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Strengthening Organic Enforcement: Comparison of Old and New Regulatory Text

This side-by-side comparison shows the changes that the Strengthening Organic Enforcement (SOE) rule makes to the Organic Regulations 

(7 CFR Part 205). This document is an unofficial copy of regulatory language meant to be read alongside the rule as an aid to understanding. The 

official regulatory text may be read at the Federal Register. 

Table of Contents

A. Applicability and Exemptions from Certification...................................................................................................................................................... 2

B. Imports to the United States...................................................................................................................................................................................... 9

C. Labeling of Nonretail Containers ............................................................................................................................................................................. 11

D. On-Site Inspections .................................................................................................................................................................................................. 12

E. Certificates of Organic Operation ............................................................................................................................................................................ 13

F. Continuation of Certification ................................................................................................................................................................................... 15

G. Paperwork Submissions to the Administrator........................................................................................................................................................ 16

H. Personnel Training and Qualifications .................................................................................................................................................................... 17

I. Oversight of Certification Activities ......................................................................................................................................................................... 21

J. Accepting Foreign Conformity Assessment Systems.............................................................................................................................................. 22

K. Compliance and Noncompliance Procedures......................................................................................................................................................... 26

L. Mediation .................................................................................................................................................................................................................. 27

M. Adverse Action Appeal Process ................................................................................................................................................................................ 30

N. Producer Group Operations..................................................................................................................................................................................... 33

O. Calculating the Percentage of Organically Produced Ingredients ......................................................................................................................... 36

P. Supply Chain Traceability and Organic Fraud Prevention...................................................................................................................................... 37

Q. Technical Corrections............................................................................................................................................................................................... 40
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A. Applicability and Exemptions from Certification

Section Former Text New Text

205.2 Handle. To sell, process, or package agricultural products, 

except such term shall not include the sale, transportation, or 

delivery of crops or livestock by the producer thereof to a 

handler.

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.

205.2 Handler. Any person engaged in the business of handling 

agricultural products, including producers who handle crops or 

livestock of their own production, except such term shall not 

include final retailers of agricultural products that do not 

process agricultural products.

Handler. Any person that handles agricultural products, except 

final retailers of agricultural products that do not process 

agricultural products.

205.2 Handling operation. Any operation or portion of an operation 

(except final retailers of agricultural products that do not 

process agricultural products) that receives or otherwise 

acquires agricultural products and processes, packages, or 

stores such products.

Handling operation. Any operation that handles agricultural 

products, except final retailers of agricultural products that do 

not process agricultural products.

205.2 Retail food establishment. A restaurant; delicatessen; bakery; 

grocery store; or any retail outlet with an in-store restaurant, 

delicatessen, bakery, salad bar, or other eat-in or carry-out 

service of processed or prepared raw and ready-to-eat-food.

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.
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205.100(a) Except for operations exempt or excluded in § 205.101, each 

production or handling operation or specified portion of a 

production or handling operation that produces or handles 

crops, livestock, livestock products, or other agricultural 

products that are 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.

Except for the exempt operations described in § 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.

205.101 Exemptions and exclusions from certification. Exemptions from certification.

205.101 [Add new introductory paragraph to describe exemptions.] 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 § 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.
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205.101(a) Exemptions. (1) 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 is 

exempt from certification under subpart E of this part and from 

submitting an organic system plan for acceptance or approval 

under § 205.201 but must comply with the applicable organic 

production and handling requirements of subpart C of this part 

and the labeling requirements of § 205.310. The products from 

such operations shall not be used as ingredients identified as 

organic in processed products produced by another handling 

operation.

(2) A handling operation that is a retail food establishment or 

portion of a retail food establishment that handles organically 

produced agricultural products but does not process them is 

exempt from the requirements in this part.

(3) A handling operation or portion of a handling operation that 

only handles agricultural products that contain less than 70 

percent organic ingredients by total weight of the finished 

product (excluding water and salt) is exempt from the 

requirements in this part, except:

(i) The provisions for prevention of contact of organic products 

with prohibited substances set forth in § 205.272 with respect 

to any organically produced ingredients used in an agricultural 

product;

(ii) The labeling provisions of §§ 205.305 and 205.310; and

(iii) The recordkeeping provisions in paragraph (c) of this 

section.

