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Data is current as of June 10, 2008

Title 7: Agriculture

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PART 205—NATIONAL ORGANIC PROGRAM

Section
Contents

Subpart
A—Definitions

§ 205.1   Meaning
of words.

§ 205.2   Terms
defined.

Subpart
B—Applicability

§ 205.100   What
has to be certified.

§ 205.101   Exemptions
and exclusions from certification.

§ 205.102   Use
of the term, “organic.”

§ 205.103   Recordkeeping
by certified operations.

§ 205.104   [Reserved]

§ 205.105   Allowed
and prohibited substances, methods, and ingredients in organic production and
handling.

§§ 205.106-205.199   [Reserved]

Subpart
C—Organic Production and Handling Requirements

§ 205.200   General.

§ 205.201   Organic
production and handling system plan.

§ 205.202   Land
requirements.

§ 205.203   Soil
fertility and crop nutrient management practice standard.

§ 205.204   Seeds
and planting stock practice standard.

§ 205.205   Crop
rotation practice standard.

§ 205.206   Crop
pest, weed, and disease management practice standard.

§ 205.207   Wild-crop
harvesting practice standard.

§§ 205.208-205.235   [Reserved]

§ 205.236   Origin
of livestock.

§ 205.237   Livestock
feed.

§ 205.238   Livestock
health care practice standard.

§ 205.239   Livestock
living conditions.

§§ 205.240-205.269   [Reserved]

§ 205.270   Organic
handling requirements.

§ 205.271   Facility
pest management practice standard.

§ 205.272   Commingling
and contact with prohibited substance prevention practice standard.

§§ 205.273-205.289   [Reserved]

§ 205.290   Temporary
variances.

§§ 205.291-205.299   [Reserved]

Subpart
D—Labels, Labeling, and Market Information

§ 205.300   Use
of the term, “organic.”

§ 205.301   Product
composition.

§ 205.302   Calculating
the percentage of organically produced ingredients.

§ 205.303   Packaged
products labeled “100 percent organic” or “organic.”

§ 205.304   Packaged
products labeled “made with organic (specified ingredients or food group(s)).”

§ 205.305   Multi-ingredient
packaged products with less than 70 percent organically produced ingredients.

§ 205.306   Labeling
of livestock feed.

§ 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)).”

§ 205.308   Agricultural
products in other than packaged form at the point of retail sale that are sold,
labeled, or represented as “100 percent organic” or “organic.”

§ 205.309   Agricultural
products in other than packaged form at the point of retail sale that are sold,
labeled, or represented as “made with organic (specified ingredients or
food group(s)).”

§ 205.310   Agricultural
products produced on an exempt or excluded operation.

§ 205.311   USDA
Seal.

§§ 205.312-205.399   [Reserved]

Subpart
E—Certification

§ 205.400   General
requirements for certification.

§ 205.401   Application
for certification.

§ 205.402   Review
of application.

§ 205.403   On-site
inspections.

§ 205.404   Granting
certification.

§ 205.405   Denial
of certification.

§ 205.406   Continuation
of certification.

§§ 205.407-205.499   [Reserved]

Subpart
F—Accreditation of Certifying Agents

§ 205.500   Areas
and duration of accreditation.

§ 205.501   General
requirements for accreditation.

§ 205.502   Applying
for accreditation.

§ 205.503   Applicant
information.

§ 205.504   Evidence
of expertise and ability.

§ 205.505   Statement
of agreement.

§ 205.506   Granting
accreditation.

§ 205.507   Denial
of accreditation.

§ 205.508   Site
evaluations.

§ 205.509   Peer
review panel.

§ 205.510   Annual
report, recordkeeping, and renewal of accreditation.

§§ 205.511-205.599   [Reserved]

Subpart
G—Administrative

The
National List of Allowed and Prohibited Substances

§ 205.600   Evaluation
criteria for allowed and prohibited substances, methods, and ingredients.

§ 205.601   Synthetic
substances allowed for use in organic crop production.

§ 205.602   Nonsynthetic
substances prohibited for use in organic crop production.

§ 205.603   Synthetic
substances allowed for use in organic livestock production.

§ 205.604   Nonsynthetic
substances prohibited for use in organic livestock production.

§ 205.605   Nonagricultural
(nonorganic) substances allowed as ingredients in or on processed products labeled
as “organic” or “made with organic (specified ingredients or
food group(s)).”

§ 205.606   Nonorganically
produced agricultural products allowed as ingredients in or on processed products
labeled as “organic.”

§ 205.607   Amending
the National List.

§§ 205.608-205.619   [Reserved]

State
Organic Programs

§ 205.620   Requirements
of State organic programs.

§ 205.621   Submission
and determination of proposed State organic programs and amendments to
approved State organic programs.

§ 205.622   Review
of approved State organic programs.

§§ 205.623-205.639   [Reserved]

Fees

§ 205.640   Fees
and other charges for accreditation.

§ 205.641   Payment
of fees and other charges.

§ 205.642   Fees
and other charges for certification.

§§ 205.643-205.649   [Reserved]

Compliance

§ 205.660   General.

§ 205.661   Investigation
of certified operations.

§ 205.662   Noncompliance
procedure for certified operations.

§ 205.663   Mediation.

§ 205.664   [Reserved]

§ 205.665   Noncompliance
procedure for certifying agents.

§§ 205.666-205.667   [Reserved]

§ 205.668   Noncompliance
procedures under State organic programs.

§ 205.669   [Reserved]

Inspection
and Testing, Reporting, and Exclusion from Sale

§ 205.670   Inspection
and testing of agricultural product to be sold or labeled “organic.”

§ 205.671   Exclusion
from organic sale.

§ 205.672   Emergency
pest or disease treatment.

§§ 205.673-205.679   [Reserved]

Adverse
Action Appeal Process

§ 205.680   General.

§ 205.681   Appeals.

§§ 205.682-205.689   [Reserved]

Miscellaneous

§ 205.690   OMB
control number.

§§ 205.691-205.699   [Reserved]

Authority:   7
U.S.C. 6501–6522.

Source:   65 FR
80637, Dec. 21, 2000, unless otherwise noted.

Subpart A—Definitions

top

§ 205.1   Meaning
of words.

top

For the
purpose of the regulations in this subpart, words in the singular form shall
be deemed to impart the plural and vice versa, as the case may demand.

§ 205.2   Terms
defined.

top

Accreditation.
A
determination made by the Secretary that authorizes a private, foreign, or
State entity to conduct certification activities as a certifying agent under
this part.

Act. The Organic Foods
Production Act of 1990, as amended (7 U.S.C. 6501 et seq.).

Action
level. The
limit at or above which the Food and Drug Administration will take legal
action against a product to remove it from the market. Action levels are
based on unavoidability of the poisonous or deleterious substances and do not
represent permissible levels of contamination where it is avoidable.

Administrator.
The
Administrator for the Agricultural Marketing Service, United States Departure
of Agriculture, or the representative to whom authority has been delegated to
act in the stead of the Administrator.

Agricultural
inputs. All
substances or materials used in the production or handling of organic
agricultural products.

Agricultural
product. Any
agricultural commodity or product, whether raw or processed, including any
commodity or product derived from livestock, that is marketed in the United
States for human or livestock consumption.

Agricultural
Marketing Service (AMS). The Agricultural Marketing Service of the United States
Department of Agriculture.

Allowed
synthetic. A
substance that is included on the National List of synthetic substances
allowed for use in organic production or handling.

AMDUCA . The Animal
Medicinal Drug Use Clarification Act of 1994 (Pub. L. 103–396).

Animal
drug. Any
drug as defined in section 201 of the Federal Food, Drug, and Cosmetic Act,
as amended (21 U.S.C. 321), that is intended for use in livestock, including
any drug intended for use in livestock feed but not including such livestock
feed.

Annual
seedling. A
plant grown from seed that will complete its life cycle or produce a
harvestable yield within the same crop year or season in which it was
planted.

Area of
operation. The
types of operations: crops, livestock, wild-crop harvesting or handling, or
any combination thereof that a certifying agent may be accredited to certify
under this part.

Audit
trail. Documentation
that is sufficient to determine the source, transfer of ownership, and
transportation of any agricultural product labeled as “100 percent
organic,” the organic ingredients of any agricultural product labeled as
“organic” or “made with organic (specified ingredients)”
or the organic ingredients of any agricultural product containing less than
70 percent organic ingredients identified as organic in an ingredients
statement.

Biodegradable.
Subject
to biological decomposition into simpler biochemical or chemical components.

Biologics.
All
viruses, serums, toxins, and analogous products of natural or synthetic
origin, such as diagnostics, antitoxins, vaccines, live microorganisms,
killed microorganisms, and the antigenic or immunizing components of
microorganisms intended for use in the diagnosis, treatment, or prevention of
diseases of animals.

Breeder
stock. Female
livestock whose offspring may be incorporated into an organic operation at
the time of their birth.

Buffer
zone. An
area located between a certified production operation or portion of a
production operation and an adjacent land area that is not maintained under organic
management. A buffer zone must be sufficient in size or other features (e.g.,
windbreaks or a diversion ditch) to prevent the possibility of unintended
contact by prohibited substances applied to adjacent land areas with an area
that is part of a certified operation.

Bulk. The presentation to
consumers at retail sale of an agricultural product in unpackaged, loose
form, enabling the consumer to determine the individual pieces, amount, or
volume of the product purchased.

Certification
or certified. A
determination made by a certifying agent that a production or handling
operation is in compliance with the Act and the regulations in this part,
which is documented by a certificate of organic operation.

Certified
operation. A
crop or livestock production, wild-crop harvesting or handling operation, or
portion of such operation that is certified by an accredited certifying agent
as utilizing a system of organic production or handling as described by the
Act and the regulations in this part.

Certifying
agent. Any
entity accredited by the Secretary as a certifying agent for the purpose of
certifying a production or handling operation as a certified production or
handling operation.

Certifying
agent's operation. All
sites, facilities, personnel, and records used by a certifying agent to
conduct certification activities under the Act and the regulations in this
part.

Claims. Oral, written,
implied, or symbolic representations, statements, or advertising or other
forms of communication presented to the public or buyers of agricultural
products that relate to the organic certification process or the term, “100
percent organic,” “organic,” or “made with organic
(specified ingredients or food group(s)),” or, in the case of
agricultural products containing less than 70 percent organic ingredients,
the term, “organic,” on the ingredients panel.

Commercially
available. The
ability to obtain a production input in an appropriate form, quality, or
quantity to fulfill an essential function in a system of organic production
or handling, as determined by the certifying agent in the course of reviewing
the organic plan.

Commingling.
Physical
contact between unpackaged organically produced and nonorganically produced
agricultural products during production, processing, transportation, storage
or handling, other than during the manufacture of a multiingredient product
containing both types of ingredients.

Compost.
The
product of a managed process through which microorganisms break down plant
and animal materials into more available forms suitable for application to
the soil. Compost must be produced through a process that combines plant and
animal materials with an initial C:N ratio of between 25:1 and 40:1. Producers
using an in-vessel or static aerated pile system must maintain the composting
materials at a temperature between 131 °F and 170 °F for 3 days.
Producers using a windrow system must maintain the composting materials at a
temperature between 131 °F and 170 °F for 15 days, during which time,
the materials must be turned a minimum of five times.

Control.
Any
method that reduces or limits damage by populations of pests, weeds, or
diseases to levels that do not significantly reduce productivity.

Crop. A plant or part of a
plant intended to be marketed as an agricultural product or fed to livestock.

Crop
residues. The
plant parts remaining in a field after the harvest of a crop, which include
stalks, stems, leaves, roots, and weeds.

Crop
rotation. The
practice of alternating the annual crops grown on a specific field in a
planned pattern or sequence in successive crop years so that crops of the
same species or family are not grown repeatedly without interruption on the
same field. Perennial cropping systems employ means such as alley cropping,
intercropping, and hedgerows to introduce biological diversity in lieu of
crop rotation.

Crop
year. That
normal growing season for a crop as determined by the Secretary.

Cultivation.
Digging
up or cutting the soil to prepare a seed bed; control weeds; aerate the soil;
or work organic matter, crop residues, or fertilizers into the soil.

Cultural
methods. Methods
used to enhance crop health and prevent weed, pest, or disease problems
without the use of substances; examples include the selection of appropriate
varieties and planting sites; proper timing and density of plantings;
irrigation; and extending a growing season by manipulating the microclimate
with green houses, cold frames, or wind breaks.

Detectable
residue. The
amount or presence of chemical residue or sample component that can be
reliably observed or found in the sample matrix by current approved
analytical methodology.

Disease
vectors. Plants
or animals that harbor or transmit disease organisms or pathogens which may
attack crops or livestock.

Drift. The physical
movement of prohibited substances from the intended target site onto an
organic operation or portion thereof.

Emergency
pest or disease treatment program. A mandatory program authorized by a
Federal, State, or local agency for the purpose of controlling or eradicating
a pest or disease.

Employee.
Any
person providing paid or volunteer services for a certifying agent.

Excipients
.
Any ingredients that are intentionally added to livestock medications but do
not exert therapeutic or diagnostic effects at the intended dosage, although
they may act to improve product delivery (e.g., enhancing absorption or
controlling release of the drug substance). Examples of such ingredients
include fillers, extenders, diluents, wetting agents, solvents, emulsifiers,
preservatives, flavors, absorption enhancers, sustained-release matrices, and
coloring agents.

Excluded
methods. A
variety of methods used to genetically modify organisms or influence their
growth and development by means that are not possible under natural
conditions or processes and are not considered compatible with organic
production. Such methods include cell fusion, microencapsulation and
macroencapsulation, and recombinant DNA technology (including gene deletion,
gene doubling, introducing a foreign gene, and changing the positions of
genes when achieved by recombinant DNA technology). Such methods do not
include the use of traditional breeding, conjugation, fermentation,
hybridization, in vitro fertilization, or tissue culture.

Feed. Edible materials
which are consumed by livestock for their nutritional value. Feed may be
concentrates (grains) or roughages (hay, silage, fodder). The term, “feed,”
encompasses all agricultural commodities, including pasture ingested by
livestock for nutritional purposes.

Feed
additive. A
substance added to feed in micro quantities to fulfill a specific nutritional
need; i.e., essential nutrients in the form of amino acids, vitamins, and
minerals.

Feed
supplement. A
combination of feed nutrients added to livestock feed to improve the nutrient
balance or performance of the total ration and intended to be:

(1) Diluted
with other feeds when fed to livestock;

(2) Offered
free choice with other parts of the ration if separately available; or

(3) Further
diluted and mixed to produce a complete feed.

Fertilizer.
A
single or blended substance containing one or more recognized plant
nutrient(s) which is used primarily for its plant nutrient content and which
is designed for use or claimed to have value in promoting plant growth.

Field. An area of land
identified as a discrete unit within a production operation.

Forage. Vegetative material
in a fresh, dried, or ensiled state (pasture, hay, or silage), which is fed
to livestock.

Governmental
entity. Any
domestic government, tribal government, or foreign governmental subdivision
providing certification services.

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.

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.

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.

Immediate
family. The
spouse, minor children, or blood relatives who reside in the immediate
household of a certifying agent or an employee, inspector, contractor, or
other personnel of the certifying agent. For the purpose of this part, the
interest of a spouse, minor child, or blood relative who is a resident of the
immediate household of a certifying agent or an employee, inspector,
contractor, or other personnel of the certifying agent shall be considered to
be an interest of the certifying agent or an employee, inspector, contractor,
or other personnel of the certifying agent.

Inert
ingredient. Any
substance (or group of substances with similar chemical structures if
designated by the Environmental Protection Agency) other than an active
ingredient which is intentionally included in any pesticide product (40 CFR
152.3(m)).

Information
panel. That
part of the label of a packaged product that is immediately contiguous to and
to the right of the principal display panel as observed by an individual
facing the principal display panel, unless another section of the label is
designated as the information panel because of package size or other package
attributes (e.g., irregular shape with one usable surface).

Ingredient.
Any
substance used in the preparation of an agricultural product that is still
present in the final commercial product as consumed.

Ingredients
statement. The
list of ingredients contained in a product shown in their common and usual
names in the descending order of predominance.

Inspection.
The
act of examining and evaluating the production or handling operation of an
applicant for certification or certified operation to determine compliance
with the Act and the regulations in this part.

Inspector.
Any
person retained or used by a certifying agent to conduct inspections of
certification applicants or certified production or handling operations.

Label. A display of
written, printed, or graphic material on the immediate container of an
agricultural product or any such material affixed to any agricultural product
or affixed to a bulk container containing an agricultural product, except for
package liners or a display of written, printed, or graphic material which
contains only information about the weight of the product.

Labeling.
All
written, printed, or graphic material accompanying an agricultural product at
any time or written, printed, or graphic material about the agricultural product
displayed at retail stores about the product.

Livestock.
Any
cattle, sheep, goat, swine, poultry, or equine animals used for food or in
the production of food, fiber, feed, or other agricultural-based consumer
products; wild or domesticated game; or other nonplant life, except such term
shall not include aquatic animals or bees for the production of food, fiber,
feed, or other agricultural-based consumer products.

Lot. Any number of
containers which contain an agricultural product of the same kind located in
the same conveyance, warehouse, or packing house and which are available for
inspection at the same time.

