SUPPORTING STATEMENT

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2026 Supporting Statement
“National Organic Program: Strengthening Organic Enforcement (SOE)”
Request for the Extension and Revision of a previously approved Information Collection
OMB# 0581-0321
A. Justification
1.	Explain the circumstances that make the collection of information necessary. Identify any legal or administrative requirements that necessitate the collection.
The Organic Foods Production Act of 1990 (OFPA), as amended (7 U.S.C. 6501–6524), authorizes the Secretary of Agriculture to establish the National Organic Program (NOP) and accredit certifying agents to certify that farms and businesses meet national organic standards. The purpose of OFPA is to: (1) establish national standards governing the marketing of certain agricultural products as organically produced products; (2) assure consumers that organically produced products meet a consistent standard; and (3) facilitate interstate commerce in fresh and processed food that is organically produced (7 U.S.C. 6501).
The organic regulations at 7 CFR part 205 fulfill the requirements of OFPA. They include comprehensive production and handling standards, labeling provisions, requirements for the certification of operations, accreditation of certifying agents by the U.S. Department of Agriculture (USDA), Agricultural Marketing Service (AMS), and an administrative subpart for fees, State programs, the National List, appeals, compliance, and pesticide residue testing.
The Strengthening Organic Enforcement (SOE) final rule and its information collection strengthen the organic supply chain. The regulations and information collection were developed using NOP’s direct experience in administering this program, particularly through complaint investigations and audits of certifying agents; requirements of the Agriculture Improvement Act of 2018;1 the recommendations of a 2017 Office of Inspector General audit; multiple recommendations of the Federal advisory committee to the NOP, the National Organic Standards Board (NOSB), from 2002 to 2018; and industry stakeholder feedback.
SOE strengthened enforcement with amendments to the USDA organic regulations. The amendments in SOE: (1) strengthened organic control systems; (2) improved organic import oversight; (3) clarified organic certification standards; and (4) enhanced supply chain traceability. Specific provisions required:
    • additional information on nonretail labels;
    • procedures to strengthen traceability;
    • the use of federated organic certificates;
    • unannounced on-site inspections;
    • import certificates for all imported organic products; 
    • additional inspector training and qualifications;
    • increased review of foreign conformity systems; and
    • the development and expansion of electronic data and document management systems governing organic certification of operations and traceability through transactions and trade.
Additionally, SOE clarified compliance and appeals processes for certifying agents and organic operations.
SOE created more consistent organic certification practices to deter and detect organic fraud and improved transparency and product traceability. In addition, the requirements assure consumers that organic products meet a robust, consistent standard and reinforce the value of the organic label.
2.	Indicate how, by whom, and for what purpose the information is to be used. Except for a new collection, indicate the actual use the agency has made of the information received from the current collection.
This collection has been used at the Federal level by AMS to evaluate compliance of organically produced imports and strengthen the organic supply chain.
Reporting and recordkeeping are essential to the integrity of the organic certification system. They create a paper trail that is a critical element in carrying out the mandate of OFPA and the NOP. They serve the AMS mission, program objectives, and management needs by providing information on the efficiency and effectiveness of the program. The information affects decisions because it is the basis for evaluating compliance with OFPA and the NOP, for administering the program, for management decisions and planning, and for establishing the cost of the program. It supports administrative and regulatory actions in response to noncompliance with OFPA and the NOP.
In general, the information collected is used by USDA, State program governing officials, and certifying agents. It is created and submitted by State and foreign program officials, accredited certifying agents, organic inspectors, certified organic operations, those seeking accreditation or certification, and parties interested in changing the National List. Additionally, all entities must have procedures and space for recordkeeping.
The final rule initiating this collection amended 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 OFPA. To protect organic product integrity and build consumer and industry trust in the USDA organic label, the information collection and recordkeeping inherent to the amendments to §§ 205.2, 205.100, 205.101, 205.103, 205.201, 205.273, 205.300–205.302, 205.307, 205.310, 205.400, 205.403–205.404, 205.406, 205.500, 205.501, 205.504, 205.511, 205.660–205.663, 205.665, 205.680, and 205.681 of the organic regulations are necessary.
