proposed regulatory text when 
writing this final rule, including revising Sec.  205.681(a)(2) and 
(b)(2) to state that the Administrator will initiate a formal 
proceeding and identify the conditions when that would not occur, i.e., 
the parties settle beforehand, or the appellant waives its right to a 
hearing. These sections explain that failing to timely request a 
hearing constitutes a waiver of hearing. AMS also deleted ``policies 
and procedures'' from 205.681(d)(3) to clarify that the USDA organic 
regulations are the basis for enforcement.
Summary of Public Comments
    Comments were generally supportive of the clarifications to the 
appeals sections of the USDA organic regulations. The main concern in 
comments was the revision to state that AMS ``may'' rather than 
``will'' initiate a formal administrative proceeding if the 
Administrator denies an appeal. The comments stated that this change 
removes due process rights of an appellant and should not be at the 
discretion of AMS. Other comments requested changes to appeal filing 
timeframes and delivery confirmation.
Responses to Public Comment
    (Comment) Comments opposed the change to not require AMS to 
initiate the hearing process following an appeal denial.
    (Response) AMS made changes to Sec.  205.681(a)(2) and (b)(2) to 
state that AMS will begin formal administrative proceedings once an 
appeal is denied. Those sections also explain that an administrative 
proceeding would not begin if the appellant waives or fails to timely 
request a hearing or AMS and the appellant reach a settlement 
agreement. This revision does not change AMS's intent that appellants 
always have the right to request a hearing following a denial of an 
appeal; it only provides options for a more expedient resolution in 
lieu of a hearing if the appellant consents to that outcome.
    (Comment) AMS received comments stating that the proposed revisions 
to Sec.  205.681(b) do not clearly provide appeal rights for certifying 
agents.
    (Response) Person, as defined in the regulations at Sec.  205.2, 
includes certifying agents and Sec.  205.681(b) allows persons to 
appeal an adverse action by the NOP Program Manager. Further, Sec.  
205.681(b)(1) explains what happens to accreditation when an appeal is 
sustained.
    (Comment) AMS received comments suggesting that dated return 
receipts should be replaced with documented delivery confirmation.
    (Response) AMS interprets dated return receipts to include 
electronic confirmation of electronic delivery, such as registered 
email which shows that a message has been delivered to recipient's 
email and the date of delivery.
    (Comment) AMS received comments that appeals should be filed within 
30 days of date of notice rather than date of receipt of notice.
    (Response) AMS is not making this change because it could interfere 
with due process rights of an appellant. We believe that appellant 
should have the full 30 days to appeal from the time that they receive 
the notice and not lose time due to possible delays in the mail or 
delivery service. Therefore, we are keeping this timeframe to 30 days 
from the date of receipt of notice to ensure that appellants have 30 
days to review the notice and to decide how to respond.
    (Comment) Comments requested that NOP timely respond to appeals 
because operations are allowed to remain certified during the appeal 
process and any subsequent hearing proceeding.
    (Response) AMS has procedures to thoroughly and efficiently 
evaluate NOP appeals. AMS generally resolves appeals within 6 months of 
receipt. AMS also frequently uses settlement agreements to resolve 
appeals which decreases the number of appeals that may potentially 
proceed to a hearing.

N. Producer Group Operations

    The table below includes the regulatory text related to this 
section of the rule. A discussion of the policy follows.

----------------------------------------------------------------------------------------------------------------
                       Section                                           Final regulatory text
----------------------------------------------------------------------------------------------------------------
205.2...............................................  Terms defined.
                                                      Definitions for Producer group member, Producer group
                                                       operation, Producer group production unit, and Internal
                                                       control system.
205.201.............................................  Organic production and handling system plan.
                                                      Paragraph (c).
205.400.............................................  General requirements for certification.
                                                      Paragraph (g).
205.403.............................................  On-site inspections.
                                                      Paragraph (a)(2).
----------------------------------------------------------------------------------------------------------------


[[Page 3593]]

    The organic industry has a longstanding practice of certifying 
groups of producers. This practice helps small farmers access the 
organic market and enables handlers to source products that are not 
produced in the United States. Compared with traditional producers and 
handlers, these groups of producers have unique needs in quality 
control and compliance. AMS is establishing requirements for producer 
group operations that promote consistent certification practices and 
ensure their continued viability and integrity. This rule codifies key 
provisions of the 2002 and 2008 NOSB recommendations on producer group 
certification, including:
     Establishing eligibility criteria for operations to 
qualify as producer group operations.
     Clarifying the function and responsibilities of Internal 
Control Systems (ICS).
     Clarifying inspection requirements for producer group 
operations.
    Additionally, this rule builds upon the NOSB recommendations with 
additional detail based on public comment and NOP's programmatic 
experience auditing certifying agents and witnessing producer group 
inspections. These additions include requirements for more specific ICS 
requirements, more specific member and group information in OSPs, and 
an improved inspection sampling rate.
    This rule strengthens the oversight of organic supply chains by 
enabling certifying agents to more readily assess a producer group 
operation's compliance with the USDA organic regulations. Certifying 
agents and operations that are certified as part of a producer group 
may be affected by these requirements. Readers should carefully review 
the regulatory text and policy discussion to determine if the 
requirements apply to them.
Background
    Producer group operations export important organic agricultural 
products to the United States, such as coffee, cocoa, bananas, tea, and 
spices.\44\ Globally, there are about 2.6 million organic producers 
organized across 5,900 producer group operations in 58 countries 
(mainly in Africa, Asia, and Latin America), managing a total area of 
about 4.5 million hectares (11 million acres) of certified organic 
land.\45\
---------------------------------------------------------------------------

    \44\ Producer groups may also be called ``grower groups.'' The 
latter term is commonly used when certification of group operations 
is limited to the production or harvest of crops or wild crops.
    \45\ Florentine Meinshausen, Toralf Richter, Johan Blockeel and 
Beate Huber Project: Consolidation of the Local Organic 
Certification Bodies--ConsCert (2014-2018)//March 2019 https://orgprints.org/id/eprint/35159/7/fibl-2019-ics.pdf.
---------------------------------------------------------------------------

    Producer group operations present unique certification challenges. 
Producer groups may have thousands of members spread across a large 
area. The collection, handling, and processing of crops may be 
centralized, and these groups may also rely on centralized input 
procurement, training, and marketing to sell their product. These 
centralized practices can introduce risks to traceability and organic 
integrity due to producer group operations' unique structure, size, and 
reliance upon internal quality control systems (the ICS) as the first 
layer of oversight. Through certification audits and field visits, USDA 
has witnessed many of the common problems created by the lack of a 
codified producer group standard.
    The most common, and difficult to address, challenge is lack of a 
well-functioning ICS. The ICS is the first line of oversight and 
enforcement and is responsible for critical functions such as education 
and inspection of members, and ensuring adherence to the organic 
regulations. A poorly functioning ICS often leads to poorly trained 
members who do not understand basic organic principles, and the ICS's 
lack of effective oversight means members' mistakes go unreported, 
resulting in a breakdown of the basic oversight necessary to ensure 
that products meet the USDA organic standard. As a result, NOP audits 
have uncovered issues such as application of prohibited synthetic 
fertilizers and pesticides, mixing of conventional and organic 
products, decentralized storage that causes mixing and contamination, 
and poor or nonexistent recordkeeping that makes traceability and 
verification of integrity difficult. These issues sometimes persist 
because the current regulations lack ICS responsibilities and NOP 
therefore has no mechanism or basis for citing noncompliance.
    Conflict of interest can also become a challenge if not 
specifically addressed by the ICS. Often, ICS personnel are relatives 
or friends of the members and may withhold or obscure evidence of 
noncompliance or fraud. In other cases, the influence of a buyer or 
exporter will lead members to compromise organic integrity in order to 
meet specific quality or volume targets.
    In addition to the ICS, the lack of general criteria that producer 
groups must meet creates challenges for certifying agents. This is most 
often seen as an absence of critical information about the producer 
group and its members. Producer groups often do not provide certifying 
agents with basic information, such as accurate maps, location of 
plots, acreage, and production practices and inputs. During inspection, 
certifying agents commonly cannot locate members, plots, boundaries, or 
central distribution points, making it difficult to complete basic 
audit techniques such as yield analysis or mass balance.
    The unique conditions of producer group production mentioned above, 
when combined with poor oversight and enforcement mechanisms at the ICS 
level, create an environment where loss of organic integrity and 
organic fraud are more likely to occur. The organic regulation 
currently does not have the specificity to address these unique 
challenges, making it challenging to both discover and correct issues 
that are prevalent in producer groups. The provisions in this rule 
codify specific eligibility criteria, ICS requirements, and inspection 
techniques to address these challenges, and the rule will give 
certifying agents the ability to successfully certify and oversee 
producer group operations and the products they produce.
    The International Federation of Organic Agriculture Movements 
(IFOAM) \46\ started developing criteria for producer group 
certification in 1994, and in 2003 published its position on ``Small 
Holder Group Certification for organic production and processing'' to 
support the concept.\47\ The criteria formed the basis for acceptance 
of producer group certification in the European Union (EU) and the 
United States. Producer group operation certification is also used by 
other standards organizations, such as the International Accreditation 
Forum and Global G.A.P., to provide small-holder farming operations 
access to markets, expand consumer choices, and ensure the integrity of 
the supply chain.\48\
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    \46\ https://www.ifoam.bio/.
    \47\ https://www.ifoam-eu.org/sites/default/files/page/files/small_holder_group_certification_0.pdf.
    \48\ https://www.iaf.nu/; https://www.globalgap.org/uk_en/.

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[[Page 3594]]

    Organic certification standards for producer group operations 
support strong and consistent oversight and enforcement of producer 
group operations. This final rule addresses 2002 and 2008 NOSB 
recommendations on producer group certification and adds detail about 
documentation requirements and inspection methods in response to public 
comments to the proposed rule.\49\ While there are only a few known 
producer groups in the U.S. at this time, setting requirements for 
producer groups may help U.S. producer group members access the organic 
cost-share program and crop insurance. These regulations support the 
legitimate status of U.S. producer group members as part of an organic 
operation.
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    \49\ NOSB Recommendation: Criteria for Certification of Grower 
Groups. October 20, 2002: https://www.ams.usda.gov/sites/default/files/media/Rec%20Criteria%20for%20Certification%20of%20Grower%20Groups.pdf.
    NOSB Recomendation: Certifiying Operations with Multiple 
Production Units, Sites, and Facilities under the National Organic 
Program. November 19, 2008: https://www.ams.usda.gov/sites/default/files/media/NOP%20Final%20Rec%20Certifying%20Operations%20with%20Multiple%20Sites.pdf.
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Qualifying as a Producer Group Operation
    Certifying agents must assess whether operations that apply for or 
maintain producer group certification meet the characteristics in the 
definitions for producer group member, producer group operation, and 
producer group production unit and the qualifications for certification 
as producer group operations in 205.400(g). Operations that do not meet 
all criteria must not be certified as a producer group operation.
    The smallest unit of a producer group operation is a producer group 
member. A producer group member is an individual engaged in the 
activity of producing or harvesting agricultural products as a member 
of a producer group operation. The practices of each producer group 
member must align with the organic system plan (OSP) of the producer 
group. Each member must use practices that comply with the requirements 
for producers and handlers in the USDA organic regulations. Some 
requirements may be met collectively by the producer group operation, 
such as submitting an organic system plan.
    Producer group members are organized into production units. A 
producer group production unit is 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. Each producer group operation determines the 
producer group production units in its operation and must identify 
these in the organic system plan per Sec.  205.201(c)(4).
    A producer group operation is 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 producer group operation must define 
its geographic proximity criteria for its producer members and 
production units Sec.  205.201(c)(4). The site-specific conditions of 
an operation, such as infrastructure, topography, common soil, water 
source, and products produced will affect ``geographic proximity.'' 
Therefore, AMS is requiring that certifying agents document and adopt 
their own criteria or guidelines for internal consistency when 
establishing acceptable distances or evaluating the geographic reach of 
a producer group operation.
    Producer group operations may be certified for crops, wild crops, 
livestock, and handling. The requirements for production and handling 
operations in the USDA organic regulations also apply to producer group 
operations.
Structure and Organization of Producer Group Operations
    A producer group operation must be organized as a person (Sec.  
205.400(g)(1)). Organization as a person provides a path to 
certification because OFPA and the USDA organic regulations apply to a 
person as the basic regulatory unit. The definition for person at 7 
U.S.C. 6502(16) and Sec.  205.2 includes groups (e.g., ``. . . 
association, cooperative, or other entity''). Therefore, certification 
may be granted to the producer group operation, rather than individual 
producer group members.
    A producer group operation must use centralized processing, 
distribution, and marketing facilities and systems (Sec.  
205.400(g)(2)). A group may have several facilities for aggregating the 
products of producer group members and production units and moving into 
commerce.
    An internal control system (ICS) is a defining component of 
producer group operations and is critical for management of the 
operation. The ICS is an additional tier of oversight and enforcement 
between the producer group members and the certifying agent. All 
producer group operations must have an ICS that implements the 
practices and procedures described in the organic system plan (Sec.  
205.400(g)(4)). Further ICS requirements are discussed in the following 
section.
    All products sold, labeled, or represented as organic by a producer 
group operation must be produced or harvested only by producer group 
members on land and using facilities that are included in the producer 
group operation's certification (Sec.  205.400(g)(5)). This means that, 
for example, a producer group member from one operation (A) must not 
use a handling facility owned by another producer group operation (B) 
unless the facility is included in the organic system plan and the 
producer group operation's (A) certification. A producer group 
operation must not buy products from non-member producers and sell, 
label, or represent them as organic using the producer group 
certification. Likewise, producer group members must not sell, label, 
or represent their products as organic outside of the producer group 
operation unless they are individually certified (Sec.  205.400(g)(6)). 
This accommodates producer group operations with members of varying 
production levels where some members have the capacity and need for 
marketing channels in addition to the producer group operation. When 
this occurs, clear and careful recordkeeping is essential for 
successful mass-balance audits.
    Producer group operations must provide a comprehensive inventory of 
the producer group operation and its capacity to the certifying agent. 
Specifically, the operation must provide the name and location of each 
producer group member and producer group production unit(s), and 
identify all products produced, estimated yield(s), and the sizes of 
the production and harvesting areas (Sec.  205.400(g)(7)). Producer 
group operations must provide this information to the certifying agent 
at least annually and should inform the certifying agent more 
frequently of changes that may affect its compliance with OFPA or the 
USDA organic regulations, e.g., additional crops produced, inclusion of 
new land area and producer group members.
    Producer group operations must also show evidence of compliance 
with the USDA organic regulations through internal inspections and 
reporting sanctions imposed on producer group members. It is not 
feasible for certifying agents to inspect each producer member 
annually, due to the number of members in any one producer group 
operation. However, the producer member must attend the internal 
inspection to provide complete information about their

[[Page 3595]]

production activities (Sec.  205.400(g)(8)). Internal inspections must 
include mass-balance audits and reconciliation of each producer group 
member's and each producer group production unit's yield and group 
sales. Records are critical to demonstrate compliance and producer 
group operations must maintain a recordkeeping system so that products 
are traceable from producer group members' individual production parcel 
to aggregation and handling at the production unit and through sale or 
transport when the products leave the custody and ownership of the 
producer group operation (Sec.  205.400(g)(9)).
Internal Control Systems
    Pursuant to the 2002 NOSB recommendation ``Criteria for 
Certification of Grower Groups'' \50\ and an August 2020 IFOAM position 
paper,\51\ all producer group operations must have an internal control 
system (ICS). The internal control system is 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 consists of both the personnel and the procedures 
that form a producer group's internal governance, verification, and 
enforcement system. The ICS is responsible for the overall governance 
and compliance of the producer group operation and verifies each 
member's adherence to the organic system plan and USDA organic 
regulations.
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    \50\ NOSB Formal Recommendation, Criteria for Certification of 
Grower Groups, October 20, 2002: https://www.ams.usda.gov/sites/default/files/media/Rec%20Criteria%20for%20Certification%20of%20Grower%20Groups.pdf.
    \51\ ``Internal Control Systems (ICS) for Group Certification,'' 
IFOAM Organics International, August 2020, https://www.ifoam.bio/our-work/how/standards-certification/internal-control.
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ICS Functions
    A producer group operation must have an OSP that meets the 
requirements for all operations in Sec.  205.201(a) and additionally 
must describe its ICS procedures and practices. Section 205.201(c) 
describes the OSP requirements that are specific to producer group 
operations. The OSP for a producer group operation needs to include a 
description of the ICS and how it verifies the operation's compliance 
with the USDA organic regulations. This includes defining the 
organizational structure, roles, qualifications, and responsibilities 
of all ICS personnel (Sec.  205.201(c)(1)). Personnel qualifications 
could include, for example, knowledge of local production practices, 
organic production and handling practices, ICS procedures, USDA organic 
regulations, and fluency in the language(s) of the producer group 
operation.
    The ICS must also describe and prevent conflicts of interest 
between ICS personnel and the producer group operation that it oversees 
(Sec.  205.201(c)(3)). The USDA organic regulations identify conflict 
of interest scenarios for certifying agent and operations (Sec.  
205.501(a)(11)). The ICS personnel-producer member relationship is 
different than the certifying agent-certified operation relationship so 
these criteria are not wholly applicable to producer group operations. 
For example, certifying agents are not permitted to consult with 
operations to overcome obstacles to certification. However, ICS 
personnel are required to provide training, education, and resources to 
assist producer members with awareness of, and compliance with, organic 
requirements. A generally accepted criteria for conflict of interest is 
whether an oversight entity, e.g., the ICS, has a financial interest in 
the regulated party or likely bias based on familial relations. For 
example, internal inspectors should not inspect family members or 
production units where the inspector is a member.
    The oversight function of the ICS places its personnel at a higher 
risk for retribution from producer group operations. To support the 
integrity of ICS oversight, the ICS must also describe how it will 
protect ICS personnel from retaliation for carrying out their 
responsibilities, and, in particular, finding and reporting 
noncompliances (Sec.  205.201(c)(3)). This could include obtaining a 
written guarantee from the producer group operation that ICS personnel 
will not be subject to retribution and requiring ICS personnel to 
disclose any conflicts of interest prior to internal inspections or 
review.
    The ICS must document and apply procedures for adding new members 
to a producer group operation (Sec.  205.201(c)(5)). These procedures 
must cover how each new member will be inspected by the ICS and 
evaluated to determine whether they can fully comply with the organic 
production and handling requirements before they are added as a 
producer member.
    Producer group members use common practices to produce, harvest, 
and handle their collective products and common inputs. Shared farming 
or harvesting practices could include fertility and pest management, 
procurement of inputs (including seeds or soil amendments), and shared 
resources could include post-harvest handling facilities. The ICS must 
describe how shared resources, including production practices and 
inputs, are procured and provided to all producer group members and 
personnel (Sec.  205.201(c)(7)). Shared practices and inputs are 
critical to fostering compliance among many individual farmers and 
documenting these practices is an important indicator of compliance for 
the entire operation. Training, education, and technical assistance are 
critical practices to support consistent and compliant practices among 
producer members and the description of the ICS must explain how these 
resources are provided (Sec.  205.201(c)(8)).
Internal Oversight
    The ICS is the first line of oversight of a producer group 
operation and is responsible for assessing the compliance of producer 
group members. The USDA organic regulations include several 
requirements to ensure that the ICS provides competent and thorough 
oversight. More generally, the ICS must have documented clear policies 
and procedures to verify the producer group operation's and producer 
group members' compliance with the USDA organic regulations (Sec.  
205.201(c)).
    The ICS must identify criteria for high-risk producer group members 
and production units (Sec.  205.201(c)(6)). Certifying agents must also 
determine which producer members are high risk. Examples of risk 
factors that may be used by both the ICS and the certifying agent are 
listed below in the discussion of on-site inspection by the certifying 
agent.
    Clear and comprehensive records are a critical component of an ICS. 
They help certifying agents understand how the operation is 
implementing its organic system plan and complying with the USDA 
organic regulations. The organic system plan must describe the system 
of records maintained by the ICS (Sec.  205.201(c)(9)). The system of 
records must show how records will support and be used for mass-balance 
calculations and traceability throughout the operation. For full 
traceability, records would need to cover the purchase, acquisition, or 
production of products for each producer member through sale or 
transport.
    The description of the ICS must explain internal monitoring, 
surveillance, sanctions, inspection, and auditing methods used to 
assess compliance of all producer group

[[Page 3596]]

members (Sec.  205.201(c)(10)). As a best practice, internal monitoring 
and surveillance should cover critical organic control points may 
include, for example, buffer areas, condition of crops and/or wild 
crops and animals, soil quality indicators, handling practices, input 
and equipment use and storage areas. A description of sanctions may 
cover the review of internal inspection results to determine member 
compliance; and the processes to address noncompliances, impose 
sanctions, remove noncompliant producer group members and reporting 
noncompliances to the certifying agent. A description of the auditing 
methods could cover mass-balance audits to reconcile the expected and 
actual yields and sales of producer members, producer group production 
units, and producer group operations.
On-Site Inspections by the Certifying Agent
    Certifying agents are the second tier of oversight for producer 
group operations. Certifying agents, in addition to verifying that 
producer group operations are fully compliant with the eligibility, 
certification and ICS requirements, must follow specific requirements 
for on-site inspections of producer group operations. Initial and 
annual on-site inspections of producer group operations must comply 
with the general requirements for inspections in Sec.  205.403. During 
annual on-site inspections of producer group operations, certifying 
agents are required to evaluate the ICS, review internal inspections 
conducted by the ICS of individual members, and observe ICS personnel 
conducting internal inspections (Sec.  205.403(a)(2)(i)-(ii)). At least 
one producer group member from each producer group production unit must 
be inspected, and each handling facility, including all collection 
sites, must be inspected (Sec.  205.403(a)(2)(iii)-(iv)). Collection 
sites, where the harvest from multiple producer group members is stored 
before transport, are handling facilities, and are inspected by 
certifying agents. USDA organic regulations do not set a minimum number 
or percentage of witness inspections that a certifying agent must 
conduct at each producer group operation inspection. Witness 
inspections are a key component of assessing the ICS and certifying 
agents will need to ensure that the number of witness inspections at a 
given operation is sufficient to evaluate ICS rigor.
    During on-site inspections, certifying agents must inspect at least 
1.4 times the square root or 2% of the total number of producer group 
members, whichever is higher (Sec.  205.403(a)(2)(iii)).\52\ The square 
root sampling rate aligns with industry practice. Two sampling rates 
are provided because the power of the square root sampling power begins 
to decline when operations exceed 5,000 members so that a smaller 
proportion of members are inspected relative to the total number of 
members. The addition of the 2% rate more evenly distributes the number 
of external inspections across producer groups regardless of the number 
of members as shown in Table 1. For each producer group operation, 
certifying agents need to calculate the number of members to inspect 
using the square root method and the 2% rate and use the higher number.
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    \52\ The square root sampling scheme was developed in the 1920s 
as a sampling scheme for agricultural regulatory inspectors. The 
formula used was the square root (Sqrt) of the lot size (N) + 1. 
Blanck, F.C. (1927). ``Report of the Committee on Sampling,'' J. 
Assoc. Official Agricultural Chemists, 10, 92-98.