Manure. Feces, urine, other
excrement, and bedding produced by livestock that has not been composted.

Market
information. Any
written, printed, audiovisual, or graphic information, including advertising,
pamphlets, flyers, catalogues, posters, and signs, distributed, broadcast, or
made available outside of retail outlets that are used to assist in the sale
or promotion of a product.

Mulch. Any nonsynthetic
material, such as wood chips, leaves, or straw, or any synthetic material
included on the National List for such use, such as newspaper or plastic that
serves to suppress weed growth, moderate soil temperature, or conserve soil
moisture.

Narrow range
oils. Petroleum
derivatives, predominately of paraffinic and napthenic fractions with 50
percent boiling point (10 mm Hg) between 415 °F and 440 °F.

National
List. A
list of allowed and prohibited substances as provided for in the Act.

National
Organic Program (NOP). The program authorized by the Act for the purpose of
implementing its provisions.

National
Organic Standards Board (NOSB). A board established by the Secretary under
7 U.S.C. 6518 to assist in the development of standards for substances to be
used in organic production and to advise the Secretary on any other aspects
of the implementation of the National Organic Program.

Natural
resources of the operation. The physical, hydrological, and biological
features of a production operation, including soil, water, wetlands,
woodlands, and wildlife.

Nonagricultural
substance. A
substance that is not a product of agriculture, such as a mineral or a
bacterial culture, that is used as an ingredient in an agricultural product.
For the purposes of this part, a nonagricultural ingredient also includes any
substance, such as gums, citric acid, or pectin, that is extracted from,
isolated from, or a fraction of an agricultural product so that the identity
of the agricultural product is unrecognizable in the extract, isolate, or
fraction.

Nonsynthetic
(natural). A
substance that is derived from mineral, plant, or animal matter and does not
undergo a synthetic process as defined in section 6502(21) of the Act (7
U.S.C. 6502(21)). For the purposes of this part, nonsynthetic is used as a
synonym for natural as the term is used in the Act.

Nonretail
container. Any
container used for shipping or storage of an agricultural product that is not
used in the retail display or sale of the product.

Nontoxic.
Not
known to cause any adverse physiological effects in animals, plants, humans,
or the environment.

Organic.
A
labeling term that refers to an agricultural product produced in accordance
with the Act and the regulations in this part.

Organic
matter. The
remains, residues, or waste products of any organism.

Organic
production. A
production system that is managed in accordance with the Act and regulations
in this part to respond to site-specific conditions by integrating cultural,
biological, and mechanical practices that foster cycling of resources,
promote ecological balance, and conserve biodiversity.

Organic
system plan. A
plan of management of an organic production or handling operation that has
been agreed to by the producer or handler and the certifying agent and that
includes written plans concerning all aspects of agricultural production or
handling described in the Act and the regulations in subpart C of this part.

Pasture.
Land
used for livestock grazing that is managed to provide feed value and maintain
or improve soil, water, and vegetative resources.

Peer
review panel. A
panel of individuals who have expertise in organic production and handling
methods and certification procedures and who are appointed by the
Administrator to assist in evaluating applicants for accreditation as
certifying agents.

Person. An individual,
partnership, corporation, association, cooperative, or other entity.

Pesticide.
Any
substance which alone, in chemical combination, or in any formulation with
one or more substances is defined as a pesticide in section 2(u) of the
Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136(u) et
seq ).

Petition.
A
request to amend the National List that is submitted by any person in
accordance with this part.

Planting
stock. Any
plant or plant tissue other than annual seedlings but including rhizomes,
shoots, leaf or stem cuttings, roots, or tubers, used in plant production or
propagation.

Practice
standard. The
guidelines and requirements through which a production or handling operation
implements a required component of its production or handling organic system
plan. A practice standard includes a series of allowed and prohibited
actions, materials, and conditions to establish a minimum level performance
for planning, conducting, and maintaining a function, such as livestock
health care or facility pest management, essential to an organic operation.

Principal
display panel. That
part of a label that is most likely to be displayed, presented, shown, or
examined under customary conditions of display for sale.

Private
entity. Any
domestic or foreign nongovernmental for-profit or not-for-profit organization
providing certification services.

Processing.
Cooking,
baking, curing, heating, drying, mixing, grinding, churning, separating,
extracting, slaughtering, cutting, fermenting, distilling, eviscerating,
preserving, dehydrating, freezing, chilling, or otherwise manufacturing and
includes the packaging, canning, jarring, or otherwise enclosing food in a
container.

Processing
aid. (1)
Substance that is added to a food during the processing of such food but is
removed in some manner from the food before it is packaged in its finished
form;

(2) a
substance that is added to a food during processing, is converted into
constituents normally present in the food, and does not significantly
increase the amount of the constituents naturally found in the food; and

(3) a
substance that is added to a food for its technical or functional effect in
the processing but is present in the finished food at insignificant levels
and does not have any technical or functional effect in that food.

Producer.
A
person who engages in the business of growing or producing food, fiber, feed,
and other agricultural-based consumer products.

Production
lot number/identifier. Identification of a product based on the production
sequence of the product showing the date, time, and place of production used
for quality control purposes.

Prohibited
substance. A
substance the use of which in any aspect of organic production or handling is
prohibited or not provided for in the Act or the regulations of this part.

Records.
Any
information in written, visual, or electronic form that documents the
activities undertaken by a producer, handler, or certifying agent to comply
with the Act and regulations in this part.

Residue
testing. An
official or validated analytical procedure that detects, identifies, and
measures the presence of chemical substances, their metabolites, or
degradations products in or on raw or processed agricultural products.

Responsibly
connected. Any
person who is a partner, officer, director, holder, manager, or owner of 10
percent or more of the voting stock of an applicant or a recipient of
certification or accreditation.

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.

Routine
use of parasiticide. The regular, planned, or periodic use of parasiticides.

Secretary.
The
Secretary of Agriculture or a representative to whom authority has been
delegated to act in the Secretary's stead.

Sewage
sludge. A
solid, semisolid, or liquid residue generated during the treatment of
domestic sewage in a treatment works. Sewage sludge includes but is not
limited to: domestic septage; scum or solids removed in primary, secondary,
or advanced wastewater treatment processes; and a material derived from
sewage sludge. Sewage sludge does not include ash generated during the firing
of sewage sludge in a sewage sludge incinerator or grit and screenings
generated during preliminary treatment of domestic sewage in a treatment
works.

Slaughter
stock. Any
animal that is intended to be slaughtered for consumption by humans or other
animals.

Soil and
water quality. Observable
indicators of the physical, chemical, or biological condition of soil and
water, including the presence of environmental contaminants.

Split
operation. An
operation that produces or handles both organic and nonorganic agricultural
products.

State. Any of the several
States of the United States of America, its territories, the District of
Columbia, and the Commonwealth of Puerto Rico.

State
certifying agent. A
certifying agent accredited by the Secretary under the National Organic
Program and operated by the State for the purposes of certifying organic
production and handling operations in the State.

State
organic program (SOP). A State program that meets the requirements of section
6506 of the Act, is approved by the Secretary, and is designed to ensure that
a product that is sold or labeled as organically produced under the Act is
produced and handled using organic methods.

State
organic program's governing State official. The chief executive
official of a State or, in the case of a State that provides for the
statewide election of an official to be responsible solely for the
administration of the agricultural operations of the State, such official who
administers a State organic certification program.

Synthetic.
A
substance that is formulated or manufactured by a chemical process or by a
process that chemically changes a substance extracted from naturally
occurring plant, animal, or mineral sources, except that such term shall not
apply to substances created by naturally occurring biological processes.

Tolerance.
The
maximum legal level of a pesticide chemical residue in or on a raw or
processed agricultural commodity or processed food.

Transplant.
A
seedling which has been removed from its original place of production,
transported, and replanted.

Unavoidable
residual environmental contamination (UREC). Background levels of
naturally occurring or synthetic chemicals that are present in the soil or
present in organically produced agricultural products that are below
established tolerances.

Wild
crop. Any
plant or portion of a plant that is collected or harvested from a site that
is not maintained under cultivation or other agricultural management.

[65 FR
80637, Dec. 21, 2000, as amended at 72 FR 70484, Dec. 12, 2007]

Subpart B—Applicability

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§ 205.100   What
has to be certified.

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(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.

(b) Any
production or handling operation or specified portion of a production or
handling operation that has been already certified by a certifying agent on
the date that the certifying agent receives its accreditation under this part
shall be deemed to be certified under the Act until the operation's next
anniversary date of certification. Such recognition shall only be available
to those operations certified by a certifying agent that receives its
accreditation within 18 months from February 20, 2001.

(c) Any
operation that:

(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 3.91(b)(1)(xxxvii)
of this title per violation.

(2) Makes a
false statement under the Act to the Secretary, a governing State official,
or an accredited certifying agent shall be subject to the provisions of
section 1001 of title 18, United States Code.

[65 FR
80637, Dec. 21, 2000, as amended at 70 FR 29579, May 24, 2005]

§ 205.101   Exemptions
and exclusions from certification.

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(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:

(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.

(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.

(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.

§ 205.102   Use
of the term, “organic.”

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Any
agricultural product that is sold, labeled, or represented as “100 percent
organic,” “organic,” or “made with organic (specified
ingredients or food group(s))” must be:

(a)
Produced in accordance with the requirements specified in §205.101 or
§§205.202 through 205.207 or §§205.236 through 205.239
and all other applicable requirements of part 205; and

(b) Handled
in accordance with the requirements specified in §205.101 or
§§205.270 through 205.272 and all other applicable requirements of
this part 205.

§ 205.103   Recordkeeping
by certified operations.

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(a) A
certified operation must maintain records concerning the production,
harvesting, and handling of agricultural products that are or that are
intended to be sold, labeled, or represented as “100 percent organic,”
“organic,” or “made with organic (specified ingredients or
food group(s)).”

(b) Such
records must:

(1) Be
adapted to the particular business that the certified operation is
conducting;

(2) Fully
disclose all activities and transactions of the certified operation in
sufficient detail as to be readily understood and audited;

(3) Be
maintained for not less than 5 years beyond their creation; and

(4) Be sufficient
to demonstrate compliance with the Act and the regulations in this part.

(c) The
certified operation must make such records available for inspection and
copying during normal business hours by authorized representatives of the
Secretary, the applicable State program's governing State official, and the
certifying agent.

§ 205.104   [Reserved]

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§ 205.105   Allowed
and prohibited substances, methods, and ingredients in organic production and
handling.

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To be sold
or labeled as “100 percent organic,” “organic,” or
“made with organic (specified ingredients or food group(s)),” the
product must be produced and handled without the use of:

(a)
Synthetic substances and ingredients, except as provided in §205.601 or
§205.603;

(b)
Nonsynthetic substances prohibited in §205.602 or §205.604;

(c)
Nonagricultural substances used in or on processed products, except as
otherwise provided in §205.605;

(d)
Nonorganic agricultural substances used in or on processed products, except
as otherwise provided in §205.606;

(e)
Excluded methods, except for vaccines: Provided, That, the vaccines
are approved in accordance with §205.600(a);

(f)
Ionizing radiation, as described in Food and Drug Administration regulation,
21 CFR 179.26; and

(g) Sewage
sludge.

§§ 205.106-205.199   [Reserved]

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Subpart C—Organic
Production and Handling Requirements

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§ 205.200   General.

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The
producer or handler of a production or handling operation intending to sell,
label, or represent agricultural products as “100 percent organic,”
“organic,” or “made with organic (specified ingredients or
food group(s))” must comply with the applicable provisions of this
subpart. Production practices implemented in accordance with this subpart
must maintain or improve the natural resources of the operation, including
soil and water quality.

§ 205.201   Organic
production and handling system plan.

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(a) The
producer or handler of a production or handling operation, except as exempt
or excluded under §205.101, intending to sell, label, or represent
agricultural products as “100 percent organic,”
“organic,” or “made with organic (specified ingredients or
food group(s))” must develop an organic production or handling system
plan that is agreed to by the producer or handler and an accredited
certifying agent. An organic system plan must meet the requirements set forth
in this section for organic production or handling. An organic production or
handling system plan must include:

(1) A
description of practices and procedures to be performed and maintained,
including the frequency with which they will be performed;

(2) A list
of each substance to be used as a production or handling input, indicating
its composition, source, location(s) where it will be used, and documentation
of commercial availability, as applicable;

(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;

(4) A
description of the recordkeeping system implemented to comply with the
requirements established in §205.103;

(5) A
description of the management practices and physical barriers established to
prevent commingling of organic and nonorganic products on a split operation
and to prevent contact of organic production and handling operations and
products with prohibited substances; and

(6)
Additional information deemed necessary by the certifying agent to evaluate
compliance with the regulations.

(b) A
producer may substitute a plan prepared to meet the requirements of another
Federal, State, or local government regulatory program for the organic system
plan: Provided, That, the submitted plan meets all the requirements of
this subpart.

§ 205.202   Land
requirements.

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Any field
or farm parcel from which harvested crops are intended to be sold, labeled,
or represented as “organic,” must:

(a) Have
been managed in accordance with the provisions of §§205.203 through
205.206;

(b) Have
had no prohibited substances, as listed in §205.105, applied to it for a
period of 3 years immediately preceding harvest of the crop; and

(c) Have
distinct, defined boundaries and buffer zones such as runoff diversions to
prevent the unintended application of a prohibited substance to the crop or
contact with a prohibited substance applied to adjoining land that is not
under organic management.

§ 205.203   Soil
fertility and crop nutrient management practice standard.

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(a) The
producer must select and implement tillage and cultivation practices that
maintain or improve the physical, chemical, and biological condition of soil
and minimize soil erosion.

(b) The
producer must manage crop nutrients and soil fertility through rotations,
cover crops, and the application of plant and animal materials.

(c) The
producer must manage plant and animal materials to maintain or improve soil
organic matter content in a manner that does not contribute to contamination
of crops, soil, or water by plant nutrients, pathogenic organisms, heavy
metals, or residues of prohibited substances. Animal and plant materials
include:

(1) Raw
animal manure, which must be composted unless it is:

(i) Applied
to land used for a crop not intended for human consumption;

(ii)
Incorporated into the soil not less than 120 days prior to the harvest of a
product whose edible portion has direct contact with the soil surface or soil
particles; or

(iii)
Incorporated into the soil not less than 90 days prior to the harvest of a
product whose edible portion does not have direct contact with the soil
surface or soil particles;

(2)
Composted plant and animal materials produced though a process that:

(i)
Established an initial C:N ratio of between 25:1 and 40:1; and

(ii)
Maintained a temperature of between 131 °F and 170 °F for 3 days
using an in-vessel or static aerated pile system; or

(iii)
Maintained a temperature of between 131 °F and 170 °F for 15 days
using a windrow composting system, during which period, the materials must be
turned a minimum of five times.

(3)
Uncomposted plant materials.

(d) A
producer may manage crop nutrients and soil fertility to maintain or improve
soil organic matter content in a manner that does not contribute to
contamination of crops, soil, or water by plant nutrients, pathogenic
organisms, heavy metals, or residues of prohibited substances by applying:

(1) A crop
nutrient or soil amendment included on the National List of synthetic
substances allowed for use in organic crop production;

(2) A mined
substance of low solubility;

(3) A mined
substance of high solubility: Provided, That, the substance is used in
compliance with the conditions established on the National List of
nonsynthetic materials prohibited for crop production;

(4) Ash
obtained from the burning of a plant or animal material, except as prohibited
in paragraph (e) of this section: Provided, That, the material burned
has not been treated or combined with a prohibited substance or the ash is
not included on the National List of nonsynthetic substances prohibited for
use in organic crop production; and

(5) A plant
or animal material that has been chemically altered by a manufacturing
process: Provided, That, the material is included on the National List
of synthetic substances allowed for use in organic crop production
established in §205.601.

(e) The
producer must not use:

(1) Any
fertilizer or composted plant and animal material that contains a synthetic
substance not included on the National List of synthetic substances allowed
for use in organic crop production;

(2) Sewage
sludge (biosolids) as defined in 40 CFR part 503; and (3) Burning as a means
of disposal for crop residues produced on the operation: Except, That,
burning may be used to suppress the spread of disease or to stimulate seed
germination.

§ 205.204   Seeds
and planting stock practice standard.

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(a) The
producer must use organically grown seeds, annual seedlings, and planting
stock: Except, That,

(1)
Nonorganically produced, untreated seeds and planting stock may be used to
produce an organic crop when an equivalent organically produced variety is
not commercially available: Except, That, organically produced seed
must be used for the production of edible sprouts;

(2)
Nonorganically produced seeds and planting stock that have been treated with
a substance included on the National List of synthetic substances allowed for
use in organic crop production may be used to produce an organic crop when an
equivalent organically produced or untreated variety is not commercially
available;

(3)
Nonorganically produced annual seedlings may be used to produce an organic
crop when a temporary variance has been granted in accordance with
§205.290(a)(2);

(4)
Nonorganically produced planting stock to be used to produce a perennial crop
may be sold, labeled, or represented as organically produced only after the
planting stock has been maintained under a system of organic management for a
period of no less than 1 year; and

(5) Seeds,
annual seedlings, and planting stock treated with prohibited substances may
be used to produce an organic crop when the application of the materials is a
requirement of Federal or State phytosanitary regulations.