These final amendments strengthen organic control systems and integrity throughout the organic supply chain, improve farm-to-market transparency and traceability, close gaps in the current regulations to build consistent certification practices, deter organic fraud, provide robust enforcement of the USDA organic regulations through a risk-based approach to oversight that benefits stakeholders at all levels of the organic industry, and assure consumers that organically produced products meet a consistent standard.
The specific respondents affected by the final rule are: certified organic operations, certifying agents, inspectors, and foreign governments. Final amendments are described below, organized by type of respondents impacted. Headings correlate with the AMS 71 Grid (supplementary document).
3.	Describe whether, and to what extent, the collection of information involves the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g. permitting electronic submission of responses, and the basis for the decision for adopting this means of collection. Also describe any consideration of using information technology to reduce burden.
AMS is committed to complying with the E-Government Act, which requires government agencies, in general, to provide the public with the option of submitting information or transacting business electronically to the maximum extent possible. As such, the NOP is a paperless office, and certifying agents submit information to the NOP electronically using email or by using the INTEGRITY database. Certified organic operations have established information submission relationships with their certifying agent, and in most cases, information collected by AMS is submitted through certifying agents.
SOE required certifying agents to issue standardized certificates of organic operations generated from the USDA’s publicly available Organic Integrity Database (OID). This requires maintenance, at least annually, to ensure that data in OID is current and accurate at https://organic.ams.usda.gov/integrity/. All certifying agents currently follow this practice.
SOE expanded and made compulsory the use of NOP Import Certificates, regardless of an imported product’s country of origin. Specifically, SOE required that all imported products intended to be sold, represented, or labeled as organic in the United States must be declared as organic to U.S. Customs and Border Protection (CBP), and that each physical shipment passing through a U.S. port of entry must be associated with its respective NOP Import Certificate.
Because OFPA enables AMS to access information available in CBP’s Automated Commercial Environment system (ACE) (7 U.S.C. 6521(c)), ACE is used to track and store NOP Import Certificates. ACE is an automated electronic system for processing commercial trade data. ACE is the primary system through which the global trade community files information about imports and exports so that admissibility into the United States can be determined by government agencies, including AMS, to ensure compliance.
4.	Describe efforts to identify duplication. Show specifically why any similar information already available cannot be used or modified for use for the purpose(s) described in item 2 above.
AMS has made every effort to maintain contact with appropriate sources within USDA, other government agencies, including CBP, and outside sources to ensure that AMS is not duplicating information collection. AMS encourages organic stakeholders to reduce the paperwork burden by establishing business operating plans and procedures that incorporate the NOP requirements.
5.	If the collection of information impacts small businesses or other small entities, item 5 of OMB form 83-I, describe the methods used to minimize burden.
The Regulatory Impact Analysis (RIA) and the Regulatory Flexibility Analysis (RFA) for SOE indicated that all of the affected businesses in the organic industry are small businesses. AMS has considered the economic impact of this action on small entities and determined that the impact would not be significant.
AMS explored several options to mitigate any negative impacts caused by a reporting or recordkeeping burden. AMS has made every possible effort to secure information about the smallest segments of the industry, to provide open dialogue with them, to develop performance standards with a range of practices, and to accept the required documents reasonably and logically. In an effort to minimize the burden on small businesses and other small entities, AMS encourages certifying agents to accept existing information and records that can be used to evaluate compliance of organic operations, where possible.
6.	Describe the consequences to Federal program or policy activities if the collection is not conducted or is conducted less frequently, as well as any technical or legal obstacles to reducing burden.
If the collection of information were not conducted, AMS would not be able to fulfill the functions of the NOP and the USDA organic regulations, as mandated by OFPA. Additionally, ending this information collection would disrupt the more than $12 billion in annual organic imports. Those imports are used by domestic operations for livestock feed and further processing and consumed by domestic consumers.
There is no mechanism for collecting the information less frequently, as the frequency of information collection is mandated by OFPA. Examples include the requirement for annual on-site inspections (7 U.S.C. 6506), review of State organic programs every five years (7 U.S.C. 6507), and the review for renewal of accreditation for certifying agents every five years (7 U.S.C. 6514).
7.	Explain any special circumstances that would cause an information collection to be conducted in a manner:
Requiring respondents to report information to the agency more often than quarterly;
No respondents associated with this information collection are required to report more than quarterly.