(4) A handling operation or portion of a handling operation that 

only identifies organic ingredients on the information panel is 

exempt from the requirements in this part, except:

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.
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(i) The provisions for prevention of contact of organic products 

with prohibited substances set forth in § 205.272 with respect 

to any organically produced ingredients used in an agricultural 

product;

(ii) The labeling provisions of §§ 205.305 and 205.310; and

(iii) The recordkeeping provisions in paragraph (c) of this 

section.
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205.101

(b)

Exclusions. (1) A handling operation or portion of a handling 

operation is excluded from the requirements of this part, 

except for the requirements for the prevention of commingling 

and contact with prohibited substances as set forth in §205.272 

with respect to any organically produced products, if such 

operation or portion of the operation only sells organic 

agricultural products labeled as “100 percent organic,” 

“organic,” or “made with organic (specified ingredients or food 

group(s))” that:

(i) Are packaged or otherwise enclosed in a container prior to 

being received or acquired by the operation; and

(ii) Remain in the same package or container and are not 

otherwise processed while in the control of the handling 

operation.

(2) A handling operation that is a retail food establishment or 

portion of a retail food establishment that processes, on the 

premises of the retail food establishment, raw and ready-to-eat 

food from agricultural products that were previously labeled as 

“100 percent organic,” “organic,” or “made with organic 

(specified ingredients or food group(s))” is excluded from the 

requirements in this part, except:

(i) The requirements for the prevention of contact with 

prohibited substances as set forth in § 205.272; and

(ii) The labeling provisions of § 205.310.

A retail establishment that does not process organically 

produced agricultural products.
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205.101(c) Records to be maintained by exempt operations. (1) Any 

handling operation exempt from certification pursuant to 

paragraph (a)(3) or (a)(4) of this section must maintain records 

sufficient to:

(i) Prove that ingredients identified as organic were organically 

produced and handled; and

(ii) Verify quantities produced from such ingredients.

(2) Records 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.

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)).”

205.101

(d)

[Modify former § 205.101(a)(3) and (4).] A handling operation that only handles agricultural products 

that contain less than 70 percent organic ingredients (as 

described in § 205.301(d)) or that only identifies organic 

ingredients on the information panel.

205.101(e) [Modify former § 205.101(b)(1).] 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.
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205.101(f) [Add new paragraph.] 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.

205.101(g) [Add new paragraph.] A Customs broker (per 19 CFR 111.1) that only conducts 

customs business but does not otherwise handle organic 

agricultural products.

205.101

(h)

[Add new paragraph.] An operation that only arranges for the shipping, storing, 

transport, or movement of organic agricultural products but 

does not otherwise handle organic products.

205.101(i) [Modify recordkeeping requirements, formerly § 205.101(c).] Recordkeeping by exempt operations.

205.101(i)

(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

205.101(i)

(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.
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205.310 Agricultural products produced on an exempt or excluded 

operation.

Agricultural products produced or processed by an exempt 

operation.

205.310(a) An agricultural product organically produced or handled on an 

exempt or excluded operation must not:

(1) Display the USDA seal or any certifying agent's seal or other 

identifying mark which represents the exempt or excluded 

operation as a certified organic operation, or 

(2) Be represented as a certified organic product or certified 

organic ingredient to any buyer.

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.

205.310

(b)

An agricultural product organically produced or handled on an 

exempt or excluded operation may be identified as an organic 

product or organic ingredient in a multi ingredient product 

produced by the exempt or excluded operation. Such product 

or ingredient must not be identified or represented as 

“organic” in a product processed by others.

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.

B. Imports to the United States

Section Former Text New Text

205.2 [Add new term.] 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.

205.2 [Add new term.] 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.