(b)
[Reserved]

§ 205.205   Crop
rotation practice standard.

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The
producer must implement a crop rotation including but not limited to sod,
cover crops, green manure crops, and catch crops that provide the following
functions that are applicable to the operation:

(a)
Maintain or improve soil organic matter content;

(b) Provide
for pest management in annual and perennial crops;

(c) Manage
deficient or excess plant nutrients; and

(d) Provide
erosion control.

§ 205.206   Crop
pest, weed, and disease management practice standard.

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(a) The
producer must use management practices to prevent crop pests, weeds, and
diseases including but not limited to:

(1) Crop
rotation and soil and crop nutrient management practices, as provided for in
§§205.203 and 205.205;

(2)
Sanitation measures to remove disease vectors, weed seeds, and habitat for
pest organisms; and

(3)
Cultural practices that enhance crop health, including selection of plant
species and varieties with regard to suitability to site-specific conditions
and resistance to prevalent pests, weeds, and diseases.

(b) Pest
problems may be controlled through mechanical or physical methods including
but not limited to:

(1)
Augmentation or introduction of predators or parasites of the pest species;

(2)
Development of habitat for natural enemies of pests;

(3)
Nonsynthetic controls such as lures, traps, and repellents.

(c) Weed
problems may be controlled through:

(1)
Mulching with fully biodegradable materials;

(2) Mowing;

(3)
Livestock grazing;

(4) Hand
weeding and mechanical cultivation;

(5) Flame,
heat, or electrical means; or

(6) Plastic
or other synthetic mulches: Provided, That, they are removed from the
field at the end of the growing or harvest season.

(d) Disease
problems may be controlled through:

(1)
Management practices which suppress the spread of disease organisms; or

(2)
Application of nonsynthetic biological, botanical, or mineral inputs.

(e) When
the practices provided for in paragraphs (a) through (d) of this section are
insufficient to prevent or control crop pests, weeds, and diseases, a
biological or botanical substance or a substance included on the National
List of synthetic substances allowed for use in organic crop production may
be applied to prevent, suppress, or control pests, weeds, or diseases: Provided,
That, the conditions for using the substance are documented in the
organic system plan.

(f) The
producer must not use lumber treated with arsenate or other prohibited
materials for new installations or replacement purposes in contact with soil
or livestock.

§ 205.207   Wild-crop
harvesting practice standard.

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(a) A wild
crop that is intended to be sold, labeled, or represented as organic must be
harvested from a designated area that has had no prohibited substance, as set
forth in §205.105, applied to it for a period of 3 years immediately
preceding the harvest of the wild crop.

(b) A wild
crop must be harvested in a manner that ensures that such harvesting or
gathering will not be destructive to the environment and will sustain the
growth and production of the wild crop.

§§ 205.208-205.235   [Reserved]

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§ 205.236   Origin
of livestock.

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(a)
Livestock products that are to be sold, labeled, or represented as organic
must be from livestock under continuous organic management from the last
third of gestation or hatching: Except, That:

(1) Poultry.
Poultry or edible poultry products must be from poultry that has been
under continuous organic management beginning no later than the second day of
life;

(2) Dairy
animals. Milk or milk products must be from animals that have been under
continuous organic management beginning no later than 1 year prior to the
production of the milk or milk products that are to be sold, labeled, or
represented as organic, Except,

(i) That,
crops and forage from land, included in the organic system plan of a dairy
farm, that is in the third year of organic management may be consumed by the
dairy animals of the farm during the 12-month period immediately prior to the
sale of organic milk and milk products; and

(ii) That,
when an entire, distinct herd is converted to organic production, the
producer may, provided no milk produced under this subparagraph enters
the stream of commerce labeled as organic after June 9, 2007: (a) For the
first 9 months of the year, provide a minimum of 80-percent feed that is
either organic or raised from land included in the organic system plan and
managed in compliance with organic crop requirements; and (b) Provide feed in
compliance with §205.237 for the final 3 months.

(iii) Once
an entire, distinct herd has been converted to organic production, all dairy
animals shall be under organic management from the last third of gestation.

(3) Breeder
stock. Livestock used as breeder stock may be brought from a nonorganic
operation onto an organic operation at any time: Provided, That, if
such livestock are gestating and the offspring are to be raised as organic
livestock, the breeder stock must be brought onto the facility no later than
the last third of gestation.

(b) The
following are prohibited:

(1)
Livestock or edible livestock products that are removed from an organic
operation and subsequently managed on a nonorganic operation may be not sold,
labeled, or represented as organically produced.

(2) Breeder
or dairy stock that has not been under continuous organic management since
the last third of gestation may not be sold, labeled, or represented as
organic slaughter stock.

(c) The
producer of an organic livestock operation must maintain records sufficient
to preserve the identity of all organically managed animals and edible and
nonedible animal products produced on the operation.

[65 FR
80637, Dec. 21, 2000, as amended at 71 FR 32807, June 7, 2006]

§ 205.237   Livestock
feed.

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(a) The
producer of an organic livestock operation must provide livestock with a
total feed ration composed of agricultural products, including pasture and
forage, that are organically produced and, if applicable, organically handled:
Except, That, nonsynthetic substances and synthetic substances allowed
under §205.603 may be used as feed additives and supplements.

(b) The
producer of an organic operation must not:

(1) Use
animal drugs, including hormones, to promote growth;

(2) Provide
feed supplements or additives in amounts above those needed for adequate
nutrition and health maintenance for the species at its specific stage of
life;

(3) Feed
plastic pellets for roughage;

(4) Feed
formulas containing urea or manure;

(5) Feed mammalian
or poultry slaughter by-products to mammals or poultry; or

(6) Use
feed, feed additives, and feed supplements in violation of the Federal Food,
Drug, and Cosmetic Act.

§ 205.238   Livestock
health care practice standard.

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(a) The
producer must establish and maintain preventive livestock health care
practices, including:

(1)
Selection of species and types of livestock with regard to suitability for
site-specific conditions and resistance to prevalent diseases and parasites;

(2)
Provision of a feed ration sufficient to meet nutritional requirements,
including vitamins, minerals, protein and/or amino acids, fatty acids, energy
sources, and fiber (ruminants);

(3)
Establishment of appropriate housing, pasture conditions, and sanitation
practices to minimize the occurrence and spread of diseases and parasites;

(4)
Provision of conditions which allow for exercise, freedom of movement, and
reduction of stress appropriate to the species;

(5)
Performance of physical alterations as needed to promote the animal's welfare
and in a manner that minimizes pain and stress; and

(6)
Administration of vaccines and other veterinary biologics.

(b) When
preventive practices and veterinary biologics are inadequate to prevent
sickness, a producer may administer synthetic medications: Provided, That,
such medications are allowed under §205.603. Parasiticides allowed under
§205.603 may be used on:

(1) Breeder
stock, when used prior to the last third of gestation but not during
lactation for progeny that are to be sold, labeled, or represented as
organically produced; and

(2) Dairy
stock, when used a minimum of 90 days prior to the production of milk or milk
products that are to be sold, labeled, or represented as organic.

(c) The
producer of an organic livestock operation must not:

(1) Sell,
label, or represent as organic any animal or edible product derived from any
animal treated with antibiotics, any substance that contains a synthetic
substance not allowed under §205.603, or any substance that contains a
nonsynthetic substance prohibited in §205.604.

(2)
Administer any animal drug, other than vaccinations, in the absence of
illness;

(3)
Administer hormones for growth promotion;

(4)
Administer synthetic parasiticides on a routine basis;

(5)
Administer synthetic parasiticides to slaughter stock;

(6)
Administer animal drugs in violation of the Federal Food, Drug, and Cosmetic
Act; or

(7)
Withhold medical treatment from a sick animal in an effort to preserve its
organic status. All appropriate medications must be used to restore an animal
to health when methods acceptable to organic production fail. Livestock
treated with a prohibited substance must be clearly identified and shall not
be sold, labeled, or represented as organically produced.

§ 205.239   Livestock
living conditions.

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(a) The
producer of an organic livestock operation must establish and maintain
livestock living conditions which accommodate the health and natural behavior
of animals, including:

(1) Access
to the outdoors, shade, shelter, exercise areas, fresh air, and direct
sunlight suitable to the species, its stage of production, the climate, and
the environment;

(2) Access
to pasture for ruminants;

(3)
Appropriate clean, dry bedding. If the bedding is typically consumed by the
animal species, it must comply with the feed requirements of §205.237;

(4) Shelter
designed to allow for:

(i) Natural
maintenance, comfort behaviors, and opportunity to exercise;

(ii)
Temperature level, ventilation, and air circulation suitable to the species;
and

(iii)
Reduction of potential for livestock injury;

(b) The
producer of an organic livestock operation may provide temporary confinement
for an animal because of:

(1)
Inclement weather;

(2) The
animal's stage of production;

(3)
Conditions under which the health, safety, or well being of the animal could
be jeopardized; or

(4) Risk to
soil or water quality.

(c) The
producer of an organic livestock operation must manage manure in a manner
that does not contribute to contamination of crops, soil, or water by plant
nutrients, heavy metals, or pathogenic organisms and optimizes recycling of
nutrients.

§§ 205.240-205.269   [Reserved]

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§ 205.270   Organic
handling requirements.

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(a)
Mechanical or biological methods, including but not limited to cooking,
baking, curing, heating, drying, mixing, grinding, churning, separating,
distilling, extracting, slaughtering, cutting, fermenting, eviscerating,
preserving, dehydrating, freezing, chilling, or otherwise manufacturing, and
the packaging, canning, jarring, or otherwise enclosing food in a container
may be used to process an organically produced agricultural product for the
purpose of retarding spoilage or otherwise preparing the agricultural product
for market.

(b)
Nonagricultural substances allowed under §205.605 and nonorganically
produced agricultural products allowed under §205.606 may be used:

(1) In or
on a processed agricultural product intended to be sold, labeled, or represented
as “organic,” pursuant to §205.301(b), if not commercially
available in organic form.

(2) In or
on a processed agricultural product intended to be sold, labeled, or
represented as “made with organic (specified ingredients or food
group(s)),” pursuant to §205.301(c).

(c) The
handler of an organic handling operation must not use in or on agricultural
products intended to be sold, labeled, or represented as “100 percent
organic,” “organic,” or “made with organic (specified
ingredients or food group(s)),” or in or on any ingredients labeled as
organic:

(1)
Practices prohibited under paragraphs (e) and (f) of §205.105.

(2) A
volatile synthetic solvent or other synthetic processing aid not allowed
under §205.605: Except, That, nonorganic ingredients in products
labeled “made with organic (specified ingredients or food group(s))”
are not subject to this requirement.

§ 205.271   Facility
pest management practice standard.

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(a) The
producer or handler of an organic facility must use management practices to
prevent pests, including but not limited to:

(1) Removal
of pest habitat, food sources, and breeding areas;

(2)
Prevention of access to handling facilities; and

(3)
Management of environmental factors, such as temperature, light, humidity,
atmosphere, and air circulation, to prevent pest reproduction.

(b) Pests
may be controlled through:

(1)
Mechanical or physical controls including but not limited to traps, light, or
sound; or

(2) Lures
and repellents using nonsynthetic or synthetic substances consistent with the
National List.

(c) If the
practices provided for in paragraphs (a) and (b) of this section are not
effective to prevent or control pests, a nonsynthetic or synthetic substance
consistent with the National List may be applied.

(d) If the
practices provided for in paragraphs (a), (b), and (c) of this section are
not effective to prevent or control facility pests, a synthetic substance not
on the National List may be applied: Provided, That, the handler and
certifying agent agree on the substance, method of application, and measures
to be taken to prevent contact of the organically produced products or
ingredients with the substance used.

(e) The
handler of an organic handling operation who applies a nonsynthetic or
synthetic substance to prevent or control pests must update the operation's
organic handling plan to reflect the use of such substances and methods of
application. The updated organic plan must include a list of all measures
taken to prevent contact of the organically produced products or ingredients
with the substance used.

(f)
Notwithstanding the practices provided for in paragraphs (a), (b), (c), and
(d) of this section, a handler may otherwise use substances to prevent or
control pests as required by Federal, State, or local laws and regulations: Provided,
That, measures are taken to prevent contact of the organically produced
products or ingredients with the substance used.

§ 205.272   Commingling
and contact with prohibited substance prevention practice standard.

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(a) The
handler of an organic handling operation must implement measures necessary to
prevent the commingling of organic and nonorganic products and protect organic
products from contact with prohibited substances.

(b) The
following are prohibited for use in the handling of any organically produced
agricultural product or ingredient labeled in accordance with subpart D of
this part:

(1)
Packaging materials, and storage containers, or bins that contain a synthetic
fungicide, preservative, or fumigant;

(2) The use
or reuse of any bag or container that has been in contact with any substance
in such a manner as to compromise the organic integrity of any organically
produced product or ingredient placed in those containers, unless such
reusable bag or container has been thoroughly cleaned and poses no risk of
contact of the organically produced product or ingredient with the substance
used.

§§ 205.273-205.289   [Reserved]

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§ 205.290   Temporary
variances.

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(a)
Temporary variances from the requirements in §§205.203 through
205.207, 205.236 through 205.239, and 205.270 through 205.272 may be
established by the Administrator for the following reasons:

(1) Natural
disasters declared by the Secretary;

(2) Damage
caused by drought, wind, flood, excessive moisture, hail, tornado,
earthquake, fire, or other business interruption; and

(3)
Practices used for the purpose of conducting research or trials of
techniques, varieties, or ingredients used in organic production or handling.

(b) A State
organic program's governing State official or certifying agent may recommend
in writing to the Administrator that a temporary variance from a standard set
forth in subpart C of this part for organic production or handling operations
be established: Provided, That, such variance is based on one or more
of the reasons listed in paragraph (a) of this section.

(c) The
Administrator will provide written notification to certifying agents upon
establishment of a temporary variance applicable to the certifying agent's
certified production or handling operations and specify the period of time it
shall remain in effect, subject to extension as the Administrator deems necessary.

(d) A
certifying agent, upon notification from the Administrator of the
establishment of a temporary variance, must notify each production or
handling operation it certifies to which the temporary variance applies.

(e)
Temporary variances will not be granted for any practice, material, or
procedure prohibited under §205.105.

§§ 205.291-205.299   [Reserved]

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Subpart D—Labels,
Labeling, and Market Information

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§ 205.300   Use
of the term, “organic.”

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(a) The
term, “organic,” may only be used on labels and in labeling of raw
or processed agricultural products, including ingredients, that have been
produced and handled in accordance with the regulations in this part. The
term, “organic,” may not be used in a product name to modify a
nonorganic ingredient in the product.

(b)
Products for export, produced and certified to foreign national organic standards
or foreign contract buyer requirements, may be labeled in accordance with the
organic labeling requirements of the receiving country or contract buyer: Provided,
That, the shipping containers and shipping documents meet the labeling
requirements specified in §205.307(c).

(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.

(d)
Livestock feeds produced in accordance with the requirements of this part
must be labeled in accordance with the requirements of §205.306.

§ 205.301   Product
composition.

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(a) Products
sold, labeled, or represented as “100 percent organic.” A raw
or processed agricultural product sold, labeled, or represented as “100
percent organic” must contain (by weight or fluid volume, excluding
water and salt) 100 percent organically produced ingredients. If labeled as
organically produced, such product must be labeled pursuant to §205.303.

(b) Products
sold, labeled, or represented as “organic.” A raw or processed
agricultural product sold, labeled, or represented as “organic”
must contain (by weight or fluid volume, excluding water and salt) not less
than 95 percent organically produced raw or processed agricultural products.
Any remaining product ingredients must be organically produced, unless not
commercially available in organic form, or must be nonagricultural substances
or nonorganically produced agricultural products produced consistent with the
National List in subpart G of this part. If labeled as organically produced,
such product must be labeled pursuant to §205.303.

(c) Products
sold, labeled, or represented as “made with organic (specified
ingredients or food group(s)).” Multiingredient agricultural product
sold, labeled, or represented as “made with organic (specified
ingredients or food group(s))” must contain (by weight or fluid volume,
excluding water and salt) at least 70 percent organically produced
ingredients which are produced and handled pursuant to requirements in
subpart C of this part. No ingredients may be produced using prohibited
practices specified in paragraphs (f)(1), (2), and (3) of §205.301. Nonorganic
ingredients may be produced without regard to paragraphs (f)(4), (5), (6),
and (7) of §205.301. If labeled as containing organically produced
ingredients or food groups, such product must be labeled pursuant to
§205.304.

(d) Products
with less than 70 percent organically produced ingredients. The organic
ingredients in multiingredient agricultural product containing less than 70
percent organically produced ingredients (by weight or fluid volume,
excluding water and salt) must be produced and handled pursuant to
requirements in subpart C of this part. The nonorganic ingredients may be
produced and handled without regard to the requirements of this part.
Multiingredient agricultural product containing less than 70 percent
organically produced ingredients may represent the organic nature of the
product only as provided in §205.305.

(e) Livestock
feed. (1) A raw or processed livestock feed product sold, labeled, or
represented as “100 percent organic” must contain (by weight or
fluid volume, excluding water and salt) not less than 100 percent organically
produced raw or processed agricultural product.

(2) A raw
or processed livestock feed product sold, labeled, or represented as “organic”
must be produced in conformance with §205.237.