                             Table 1--Certifying Agent ICS Inspection Sampling Rates
----------------------------------------------------------------------------------------------------------------
                  Producer group members (N)                      Square root       Flat 2%        Final rule
---------------------------------------------------------------     method     ---------------------------------
                                                               ----------------                 Greater of 1.4 *
                               N                                1.4 * [radic]N        2%         [radic]N or 2%
----------------------------------------------------------------------------------------------------------------
50............................................................              10               1                10
100...........................................................              14               2                14
250...........................................................              23               5                23
500...........................................................              32              10                32
1000..........................................................              45              20                45
5000..........................................................              99             100               100
7500..........................................................             122             150               150
10000.........................................................             140             200               200
----------------------------------------------------------------------------------------------------------------

    The number of producer group members inspected by the certifying 
agent must include all high-risk members (Sec.  205.403(a)(2)(iii)). 
Certifying agents must inspect at least one producer group member in 
each production unit (as defined in Sec.  205.2) to ensure all producer 
group production units are inspected, as well as each handling 
facility. As a best practice, AMS recommends that certifying agents 
also select members from across the risk spectrum--including lower-risk 
members--so that the same producer members are not inspected year after 
year. This may require a sample size larger than the minimum required 
(i.e., more than 1.4 times the square root or more than 2% of the 
number of producer group members). All numbers must be rounded up to 
the next whole number (e.g., using square root method, 50 members = 10 
inspections, 100 members = 14 inspections, 500 members = 31 
inspections, and 1,000 members = 44 inspections). The certifying agent 
has the discretion to inspect more producer group members than the 
minimum indicated by the calculation.
    Risk-based inspections rely upon certifying agents having policies 
and procedures to determine the risk factors associated with producer 
group operations. While the ICS determines which producer members and 
production units are high-risk according to their criteria, the 
certifying agent needs to independently determine which members are 
high-risk (Sec.  205.403(a)(2)(iii)). The certifying agent should apply 
the risk assessment procedures to determine and instruct the inspector 
on which producer group members to inspect during the annual 
inspection. After all risk-based and other inspection selection 
criteria are satisfied, certifying agents should randomly select the 
remaining member inspections so that different lower-risk producer 
group members are inspected each year.
    Risk factors may include, but are not limited to, producer group 
administrative capacity, organization complexity, and variations in 
members and production units (such as product quantity and value, 
member size,

[[Page 3597]]

number of products), rate of growth, and compliance and enforcement 
history. For example, a producer group member selling products outside 
of the producer group or a producer group member that is considerably 
larger than the other producer group members in a production unit 
represent compliance risks to the overall producer group operation. 
When assessing the risks of the producer group operation to determine 
which producer group members to inspect, examples of risk factors that 
the certifying agent may consider include, but are not limited to:
     Noncompliance history of overall producer group and of 
individual members;
     The criteria used to designate a collection of producer 
group members as a single producer group production unit;
     High-risk members identified in the ICS and producer 
groups member with noncompliances;
     Application of prohibited materials adjacent to member 
fields;
     Split or parallel operations (i.e., operations that are 
also producing nonorganic agricultural products);
     Producer group members with incomes greater than $5,000 
USD per year;
     The procurement, availability, and distribution of inputs 
and resources to members;
     The prevalence of nonorganic production of similar 
products and crops in the region;
     Post-harvest handling practices designed to prevent 
commingling and contact with prohibited substances;
     New producer group members;
     Size of producer group member's production or gathering 
areas; and
     Significant expansion of a producer group member's 
production area.
    As a best practice, the inspection of the ICS should also include: 
document review; auditing of production and sales/distribution records; 
reconciliation of product inventory; review of procurement and 
distribution of inputs; review of the inspections conducted by the ICS; 
review of ICS personnel qualifications and training; witness audits to 
observe ICS inspectors; review of noncompliance actions for producer 
group members; examination of organic control points and high-risk 
areas; interviews with managers responsible for the OSP, governance of 
the ICS, and producer group members and individuals overseen by the 
ICS; and review of training provided to ICS staff and producer group 
members.
Summary of Changes to Final Rule
    AMS made several changes to the proposed regulatory text when 
writing this final rule. Changes to the final rule are discussed below 
and are followed by responses to specific themes from public comment.
     AMS revised the definitions of producer group member, 
producer group operation, producer group production unit and internal 
control system to allow livestock production and to clarify that the 
operation is regulated as a person. Use of the term ``individual'' in 
producer group member and ``person'' in producer group operation more 
clearly indicates that the operation is the legal regulated entity, 
which is consistent with current regulation and ties to the existing 
defined term person (see Sec.  205.2).
     AMS replaced ``crop/wild-crop'' with ``agricultural 
product'' throughout so that livestock and livestock products are not 
excluded from producer group operation production. Public commenters 
argued that a prohibition on livestock in producer group certification 
may disproportionately affect poor and small-scale farmers that depend 
on producer groups to access the organic market. Livestock production 
in producer group certification is consistent with EU organic 
standards, IFOAM, the 2008 NOSB recommendation, and current practice in 
the organic industry. Allowing livestock production avoids market 
disruption and negative impact to operations that depend on producer 
group certification for market access.
     AMS added more specificity to the description of the ICS 
in the organic system plan, including: describing qualifications of ICS 
personnel; procedures for approving new members; policies to protect 
ICS personnel from retribution; description of technical assistance to 
members; and a system of records that covers each member and support 
mass-balance audits and traceability. Public comments stressed the 
importance of the ICS and suggested modifications to strengthen the 
ICS's ability to enforce the organic regulations and maintain organic 
integrity. AMS agrees with public comments and has revised ICS 
requirements to be more specific because this is necessary to bolster 
the oversight and enforcement of producer groups.
     AMS clarified that producer group operations must only 
sell products from the land and facilities included in the 
certification. The proposed text only specified ``from grower group 
members.'' Additionally, requiring that producer groups only sell 
products produced using land and facilities within the certified 
operation improves oversight because these facilities and land are 
routinely inspected by the ICS and the certifying agent.
     AMS added a requirement that producer group operations 
must maintain an ICS as described in the organic system plan. Although 
it was implied, proposed Sec.  205.400(g) did not include an explicit 
requirement to maintain an ICS and did not reference the ICS 
requirements (Sec.  205.201(c)). Adding this explicit requirement makes 
an ICS a clear condition of certification that must be included as part 
of an organic system plan.
     AMS clarified that producer group members must be present 
during internal inspections. Having producer group members present 
during onsite internal inspections is necessary so that ICS personnel 
can interact with and ask questions of the members to ensure a full 
understanding of the activities on the members' production sites.
     AMS removed a redundant requirement from Sec.  205.400(g) 
that the producer group operation must document and report the use of 
sanctions; the description and implementation of a system of sanctions 
is covered in Sec. Sec.  205.201(c)(10) and 205.400(g)(4) and (10).
     AMS adjusted the sampling rates certifying agents must use 
when inspecting producer groups to 1.4 times the square root or 2% of 
the total number of producer group members, whichever is higher. The 
proposed inspection rate of 1.4 times the number of members is a 
digressive rate, which samples a smaller percentage of members as a 
group grows larger. Combining this with a linear 2% sampling rate 
ensures that larger producer groups (those with more than 5,000 
members) are inspected at a similar rate as smaller groups.
     AMS revised Sec.  205.403(a)(2)(iii) to clarify that a 
certifying agent must inspect all producer group members determined to 
be high-risk by the certifying agent. The proposed rule had stated that 
high-risk members should be chosen based on the ICS's risk criteria. 
This change improves oversight by ensuring that a certifying agent 
conducts independent risk assessments based on their own risk criteria, 
rather than relying only on the ICS's assessment.
Summary of Public Comments
    The majority of public comments received supported AMS's 
codification of producer group standards in the USDA organic 
regulations. Many comments provided suggestions and

[[Page 3598]]

recommendations to the proposed policy.
    Many comments strongly opposed the proposed prohibition of 
livestock production within producer groups, requesting that AMS revise 
the standard to allow ``scope neutrality'' and the production of 
livestock and livestock products. Several commenters stated that many 
certified producer groups already produce livestock and livestock 
products, and that prohibiting livestock would negatively impact these 
operations.
    Several comments suggested AMS add more specificity to the proposed 
ICS requirements to ensure the ICS can manage the unique challenges of 
producer groups. Commenters requested more detail about conflict of 
interest, training, risk assessment, inspections, recordkeeping, 
personnel qualifications, protections for farmers, and evaluation of 
the ICS by the certifying agent. Commenters pointed to specific details 
found in the preamble describing organic system plans and the internal 
control system and requested these be added to the final rule to 
support clarity and consistency.
    The proposed rule asked if producer group risk should be managed by 
placing limits on scale (e.g., number of members, size of individual 
members, geographic distribution of members). Most commenters agreed 
that the risks of uncontrolled size or scale should be addressed but 
felt prescriptive limits may arbitrarily exclude members, disrupt well-
functioning groups, restrict economic opportunity, or force producers 
to revert to conventional methods. The majority of commenters advocated 
for ``scale neutrality'' and requested NOP develop alternate strategies 
to manage the risks of large producer group operations.
    Several comments requested that AMS require the use of risk 
criteria and assessment to control issues of scale. Others recommended 
that AMS develop a separate scope of accreditation specifically for 
producer groups, arguing that certification of these operations 
requires specialized skill and oversight. A few comments noted the 
difficultly of identifying producer groups in the Organic Integrity 
Database, and asked for identification to be mandatory. Some comments 
noted differences between the proposed policy and other international 
standards, and asked AMS to align its producer group standards with EU 
and IFOAM. Finally, a few comments expressed concern that the producer 
group standard may be used by large livestock or poultry cooperatives 
in the United States, which they argue is against the intent of the 
standard to support opportunity and growth for very small organic 
farmers.
Responses to Public Comments
    (Comment) Some commenters recommended specific limits on parcel 
size and number of members in a producer group operation because a lack 
of controls on scale could lead to inadequate and inconsistent 
enforcement. Commenters mentioned that an ICS could be reluctant to 
enforce against a large producer member without which the producer 
group could fail.
    (Response) AMS is not setting size limitations, in terms of land 
area or number of members, on producer group operations. The ICS 
requirements support effective oversight of producer group operations 
regardless of their size.
    (Comment) Comments opposed the proposed prohibition of livestock 
producer group operations. Commenters argued that this may 
disproportionately affect poor and small-scale farmers that depend on 
producer groups to access the organic market. Some comments mentioned 
that livestock producer group operations are already certified for beef 
and honey production.
    (Response) AMS revised the proposed rule to allow the certification 
of livestock production as producer group operations. This allowance 
aligns with the EU organic standards for producer group operations and 
the 2008 NOSB recommendation, which did not restrict producer group 
certification to crop and wild crop operations. Livestock producer 
group operations may be more complex and higher risk than crop and wild 
crop producer group operations. In practice, this will require careful 
oversight of the ICS and qualifications of ICS inspectors and 
personnel. Further, some types of livestock production may be 
unsuitable for group certification (e.g., intensive livestock farming, 
variability between producer members) because it is more difficult for 
them to meet the requirements for certification as a producer group 
operation.
    (Comment) Comments requested a separate scope of accreditation for 
producer group certification to ensure that certifying agents are 
sufficiently qualified to certify producer groups.
    (Response) Establishing a separate scope of accreditation would 
require more input and assessment of impacts, as this was not included 
in the proposed rule. This type of certification is complex and 
presents higher risks for organic integrity. AMS will assess certifying 
agents' oversight of and qualifications for producer group 
certification through rigorous audits.
    (Comment) Comments suggested that the ICS should describe the 
qualifications of all ICS personnel and the procedure to ensure the 
availability of a sufficient number of qualified personnel. Comments 
specified that the ICS should describe how ICS personnel are familiar 
with the local production practices, general organic production and 
handling practices, the USDA organic regulations, ICS procedures and 
regulations, and be fluent in the language(s) of the producer group 
members and the ICS.
    (Response) The description of the ICS must describe the 
qualifications and responsibilities of ICS personnel. AMS has 
identified examples of the knowledge qualifications for ICS personnel, 
but is not adding these as required to give flexibility to certifying 
agents to determine the suitable qualifications on specific operations.
    (Comment) Comments asserted that producer group operations must 
ensure that all group members understand and can comply with the USDA 
organic regulations. Commenters urged that the ICS should describe how 
the training, education, and technical assistance that is provided to 
producer group members and ICS personnel ensures their understanding of 
and compliance with internal control system's policies, the organic 
system plan, and the USDA organic regulations.
    (Response) Producer group operation compliance requires that each 
member understand the required and prohibited practices for organic 
production and handling. AMS has added a requirement for the ICS to 
include training, education, and technical assistance to producer 
members (205.201(c)(8)). Given that producer group operations are 
located in areas with varying language and literacy proficiency, it is 
the responsibility of the operation to effectively communicate this 
information to all members on an ongoing basis.
    (Comment) Comments stated that the ICS should explain how it 
manages conflicts of interest by addressing or prohibiting internal 
inspectors from inspecting or acting as buying officers for their own 
relatives. Comments also requested guidance around conflict-of-interest 
scenarios and that internal inspectors are not restricted from 
providing training, education, or technical assistance to producer 
group members.
    (Response) The description of the ICS must explain how it will 
prevent potential conflicts of interest. The development of guidance on 
specific examples of conflict of interest needs further public input 
and discussion and

[[Page 3599]]

that level of detail was not included in the scope of this rule. 
Certifying agents will review the ICS to determine if known potential 
conflicts of interest are identified and prevented. AMS agrees that 
internal inspectors inspecting or procuring products from their 
relatives would be potential conflicts of interest because the 
relationship may compromise the inspector's objectivity in assessing 
compliance.
    (Comment) Comments stressed that group members need to be present 
during their internal inspection and that more guidance is needed to 
ensure the ICS is addressing noncompliances and reporting major 
noncompliances to the certifying agent.
    (Response) AMS has added the requirement for producer members to be 
present at the inspection of their production site(s). Maintaining an 
organized, transparent, and equitable system of sanctions is critical 
for producer group certification. The ICS must have procedures for 
implementing a system of sanctions, and the producer group operation 
must report sanctions for noncompliant members to the certifying agent. 
The requirements for recordkeeping that covers internal inspection 
reports, sanctions, and corrective actions plus the external inspection 
requirements will help certifying agents to assess whether the ICS is 
reporting noncompliances and sanctions to the certifying agent.
    (Comment) Comments supported that the ICS describe the 
recordkeeping system that must cover signed member agreements, internal 
inspection reports, documents related to internal sanctions and 
corrections, and formal agreements for each producer group member that 
commits them to complying with ICS, OSP, and USDA organic regulations, 
along with all training records for members and personnel. The ICS 
procedures should state how lists of individual members, locations, 
products, acreage, copies of inspection reports, sanctions, and 
corrections are stored and made available during inspection by the 
certifying agent.
    (Response) The USDA organic regulations require a description and 
implementation of the recordkeeping system. The critical objective of 
recordkeeping is to support traceability of production, inputs, and 
transactions throughout the producer group operation. Information about 
sanctions and internal inspection reports are required by separate 
provisions.
    (Comment) Comments requested clarification about what types of 
noncompliances (i.e., major vs minor) must be reported to the 
certifying agent.
    (Response) The requirement to report noncompliances to the 
certifying agent enables the certifying agent to assess ICS oversight. 
It also leaves flexibility for the ICS to describe different timing and 
reporting methods for noncompliances of varying scope and severity. 
Noncompliances that may result in removal of the member(s) from the 
producer group, for example, application of prohibited substances, 
warrant timely notification to the certifying agent. In contrast, 
maintaining records of correctable noncompliances for the certifying 
agent to review during external inspections would be acceptable.
    (Comment) Comments stated that the use of 1.4 times the square root 
of the number of members is not adequate for external inspections. They 
explained that this inspection rate is either too low for a producer 
group with more than 5,000 members, resulting in potentially inadequate 
oversight of very large groups, or the inspection rate is too high and 
burdensome for small producers, resulting in pressure to grow larger to 
reduce certification costs. Comments suggested other rates including a 
flat percentage rate of 2-3%, a combination of square root and flat 
rate methods, or a minimum of 10% of producer group members.
    (Response) The external inspection sampling rate should be equally 
stringent for producer member operations regardless of size. The USDA 
organic regulations specify that certifying agents must use the higher 
result of 2 sampling rates to set the minimum number of producer 
members that need to be inspected. Setting 2 rates is necessary because 
the square root sampling power begins to decline when producer groups 
are larger than 5,000 members. The use of 1.4 times the square root or 
2% of the total number of producer members is a minimum and does not 
prevent certifying agents from using sampling sizes that exceed the 
results of those rates. Higher levels of inspection rates may be 
warranted when necessary if a producer group operation has a history of 
inadequate internal controls and poorly trained personnel with 
ineffective policies, procedures, or sanctions, and is failing to 
enforce against noncompliant members, failing to inspect all members, 
or is not completing mass-balance audits.

O. Calculating the Percentage of Organically Produced Ingredients

    The table below includes the regulatory text related to this 
section of the rule. A discussion of the policy follows.

----------------------------------------------------------------------------------------------------------------
                       Section                                           Final regulatory text
----------------------------------------------------------------------------------------------------------------
205.302.............................................  Calculating the percentage of organically produced
                                                       ingredients.
                                                      Paragraphs (a)(1), (2), and (3).
----------------------------------------------------------------------------------------------------------------

    This rulemaking revises Sec.  205.302(a) to clarify that the 
percentage of organic ingredients in multi-ingredient products should 
be calculated by dividing the weight or volume of the organic 
ingredients at formulation by the total weight or volume of the product 
at formulation, with water and salt added as ingredients at formulation 
excluded from the calculation.
    This policy may affect certified operations, noncertified 
operations that process products containing organic ingredients, 
applicants for organic certification, and certifying agents. The reader 
should carefully examine the regulatory text and discussion below.
Background
    Section 205.301 of the organic regulations classify products 
containing organic ingredients into several categories based on percent 
composition--e.g., ``100 percent organic,'' ``organic,'' ``made with 
organic (specified ingredients or food group(s)).'' Clear and easily 
understood instructions for calculating product composition are needed 
to ensure consistent classification by the organic industry.
    Previous policy had sometimes caused inconsistent implementation 
because it required calculation based on ``total weight of the finished 
product.'' It was unclear if this meant products before or after 
processing. Because processing (e.g., cooking, baking, dehydrating, 
freeze drying) often causes water loss from ingredients, using the 
total weight of the product after processing sometimes resulted in 
inflated percent organic content calculations. This rulemaking 
clarifies that organic content must be calculated from the weight of 
ingredients at formulation (i.e., before processing such

[[Page 3600]]

as baking or cooking). This will ensure correct calculation of organic 
content so that labels on multi-ingredient organic products are 
accurately listed. This requirement also addresses an existing point of 
confusion and will increase the consistency of organic labeling claims 
in processed organic products. This policy is consistent with both an 
April 2013 NOSB recommendation \53\ and NOP 5037 Draft Guidance 
published by AMS in December 2016.\54\
---------------------------------------------------------------------------

    \53\ NOSB Recommendation, Calculating Percentage Organic in 
Multi-Ingredient Products, April 11, 2013: https://www.ams.usda.gov/sites/default/files/media/NOP%20CACC%20Final%20Rec%20Calculating%20Percentage.pdf.
    \54\ The draft guidance and comments can be viewed at https://www.regulations.gov/document?D=AMS-NOP-16-0085-0001 and in the NOP 
Program Handbook: https://www.ams.usda.gov/sites/default/files/media/NOP5037DraftGuidancePercentCalculations.pdf.
---------------------------------------------------------------------------

Calculating Percentage of Organic Ingredients
    To calculate the percentage of organic ingredients in a multi-
ingredient product, divide the weight or volume of the organic 
ingredients at formulation by the total weight or volume of the product 
at formulation. If water and salt are added as ingredients, these must 
be excluded from the calculation. If a multi-ingredient product 
contains only liquids, volume must be used for calculation. If a 
product contains both solid and liquid ingredients, weight must be used 
for calculation. Please see Table 2, below, for an example of how to 
calculate the percentage organic content of a multi-ingredient product.
    Liquid ingredients being reconstituted from concentrates should be 
calculated based on single-strength concentrations. The term ``single-
strength'' is defined by the Food and Drug Administration (21 CFR 101) 
as equivalent to the Brix value of 100 percent juice. Brix is a 
measurement referring to the percent, by mass, of soluble solids 
(generally sugar) in a solution. Brix is a useful reference in 
identifying single-strength identities of juices (see 21 CFR 
101.30(h)(1)) as the mass of sugar and other soluble solids is not 
affected by the concentration process (i.e., the same mass of sugar 
will be present in 1 liter of apple juice measured at 11.5 Brix, as is 
present in 0.5 liters of concentrated apple juice measured at 23 Brix). 
Reconstitution is taking a concentrated juice product and adding water 
to dilute the concentrated juice back to single-strength values. Using 
the previous example, if a producer starts with 0.5 liters of 
concentrated apple juice, they could add water to increase the total 
volume to 1 liter, bringing the juice back to the original Brix value 
of 11.5. Allowing for reconstituting concentrated juice gives producers 
flexibility in shipping, storage, and use of juice products in organic 
production.
    For products that have ingredients composed of multiple ingredients 
(also referred to as ``multi-ingredient ingredients''), the exact 
organic content should be obtained of that multi-ingredient ingredient 
when calculating the total organic content of the final organic 
product. In this case, the calculation should identify the organic and 
nonorganic parts of the multi-ingredient ingredient and supporting 
documentation should be available for the certifying agent to review. 
Alternatively, these ingredients should be calculated as contributing 
either 95% organic content or 70% organic content depending on how the 
product is classified (i.e., either ``organic'' or ``made with organic 
(specified ingredients or food groups)'' respectively).

                             Table 2--Calculating Percent Organic of a Soy Beverage
----------------------------------------------------------------------------------------------------------------
                                                          Weight of
                                                        ingredient at    % Organic        % In          Actual
                      Ingredient                         formulation     content of    formulation    organic %
                                                            (lbs.)       ingredient
----------------------------------------------------------------------------------------------------------------
Organic Soy Base.....................................            1,100          100           16.42      16.4200
Organic Cane Sugar...................................            5,288          100           78.94      78.9400
Organic Vanilla Extract..............................               60           95            0.89       0.8455
Vitamins.............................................               50            0            0.74       0.0000
Calcium Phosphate....................................              100            0            1.49       0.0000
Carrageenan..........................................              100            0            1.49       0.0000
Added Water..........................................           10,000
Added Salt...........................................                5
                                                      ----------------------------------------------------------
    Total weight (excluding added salt and water)....            6,698
                                                      ----------------------------------------------------------
    Total % Organic..................................  ...............  ...........  ..............      96.2055
----------------------------------------------------------------------------------------------------------------

Summary of Changes to the Final Rule
    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.
Summary of Public Comment
    In general, almost all public comments supported AMS's 
clarification that percent organic content must be calculated based on 
weights/volumes at formulation. However, many comments noted that the 
proposed text could be interpreted to mean that salt and water must be 
excluded from each ingredient during calculation. Commenters explained 
this would be difficult and unnecessary to calculate the amount of 
water and salt in some ingredients and asked that AMS revise Sec.  
205.302(a) to state that only water and salt added as ingredients 
should be excluded from calculation. However, several comments also 
asked AMS to clarify that water and salt added to individual 
ingredients (e.g., broth or tea) should be excluded from calculation.
Responses to Public Comment
    (Comment) Many comments noted that the proposed text could be 
interpreted to mean that salt and water must be excluded from 
individual ingredients during calculation. Commenters explained this 
would be difficult and unnecessary to calculate the amount of water and 
salt in some ingredients, and asked that AMS revise Sec.  205.302(a) to 
state that only water and salt added as ingredients should be excluded 
from calculation.

[[Page 3601]]

    (Response) AMS has 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 clearly states that only water and salt added as 
ingredients are excluded from calculation.
    (Comment) Several comments asked NOP to clarify how to calculate 
percentage organic content when ingredients are composed of more than 
one ingredient (a ``multi-ingredient ingredient'').
    (Response) The exact organic content of a multi-ingredient 
ingredient should be used when calculating the total organic content of 
the final organic product.

