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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 on-
site 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 mass-
balance audits; and
(10) Describe how internal monitoring, surveillance, inspection,
sanctions, and auditing are used to assess the compliance of all
producer group members.
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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;
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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;