(f) All
products labeled as “100 percent organic” or “organic”
and all ingredients identified as “organic” in the ingredient
statement of any product must not:

(1) Be
produced using excluded methods, pursuant to §201.105(e) of this
chapter;

(2) Be
produced using sewage sludge, pursuant to §201.105(f) of this chapter;

(3) Be
processed using ionizing radiation, pursuant to §201.105(g) of this
chapter;

(4) Be
processed using processing aids not approved on the National List of Allowed
and Prohibited Substances in subpart G of this part: Except, That, products
labeled as “100 percent organic,” if processed, must be processed
using organically produced processing aids;

(5) Contain
sulfites, nitrates, or nitrites added during the production or handling
process, Except, that, wine containing added sulfites may be labeled “made
with organic grapes”;

(6) Be
produced using nonorganic ingredients when organic ingredients are available;
or

(7) Include
organic and nonorganic forms of the same ingredient.

§ 205.302   Calculating
the percentage of organically produced ingredients.

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(a) The
percentage of all organically produced ingredients in an agricultural product
sold, labeled, or represented as “100 percent organic,”
“organic,” or “made with organic (specified ingredients or
food group(s)),” or that include organic ingredients must be calculated
by:

(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.

(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.

(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.

(b) The
percentage of all organically produced ingredients in an agricultural product
must be rounded down to the nearest whole number.

(c) The
percentage must be determined by the handler who affixes the label on the
consumer package and verified by the certifying agent of the handler. The
handler may use information provided by the certified operation in
determining the percentage.

§ 205.303   Packaged
products labeled “100 percent organic” or “organic.”

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(a)
Agricultural products in packages described in §205.301(a) and (b) may
display, on the principal display panel, information panel, and any other
panel of the package and on any labeling or market information concerning the
product, the following:

(1) The
term, “100 percent organic” or “organic,” as applicable,
to modify the name of the product;

(2) For
products labeled “organic,” the percentage of organic ingredients
in the product; (The size of the percentage statement must not exceed
one-half the size of the largest type size on the panel on which the
statement is displayed and must appear in its entirety in the same type size,
style, and color without highlighting.)

(3) The term,
“organic,” to identify the organic ingredients in multiingredient
products labeled “100 percent organic”;

(4) The
USDA seal; and/or

(5) The
seal, logo, or other identifying mark of the certifying agent which certified
the production or handling operation producing the finished product and any
other certifying agent which certified production or handling operations
producing raw organic product or organic ingredients used in the finished
product: Provided, That, the handler producing the finished product maintain
records, pursuant to this part, verifying organic certification of the
operations producing such ingredients, and: Provided further, That,
such seals or marks are not individually displayed more prominently than the
USDA seal.

(b)
Agricultural products in packages described in §205.301(a) and (b) must:

(1) For
products labeled “organic,” identify each organic ingredient in the
ingredient statement with the word, “organic,” or with an asterisk
or other reference mark which is defined below the ingredient statement to
indicate the ingredient is organically produced. Water or salt included as
ingredients cannot be identified as organic.

(2) On the
information panel, below the information identifying the handler or
distributor of the product and preceded by the statement, “Certified
organic by  *  *  *,” or similar phrase,
identify the name of the certifying agent that certified the handler of the
finished product and may display the business address, Internet address, or
telephone number of the certifying agent in such label.

§ 205.304   Packaged
products labeled “made with organic (specified ingredients or food
group(s)).”

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(a)
Agricultural products in packages described in §205.301(c) may display
on the principal display panel, information panel, and any other panel and on
any labeling or market information concerning the product:

(1) The
statement:

(i) “Made
with organic (specified ingredients)”: Provided, That, the
statement does not list more than three organically produced ingredients; or

(ii) “Made
with organic (specified food groups)”: Provided, That, the
statement does not list more than three of the following food groups: beans,
fish, fruits, grains, herbs, meats, nuts, oils, poultry, seeds, spices,
sweeteners, and vegetables or processed milk products; and, Provided
further, That, all ingredients of each listed food group in the product
must be organically produced; and

(iii) Which
appears in letters that do not exceed one-half the size of the largest type
size on the panel and which appears in its entirety in the same type size,
style, and color without highlighting.

(2) The
percentage of organic ingredients in the product. The size of the percentage
statement must not exceed one-half the size of the largest type size on the
panel on which the statement is displayed and must appear in its entirety in
the same type size, style, and color without highlighting.

(3) The
seal, logo, or other identifying mark of the certifying agent that certified
the handler of the finished product.

(b)
Agricultural products in packages described in §205.301(c) must:

(1) In the
ingredient statement, identify each organic ingredient with the word, “organic,”
or with an asterisk or other reference mark which is defined below the
ingredient statement to indicate the ingredient is organically produced.
Water or salt included as ingredients cannot be identified as organic.

(2) On the
information panel, below the information identifying the handler or
distributor of the product and preceded by the statement, “Certified
organic by  *  *  *,” or similar phrase,
identify the name of the certifying agent that certified the handler of the
finished product: Except, That, the business address, Internet
address, or telephone number of the certifying agent may be included in such
label.

(c)
Agricultural products in packages described in §205.301(c) must not
display the USDA seal.

§ 205.305   Multi-ingredient
packaged products with less than 70 percent organically produced ingredients.

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(a) An
agricultural product with less than 70 percent organically produced
ingredients may only identify the organic content of the product by:

(1)
Identifying each organically produced ingredient in the ingredient statement
with the word, “organic,” or with an asterisk or other reference
mark which is defined below the ingredient statement to indicate the
ingredient is organically produced, and

(2) If the
organically produced ingredients are identified in the ingredient statement,
displaying the product's percentage of organic contents on the information
panel.

(b)
Agricultural products with less than 70 percent organically produced
ingredients must not display:

(1) The
USDA seal; and

(2) Any
certifying agent seal, logo, or other identifying mark which represents
organic certification of a product or product ingredients.

§ 205.306   Labeling
of livestock feed.

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(a)
Livestock feed products described in §205.301(e)(1) and (e)(2) may
display on any package panel the following terms:

(1) The
statement, “100 percent organic” or “organic,” as
applicable, to modify the name of the feed product;

(2) The
USDA seal;

(3) The
seal, logo, or other identifying mark of the certifying agent which certified
the production or handling operation producing the raw or processed organic
ingredients used in the finished product, Provided, That, such seals
or marks are not displayed more prominently than the USDA seal;

(4) The
word, “organic,” or an asterisk or other reference mark which is
defined on the package to identify ingredients that are organically produced.
Water or salt included as ingredients cannot be identified as organic.

(b)
Livestock feed products described in §205.301(e)(1) and (e)(2) must:

(1) On the
information panel, below the information identifying the handler or
distributor of the product and preceded by the statement, “Certified
organic by  *  *  *,” or similar phrase,
display the name of the certifying agent that certified the handler of the
finished product. The business address, Internet address, or telephone number
of the certifying agent may be included in such label.

(2) Comply
with other Federal agency or State feed labeling requirements as applicable.

§ 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)).”

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(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.

(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.

(c)
Shipping containers of domestically produced product labeled as organic
intended for export to international markets may be labeled in accordance
with any shipping container labeling requirements of the foreign country of
destination or the container labeling specifications of a foreign contract
buyer: Provided, That, the shipping containers and shipping documents
accompanying such organic products are clearly marked “For Export
Only” and: Provided further, That, proof of such container
marking and export must be maintained by the handler in accordance with
recordkeeping requirements for exempt and excluded operations under
§205.101.

§ 205.308   Agricultural
products in other than packaged form at the point of retail sale that are
sold, labeled, or represented as “100 percent organic” or
“organic.”

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(a)
Agricultural products in other than packaged form may use the term, “100
percent organic” or “organic,” as applicable, to modify the
name of the product in retail display, labeling, and display containers: Provided,
That, the term, “organic,” is used to identify the organic
ingredients listed in the ingredient statement.

(b) If the
product is prepared in a certified facility, the retail display, labeling,
and display containers may use:

(1) The
USDA seal; and

(2) The
seal, logo, or other identifying mark of the certifying agent that certified the
production or handling operation producing the finished product and any other
certifying agent which certified operations producing raw organic product or
organic ingredients used in the finished product: Provided, That, such
seals or marks are not individually displayed more prominently than the USDA
seal.

§ 205.309   Agricultural
products in other than packaged form at the point of retail sale that are
sold, labeled, or represented as “made with organic (specified
ingredients or food group(s)).”

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(a)
Agricultural products in other than packaged form containing between 70 and
95 percent organically produced ingredients may use the phrase, “made
with organic (specified ingredients or food group(s)),” to modify the
name of the product in retail display, labeling, and display containers.

(1) Such
statement must not list more than three organic ingredients or food groups,
and

(2) In any
such display of the product's ingredient statement, the organic ingredients
are identified as “organic.”

(b) If
prepared in a certified facility, such agricultural products labeled as “made
with organic (specified ingredients or food group(s))” in retail
displays, display containers, and market information may display the
certifying agent's seal, logo, or other identifying mark.

§ 205.310   Agricultural
products produced on an exempt or excluded operation.

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(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.

(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
multiingredient 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.

(c) Such
product is subject to requirements specified in paragraph (a) of
§205.300, and paragraphs (f)(1) through (f)(7) of §205.301.

§ 205.311   USDA
Seal.

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(a) The
USDA seal described in paragraphs (b) and (c) of this section may be used
only for raw or processed agricultural products described in paragraphs (a),
(b), (e)(1), and (e)(2) of §205.301.

(b) The
USDA seal must replicate the form and design of the example in figure 1 and
must be printed legibly and conspicuously:

(1) On a
white background with a brown outer circle and with the term, “USDA,”
in green overlaying a white upper semicircle and with the term, “organic,”
in white overlaying the green lower half circle; or

(2) On a
white or transparent background with black outer circle and black “USDA”
on a white or transparent upper half of the circle with a contrasting white
or transparent “organic” on the black lower half circle.

(3) The
green or black lower half circle may have four light lines running from left
to right and disappearing at the point on the right horizon to resemble a
cultivated field.

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§§ 205.312-205.399   [Reserved]

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Subpart E—Certification

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§ 205.400   General
requirements for certification.

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A person
seeking to receive or maintain organic certification under the regulations in
this part must:

(a) Comply
with the Act and applicable organic production and handling regulations of
this part;

(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;

(c) Permit
on-site inspections with complete access to the production or handling
operation, including noncertified production and handling areas, structures,
and offices by the certifying agent as provided for in §205.403;

(d)
Maintain all records applicable to the organic operation for not less than 5
years beyond their creation and allow authorized representatives of the
Secretary, the applicable State organic program's governing State official,
and the certifying agent access to such records during normal business hours
for review and copying to determine compliance with the Act and the
regulations in this part, as provided for in §205.104;

(e) Submit
the applicable fees charged by the certifying agent; and

(f)
Immediately notify the certifying agent concerning any:

(1)
Application, including drift, of a prohibited substance to any field,
production unit, site, facility, livestock, or product that is part of an
operation; and

(2) Change
in a certified operation or any portion of a certified operation that may
affect its compliance with the Act and the regulations in this part.

§ 205.401   Application
for certification.

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A person
seeking certification of a production or handling operation under this
subpart must submit an application for certification to a certifying agent. The
application must include the following information:

(a) An
organic production or handling system plan, as required in §205.200;

(b) The
name of the person completing the application; the applicant's business name,
address, and telephone number; and, when the applicant is a corporation, the
name, address, and telephone number of the person authorized to act on the
applicant's behalf;

(c) The
name(s) of any organic certifying agent(s) to which application has
previously been made; the year(s) of application; the outcome of the
application(s) submission, including, when available, a copy of any
notification of noncompliance or denial of certification issued to the
applicant for certification; and a description of the actions taken by the
applicant to correct the noncompliances noted in the notification of
noncompliance, including evidence of such correction; and

(d) Other
information necessary to determine compliance with the Act and the
regulations in this part.

§ 205.402   Review
of application.

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(a) Upon
acceptance of an application for certification, a certifying agent must:

(1) Review
the application to ensure completeness pursuant to §205.401;

(2)
Determine by a review of the application materials whether the applicant
appears to comply or may be able to comply with the applicable requirements
of subpart C of this part;

(3) Verify
that an applicant who previously applied to another certifying agent and
received a notification of noncompliance or denial of certification, pursuant
to §205.405, has submitted documentation to support the correction of
any noncompliances identified in the notification of noncompliance or denial
of certification, as required in §205.405(e); and

(4)
Schedule an on-site inspection of the operation to determine whether the
applicant qualifies for certification if the review of application materials
reveals that the production or handling operation may be in compliance with
the applicable requirements of subpart C of this part.

(b) The
certifying agent shall within a reasonable time:

(1) Review
the application materials received and communicate its findings to the
applicant;

(2) Provide
the applicant with a copy of the on-site inspection report, as approved by
the certifying agent, for any on-site inspection performed; and

(3) Provide
the applicant with a copy of the test results for any samples taken by an
inspector.

(c) The
applicant may withdraw its application at any time. An applicant who
withdraws its application shall be liable for the costs of services provided
up to the time of withdrawal of its application. An applicant that
voluntarily withdrew its application prior to the issuance of a notice of
noncompliance will not be issued a notice of noncompliance. Similarly, an
applicant that voluntarily withdrew its application prior to the issuance of
a notice of certification denial will not be issued a notice of certification
denial.

§ 205.403   On-site
inspections.

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(a) On-site
inspections. (1) A certifying agent must conduct an initial on-site
inspection of each production unit, facility, and site that produces or
handles organic products and that is included in an operation for which
certification is requested. An on-site inspection shall be conducted annually
thereafter for each certified operation that produces or handles organic
products for the purpose of determining whether to approve the request for
certification or whether the certification of the operation should continue.

(2) (i) A
certifying agent may conduct additional on-site inspections of applicants for
certification and certified operations to determine compliance with the Act
and the regulations in this part.

(ii) The
Administrator or State organic program's governing State official may require
that additional inspections be performed by the certifying agent for the
purpose of determining compliance with the Act and the regulations in this
part.

(iii)
Additional inspections may be announced or unannounced at the discretion of
the certifying agent or as required by the Administrator or State organic
program's governing State official.

(b) Scheduling.
(1) The initial on-site inspection must be conducted within a reasonable
time following a determination that the applicant appears to comply or may be
able to comply with the requirements of subpart C of this part: Except, That,
the initial inspection may be delayed for up to 6 months to comply with the
requirement that the inspection be conducted when the land, facilities, and
activities that demonstrate compliance or capacity to comply can be observed.

(2) All
on-site inspections must be conducted when an authorized representative of
the operation who is knowledgeable about the operation is present and at a
time when land, facilities, and activities that demonstrate the operation's
compliance with or capability to comply with the applicable provisions of
subpart C of this part can be observed, except that this requirement does not
apply to unannounced on-site inspections.

(c) Verification
of information. The on-site inspection of an operation must verify:

(1) The
operation's compliance or capability to comply with the Act and the
regulations in this part;

(2) That
the information, including the organic production or handling system plan,
provided in accordance with §§205.401, 205.406, and 205.200,
accurately reflects the practices used or to be used by the applicant for
certification or by the certified operation;

(3) That
prohibited substances have not been and are not being applied to the
operation through means which, at the discretion of the certifying agent, may
include the collection and testing of soil; water; waste; seeds; plant
tissue; and plant, animal, and processed products samples.

(d) Exit
interview. The inspector must conduct an exit interview with an
authorized representative of the operation who is knowledgeable about the
inspected operation to confirm the accuracy and completeness of inspection
observations and information gathered during the on-site inspection. The
inspector must also address the need for any additional information as well
as any issues of concern.

(e) Documents
to the inspected operation. (1) At the time of the inspection, the
inspector shall provide the operation's authorized representative with a
receipt for any samples taken by the inspector. There shall be no charge to
the inspector for the samples taken.

(2) A copy
of the on-site inspection report and any test results will be sent to the
inspected operation by the certifying agent.

§ 205.404   Granting
certification.

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(a) Within
a reasonable time after completion of the initial on-site inspection, a
certifying agent must review the on-site inspection report, the results of
any analyses for substances conducted, and any additional information
requested from or supplied by the applicant. If the certifying agent
determines that the organic system plan and all procedures and activities of
the applicant's operation are in compliance with the requirements of this
part and that the applicant is able to conduct operations in accordance with
the plan, the agent shall grant certification. The certification may include
requirements for the correction of minor noncompliances within a specified
time period as a condition of continued certification.

(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.

(c) Once
certified, a production or handling operation's organic certification
continues in effect until surrendered by the organic operation or suspended
or revoked by the certifying agent, the State organic program's governing
State official, or the Administrator.

§ 205.405   Denial
of certification.

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(a) When
the certifying agent has reason to believe, based on a review of the
information specified in §205.402 or §205.404, that an applicant
for certification is not able to comply or is not in compliance with the
requirements of this part, the certifying agent must provide a written
notification of noncompliance to the applicant. When correction of a
noncompliance is not possible, a notification of noncompliance and a
notification of denial of certification may be combined in one notification.
The notification of noncompliance 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 applicant must rebut or correct each noncompliance and
submit supporting documentation of each such correction when correction is
possible.