P. Supply Chain Traceability and Organic Fraud Prevention

    The table below includes the regulatory text related to this 
section of the rule. A discussion of the policy follows.

----------------------------------------------------------------------------------------------------------------
                       Section                                           Final regulatory text
----------------------------------------------------------------------------------------------------------------
205.2...............................................  Terms defined.
                                                      Definitions for Organic fraud and Supply chain
                                                       traceability.
205.103.............................................  Recordkeeping by certified operations.
                                                      Paragraphs (b)(2), and (3).
205.201.............................................  Organic production and handling system plan.
                                                      Paragraph (a)(3).
205.501.............................................  General requirements for accreditation.
                                                      Paragraphs (a)(10), (13), and (21).
205.504.............................................  Evidence of expertise and ability.
                                                      Paragraphs (b)(4) and (7).
----------------------------------------------------------------------------------------------------------------

    Traceability and fraud prevention are essential in complex organic 
supply chains. Because protecting and verifying organic integrity is a 
responsibility shared by many participants in the organic industry, 
this rulemaking requires certified operations and certifying agents to 
incorporate supply chain traceability and organic fraud prevention into 
their practices. These actions will strengthen organic integrity and 
reinforce trust in the USDA organic label.
    Certified organic operations must:
     Maintain records of their activities that span the time of 
purchase or acquisition, through production, to sale or transport;
     Maintain records that trace back to the last certified 
operations in their supply chain;
     Maintain audit trail documentation to facilitate supply 
chain traceability, including identification of agricultural products 
as organic on audit trail documents; and
     Describe in their organic system plan the monitoring 
practices and procedures used to prevent organic fraud and verify 
suppliers and organic product status.
    Certifying agents must:
     Conduct risk-based supply chain traceability audits of 
products they certify to verify compliance;
     Maintain procedures for identifying high-risk operations 
and agricultural products, conducting risk-based supply chain audits, 
and reporting credible evidence of organic fraud to the USDA; and
     Share information with other certifying agents to conduct 
investigations, conduct supply chain traceability audits, and verify 
compliance of organic products.
    These requirements may affect certified organic operations, 
certifying agents, and operations applying for organic certification. 
Organic stakeholders should carefully examine the regulatory text and 
policy discussion below.
Background
    Because organic products are credence goods, the organic system 
relies upon on trust between entities in organic supply chains.\55\ 
Therefore, traceability and verification of organic products are 
essential to the function of a healthy organic market. This is 
especially true of modern organic supply chains, which have grown 
longer and more complex. Organic products and ingredients are often 
handled by dozens of operations, including uncertified entities, on 
their way to the consumer. A robust system of traceability and fraud 
prevention can help reduce the risks of complex supply chains and 
minimize fraud.
---------------------------------------------------------------------------

    \55\ A credence good is something with value or qualities that 
cannot be easily determined by the consumer before, or even after, 
purchase.
---------------------------------------------------------------------------

    The length and complexity of modern supply chains present many 
risks to organic integrity. Activities that can compromise organic 
integrity and void the use of the USDA organic label include physical 
risks such as contact with substances prohibited in organic production 
(e.g., pesticides, fumigants, or cleaning agents) and mixing or 
commingling of organic and nonorganic products. Integrity can also be 
compromised if a nonorganic product is mistakenly labeled or identified 
as organic, or if poor recordkeeping cannot demonstrate that a product 
was produced on a certified farm and handled according to the organic 
regulations. Additionally, fraud can occur through falsification of 
records and labeling to claim that a nonorganic product is certified 
organic. Breach of integrity can occur at any point in a supply chain, 
from production to final sale. In addition, the prevalence in organic 
supply chains of uncertified operations, who do not have direct USDA or 
certifying agent oversight, increases the chance that loss of integrity 
may occur and/or go unreported.
    Organic products therefore require additional care to verify 
organic status and ensure that products bought and sold are genuinely 
organic and have not been compromised. Because full visibility across 
an entire supply chain is difficult, this rule focuses on using 
critical information at control points where risk is highest to verify 
chain of custody and confirm organic integrity. This is primarily done 
by building a record of product transaction and movement that 
demonstrates proper handling and maintenance of integrity. Without a 
verified transaction record, operations (and by extension, consumers) 
don't have a full picture of a product's history, and breaches of 
integrity can go unnoticed, allowing compromised product to continue 
along a supply chain to the consumer.
    The current USDA organic regulations require general recordkeeping 
and verification of organic integrity, but the requirements are not 
specific and lack key types of information and practices that are 
necessary to prove the integrity of products from long, complex supply 
chains. This lack of recordkeeping information often leads to 
incomplete audit trails, and operations and

[[Page 3602]]

certifying agents are often unable to verify product origin or organic 
integrity. The specific recordkeeping, auditing, and fraud prevention 
procedures in this rule will augment existing practice to ensure more 
complete visibility into organic supply chains. This visibility will 
allow operations and certifying agents to complete more rigorous 
verification of organic products and identify and stop loss of organic 
integrity before it moves further into organic supply chains.
    All successful systems of traceability include three common 
elements: (1) traceability within a single operation; (2) traceability 
one step forward and one step back from an operation in a supply chain; 
and (3) bidirectional traceability along a supply chain by a third 
party. This rulemaking supports traceability by clarifying who is 
responsible for each element: certified organic operations are 
responsible for traceability within their operation, back to their 
suppliers, and forward to their customers; certifying agents are 
responsible for verifying and tracing products along a supply chain and 
assessing a certified operation's system of traceability.
    Fraud is also a significant risk to organic integrity; this 
rulemaking therefore focuses effort on its prevention. To clarify what 
this means, Sec.  205.2 of the organic regulations includes a 
definition of organic fraud: deceptive representation, sale, or 
labeling of nonorganic products as ``100 percent organic,'' 
``organic,'' or ``made with organic (specified ingredients or food 
group(s)).'' This broad definition helps clarify portions of this 
rulemaking's policy (e.g., Sec. Sec.  205.201(a)(3) and 205.504(b)(7)), 
but is not intended to be used as a mechanism or criterion for 
enforcement.
Certified Operations
Recordkeeping
    Section 205.103 of the organic regulations describes the 
recordkeeping responsibilities of certified operations. Records are 
used by operations, certifying agents, the USDA, and others to verify 
the compliance of organic operations and products. Clear and auditable 
records also support traceability. This rulemaking clarifies 
recordkeeping requirements to support the traceability of organic 
products both within and between operations.
General Recordkeeping Requirements
    Section 205.103(b)(2) specifies that a certified operation's 
records must describe all activities and transactions of the operation. 
This includes physical and financial possession, production, handling, 
title, and contractual oversight responsibilities of the organic 
products and ingredients the operation produces or handles. Such 
records must span the time of purchase or acquisition, through 
production, to sale or transport. This requirement supports 
``internal'' traceability, or the ability to track the movement, 
handling, and organic status of products within a single operation. 
These records are needed to verify the compliance of an organic 
operation and its products, and supports on-site inspections by 
providing information for mass-balance audits and traceability 
verification by certifying agents (see Sec.  205.403(d)(4)-(5)).
    Section 205.103(b)(2) also requires that an operation's records 
must be sufficient to trace products back through a supply chain to the 
last certified operation. Keeping ``external'' records back to the last 
certified operation is needed to verify the source of organic products. 
Note that records must reach back to the last certified operation. 
Operations receiving organic products from uncertified suppliers (e.g., 
an exempt wholesaler) must keep records demonstrating how the 
uncertified operation maintained organic product integrity. This may 
require keeping records from several uncertified operations in 
sequence; in all cases the records must show an audit trail back to the 
last certified operation. Operations can demonstrate an audit trail by 
using various types of documentation that are typically used during 
sale, purchase, and transfer, such as receipts, invoices, shipping or 
receiving manifests, shipping logs, bills of lading, or transaction 
certificates. The organic industry creates and transfers this 
documentation (almost always electronically) in the usual course of 
business, and sales contracts often list this documentation as a 
condition of the sale. Typically, handling entities along a supply 
chain (such as a transporter, broker, or storage facility) will send 
electronic documentation directly to the buyer either before or at 
receipt of a product. A buyer may also obtain additional documents or 
records directly from the certified operation that sold the product.
    Maintaining records back to the last certified operation will 
support supplier verification and fraud prevention plans (Sec.  
205.201(a)(3)). Such records will also ensure certifying agents have 
the information they need to verify the compliance of products during 
on-site inspections (Sec.  205.403(d)(5)) and during supply chain 
traceability audits (Sec.  205.501(a)(21)).
    Section 205.103(b)(2) describes a certified operation's minimum 
recordkeeping requirements. Certified operations may need to keep 
additional records beyond the scope of Sec.  205.103(b)(2) to comply 
with other portions of the organic regulations and the Act. For 
example, to comply with Sec.  205.236, Origin of livestock, livestock 
operations must maintain records demonstrating that animals were 
organically managed from the last third of gestation, which may include 
place and date of birth. This may require records that trace purchased 
animals back to the operation where the animal was born to prove origin 
and organic management (i.e., the records must trace beyond the last 
certified operation to prove compliance).
Audit Trail Documentation
    Certified operations must keep audit trail documentation for all 
organic products they produce or handle. Audit trail documents are 
records used to determine the source, transfer of ownership, and 
transportation of organic products (see definition of audit trail in 
Sec.  205.2). For the purpose of audit trail documentation, the 
``source'' of organic products is the certified operation that supplied 
the product to the operation. Examples of audit trail documentation may 
include but are not limited to receipts, invoices, shipping or 
receiving manifests, shipping logs, bills of lading, and transaction 
certificates. Audit trails must document the history of organic 
products back to the last certified operation (per Sec.  
205.103(b)(2)).
    Audit trail documentation must identify organic products as ``100% 
organic,'' ``organic,'' or ``made with organic (specified ingredients 
or food group(s)),'' as appropriate. Operations may use abbreviations 
or acronyms to identify products, provided that the abbreviations or 
acronyms are easily understood. Certified operations should consider 
describing use of any abbreviations or acronyms in their OSP; this will 
facilitate on-site inspections and record audits by certifying agents, 
and help ensure that records are ``readily understood and audited'' 
(Sec.  205.103(b)(2)).
    Explicit identification of products as organic is required for 
audit trail records (i.e., ``transaction'' or ``external'' records). 
``Internal'' records do not need to provide explicit organic 
identification (e.g., ``100 percent organic''). However, all systems of 
records must be ``in sufficient detail as to be readily understood and 
audited'' to meet the requirements of Sec.  205.103(b)(2). This means 
that operations must be able to identify products they produce or

[[Page 3603]]

handle as organic, even if records do not explicitly state ``organic.'' 
For example, an operation may use an inventory management system that 
uses lot codes, batch numbers, or other designation system that 
indicates organic status. Such designation systems must be clear and 
auditable to facilitate on-site inspection and verification of 
compliance.
    Audit trail documentation that clearly identifies organic products 
will support an operation's verification of suppliers and 
implementation of fraud prevention plans. They will also allow 
certifying agents to verify compliance of suppliers and products during 
on-site inspections (Sec.  205.403(d)(5)) and supply chain traceability 
audits (Sec.  205.501(a)(21)).
Fraud Prevention Plans
    Section 205.201(a)(3) requires all certified operations to maintain 
and implement practices to verify the organic status of suppliers and 
products in their supply chain and to prevent organic fraud. Often 
called ``fraud prevention plans,'' these procedures and practices 
support early detection, prevention, and mitigation of fraud, and 
strengthen integrity across organic supply chains.
    A fraud prevention plan must be included in an operation's OSP. 
This allows certifying agents to assess the effectiveness of certified 
operations' anti-fraud practices and compliance with the organic 
regulations. A fraud prevention plan must be appropriate to the 
activities, scope, and complexity of the operation, and should be 
sufficient to address the verification and anti-fraud needs of the 
particular operation. This means not all fraud prevention plans will be 
alike. For example, a producer who does not handle another operation's 
organic products may develop a simple fraud prevention that verifies 
purchased inputs comply with organic regulation. In contrast, a 
processor that receives many organic ingredients from numerous 
suppliers should develop a fraud prevention plan that describes 
practices to detect, prevent, minimize, and mitigate organic fraud 
risks in lengthy supply chains.
    Because fraud prevention plans must verify the organic status of 
suppliers and organic products, they should include a description of 
how an operation verifies organic status back to the last certified 
operation in the supply chain. This supports recordkeeping and audit 
trail requirements at Sec.  205.103(b)(2) and (3) and allows certifying 
agents to verify compliance during on-site inspections and supply chain 
traceability audits.
    As a best practice, a robust plan for supply chain oversight and 
organic fraud prevention may include:
     A map or inventory of the operation's supply chain that 
identifies suppliers;
     Identification of critical control points in the supply 
chain where organic fraud or loss of organic status are most likely to 
occur;
     A vulnerability assessment to identify weaknesses in the 
operation's practices and supply chain;
     Practices for verifying the organic status of any product 
they acquire and/or use;
     A process to verify suppliers and minimize supplier risk 
to organic integrity;
     Mitigation measures to correct vulnerabilities and 
minimize risks;
     Monitoring practices and verification tools to assess the 
effectiveness of mitigation measures; and
     A process for reporting suspected organic fraud to 
certifying agents and the NOP.
Certifying Agents
Supply Chain Traceability Audits
    Traceability of organic products across multiple operations in a 
supply chain is an effective strategy to detect fraud, conduct 
investigations, and verify compliance of products and operations. 
Therefore, Sec.  205.501(a)(21) of the organic regulations requires 
certifying agents to conduct risk-based supply chain traceability 
audits of products and operations they certify.
What is a supply chain traceability audit?
    A supply chain traceability audit (SCT audit) is the process of 
identifying and tracking the movement, sale, custody, handling, and 
organic status of a product along a supply chain. The objective of a 
supply chain audit is to verify a product's compliance with the organic 
regulations. SCT audits can be used to investigate evidence or 
suspicion of fraud, verify compliance of high-risk products, 
investigate patterns of activity, trace the source of products 
contaminated with prohibited substances, surveil high-risk supply 
chains, or for other compliance-related reasons.
Criteria and Procedures for Supply Chain Traceability Audits
    Certifying agents must maintain criteria and procedures that 
describe the use of risk-based SCT audits. This must include (1) 
criteria used to identify high-risk operations and products for SCT 
audits, and (2) procedures used to conduct SCT audits. SCT audits 
conducted by the certifying agent must be based on these criteria and 
procedures. To ensure that AMS is made aware of organic fraud when it 
is discovered, certifying agents must also maintain procedures to 
report credible evidence of fraud to the USDA. Copies of these 
procedures and criteria should be kept by the certifying agent to 
demonstrate its expertise and ability (Sec.  205.504(b)(7)); this 
allows AMS to review and evaluate use of SCT audits during regular 
accreditation audits.
    SCT audits should be initiated by events or criteria chosen and 
described by the certifying agent. For example, SCT audits may be 
initiated to investigate evidence or suspicion of fraud, verify 
compliance of an organic product, investigate patterns of activity, 
trace the source of positive residue testing, surveil high-risk supply 
chains or products, or to address any other compliance-related risk, 
activity, or need identified by the certifying agent.
Use of Supply Chain Traceability Audits
    The length, extent, and frequency of an SCT audit may vary and 
should be determined by the objective of the audit (i.e., an SCT audit 
ends when its objective is achieved). SCT audits may trace back to the 
origin (production site) of a product, or until a noncompliance is 
verified or cleared. For example, if a certifying agent's objective is 
to verify the production origin of an ingredient, the SCT audit should 
trace the ingredient through the entire supply chain to the farm or 
ranch where the ingredient was produced. In contrast, if an SCT audit 
is initiated to determine the source of a positive residue test, the 
SCT audit may conclude when the source of the contamination is 
identified (which may only be several ``steps'' back in the supply 
chain).
    The number, frequency, type, and extent of SCT audits should be 
appropriate to the number, scope, and complexity of operations the 
certifying agent certifies.
Information Sharing
    To facilitate supply chain traceability audits, investigations, and 
verification of organic status, AMS requires certifying agents share 
compliance- and enforcement-related information with each other. Per 
Sec.  205.501(a)(10), certifying agents must maintain strict 
confidentiality with respect to its clients and not disclose business-
related information to third parties that are not involved in the 
regulation or certification of operations, as required by the OFPA (7 
U.S.C. 6515(f)).

[[Page 3604]]

    Certifying agents must exchange information that is credibly needed 
to determine an operation's compliance with the USDA organic 
regulations, including assessment of applications for certification, 
noncompliance investigations, suspension/revocation of certification, 
supply chain traceability audits, verification of audit trail 
documentation, and verification of the organic status of products 
represented as organic (see Sec.  205.501(a)(10)(ii) and (a)(13)).
    Section 205.501(a)(10)(iii) requires that compliance-related 
proprietary business information exchanged between certifying agents 
must remain proprietary, and that all certifying agents involved in the 
exchange must preserve the confidentiality of the information during 
and after the exchange. Certifying agents must maintain copies of the 
procedures used to exchange information and maintain confidentiality of 
information (Sec.  205.504(b)(4)). These requirements will ensure 
confidentiality of information during compliance activities that span 
multiple certified operations and certifying agents, such as supply 
chain traceability audits and investigations.
Conclusion
    The traceability and fraud prevention requirements discussed above 
are part of a holistic organic control system that enhances the 
oversight, enforcement, and integrity of organic products. Many other 
sections of this rule support and facilitate traceability and fraud 
prevention; stakeholders should read the following sections to better 
understand how to implement this rule's traceability and fraud 
prevention requirements:
     Section III. A: Applicability and Exemptions from 
Certification;
     Section III. B: Imports to the United States;
     Section III. C: Labeling of Nonretail Containers;
     Section III. D: On-Site Inspections;
     Section III. G: Paperwork Submissions to the 
Administrator; and
     Section III. H: Personnel Training and Qualifications.
Summary of Changes to the Final Rule
    AMS made several changes to the proposed regulatory text when 
writing this final rule. Changes to the proposed rule are discussed 
below and are followed by responses to specific themes from public 
comment:
     AMS revised the definition of organic fraud to remove 
``intentional'' and ``for illicit economic gain.'' ``Intentional'' is 
not needed because this defined term is not used for enforcement; it is 
used to help explain the objective of this rulemaking and many of its 
provisions. AMS removed the phrase ``for illicit economic gain'' 
because not all fraud results in or is motivated by economic gain. The 
final defined term is more flexible than proposed and encompasses a 
broader range of potential fraud types.
     AMS added the new term supply chain traceability audit. A 
similar definition was used in the preamble of the proposed rule to 
help stakeholders understand the rule and its objectives. AMS added 
this new term to more formally clarify its purpose and objective, and 
to more clearly define the expectations of traceability audits by 
certifying agents (see Sec.  205.501(a)(21)).
     AMS removed the requirement in Sec.  205.103(b)(2) to 
identify specific labeling categories (e.g., ``100% organic'') in 
records. Removing this requirement avoids the potential for additional 
recordkeeping burden that some comments noted the proposed rule could 
unintentionally create, and gives operations more flexibility in how 
they keep records.
     AMS specified the scope of recordkeeping in Sec.  
205.103(b)(2) to more clearly indicate the types of records that 
operations should keep, and what timeframe they should span. This 
presents clear expectations that support traceability and verification 
of organic products, but also puts clear boundaries on the scope of 
records to control burden and cost to operations.
     AMS added a requirement to identify organic status (e.g., 
``100 organic'') in audit trail documentation at Sec.  205.103(b)(3) 
and added ``or similar terms, as applicable.'' The proposed rule had 
included this at (b)(2) as a general requirement for all records; the 
rulemaking only requires such identification on audit trail 
documentation (see audit trail at Sec.  205.2). This change will avoid 
the potential for additional recordkeeping burden that some comments 
noted the proposed rule could unintentionally create, but still ensures 
that this critical information is available to trace organic products 
between operations and to verify integrity.
     AMS revised Sec.  205.201(a)(3) to clarify that fraud 
prevention plans must be appropriate to an operation's activities, 
scope, and complexity. This change responds to public comments that 
were concerned about disproportionate burden (i.e., greater cost) on 
small operations, especially small producers. This change may allow 
operations with less complex activities and/or a more limited scope to 
write and implement simpler fraud prevention plans.
     AMS removed ``back to the source'' in Sec.  205.501(a)(21) 
because public comments indicated this phrase was unclear and that the 
length of supply chain traceability audits varies. The new term supply 
chain traceability audit states the objective of such an audit--to 
verify an organic product's compliance--and therefore serves to clarify 
that the length and extent of supply chain traceability audits will 
vary depending on the objective and findings of the process.
     In Sec.  205.501(a)(15), AMS added references to Sec.  
205.504(b)(7) and Sec.  205.501(a)(13). This more clearly specifies 
that certifying agents are to use their own criteria for identifying 
high-risk operations and conducting supply chain traceability audits, 
and that they are to share information with other certifying agents to 
conduct audits and verify compliance.
     AMS added the term supply chain traceability audit to 
Sec.  205.504(b)(7) to more clearly state the need for and objectives 
of the risk criteria and procedures in this paragraph.
     AMS did not change Sec.  205.501(a)(10), Sec.  
205.501(a)(13), or Sec.  205.504(b)(4).
Summary of Public Comment
    The majority of public comments supported AMS's proposed revisions 
to recordkeeping requirements for certified operations. Many comments 
noted that including a description of full organic status (e.g., ``100 
percent organic . . .'') on all records may be burdensome and suggested 
that AMS allow the use of abbreviations, acronyms, or shorthand when 
identifying organic ingredients. Other comments asked for additional 
clarity about the definition of audit trail and what types of 
documentation are needed to meet the requirements of Sec.  
205.103(b)(3). Finally, a few comments claimed that keeping full 
organic identification on all records may be burdensome and asked that 
AMS not finalize this requirement in cases where inventory management 
systems can indicate organic status via lot codes or batch numbers.
    Comments largely supported AMS's proposed use of fraud prevention 
plans by certified operations. However, many comments requested 
additional specificity about what should be included in fraud 
prevention plans. Other comments noted that fraud prevention plans may 
be difficult for very small businesses to write and implement and 
recommended AMS develop templates, examples, and