Requiring respondents to prepare a written response to a collection of information in fewer than 30 days after receipt of it;
No respondents associated with this information collection are required to respond in fewer than 30 days.
Requiring respondents to submit more than an original and two copies of any document;
No respondents associated with this information collection are required to submit more than an original and two copies of any document.
Requiring respondents to retain records, other than health, medical, government contract, grant-in-aid, or tax records for more than three years;
Respondents associated with this information collection are required to retain records for more than three years. However, this is not a new requirement associated with this information collection. Respondents associated with this information collection are subject to record retentions mandated by OFPA [7 U.S.C. 6519(a)] and the USDA organic regulations (7 CFR 205.103 and 205.510). These record retentions are covered in the currently approved information collection package for the NOP (OMB Control Number 0581-0191). These existing record retentions include the following:
    A. Certified organic livestock operations must maintain, for no less than five (5) years, records concerning the production or handling of certified organic agricultural products [7 CFR 205.103(b)(4)].
    B. Certifying agents must maintain, for no less than 10 years, records concerning the activities of the certifying agent [7 CFR 205.510(b)].
In connection with a statistical survey, that is not designed to produce valid and reliable results that can be generalized to the universe of study;
Respondent information collected is not connected to a statistical survey.
Requiring the use of a statistical data classification that has not been reviewed and approved by OMB;
Respondents are not required to use statistical data classifications that has not been reviewed and approved by OMB.
That includes a pledge of confidentiality that is not supported by authority established in statue or regulation, that is not supported by disclosure and data security policies that are consistent with the pledge, or which unnecessarily impedes sharing of data with other agencies for compatible confidential use; or
No unsupported pledge of confidentiality is used in this information collection. Confidentiality is addressed in OFPA [7 U.S.C. 6519(a)(5)], which states:
§6519. Recordkeeping, investigations, and enforcement
(a) Recordkeeping
…
(5) Confidentiality
Except as provided in section 6506(a)(9) of this title, or as otherwise directed by the Secretary or the Attorney General for enforcement purposes, no officer, employee, or agent of the United States shall make available to the public any information, statistic, or document obtained from, or made available by, any person under this chapter, other than in a manner that ensures that confidentiality is preserved regarding—
(A) the identity of all relevant persons (including parties to a contract); and
(B) proprietary business information.
Certifying agents must also remain compliant with the USDA organic regulations, 7 CFR 205.501(a)(10), which incorporates additional certifying agent confidentiality requirements from OFPA 7 U.S.C. 6515(f). The USDA organic regulations state:
§ 205.501 General requirements for accreditation.
(a) A private or governmental entity accredited as a certifying agent under this subpart must:
…
(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 § 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.
Requiring respondents to submit proprietary trade secret, or other confidential information unless the agency can demonstrate that it has instituted procedures to protect the information’s confidentiality to the extent permitted by law.
There are no other special circumstances that require respondents to submit proprietary trade secret, or other confidential information. Confidentiality is addressed in OFPA [7 U.S.C. 6519(a)(5)], which states:
§6519. Recordkeeping, investigations, and enforcement
(a) Recordkeeping
…
(5) Confidentiality
Except as provided in section 6506(a)(9) of this title, or as otherwise directed by the Secretary or the Attorney General for enforcement purposes, no officer, employee, or agent of the United States shall make available to the public any information, statistic, or document obtained from, or made available by, any person under this chapter, other than in a manner that ensures that confidentiality is preserved regarding—
(A) the identity of all relevant persons (including parties to a contract); and
(B) proprietary business information.
Certifying agents must also remain compliant with the USDA organic regulations, 7 CFR 205.501(a)(10), which incorporates additional certifying agent confidentiality requirements from OFPA 7 U.S.C. 6515(f). The USDA organic regulations state:
§ 205.501 General requirements for accreditation.
(a) A private or governmental entity accredited as a certifying agent under this subpart must:
…
(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 § 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.
8.	If applicable, provide a copy and identify the date and page number of publication in the Federal Register of the agency’s notice, required by 5 CFR 1320.8(d), soliciting comments on the information collection prior to submission to OMB. Summarize public comments received in response to that notice and describe actions taken by the agency in response to these comments. Specifically address comments received on cost and hour burden.