205.273 [Add new § 205.273.] Imports to the United States.
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205.273 Each shipment of organic agricultural products imported into 

the United States must be certified pursuant to subpart E of 

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

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

and be associated with valid NOP Import Certificate data.

205.273(a) Persons exporting organic agricultural products to the United 

States must request an NOP Import Certificate from a certifying 

agent prior to their export. Only certifying agents accredited by 

the USDA or foreign certifying agents authorized under an 

organic trade arrangement may issue an NOP Import 

Certificate.

205.273(b) The certifying agent must review an NOP Import Certificate 

request and determine whether the export complies with the 

USDA organic regulations. The certifying agent must have and 

implement a documented organic control system for intaking 

and approving or rejecting the validity of an NOP Import 

Certificate request. The certifying agent shall issue the NOP 

Import Certificate through the Organic Integrity Database only 

if the export complies with the USDA organic regulations.

205.273(c) Each compliant organic import must be declared as organic to 

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

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

Automated Commercial Environment system. Organic imports 

must be clearly identified and marked as organic on all import 

documents including but not limited to invoices, packing lists, 

bills of lading, and U.S. Customs and Border Protection entry 

data. Only NOP Import Certificate data generated by the 

Organic Integrity Database are valid.
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205.273(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 § 205.272 or exposure to ionizing radiation 

pursuant to § 205.105, since export. The organic importer must 

have a documented organic control system to conduct this 

verification.

205.273(e) Products produced in a foreign country and exported for sale in 

the United States must be certified pursuant to subpart E of 

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

with the requirements in § 205.273, Imports to the United 

States.

205.300(c) Products produced in a foreign country and exported for sale in 

the United States must be certified pursuant to subpart E of 

this part and labeled pursuant to this subpart D.

Products produced in a foreign country and exported for sale in 

the United States must be certified pursuant to subpart E of 

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

with the requirements in § 205.273.

C. Labeling of Nonretail Containers

Section Former Text New Text

205.307 Labeling of nonretail containers used for only shipping or 

storage of raw or processed agricultural products labeled as 

“100 percent organic,” “organic,” or “made with organic 

(specified ingredients or food group(s)).”

Labeling of nonretail containers.
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205.307(a) Nonretail containers used only to ship or store raw or 

processed agricultural product labeled as containing organic 

ingredients may display the following terms or marks:

(1) The name and contact information of the certifying agent 

which certified the handler which assembled the final product;

(2) Identification of the product as organic;

(3) Special handling instructions needed to maintain the 

organic integrity of the product;

(4) The USDA seal;

(5) The seal, logo, or other identifying mark of the certifying 

agent that certified the organic production or handling 

operation that produced or handled the finished product.

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.

205.307(b) Nonretail containers used to ship or store raw or processed 

agricultural product labeled as containing organic ingredients 

must display the production lot number of the product if 

applicable.

Audit trail documentation for nonretail containers must identify 

the last certified operation that handled the agricultural 

product.

205.307(c) [Add new paragraph.] 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. On-Site Inspections

Section Former Text New Text

205.2 [Add new term.] 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.
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205.403

(b)

[Redesignate paragraphs (b) – (e) as (c) – (f); add new paragraph 

(b) on unannounced inspections.] 

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.

205.403

(d)(4)

[Add mass-balance requirements to “Verification of Information,”

formerly § 205.403(c).] 

Mass-balances, in that quantities of organic product and 

ingredients produced or purchased account for organic product 

and ingredients used, stored, sold, or transported; and

205.403

(d)(5)

[Add traceability requirements to “Verification of Information,” 

formerly § 205.403(c).] 

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.

E. Certificates of Organic Operation

Section Former Text New Text

205.2 [Add new term.] 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.
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205.404(b) The certifying agent must issue a certificate of organic 

operation which specifies the:

(1) Name and address of the certified operation;

(2) Effective date of certification;

(3) Categories of organic operation, including crops, wild crops, 

livestock, or processed products produced by the certified 

operation; and

(4) Name, address, and telephone number of the certifying 

agent.

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.

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

(c) on certificate addenda.] 