[[Page 3605]]

generic forms for small operations to use.
    AMS received many comments about the proposed definition of organic 
fraud. Some comments requested that AMS remove ``illicit'' and from the 
definition, arguing that fraud may not always constitute illegal 
activity. Others suggested removing ``intentional,'' citing the 
difficulty of proving intent. Several comments also suggested AMS 
harmonize the proposed definition with existing definitions from other 
organizations such as GFSI, the EU, ISO, and FDA.
    Public comment generally supported the proposed use of supply chain 
traceability audits. Many comments asked AMS to clarify the 
requirements of and extent of supply chain traceability audits, 
particularly how far back an audit should trace a product. Others 
suggested adding a definition of supply chain audit or traceability. 
Opinions varied widely on the number of supply chain traceability 
audits to be conducted, with many comments suggesting a minimum 
percentage of operations or a risk-based selection. Many comments also 
discussed the administrative impacts of supply chain traceability 
audits: a few comments claimed some certifying agents may not have the 
capacity of expertise to conduct audits; others highlighted challenges 
with information sharing and coordination among certifying agents. A 
few comments expressed a desire for AMS to coordinate supply chain 
traceability audits.
    Finally, some comments suggested alternatives to AMS's proposed 
traceability and fraud prevention strategy, including trusted trader 
programs, increased surveillance by AMS, and exemptions for businesses 
that already participate in other traceability programs.
Responses to Public Comment
Definition of Organic Fraud
    (Comment) Comments asked AMS to use ``willful'' instead of 
``intentional'' in the definition of organic fraud.
    (Response) The rulemaking does not use ``willful'' or 
``intentional'' in the final definition. This allows for a more 
flexible definition that encompasses a broader range of potential fraud 
types. ``Willful'' and ``intentional'' are not needed because organic 
fraud is not used for enforcement; it is used to help explain the 
objective of this final rule and many of its provisions.
    (Comment) Comments asked AMS to remove ``for illicit economic 
gain,'' claiming that not all fraud is illicit or economic in nature. 
Comments also asked AMS to harmonize the definition of organic fraud 
with terms used by other standards organizations such as ISO, GFSI, 
FDA, and the EU.
    (Response) Many of the organizations mentioned in public comment 
focus on ``economic gain'' as a key factor in defining fraud. The final 
rule does not include the phrase ``for illicit economic gain'' because 
not all fraud results in or is motivated by economic gain. This 
definition is more flexible and encompasses a broader range of 
potential fraud types than terms used by other standards organizations.
Recordkeeping
    (Comment) Comments requested that the regulatory text explicitly 
allow use of abbreviations for indicating organic status on records.
    (Response) AMS amended Sec.  205.103(b)(3) to allow use of similar 
terms such as acronyms or abbreviations for identifying organic status 
on audit trail documentation. Abbreviations or acronyms should be 
easily understood to meet the requirement that all records ``be readily 
understood and audited'' (Sec.  205.103(b)(2).
    (Comment) Comments are concerned that the requirement to identify 
organic products as such on all records will add an unnecessary 
recordkeeping burden that duplicates existing recordkeeping or 
inventory management systems.
    (Response) The requirement to identify products as ``100% 
organic,'' ``organic,'' or ``made with organic (specified ingredients 
or food group(s)),'' has been revised to apply only to audit trail 
documentation. Other records should also indicate organic status to 
meet the requirement that all records ``be readily understood and 
audited'' (Sec.  205.103(b)(2)). However, operations may use a system 
of recordkeeping or inventory management system that uses lot codes, 
batch numbers, or other designation system that indicates organic 
status, as long as such designations are clear and auditable.
    (Comment) Commenters requested clarity on the use of ``internal'' 
vs. ``external'' records for purposes of supply chain traceability.
    (Response) The requirements of Sec.  205.103(b)(2) applies to 
broadly all records maintained by an operation, including both 
``external'' and ``internal'' records. Section 205.103(b)(3) applies 
only to audit trail documentation, i.e., ``external'' or 
``transaction'' records.
Fraud Prevention Plans
    (Comment) Comments asked AMS for more detail about the scope of 
fraud prevention plans and what elements should be included in them.
    (Response) The preamble of this rulemaking describes best practices 
that operations may use to develop and implement fraud prevention 
plans. The final regulatory text does not include specific practices or 
requirements; this provides maximum flexibility for operations and 
certifying agents to determine what is appropriate for individual 
operations. A fraud prevention plan must describe the operation's 
monitoring practices and procedures they use to verify suppliers, 
verify products received, and prevent organic fraud. The plan must be 
appropriately tailored to the activities, scope, and complexity of the 
operation.
    (Comment) Comments stated that the fraud prevention plan 
requirement would cause a disproportionate burden (i.e., greater cost) 
on small operations, especially small producers.
    (Response) The final rule regulatory text and the preamble explain 
that an operation's fraud prevention plan must be appropriate to the 
operation's complexity, scope, and activities. This may allow 
operations with less complex activities and/or a more limited scope to 
write and implement simpler fraud prevention plans.
Supply Chain Traceability Audits
    (Comment) Comments requested greater clarity about the proposed 
rule's use of the terms traceback, mass-balance, and supply chain 
audits.
    (Response) Verification of traceability back to the last certified 
operation and mass-balance audits are routine practice during on-site 
inspection of certified operations. Section 205.403(d)(4)-(5) describe 
the use of these mechanisms. In contrast, supply chain traceability 
audits are triggered by criteria defined by the certifying agent. A 
supply chain traceability audit generally encompasses at least a 
portion of a supply chain and is conducted to verify the compliance of 
a product with the organic regulations and the Act.
    ``Traceback'' is a term commonly used in the organic industry. 
However, this term was used inconsistently in public comment and there 
was no clear preference for how to define it. Therefore, AMS has 
avoided using this term in the final rule. AMS defines and uses the 
term supply chain traceability audit to describe certain activities, 
and the regulatory text clarifies the extent of other traceability 
requirements (e.g., Sec.  205.103(b)(2)) requires that an operation's 
records must be traceable back to the last certified operation).
    (Comment) Comments asked AMS for clarification about the phrase 
``back to

[[Page 3606]]

the source'' in the proposed rule's revision to Sec.  205.501(a)(21).
    (Response) This phrase is not used in the SOE final rule. The 
length and extent of supply chain traceability audits will vary 
depending on the objective and findings of the process. Some supply 
chain traceability audits may extend back to the site of production, 
while others may only go a few steps back in a supply chain; the audit 
ends when its objective (e.g., verification of compliance) is achieved.
    (Comment) Many comments discussed the administrative impacts of 
supply chain traceability audits: a few comments claimed some 
certifying agents may not have the capacity or expertise to conduct 
audits; others highlighted challenges with information sharing and 
coordination among certifying agents.
    (Response) Supply chain audits are an important tool for oversight 
in the organic market. AMS has added flexibility for certifying agents 
to define the conditions for when supply chain audits are necessary. 
Further, there are other requirements in this rule that will support 
supply chain audits: certification of additional handlers in supply 
chains, mandatory NOP Import Certificates, identifying organic products 
on audit trail documentation, and information sharing among certifying 
agents.

Q. Technical Corrections

    The table below includes the regulatory text related to this 
section of the rule. A discussion of the policy follows.

----------------------------------------------------------------------------------------------------------------
                       Section                                           Final regulatory text
----------------------------------------------------------------------------------------------------------------
205.301.............................................  Product composition.
                                                      Paragraphs (f)(2) and (3).
205.400.............................................  General requirements for certification.
                                                      Paragraph (b).
205.401.............................................  Application for certification.
                                                      Paragraph (a).
----------------------------------------------------------------------------------------------------------------

    AMS has revised Sec.  205.301 to correct a technical error in the 
description of the prohibition of ionizing radiation and sewage sludge. 
A previous technical correction (80 FR 6429) contained an error in the 
language used to describe the prohibition on ionizing radiation and 
sewage sludge. The terms ``produced'' and ``processed'' were 
erroneously used to describe the use of ionizing radiation and sewage 
sludge, respectively, in the current regulatory text. This action 
corrects the language at paragraphs (f)(2) and (f)(3) to clarify that 
all products labeled as ``100% organic'' or ``organic'' and all 
ingredients identified as organic in the ingredient statement of any 
product must not be processed using ionizing radiation or produced 
using sewage sludge.
    AMS also revised Sec. Sec.  205.400(b) and 205.401(a) to correct 
the references to organic system plans (Sec.  205.201), which was 
incorrectly cited in the previous organic regulation.

R. Additional Amendments Considered But Not Included in This Rule

    The Strengthening Organic Enforcement proposed rule asked the 
public for feedback on two additional subjects: packaged product 
labeling and expiration of certification. AMS did not propose amending 
the portions of the USDA organic regulations that relate to these 
subjects. The specific questions asked in the proposed rule were meant 
to elicit feedback from stakeholders about the two topics for possible 
future consideration. AMS has summarized the public comment received 
below.
Summary of Public Comments: Packaged Product Labeling
    Processed and/or packaged food products are often manufactured or 
packaged by one business and labeled for sale/distribution by another 
business. This type of relationship, sometimes called contract 
manufacturing and private labeling, is common in both the organic and 
nonorganic markets. This rulemaking does not change how such products 
are labeled for retail sale. However, in the proposed rule AMS asked 
for public comment on private-labeled product labeling, prompting 
feedback about preferred terminology and which businesses should be 
listed on labels.
    Overall, there was no consensus among comments about issues of 
organic private-labeled products, including who should be certified, 
what terminology to use, and which operations and certifying agents 
should be listed on labels. Because private label and brand/contract 
relationships are on a contract-by-contract basis to protect 
proprietary information, some comments argued that creating a single 
set of rules to govern these relationships may change how private 
labels operate in the future. The comments received reflect this, and 
include a variety of opinions based on a commenter's position in the 
organic supply chain. Responses from public comments are summarized 
below along with background information to provide context and help 
explain comments.
Preferred Terminology To Describe Private Label Products and Parties
    Throughout the supply chain there are many steps where brand 
companies can leverage contracted companies to produce items for sale 
under the brand. After raw material sourcing, there are opportunities 
for a company to contract out steps such as manufacturing, packaging, 
and distribution.
    Because of the variable use and function of contracted 
organizations in organic production, it is important to use common 
terminology to refer to organic operations and their certifying agents. 
Many comments requested consistent regulatory terminology to categorize 
these operations in relation to the organic supply chain, but there was 
no clear preference for certain terminology. Terms and relationships 
between contract food producers and brand owners are highly variable in 
the organic industry, but comments highlighted opportunities to align 
with commonly used and understood terminology. Comments suggested terms 
that could be consistently used to prevent confusion about which 
companies should appear on product labels, including contract 
manufacturer or ``co-man,'' contract packer or ``co-packer,'' external 
distributors, Private label entities/owners, and brand owners.''
Listing Contract Manufacturers on Labels
    The SOE proposed rule asked the public if private label products or 
brands that use contract manufacturers should list those manufacturers 
on the product label. The majority of

[[Page 3607]]

comments supported optionally listing contract manufacturers. Those who 
did not agree with this opinion requested that products should list the 
brand name and the contract manufacturer. Currently, it is mandatory 
for some product categories such as meat, poultry, and dairy to have an 
Establishment Number that can trace back to the facility where it was 
processed. For other products that are not currently mandated to 
provide this information, identity of the contract manufacturer is 
often considered proprietary information, and in some instances, there 
could be multiple contract manufacturers operating at the direction of 
one brand owner.
    Commenters were concerned that listing contract manufacturers would 
result in a loss of competitiveness; mandatory listings would expose 
proprietary information and undercut the success of these 
relationships. For brand owners that use several contracted companies, 
their products would need multiple versions of labels and traceability 
would become more complex. Comments also questioned the purpose of 
listing contract manufacturers on labels, some arguing that it would 
not improve organic integrity or traceability, especially because 
certifying agents are already listed on products. Some comments 
discussed that certifying agent information is enough to trace the 
product back to the manufacturer, making the listing of contract 
manufacturers unnecessary.
Listing Certified Operations on Private-Label Packaged Products
    The organic regulations currently require listing a certified 
operation on branded products. The proposed rule asked commenters which 
certified operations should be added to the packaging of private label 
products, in the interest of furthering traceability. Many comments 
recommend the brand owner/distributor and their certifying agent be 
listed on retail labels, with some comments stating no preference. Some 
commenters stated listing the brand owner would require companies to 
impose traceability standards on the contract companies they use.
    Some individuals recommend listing the last certified operation in 
the supply chain, to improve clarity and traceability, while others 
contradict this point by discussing the confidentiality concerns of 
listing the contract manufacturer. Commenters noted that distributors 
may be the best certified operation to list because they are often the 
last step in the organic handling process and can trace a product back 
through manufacturing and sourcing. Conversely, others noted that not 
all companies handle distribution internally (choosing instead to use a 
contracted company).
    Other comments claim that listing co-packers on labels is not 
necessary if brand owners are certified; however, some comments 
indicated it is unclear if brand owners need to be certified. Finally, 
a few comments recommended AMS assess the labeling requirements' 
alignment with the FDA.
Listing Certifying Agents on Private-Label Packaged Products
    Multiple certifying agents are typically involved in the production 
and processing of organic products (from raw materials to material 
refining, manufacturing, and distribution); each assures that an 
individual process or step meets the organic standard. In the case of 
brand companies with contract manufacturers, comments did not clearly 
agree on which certifying agent (that of the brand company or that of 
the contract manufacturer) to list on the product label. Many 
individuals supported listing the certifying agent of the brand owner/
distributor, but the brand owner may not be certified. For example, 
some comments pointed out that retailers are often the brand owners/
distributors of organic products, but they are often exempt from 
organic certification. In this case, some commenters recommended 
listing the contract manufacturer's certifying agent.
    Others recommended listing the certifying agent that certified that 
last handling operation in the supply chain, arguing that this would 
aid traceability. However, due to the variety of different 
manufacturing/branding relationships, this could be either the 
certifying agent of the brand owner or the manufacturer.
Matching the Certifying Agent to the Listed Operation
    Organic product labels currently must include both a certifying 
agent and an operation. Commenters generally agreed that if a specific 
operation is listed (i.e., contract manufacturer), that the certifying 
agent on the label should match. Comments explained that matching the 
two organizations would make it easier to contact a responsible party 
or file a complaint. Commenters on the proposed rule also agree that a 
label that lists the brand name next to the contract manufacturer's 
certifying agent would be confusing. However, given that some brand 
owners may not be certified, commenters noted this mismatch may already 
be happening in the marketplace.
Summary of Public Comments: Expiration of Certification
    Under current USDA regulation, organic certification continues 
until surrendered, revoked, or suspended (Sec.  205.404(c)). Certified 
operations must undergo an annual recertification process (Sec.  
205.406), but certification does not expire after one year. While 
developing the SOE proposed rule, AMS considered, but did not propose, 
adding a mechanism where certification would expire if an operation did 
not complete the annual recertification process timely.
    The proposed rule included specific questions about expiration of 
certification and asked the public to comment on the subject. At this 
time, AMS has chosen not to pursue a policy of expiration of 
certification. The following is a summary of public comments received 
in response to the questions AMS asked the public in the SOE proposed 
rule.
Potential Improvements to Organic Integrity
    The SOE proposed rule asked the public how annual expiration of 
certification could improve organic integrity. Some comments suggested 
that expiration could be an incentive for operations to punctually 
renew. Some comments adverted that it may help address the common 
incident of adverse action circumstances by encouraging operations to 
update their (organic system plan) OSP and pay fees on time. Commenters 
expressed if operations understood the annual expiration date, 
operations with unresolved noncompliances would risk losing 
certification via expiration. Those who did not agree indicated that 
current regulation specifies that operations are certified unless 
suspended or revoked. The annual expiration would disrupt this current 
system of recertification.
Limitations of Expiration of Certification
    The proposed rule requested the public to comment on what the 
limitations of requiring expiration of certification may be. Commenters 
forecast potential negative effects such as marketplace disruption, 
communication burdens and administrative burdens. Commentators 
mentioned that expiration may negatively impact the status of inventory 
of operations who allowed their certification to expire. One remark 
stated that the requirement could place additional administrative 
burden on the certifying agent: expiration of certification would 
result in the

[[Page 3608]]

certifying agent having to update systems, train staff, educate 
operations on the policy change, and frequently remind operations of 
the upcoming expiration date.
Minimum Requirement for Renewing Certification
    The SOE proposed rule asked for comments on what the minimum 
requirement for renewing certification should be. Many commenters 
recommended the following process: submit required paperwork, pay 
annual fee, and confirm interest in renewing. It was also recommended 
that on-site inspection should not be a requirement for 
recertification.
Operations With Adverse Actions
    The proposed rule asked the public if an operation with adverse 
actions that are in the appeals process could renew certification. 
Comments expressed contrasting views on this matter, some finding that 
operations should be able to renew, and some communicating that those 
operations should not have the flexibility to renew their 
certification. Some comments pointed out that the appeal process for a 
proposed suspension is lengthy, and that not allowing an operation with 
pending adverse actions to renew certification would promptly remove 
them from the system and prevent potentially noncompliant product from 
entering the market. Some individuals stated that depending on the 
severity of the pending adverse action, AMS should administer a system 
that would not block an operation from renewing its certification due 
to minor non-compliances. Others asked that if an operation has a 
record of failing to address certain adverse actions, then the system 
should prevent them from renewing their certification.
Grace Period for Renewing Certification
    The SOE proposed rule asked commenters if a grace period would be 
appropriate for operations that failed to renew by the expiration date. 
Commenters were also asked what the length of the grace period should 
be. Overall, comments proffered a 30- or 90-day grace period or 
mentioned that the current system already has a grace period built into 
the timeline. Some individuals suggested that a grace period would 
improve assurance among farmers.
Process of Regaining Certification
    The SOE proposed rule asked the public to express their opinion on 
what process should exist for an operation to regain organic 
certification should they allow it to expire. Many individuals 
communicated that the process of regaining an expired certification 
should be different than regaining a suspended/revoked certification. 
They stated the process should also be dependent on the presence and 
severity of adverse actions and there should be leniency within the 
duration. Some commentators proposed that operations with expired 
certification should apply as a new applicant, unless applying within 
the grace period. However, a commenter identified a potential loophole 
in tracking pending adverse actions of operations with expired 
certification; they recommended a system that would keep a record of 
operations with any pending adverse actions.
Notification of Upcoming Expiration of Certification
    The SOE proposed rule asked the public if certified agents should 
notify certified operations of their upcoming expiration of 
certification. Commenters clarified that notifying certified operations 
is currently a widespread practice. Moreover, a commenter suggested 
that notification should be sent from the Organic Integrity Database, 
which may normalize the process.

IV. Regulatory Analyses

A. Summary of Economic Analyses

    Executive Orders 12866 and 13563 control regulatory review.\56\ 
Executive Orders 12866 and 13563 direct agencies to assess all costs 
and benefits of available regulatory alternatives, and, if regulation 
is necessary, to select regulatory approaches that maximize net 
benefits (including potential economic, environmental, public health 
and safety effects, distributive impacts, and equity). Executive Order 
13563 emphasizes the importance of quantifying both costs and benefits, 
reducing costs, harmonizing rules, and promoting flexibility.
---------------------------------------------------------------------------

    \56\ Executive Order 12866, Regulatory Planning and Review, 
September 30, 1993: https://www.archives.gov/files/federal-register/executive-orders/pdf/12866.pdf.
    Executive Order 13563, Improving Regulation and Regulatory 
Review: https://www.federalregister.gov/documents/2011/01/21/2011-1385/improving-regulation-and-regulatory-review.
---------------------------------------------------------------------------

    The Regulatory Flexibility Act (5 U.S.C. 601-612) requires agencies 
to consider the economic impact of each rule on small entities and 
evaluate alternatives that would accomplish the objectives of the rule 
without unduly burdening small entities or erecting barriers that would 
restrict their ability to compete in the market.
    This rulemaking amends amending several portions of the USDA 
organic regulations (7 CFR part 205) to strengthen oversight and 
enforcement of the production, handling, sale, and marketing of organic 
agricultural products in the United States. The amendments address gaps 
in the organic standards to deter organic fraud and create a level 
playing field for farms and businesses. This reinforces the value of 
the organic label by assuring consumers and stakeholders that organic 
products meet a robust and consistent standard.
    The revised organic standards in this rule affect: certifying 
agents; certified operations (farms, processers, and handlers); and 
certain operations that are currently excluded or exempt from organic 
certification (e.g., certain brokers, traders, importers, exporters).
    The following discussion summarizes the economic analysis AMS 
performed to estimate the impacts of this rule. A complete economic 
analysis of this rulemaking is available at https://www.regulations.gov/. You can access the economic analysis by searching 
for document number AMS-NOP-17-0065.

B. Regulatory Impact Analysis

    The costs of this rule are primarily due to new or additional 
reporting and recordkeeping (paperwork) activities. In addition, there 
is cost for some currently excluded and exempt operations to become 
certified to handle organic products. AMS estimated the benefits of 
this rule by quantifying the organic fraud that will be prevented by 
implementation of the rule. The estimated benefits are expected to 
outweigh the estimated costs. Total estimated costs and benefits of the 
rule are summarized below.

[[Page 3609]]



                            Costs and Benefits of Rulemaking Discounted at 3% and 7%
----------------------------------------------------------------------------------------------------------------
                                                      Average annual cost \a\             Total cost \b\
                                                 ---------------------------------------------------------------
                   Amendments                       3% Discount     7% Discount     3% Discount     7% Discount
                                                       rate            rate            rate            rate
----------------------------------------------------------------------------------------------------------------
                                           Domestic Certifying Agents
----------------------------------------------------------------------------------------------------------------
Imports to the United States....................         $50,247         $37,534        $753,710        $563,016
Certificates of Org. Operation & Cont. of                 22,742          21,892         341,130         328,377
 Certification..................................
Personnel Training & Qualifications.............         144,661         108,061       2,169,922       1,620,918
On-Site Inspections.............................          96,402          72,012       1,446,031       1,080,176
Supply Chain Traceability & Organic Fraud                  4,089           3,054          61,333          45,815
 Prevention.....................................
Mediation.......................................             139             134           2,091           2,013
----------------------------------------------------------------------------------------------------------------
                                           Domestic Excluded Handlers
----------------------------------------------------------------------------------------------------------------
Applicability and Exemptions....................       8,349,390       6,236,939     125,240,844      93,554,079
Imports to the United States....................         369,807         276,243       5,547,100       4,143,647
----------------------------------------------------------------------------------------------------------------
                                          Domestic Certified Operations
----------------------------------------------------------------------------------------------------------------
Labeling of Nonretail Containers................         901,966         673,763      13,529,496      10,106,444
Supply Chain Traceability & Organic Fraud                609,066         454,968       9,135,993       6,824,526
 Prevention.....................................
----------------------------------------------------------------------------------------------------------------
                               Total Costs and Benefits, Discounted Over 15 Years
----------------------------------------------------------------------------------------------------------------
    Total Expected Domestic Costs...............      10,548,510       7,884,601     158,227,651     118,269,011
    Total Expected Foreign \c\ Costs............       8,769,681       6,550,892     131,545,210      98,263,398
    Total Expected Domestic & Foreign Costs.....      19,318,191      14,435,494     289,772,861     216,532,409
    Total Expected Benefit of Rulemaking........      32,944,811      24,272,099     494,172,179     364,081,491
----------------------------------------------------------------------------------------------------------------
\a\ These are the estimated annual averages of the 15-year Net Present Value domestic costs discounted at 3 and
  7 percent.
\b\ These are the estimated total domestic costs for affected industry in Net Present Value of the stream of
  future costs, discounted at 3 and 7 percent.
\c\ AMS assumes all foreign costs will pass through to U.S. consumers and therefore includes these costs in the
  final rule. See the full Regulatory Impact Analysis for more detail.

