Reglamento USDA

SUBCHAPTER M—ORGANIC FOODS PRODUCTION ACT
PROVISIONS
PART 205—NATIONAL ORGANIC 205.301 Product composition.

205.302 Calculating the percentage of or-
PROGRAM ganically produced ingredients.
205.303 Packaged products labeled ‘‘100 per-
Subpart A—Definitions cent organic’’ or ‘‘organic.’’
205.304 Packaged products labeled ‘‘made
Sec.
with organic (specified ingredients or
205.1 Meaning of words.
205.2 Terms defined. food group(s)).’’
205.3 Incorporation by reference. 205.305 Multiingredient packaged products
with less that 70 percent organically pro-
Subpart B—Applicability duced ingredients.
205.306 Labeling of livestock feed.
205.100 What has to be certified. 205.307 Labeling of nonretail containers
205.101 Exemptions and exclusions from cer- used for only shipping or storage of raw
tification. or processed agricultural products la-
205.102 Use of the term, ‘‘organic.’’ beled as ‘‘100 percent organic,’’ ‘‘or-
205.103 Recordkeeping by certified oper- ganic,’’ or ‘‘made with organic (specified
ations. ingredients or food group(s)).’’
205.104 [Reserved] 205.308 Agricultural products in other than
205.105 Allowed and prohibited substances, packaged form at the point of retail sale
methods, and ingredients in organic pro- that are sold, labeled, or represented as
duction and handling. ‘‘100 percent organic’’ or ‘‘organic.’’
205.106–205.199 [Reserved] 205.309 Agricultural products in other than
packaged form at the point of retail sale
Subpart C—Organic Production and that are sold, labeled, or represented as
Handling Requirements ‘‘made with organic (specified ingredi-
ents or food group(s)).’’
205.200 General. 205.310 Agricultural products produced on
205.201 Organic production and handling an exempt or excluded operation.
system plan.
205.311 USDA Seal.
205.202 Land requirements.
205.312–205.399 [Reserved]
205.203 Soil fertility and crop nutrient man-
agement practice standard.
205.204 Seeds and planting stock practice
Subpart E—Certification
standard. 205.400 General requirements for certifi-
205.205 Crop rotation practice standard. cation.
205.206 Crop pest, weed, and disease manage- 205.401 Application for certification.
ment practice standard. 205.402 Review of application.
205.207 Wild-crop harvesting practice stand- 205.403 On-site inspections.
ard. 205.404 Granting certification.
205.208–205.235 [Reserved]
205.405 Denial of certification.
205.236 Origin of livestock.
205.406 Continuation of certification.
205.237 Livestock feed.
205.407–205.499 [Reserved]
205.238 Livestock health care practice
standard.
205.239 Livestock living conditions. Subpart F—Accreditation of Certifying
205.240 Pasture practice standard. Agents
205.243–205.269 [Reserved]
205.500 Areas and duration of accreditation.
205.270 Organic handling requirements.
205.271 Facility pest management practice 205.501 General requirements for accredita-
standard. tion.
205.272 Commingling and contact with pro- 205.502 Applying for accreditation.
hibited substance prevention practice 205.503 Applicant information.
standard. 205.504 Evidence of expertise and ability.
205.273–205.289 [Reserved] 205.505 Statement of agreement.
205.290 Temporary variances. 205.506 Granting accreditation.
205.291–205.299 [Reserved] 205.507 Denial of accreditation.
205.508 Site evaluations.
Subpart D—Labels, Labeling, and Market 205.509 Peer review panel.
kpayne on VMOFRWIN702 with $$_JOB
Information 205.510 Annual report, recordkeeping, and

renewal of accreditation.
205.300 Use of the term, ‘‘organic.’’ 205.511–205.599 [Reserved]
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Agricultural Marketing Service, USDA § 205.2
Subpart G—Administrative ‘‘made with organic (specified ingredi-

THE NATIONAL LIST OF ALLOWED AND 205.671 Exclusion from organic sale.
PROHIBITED SUBSTANCES 205.672 Emergency pest or disease treat-
ment.
205.600 Evaluation criteria for allowed and
205.673–205.679 [Reserved]
prohibited substances, methods, and in-
gredients. ADVERSE ACTION APPEAL PROCESS
205.601 Synthetic substances allowed for use
in organic crop production. 205.680 General.
205.602 Nonsynthetic substances prohibited 205.681 Appeals.
for use in organic crop production. 205.682–205.689 [Reserved]
205.603 Synthetic substances allowed for use MISCELLANEOUS
in organic livestock production.
205.604 Nonsynthetic substances prohibited 205.690 OMB control number.
for use in organic livestock production. 205.691–205.699 [Reserved]
205.605 Nonagricultural (nonorganic) sub- AUTHORITY: 7 U.S.C. 6501–6524.
stances allowed as ingredients in or on
processed products labeled as ‘‘organic,’’ SOURCE: 65 FR 80637, Dec. 21, 2000, unless
or ‘‘made with organic (specified ingredi- otherwise noted.
205.606 Nonorganically produced agricul- Subpart A—Definitions
tural products allowed as ingredients in
or on processed products labeled as ‘‘or- § 205.1 Meaning of words.
ganic.’’
205.607 Amending the National List. For the purpose of the regulations in
205.608–205.619 [Reserved] this subpart, words in the singular
form shall be deemed to impart the
STATE ORGANIC PROGRAMS plural and vice versa, as the case may
205.620 Requirements of State organic pro- demand.
grams.
205.621 Submission and determination of § 205.2 Terms defined.
proposed State organic programs and Accreditation. A determination made
amendments to approved State organic
by the Secretary that authorizes a pri-
programs.
205.622 Review of approved State organic vate, foreign, or State entity to con-
programs. duct certification activities as a certi-
205.623–205.639 [Reserved] fying agent under this part.
Act. The Organic Foods Production
FEES Act of 1990, as amended (7 U.S.C. 6501 et
205.640 Fees and other charges for accredita- seq.).
tion. Action level. The limit at or above
205.641 Payment of fees and other charges. which the Food and Drug Administra-
205.642 Fees and other charges for certifi- tion will take legal action against a
cation. product to remove it from the market.
205.643–205.649 [Reserved] Action levels are based on
COMPLIANCE unavoidability of the poisonous or del-
eterious substances and do not rep-
205.660 General.
205.661 Investigation of certified operations.
resent permissible levels of contamina-
205.662 Noncompliance procedure for cer- tion where it is avoidable.
tified operations. Administrator. The Administrator for
205.663 Mediation. the Agricultural Marketing Service,
205.664 [Reserved] United States Departure of Agri-
205.665 Noncompliance procedure for certi- culture, or the representative to whom
fying agents. authority has been delegated to act in
205.666–205.667 [Reserved] the stead of the Administrator.
205.668 Noncompliance procedures under Agricultural inputs. All substances or
State Organic Programs.
205.699 [Reserved]
materials used in the production or
handling of organic agricultural prod-
INSPECTION AND TESTING, REPORTING, AND ucts.
EXCLUSION FROM SALE Agricultural product. Any agricultural
commodity or product, whether raw or
205.670 Inspection and testing of agricul-