(b) Upon
receipt of such notification of noncompliance, the applicant may:

(1) Correct
noncompliances and submit a description of the corrective actions taken with
supporting documentation to the certifying agent;

(2) Correct
noncompliances and submit a new application to another certifying agent: Provided,
That, the applicant must include a complete application, the notification
of noncompliance received from the first certifying agent, and a description
of the corrective actions taken with supporting documentation; or

(3) Submit
written information to the issuing certifying agent to rebut the
noncompliance described in the notification of noncompliance.

(c) After
issuance of a notification of noncompliance, the certifying agent must:

(1)
Evaluate the applicant's corrective actions taken and supporting
documentation submitted or the written rebuttal, conduct an on-site
inspection if necessary, and

(i) When
the corrective action or rebuttal is sufficient for the applicant to qualify
for certification, issue the applicant an approval of certification pursuant
to §205.404; or

(ii) When
the corrective action or rebuttal is not sufficient for the applicant to
qualify for certification, issue the applicant a written notice of denial of
certification.

(2) Issue a
written notice of denial of certification to an applicant who fails to respond
to the notification of noncompliance.

(3) Provide
notice of approval or denial to the Administrator, pursuant to
§205.501(a)(14).

(d) A
notice of denial of certification must state the reason(s) for denial and the
applicant's right to:

(1) Reapply
for certification pursuant to §§205.401 and 205.405(e);

(2) Request
mediation pursuant to §205.663 or, if applicable, pursuant to a State
organic program; or

(3) File an
appeal of the denial of certification pursuant to §205.681 or, if
applicable, pursuant to a State organic program.

(e) An
applicant for certification who has received a written notification of
noncompliance or a written notice of denial of certification may apply for
certification again at any time with any certifying agent, in accordance with
§§205.401 and 205.405(e). When such applicant submits a new
application to a certifying agent other than the agent who issued the
notification of noncompliance or notice of denial of certification, the
applicant for certification must include a copy of the notification of
noncompliance or notice of denial of certification and a description of the
actions taken, with supporting documentation, to correct the noncompliances
noted in the notification of noncompliance.

(f) A
certifying agent who receives a new application for certification, which
includes a notification of noncompliance or a notice of denial of
certification, must treat the application as a new application and begin a
new application process pursuant to §205.402.

(g)
Notwithstanding paragraph (a) of this section, if a certifying agent has
reason to believe that an applicant for certification has willfully made a
false statement or otherwise purposefully misrepresented the applicant's
operation or its compliance with the certification requirements pursuant to
this part, the certifying agent may deny certification pursuant to paragraph
(c)(1)(ii) of this section without first issuing a notification of
noncompliance.

§ 205.406   Continuation
of certification.

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(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.

(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.

(c) If the
certifying agent has reason to believe, based on the on-site inspection and a
review of the information specified in §205.404, that a certified
operation is not complying with the requirements of the Act and the
regulations in this part, the certifying agent shall provide a written
notification of noncompliance to the operation in accordance with
§205.662.

(d) If the
certifying agent determines that the certified operation is complying with
the Act and the regulations in this part and that any of the information
specified on the certificate of organic operation has changed, the certifying
agent must issue an updated certificate of organic operation pursuant to
§205.404(b).

§§ 205.407-205.499   [Reserved]

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Subpart F—Accreditation
of Certifying Agents

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§ 205.500   Areas
and duration of accreditation.

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(a) The
Administrator shall accredit a qualified domestic or foreign applicant in the
areas of crops, livestock, wild crops, or handling or any combination thereof
to certify a domestic or foreign production or handling operation as a
certified operation.

(b)
Accreditation shall be for a period of 5 years from the date of approval of
accreditation pursuant to §205.506.

(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.

§ 205.501   General
requirements for accreditation.

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(a) A
private or governmental entity accredited as a certifying agent under this
subpart must:

(1) Have
sufficient expertise in organic production or handling techniques to fully
comply with and implement the terms and conditions of the organic certification
program established under the Act and the regulations in this part;

(2)
Demonstrate the ability to fully comply with the requirements for
accreditation set forth in this subpart;

(3) Carry
out the provisions of the Act and the regulations in this part, including the
provisions of §§205.402 through 205.406 and §205.670;

(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;

(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.

(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;

(7) Have an
annual program review of its certification activities conducted by the
certifying agent's staff, an outside auditor, or a consultant who has
expertise to conduct such reviews and implement measures to correct any
noncompliances with the Act and the regulations in this part that are
identified in the evaluation;

(8) Provide
sufficient information to persons seeking certification to enable them to
comply with the applicable requirements of the Act and the regulations in
this part;

(9)
Maintain all records pursuant to §205.510(b) and make all such records
available for inspection and copying during normal business hours by
authorized representatives of the Secretary and the applicable State organic
program's governing State official;

(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);

(11)
Prevent conflicts of interest by:

(i) Not
certifying a production or handling operation if the certifying agent or a
responsibly connected party of such certifying agent has or has held a
commercial interest in the production or handling operation, including an
immediate family interest or the provision of consulting services, within the
12-month period prior to the application for certification;

(ii)
Excluding any person, including contractors, with conflicts of interest from
work, discussions, and decisions in all stages of the certification process
and the monitoring of certified production or handling operations for all
entities in which such person has or has held a commercial interest,
including an immediate family interest or the provision of consulting
services, within the 12-month period prior to the application for
certification;

(iii) Not
permitting any employee, inspector, contractor, or other personnel to accept
payment, gifts, or favors of any kind, other than prescribed fees, from any
business inspected: Except, That, a certifying agent that is a
not-for-profit organization with an Internal Revenue Code tax exemption or,
in the case of a foreign certifying agent, a comparable recognition of
not-for-profit status from its government, may accept voluntary labor from
certified operations;

(iv) Not
giving advice or providing consultancy services, to certification applicants
or certified operations, for overcoming identified barriers to certification;

(v)
Requiring 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 all parties responsibly connected to the
certifying agent to complete an annual conflict of interest disclosure
report; and

(vi)
Ensuring that the decision to certify an operation is made by a person
different from those who conducted the review of documents and on-site
inspection.

(12)(i)
Reconsider a certified operation's application for certification and, if
necessary, perform a new on-site inspection when it is determined, within 12
months of certifying the operation, that any person participating in the
certification process and covered under §205.501(a)(11)(ii) has or had a
conflict of interest involving the applicant. All costs associated with a reconsideration
of application, including onsite inspection costs, shall be borne by the
certifying agent.

(ii) Refer
a certified operation to a different accredited certifying agent for
recertification and reimburse the operation for the cost of the recertification
when it is determined that any person covered under §205.501(a)(11)(i)
at the time of certification of the applicant had a conflict of interest
involving the applicant.

(13) Accept
the certification decisions made by another certifying agent accredited or
accepted by USDA pursuant to §205.500;

(14)
Refrain from making false or misleading claims about its accreditation
status, the USDA accreditation program for certifying agents, or the nature
or qualities of products labeled as organically produced;

(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;

(16) Charge
applicants for certification and certified production and handling operations
only those fees and charges for certification activities that it has filed
with the Administrator;

(17) Pay
and submit fees to AMS in accordance with §205.640;

(18)
Provide the inspector, prior to each on-site inspection, with previous
on-site inspection reports and notify the inspector of its decision regarding
certification of the production or handling operation site inspected by the
inspector and of any requirements for the correction of minor noncompliances;

(19) Accept
all production or handling applications that fall within its area(s) of
accreditation and certify all qualified applicants, to the extent of its
administrative capacity to do so without regard to size or membership in any
association or group; and

(20)
Demonstrate its ability to comply with a State's organic program to certify
organic production or handling operations within the State.

(21) Comply
with, implement, and carry out any other terms and conditions determined by
the Administrator to be necessary.

(b) A
private or governmental entity accredited as a certifying agent under this
subpart may establish a seal, logo, or other identifying mark to be used by
production and handling operations certified by the certifying agent to
indicate affiliation with the certifying agent: Provided, That, the
certifying agent:

(1) Does
not require use of its seal, logo, or other identifying mark on any product
sold, labeled, or represented as organically produced as a condition of
certification and

(2) Does
not require compliance with any production or handling practices other than
those provided for in the Act and the regulations in this part as a condition
of use of its identifying mark: Provided, That, certifying agents certifying
production or handling operations within a State with more restrictive
requirements, approved by the Secretary, shall require compliance with such
requirements as a condition of use of their identifying mark by such
operations.

(c) A
private entity accredited as a certifying agent must:

(1) Hold
the Secretary harmless for any failure on the part of the certifying agent to
carry out the provisions of the Act and the regulations in this part;

(2) Furnish
reasonable security, in an amount and according to such terms as the
Administrator may by regulation prescribe, for the purpose of protecting the
rights of production and handling operations certified by such certifying
agent under the Act and the regulations in this part; and

(3)
Transfer to the Administrator and make available to any applicable State
organic program's governing State official all records or copies of records
concerning the person's certification activities in the event that the
certifying agent dissolves or loses its accreditation; Provided, That,
such transfer shall not apply to a merger, sale, or other transfer of
ownership of a certifying agent.

(d) No
private or governmental entity accredited as a certifying agent under this
subpart shall exclude from participation in or deny the benefits of the
National Organic Program to any person due to discrimination because of race,
color, national origin, gender, religion, age, disability, political beliefs,
sexual orientation, or marital or family status.

§ 205.502   Applying
for accreditation.

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(a) A
private or governmental entity seeking accreditation as a certifying agent
under this subpart must submit an application for accreditation which
contains the applicable information and documents set forth in
§§205.503 through 205.505 and the fees required in §205.640
to: Program Manager, USDA-AMS-TMP-NOP, Room 2945—South Building, P.O.
Box 96456, Washington, DC 20090–6456.

(b)
Following the receipt of the information and documents, the Administrator
will determine, pursuant to §205.506, whether the applicant for
accreditation should be accredited as a certifying agent.

§ 205.503   Applicant
information.

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A private
or governmental entity seeking accreditation as a certifying agent must
submit the following information:

(a) The
business name, primary office location, mailing address, name of the
person(s) responsible for the certifying agent's day-to-day operations,
contact numbers (telephone, facsimile, and Internet address) of the
applicant, and, for an applicant who is a private person, the entity's
taxpayer identification number;

(b) The
name, office location, mailing address, and contact numbers (telephone,
facsimile, and Internet address) for each of its organizational units, such
as chapters or subsidiary offices, and the name of a contact person for each unit;

(c) Each
area of operation (crops, wild crops, livestock, or handling) for which
accreditation is requested and the estimated number of each type of operation
anticipated to be certified annually by the applicant along with a copy of
the applicant's schedule of fees for all services to be provided under these
regulations by the applicant;

(d) The
type of entity the applicant is (e.g., government agricultural office,
for-profit business, not-for-profit membership association) and for:

(1) A
governmental entity, a copy of the official's authority to conduct
certification activities under the Act and the regulations in this part,

(2) A
private entity, documentation showing the entity's status and organizational
purpose, such as articles of incorporation and by-laws or ownership or
membership provisions, and its date of establishment; and

(e) A list
of each State or foreign country in which the applicant currently certifies
production and handling operations and a list of each State or foreign
country in which the applicant intends to certify production or handling
operations.

§ 205.504   Evidence
of expertise and ability.

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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) Personnel.
(1) A copy of the applicant's policies and procedures for training,
evaluating, and supervising personnel;

(2) The
name and position description of all personnel to be used in the
certification operation, including administrative staff, certification
inspectors, members of any certification review and evaluation committees,
contractors, and all parties responsibly connected to the certifying agent;

(3) A
description of the qualifications, including experience, training, and
education in agriculture, organic production, and organic handling, for:

(i) Each
inspector to be used by the applicant and

(ii) Each
person to be designated by the applicant to review or evaluate applications
for certification; and

(4) A
description of any training that the applicant has provided or intends to
provide to personnel to ensure that they comply with and implement the
requirements of the Act and the regulations in this part.

(b) Administrative
policies and procedures. (1) A copy of the procedures to be used to
evaluate certification applicants, make certification decisions, and issue
certification certificates;

(2) A copy
of the procedures to be used for reviewing and investigating certified
operation compliance with the Act and the regulations in this part and the
reporting of violations of the Act and the regulations in this part to the
Administrator;

(3) A copy
of the procedures to be used for complying with the recordkeeping
requirements set forth in §205.501(a)(9);

(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);

(5) A copy
of the procedures to be used, including any fees to be assessed, for making
the following information available to any member of the public upon request:

(i)
Certification certificates issued during the current and 3 preceding calender
years;

(ii) A list
of producers and handlers whose operations it has certified, including for
each the name of the operation, type(s) of operation, products produced, and
the effective date of the certification, during the current and 3 preceding
calender years;

(iii) The
results of laboratory analyses for residues of pesticides and other
prohibited substances conducted during the current and 3 preceding calender
years; and

(iv) Other
business information as permitted in writing by the producer or handler; and

(6) A copy
of the procedures to be used for sampling and residue testing pursuant to
§205.670.

(c) Conflicts
of interest. (1) A copy of procedures intended to be implemented to
prevent the occurrence of conflicts of interest, as described in
§205.501(a)(11).

(2) For 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 all parties responsibly connected to the
certifying agent, a conflict of interest disclosure report, identifying any
food- or agriculture-related business interests, including business interests
of immediate family members, that cause a conflict of interest.

(d) Current
certification activities. An applicant who currently certifies production
or handling operations must submit: (1) A list of all production and handling
operations currently certified by the applicant;

(2) Copies
of at least 3 different inspection reports and certification evaluation
documents for production or handling operations certified by the applicant
during the previous year for each area of operation for which accreditation
is requested; and

(3) The
results of any accreditation process of the applicant's operation by an
accrediting body during the previous year for the purpose of evaluating its
certification activities.

(e) Other
information. Any other information the applicant believes may assist in
the Administrator's evaluation of the applicant's expertise and ability.

§ 205.505   Statement
of agreement.

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(a) A
private or governmental entity seeking accreditation under this subpart must
sign and return a statement of agreement prepared by the Administrator which
affirms that, if granted accreditation as a certifying agent under this
subpart, the applicant will carry out the provisions of the Act and the
regulations in this part, including:

(1) Accept
the certification decisions made by another certifying agent accredited or
accepted by USDA pursuant to §205.500;

(2) Refrain
from making false or misleading claims about its accreditation status, the USDA
accreditation program for certifying agents, or the nature or qualities of
products labeled as organically produced;

(3) 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;

(4) Have an
annual internal program review conducted of its certification activities by
certifying agent staff, an outside auditor, or a consultant who has the
expertise to conduct such reviews and implement measures to correct any
noncompliances with the Act and the regulations in this part;

(5) Pay and
submit fees to AMS in accordance with §205.640; and

(6) Comply
with, implement, and carry out any other terms and conditions determined by
the Administrator to be necessary.

(b) A
private entity seeking accreditation as a certifying agent under this subpart
must additionally agree to:

(1) Hold
the Secretary harmless for any failure on the part of the certifying agent to
carry out the provisions of the Act and the regulations in this part;

(2) Furnish
reasonable security, in an amount and according to such terms as the
Administrator may by regulation prescribe, for the purpose of protecting the
rights of production and handling operations certified by such certifying
agent under the Act and the regulations in this part; and

(3) Transfer
to the Administrator and make available to the applicable State organic
program's governing State official all records or copies of records
concerning the certifying agent's certification activities in the event that
the certifying agent dissolves or loses its accreditation; Provided, That
such transfer shall not apply to a merger, sale, or other transfer of
ownership of a certifying agent.

§ 205.506   Granting
accreditation.

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(a)
Accreditation will be granted when:

(1) The
accreditation applicant has submitted the information required by
§§205.503 through 205.505;

(2) The
accreditation applicant pays the required fee in accordance with
§205.640(c); and

(3) The
Administrator determines that the applicant for accreditation meets the
requirements for accreditation as stated in §205.501, as determined by a
review of the information submitted in accordance with §§205.503
through 205.505 and, if necessary, a review of the information obtained from
a site evaluation as provided for in §205.508.

(b) On
making a determination to approve an application for accreditation, the
Administrator will notify the applicant of the granting of accreditation in
writing, stating:

(1) The
area(s) for which accreditation is given;

(2) The
effective date of the accreditation;

(3) Any
terms and conditions for the correction of minor noncompliances; and

(4) For a
certifying agent who is a private entity, the amount and type of security
that must be established to protect the rights of production and handling
operations certified by such certifying agent.

(c) The
accreditation of a certifying agent shall continue in effect until such time
as the certifying agent fails to renew accreditation as provided in
§205.510(c), the certifying agent voluntarily ceases its certification
activities, or accreditation is suspended or revoked pursuant to
§205.665.

§ 205.507   Denial
of accreditation.

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(a) If the
Program Manager has reason to believe, based on a review of the information
specified in §§205.503 through 205.505 or after a site evaluation
as specified in §205.508, that an applicant for accreditation is not
able to comply or is not in compliance with the requirements of the Act and
the regulations in this part, the Program Manager shall provide a written
notification of noncompliance to the applicant. 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 applicant must rebut or correct each noncompliance and
submit supporting documentation of each such correction when correction is
possible.

(b) When
each noncompliance has been resolved, the Program Manager will send the
applicant a written notification of noncompliance resolution and proceed with
further processing of the application.