In addition to the certificate of organic operation provided for 

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

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

any addenda must include:

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

operation;

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

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

Organic Integrity Database;

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

certified operation's profile in the Organic Integrity Database, 

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

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.”
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F. Continuation of Certification

Section Former Text New Text

205.406(a) To continue certification, a certified operation must annually 

pay the certification fees and submit the following information, 

as applicable, to the certifying agent:

(1) An updated organic production or handling system plan 

which includes:

(i) A summary statement, supported by documentation, 

detailing any deviations from, changes to, modifications to, or 

other amendments made to the previous year’s organic system 

plan during the previous year; and

(ii) Any additions or deletions to the previous year’s organic 

system plan, intended to be undertaken in the coming year, 

detailed pursuant to §205.200;

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

pursuant to §205.401(b);

(3) An update on the correction of minor noncompliances 

previously identified by the certifying agent as requiring 

correction for continued certification; and

(4) Other information as deemed necessary by the certifying 

agent to determine compliance with the Act and the 

regulations in this part.

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 § 205.201;

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

pursuant to § 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.
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205.406(b) Following the receipt of the information specified in paragraph 

(a) of this section, the certifying agent shall within a reasonable 

time arrange and conduct an on-site inspection of the certified 

operation pursuant to §205.403: Except, That, when it is 

impossible for the certifying agent to conduct the annual onsite inspection following receipt of the certified operation’s 

annual update of information, the certifying agent may allow 

continuation of certification and issue an updated certificate of 

organic operation on the basis of the information submitted 

and the most recent on-site inspection conducted during the 

previous 12 months: Provided, That, the annual on-site 

inspection, required pursuant to §205.403, is conducted within 

the first 6 months following the certified operation’s scheduled 

date of annual update.

The certifying agent must arrange and conduct an on-site 

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

least once per calendar year.

G. Paperwork Submissions to the Administrator

Section Former Text New Text

205.405(c) 

(3)

Provide notice of approval or denial to the Administrator, 

pursuant to §205.501(a)(14).

[Remove former paragraph (c)(3).]
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205.501(a) 

(15)

Submit to the Administrator a copy of:

(i) Any notice of denial of certification issued pursuant to 

§205.405, notification of noncompliance, notification of 

noncompliance correction, notification of proposed 

suspension or revocation, and notification of suspension or 

revocation sent pursuant to §205.662 simultaneously with its 

issuance; and

(ii) A list, on January 2 of each year, including the name, 

address, and telephone number of each operation granted 

certification during the preceding year;

Maintain current and accurate data in the Organic Integrity 

Database for each operation which it certifies;

H. Personnel Training and Qualifications

Section Former Text New Text

205.2 [Add new term.] 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.
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205.501(a) 

(4)

Use a sufficient number of adequately trained personnel, 

including inspectors and certification review personnel, to 

comply with and implement the organic certification program 

established under the Act and the regulations in subpart E of 

this part;

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 § 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 
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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.
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205.501(a) 

(5)

Ensure that its responsibly connected persons, employees, and 

contractors with inspection, analysis, and decision-making 

responsibilities have sufficient expertise in organic production 

or handling techniques to successfully perform the duties 

assigned.

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.

205.501(a) 

(6)

Conduct an annual performance evaluation of all persons who 

review applications for certification, perform on-site 

inspections, review certification documents, evaluate 

qualifications for certification, make recommendations 

concerning certification, or make certification decisions and 

implement measures to correct any deficiencies in certification 

services;

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 records for annual performance evaluations 

and witness inspections.
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I. Oversight of Certification Activities

Section Former Text New Text

205.2 [Add new term.] 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.

205.2 [Add new term.] 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.

205.501(a)

(22)

[Add new paragraph.] 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.
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205.665(a) Notification. When 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, a 

written notification of noncompliance shall be sent to the 

certifying agent. Such notification shall provide:

(1) A description of each noncompliance;

(2) The facts upon which the notification of noncompliance is 

based; and

(3) The date by which the certifying agent must rebut or correct 

each noncompliance and submit supporting documentation of 

each correction when correction is possible.