Estimation of Benefits
    AMS expects that this rule will reduce organic fraud in the U.S. 
market. Therefore, AMS quantified the estimated benefits of the 
rulemaking as the value of the projected reduction in organic fraud in 
the U.S. organic marketplace following implementation. AMS reviewed 
economic studies that identify and quantify fraudulent activity in 
retail food markets. AMS then used these estimates of fraud as a 
benchmark to quantify the benefits of the rulemaking.
    Based on analysis of these food fraud studies, AMS estimated that 2 
percent of organic products sold in the United States are currently 
subject to some form of fraud. This estimate aligns with rates of food 
fraud reported in multiple studies. Therefore, AMS estimated the total 
value of organic fraud in the United States as 2 percent of the total 
annual organic premiums for domestic organic production and organic 
imports, or approximately $109 million annually. AMS chose to use 
organic premiums (the cost difference between organic and nonorganic 
products) to estimate fraud because this more accurately measures the 
value lost to fraud than total sales value (i.e., a fraudulent organic 
product only loses the value of its organic attributes, not its entire 
value as a food product).
    AMS expects the changes from this rule will reduce the amount of 
organic fraud (estimated at $109 million annually) by half (an 
estimated $54 million). However, it is unclear what proportion of this 
$54-million fraud reduction translates directly into social welfare 
loss. For example, some certified operations and other compliant 
entities in organic supply chains may unknowingly experience some 
economic gain from fraud elsewhere in the supply chain. Additionally, 
AMS cannot accurately predict how fraud reduction efforts would impact 
organic prices, and hence premiums. Given this uncertainty about the 
true value of social welfare loss, AMS reduced the estimated $54 
million fraud reduction by half for an estimated social welfare gain 
(benefit) of $27 million in the first year following implementation of 
the rule. Estimated over a 15-year period, and accounting for projected 
future annual growth rates of the U.S. organic market, annual benefits 
from fraud reduction are estimated to reach $57 million in year 2036. 
When discounted over the 15-year period, total economic benefits of the 
rulemaking range from $364 to $494 million. When averaged, the economic 
benefits range from $24.3 to $32.9 million annually.
Estimation of Costs
    The costs of this rule are driven primarily by new or additional 
reporting and recordkeeping (paperwork) activities. AMS estimated 
additional paperwork cost for each provision of the rule by identifying 
the affected population (e.g., number of producers affected by a 
change), estimating the time for each affected entity to comply with a 
new change, and assigning an appropriate labor category and wage rate. 
This accounting of new reporting and recordkeeping costs is discussed 
in more detail in the Paperwork Reduction Act section of this 
rulemaking.
    This rule would also require some currently excluded and exempt 
operations to become certified to handle organic products. AMS predicts 
that these businesses fall within NAICS categories 425 (Wholesale 
Electronic Markets and Agents and Brokers) and 4244 (Grocery and 
Related Product Merchant Wholesalers). These categories are very broad 
and include mostly businesses that do not handle organic products. 
Therefore, AMS used participation rates in the organic sector to 
estimate that 1,985 domestic businesses would need to become

[[Page 3610]]

certified organic. Using historic knowledge of certification costs, AMS 
estimated that each of the affected 1,985 domestic businesses would 
spend $2,000 to become certified organic.
    AMS also estimated the cost of this rule to foreign entities, 
including both paperwork and recordkeeping burden and costs for certain 
businesses to obtain certification. AMS assumes that all foreign costs 
will be passed along to U.S. consumers. This may create some tendency 
to overstate U.S.-borne costs, as competitive pressures will lead some 
compliance costs to be absorbed by businesses and other entities as the 
cost of doing business.
Alternatives
    AMS also considered three alternatives when developing this 
rulemaking.
    1. Make no change to the organic regulations. This option would not 
implement this rulemaking and leave the organic regulation as-is. AMS 
did not select this option because it does not address organic fraud or 
other issues affecting organic integrity. AMS considers this a costly 
alternative because it forgoes the fraud reduction benefits of the 
rulemaking. Regulatory inaction would create social costs that increase 
over time. AMS believes the rulemaking will mitigate social welfare 
losses by approximately half through the use of practical, risk-based 
oversight and enforcement.
    2. Require NOP Import Certificates for individual imported 
shipments of organic product. The rulemaking will allow NOP Import 
Certificates to be issued for multiple shipments over a time span to be 
determined at the discretion of each certifying agent. In contrast, 
this alternative would require the use of NOP Import Certificates for 
each physical shipment of organic products imported into the United 
States. AMS found this alternative to be inferior to the rulemaking 
because it would create greater cost with limited additional benefit. 
AMS believes that the rulemaking's option to issue NOP Import 
Certificates on a periodic basis is the most practical, effective, and 
cost-sensitive means to address fraudulent imported organic products.
    3. Require less-stringent data reporting and training requirements 
for certifying agents. AMS also considered a less-stringent alternative 
to the rulemaking to assesses if this could lower costs while 
maintaining the effectiveness of the rulemaking. Relative to the 
rulemaking, this alternative would (1) omit the requirement for 
certifying agents to issue standardized certificates of organic 
operation generated in the USDA Organic Integrity Database; and (2) 
reduce the annual training hours that must be completed by organic 
inspectors and certification review personnel. AMS chose not to pursue 
this alternative because it would weaken other critical, interdependent 
amendments in the rulemaking. AMS predicts any cost reduction of this 
alternative would be accompanied by a significant reduction in 
effectiveness of the rulemaking.
Regulatory Flexibility Act
    AMS also performed additional analysis to determine the rule's 
impact to domestic small businesses. This analysis revealed that small 
businesses producing, selling, handling, and marketing organic products 
would not be adversely affected by the amendments in this rule. AMS 
expects that most of the entities affected by this rule are small 
businesses as defined by Small Business Administration criteria. For 
each category of affected entity (certifying agents, certified 
operations, and exempt or excluded operations that need to become 
certified), AMS estimates that the costs of the rule for each business 
type will be less than one percent of the annual revenue.
    A full economic analysis of this rulemaking is available at https://www.regulations.gov/. You can access this rule and the economic 
analysis by searching for document number AMS-NOP-17-0065.

C. Executive Order 12988

    Executive Order 12988 instructs each executive agency to adhere to 
certain requirements in the development of new and revised regulations 
in order to avoid unduly burdening the court system. This rule cannot 
be applied retroactively. States and local jurisdictions are preempted 
under the OFPA from creating programs of accreditation for private 
persons or state officials who want to become certifying agents of 
organic farms or handling operations. A governing state official would 
have to apply to USDA to be accredited as a certifying agent, as 
described in section 6514(b) of the OFPA. States are also preempted 
under sections 6503 through 6507 of the OFPA from creating 
certification programs to certify organic farms or handling operations 
unless the state programs have been submitted to, and approved by, the 
Secretary as meeting the requirements of the OFPA.
    Pursuant to section 6507(b)(2) of the OFPA, a state organic 
certification program that has been approved by the Secretary may 
contain additional requirements for the production and handling of 
agricultural products organically produced in the state and for the 
certification of organic farm and handling operations located within 
the state under certain circumstances. Such additional requirements 
must (a) further the purposes of the OFPA, (b) not be inconsistent with 
the OFPA, (c) not be discriminatory toward agricultural commodities 
organically produced in other States, and (d) not be effective until 
approved by the Secretary.
    In addition, pursuant to section 6519(c)(6) of the OFPA, this 
rulemaking does not supersede or alter the authority of the Secretary 
under the Federal Meat Inspection Act (21 U.S.C. 601-624), the Poultry 
Products Inspection Act (21 U.S.C. 451-471), or the Egg Products 
Inspection Act (21 U.S.C. 1031-1056), concerning meat, poultry, and egg 
products, respectively, nor any of the authorities of the Secretary of 
Health and Human Services under the Federal Food, Drug and Cosmetic Act 
(21 U.S.C. 301-399), nor the authority of the Administrator of the 
Environmental Protection Agency under the Federal Insecticide, 
Fungicide and Rodenticide Act (7 U.S.C. 136-136(y)).
    OFPA at 7 U.S.C. 6520 provides for the Secretary to establish an 
expedited administrative appeals procedure under which persons may 
appeal an action of the Secretary, the applicable governing State 
official, or a certifying agent under this title that adversely affects 
such person or is inconsistent with the organic certification program 
established under this title. The OFPA also provides that the U.S. 
District Court for the district in which a person is located has 
jurisdiction to review the Secretary's decision.

D. Paperwork Reduction Act

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501-3520) (PRA), AMS is requesting OMB approval for a new information 
collection totaling 368,321 hours for the reporting and recordkeeping 
requirements contained in this rulemaking. OMB previously approved 
information collection requirements associated with NOP and assigned 
OMB control number 0581-0191. AMS intends to merge this new information 
collection (0581-0321), upon OMB approval, into the approved 0581-0191 
collection. Below, AMS has described and estimated the annual burden 
(i.e., the amount of time and cost of labor), for entities to prepare 
and maintain information to participate in this voluntary labeling 
program. The Organic Foods Production Act of 1990

[[Page 3611]]

(OFPA) provides authority for this action.\57\
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    \57\ The Organic Foods Production Act of 1990, 7 U.S.C. 6501-
6524, is the statute from which the Agricultural Marketing Service 
derives authority to administer the NOP, and authority to amend the 
regulations as described in this rulemaking. This document is 
available at: https://uscode.house.gov/view.xhtml?path=/prelim@title7/chapter94&edition=prelim.
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    Title: National Organic Program.
    OMB Control Number: 0581-0321.
    Expiration Date of Approval: 3 years from OMB date of approval.
    Type of Request: New collection.
    Abstract: Information collection and recordkeeping are necessary to 
implement reporting and recordkeeping necessitated by amendments to 
Sec. Sec.  205.2, 205.100, 205.101, 205.103, 205.201, 205.273, 205.300-
205.302, 205.310, 205.307, 205.310, 205.400, 205.403-205.404, 205.406, 
205.500-501, 205.504, 205.511, 205.660-205.663, 205.665, 205.680, and 
205.681 of the USDA organic regulations. The rulemaking will protect 
organic product integrity and build consumer and industry trust in the 
USDA organic label by strengthening organic control systems, improving 
organic import oversight, clarifying organic certification standards, 
and enhancing farm to market traceability.
    This rulemaking amends several sections of the USDA organic 
regulations, 7 CFR part 205, to strengthen the NOP's ability to oversee 
and enforce the production, handling, marketing, and sale of organic 
agricultural products as established by the OFPA. The rule will improve 
organic integrity throughout the organic supply chain and benefit 
stakeholders at all levels of the organic industry. The amendments will 
close gaps in the current regulations to build consistent certification 
practices, deter organic fraud, and improve transparency and product 
traceability. NOP identified the need for many of the amendments as 
part of its direct experience in administering this program, 
particularly via complaint investigation and audits of certifying 
agents. Other amendments are based on changes to the OFPA included in 
the Agriculture Improvement Act of 2018; \58\ the recommendations of a 
2017 Office of Inspector General audit; \59\ the recommendations of the 
National Organic Standards Board (a federal advisory committee to NOP); 
and industry stakeholder feedback.
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    \58\ The Agriculture Improvement Act of 2018 (Public Law No: 
115-334), commonly known as the ``2018 Farm Bill,'' is available at 
https://www.congress.gov/115/plaws/publ334/PLAW-115publ334.pdf. 
Organic certification is discussed in Title X, Section 10104.
    \59\ The National Organic Program International Trade 
Arrangements and Agreements Audit Report 01601-0001-21, September 
2017: https://www.usda.gov/sites/default/files/01601-0001-21.pdf.
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    This rulemaking strengthens enforcement with amendments to the USDA 
organic regulations and modifies the reporting and recordkeeping 
burdens as summarized below.
    1. Reduces the types of uncertified handling operations in the 
organic supply chain that operate without USDA oversight.\60\ The 
amendments require certification of operations that facilitate the sale 
or trade of organic products, including but not limited to certain 
brokers, importers, and traders. These handlers must obtain organic 
certification and develop an organic system plan (OSP) to describe the 
practices and procedures used in their operations. Certifying agents 
customize the format of the OSP to cover standards applicable to 
operations seeking certification. Because traders and brokers do not 
farm or manufacture organic products, the OSPs for traders and brokers 
will address fewer sections of the organic regulations than OSPs for 
operations that farm or manufacture organic products. Therefore, 
uncertified traders and brokers will take 40 hours in the first year 
after the rule going into effect to prepare an initial OSP. In 
subsequent years, AMS estimates each of these entities will incur a 
recordkeeping burden of 10 hours annually, and a reporting burden of 20 
hours annually, to update their OSP (Sec. Sec.  205.2, 205.100, 
205.101, and 205.103).
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    \60\ Mandated by the Agriculture Improvement Act of 2018. See 
section 10104(a).
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    Burden is increased in the rulemaking due to refinements in NAICS 
code 425 and the addition of operations from NAICS code 4244 in 
response to public comment. The 2018 Farm Bill mandates that NOP reduce 
the number of operations excluded from certification at Sec.  205.101. 
AMS's revised estimate indicates 1,985 formerly excluded domestic 
operations now require organic certification. This includes 855 
operations in NAICS code 425 (Wholesale Electronic Markets and Agents 
and Brokers) and 1,130 operations in NAICS code 4244 (Grocery and 
Related Product Merchant Wholesalers). See the accompanying Regulatory 
Impact Analysis (RIA) for more information. AMS assumes the 1,985 
domestic excluded operations represent 59 percent of the global total 
of excluded handlers (using a benchmark 59 percent to 41 percent ratio 
of domestic to foreign operations). Therefore, AMS estimates there are 
an additional 1,379 foreign formerly excluded operations, for a total 
of 3,364 new handlers that will need organic certification.
    2. Requires all currently certified organic operations and new 
applicants to describe their procedures for monitoring, verifying, and 
demonstrating the organic status of their suppliers and products 
received to prevent organic fraud. Operations will include this 
information as a supplemental part of the OSP; therefore, AMS allocates 
the time to develop these procedures separately from the initial 40 
hours to develop an OSP. AMS estimates that each currently certified 
operation and applicant seeking certification will need 30 minutes to 
describe the supply chain verification procedures and monitoring 
practices required by this regulation (Sec. Sec.  205.103 and 205.201). 
Burden is increased in the rulemaking due to industry growth.
    3. Mandates the use of NOP Import Certificates. Each shipment of 
organic products imported into the United States must be declared as 
organic to U.S. Customs and Border Protection (CBP) and associated with 
a valid NOP Import Certificate (currently form NOP 2110-1).\61\ The NOP 
Import Certificate contains specific information about the quantity and 
source of a shipment of imported organic products. NOP Import 
Certificates are currently used for organic products imported from 
countries with which NOP has trade arrangements. This rulemaking will 
expand and make compulsory the use of NOP Import Certificates, 
regardless of an imported product's country of origin.
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    \61\ Office of Management and Budget (OMB) approved form NOP 
2110-1 NOP Import Certificate. https://www.ams.usda.gov/resources/nop-2110-1.
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    In response to public comments, the final rule allows NOP Import 
Certificates to be issued for a given time period (e.g., quarterly) 
rather than with every shipment as proposed. AMS estimates that NOP 
Import Certificates will be issued quarterly, as this will reduce costs 
and limit disruption to the speed of imports. Additionally, the 
estimated number of annual shipments has increased from 67,023 in 2017 
to 80,109 in 2020 due to industry growth.\62\ Therefore, AMS estimates 
3,856 exporters will request from their certifying agents an annual 
total of 15,424 NOP Import Certificates,

[[Page 3612]]

covering 80,109 annual shipments.\63\ AMS estimates each exporter and 
certifying agent will spend an average of 30 minutes to request and 
approve each NOP Import Certificate. This estimate accounts for some 
learning within the first year, as well as the option to issue a single 
NOP Import Certificate for multiple shipments over a specific timeframe 
and amount or volume. Additionally, AMS estimates that importers and 
their certifying agents will need an average of one tenth (0.1) of an 
hour, or 6 minutes, to compare the shipping manifest of each shipment 
with its respective NOP Import Certificate to verify the accuracy and 
organic compliance of each shipment.
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    \62\ Data source: USDA Foreign Agricultural Service (FAS) Global 
Agricultural Trade System (GATS). Select: Partners, World Total, 
Product Type, Imports--General, Products: All Aggregates; Product 
Groups: Organic--Selected: https://apps.fas.usda.gov/gats/default.aspx.
    \63\ NOP International Division reports that 3,303 organic 
exporters are certified by foreign (non-USDA) certifiers. Plus, the 
Organic Integrity Database shows that 553 foreign-based handlers are 
certified by USDA-accredited certifying agents. The total number of 
NOP Import Certificates assumes each exporter is issued NOP Import 
Certificates quarterly (four annually).
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    Further, certifying agents must have and implement a documented 
organic control system for intaking and approving or rejecting the 
validity of an NOP Import Certificate request, and importers must have 
and implement a documented organic control system to verify that 
shipments of organic products are accompanied by accurate NOP Import 
Certificate data and have not had contact with prohibited substances or 
ionizing radiation (Sec. Sec.  205.273 and 205.300).
    4. Clarifies nonretail containers used to ship or store organic 
products must display organic identification and information that links 
the container to audit trail documentation. This will help maintain the 
integrity of organic products by reducing misidentification and 
mishandling, facilitating traceability through the supply chain, 
reducing organic fraud, and allowing accurate identification of organic 
product by customs officials and transportation agents.
    The rulemaking reduces burden because the revised regulation 
requires less information on nonretail container labels and provides 
exceptions for certain types of containers in response to public 
comment. AMS estimates that 35,698 producers and/or processers will 
need one tenth (0.1) of an hour, or 6 minutes, to add the required 
information to the labels that are displayed on the nonretail 
containers of an estimated 275,596 annual shipments (Sec.  
205.307).\64\
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    \64\ 29,929 (existing and new domestic operations and traders) 
certified operations will be modifying how they label 195,387 
nonretail shipments and 5,769 (existing, new, and domestic 
operations and traders) certified operations will be modifying how 
they label 80,109 nonretail shipments exported to the US.
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    5. Codifies current practices for the certification of producer 
group operations (groups of producers organized and certified as a 
single operation).\65\ The rulemaking describes the criteria to qualify 
as a producer group, how producer group operations must comply with the 
USDA organic regulations, and how certifying agents should inspect 
these operations. It also sets a risk-based benchmark to determine how 
many producer group members in an operation need to be inspected by 
certifying agents annually.
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    \65\ NOP Policy Memo 11-10. Grower Group Certification, October 
31, 2011: https://www.ams.usda.gov/sites/default/files/media/NOP-11-10-GroupGrowerCert.pdf.
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    In response to public comment, AMS expects that these requirements 
will add 11,800 hours of one-time paperwork burden for 5,900 producer 
group operations \66\ to prepare a detailed Internal Control System for 
their OSP, including procedures to address conflicts of interest and 
manage the unique challenges of producer group oversight. In addition, 
AMS estimates 5 hours to prepare and deliver training, outreach and 
technical assistance to ICS personnel and producer group members, 
leading to a total annual burden of 29,500 hours of burden annually 
(Sec. Sec.  205.201, 205.400(g) and 205.403).
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    \66\ Meinshausen F., Richter, T., Blockeel, J., and Huber, B., 
Group Certification: Internal Control Systems in Organic 
Agriculture: Significance, Opportunities and Challenges, Research 
Institute of Organic Agriculture FiBL, March 2019.
---------------------------------------------------------------------------

    6. Clarifies how certified operations may submit annual updates to 
their OSP. This includes the option to only submit practices or 
procedures that have changed since their last approved OSP, rather than 
submitting an OSP in its entirety. This will reduce unnecessary 
paperwork without compromising oversight because operations will 
continue to maintain an OSP that accurately reflects current practices 
and procedures of the operation. This codifies current policy and does 
not modify the paperwork burden (Sec.  205.406).
    7. Requires certifying agents to issue standardized certificates of 
organic operation generated from the USDA's publicly available Organic 
Integrity Database (OID).\67\ This will require an initial upload of 
mandatory data for each operation and maintenance to ensure that data 
in OID are current and accurate. Currently, all certifying agents have 
voluntarily uploaded data and maintain an estimated 50% or more data on 
all certified operations per the recommendations found in the NOP's 
Data Quality Best Practices.\68\
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    \67\ Organic Integrity Database: https://organic.ams.usda.gov/integrity. Accessed September 2021.
    \68\ Data Quality Best Practices: https://www.ams.usda.gov/sites/default/files/media/INTEGRITY%20Data%20Quality.pdf.
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    These amendments will require a new, one-time burden of reporting 
hours for certifying agents to upload existing data pertaining to 
currently certified operations into OID for the first time. It is 
estimated that uploading these data into OID will require 30 minutes 
for each operation and will be performed by administrative support 
personnel who have a lower wage rate than review and compliance staff. 
The rulemaking's burden increases slightly due to industry growth.
    These amendments will simultaneously eliminate the requirement to 
physically mail the Administrator or State organic program paper copies 
of: (1) the list of operations certified annually; (2) notifications of 
proposed adverse actions, approvals, or denials of corrective actions; 
and (3) notifications of executions of adverse actions regarding 
certified operations or operations applying for certification 
(Sec. Sec.  205.405 and 205.501). AMS is not modifying the estimate of 
paperwork burden associated with these changes in requirements because 
any change will be very small, and these activities and tasks are still 
occurring electronically as a part of maintaining the data on all 
operations over time.
    8. Requires certifying agents to develop procedures to: (1) 
identify high-risk operations and agricultural products; (2) conduct 
supply chain traceability audits, (3) share information with other 
certifying agents to verify supply chains and conduct investigations, 
and (4) report credible evidence of organic fraud to the USDA. Due to 
the complexity of these procedures, AMS estimates each certifying agent 
will spend two hours documenting these procedures (Sec. Sec.  205.501 
and 205.504) rather than one hour as proposed. The rulemaking's burden 
increases due to an increase in time for preparing procedures despite a 
net loss of certifying agents since 2017 (the net value reflects that 
while some certifiers have been suspended or have surrendered, others 
have been newly accredited).
    9. Requires certifying agents to submit their decision criteria for 
acceptance of mediation, and a process for identifying personnel to 
conduct mediation and set up mediation sessions with its administrative 
policies and procedures required by Sec.  205.504(b). AMS estimates 
each certifying agent will spend one