On August 19, 2026, a 60-day notice was published at 91 FR 53598 requesting a renewal of a currently approved information collection. AMS requested comments regarding four specific questions discussed below.
    1) Whether the collection of information continues to be necessary for the proper performance of the functions of the NOP, including whether the information has practical utility;
    2) The accuracy of the burden estimates of the collection of information;
    3) Ways to enhance the quality, utility, and clarity of the collected information; and
    4) Ways to minimize the burden of the collection of information on those who must respond, including the use of automated collection techniques or other forms of information technology.
AMS received four relevant public comments. All comments supported the renewal. Comments also stated the need for continued enforcement and risk-based oversight and provided input on policy or regulatory actions that could be taken. One comment provided detailed feedback directly related to the collection, which is addressed below.
The commenter agreed with AMS’s effort to remove one-time burdens from the renewal. However, the commenter stated that developing SOE-required monitoring practices and uploading SOE procedures to OID were also one-time burdens.
AMS agrees that these activities have likely become routine parts of developing and renewing an OSP. However, the currently approved program collection (OMB Control Number 0581-0191) does not yet include SOE requirements. AMS has included SOE requirements in the estimates for the program renewal and is seeking public comment on them through Docket Number AMS-NOP-26-1024. AMS believes these items should remain in the SOE collection until they are formally added to the program collection to ensure proper estimation.
The commenter also stated that AMS should not have removed the burden for operations that became newly subject to certification under SOE because new operations continue to enter the program.
AMS disagrees. This burden was intended only to cover operations that were not required to be certified before SOE. All these existing operations needed to be certified at the same time. The existing program collection accounts for new operations that enter the program due to sector growth. AMS is seeking feedback on new operation growth in the program collection renewal.
The commenter also stated that import certificates were counted inconsistently. The burden table reports 15,424 certificates generated and 80,109 certificates verified. Additionally, the commenter stated NOP 2110-1 is used in both the SOE and program collections. 
Both observations are correct, but they do not require adjustments. AMS assumes that each generated import certificate is used multiple times. Therefore, 15,424 certificates are generated, while importers and certifiers complete 80,109 verification reviews. NOP 2110-1 is used under both the SOE and program collections to address different regulatory requirements. AMS is seeking to update and combine these estimates in the program collection renewal.
The commenter also provided constructive feedback about OID and import data outside the scope of this renewal. AMS notes that organic import data is available at https://www.ams.usda.gov/services/organic-certification/import-data and https://apps.fas.usda.gov/gats/. 
Describe efforts to consult with persons outside the agency to obtain their views on the availability of data, frequency of collection, the clarity of instructions and recordkeeping, disclosure, or reporting format (if any), and on the data elements to be recorded, disclosed, or reported.
AMS maintains a working relationship with affected regulatory agencies to ensure compliances with existing laws and regulations. The National Organic Standards Board (NOSB) holds biannual public meetings to discuss and make recommendations to the Secretary on materials to be added or deleted from the National List of Allowed and Prohibited Substances, to amend portions of the USDA organic regulations, and to receive public comment on issues of concern to the industry.
In addition, the Organic Trade Association (OTA), represents and encourages all sectors of organic stakeholders to provide public comment on Federal Register dockets and to participate in opportunities for public engagement.
Over the period from 2002 to 2018, the NOSB held public meetings and made multiple recommendations to AMS regarding the USDA organic regulations covered under this collection. These recommendations incorporated public comment and input from certified operations, certifying agents, industry experts, public-interest groups, academia, and the general public.
In July 2018, AMS offered an interactive webinar on the proposed rule topics with open-ended questions that allowed stakeholders to offer public comment through a public online chat offered in compliance with OMB’s media guidance from 2010.  The interactive webinar, associated recording, and the comments provided can be viewed on the AMS website at www.ams.usda.gov/reports/strengthening-organic-enforcement-town-hall-slides. The proposed rule provided for a 60-day comment period for stakeholders on the accuracy of the information collection request. Additional public comment was gathered through engagement with the National Customs Brokers and Forwarders Association of America (NCBFAA). Overall, commenters were very supportive of changes.