(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.

J. Accepting Foreign Conformity Assessment Systems

Section Former Text New Text

205.2 [Add new term.] 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.
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205.2 [Add new term.] 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.

205.500(c) In lieu of accreditation under paragraph (a) of this section, 

USDA will accept a foreign certifying agent's accreditation to 

certify organic production or handling operations if:

(1) USDA determines, upon the request of a foreign 

government, that the standards under which the foreign 

government authority accredited the foreign certifying agent 

meet the requirements of this part; or

(2) The foreign government authority that accredited the 

foreign certifying agent acted under an equivalency agreement 

negotiated between the United States and the foreign 

government.

[Remove; replace with new § 205.511.]

205.511 [Add new § 205.511.] Accepting foreign conformity assessment systems.

205.511(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.
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205.511(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.

205.511(c) AMS will describe the scope of an equivalence determination.
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205.511(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.

205.511(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.
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K. Compliance and Noncompliance Procedures

Section Former Text New Text

205.660(c) [Redesignate § 205.660(c) and (d) as (d) and (e); add new 

paragraph (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.

205.661 Investigation of certified operations. Investigation.

205.100(c) Any operation that: Any person or responsibly connected person that:

205.662(e)

(3)

[Add new section.] 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.

205.662(f) 

(1)

A certified operation whose certification has been suspended 

under this section may at any time, unless otherwise stated in 

the notification of suspension, submit a request to the 

Secretary for reinstatement of its certification. The request 

must be accompanied by evidence demonstrating correction of 

each noncompliance and corrective actions taken to comply 

with and remain in compliance with the Act and the regulations 

in this part.

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. The request must be accompanied by evidence 

demonstrating correction of each noncompliance and 

corrective actions taken to comply with and remain in 

compliance with the Act and the regulations in this part.

205.662(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 §3.91(b)(1) of this title 

per violation.

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.
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L. Mediation

Section Former Text New Text

205.504 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 §§ 

205.100 and 205.101, §§ 205.201 through 205.203, §§ 205.300

through 205.303, §§ 205.400 through 205.406, and §§ 205.661

and 205.662; and its ability to comply with the requirements for 

accreditation set forth in § 205.501:

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 §§ 

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 § 205.501:

205.504

(b)(8)

[Add new paragraph.] Administrative policies and procedures. (8) A copy of reasonable 

decision criteria for acceptance of mediation, and a process for 

identifying personnel conducting mediation and setting up 

mediation.
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205.663 Any dispute with respect to denial of certification or proposed 

suspension or revocation of certification under this part may be 

mediated at the request of the applicant for certification or 

certified operation and with acceptance by the certifying agent. 

Mediation shall be requested in writing to the applicable 

certifying agent. If the certifying agent rejects the request for 

mediation, the certifying agent shall provide written 

notification to the applicant for certification or certified 

operation. The written notification shall advise the applicant for 

certification or certified operation of the right to request an 

appeal, pursuant to §205.681, within 30 days of the date of the 

written notification of rejection of the request for mediation. If 

mediation is accepted by the certifying agent, such mediation 

shall be conducted by a qualified mediator mutually agreed 

upon by the parties to the mediation. If a State organic program 

is in effect, the mediation procedures established in the State 

organic program, as approved by the Secretary, will be 

followed. The parties to the mediation shall have no more than 

30 days to reach an agreement following a mediation session. If 

mediation is unsuccessful, the applicant for certification or 

certified operation shall have 30 days from termination of 

mediation to appeal the certifying agent's decision pursuant to 

§205.681. Any agreement reached during or as a result of the 

mediation process shall be in compliance with the Act and the 

regulations in this part. The Secretary may review any mediated 

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.

(a) A certifying agent must submit with its administrative 

policies and procedures: decision criteria for acceptance of 

mediation, and a process for identifying personnel conducting 

mediation and setting up mediation sessions per 

§ 205.504(b)(8).

(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 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 § 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. 
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(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 to reach an agreement from the start of mediation. 