[[Page 3613]]

hour documenting these procedures, which they are already implementing. 
The rulemaking's burden changes due to the net loss of 3 certifying 
agents since 2017.
    10. Requires certifying agents to establish procedures to conduct 
inspector field evaluations (``witness inspections''), demonstrate that 
they are sufficiently staffed with qualified personnel, and demonstrate 
that all inspectors, certification reviewers, and in-field evaluators 
meet knowledge, skills, and experience qualifications. AMS estimates 
that each certifying agent will spend 60 minutes to draft policies and 
procedures for conducting inspector field evaluations. Further, 
certifying agents must observe an inspector performing an on-site 
inspection at least once every three years (or annually for inspectors 
with fewer than three years of experience).
    The rulemaking's burden is reduced due to narrowed training 
requirements and the net loss of 3 certifying agents since 2017. AMS 
estimates each certifying agent will conduct an average of two field 
evaluations of an inspector and certification review personnel per 
year, rather than four as proposed, and that this activity will require 
7.5 hours per evaluation (Sec. Sec.  205.2 and 205.501).
    11. Requires some additional training of new inspectors and 
certification review personnel. Inspectors and certification review 
personnel play a crucial role in determining whether an operation is 
granted organic certification initially and whether certified 
operations comply with the USDA organic regulations. Certification 
review personnel may also serve as inspectors. Through insight gained 
during regular audits of certifying agents, AMS estimates that 
inspectors and certification review staff currently receive at least 10 
hours of training per year from certifying agents on topics related to 
the USDA organic regulations.
    In response to public comment, 40 hours of additional training is 
required for inspectors and certification review personnel with less 
than one year of experience.\69\ Based on an estimated separation rate 
of 14 percent,\70\ AMS estimates that certifying agents will annually 
hire 35 new certification review staff and hire or contract with 35 
inspectors with less than one year of experience to replace the 
certification review staff and inspectors that exit the labor pool. 
Training offered by NOP through its online Organic Integrity Learning 
Center (OILC) and training provided by the certifying agents or other 
providers may qualify towards the minimum annual training requirements 
(Sec. Sec.  205.2 and 205.501).
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    \69\ Ten hours of training are accounted for in the 2020 
Information Collections Renewal for NOP (AMS-NOP-19-0090; OMB 
Control Number: 0581-0191). Our internal on-site accreditation audit 
checklist used by our accreditation audit team includes a question 
on training. With the implementation of this rule, the specific 
hours of training offered by the 75 certifying agents will be 
documented.
    \70\ The US Bureau of Labor and Statistics reports that the 
average separation rate (which captures both labor force exits and 
transfers in occupation) for agricultural inspectors is 14 percent. 
https://www.bls.gov/news.release/jolts.t16.htm.
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    12. Requires that certifying agents conduct unannounced inspections 
of at least 5 percent of the operations they certify, which is the 
current recommended practice in NOP Instruction 2609.\71\ For the 
purposes of estimating paperwork impacts, AMS expects that half of the 
unannounced inspections (2.5% of total inspections) will meet the 
requirement for a full annual inspection and will not impact current 
paperwork burden. The remaining half of the unannounced inspections 
(2.5% of total inspections) will be limited in scope and target high-
risk operations and will not count as a full annual inspection. 
Examples of targeted, limited-scope unannounced inspections include but 
are not limited to verifying livestock on pasture or performing 
targeted mass-balance or traceability audits. AMS estimates that the 
paperwork impacts associated with these unannounced inspections will 
average inspectors 5 hours per inspection; half of the estimated 10 
hours for a full annual inspection (Sec.  205.403).
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    \71\ NOP 2609, Instruction, Unannounced Inspections. September 
12, 2012. Available in the NOP Program Handbook: https://www.ams.usda.gov/sites/default/files/media/2609.pdf.
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    13. Clarifies the process for accepting foreign conformity 
assessment systems that oversee organic certification in foreign 
countries.\72\ The OFPA (7 U.S.C. 6505(b)) and the USDA organic 
regulations provide the authority to establish organic equivalency. The 
revised regulations describe the criteria, scope, and other parameters 
for ongoing peer review audits of foreign organic conformity systems to 
determine whether the United States should continue, revise, or 
terminate such equivalence determinations. These peer review audits of 
equivalence determinations occur as needed and will result in new 
periodic paperwork impacts for foreign governments. The rulemaking's 
burden is reduced because AMS estimates it will review one foreign 
government conformity assessment system per year. AMS estimates the 
reporting impacts for foreign governments when USDA reviews the 
applicable trade arrangement or agreement to be 60 hours. Since 
recordkeeping is ongoing requirement, recordkeeping is calculated as 10 
hours per year per foreign government. These impacts are comparable to 
the estimated paperwork impacts for AMS audits of certifying agents 
(Sec.  205.511).
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    \72\ Currently, the United States has established organic trade 
arrangements with Canada, the European Union, the United Kingdom, 
Israel, Japan, New Zealand, South Korea, Taiwan, and Switzerland.
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Respondents
    AMS has identified four primary types of entities (respondents) 
that will need to submit and maintain information as a result of this 
rulemaking: certified organic operations; accredited certifying agents; 
organic inspectors; and foreign governments. Three respondent types--
certified operations (producers and handlers), certifying agents, and 
inspectors--have been identified in a currently approved information 
collection (0581-0191). To implement a 2018 Farm Bill mandate, AMS is 
requiring certification of additional types of operations in the 
organic supply chain and regular audits of trade arrangements or 
agreements with foreign governments.\73\ This adds new types of 
handlers as a subcategory of certified operations and foreign 
governments as a new type of respondent.
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    \73\ See Section 10104(a) of the Agriculture Improvement Act of 
2018, Public Law No: 115-334, available at: https://www.congress.gov/115/plaws/publ334/PLAW-115publ334.pdf.
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    To more precisely understand the paperwork impacts of this 
rulemaking, AMS has divided the categories of respondents into domestic 
and foreign, as appropriate, to show the potential impacts on domestic-
based versus foreign-based USDA-accredited certifying agents, 
inspectors, and certified operations, along with foreign-accredited 
certifying agents, and foreign governments serving as accrediting 
bodies. For each type of respondent, we describe the general paperwork 
submission and recordkeeping activities and estimate: (1) the number of 
respondents; (2) the hours they spend, annually, creating and storing 
records to meet the paperwork requirements of the organic labeling 
program; and (3) the costs of those activities based on prevailing 
domestic and foreign wages and benefits.
Certifying Agents
    Certifying agents are State, private, or foreign entities 
accredited by the USDA,

[[Page 3614]]

or by accreditation bodies of foreign governments with which USDA has a 
trade arrangement or agreement. Certifying agents certify domestic and 
foreign producers and handlers as organic in accordance with the OFPA 
and the USDA organic regulations. Certifying agents determine whether a 
producer or handler meets the organic requirements, using detailed 
information from the operation about its specific practices and on-site 
inspection reports from organic inspectors.
    Currently, there are 75 USDA-accredited certifying agents (down 
from 78 in 2017) 45 are based in the United States and 30 are 
headquartered in foreign countries. Both domestic- and foreign-based 
USDA-accredited certifying agents certify operations based in the 
United States and abroad. AMS assumes all currently accredited 
certifying agents evaluate all types of production and handling 
operations for compliance with the USDA organic regulations and will be 
subject to the reporting and recordkeeping burdens of this rulemaking. 
In addition, AMS assumes there are 30 foreign government-accredited 
foreign-based certifying agents that certify handlers in accordance 
with the USDA organic regulations and that will issue NOP Import 
Certificates for organic product shipments to the United States.\74\
---------------------------------------------------------------------------

    \74\ An estimate based on the number of foreign-based USDA-
accredited certifying agents.
---------------------------------------------------------------------------

    Certifying agents of operations that export to the United States 
must issue NOP Import Certificates for all shipments of organic 
products being exported. The USDA Foreign Agricultural Service (FAS) 
Global Agricultural Trade System (GATS) showed 80,109 shipments of 
organic product coming into the United States in 2020 (up from 67,023 
in 2017 due to industry growth).\75\ In response to public comments, 
AMS estimates that NOP Import certificates will be issued seasonally 
(e.g., quarterly) rather than with every shipment as proposed. AMS 
estimates that 3,856 foreign exporters will request from their 
certifying agents an annual total of 15,424 NOP Import Certificates, 
covering 80,109 annual shipments.\76\ AMS estimates each exporter and 
certifying agent will spend 30 minutes to request and approve each NOP 
Import Certificate.
---------------------------------------------------------------------------

    \75\ Data source: USDA Foreign Agricultural Service (FAS) Global 
Agricultural Trade System (GATS). Select: Partners, World Total, 
Product Type, Imports--General, Products: All Aggregates; Product 
Groups: Organic--Selected: https://apps.fas.usda.gov/gats/default.aspx.
    \76\ NOP International Division reports that 3,303 organic 
exporters are certified by foreign (non-USDA) certifiers. Plus, the 
Organic Integrity Database shows that 553 foreign-based handlers are 
certified by USDA-accredited certifying agents. The total number of 
NOP Import Certificates assumes each exporter is issued NOP Import 
Certificates quarterly (four annually).
---------------------------------------------------------------------------

    Thirty (30) USDA-accredited certifying agents based in foreign 
countries certify 92% of the foreign operations certified under USDA 
organic standards. Of the 45 domestic-based USDA accredited certifying 
agents, 15 certifying agents certify 8% of the foreign operations 
certified under USDA.\77\ This means that 30 domestic-based USDA-
accredited certify agents only certify domestic-based operations that 
do not import foreign organic products or ingredients. AMS estimates 
there are 30 foreign-accredited certifying agents that certify foreign 
operations under trade arrangements.\78\
---------------------------------------------------------------------------

    \77\ Organic Integrity Database: https://organic.ams.usda.gov/integrity/.
    \78\ An estimate based on the number of foreign-based USDA-
accredited certifying agents.
---------------------------------------------------------------------------

    AMS will review documents regarding imports during the 
accreditation audits of USDA-accredited certifying agents. AMS 
estimates 30 minutes for the 3,856 exporters and their certifying 
agents to prepare and approve each of the 15,424 NOP Import 
Certificates and one tenth of an hour, or 6 minutes, for importers to 
verify and reconcile all 80,109 subsequent associated shipments 
exported to the United States.\76\ USDA-accredited domestic-based 
certifying agents must work with their foreign-based operations to 
verify their associated shipments for 8%, or 6,409, of 80,109 annual 
shipments. USDA-accredited foreign-based certifying agents must work 
with their foreign-based operations to verify their associated 
shipments for 46%, or 36,850, of 80,109 annual shipments. Foreign-
accredited certifying agents must work with their foreign-based 
operations to verify 46% of 80,109 annual shipments.
    In addition, this rulemaking reduces the current paperwork burden 
of accredited certifying agents by eliminating the need to provide 
notices of approval or denial of certification to the Administrator 
following the issuance of a notice of noncompliance or adverse action 
to an applicant for certification. Also, the rulemaking removes the 
annual requirement for certifying agents to submit by January 2 an 
annual list of operations certified. Certifying agents will instead be 
required to update data in OID for each operation they certify. AMS is 
not modifying the estimate of paperwork burden with these changes in 
requirements because any change will be very small. These activities 
and tasks are still occurring electronically as a part of maintaining 
the data on all operations over time. Certifying agents must issue 
organic certificates generated in OID.

[[Page 3615]]

    In addition, all USDA-accredited certifying agents must write 
detailed procedures to identify high-risk operations and products they 
certify and procedures to conduct supply-chain traceability audits. 
Certifying agents must write fraud prevention and reporting procedures, 
and mediation procedures per Sec.  205.504(b). Certifying agents must 
write procedures to demonstrate how they are sufficiently staffed and 
that all persons who perform certification review activities and on-
site inspections (inspectors) are qualified and complying with training 
requirements for their new certification review personnel. AMS 
estimates that 14 percent, or 35, new certification review staff with 
less than one year of experience must complete 40 hours of training in 
their first year in addition to the baseline training requirement of 10 
hours annually already accounted for in the overall program ICR 
(0191).79 80
---------------------------------------------------------------------------

    \79\ Ten hours of training are accounted for in the 2020 
Information Collections Renewal for the NOP (AMS-NOP-19-0090; OMB 
Control Number: 0581-0191). Our internal onsite accreditation audit 
checklist used by our accreditation audit team includes a question 
on training. With the implementation of this rule, the specific 
hours of training offered by our 75 certifying agents will be 
documented.
    \80\ The US Bureau of Labor and Statistics reports that the 
average separation rate (which captures both labor force exits and 
transfers in occupation) for agricultural inspectors is 14 percent. 
https://www.bls.gov/news.release/jolts.t16.htm.
---------------------------------------------------------------------------

    This rulemaking increases the overall reporting and recordkeeping 
burden for certifying agents (See Summary Table 1: Certifying Agents). 
AMS estimates the annual collection cost per domestic-based USDA-
accredited certifying agents will be $13,511.\81\ This cost is based on 
an estimated 109.23 labor hours per certifying agent per year for staff 
with certification review responsibilities at $47.97 per labor hour, 
including 31.7% benefits, for a total salary component of $5,229 per 
year.\82\ The estimated cost for domestic certifying agents also 
includes 332.55 labor hours per certifying agent per year for 
administrative support staff to upload data about certified operations 
to OID at $24.90 per labor hour, including 31.7% benefits, for a total 
salary component of $8,282 per year.\83\
---------------------------------------------------------------------------

    \81\ In this assessment, all domestic labor rates are sourced 
from the U.S. Bureau of Labor Statistics National Compensation 
Survey, Occupational Employment and Wages, May 2020: https://www.bls.gov/oes/current/oes_nat.htm. Domestic benefits are based on 
a Bureau of Labor Statistics News Release on Employer Costs for 
Employee Compensation, which states that benefits account for 31.7% 
of total average employer compensation costs, December 17, 2020.
    \82\ The labor rate for certification review staff is based on 
Occupational Employment Statistics group 13-1041, Compliance 
Officers. Compliance officers examine, evaluate, and investigate 
eligibility for or conformity with laws and regulations governing 
contract compliance of licenses and permits, and perform other 
compliance and enforcement inspection and analysis activities not 
classified elsewhere. Compliance Officers (bls.gov).
    \83\ The labor rate for administrative support staff is based on 
Occupational Employment Statistics group 43-9199, Office and 
Administrative Support Workers, who support general office work and 
data entry functions. Office and Administrative Support Workers, All 
Other (bls.gov).
---------------------------------------------------------------------------

    In addition, AMS estimates the annual collection cost for all 
domestic-based USDA-accredited certifying agents will be $608,001. This 
cost is based on a total of 4,915 hours for all staff with 
certification review responsibilities at $47.87 per labor hour, 
including 31.7% benefits, for a total salary component of $235,313 for 
all staff with certification review and procedure writing 
responsibilities of all domestic-based USDA-accredited certifying 
agents. The estimated cost for all domestic-based certifying agents 
also includes 14,965 hours total hours for administrative support staff 
uploading data about certified operations to OID at $24.90 per labor 
hour, including 31.7% benefits for a total salary component of 
$372,688.

                                                           Summary Table 1--Certifying Agents
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                               Cost per
                    Respondent categories                         Number of      Wages +       Hours per      respondent     Total all   Total all costs
                                                                 respondents     benefits     respondent         type          hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
US Based USDA Certifying Agents..............................              45       $47.87          109.23       $5,229.17     4,915.36      $235,312.78
US Based USDA Certifying Agents--data entry..................              45        24.90          332.55        8,281.95    14,964.69       372,687.76
                                                              ------------------------------------------------------------------------------------------
    Subtotal U.S.-Based USDA Certifying Agents...............              45  ...........          441.78       13,511.12    19,880.05       608,000.54
                                                              ------------------------------------------------------------------------------------------
Foreign-Based USDA Certifying Agents.........................              30        34.40          653.80       22,493.03    19,614.07       674,791.04
Foreign-Based USDA Certifying Agents--data entry.............              30        17.90          346.64        6,203.93    10,399.19       186,118.00
                                                              ------------------------------------------------------------------------------------------
    Subtotal Foreign-Based USDA Certifying Agents............              30  ...........        1,000.44       28,696.97    30,013.26       860,909.04
                                                              ------------------------------------------------------------------------------------------
Total USDA Accredited Certifying Agents......................              75  ...........  ..............       42,208.09    49,893.31     1,468,909.58
                                                              ------------------------------------------------------------------------------------------
Foreign (Non-USDA) Accredited Certifying Agents..............              30        34.40          614.17       21,129.51    18,425.07       633,885.38
All Certifying Agents........................................             105  ...........  ..............  ..............    68,318.38     2,102,794.96
--------------------------------------------------------------------------------------------------------------------------------------------------------

    For foreign-based USDA-accredited certifying agents, AMS estimates 
the annual cost per certifying agent will be $28,697 per year. This 
cost is based on an estimated 653.80 labor hours for staff with 
certification review and procedure writing responsibilities at $34.40 
per labor hour, including 34.63% benefits, for a total salary component 
of $22,493 per foreign-based USDA-accredited certifying agent per year. 
These estimated costs primarily pertain to the issuance and review of 
NOP Import Certificates. The estimated cost for foreign-based USDA-
accredited certifying agents also includes 346.64 labor hours per 
certifying agent per year for administrative support staff to upload 
data about certified operations to OID at $17.90 per labor hour, 
including 34.63% benefits, for a total salary component of $6,204 per 
year.84 85
---------------------------------------------------------------------------

    \84\ The source of the data is based on average World Bank wage 
rates for countries with USDA-accredited certifying agents, which 
were 70.3% of U.S. labor rates in 2020. https://data.worldbank.org/indicator/NY.GDP.PCAP.PP.CD. Agents: https://stats.oecd.org/Index.aspx?DataSetCode=AWCOMP.
    \85\ Benefits are based on a review of data from the 
Organisation for Economic Co-Operation and Development (OECD), which 
indicates that benefits account for 34.63% of total compensation in 
foreign countries with USDA-accredited certifying agents.
---------------------------------------------------------------------------

    AMS estimates the annual collection cost for all foreign-based USDA 
accredited certifying agents will total $860,909. This cost is based on 
a total of 19,614.07 hours for all staff with certification review 
responsibilities at $24.90 per labor hour, including 34.63% benefits, 
for a total salary component of $674,791 for staff with certification 
review and procedure writing responsibilities of all foreign-based 
USDA-accredited certifying agents. The estimated cost for all foreign-
based USDA-accredited certifying agents also includes 10,399.19 hours 
total hours for administrative support staff uploading data about 
certified operations to OID at $17.90 per labor hour, including 34.63%

[[Page 3616]]

benefits, for a total salary component of $186,118.86 87
---------------------------------------------------------------------------

    \86\ The source of the data is based on average World Bank wage 
rates for countries with USDA-accredited certifying agents which 
were 70.3% of U.S. labor rates in 2020. https://data.worldbank.org/indicator/NY.GDP.PCAP.PP.CD. Agents: https://stats.oecd.org/Index.aspx?DataSetCode=AWCOMP.
    \87\ Benefits are based on a review of data from the 
Organisation for Economic Co-Operation and Development (OECD), which 
indicates that benefits account for 34.63% of total compensation in 
foreign countries with USDA-accredited certifying agents.
---------------------------------------------------------------------------

    For foreign-accredited certifying agents (non-USDA accredited), AMS 
estimates the annual cost will be $21,130 per certifying agent. This 
cost is based on an estimated 614.17 labor hours per year for staff to 
issue and review NOP Import Certificates, at $34.40 per labor hour plus 
34.63% benefits. The total for all foreign-accredited certifying agents 
is estimated to be $633,885. The cost is based on an estimated 18,425 
total hours for all staff involved in the issuance and review of NOP 
Import Certificates, at $34.40 per labor hour plus 34.63% benefits. 
88 89
---------------------------------------------------------------------------

    \88\ The source of the data is based on average World Bank wage 
rates for countries with USDA-accredited certifying agents which 
were 70.3% of U.S. labor rates in 2020. https://data.worldbank.org/indicator/NY.GDP.PCAP.PP.CD.agents: https://stats.oecd.org/Index.aspx?DataSetCode=AWCOMP.
    \89\ Benefits are based on a review of data from the 
Organisation for Economic Co-Operation and Development (OECD), which 
indicates that benefits account for 34.63% of total compensation in 
foreign countries with USDA-accredited certifying agents.
---------------------------------------------------------------------------

    The total cost for all certifying agents--including the 75 USDA-
accredited certifying agents, domestic- and foreign-based, and the 
estimated 30 foreign-accredited (non-USDA) certifying agents who 
certify operations that export products to the U.S.--is $2,102,795. 
This cost is based on 68,318.38 total hours at their respective wage 
rates and benefits to comply with the rulemaking's requirements.
Organic Inspectors
    Inspectors conduct on-site inspections of certified operations and 
operations applying for certification and report the findings to the 
certifying agent. Inspectors may be independent contractors or 
employees of certifying agents. Certified operations must be inspected 
annually, and a certifying agent may call for additional inspections or 
unannounced inspections on an as-needed basis (Sec.  205.403(a)). Any 
individuals who apply to conduct inspections of operations will need to 
submit information documenting their qualifications to the certifying 
agent (Sec.  205.504(a)(3)).
    Inspectors provide an inspection report to the certifying agent for 
each operation inspected (Sec.  205.403(e)) but are not expected to 
store the record. Currently, AMS estimates that inspectors spend 10 
hours on average to complete an inspection report for a full annual 
inspection of an organic operation. The additional unannounced 
inspections required by this rulemaking are likely to be more limited 
in scope (such as pasture or dairy surveillance, or mass-balance and 
supply chain traceability audits). AMS projects, on average, that 
inspectors will spend 5 hours to complete an inspection report for an 
unannounced targeted-scope inspection. Organic inspectors do not have 
recordkeeping obligations; certifying agents maintain the records of 
inspection reports (see Summary Table 2: Inspectors).

                                                               Summary Table 2--Inspectors
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                               Cost per
                    Respondent categories                         Number of      Wages +       Hours per      respondent     Total all   Total all costs
                                                                 respondents     benefits     respondent         type          hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
USDA US based Inspectors.....................................             148       $30.79           30.86         $950.20     4,567.17      $140,629.94
USDA Foreign based inspectors................................             102        22.13           31.12          688.53     3,173.80        70,229.73
                                                              ------------------------------------------------------------------------------------------
    All USDA Inspectors......................................             250  ...........  ..............  ..............     7,740.97       210,859.67
--------------------------------------------------------------------------------------------------------------------------------------------------------

    According to the International Organic Inspectors Association 
(IOIA), there are approximately 250 inspectors currently inspecting 
crop, livestock, handling, and/or wild crop operations that are 
certified or have applied for certification. To comply with this 
rulemaking, AMS estimates that 14 percent, or 35, new inspectors with 
less than one year of experience must complete 40 hours of training in 
their first year in addition to the baseline training requirement of 10 
hours annually already accounted for in the overall program ICR 
(0191).90 91
---------------------------------------------------------------------------

    \90\ Ten hours of training are accounted for in the 2020 
Information Collections Renewal for the NOP (AMS-NOP-19-0090; OMB 
Control Number: 0581-0191). Our internal onsite accreditation audit 
checklist used by our accreditation audit team includes a question 
on training. With the implementation of this rule, the specific 
hours of training offered by our 75 certifying agents will be 
documented.
    \91\ The US Bureau of Labor and Statistics reports that the 
average separation rate (which captures both labor force exits and 
transfers in occupation) for agricultural inspectors is 14 percent. 
https://www.bls.gov/news.release/jolts.t16.htm.
---------------------------------------------------------------------------

    AMS estimates that 148 inspectors are working for USDA-accredited 
certifying agents in the United States. For the additional training of 
new inspectors, and for conducting unannounced targeted-scope 
inspections, AMS estimates the annual paperwork impact cost per 
domestic-based inspector is $950.20. This is based on an estimated 
30.86 labor hours per year at $30.79 per labor hour, including 31.7% 
benefits. The total annual cost for all domestic-based inspectors is 
$140,630. This cost is based on 4,567 total hours for all domestic 
based inspectors at $30.79 per labor hour, including 31.7% 
benefits.\92\
---------------------------------------------------------------------------

    \92\ The labor rate for inspectors is based on Occupational 
Employment Statistics group 45-2011, Agricultural Inspectors. 
Agricultural inspectors inspect agricultural commodities, processing 
equipment, facilities, and fish and logging operations to ensure 
compliance with regulations and laws governing health, quality, and 
safety.
---------------------------------------------------------------------------

    AMS estimates that 102 inspectors are working for USDA-accredited 
certifying agents in foreign countries. AMS estimates the annual 
paperwork impact cost per foreign-based inspector is $688.53. This 
estimate is based on an estimated 31.12 labor hours per year at $22.13 
per labor hour, including 34.63% benefits for the additional training 
of new inspectors and for conducting unannounced targeted-scope 
inspections. This rule does not impose additional recordkeeping costs 
for inspectors. The total annual cost for all foreign-based inspectors 
is $70,230 at $31.12 per labor hour, including 34.63% benefits. The 
total annual cost for all inspectors working for USDA-accredited 
certifying agents is $210,860, at their respective wage rates and 
benefits.93 94
---------------------------------------------------------------------------

    \93\ The source of the data is based on average World Bank wage 
rates for countries with USDA-accredited certifying agents which 
were 70.3% of U.S. labor rates in 2020. https://data.worldbank.org/indicator/NY.GDP.PCAP.PP.CD. Agents: https://stats.oecd.org/Index.aspx?DataSetCode=AWCOMP.
    \94\ Benefits are based on a review of data from the 
Organisation for Economic Co-Operation and Development (OECD), which 
indicates that benefits account for 34.63% of total compensation in 
foreign countries with USDA-accredited certifying agents.