(c) If an
applicant fails to correct the noncompliances, fails to report the
corrections by the date specified in the notification of noncompliance, fails
to file a rebuttal of the notification of noncompliance by the date
specified, or is unsuccessful in its rebuttal, the Program Manager will
provide the applicant with written notification of accreditation denial. An
applicant who has received written notification of accreditation denial may
apply for accreditation again at any time in accordance with §205.502,
or appeal the denial of accreditation in accordance with §205.681 by the
date specified in the notification of accreditation denial.

(d) If the
certifying agent was accredited prior to the site evaluation and the
certifying agent fails to correct the noncompliances, fails to report the
corrections by the date specified in the notification of noncompliance, or
fails to file a rebuttal of the notification of noncompliance by the date
specified, the Administrator will begin proceedings to suspend or revoke the
certifying agent's accreditation. A certifying agent who has had its
accreditation suspended may at any time, unless otherwise stated in the
notification of suspension, submit a request to the Secretary for
reinstatement of its accreditation. 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 certifying agent whose accreditation is revoked
will be ineligible for accreditation for a period of not less than 3 years
following the date of such determination.

§ 205.508   Site
evaluations.

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(a) Site
evaluations of accredited certifying agents shall be conducted for the
purpose of examining the certifying agent's operations and evaluating its
compliance with the Act and the regulations of this part. Site evaluations
shall include an on-site review of the certifying agent's certification
procedures, decisions, facilities, administrative and management systems, and
production or handling operations certified by the certifying agent. Site
evaluations shall be conducted by a representative(s) of the Administrator.

(b) An
initial site evaluation of an accreditation applicant shall be conducted
before or within a reasonable period of time after issuance of the
applicant's “notification of accreditation.” A site evaluation shall
be conducted after application for renewal of accreditation but prior to the
issuance of a notice of renewal of accreditation. One or more site
evaluations will be conducted during the period of accreditation to determine
whether an accredited certifying agent is complying with the general
requirements set forth in §205.501.

§ 205.509   Peer
review panel.

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The
Administrator shall establish a peer review panel pursuant to the Federal
Advisory Committee Act (FACA) (5 U.S.C. App. 2 et seq.). The peer review
panel shall be composed of not less than 3 members who shall annually
evaluate the National Organic Program's adherence to the accreditation
procedures in this subpart F and ISO/IEC Guide 61, General requirements for
assessment and accreditation of certification/registration bodies, and the
National Organic Program's accreditation decisions. This shall be accomplished
through the review of accreditation procedures, document review and site
evaluation reports, and accreditation decision documents or documentation.
The peer review panel shall report its finding, in writing, to the National
Organic Program's Program Manager.

§ 205.510   Annual
report, recordkeeping, and renewal of accreditation.

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(a) Annual
report and fees. An accredited certifying agent must submit annually to
the Administrator, on or before the anniversary date of the issuance of the
notification of accreditation, the following reports and fees:

(1) A
complete and accurate update of information submitted pursuant to
§§205.503 and 205.504;

(2)
Information supporting any changes being requested in the areas of accreditation
described in §205.500;

(3) A
description of the measures implemented in the previous year and any measures
to be implemented in the coming year to satisfy any terms and conditions
determined by the Administrator to be necessary, as specified in the most
recent notification of accreditation or notice of renewal of accreditation;

(4) The
results of the most recent performance evaluations and annual program review
and a description of adjustments to the certifying agent's operation and
procedures implemented or to be implemented in response to the performance
evaluations and program review; and

(5) The
fees required in §205.640(a).

(b) Recordkeeping.
Certifying agents must maintain records according to the following
schedule:

(1) Records
obtained from applicants for certification and certified operations must be
maintained for not less than 5 years beyond their receipt;

(2) Records
created by the certifying agent regarding applicants for certification and
certified operations must be maintained for not less than 10 years beyond
their creation; and

(3) Records
created or received by the certifying agent pursuant to the accreditation
requirements of this subpart F, excluding any records covered by
§§205.510(b)(2), must be maintained for not less than 5 years
beyond their creation or receipt.

(c) Renewal
of accreditation. (1) The Administrator shall send the accredited
certifying agent a notice of pending expiration of accreditation
approximately 1 year prior to the scheduled date of expiration.

(2) An
accredited certifying agent's application for accreditation renewal must be
received at least 6 months prior to the fifth anniversary of issuance of the
notification of accreditation and each subsequent renewal of accreditation.
The accreditation of certifying agents who make timely application for
renewal of accreditation will not expire during the renewal process. The
accreditation of certifying agents who fail to make timely application for
renewal of accreditation will expire as scheduled unless renewed prior to the
scheduled expiration date. Certifying agents with an expired accreditation
must not perform certification activities under the Act and the regulations
of this part.

(3)
Following receipt of the information submitted by the certifying agent in
accordance with paragraph (a) of this section and the results of a site
evaluation, the Administrator will determine whether the certifying agent
remains in compliance with the Act and the regulations of this part and
should have its accreditation renewed.

(d) Notice
of renewal of accreditation. Upon a determination that the certifying
agent is in compliance with the Act and the regulations of this part, the
Administrator will issue a notice of renewal of accreditation. The notice of
renewal will specify any terms and conditions that must be addressed by the
certifying agent and the time within which those terms and conditions must be
satisfied.

(e) Noncompliance.
Upon a determination that the certifying agent is not in compliance with
the Act and the regulations of this part, the Administrator will initiate
proceedings to suspend or revoke the certifying agent's accreditation.

(f) Amending
accreditation. Amendment to scope of an accreditation may be requested at
any time. The application for amendment shall be sent to the Administrator
and shall contain information applicable to the requested change in
accreditation, a complete and accurate update of the information submitted
pursuant to §§205.503 and 205.504, and the applicable fees required
in §205.640.

§§ 205.511-205.599   [Reserved]

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Subpart G—Administrative

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The
National List of Allowed and Prohibited Substances

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§ 205.600   Evaluation
criteria for allowed and prohibited substances, methods, and ingredients.

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The
following criteria will be utilized in the evaluation of substances or
ingredients for the organic production and handling sections of the National
List:

(a)
Synthetic and nonsynthetic substances considered for inclusion on or deletion
from the National List of allowed and prohibited substances will be evaluated
using the criteria specified in the Act (7 U.S.C. 6517 and 6518).

(b) In
addition to the criteria set forth in the Act, any synthetic substance used
as a processing aid or adjuvant will be evaluated against the following
criteria:

(1) The
substance cannot be produced from a natural source and there are no organic
substitutes;

(2) The
substance's manufacture, use, and disposal do not have adverse effects on the
environment and are done in a manner compatible with organic handling;

(3) The
nutritional quality of the food is maintained when the substance is used, and
the substance, itself, or its breakdown products do not have an adverse
effect on human health as defined by applicable Federal regulations;

(4) The
substance's primary use is not as a preservative or to recreate or improve
flavors, colors, textures, or nutritive value lost during processing, except
where the replacement of nutrients is required by law;

(5) The
substance is listed as generally recognized as safe (GRAS) by Food and Drug
Administration (FDA) when used in accordance with FDA's good manufacturing
practices (GMP) and contains no residues of heavy metals or other
contaminants in excess of tolerances set by FDA; and

(6) The
substance is essential for the handling of organically produced agricultural
products.

(c)
Nonsynthetics used in organic processing will be evaluated using the criteria
specified in the Act (7 U.S.C. 6517 and 6518).

§ 205.601   Synthetic
substances allowed for use in organic crop production.

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In
accordance with restrictions specified in this section, the following
synthetic substances may be used in organic crop production: Provided, That,
use of such substances do not contribute to contamination of crops, soil, or
water. Substances allowed by this section, except disinfectants and
sanitizers in paragraph (a) and those substances in paragraphs (c), (j), (k),
and (l) of this section, may only be used when the provisions set forth in
§205.206(a) through (d) prove insufficient to prevent or control the
target pest.

(a) As
algicide, disinfectants, and sanitizer, including irrigation system cleaning
systems.

(1)
Alcohols.

(i)
Ethanol.

(ii)
Isopropanol.

(2)
Chlorine materials— Except, That, residual chlorine levels in the
water shall not exceed the maximum residual disinfectant limit under the Safe
Drinking Water Act.

(i) Calcium
hypochlorite.

(ii)
Chlorine dioxide.

(iii)
Sodium hypochlorite.

(3) Copper
sulfate—for use as an algicide in aquatic rice systems, is limited to
one application per field during any 24-month period. Application rates are
limited to those which do not increase baseline soil test values for copper
over a timeframe agreed upon by the producer and accredited certifying agent.

(4)
Hydrogen peroxide.

(5) Ozone
gas—for use as an irrigation system cleaner only.

(6)
Peracetic acid—for use in disinfecting equipment, seed, and asexually
propagated planting material.

(7)
Soap-based algicide/demossers.

(b) As
herbicides, weed barriers, as applicable.

(1)
Herbicides, soap-based—for use in farmstead maintenance (roadways,
ditches, right of ways, building perimeters) and ornamental crops.

(2)
Mulches.

(i)
Newspaper or other recycled paper, without glossy or colored inks.

(ii)
Plastic mulch and covers (petroleum-based other than polyvinyl chloride
(PVC)).

(c) As
compost feedstocks—Newspapers or other recycled paper, without glossy or
colored inks.

(d) As
animal repellents—Soaps, ammonium—for use as a large animal
repellant only, no contact with soil or edible portion of crop.

(e) As
insecticides (including acaricides or mite control).

(1)
Ammonium carbonate—for use as bait in insect traps only, no direct
contact with crop or soil.

(2) Boric
acid—structural pest control, no direct contact with organic food or
crops.

(3) Copper
sulfate—for use as tadpole shrimp control in aquatic rice production, is
limited to one application per field during any 24-month period. Application
rates are limited to levels which do not increase baseline soil test values
for copper over a timeframe agreed upon by the producer and accredited
certifying agent.

(4)
Elemental sulfur.

(5) Lime
sulfur—including calcium polysulfide.

(6) Oils,
horticultural—narrow range oils as dormant, suffocating, and summer
oils.

(7) Soaps,
insecticidal.

(8) Sticky
traps/barriers.

(9) Sucrose
octanoate esters (CAS #s—42922–74–7;
58064–47–4)—in accordance with approved labeling.

(f) As
insect management. Pheromones.

(g) As
rodenticides.

(1) Sulfur
dioxide—underground rodent control only (smoke bombs).

(2) Vitamin
D3.

(h) As slug
or snail bait. Ferric phosphate (CAS # 10045–86–0).

(i) As
plant disease control.

(1)
Coppers, fixed—copper hydroxide, copper oxide, copper oxychloride,
includes products exempted from EPA tolerance, Provided, That,
copper-based materials must be used in a manner that minimizes accumulation
in the soil and shall not be used as herbicides.

(2) Copper
sulfate—Substance must be used in a manner that minimizes accumulation
of copper in the soil.

(3)
Hydrated lime.

(4)
Hydrogen peroxide.

(5) Lime
sulfur.

(6) Oils,
horticultural, narrow range oils as dormant, suffocating, and summer oils.

(7)
Peracetic acid—for use to control fire blight bacteria.

(8)
Potassium bicarbonate.

(9)
Elemental sulfur.

(10)
Streptomycin, for fire blight control in apples and pears only.

(11)
Tetracycline (oxytetracycline calcium complex), for fire blight control only.

(j) As
plant or soil amendments.

(1) Aquatic
plant extracts (other than hydrolyzed)—Extraction process is limited to
the use of potassium hydroxide or sodium hydroxide; solvent amount used is
limited to that amount necessary for extraction.

(2)
Elemental sulfur.

(3) Humic
acids—naturally occurring deposits, water and alkali extracts only.

(4) Lignin
sulfonate—chelating agent, dust suppressant, floatation agent.

(5)
Magnesium sulfate—allowed with a documented soil deficiency.

(6)
Micronutrients—not to be used as a defoliant, herbicide, or desiccant.
Those made from nitrates or chlorides are not allowed. Soil deficiency must
be documented by testing.

(i) Soluble
boron products.

(ii)
Sulfates, carbonates, oxides, or silicates of zinc, copper, iron, manganese,
molybdenum, selenium, and cobalt.

(7) Liquid
fish products—can be pH adjusted with sulfuric, citric or phosphoric
acid. The amount of acid used shall not exceed the minimum needed to lower
the pH to 3.5.

(8)
Vitamins, B1, C, and E.

(k) As
plant growth regulators. Ethylene gas—for regulation of pineapple
flowering.

(l) As
floating agents in postharvest handling.

(1) Lignin
sulfonate.

(2) Sodium
silicate—for tree fruit and fiber processing.

(m) As
synthetic inert ingredients as classified by the Environmental Protection
Agency (EPA), for use with nonsynthetic substances or synthetic substances
listed in this section and used as an active pesticide ingredient in
accordance with any limitations on the use of such substances.

(1) EPA
List 4—Inerts of Minimal Concern.

(2) EPA
List 3—Inerts of Unknown Toxicity allowed:

(i)
Glycerine Oleate (Glycerol monooleate) (CAS #s 37220–82–9)—for
use only until December 31, 2006.

(ii) Inerts
used in passive pheromone dispensers.

(n) Seed
preparations. Hydrogen chloride (CAS # 7647–01–0)—for
delinting cotton seed for planting.

(o)–(z)
[Reserved]

[65 FR
80637, Dec. 21, 2000, as amended at 68 FR 61992, Oct. 31, 2003; 71 FR 53302
Sept. 11, 2006; 72 FR 69572, Dec. 10, 2007]

§ 205.602   Nonsynthetic
substances prohibited for use in organic crop production.

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The
following nonsynthetic substances may not be used in organic crop production:

(a) Ash
from manure burning.

(b)
Arsenic.

(c) Calcium
chloride, brine process is natural and prohibited for use except as a foliar
spray to treat a physiological disorder associated with calcium uptake.

(d) Lead
salts.

(e)
Potassium chloride—unless derived from a mined source and applied in a
manner that minimizes chloride accumulation in the soil.

(f) Sodium
fluoaluminate (mined).

(g) Sodium
nitrate—unless use is restricted to no more than 20% of the crop's total
nitrogen requirement; use in spirulina production is unrestricted until October
21, 2005.

(h)
Strychnine.

(i) Tobacco
dust (nicotine sulfate).

(j)–(z)
[Reserved]

[68 FR
61992, Oct. 31, 2003]

§ 205.603   Synthetic
substances allowed for use in organic livestock production.

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In
accordance with restrictions specified in this section the following
synthetic substances may be used in organic livestock production:

(a) As
disinfectants, sanitizer, and medical treatments as applicable.

(1)
Alcohols.

(i)
Ethanol-disinfectant and sanitizer only, prohibited as a feed additive.

(ii)
Isopropanol-disinfectant only.

(2)
Aspirin-approved for health care use to reduce inflammation.

(3)
Atropine (CAS #–51–55–8)—federal law restricts this drug
to use by or on the lawful written or oral order of a licensed veterinarian,
in full compliance with the AMDUCA and 21 CFR part 530 of the Food and Drug
Administration regulations. Also, for use under 7 CFR Part 205, the NOP
requires:

(i) Use by
or on the lawful written order of a licensed veterinarian; and

(ii) A meat
withdrawal period of at least 56 days after administering to livestock
intended for slaughter; and a milk discard period of at least 12 days after
administering to dairy animals.

(4)
Biologics—Vaccines.

(5)
Butorphanol (CAS #–42408–82–2)—federal law restricts this
drug to use by or on the lawful written or oral order of a licensed
veterinarian, in full compliance with the AMDUCA and 21 CFR part 530 of the
Food and Drug Administration regulations. Also, for use under 7 CFR Part 205,
the NOP requires:

(i) Use by
or on the lawful written order of a licensed veterinarian; and

(ii) A meat
withdrawal period of at least 42 days after administering to livestock
intended for slaughter; and a milk discard period of at least 8 days after
administering to dairy animals.

(6)
Chlorhexidine—Allowed for surgical procedures conducted by a
veterinarian. Allowed for use as a teat dip when alternative germicidal agents
and/or physical barriers have lost their effectiveness.

(7)
Chlorine materials—disinfecting and sanitizing facilities and equipment.
Residual chlorine levels in the water shall not exceed the maximum residual
disinfectant limit under the Safe Drinking Water Act.

(i) Calcium
hypochlorite.

(ii)
Chlorine dioxide.

(iii)
Sodium hypochlorite.

(8)
Electrolytes—without antibiotics.

(9)
Flunixin (CAS #–38677–85–9)—in accordance with approved
labeling; except that for use under 7 CFR Part 205, the NOP requires a
withdrawal period of at least two-times that required by the FDA.

(10)
Furosemide (CAS #–54–31–9)—in accordance with approved
labeling; except that for use under 7 CFR Part 205, the NOP requires a
withdrawal period of at least two-times that required that required by the
FDA.

(11)
Glucose.

(12)
Glycerine—Allowed as a livestock teat dip, must be produced through the
hydrolysis of fats or oils.

(13)
Hydrogen peroxide.

(14)
Iodine.

(15)
Magnesium hydroxide (CAS #–1309–42–8)—federal law
restricts this drug to use by or on the lawful written or oral order of a
licensed veterinarian, in full compliance with the AMDUCA and 21 CFR part 530
of the Food and Drug Administration regulations. Also, for use under 7 CFR
part 205, the NOP requires use by or on the lawful written order of a
licensed veterinarian.