Successful mediation results in a settlement agreement agreed 

to in writing by both the certifying agent and the certified 

operation. If mediation is unsuccessful, the applicant for 

certification or certified operation has 30 calendar days from 

receipt of a written notice of termination of mediation to appeal 

the denial of certification or proposed suspension or revocation 

pursuant to § 205.681.

(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.
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M. Adverse Action Appeal Process

Section Former Text New Text

205.2 [Add new term.] 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.

205.680

(a)

Persons subject to the Act who believe they are adversely 

affected by a noncompliance decision of the National Organic 

Program's Program Manager may appeal such decision to the 

Administrator.

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.

205.680

(b)

Persons subject to the Act who believe that they are adversely 

affected by a noncompliance decision 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.

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.

205.680

(c)

Persons subject to the Act who believe that they are adversely 

affected by a noncompliance decision of a certifying agent may 

appeal such decision to the Administrator, Except, That, when 

the person is subject to an approved State organic program, the 

appeal must be made to the State organic program.

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 organic program, the 

appeal must be made to the State organic program.

205.680

(d)

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.

[Redesignate as § 205.680(f); add new paragraph (d) on 

mediation.]

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 § 

205.663.
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205.680

(e)

All appeals shall be reviewed, heard, and decided by persons 

not involved with the decision being appealed. [Redesignate as 

§ 205.680(g); add new paragraph (e) on procedure.]

All appeals must comply with the procedural requirements in 

§ 205.681(c) and (d). 

205.680

(f)

[Formerly paragraph (d).] 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.

205.680

(g)

[Modify former paragraph (e).] All appeals must be reviewed, heard, and decided by persons 

not involved with the adverse action being appealed.

205.681

(a)

Certification appeals. 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 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.

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.

205.681

(a)(2)

If the Administrator or State organic program denies an appeal, 

a formal administrative proceeding will be initiated to deny, 

suspend, or revoke the certification. Such proceeding shall 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.

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 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.
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205.681

(b)

Accreditation appeals. An applicant for accreditation and an 

accredited certifying agent may appeal the Program Manager's 

denial of accreditation or proposed suspension or revocation of 

accreditation to the Administrator.

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

issued accreditation, or a certifying agent will continue its 

accreditation, as applicable to the operation.

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

administrative proceeding to deny, suspend, or revoke the 

accreditation will be initiated. Such proceeding shall be 

conducted pursuant to the U.S. Department of Agriculture's 

Uniform Rules of Practice, 7 CFR part 1, Subpart H.

Adverse actions by the NOP Program Manager. A person affected 

by an adverse action, as defined by § 205.2, issued by the NOP 

Program Manager, may appeal to the Administrator.

(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.

205.681

(c)

Filing period. An appeal of a noncompliance decision must be 

filed 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. 

A decision to deny, suspend, or revoke certification or 

accreditation will become final and nonappealable unless the 

decision is appealed in a timely manner.

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.

205.681

(d)(1)

Appeals to the Administrator must be filed in writing and 

addressed to: Administrator, USDA, AMS, c/o NOP Appeals 

Team, 1400 Independence Avenue SW., Room 2648-So., Stop 

0268, Washington, DC 20250-0268.

Appeals to the Administrator and Requests for Hearing must be 

filed in writing and addressed to: 1400 Independence Ave., S.W., 

Room 2642, Stop 0268, Washington, D.C. 20250, or electronic 

transmission, NOPAppeals@usda.gov.
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205.681

(d)(3)

All appeals must include a copy of the adverse decision and a 

statement of the appellant's reasons for believing that the 

decision was not proper or made in accordance with applicable 

program regulations, policies, or procedures.

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.

N. Producer Group Operations

Section Former Text New Text

205.2 [Add new term.] Producer group member. An individual engaged in the activity 

of producing or harvesting agricultural products as a member 

of a producer group operation.

205.2 [Add new term.] 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.

205.2 [Add new term.] 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.