Since implementation of SOE, AMS has hosted and participated in several webinars, conferences, and meetings with stakeholders covered under the information collection on the topic of SOE and its implementation. This has allowed AMS to disseminate information and make changes to allow for better implementation of the requirements. These stakeholders include certifiers, certified operations, partner governments, and customs brokers.
Consultation with representatives of those from whom information is to be obtained or those who must compile records should occur at least once every three years – even if the collection of information activity is the same as in prior periods. There may be circumstances that may preclude consultation in a specific situation. These circumstances should be explained.
AMS is requesting a one-year extension to allow time to add the activities covered under this collection to the overall program information collection (OMB Control Number 0581-0191). AMS is in the process of renewing and consulting with industry stakeholders on the program collection (OMB Control Number 0581-0191). The two collections have overlapping forms and related collections. To not burden stakeholders with duplicative requests, AMS solicited feedback on this collection during those discussions on August 13, 2026. AMS has added the activities covered under this collection to the program collection and incorporated feedback and necessary changes in the currently published renewal for the program collection.
9.	Explain any decision to provide any payment or gift to respondents, other than remuneration of contractors or grantees.
No payments or gifts will be provided to respondents.
10.	Describe any assurance of confidentiality provided to respondents and the basis for the assurance in statue, regulation, or agency policy.
Respondents are provided confidentiality assurance as the information collected from USDA certified organic respondents is to be submitted to AMS through their certifying agent. As certifying agents accredited by AMS, certifying agents (along with all government employees and government contractors) are considered an “agent of the United States” and are held to the confidentiality statutes in OFPA [7 U.S.C. 6519(a)(5)], which states:
§6519. Recordkeeping, investigations, and enforcement
(a) Recordkeeping
…
(5) Confidentiality
Except as provided in section 6506(a)(9) of this title, or as otherwise directed by the Secretary or the Attorney General for enforcement purposes, no officer, employee, or agent of the United States shall make available to the public any information, statistic, or document obtained from, or made available by, any person under this chapter, other than in a manner that ensures that confidentiality is preserved regarding—
(A) the identity of all relevant persons (including parties to a contract); and
(B) proprietary business information.
Certifying agents must also remain compliant with the USDA organic regulations, 7 CFR 205.501(a)(10), which incorporates additional certifying agent confidentiality requirements from OFPA 7 U.S.C. 6515(f). The USDA organic regulations state:
§ 205.501 General requirements for accreditation.
(a) A private or governmental entity accredited as a certifying agent under this subpart must:
…
(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 § 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.
In addition to USDA certified organic respondents, all respondents to this information collection are provided confidentiality assurance as the information collected by AMS is held to the confidentiality statutes in OFPA [7 U.S.C. 6519(a)(5)] stated above.
11.	Provide additional justification for any questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private. This justification should include the reasons why the agency considers the questions necessary. The specific uses to be made of the information, the explanation to be given to persons from whom the information is requested, and any steps to be taken to obtain their consent.
No questions in this information collection relate to sexual behavior and attitudes or religious beliefs.
12.	Provide estimates of the hour burden of the collection of information. The statement should:
Indicate the number of respondents, frequency of response, annual hour burden, and an explanation of how the burden was estimated. Unless directed to do so, agencies should not conduct special surveys to obtain information on which to base hour burden estimates. Consultation with a sample (fewer than 10) of potential respondents is desirable. If the hour burden on respondents is expected to vary widely because of difference in activity, size, or complexity, show the range of estimated hour burden, and explain the reasons for the variance. Generally, estimates should not include burden hours for customary and usual business practices.
Estimated Number of Respondents: 51,091 respondents.
Estimated Number of Responses per Respondent (frequency): 12 responses per respondent per year.
Estimated Total Annual Burden on Respondents: 231,617 hours.
This estimated burden includes Organic System Plan management, import requirements including certificate creation and labeling, and paperwork related to training and inspection under these regulations. These estimates are covered in further detail in the accompanying OMB form 83-I and AMS 71 Grid spreadsheet.
If this request for approval covers more than one form, provide separate hour burden estimates for each form and aggregate the hour burdens in item 13 of OMB form 83-I.
TM-10CG: 75 recordkeeping hours.
NOP 2110-1: 55,777 reporting hours.