(16)
Magnesium sulfate.

(17)
Oxytocin—use in postparturition therapeutic applications.

(18)
Paraciticides. Ivermectin—prohibited in slaughter stock, allowed in
emergency treatment for dairy and breeder stock when organic system
plan-approved preventive management does not prevent infestation. Milk or
milk products from a treated animal cannot be labeled as provided for in
subpart D of this part for 90 days following treatment. In breeder stock,
treatment cannot occur during the last third of gestation if the progeny will
be sold as organic and must not be used during the lactation period for
breeding stock.

(19)
Peroxyacetic/peracetic acid (CAS #–79–21–0)—for sanitizing
facility and processing equipment.

(20)
Phosphoric acid—allowed as an equipment cleaner, Provided , That,
no direct contact with organically managed livestock or land occurs.

(21)
Poloxalene (CAS #–9003–11–6)—for use under 7 CFR Part
205, the NOP requires that poloxalene only be used for the emergency
treatment of bloat.

(22)
Tolazoline (CAS #–59–98–3)—federal law restricts this
drug to use by or on the lawful written or oral order of a licensed
veterinarian, in full compliance with the AMDUCA and 21 CFR part 530 of the
Food and Drug Administration regulations. Also, for use under 7 CFR Part 205,
the NOP requires:

(i) Use by
or on the lawful written order of a licensed veterinarian;

(ii) Use
only to reverse the effects of sedation and analgesia caused by Xylazine; and

(iii) A
meat withdrawal period of at least 8 days after administering to livestock
intended for slaughter; and a milk discard period of at least 4 days after
administering to dairy animals.

(23)
Xylazine (CAS #–7361–61–7)—federal law restricts this
drug to use by or on the lawful written or oral order of a licensed
veterinarian, in full compliance with the AMDUCA and 21 CFR part 530 of the
Food and Drug Administration regulations. Also, for use under 7 CFR Part 205,
the NOP requires:

(i) Use by
or on the lawful written order of a licensed veterinarian;

(ii) The
existence of an emergency; and

(iii) A
meat withdrawal period of at least 8 days after administering to livestock
intended for slaughter; and a milk discard period of at least 4 days after
administering to dairy animals.

(b) As
topical treatment, external parasiticide or local anesthetic as applicable.

(1) Copper
sulfate.

(2) Iodine.

(3)
Lidocaine—as a local anesthetic. Use requires a withdrawal period of 90
days after administering to livestock intended for slaughter and 7 days after
administering to dairy animals.

(4) Lime,
hydrated—as an external pest control, not permitted to cauterize
physical alterations or deodorize animal wastes.

(5) Mineral
oil—for topical use and as a lubricant.

(6)
Procaine—as a local anesthetic, use requires a withdrawal period of 90
days after administering to livestock intended for slaughter and 7 days after
administering to dairy animals.

(7) Sucrose
octanoate esters (CAS #s–42922–74–7;
58064–47–4)—in accordance with approved labeling.

(c) As feed
supplements—None.

(d) As feed
additives.

(1) DL–Methionine,
DL–Methionine—hydroxy analog, and DL–Methionine—hydroxy
analog calcium (CAS #–59–51–8; 63–68–3; 348–67–4)—for
use only in organic poultry production until October 1, 2008.

(2) Trace
minerals, used for enrichment or fortification when FDA approved.

(3)
Vitamins, used for enrichment or fortification when FDA approved.

(e) As
synthetic inert ingredients as classified by the Environmental Protection
Agency (EPA), for use with nonsynthetic substances or synthetic substances
listed in this section and used as an active pesticide ingredient in
accordance with any limitations on the use of such substances.

(1) EPA
List 4—Inerts of Minimal Concern.

(2)
[Reserved]

(f)
Excipients, only for use in the manufacture of drugs used to treat organic
livestock when the excipient is: Identified by the FDA as Generally
Recognized As Safe; Approved by the FDA as a food additive; or Included in
the FDA review and approval of a New Animal Drug Application or New Drug
Application.

(g)–(z)
[Reserved]

[72 FR
70484, Dec. 12, 2007]

§ 205.604   Nonsynthetic
substances prohibited for use in organic livestock production.

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The
following nonsynthetic substances may not be used in organic livestock
production:

(a)
Strychnine.

(b)–(z)
[Reserved]

§ 205.605   Nonagricultural
(nonorganic) substances allowed as ingredients in or on processed products
labeled as “organic” or “made with organic (specified
ingredients or food group(s)).”

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The
following nonagricultural substances may be used as ingredients in or on
processed products labeled as “organic” or “made with organic (specified
ingredients or food group(s))” only in accordance with any restrictions
specified in this section.

(a) Nonsynthetics
allowed:

Acids
(Alginic; Citric—produced by microbial fermentation of carbohydrate
substances; and Lactic).

Agar-agar.

Animal
enzymes—(Rennet—animals derived; Catalase—bovine liver; Animal
lipase; Pancreatin; Pepsin; and Trypsin).

Bentonite.

Calcium
carbonate.

Calcium
chloride.

Calcium
sulfate—mined.

Carageenan.

Dairy
cultures.

Diatomaceous
earth—food filtering aid only.

Egg white
lysozyme (CAS # 9001–63–2)

Enzymes—must
be derived from edible, nontoxic plants, nonpathogenic fungi, or
nonpathogenic bacteria.

Flavors,
nonsynthetic sources only and must not be produced using synthetic solvents
and carrier systems or any artificial preservative.

Glucono
delta-lactone—production by the oxidation of D-glucose with bromine
water is prohibited.

Kaolin.

L-Malic
acid (CAS # 97–67–6).

Magnesium
sulfate, nonsynthetic sources only.

Microorganisms—any
food grade bacteria, fungi, and other microorganism.

Nitrogen—oil-free
grades.

Oxygen—oil-free
grades.

Perlite—for
use only as a filter aid in food processing.

Potassium
chloride.

Potassium
iodide.

Sodium
bicarbonate.

Sodium
carbonate.

Tartaric
acid.

Waxes—nonsynthetic
(Carnauba wax; and Wood resin).

Yeast—nonsynthetic,
growth on petrochemical substrate and sulfite waste liquor is prohibited
(Autolysate; Bakers; Brewers; Nutritional; and Smoked—nonsynthetic smoke
flavoring process must be documented).

(b) Synthetics
allowed:

Activated
charcoal (CAS #s 7440–44–0; 64365–11–3)—only from
vegetative sources; for use only as a filtering aid.

Alginates.

Ammonium
bicarbonate—for use only as a leavening agent.

Ammonium
carbonate—for use only as a leavening agent.

Ascorbic
acid.

Calcium
citrate.

Calcium
hydroxide.

Calcium
phosphates (monobasic, dibasic, and tribasic).

Carbon
dioxide.

Cellulose—for
use in regenerative casings, as an anti-caking agent (non-chlorine bleached)
and filtering aid.

Chlorine
materials—disinfecting and sanitizing food contact surfaces, Except, That,
residual chlorine levels in the water shall not exceed the maximum residual
disinfectant limit under the Safe Drinking Water Act (Calcium hypochlorite;
Chlorine dioxide; and Sodium hypochlorite).

Cyclohexylamine
(CAS # 108–91–8)—for use only as a boiler water additive for
packaging sterilization.

Diethylaminoethanol
(CAS # 100–37–8)—for use only as a boiler water additive for
packaging sterilization.

Ethylene—allowed
for postharvest ripening of tropical fruit and degreening of citrus.

Ferrous
sulfate—for iron enrichment or fortification of foods when required by
regulation or recommended (independent organization).

Glycerides
(mono and di)—for use only in drum drying of food.

Glycerin—produced
by hydrolysis of fats and oils.

Hydrogen
peroxide.

Lecithin—bleached.

Magnesium
carbonate—for use only in agricultural products labeled “made with
organic (specified ingredients or food group(s)),” prohibited in agricultural
products labeled “organic”.

Magnesium
chloride—derived from sea water.

Magnesium
stearate—for use only in agricultural products labeled “made with
organic (specified ingredients or food group(s)),” prohibited in agricultural
products labeled “organic”.

Nutrient
vitamins and minerals, in accordance with 21 CFR 104.20, Nutritional Quality
Guidelines For Foods.

Octadecylamine
(CAS # 124–30–1)—for use only as a boiler water additive for packaging
sterilization.

Ozone.

Pectin
(low-methoxy).

Peracetic
acid/Peroxyacetic acid (CAS # 79–21–0)—for use in wash and/or
rinse water according to FDA limitations. For use as a sanitizer on food
contact surfaces.

Phosphoric
acid—cleaning of food-contact surfaces and equipment only.

Potassium
acid tartrate.

Potassium
carbonate.

Potassium
citrate.

Potassium
hydroxide—prohibited for use in lye peeling of fruits and vegetables
except when used for peeling peaches during the Individually Quick Frozen
(IQF) production process.

Potassium
iodide—for use only in agricultural products labeled “made with
organic (specified ingredients or food group(s)),” prohibited in agricultural
products labeled “organic”.

Potassium
phosphate—for use only in agricultural products labeled “made with
organic (specific ingredients or food group(s)),” prohibited in agricultural
products labeled “organic”.

Silicon
dioxide.

Sodium acid
pyrophosphate (CAS # 7758–16–9)—for use only as a leavening
agent.

Sodium
citrate.

Sodium
hydroxide—prohibited for use in lye peeling of fruits and vegetables.

Sodium
phosphates—for use only in dairy foods.

Sulfur
dioxide—for use only in wine labeled “made with organic
grapes,” Provided, That, total sulfite concentration does not exceed 100
ppm.

Tartaric
acid.

Tetrasodium
pyrophosphate (CAS # 7722–88–5)—for use only in meat analog
products.

Tocopherols—derived
from vegetable oil when rosemary extracts are not a suitable alternative.

Xanthan
gum.

(c)–(z)
[Reserved]

[68 FR
61993, Oct. 31, 2003, as amended as 68 FR 62217, Nov. 3, 2003; 71 FR 53302,
Sept. 11, 2006; 72 FR 58473, Oct. 16, 2007]

§ 205.606   Nonorganically
produced agricultural products allowed as ingredients in or on processed
products labeled as “organic.”

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Only the
following nonorganically produced agricultural products may be used as
ingredients in or on processed products labeled as “organic,” only
in accordance with any restrictions specified in this section, and only when
the product is not commercially available in organic form.

(a)
Casings, from processed intestines.

(b) Celery
powder.

(c) Chia ( Salvia
hispanica L. ).

(d) Colors
derived from agricultural products.

(1) Annatto
extract color (pigment CAS # 1393–63–1)—water and oil soluble.

(2) Beet
juice extract color (pigment CAS # 7659–95–2).

(3)
Beta-carotene extract color, derived from carrots (CAS # 1393–63–1).

(4) Black
currant juice color (pigment CAS #'s: 528–58–5, 528–53–0,
643–84–5, 134–01–0, 1429–30–7, and
134–04–3).

(5)
Black/Purple carrot juice color (pigment CAS #'s: 528–58–5, 528–53–0,
643–84–5, 134–01–0, 1429–30–7, and
134–04–3).

(6)
Blueberry juice color (pigment CAS #'s: 528–58–5,
528–53–0, 643–84–5, 134–01–0,
1429–30–7, and 134–04–3).

(7) Carrot
juice color (pigment CAS # 1393–63–1).

(8) Cherry
juice color (pigment CAS #'s: 528–58–5, 528–53–0,
643–84–5, 134–01–0, 1429–30–7, and
134–04–3).

(9)
Chokeberry—Aronia juice color (pigment CAS #'s: 528–58–5,
528–53–0, 643–84–5, 134–01–0,
1429–30–7, and 134–04–3).

(10)
Elderberry juice color (pigment CAS #'s: 528–58–5,
528–53–0, 643–84–5, 134–01–0,
1429–30–7, and 134–04–3).

(11) Grape
juice color (pigment CAS #'s: 528–58–5, 528–53–0,
643–84–5, 134–01–0, 1429–30–7, and
134–04–3).

(12) Grape
skin extract color (pigment CAS #'s: 528–58–5, 528–53–0, 643–84–5,
134–01–0, 1429–30–7, and 134–04–3).

(13)
Paprika color (CAS # 68917–78–2)—dried, and oil extracted.

(14)
Pumpkin juice color (pigment CAS # 127–40–2).

(15) Purple
potato juice (pigment CAS #'s: 528–58–5, 528–53–0, 643–84–5,
134–01–0, 1429–30–7, and 134–04–3).

(16) Red
cabbage extract color (pigment CAS #'s: 528–58–5,
528–53–0, 643–84–5, 134–01–0,
1429–30–7, and 134–04–3).

(17) Red
radish extract color (pigment CAS #'s: 528–58–5,
528–53–0, 643–84–5, 134–01–0,
1429–30–7, and 134–04–3).

(18)
Saffron extract color (pigment CAS # 1393–63–1).

(19)
Turmeric extract color (CAS # 458–37–7).

(e)
Dillweed oil (CAS # 8006–75–5).

(f) Fish
oil (Fatty acid CAS #'s: 10417–94–4, and 25167–62–8)—stabilized
with organic ingredients or only with ingredients on the National List,
§§205.605 and 205.606.

(g)
Fructooligosaccharides (CAS # 308066–66–2).

(h)
Galangal, frozen.

(i) Gelatin
(CAS # 9000–70–8).

(j) Gums—water
extracted only (Arabic; Guar; Locust bean; and Carob bean).

(k) Hops ( Humulus
luplus ).

(l)
Inulin-oligofructose enriched (CAS # 9005–80–5).

(m) Kelp—for
use only as a thickener and dietary supplement.

(n) Konjac
flour (CAS # 37220–17–0).

(o)
Lecithin—unbleached.

(p)
Lemongrass—frozen.

(q) Orange
shellac-unbleached (CAS # 9000–59–3).

(r) Pectin
(high-methoxy).

(s) Peppers
(Chipotle chile).

(t)
Starches.

(1)
Cornstarch (native).

(2) Rice
starch, unmodified (CAS # 977000–08–0)—for use in organic
handling until June 21, 2009.

(3) Sweet
potato starch—for bean thread production only.

(u) Turkish
bay leaves.

(v) Wakame
seaweed ( Undaria pinnatifida ).

(w) Whey
protein concentrate.

[72 FR
35140, June 27, 2007]

§ 205.607   Amending
the National List.

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(a) Any
person may petition the National Organic Standard Board for the purpose of
having a substance evaluated by the Board for recommendation to the Secretary
for inclusion on or deletion from the National List in accordance with the
Act.

(b) A
person petitioning for amendment of the National List should request a copy
of the petition procedures from the USDA at the address in §205.607(c).

(c) A
petition to amend the National List must be submitted to: Program Manager,
USDA/AMS/TMP/NOP, 1400 Independence Ave., SW., Room 4008–So., Ag Stop
0268, Washington, DC 20250.

[65 FR
80637, Dec. 21, 2000, as amended at 68 FR 61993, Oct. 31, 2003]

§§ 205.608-205.619   [Reserved]

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State
Organic Programs

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§ 205.620   Requirements
of State organic programs.

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(a) A State
may establish a State organic program for production and handling operations
within the State which produce and handle organic agricultural products.

(b) A State
organic program must meet the requirements for organic programs specified in
the Act.

(c) A State
organic program may contain more restrictive requirements because of
environmental conditions or the necessity of specific production or handling practices
particular to the State or region of the United States.

(d) A State
organic program must assume enforcement obligations in the State for the
requirements of this part and any more restrictive requirements approved by
the Secretary.

(e) A State
organic program and any amendments to such program must be approved by the
Secretary prior to being implemented by the State.

§ 205.621   Submission
and determination of proposed State organic programs and amendments to
approved State organic programs.

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(a) A State
organic program's governing State official must submit to the Secretary a
proposed State organic program and any proposed amendments to such approved
program.

(1) Such
submission must contain supporting materials that include statutory authorities,
program description, documentation of the environmental conditions or
specific production and handling practices particular to the State which
necessitate more restrictive requirements than the requirements of this part,
and other information as may be required by the Secretary.

(2)
Submission of a request for amendment of an approved State organic program
must contain supporting materials that include an explanation and
documentation of the environmental conditions or specific production and
handling practices particular to the State or region, which necessitates the
proposed amendment. Supporting material also must explain how the proposed
amendment furthers and is consistent with the purposes of the Act and the
regulations of this part.

(b) Within
6 months of receipt of submission, the Secretary will: Notify the State
organic program's governing State official of approval or disapproval of the
proposed program or amendment of an approved program and, if disapproved, the
reasons for the disapproval.

(c) After
receipt of a notice of disapproval, the State organic program's governing
State official may submit a revised State organic program or amendment of
such a program at any time.

§ 205.622   Review
of approved State organic programs.

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The
Secretary will review a State organic program not less than once during each
5-year period following the date of the initial program approval. The
Secretary will notify the State organic program's governing State official of
approval or disapproval of the program within 6 months after initiation of
the review.

§§ 205.623-205.639   [Reserved]

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Fees

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§ 205.640   Fees
and other charges for accreditation.