205.2 [Add new term.] 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.
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205.201(c) [Add new paragraph describing internal control systems.] 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, qualifications, 

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 massbalance audits; and

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

sanctions, and auditing are used to assess the compliance of all 

producer group members.
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205.400(g) [Add new paragraph describing eligibility criteria.] 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 § 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; 
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(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.

205.403(a) 

(2)

[Redesignate as § 205.403(a)(2) as (3); add new paragraph

describing inspection of producer groups.] 

Inspections of a producer group operation must:

(i) Assess the internal control system’s compliance, or ability to 

comply, with the requirements of § 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.

O. Calculating the Percentage of Organically Produced Ingredients

Section Former Text New Text

205.302(a)

(1)

Dividing the total net weight (excluding water and salt) of 

combined organic ingredients at formulation by the total 

weight (excluding water and salt) of the finished product.

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.
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205.302(a)

(2)

Dividing the fluid volume of all organic ingredients (excluding 

water and salt) by the fluid volume of the finished product 

(excluding water and salt) if the product and ingredients are 

liquid. If the liquid product is identified on the principal display 

panel or information panel as being reconstituted from 

concentrates, the calculation should be made on the basis of 

single-strength concentrations of the ingredients and finished 

product.

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.

205.302(a)

(3)

For products containing organically produced ingredients in 

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

solid ingredients and the weight of the liquid ingredients 

(excluding water and salt) by the total weight (excluding water 

and salt) of the finished product.

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.

P. Supply Chain Traceability and Organic Fraud Prevention

Section Former Text New Text

205.2 [Add new term.] 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)).”

205.2 [Add new term.] 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.
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205.103(b) 

(2)

Fully disclose all activities and transactions of the certified 

operation in sufficient detail as to be readily understood and 

audited;

Fully disclose all activities and transactions of the certified 

operation, in sufficient detail as to be readily understood and 

audited; records must span the time of purchase or acquisition, 

through production, to sale or transport and be traceable back 

to the last certified operation;

205.103(b) 

(3)

[Redesignate § 205.103(b)(3) and (4) as (4) and (5); add new 

paragraph (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;

205.201(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;

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;
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205.501(a) 

(10)

Maintain strict confidentiality with respect to its clients under 

the applicable organic certification program and not disclose 

to third parties (with the exception of 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 as provided 

for in §205.504(b)(5);

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.

205.501(a) 

(13)

Accept the certification decisions made by another certifying 

agent accredited or accepted by USDA pursuant to §205.500;

Accept the certification decisions made by another certifying 

agent accredited or accepted by USDA pursuant to § 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;
Unofficial Copy

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205.501(a) 

(21)

Comply with, implement, and carry out any other terms and 

conditions determined by the Administrator to be necessary.

[Redesignate as § 205.501(a)(23); add new paragraph (21)]

Conduct risk-based supply chain traceability audits as 

described in the criteria and procedures for supply chain 

audits, per § 205.504(b)(7), and share audit findings with other 

certifying agents as needed to determine compliance, per 

paragraph (a)(13) of this section.

205.504(b) 

(4)

A copy of the procedures to be used for maintaining the 

confidentiality of any business-related information as set forth 

in §205.501(a)(10);

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 § 205.501(a)(10);

205.504(b)

(7)

[Add new paragraph.] 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 § 205.501(a)(21); and procedures to 

report credible evidence of organic fraud to the Administrator.

Q. Technical Corrections

Section Former Text New Text

205.301(f)

(2)

Be produced using ionizing radiation, pursuant to §205.105(f); Be processed using ionizing radiation, pursuant to § 205.105(f);

205.301(f)

(3)

Be processed using sewage sludge, pursuant to §205.105(g); Be produced using sewage sludge, pursuant to § 205.105(g);

205.400(b) Establish, implement, and update annually an organic 

production or handling system plan that is submitted to an 

accredited certifying agent as provided for in §205.200;

Establish, implement, and update annually an organic 

production or handling system plan that is submitted to an 

accredited certifying agent as provided for in § 205.201;

205.401(a) An organic production or handling system plan, as required in 

§205.200;

An organic production or handling system plan, as required in § 

205.201;