---------------------------------------------------------------------------

[[Page 3617]]

Producers and Handlers
    Domestic and foreign producers and handlers seeking organic 
certification must submit an OSP that details the practices and 
activities specific to their operation. Once certified, operations are 
required to update any changes in their operation or practices to their 
certifying agent at least annually.
    Uncertified Handlers. This rulemaking requires that operations that 
facilitate the sale or trade of organic products--including, but not 
limited to, certain brokers, importers, and traders--obtain organic 
certification and submit and maintain an OSP. AMS estimates that 1,985 
domestic \95\ and 1,379 foreign-based \96\ operations will need to 
become certified as a result of the rule. Traders and brokers do not 
farm or manufacture organic products, so the OSPs for traders and 
brokers will address fewer sections of USDA organic regulations than 
OSPs for operations that produce or manufacture organic products. 
Certifying agents customize the format of the OSP to cover standards 
applicable to the operations seeking certification. Therefore, AMS 
estimates that preparation of an initial OSP will require 40 reporting 
hours, plus 10 hours of annual recordkeeping. The estimated annual 
reporting burden for each entity to update its OSP in future years is 
20 hours (See Summary Table 3a: Uncertified Handlers).
---------------------------------------------------------------------------

    \95\ Please refer to the ``Applicability and Exemptions from 
Certification (Sec. Sec.  205.100-101)'' chapter in the Regulatory 
Impact Analysis (RIA) for an explanation of how previously excluded 
domestic handlers were estimated.
    \96\ AMS assumes the 1,985 domestic excluded operations 
represent 59% of the global total benchmarked 59%/41% ratio of 
domestic to foreign operations and certifying agents. Therefore, AMS 
estimate there are an additional 1,379 foreign formerly excluded 
operations, for a total of 3,364 new handlers that will need organic 
certification.
---------------------------------------------------------------------------

    All operations that export organic products to the United States 
must request an NOP Import Certificate from their certifying agent. 
Further, operations that import organic products must verify and 
reconcile each shipment with its associated NOP Import Certificate and 
verify that organic integrity was maintained throughout the import 
process. In addition, domestic and foreign handlers that must obtain 
organic certification as a result of this rulemaking will also need to 
comply with the labeling requirements for nonretail containers.

                                                         Summary Table 3a--Uncertified Handlers
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                            Total cost per
                    Respondent categories                         Number of      Wages +      Total hours     respondent     Total all   Total all costs
                                                                 respondents     benefits   per respondent       type          hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Formerly Excluded Handlers--Domestic.........................           1,985       $48.64           50.97       $2,478.80   101,166.47    $4,920,414.48
Formerly Excluded Handlers--Foreign..........................           1,379        34.95           53.42        1,867.02    73,660.94     2,574,623.40
                                                              ------------------------------------------------------------------------------------------
    All Uncertified Handlers.................................           3,364  ...........  ..............  ..............   174,827.41     7,495,037.88
--------------------------------------------------------------------------------------------------------------------------------------------------------

    AMS estimates the annual paperwork impact for each domestic handler 
to prepare their initial organic system plan, verify and reconcile 
imported shipments with their respective NOP Import Certificates, and 
verify that the organic integrity of the product was maintained through 
shipping is 2,478.80. This is based on an estimated 50.97 labor hours 
at $48.64 per labor hour, including 31.7% benefits. The total cost to 
all previously uncertified domestic handlers is $4,920,415. This cost 
is based on 101,166.47 total labor hours at $48.64 per labor hour, 
including 31.7% benefits.\97\
---------------------------------------------------------------------------

    \97\ For uncertified handlers, AMS chose to use the same labor 
rate as certified producers and handlers: Occupational Employment 
Statistics group 11-9013, Farmers, Ranchers, and Other Agricultural 
Managers.
---------------------------------------------------------------------------

    AMS estimates the annual paperwork impact for each foreign-based 
handler to prepare their initial organic system plan and to work with 
their certifying agent to prepare NOP Import Certificates for the 
products they export is $1,867.02. This is based on an estimated 53.42 
labor hours per year at $34.95 per labor hour, which includes 34.63% 
for benefits. The total cost to all previously uncertified foreign 
handlers is $2,574,623.40. This cost is based on 73,660.94 total labor 
hours at $34.95 per labor hour, which includes 34.63% for benefits. 
Total costs to the 3,364 previously uncertified handlers, domestic and 
foreign, is $7,495,038, based on 174,827 total labor hours at their 
respective domestic and foreign wage rates and benefits. This cost is 
to prepare and keep initial OSPs and related records, and to prepare, 
verify, and reconcile NOP Import Certificates for 
compliance.98 99
---------------------------------------------------------------------------

    \98\ The source of the data is based on average World Bank wage 
rates for countries with USDA-accredited certifying agents which 
were 70.3% of U.S. labor rates in 2020. https://data.worldbank.org/indicator/NY.GDP.PCAP.PP.CD.agents: https://stats.oecd.org/Index.aspx?DataSetCode=AWCOMP.
    \99\ Benefits are based on a review of data from the 
Organisation for Economic Co-Operation and Development (OECD), which 
indicates that benefits account for 34.63% of total compensation in 
foreign countries with USDA-accredited certifying agents.
---------------------------------------------------------------------------

    Certified Operations and New Applicants under Current Rules. There 
currently are 44,725 organic operations worldwide that are certified to 
the USDA organic standards. Over the next 12 months, AMS expects 2,639 
operations will seek organic certification, based on the 5.9% rate of 
growth in number of operations observed in the last 12 months under 
current rules. Therefore, AMS estimates that 27,945 operations based in 
the United States, and 19,419 operations based in foreign countries, 
including the respective applicants for certification, will be impacted 
by this rulemaking.\100\
---------------------------------------------------------------------------

    \100\ Organic Integrity Database: https://organic.ams.usda.gov/integrity/.
---------------------------------------------------------------------------

    All currently certified organic operations and projected new 
applicants must describe in their OSP their procedures for monitoring, 
verifying, and demonstrating the organic status of their suppliers and 
products received to prevent organic fraud. All certified organic 
operations must also comply with revised nonretail container labeling 
requirements and must maintain all records about their organic 
production and/or handling for five years (Sec.  205.103(b)(3)).

[[Page 3618]]

    In addition, AMS estimates a one-time paperwork burden of 11,800 
hours for 5,900 producer group operations to prepare a detailed 
Internal Control System (ICS) for their OSP, including procedures to 
address conflicts of interest and manage the unique challenges of 
producer group oversight. In addition, training requirements for ICS 
personnel and producer group members are expanded to 29,500 hours 
annually (Sec. Sec.  205.201, 205.400(g) and 205.403).\101\
---------------------------------------------------------------------------

    \101\ Meinshausen F., Richter, T., Blockeel, J., and Huber, B., 
Group Certification: Internal Control Systems in Organic 
Agriculture: Significance, Opportunities and Challenges, Research 
Institute of Organic Agriculture FiBL, March 2019.

                                            Summary Table 3b--Certified Organic Operations and New Applicants
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                              Total cost/
                    Respondent categories                         Number of      Wages +     Total hours/     respondent     Total all   Total all costs
                                                                 respondents     benefits     respondent         type          hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Certified Producers & Handlers--New and Existing Domestic....          27,945       $48.64            1.67          $81.07    46,579.60    $2,265,483.08
Certified Producers & Handlers--New and Existing Foreign.....          19,419        34.95            3.44          120.39    66,888.32     2,337,904.67
                                                              ------------------------------------------------------------------------------------------
All New and Existing Producers & Handlers....................          47,364  ...........  ..............  ..............   113,467.92     4,603,388.08
--------------------------------------------------------------------------------------------------------------------------------------------------------

    AMS estimates that the average annual paperwork impact for domestic 
USDA-certified organic producers and handlers to develop fraud 
prevention procedures and to comply with nonretail container labeling 
requirements is $81.07. This is based on an estimated 1.67 labor hours 
at $48.64 per labor hour, including 31.7% benefits. The total cost for 
all domestic certified organic producers and handlers to comply with 
these new requirements is $2,265,483.08. This cost is based on 
46,579.60 labor hours at $48.64 per labor hour, including 31.7% 
benefits.\102\
---------------------------------------------------------------------------

    \102\ The labor rate for producers and handlers is based on 
Occupational Employment Statistics group 11-9013, Farmers, Ranchers, 
and Other Agricultural Managers, who plan, direct, or coordinate the 
management or operation of farms, ranches, or other agricultural 
establishments.
---------------------------------------------------------------------------

    AMS estimates the average annual paperwork impact for foreign-based 
USDA-certified organic producers and handers to create fraud prevention 
procedures and to comply with nonretail container labeling requirements 
is $120.39. This is based on an estimated 3.44 labor hours per year at 
$34.95 per labor hour, including 34.63% benefits. The total cost for 
all foreign producers and handlers certified to the USDA organic 
standards is $2,337,904.67. This cost is based on 66,888.32 labor hours 
year at $34.95 per labor hour, including 34.63% benefits. The total 
cost for the 47,364 current and projected certified organic producers 
and handlers, domestic and foreign, is $4,603,388. This cost is based 
on 113,4677.92 labor hours at their respective domestic and foreign 
wages and benefits.103 104
---------------------------------------------------------------------------

    \103\ The source of the data is based on average World Bank wage 
rates for countries with USDA-accredited certifying agents which 
were 70.3% of U.S. labor rates in 2020. https://data.worldbank.org/indicator/NY.GDP.PCAP.PP.CD. Agents: https://stats.oecd.org/Index.aspx?DataSetCode=AWCOMP.
    \104\ Benefits are based on a review of data from the 
Organisation for Economic Co-Operation and Development (OECD), which 
indicates that benefits account for 34.63% of total compensation in 
foreign countries with USDA-accredited certifying agents.
---------------------------------------------------------------------------

Foreign Governments
    The U.S. government, including the USDA and the U.S. Trade 
Representative, work closely together to implement processes that 
determine the equivalence of foreign organic certification programs and 
then negotiate an arrangement or agreement as appropriate.\105\ 
Formerly, the organic regulations only addressed this authority in 
general terms under Sec.  205.500(c) but did not describe the criteria, 
scope, and other parameters to establish, oversee, or terminate such 
arrangements or agreements. The rulemaking describes equivalence 
determinations in more detail; this creates a new type of PRA 
respondent category. The rulemaking allows an equivalence determination 
if the U.S. government determines that the technical requirements and 
conformity assessment system under which foreign products labeled as 
organic are produced and handled are at least equivalent to the 
requirements of the OFPA and the USDA organic regulations. The 
rulemaking requires periodic assessment.
---------------------------------------------------------------------------

    \105\ The United States currently has organic trade arrangements 
with Canada, the European Union, the United Kingdom, Israel, Japan, 
New Zealand, South Korea, Taiwan, and Switzerland.
---------------------------------------------------------------------------

    AMS expects these periodic peer review assessments will be similar 
in depth and frequency to the audits of USDA-accredited certifying 
agents and estimates a comparable level of reporting and recordkeeping 
burden by foreign governments with which USDA has negotiated trade 
arrangements or agreements. AMS estimates the collection cost for the 
periodic review of a single foreign government is $602. This cost is 
based on 7.5 reporting labor hours averaged as needed and an estimated 
10 hours of annual recordkeeping per foreign government per year at 
$24.59 per labor hour, including 34.63% benefits, for a total salary 
component of $602.06 per year reviewed. The total cost for foreign 
governments to be assessed for a trade arrangement or agreement is 
$4,816. This cost is averaged as 140 total labor hours for all foreign 
governments at $24.59 per labor hour, including 34.63% benefits. 
106 107
---------------------------------------------------------------------------

    \106\ The source of the data is based on average World Bank wage 
rates for countries with USDA-accredited certifying agents which 
were 70.3% of U.S. labor rates in 2020. https://data.worldbank.org/indicator/NY.GDP.PCAP.PP.CD. Agents: https://stats.oecd.org/Index.aspx?DataSetCode=AWCOMP.
    \107\ Benefits are based on a review of data from the 
Organisation for Economic Co-Operation and Development (OECD), which 
indicates that benefits account for 34.63% of total compensation in 
foreign countries with USDA-accredited certifying agents.
---------------------------------------------------------------------------

    Total (Domestic and Foreign) Information Collection Cost (Reporting 
and Recordkeeping) of Rulemaking: $14,416,897 (Also, see Summary Table 
4: All Reporting and Recordkeeping Hours and Costs, and All Domestic 
Reporting and Recordkeeping Hours and Costs).
    Total All Reporting Burden Cost: $12,454,097.
    Estimate of Burden: Public reporting burden for the collection of 
information is estimated to average 0.56 hours per year per response.
    Respondents: Certifying agents, certified operations, inspectors, 
and foreign governments.
    Estimated Number of Reporting Respondents: 51,091.
    Estimated Number of Reporting Responses: 566,387.
    Estimated Total Annual Burden on Reporting Respondents: 318,859 
hours.
    Estimated Total Annual Reporting Responses per Reporting 
Respondents: 11.09 reporting responses per reporting respondents.
    Total All Recordkeeping Burden Cost: $1,962,800.
    Estimate of Burden: Public recordkeeping burden is estimated to be

[[Page 3619]]

an annual total of 0.90 hours per year per respondent.
    Respondents: Certifying agents, certified operations, and foreign 
governments.
    Estimated Number of Recordkeeping Respondents: 50,811.
    Estimated Total Recordkeeping Burden on Respondents: 45,636 hours.
    Estimated Total Recordkeeping Responses per Recordkeeping 
Respondents: 1 recordkeeping response per recordkeeping respondents.
    Total Domestic Only Information Collection Cost (Reporting and 
Recordkeeping) of Rulemaking: $7,934,528.
    Total Domestic Only Reporting Burden Cost: $6,627,301.
    Estimate of Burden: Public domestic only reporting burden is 
estimated to be an annual total 0.43 hours per year per domestic 
respondent.
    Respondents: Certifying agents, certified operations, and 
inspectors.
    Estimated Number of Domestic Reporting Respondents: 30,123.
    Estimated Number of Domestic Reporting Responses: 334,168.
    Estimated Total Annual Reporting Burden on Domestic Respondents: 
145,315 hours.
    Estimated Total Domestic Reporting Responses per Reporting 
Respondents: 11.09 reporting response per reporting respondents.
    Total Domestic Only Recordkeeping Burden Cost: $1,307,227.
    Estimate of Burden: Public domestic only recordkeeping burden is 
estimated to be an annual total of 1 hours per year per respondent.
    Respondents: Certifying agents and certified operations.
    Estimated Number of Domestic Recordkeeping Respondents: 29,975.
    Estimated Total Annual Recordkeeping Burden on Domestic 
Respondents: 26,878 hours.
    Estimated Number of Domestic Recordkeeping Responses: 29,929.
    Estimated Total Domestic Recordkeeping Responses per Recordkeeping 
Respondents: 1 recordkeeping response per recordkeeping respondents.

       Summary Table 4--All Hours and Costs, All Domestic Hours and Costs, and All Foreign Hours and Costs
----------------------------------------------------------------------------------------------------------------
                                                                           Number of
                                             Hours           Costs        respondents       Respondent types
----------------------------------------------------------------------------------------------------------------
Total for All (Reporting &                     364,495     $14,416,897          51,091  Certifying agents,
 Recordkeeping).                                                                         certified operations,
                                                                                         inspectors, and foreign
                                                                                         governments.
    All Reporting.....................         318,859      12,454,097          51,091  Certifying agents,
                                                                                         certified operations,
                                                                                         inspectors, and foreign
                                                                                         governments.
    All Recordkeeping.................          45,636       1,962,800          50,811  Certifying agents,
                                                                                         certified operations,
                                                                                         and foreign
                                                                                         governments.
----------------------------------------------------------------------------------------------------------------
Just Domestic--All (Reporting &                172,193       7,934,528          30,123  Certifying agents,
 Recordkeeping).                                                                         certified operations,
                                                                                         and inspectors.
    Just Domestic Reporting...........         145,315       6,627,301          30,123  Certifying agents,
                                                                                         certified operations,
                                                                                         and inspectors.
    Just Domestic Recordkeeping.......          26,878       1,307,227          29,975  Certifying agents and
                                                                                         certified operations.
----------------------------------------------------------------------------------------------------------------
Just Foreign--All (Reporting &                 192,301       6,482,369          20,968  Certifying agents,
 Recordkeeping).                                                                         certified operations,
                                                                                         inspectors, and foreign
                                                                                         governments.
    Just Foreign Reporting............         173,543       5,826,795          20,968  Certifying agents,
                                                                                         certified operations,
                                                                                         inspectors, and foreign
                                                                                         governments.
    Just Foreign Recordkeeping........          18,758         655,573          20,836  Certifying agents,
                                                                                         certified operations,
                                                                                         and foreign
                                                                                         governments.
----------------------------------------------------------------------------------------------------------------

E. Executive Order 13175

    Executive Order 13175 requires Federal agencies to consult and 
coordinate with Tribes on a government-to-government basis on policies 
that have Tribal implications, including regulations, legislative 
comments, or proposed legislation. Additionally, other policy 
statements or actions that have substantial direct effects on one or 
more Indian Tribes, the relationship between the Federal Government and 
Indian Tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian Tribes also require 
consultation.
    AMS hosted a virtual tribal listening session on April 9, 2020, to 
discuss the Strengthening Organic Enforcement proposed rule and 
upcoming public comment opportunity. AMS has not received comments from 
Tribes during the rulemaking process. AMS conducted an analysis of 
possible Tribal impacts and determined that any impact is most likely 
to be positive. AMS finds oversight protections and fraud deterrence 
actions that will have positive benefits for organic producers extend 
to any Tribal organic producers. Further, the specific provisions 
related to grower groups may benefit small producers in a Tribe who 
wish to join together under a shared certification for market 
development purposes.
    If a tribe requests consultation in the future, AMS will work with 
the Office of Tribal Relations to ensure meaningful consultation is 
provided. AMS also stands ready to provide technical assistance to 
Tribes and operators wishing to participate in the organic 
certification process.

F. Executive Order 13132

    Executive Order 13132 mandates that federal agencies consider how 
their policymaking and regulatory activities impact the policymaking 
discretion of States and local officials and how well such efforts 
conform to the principles of federalism defined in said order. This 
executive order only pertains to regulations with clear federalism 
implications.
    AMS has determined that this rulemaking conforms with the 
principles of federalism described in E.O. 13132. The rule does not 
impose substantial direct costs or effects on States, does not alter 
the relationship between States and the federal government, and does 
not alter the distribution of powers and responsibilities among the 
various levels of government. States had the opportunity to comment on 
the proposed rule. No States provided public comment on the federalism 
implications of this rule. Therefore, AMS has concluded that this 
rulemaking does not have federalism implications.

G. Civil Rights Impact Analysis

    AMS has reviewed this rulemaking in accordance with the Department 
Regulation 4300-4, Civil Rights Impact Analysis, to address any major 
civil rights impacts the rule might have on minorities, women, and 
persons with disabilities. After a careful review of the rule's intent 
and provisions, AMS determined that this rule will affect certifying 
agents and organic inspectors, handlers of organic products, and 
organic producers. AMS also determined that this rule has no

[[Page 3620]]

potential for affecting producers, handlers, certifying agents, or 
inspectors in protected groups differently than the general population 
of producers, handlers, certifying agents, or inspectors.
    Protected individuals have the same opportunity to participate in 
NOP as non-protected individuals. The USDA organic regulations prohibit 
discrimination by certifying agents. Specifically, Sec.  205.501(d) of 
the current regulations for accreditation of certifying agents provides 
that ``No private or governmental entity accredited as a certifying 
agent under this subpart shall exclude from participation in or deny 
the benefits of NOP to any person due to discrimination because of 
race, color, national origin, gender, religion, age, disability, 
political beliefs, sexual orientation, or marital or family status.'' 
Section 205.501(a)(2) requires ``certifying agents to demonstrate the 
ability to fully comply with the requirements for accreditation set 
forth in this subpart'' including the prohibition on discrimination. 
The granting of accreditation to certifying agents under Sec.  205.506 
requires the review of information submitted by the certifying agent 
and an on-site review of the certifying agent's client operation. 
Further, if certification is denied, Sec.  205.405(d) requires that the 
certifying agent notify the applicant of their right to file an appeal 
to the AMS Administrator in accordance with Sec.  205.681.
    These regulations provide protections against discrimination, 
thereby permitting all producers, regardless of race, color, national 
origin, gender, religion, age, disability, political beliefs, sexual 
orientation, or marital or family status, who voluntarily choose to 
adhere to the rule and qualify, to be certified as meeting NOP 
requirements by an accredited certifying agent. This action in no way 
changes any of these protections against discrimination.

H. Related Documents

    Documents related to this rule include the Organic Foods Production 
Act of 1990, as amended, (7 U.S.C. 6501-6524) and its implementing 
regulations (7 CFR part 205). On August 5, 2020, AMS published the 
proposed rule (85 FR 47536) to notify the public of and request 
comments on the potential changes to the organic regulations discussed 
in this rulemaking.

List of Subjects in 7 CFR Part 205

    Administrative practice and procedure, Agricultrual Commodities, 
Agriculture, Animals, Archives and records, Fees, Imports, Labeling, 
Livestock, Organically produced products, Plants, Reporting and 
recordkeeping requirements, Seals and insignia, Soil conservation.

    For the reasons set forth in the preamble, the Agricultural 
Marketing Service amends 7 CFR part 205 as follows:

PART 205--NATIONAL ORGANIC PROGRAM

0
1. The authority citation for part 205 continues to read as follows:

    Authority:  7 U.S.C. 6501-6524.


0
2. Section 205.2 is amended by:
0
a. Adding in alphabetical order the terms ``Adverse action'', 
``Certification activity'', ``Certification office'', ``Certification 
review'', and ``Conformity assessment system'';
0
b. Revising the terms ``Handle'', ``Handler'', and ``Handling 
operation'';
0
c. Adding in alphabetical order the terms ``Internal control system'', 
``Organic exporter'', ``Organic fraud'', ``Organic importer'', 
``Organic Integrity Database'', ``Producer group member'', ``Producer 
group operation'', ``Producer group production unit'', and ``Retail 
establishment'';
0
d. Removing the terms ``Retail food establishment''; and
0
e. Adding in alphabetical order the terms ``Supply chain traceability 
audit'', ``Technical requirements'', and ``Unannounced inspection''.
    The revisions and additions read as follows:


Sec.  205.2  Terms defined.

* * * * *
    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.
* * * * *
    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.
    Certification office. Any site or facility where certification 
activities are conducted, except for certification activities that 
occur at certified operations or applicants for certification, such as 
inspections and sampling.
* * * * *
    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.
* * * * *
    Conformity assessment system. All activities, including oversight, 
accreditation, compliance review, and enforcement, undertaken by a 
government to ensure that the applicable technical requirements for the 
production and handling of organic agricultural products are fully and 
consistently applied.
* * * * *
    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.
    Handler. Any person that handles agricultural products, except 
final retailers of agricultural products that do not process 
agricultural products.
    Handling operation. Any operation that handles agricultural 
products, except final retailers of agricultural products that do not 
process agricultural products.
* * * * *
    Internal control system. 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.
* * * * *
    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 fraud. Deceptive representation, sale, or labeling of 
nonorganic agricultural products or ingredients as ``100 percent 
organic,'' ``organic,'' or ``made with organic (specified ingredients 
or food group(s)).''

[[Page 3621]]

    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 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.
* * * * *
    Producer group member. An individual engaged in the activity of 
producing or harvesting agricultural products as a member of a producer 
group operation.
    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.
    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.
* * * * *
    Retail establishment. Restaurants, delicatessens, bakeries, grocery 
stores, or any retail business with a restaurant, delicatessen, bakery, 
salad bar, bulk food self-service station, or other eat-in, carry-out, 
mail-order, or delivery service of raw or processed agricultural 
products.
* * * * *
    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 the agricultural 
product's compliance with this part.
* * * * *
    Technical requirements. A system of relevant laws, regulations, 
regulatory practices, standards, policies, and procedures that address 
the certification, production, and handling of organic agricultural 
products.
* * * * *
    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.
* * * * *

0
3. Section 205.100 is amended by revising paragraph (a) and paragraph 
(c) introductory text to read as follows:


Sec.  205.100  What has to be certified.

    (a) Except for the exempt operations described in Sec.  205.101, 
each operation or portion of an operation that produces or handles 
agricultural products intended to be sold, labeled, or represented as 
``100 percent organic,'' ``organic,'' or ``made with organic (specified 
ingredients or food group(s))'' must be certified according to the 
provisions of subpart E of this part and must meet all other applicable 
requirements of this part.
* * * * *
    (c) Any person or responsibly connected person that:
* * * * *

0
4. Revise Sec.  205.101 to read as follows:


Sec.  205.101  Exemptions from certification.