Provide estimates of annualized cost to respondents for the hour burdens for collections of information, identifying and using appropriate wage rate categories.
These estimates for the burden of collecting information are summarized in the form OMB 83-I. AMS has identified four primary types of entities (respondents) that need to submit and maintain information as a result of this final rule: certified organic operations; certifying agents; organic inspectors; and foreign governments. Three respondent types—certified organic operations, certifying agents, and inspectors—have been identified in the currently approved information collection (0581-0191). To implement a 2018 Farm Bill mandate,1 AMS requires certification of additional types of operations in the organic supply chain and regular audits of trade arrangements with foreign governments.
To more precisely understand the paperwork impacts of this final rule, AMS has divided the categories of respondents into domestic and foreign, as appropriate. This shows the potential impacts on domestic- versus foreign-based USDA-accredited certifying agents, inspectors, and certified operations, along with foreign governments serving as accrediting bodies and their (foreign) accredited certifying agents. AMS estimates: (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.
For the 51,091 reporting and recordkeeping respondents, the total information collection for both reporting and recordkeeping is 231,617 hours and a total cost of $10,765,642 annually.
Total Reporting Burden Cost: $8,266,543
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: 566,388
Estimated Total Annual Burden on Reporting Respondents: 185,981 hours
Estimated Total Annual Reporting Responses per Reporting Respondent: 11 reporting responses per reporting respondent
AMS estimates that the public reporting burden for this collection of information is estimated to be 185,981 hours per year at a total cost of $8,266,543, across 51,091 respondents. Respondents consist of currently certified operations, operations that will seek certification over the next 12 months, traders that were previously excluded from certification, USDA- and foreign-accredited certifying agents, inspectors, and foreign governments with whom AMS has trade arrangements. Each of the respondent categories is explained in more detail below.
SUMMARY TABLE 1
Reporting Burden

Number of Respondents2
Wage & Benefits3
Total Reporting Hours
Total Reporting Costs
Organic Operations - Domestic
29,930
$62.434
42,515
$2,654,211 
Organic Operations - Foreign
20,798
$43.82
67,422
$2,954,432 
Total Organic Operations - All
50,728

109,937
$5,608,643 
USDA U.S.-Based Certifiers
45
$55.295
4,871
$269,318 
USDA U.S.-Based Certifiers – Data Entry (Same Respondents)
45
$30.446
14,965
$455,535
USDA Foreign-Based Certifiers
30
$38.81
19,583
$760,016
USDA Foreign-Based Certifiers – Data Entry (Same Respondents)
30
$21.37
10,399
$222,227
Foreign Accredited Certifiers
30
$38.81
18,425
$715,074
Total Certifiers - All
105
 
68,243
$2,422,169
USDA U.S.-based Inspectors
148
$34.357
4,567
$156,876
USDA Foreign-based inspectors
102
$24.11
3,174
$76,525
USDA Inspectors - All
250

7,741
$233,402
Foreign Governments - All
8
$38.818
60
$2,329
All Respondents - Reporting Burden
51,091

185,981
$8,266,543
Certified Organic Operations. Domestic and foreign operations seeking organic certification (referred to as “organic operations”) must submit an Organic System Plan (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. SOE requires all organic operations to maintain monitoring practices to verify their supply chain in their OSP. Additionally, producer groups must maintain and document an internal control system in their OSP, imports require an import certificate to be requested and verified, and all bulk nonretail containers must be labeled. The total reporting burden for all organic operations, foreign and domestic, is estimated to be 109,937 hours at an annual total cost of $5,608,643 in Summary Table 1.
Accredited Certifying Agents. Certifying agents are State, private, or foreign entities accredited by USDA, or by foreign government accreditation bodies with whom USDA has trade arrangements, to certify domestic and foreign operations as organic in accordance with OFPA and the USDA organic regulations.
Under SOE, all USDA-accredited certifying agents and 30 certification agents accredited by a foreign government must maintain procedures for fraud prevention and supply chain verification and are required to issue organic certificates generated by OID. Certifying agents are required to conduct unannounced inspections and ensure that certification review staff and inspectors are qualified and comply with annual training requirements. Certifying agents of operations that export to the United States issue import certificates for all shipments of imported organic products. Certifying agents also need to submit their decision criteria for acceptance of mediation and a process for identifying personnel conducting mediation and setting up mediation sessions in its administrative policies and procedures.