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Fees and
other charges equal as nearly as may be to the cost of the accreditation
services rendered under the regulations, including initial accreditation, review
of annual reports, and renewal of accreditation, shall be assessed and
collected from applicants for initial accreditation and accredited certifying
agents submitting annual reports or seeking renewal of accreditation in
accordance with the following provisions:

(a) Fees-for-service.
(1) Except as otherwise provided in this section, fees-for-service shall
be based on the time required to render the service provided calculated to
the nearest 15-minute period, including the review of applications and accompanying
documents and information, evaluator travel, the conduct of on-site
evaluations, review of annual reports and updated documents and information,
and the time required to prepare reports and any other documents in
connection with the performance of service. The hourly rate shall be the same
as that charged by the Agricultural Marketing Service, through its Quality
Systems Certification Program, to certification bodies requesting conformity
assessment to the International Organization for Standardization “General
Requirements for Bodies Operating Product Certification Systems” (ISO
Guide 65).

(2)
Applicants for initial accreditation and accredited certifying agents
submitting annual reports or seeking renewal of accreditation during the
first 18 months following the effective date of subpart F of this part shall
receive service without incurring an hourly charge for service.

(3)
Applicants for initial accreditation and renewal of accreditation must pay at
the time of application, effective 18 months following February 20, 2001, a
nonrefundable fee of $500.00 which shall be applied to the applicant's
fees-for-service account.

(b) Travel
charges. When service is requested at a place so distant from the evaluator's
headquarters that a total of one-half hour or more is required for the
evaluator(s) to travel to such place and back to the headquarters or at a
place of prior assignment on circuitous routing requiring a total of one-half
hour or more to travel to the next place of assignment on the circuitous
routing, the charge for such service shall include a mileage charge
administratively determined by the U.S. Department of Agriculture and travel
tolls, if applicable, or such travel prorated among all the applicants and
certifying agents furnished the service involved on an equitable basis or,
when the travel is made by public transportation (including hired vehicles),
a fee equal to the actual cost thereof. Travel charges shall become effective
for all applicants for initial accreditation and accredited certifying agents
on February 20, 2001. The applicant or certifying agent will not be charged a
new mileage rate without notification before the service is rendered.

(c) Per
diem charges. When service is requested at a place away from the
evaluator's headquarters, the fee for such service shall include a per diem
charge if the employee(s) performing the service is paid per diem in
accordance with existing travel regulations. Per diem charges to applicants
and certifying agents will cover the same period of time for which the
evaluator(s) receives per diem reimbursement. The per diem rate will be
administratively determined by the U.S. Department of Agriculture. Per diem
charges shall become effective for all applicants for initial accreditation
and accredited certifying agents on February 20, 2001. The applicant or
certifying agent will not be charged a new per diem rate without notification
before the service is rendered.

(d) Other
costs. When costs, other than costs specified in paragraphs (a), (b), and
(c) of this section, are associated with providing the services, the
applicant or certifying agent will be charged for these costs. Such costs
include but are not limited to equipment rental, photocopying, delivery,
facsimile, telephone, or translation charges incurred in association with
accreditation services. The amount of the costs charged will be determined
administratively by the U.S. Department of Agriculture. Such costs shall
become effective for all applicants for initial accreditation and accredited
certifying agents on February 20, 2001.

§ 205.641   Payment
of fees and other charges.

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(a)
Applicants for initial accreditation and renewal of accreditation must remit
the nonrefundable fee, pursuant to §205.640(a)(3), along with their
application. Remittance must be made payable to the Agricultural Marketing
Service, USDA, and mailed to: Program Manager, USDA-AMS-TMP-NOP, Room
2945-South Building, P.O. Box 96456, Washington, DC 20090–6456 or such
other address as required by the Program Manager.

(b)
Payments for fees and other charges not covered under paragraph (a) of this
section must be:

(1)
Received by the due date shown on the bill for collection;

(2) Made
payable to the Agricultural Marketing Service, USDA; and

(3) Mailed
to the address provided on the bill for collection.

(c) The
Administrator shall assess interest, penalties, and administrative costs on
debts not paid by the due date shown on a bill for collection and collect
delinquent debts or refer such debts to the Department of Justice for
litigation.

§ 205.642   Fees
and other charges for certification.

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Fees
charged by a certifying agent must be reasonable, and a certifying agent
shall charge applicants for certification and certified production and
handling operations only those fees and charges that it has filed with the
Administrator. The certifying agent shall provide each applicant with an
estimate of the total cost of certification and an estimate of the annual
cost of updating the certification. The certifying agent may require
applicants for certification to pay at the time of application a
nonrefundable fee which shall be applied to the applicant's fees-for-service
account. The certifying agent may set the nonrefundable portion of
certification fees; however, the nonrefundable portion of certification fees
must be explained in the fee schedule submitted to the Administrator. The fee
schedule must explain what fee amounts are nonrefundable and at what stage
during the certification process fees become nonrefundable. The certifying
agent shall provide all persons inquiring about the application process with
a copy of its fee schedule.

§§ 205.643-205.649   [Reserved]

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Compliance

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§ 205.660   General.

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(a) The
National Organic Program's Program Manager, on behalf of the Secretary, may
inspect and review certified production and handling operations and
accredited certifying agents for compliance with the Act or regulations in
this part.

(b) The
Program Manager may initiate suspension or revocation proceedings against a
certified operation:

(1) When
the Program Manager has reason to believe that a certified operation has
violated or is not in compliance with the Act or regulations in this part; or

(2) When a
certifying agent or a State organic program's governing State official fails
to take appropriate action to enforce the Act or regulations in this part.

(c) The
Program Manager may initiate suspension or revocation of a certifying agent's
accreditation if the certifying agent fails to meet, conduct, or maintain
accreditation requirements pursuant to the Act or this part.

(d) Each
notification of noncompliance, rejection of mediation, noncompliance
resolution, proposed suspension or revocation, and suspension or revocation
issued pursuant to §205.662, §205.663, and §205.665 and each
response to such notification must be sent to the recipient's place of
business via a delivery service which provides dated return receipts.

§ 205.661   Investigation
of certified operations.

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(a) A
certifying agent may investigate complaints of noncompliance with the Act or
regulations of this part concerning production and handling operations certified
as organic by the certifying agent. A certifying agent must notify the
Program Manager of all compliance proceedings and actions taken pursuant to
this part.

(b) A State
organic program's governing State official may investigate complaints of
noncompliance with the Act or regulations in this part concerning organic
production or handling operations operating in the State.

§ 205.662   Noncompliance
procedure for certified operations.

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(a) Notification.
When an inspection, review, or investigation of a certified operation by
a certifying agent or a State organic program's governing State official
reveals any noncompliance with the Act or regulations in this part, a written
notification of noncompliance shall be sent to the certified operation. 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 certified operation must rebut or correct each
noncompliance and submit supporting documentation of each such correction
when correction is possible.

(b) Resolution.
When a certified operation demonstrates that each noncompliance has been
resolved, the certifying agent or the State organic program's governing State
official, as applicable, shall send the certified operation a written
notification of noncompliance resolution.

(c) Proposed
suspension or revocation. When rebuttal is unsuccessful or correction of
the noncompliance is not completed within the prescribed time period, the
certifying agent or State organic program's governing State official shall
send the certified operation a written notification of proposed suspension or
revocation of certification of the entire operation or a portion of the
operation, as applicable to the noncompliance. When correction of a
noncompliance is not possible, the notification of noncompliance and the
proposed suspension or revocation of certification may be combined in one
notification. The notification of proposed suspension or revocation of
certification shall state:

(1) The
reasons for the proposed suspension or revocation;

(2) The
proposed effective date of such suspension or revocation;

(3) The
impact of a suspension or revocation on future eligibility for certification;
and

(4) The
right to request mediation pursuant to §205.663 or to file an appeal
pursuant to §205.681.

(d) Willful
violations. Notwithstanding paragraph (a) of this section, if a
certifying agent or State organic program's governing State official has
reason to believe that a certified operation has willfully violated the Act
or regulations in this part, the certifying agent or State organic program's
governing State official shall send the certified operation a notification of
proposed suspension or revocation of certification of the entire operation or
a portion of the operation, as applicable to the noncompliance.

(e) Suspension
or revocation. (1) If the certified operation fails to correct the
noncompliance, to resolve the issue through rebuttal or mediation, or to file
an appeal of the proposed suspension or revocation of certification, the
certifying agent or State organic program's governing State official shall
send the certified operation a written notification of suspension or
revocation.

(2) A
certifying agent or State organic program's governing State official must not
send a notification of suspension or revocation to a certified operation that
has requested mediation pursuant to §205.663 or filed an appeal pursuant
to §205.681, while final resolution of either is pending.

(f) Eligibility.
(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.

(2) A
certified operation or a person responsibly connected with an operation whose
certification has been revoked will be ineligible to receive certification
for a period of 5 years following the date of such revocation, Except, That,
the Secretary may, when in the best interest of the certification program,
reduce or eliminate the period of ineligibility.

(g) Violations
of Act. In addition to suspension or revocation, any certified operation
that:

(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 $10,000 per
violation.

(2) Makes a
false statement under the Act to the Secretary, a State organic program's
governing State official, or a certifying agent shall be subject to the
provisions of section 1001 of title 18, United States Code.

§ 205.663   Mediation.

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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.

§ 205.664   [Reserved]

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§ 205.665   Noncompliance
procedure for certifying agents.

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(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.

(b) Resolution.
When the certifying agent demonstrates that each noncompliance has been
resolved, the Program Manager shall send the certifying agent a written
notification of noncompliance resolution.

(c) Proposed
suspension or revocation. When rebuttal is unsuccessful or correction of
the noncompliance is not completed within the prescribed time period, the
Program Manager shall send a written notification of proposed suspension or
revocation of accreditation to the certifying agent. The notification of
proposed suspension or revocation shall state whether the certifying agent's
accreditation or specified areas of accreditation are to be suspended or
revoked. When correction of a noncompliance is not possible, the notification
of noncompliance and the proposed suspension or revocation may be combined in
one notification. The notification of proposed suspension or revocation of
accreditation shall state:

(1) The
reasons for the proposed suspension or revocation;

(2) The
proposed effective date of the suspension or revocation;

(3) The
impact of a suspension or revocation on future eligibility for accreditation;
and

(4) The
right to file an appeal pursuant to §205.681.

(d) Willful
violations. Notwithstanding paragraph (a) of this section, if the Program
Manager has reason to believe that a certifying agent has willfully violated
the Act or regulations in this part, the Program Manager shall send a written
notification of proposed suspension or revocation of accreditation to the
certifying agent.

(e) Suspension
or revocation. When the accredited certifying agent fails to file an
appeal of the proposed suspension or revocation of accreditation, the Program
Manager shall send a written notice of suspension or revocation of
accreditation to the certifying agent.

(f) Cessation
of certification activities. A certifying agent whose accreditation is
suspended or revoked must:

(1) Cease
all certification activities in each area of accreditation and in each State
for which its accreditation is suspended or revoked.

(2)
Transfer to the Secretary and make available to any applicable State organic
program's governing State official all records concerning its certification
activities that were suspended or revoked.

(g) Eligibility.
(1) A certifying agent whose accreditation is suspended by the Secretary
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 accreditation. 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.

(2) A
certifying agent whose accreditation is revoked by the Secretary shall be
ineligible to be accredited as a certifying agent under the Act and the
regulations in this part for a period of not less than 3 years following the
date of such revocation.

§§ 205.666-205.667   [Reserved]

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§ 205.668   Noncompliance
procedures under State organic programs.

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(a) A State
organic program's governing State official must promptly notify the Secretary
of commencement of any noncompliance proceeding against a certified operation
and forward to the Secretary a copy of each notice issued.

(b) A
noncompliance proceeding, brought by a State organic program's governing
State official against a certified operation, shall be appealable pursuant to
the appeal procedures of the State organic program. There shall be no
subsequent rights of appeal to the Secretary. Final decisions of a State may
be appealed to the United States District Court for the district in which
such certified operation is located.

(c) A State
organic program's governing State official may review and investigate
complaints of noncompliance with the Act or regulations concerning
accreditation of certifying agents operating in the State. When such review
or investigation reveals any noncompliance, the State organic program's
governing State official shall send a written report of noncompliance to the
Program Manager. The report shall provide a description of each noncompliance
and the facts upon which the noncompliance is based.

§ 205.669   [Reserved]

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Inspection
and Testing, Reporting, and Exclusion from Sale

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§ 205.670   Inspection
and testing of agricultural product to be sold or labeled “organic.”

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(a) All
agricultural products that are to be sold, labeled, or represented as “100
percent organic,” “organic,” or “made with organic (specified
ingredients or food group(s))” must be made accessible by certified
organic production or handling operations for examination by the
Administrator, the applicable State organic program's governing State
official, or the certifying agent.

(b) The
Administrator, applicable State organic program's governing State official,
or the certifying agent may require preharvest or postharvest testing of any
agricultural input used or agricultural product to be sold, labeled, or
represented as “100 percent organic,” “organic,” or “made
with organic (specified ingredients or food group(s))” when there is
reason to believe that the agricultural input or product has come into
contact with a prohibited substance or has been produced using excluded
methods. Such tests must be conducted by the applicable State organic
program's governing State official or the certifying agent at the official's
or certifying agent's own expense.

(c) The
preharvest or postharvest tissue test sample collection pursuant to paragraph
(b) of this section must be performed by an inspector representing the
Administrator, applicable State organic program's governing State official,
or certifying agent. Sample integrity must be maintained throughout the chain
of custody, and residue testing must be performed in an accredited
laboratory. Chemical analysis must be made in accordance with the methods
described in the most current edition of the Official Methods of Analysis
of the AOAC International or other current applicable validated
methodology determining the presence of contaminants in agricultural
products.

(d) Results
of all analyses and tests performed under this section:

(1) Must be
promptly provided to the Administrator; Except, That, where a State
organic program exists, all test results and analyses shall be provided to
the State organic program's governing State official by the applicable
certifying party that requested testing; and

(2) Will be
available for public access, unless the testing is part of an ongoing
compliance investigation.

(e) If test
results indicate a specific agricultural product contains pesticide residues
or environmental contaminants that exceed the Food and Drug Administration's
or the Environmental Protection Agency's regulatory tolerences, the
certifying agent must promptly report such data to the Federal health agency
whose regulatory tolerance or action level has been exceeded.

§ 205.671   Exclusion
from organic sale.

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When
residue testing detects prohibited substances at levels that are greater than
5 percent of the Environmental Protection Agency's tolerance for the specific
residue detected or unavoidable residual environmental contamination, the
agricultural product must not be sold, labeled, or represented as organically
produced. The Administrator, the applicable State organic program's governing
State official, or the certifying agent may conduct an investigation of the
certified operation to determine the cause of the prohibited substance.

§ 205.672   Emergency
pest or disease treatment.

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When a
prohibited substance is applied to a certified operation due to a Federal or
State emergency pest or disease treatment program and the certified operation
otherwise meets the requirements of this part, the certification status of
the operation shall not be affected as a result of the application of the
prohibited substance: Provided, That:

(a) Any
harvested crop or plant part to be harvested that has contact with a
prohibited substance applied as the result of a Federal or State emergency
pest or disease treatment program cannot be sold, labeled, or represented as
organically produced; and

(b) Any
livestock that are treated with a prohibited substance applied as the result
of a Federal or State emergency pest or disease treatment program or product
derived from such treated livestock cannot be sold, labeled, or represented
as organically produced: Except, That:

(1) Milk or
milk products may be sold, labeled, or represented as organically produced
beginning 12 months following the last date that the dairy animal was treated
with the prohibited substance; and

(2) The
offspring of gestating mammalian breeder stock treated with a prohibited
substance may be considered organic: Provided, That, the breeder stock
was not in the last third of gestation on the date that the breeder stock was
treated with the prohibited substance.

§§ 205.673-205.679   [Reserved]

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Adverse
Action Appeal Process

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§ 205.680   General.

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(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.

(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.

(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.

(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.

(e) All
appeals shall be reviewed, heard, and decided by persons not involved with
the decision being appealed.

§ 205.681   Appeals.

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(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.

(1) If the
Administrator or State organic program sustains a certification applicant's
or certified operation's appeal of a certifying agent's decision, the
applicant will be issued organic certification, or a certified operation will
continue its certification, as applicable to the operation. The act of
sustaining the appeal shall not be an adverse action subject to appeal by the
affected certifying agent.

(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 or the State organic
program's rules of procedure.

(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.

(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.

(d) Where
and what to file. (1) Appeals to the Administrator must be filed in
writing and addressed to: Administrator, USDA, AMS, c/o NOP Appeals Staff,
Stop 0203, Room 302-Annex, 1400 Independence Avenue, SW., Washington, DC
20250–0203.

(2) Appeals
to the State organic program must be filed in writing to the address and
person identified in the letter of notification.

(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.

[65 FR
80637, Dec. 21, 2000, as amended at 71 FR 53303, Sept. 11, 2006]

§§ 205.682-205.689   [Reserved]

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Miscellaneous

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§ 205.690   OMB
control number.

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The control
number assigned to the information collection requirements in this part by
the Office of Management and Budget pursuant to the Paperwork Reduction Act
of 1995, 44 U.S C. Chapter 35, is OMB number 0581–0181.

§§ 205.691-205.699   [Reserved]

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