    The following operations in paragraphs (a) through (h) of this 
section are exempt from certification under subpart E of this part and 
from submitting an organic system plan for acceptance or approval under 
Sec.  205.201 but must comply with the applicable organic production 
and handling requirements of subpart C of this part, the applicable 
labeling requirements of subpart D of this part, and any requirements 
described in paragraphs (a) through (i) of this section.
    (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.
    (b) A retail establishment that does not process organically 
produced agricultural products.
    (c) A retail establishment that processes, at the point of final 
sale, agricultural products certified under this part as ``100 percent 
organic,'' ``organic,'' or ``made with organic (specified ingredients 
or food group(s)).''
    (d) A handling operation that only handles agricultural products 
that contain less than 70 percent organic ingredients (as described in 
Sec.  205.301(d)) or that only identifies organic ingredients on the 
information panel.
    (e) An operation that only receives, stores, and/or prepares for 
shipment, but does not otherwise handle, organic agricultural products 
that:
    (1) Are enclosed in sealed, tamper-evident packages or containers 
prior to being received or acquired by the operation; and
    (2) Remain in the same sealed, tamper-evident packages or 
containers and are not otherwise handled while in the control of the 
operation.
    (f) An operation that only buys, sells, receives, stores, and/or 
prepares for shipment, but does not otherwise handle, organic 
agricultural products already labeled for retail sale that:
    (1) Are enclosed in sealed, tamper-evident packages or containers 
that are labeled for retail sale prior to being received or acquired by 
the operation; and
    (2) 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.
    (g) A Customs broker (per 19 CFR 111.1) that only conducts customs 
business but does not otherwise handle organic agricultural products.
    (h) An operation that only arranges for the shipping, storing, 
transport, or movement of organic agricultural products but does not 
otherwise handle organic products.
    (i) Recordkeeping by exempt operations.
    (1) Exempt operations described in paragraphs (a) and (c) through 
(f) of this section must make available to representatives of the 
Secretary, upon request, records that:
    (i) Demonstrate that agricultural products identified as organic 
were organically produced and handled; and
    (ii) Verify quantities of organic agricultural products received 
and shipped or sold
    (2) All records described in this section must be maintained for no 
less than 3 years beyond their creation, and the operations must allow 
representatives of the Secretary and the applicable State organic 
programs' governing State official access to these records for 
inspection and copying during normal business hours to determine 
compliance with the applicable regulations set forth in this part.

0
5. Section 205.103 is amended by:
0
a. Revising paragraph (b)(2);
0
b. Redesignating paragraphs (b)(3) and (4) as paragraphs (b)(4) and 
(5); and
0
c. Adding new paragraph (b)(3).
    The revision and addition read as follows:


Sec.  205.103  Recordkeeping by certified operations.

* * * * *
    (b) * * *
    (2) 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

[[Page 3622]]

or transport and be traceable back to the last certified operation;
    (3) Include audit trail documentation for agricultural products 
handled or produced by the certified operation and identify 
agricultural products on these records as ``100% organic,'' 
``organic,'' or ``made with organic (specified ingredients or food 
group(s)),'' or similar terms, as applicable;
* * * * *

0
6. Section 205.201 is amended by:
0
a. Removing the words ``or excluded'' in paragraph (a) introductory 
text;
0
b. Revising paragraph (a)(3); and
0
c. Adding paragraph (c).
    The revision and addition to read as follows:


Sec.  205.201  Organic production and handling system plan.

    (a) * * *
    (3) A description of the monitoring practices and procedures to be 
performed and maintained, including the frequency with which they will 
be performed, to verify that the plan is effectively implemented. This 
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;
* * * * *
    (c) In addition to paragraph (a) of this section, a producer group 
operation's organic system plan must describe its internal control 
system. The description of the internal control system must:
    (1) Define the organizational structure, roles, and 
responsibilities of all personnel;
    (2) Identify producer group production units and locations;
    (3) Describe measures to protect against potential conflicts of 
interest and protect internal control system personnel from 
retribution;
    (4) Define geographic proximity criteria for producer group members 
and producer group production units;
    (5) Describe procedures for accepting new members into the producer 
group operation, including initial inspection and compliance 
determination;
    (6) Describe characteristics of high-risk producer group members 
and producer group production units;
    (7) Describe how shared resources, including production practices 
and inputs, are procured and provided to all producer group members and 
personnel;
    (8) Describe how training, education, and technical assistance is 
provided to producer group members and internal control system 
personnel;
    (9) Describe the system of records used to demonstrate compliance 
with this part, including traceability and mass-balance audits; and
    (10) Describe how internal monitoring, surveillance, inspection, 
sanctions, and auditing are used to assess the compliance of all 
producer group members.

0
7. Add Sec.  205.273 to subpart C to read as follows:


Sec.  205.273  Imports to the United States.

    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.
    (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 
or agreement may issue an NOP Import Certificate.
    (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 Import Certificate through the Organic Integrity 
Database only if the export complies with the USDA organic regulations.
    (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.
    (d) Upon receiving a shipment with organic agricultural products, 
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 pursuant to Sec.  205.272 or 
exposure to ionizing radiation pursuant to Sec.  205.105, since export. 
The organic importer must have a documented organic control system to 
conduct this verification.

0
8. Amend Sec.  205.300 by revising paragraph (c) to read as follows:


Sec.  205.300  Use of the term, ``organic.''

* * * * *
    (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 Sec.  205.273.
* * * * *

0
9. Amend Sec.  205.301 by revising paragraphs (f)(2) and (3) to read as 
follows:


Sec.  205.301  Product composition.

* * * * *
    (f) * * *
    (2) Be processed using ionizing radiation, pursuant to Sec.  
205.105(f);
    (3) Be produced using sewage sludge, pursuant to Sec.  205.105(g);
* * * * *

0
10. Amend Sec.  205.302 by revising paragraphs (a)(1) through (3) to 
read as follows:


Sec.  205.302  Calculating the percentage of organically produced 
ingredients.

    (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.
    (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.
    (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.
* * * * *

0
11. Revise Sec.  205.307 to read as follows:

[[Page 3623]]

Sec.  205.307  Labeling of nonretail containers.

    (a) Nonretail containers used to ship or store certified organic 
agricultural products must display:
    (1) Identification of the product as organic; and
    (2) The production lot number, shipping identification, or other 
unique information that links the container to audit trail 
documentation.
    (b) Audit trail documentation for nonretail containers must 
identify the last certified operation that handled the agricultural 
product.
    (c) Paragraph (a)(1) of this section does not apply to nonretail 
containers used to ship or store agricultural products packaged for 
retail sale with organic identification visible on the retail label.
    (d) Shipping containers of domestically produced product labeled as 
organic intended for export to international markets may be labeled in 
accordance with any shipping container labeling requirements of the 
foreign country of destination or the container labeling specifications 
of a foreign contract buyer: Provided, that, the shipping containers 
and shipping documents accompanying such organic products are clearly 
marked ``For Export Only'' and: Provided further, that proof of such 
container marking and export must be maintained by the handler in 
accordance with recordkeeping requirements for exempt operations under 
Sec.  205.101.

0
12. Section 205.310 is amended by revising the section heading and 
paragraphs (a) and (b) to read as follows:


Sec.  205.310  Agricultural products produced or processed by an exempt 
operation.

    (a) An agricultural product organically produced or processed by an 
exempt operation must not:
    (1) Display the USDA seal or any certifying agent's seal or other 
identifying mark which represents the exempt operation as a certified 
organic operation; or
    (2) Be represented as a certified organic product or certified 
organic ingredient to any buyer.
    (b) An agricultural product organically produced or processed by an 
exempt operation may be identified as an organic product or organic 
ingredient in a multi-ingredient product produced by the exempt 
operation. Such product or ingredient must not be identified or 
represented as ``organic'' in a product processed by others.
* * * * *

0
13. Section 205.400 is amended by:
0
a. Removing ``Sec.  205.200'' and adding in its place ``Sec.  205.201'' 
in paragraph (b); and
0
b. Adding paragraph (g).
    The addition reads as follows:


Sec.  205.400  General requirements for certification.

* * * * *
    (g) In addition to paragraphs (a) through (f) of this section, a 
producer group operation must:
    (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 to implement the practices 
described in Sec.  205.201(c) and ensure compliance with this part;
    (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;
    (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;
    (7) Report to the certifying agent, at least annually, the name and 
location of all producer group members and producer group production 
units, the agricultural products produced, estimated yields, and size 
of production areas;
    (8) Conduct internal inspections of each producer group member, at 
least annually, by internal inspectors with the member present, which 
must include mass-balance audits and reconciliation of each producer 
group member's and each producer group production unit's yield and 
group sales;
    (9) Implement recordkeeping requirements to ensure traceability 
from production at each producer group member and production unit 
through handling to sale and transport;
    (10) Implement procedures to ensure all production and handling by 
the producer group operation is compliant with the USDA organic 
regulations and the Act; and
    (11) Address any other terms or conditions determined by the 
Administrator to be necessary to enforce compliance with the USDA 
organic regulations and the Act.


Sec.  205.401  [Amended]

0
14. Amend Sec.  205.401 in paragraph (a) by removing ``Sec.  205.200'' 
and adding in its place ``Sec.  205.201''.

0
15. Section 205.403 is amended by:
0
a. Redesignating paragraph (a)(2) as paragraph (a)(3);
0
b. Adding new paragraph (a)(2);
0
c. Redesignating paragraphs (b) through (e) as paragraphs (c) through 
(f);
0
d. Adding new paragraph (b);
0
e. In newly redesignated paragraph (d)(2), removing ``Sec.  205.200'' 
and adding in its place ``Sec.  205.201''; and
0
f. Adding paragraphs (d)(4) and (5).
    The additions read as follows:


Sec.  205.403  On-site inspections.

    (a) * * *
    (2) Inspections of a producer group operation must:
    (i) Assess the internal control system's compliance, or ability to 
comply, with the requirements of Sec.  205.400(g)(8). This must include 
review of the internal inspections conducted by the internal control 
system.
    (ii) Conduct witness audits of internal control system inspectors 
performing inspections of the producer group operation.
    (iii) Individually inspect at least 1.4 times the square root or 2% 
of the total number of producer group members, whichever is higher. All 
producer group members determined to be high risk by the certifying 
agent must be inspected. At least one producer group member in each 
producer group production unit must be inspected.
    (iv) Inspect each handling facility.
* * * * *
    (b) 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.
* * * * *
    (d) * * *
    (4) Mass-balances, in that quantities of organic product and 
ingredients produced or purchased account for organic product and 
ingredients used, stored, sold, or transported (that is, inputs account 
for outputs); and
    (5) 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.
* * * * *

0
16. Section Sec.  205.404 is amended by revising paragraph (b), 
redesignating paragraph (c) as paragraph (d), and adding a new 
paragraph (c).
    The revision and addition read as follows:

[[Page 3624]]

Sec.  205.404  Certificates of organic operation.

* * * * *
    (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.
    (c) 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 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.''
* * * * *


Sec.  205.405  [Amended]

0
17. Amend Sec.  205.405 by removing paragraph (c)(3).

0
18. Amend 205.406 by revising paragraphs (a) and (b) to read as 
follows:


Sec.  205.406  Continuation of certification.

    (a) To continue certification, a certified operation must annually 
pay the certification fees and submit the following information to the 
certifying agent:
    (1) A summary statement, supported by documentation, detailing any 
deviations from, changes to, modifications to, or other amendments made 
to the organic system plan submitted during the previous year;
    (2) Any additions or deletions to the previous year's organic 
system plan, intended to be undertaken in the coming year, detailed 
pursuant to Sec.  205.201;
    (3) Any additions to or deletions from the information required 
pursuant to Sec.  205.401(b); and
    (4) Other information as deemed necessary by the certifying agent 
to determine compliance with the Act and the regulations in this part.
    (b) The certifying agent must arrange and conduct an on-site 
inspection, pursuant to Sec.  205.403, of the certified operation at 
least once per calendar year.
* * * * *


Sec.  205.500  [Amended]

0
19. Amend Sec.  205.500 by removing paragraph (c).

0
20. Section 205.501 is amended by:
0
a. Revising paragraphs (a)(4), (5), (6), (10), (13), and (15);
0
b. Redesignating paragraph (a)(21) as paragraph (a)(23); and
0
c. Adding new paragraph (a)(21) and paragraph (a)(22).
    The revisions and additions read as follows:


Sec.  205.501  General requirements for accreditation.

    (a) * * *
    (4) Continuously use a sufficient number of qualified and 
adequately trained personnel, including inspectors and certification 
review personnel, to comply with and implement the USDA organic 
standards.
    (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 regulations of this part.
    (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.
    (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 Sec.  205.2) and an 
additional 5 hours of training for each additional area of operation 
inspected.
    (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.
    (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.
    (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.
    (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 additional 
5 hours of training for each additional area of operation.
    (iii) Certifying agents must maintain current training 
requirements, training procedures, and training records for all 
inspectors and certification review personnel.
    (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.
    (6) Conduct an annual performance evaluation of all persons who 
conduct inspections, certification review, or implement measures to 
correct any deficiencies in certification services.
    (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.
    (ii) Certifying agents must maintain documented policies, 
procedures, and

[[Page 3625]]

records for annual performance evaluations and witness inspections.
* * * * *
    (10) Maintain strict confidentiality with respect to its clients 
under the applicable organic certification program and not disclose to 
third parties (except for the Secretary or the applicable State organic 
program's governing State official or their authorized representatives) 
any business-related information concerning any client obtained while 
implementing the regulations in this part, except:
    (i) For information that must be made available to any member of 
the public, as provided for in Sec.  205.504(b)(5);
    (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) If a certified operation's proprietary business information 
is compliance-related and thus credibly needed to certify, decertify, 
or investigate that operation, certifying agents may exchange that 
information for the purposes of enforcing the Act, but the information 
in question still retains its proprietary character even after it is 
exchanged and all of the certifying agents that are involved in the 
exchange still have a duty to preserve the confidentiality of that 
information after the exchange.
* * * * *
    (13) Accept the certification decisions made by another certifying 
agent accredited or accepted by USDA pursuant to Sec.  205.500. 
Certifying agents must 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;
* * * * *
    (15) Maintain current and accurate data in the Organic Integrity 
Database for each operation which it certifies;
* * * * *
    (21) Conduct risk-based supply chain traceability audits as 
described in the criteria and procedures for supply chain audits, per 
Sec.  205.504(b)(7), and share audit findings with other certifying 
agents as needed to determine compliance, per paragraph (a)(13) of this 
section.
    (22) Notify AMS not later than 90 calendar days after certification 
activities begin in a new certification office. The notification must 
include the countries where the certification activities are being 
provided, the nature of the certification activities, and the 
qualifications of the personnel providing the certification activities.
* * * * *

0
21. Section 205.504 is amended by revising the introductory text and 
paragraph (b)(4) and adding paragraphs (b)(7) and (8) to read as 
follows:


Sec.  205.504  Evidence of expertise and ability.

    A private or governmental entity seeking accreditation as a 
certifying agent must submit the following documents and information to 
demonstrate its expertise in organic production or handling techniques; 
its ability to fully comply with and implement the organic 
certification program established in Sec. Sec.  205.100 and 205.101, 
205.201 through 205.203, 205.300 through 205.303, 205.400 through 
205.406, and 205.661 through 205.663; and its ability to comply with 
the requirements for accreditation set forth in Sec.  205.501:
* * * * *
    (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 as set forth in Sec.  205.501(a)(10);
* * * * *
    (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, as 
required in Sec.  205.501(a)(21); and procedures to report credible 
evidence of organic fraud to the Administrator.
    (8) A copy of reasonable decision criteria for acceptance of 
mediation, and a process for identifying personnel conducting mediation 
and setting up mediation.
* * * * *

0
22. Add Sec.  205.511 to subpart F to read as follows:


Sec.  205.511  Accepting foreign conformity assessment systems.

    (a) Foreign product may be certified under the USDA organic 
regulations by a USDA-accredited certifying agent and imported for sale 
in the United States. 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 governing the production and handling of such 
products that are at least equivalent to the requirements of the Act 
and the regulations in this part.
    (b) Countries desiring to establish eligibility of product 
certified under that country's organic certification program to be 
sold, labeled, or represented in the United States as organically 
produced may request equivalence determinations from AMS. A foreign 
government must maintain compliance and enforcement mechanisms to 
ensure that its organic certification program is fully meeting the 
terms and conditions of any equivalence determination provided by the 
U.S. Government pursuant to this section. To request an equivalence 
determination, the requesting country must submit documentation that 
fully describes its technical requirements and conformity assessment 
system. If the U.S. Government determines it can proceed, AMS will 
assess the country's organic certification program to evaluate if it is 
equivalent.
    (c) USDA, working with other Federal agencies, will describe the 
scope of an equivalence determination.
    (d) AMS will conduct regular reviews and reassessments of countries 
deemed equivalent to verify that the foreign government's technical 
requirements and conformity assessment system continue to be at least 
equivalent to the requirements of the Act and the regulations of this 
part, and will determine if the equivalence determination should be 
continued, amended, or terminated. AMS will determine the timing and 
scope of reviews and re-assessments based on, but not limited to, 
factors such as: the terms of the equivalence determination, changes to 
the foreign country's technical requirements or conformity assessment 
system, the results of previous reviews and re-assessments, instances 
of suspected or verified noncompliance issues, the volume of trade, and 
other factors contributing to the risk level of the equivalence 
determination.
    (e) The U.S. Government may terminate an equivalence determination 
if the terms or conditions established under the equivalence 
determination are not met; 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 to ensure that the country's 
organic certification program is fully meeting the terms and conditions 
under the equivalence determination; or for other good cause.

[[Page 3626]]


0
23. Amend Sec.  205.660 by redesignating paragraphs (c) and (d) as 
paragraphs (d) and (e) and adding new paragraph (c).
    The addition reads as follows:


Sec.  205.660  General.

* * * * *
    (c) The Program Manager may initiate enforcement action against any 
person who sells, labels, or provides other market information 
concerning an agricultural product if such label or information implies 
that such product is produced or handled using organic methods, if the 
product was produced or handled in violation of the Organic Foods 
Production Act or the regulations in this part.
* * * * *

0
24. Amend Sec.  205.661 by revising the section heading to read as 
follows:


Sec.  205.661  Investigation.

* * * * *

0
25. Section 205.662 is amended by:
0
a. Adding paragraph (e)(3);
0
b. Revising the first sentence of paragraph (f)(1); and
0
c. Revising paragraph (g)(1).
    The addition and revisions read as follows:


Sec.  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.
    (f) * * *
    (1) A certified operation or a person responsibly connected with an 
operation whose certification has been suspended may at any time, 
unless otherwise stated in the notification of suspension, submit a 
request to the Secretary for reinstatement of its certification, or 
submit a request for eligibility to be certified. * * *
* * * * *
    (g) * * *
    (1) 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.
* * * * *

0
26. Revise Sec.  205.663 to read as follows:


Sec.  205.663  Mediation.

    (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 Sec.  205.504(b)(8).
    (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.
    (1) A certified operation or applicant for certification must 
submit any request for mediation in writing to the applicable 
certifying agent or State organic program within 30 calendar days of 
receipt of the notice of proposed suspension or proposed revocation of 
certification or denial of certification.
    (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.
    (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 to 
Sec.  205.681, within 30 calendar days of the date of receipt of the 
written notification of rejection of the request for mediation.
    (4) When an operation appeals a rejection of mediation, the adverse 
action which is contested must not be finalized during the appeal 
proceeding.
    (c) Both parties must agree on the person conducting the 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.
    (e) The parties to the mediation have a maximum of 30 calendar days 
from the start of mediation to reach an agreement. 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 Sec.  205.681.
    (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.
    (g) The Program Manager may propose mediation and enter into a 
settlement agreement at any time to resolve any adverse action notice.

0
27. Amend Sec.  205.665 by revising paragraph (a) to read as follows:


Sec.  205.665  Noncompliance procedure for certifying agents.

    (a) Notification. (1) A written notification of noncompliance will 
be sent to the certifying agent when:
    (i) An inspection, review, or investigation of an accredited 
certifying agent by the Program Manager reveals any noncompliance with 
the Act or regulations in this part; or
    (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 with the Act or the regulations in this part; or
    (iii) The Program Manager determines that the certification 
activities at a certification office, and/in specific countries, are 
not compliant with the Act or the regulations in this part.
    (2) Such notification must provide:
    (i) A description of each noncompliance;
    (ii) The facts upon which the notification of noncompliance is 
based; and
    (iii) The date by which the certifying agent must rebut or correct 
each noncompliance and submit supporting documentation of each 
correction when correction is possible.
* * * * *

0
28. Revise Sec.  205.680 to read as follows:


Sec.  205.680  General.

    (a) Persons subject to the Act who believe they are adversely 
affected by an adverse action of the National Organic Program's Program 
Manager may appeal such decision to the Administrator.
    (b) Persons subject to the Act who believe they are adversely 
affected by an adverse action of a State organic program may appeal 
such decision to the State organic program's governing State official, 
who will initiate handling of the appeal pursuant to appeal procedures 
approved by the Secretary.
    (c) Persons subject to the Act who believe they are adversely 
affected by an adverse action of a certifying agent may appeal such 
decision to the Administrator, Except, that, when the person is subject 
to an approved State

[[Page 3627]]

organic program, the appeal must be made to the State organic program.
    (d) Persons subject to the Act who believe they are adversely 
affected by an adverse action of a certifying agent or a State organic 
program may request mediation as provided in Sec.  205.663.
    (e) All appeals must comply with the procedural requirements in 
Sec.  205.681(c) and (d).
    (f) All written communications between parties involved in appeal 
proceedings must be sent to the recipient's place of business by a 
delivery service which provides dated return receipts.
    (g) All appeals must be reviewed, heard, and decided by persons not 
involved with the adverse action being appealed.

0
29. Amend Sec.  205.681 by revising paragraph (a) introductory text and 
paragraphs (a)(2), (b), (c), and (d)(1) and (3) to read as follows:


Sec.  205.681  Appeals.

    (a) Adverse actions by certifying agents. An applicant for 
certification may appeal a certifying agent's notice of denial of 
certification, and a certified operation may appeal a certifying 
agent's notification of proposed suspension or proposed revocation of 
certification to the Administrator, Except, that, when the applicant or 
certified operation is subject to an approved State organic program, 
the appeal must be made to the State organic program which will carry 
out the appeal pursuant to the State organic program's appeal 
procedures approved by the Secretary.
* * * * *
    (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. Such proceeding must be conducted pursuant to the U.S. 
Department of Agriculture's Uniform Rules of Practice, 7 CFR part 1, 
subpart H, or the State organic program's rules of procedure.
    (b) Adverse actions by the NOP Program Manager. A person affected 
by an adverse action, as defined by Sec.  205.2, issued by the NOP 
Program Manager, may appeal to the Administrator.
    (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.
    (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. Such 
proceeding must be conducted pursuant to the U.S. Department of 
Agriculture's Uniform Rules of Practice, 7 CFR part 1, subpart H.
    (c) Filing period. An appeal must be filed in writing within the 
time period provided in the letter of notification or within 30 days 
from receipt of the notification, whichever occurs later. The appeal 
will be considered ``filed'' on the date received by the Administrator 
or by the State organic program. An adverse action will become final 
and nonappealable 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. SW, Room 
2642, Stop 0268, Washington, DC 20250, or electronic transmission, 
[email protected].
* * * * *
    (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 or made in accordance with applicable program regulations.

Erin Morris,
Associate Administrator, Agricultural Marketing Service.
[FR Doc. 2023-00702 Filed 1-18-23; 8:45 am]
BILLING CODE 3410-02-P