In Summary Table 1 above, AMS estimates the annual reporting burden for all certifying agents, including foreign accredited certifying agents, will be 68,243 hours, costing $2,422,169 annually.
Organic Inspectors. Inspectors conduct on-site inspections of certified operations and operations applying for certification and report the findings to the certifying agent. SOE added requirements for unannounced inspections and training for inspectors. Under SOE and this collection, inspectors must provide an inspection report to the certifying agent for each operation receiving an unannounced inspection and submit information documenting their qualifications to the certifying agent.
Shown in Summary Table 1, AMS estimates total reporting burden for all USDA inspectors to comply with this collection to be 7,741 hours, costing $233,402 annually.
Foreign Governments. USDA has approved trade arrangements with foreign governments to facilitate the international trade of organic products.9 SOE required periodic assessment of trade arrangements.
In Summary Table 1, AMS estimates these periodic peer review assessments to be similar in depth and frequency to the audits of accrediting certifying agents under USDA organic regulations and estimates a comparable level of reporting and recordkeeping burden by foreign governments with whom AMS has negotiated trade arrangements, resulting in approximately one review annually. AMS estimates total reporting burden for all foreign governments to comply with this collection to be 60 hours, costing $2,329 annually.
Total Recordkeeping Burden Cost: $2,499,099
Estimate of Burden: 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 Respondent: 1 recordkeeping response per recordkeeping respondent
AMS estimates that the public recordkeeping burden for this collection of information is 45,636 hours per year at a cost of $2,499,099 across 50,811 respondents. Respondents consist of currently certified operations, operations that will seek certification over the next 12 months, traders that were previously excluded from certification, USDA-accredited certifying agents, and foreign governments with whom AMS has trade arrangements. Each of the respondent categories for recordkeeping is explained below.
Certified Organic Operations. In Summary Table 2, the total recordkeeping burden for all organic operations, foreign and domestic, to maintain records related to changes to their OSPs is estimated to be 45,481 hours at an annual total cost of $2,492,358.
Certifying agents. In Summary Table 2, AMS estimates the annual recordkeeping burden for both domestic- and foreign-based USDA accredited certifying agents to maintain records related to changes to their TM-10CG is estimated to be 75 hours totaling $3,636.
Foreign Governments. In Summary Table 2, AMS estimates the annual recordkeeping burden for foreign governments to maintain records related to trade arrangements and reviews is estimated to be 80 hours totaling $3,105.
SUMMARY TABLE 2
Recordkeeping Burden

Number of Respondents2
Wage & Benefits3
Total Recordkeeping Hours
Total Recordkeeping Costs
Organic Operations - Domestic
29,930
$62.434
26,834
$1,675,247
Organic Operations - Foreign
20,798
$43.82
18,647
$817,112
Total Organic Operations- All
50,728

45,481
$2,492,358
USDA U.S.-Based Certifiers
45
$55.295
44
$2,433
USDA Foreign-Based Certifiers
30
$38.81
31
$1,203
Total Certifiers – All
75
 
75
$3,636
Foreign Governments – All
8
$38.818
80
$3,105
All Respondents – Recordkeeping Burden
50,811

45,636
$2,499,099 
13.	Provide an estimate of the total annual cost burden to respondents for recordkeepers resulting from the collection of information. Do not include the cost of any hour burden shown in items 12 and 14.
The hourly burden estimate resulting from this information collection is described in Item 12. There is no other annual cost burden to respondents for recordkeepers to describe here as there are no capital and start-up costs associated with this information collection.
The cost estimate should be split into two components: (a) A total capital and start-up cost component (annualized over its expected useful life); and (b) A total operation and maintenance and purchase of services component. The estimates should take into account costs associated with generating, maintaining, and disclosing or providing the information. Include descriptions of methods used to estimate major cost factors including system and technology acquisition, expected useful life of capital equipment, the discount rate(s), and the time period over which costs would be incurred. Capital and start-up costs include, among other items, preparations for collecting information such as purchasing computers and software; monitoring, sampling, drilling and testing equipment; and record storage facilities.
There is no (a) capital and start-up cost estimated or (b) operation maintenance or service purchasing cost associated with this information collection. Equipment or services used by respondents to this information collection is part of customary and usual business and private practices.
If cost estimates are expected to vary widely, agencies should present ranges of cost burdens and explain the reasons for the variance. The cost of purchasing or contracting out information collection services should be a part of this cost burden estimate. In developing cost burden estimates, agencies may consult with a sample of respondents (fewer than 10), utilize the 60-day pre-OMB submission public comment process and use existing economic or regulatory impact analysis associated with the rulemaking containing the information collection, as appropriate.
Burden estimates and their associated cost are described in Item 12. AMS does not expect a wide range of recordkeeping or reporting burden due to this collection of information.
Generally, estimates should not include purchases of equipment or services, or portions thereof, made: (1) Prior to October 1, 1995, (2) To achieve regulatory compliance with requirements not associated with the information collection, (3) For reasons other than to provide information or keeping records for the government, or (4) As part of customary and usual business or private practices.
There are no capital and start-up costs associated with this collection. Under the NOP (§ 205.103), each operation is required to maintain and make available upon request, for five years, such records as are necessary to verify compliance with the NOP. There are no additional costs to maintain the required records.
14.	Provide estimates of annualized cost to the Federal Government. Also, provide a description of the method used to estimate cost, which should include quantification of hours, operation expenses (such as equipment, overhead, printing, and support staff), and any other expense that would not have been incurred without this collection of information. Agencies also may aggregate cost estimates from items 12, 13, and 14 in a single table.
AMS does not expect any information related to this collection to impact the existing cost of conducting business at AMS or the NOP.
AMS estimates the annual cost to operate the NOP at approximately $23 million. These costs include salaries and benefits; travel and transportation; rent, communications, utilities; printing; contractual services; supplies; and equipment. The NOP currently operates on appropriated funds.
15.	Explain the reason for any program changes or adjustments reported in items 13 or 14 of the OMB form 83-I.
AMS made a set of internal changes to this collection: AMS moved respondents who needed to comply with the organic regulations for the first time under the previous information collection (a one-time reporting burden to create an OSP) to the currently certified respondents category (an ongoing reporting burden to maintain and verify the monitoring practices and procedures). This maintained the number of respondents and responses but reduced the number of reporting hours.
AMS made no other changes to this collection’s estimates. AMS finds that the estimates of the original information generally hold, but plans to update and unify them with the existing program collection (OMB Control Number 0581-0191) when it is renewed in early 2027.
16.	For collections of information whose results would be published, outline plans for tabulation, and publication. Address any complex analytical techniques that will be used. Provide the time schedule for the entire project, including beginning and ending dates of the collection of information, completion of report, publication dates, and other actions.
No publication of data obtained through the regulation is planned.
17.	If seeking approval to not display the expiration date for OMB approval of the information collection, explain the reasons that display would be inappropriate.
All forms are currently approved under OMB Control Number 0581-0191 for the National Organic Program. AMS will continue to list the expiration date for that collection on the forms.
18.	Explain each exception to the certification statement identified in item 19, “Certification for Paperwork Reduction Act Submissions” of OMB form 83-I.
AMS is not claiming any exceptions to the certification statement identified in Item 19 of the OMB form 83-I.
In Item 19 (Certification for Paperwork Reduction Act Submissions) of OMB form 83-I, AMS certifies that the collection of information encompassed by this request complies with 5 CFR 1320.9. The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
    (a) It is necessary for the proper performance of agency functions;
    (b) It avoids unnecessary duplication;
    (c) It reduces burden on small entities;
    (d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;
    (e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
    (f) It indicates the retention period for recordkeeping requirements;
    (g) It informs respondents of the information called for under 5 CFR 1320.8(b)(3):
        i. Why the information is being collected;
        ii. Use of information;
        iii. Nature of response (voluntary, required for a benefit, or mandatory);
        iv. Nature and extent of confidentiality; and
        v. Need to display currently valid OMB control number;
    (h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected (see note in Item 19 of the instructions);
    (i) It uses effective and efficient statistical survey methodology; and
    (j) It makes appropriate use of information technology.