tural products to be sold or labeled as processed, including any commodity or
‘‘100 percent organic,’’ ‘‘organic,’’ or product derived from livestock, that is
397
§ 205.2 7 CFR Ch. I (1–1–22 Edition)
marketed in the United States for or ASTM D5988 (both incorporated by

human or livestock consumption. reference; see § 205.3); and
Agricultural Marketing Service (AMS). (3) Must be biobased with content de-
The Agricultural Marketing Service of termined using ASTM D6866 (incor-
the United States Department of Agri- porated by reference; see § 205.3).
culture. Biologics. All viruses, serums, toxins,
Allowed synthetic. A substance that is and analogous products of natural or
included on the National List of syn- synthetic origin, such as diagnostics,
thetic substances allowed for use in or- antitoxins, vaccines, live microorga-
ganic production or handling. nisms, killed microorganisms, and the
AMDUCA. The Animal Medicinal antigenic or immunizing components
Drug Use Clarification Act of 1994 (Pub. of microorganisms intended for use in
L. 103–396). the diagnosis, treatment, or prevention
Animal drug. Any drug as defined in of diseases of animals.
section 201 of the Federal Food, Drug, Breeder stock. Female livestock whose
and Cosmetic Act, as amended (21 offspring may be incorporated into an
U.S.C. 321), that is intended for use in organic operation at the time of their
livestock, including any drug intended birth.
for use in livestock feed but not includ- Buffer zone. An area located between
ing such livestock feed. a certified production operation or por-
Annual seedling. A plant grown from tion of a production operation and an
seed that will complete its life cycle or adjacent land area that is not main-
produce a harvestable yield within the tained under organic management. A
same crop year or season in which it buffer zone must be sufficient in size or
was planted. other features (e.g., windbreaks or a di-
Area of operation. The types of oper- version ditch) to prevent the possi-
ations: crops, livestock, wild-crop har- bility of unintended contact by prohib-
vesting or handling, or any combina- ited substances applied to adjacent
tion thereof that a certifying agent land areas with an area that is part of
may be accredited to certify under this a certified operation.
part. Bulk. The presentation to consumers
Audit trail. Documentation that is at retail sale of an agricultural product
sufficient to determine the source, in unpackaged, loose form, enabling
transfer of ownership, and transpor- the consumer to determine the indi-
tation of any agricultural product la- vidual pieces, amount, or volume of the
beled as ‘‘100 percent organic,’’ the or- product purchased.
ganic ingredients of any agricultural Certification or certified. A determina-
product labeled as ‘‘organic’’ or ‘‘made tion made by a certifying agent that a
with organic (specified ingredients)’’ or production or handling operation is in
the organic ingredients of any agricul- compliance with the Act and the regu-
tural product containing less than 70 lations in this part, which is docu-
percent organic ingredients identified mented by a certificate of organic op-
as organic in an ingredients statement. eration.
Biodegradable. Subject to biological Certified operation. A crop or live-
decomposition into simpler bio- stock production, wild-crop harvesting
chemical or chemical components. or handling operation, or portion of
Biodegradable biobased mulch film. A such operation that is certified by an
synthetic mulch film that meets the accredited certifying agent as utilizing
following criteria: a system of organic production or han-
(1) Meets the compostability speci- dling as described by the Act and the
fications of one of the following stand- regulations in this part.
ards: ASTM D6400, ASTM D6868, EN Certifying agent. Any entity accred-
13432, EN 14995, or ISO 17088 (all incor- ited by the Secretary as a certifying
porated by reference; see § 205.3); agent for the purpose of certifying a
(2) Demonstrates at least 90% bio- production or handling operation as a
degradation absolute or relative to certified production or handling oper-
microcrystalline cellulose in less than ation.
two years, in soil, according to one of Certifying agent’s operation. All sites,
the following test methods: ISO 17556 facilities, personnel, and records used
398
by a certifying agent to conduct cer- Crop. Pastures, cover crops, green

tification activities under the Act and manure crops, catch crops, or any
the regulations in this part. plant or part of a plant intended to be
Claims. Oral, written, implied, or marketed as an agricultural product,
symbolic representations, statements, fed to livestock, or used in the field to
or advertising or other forms of com- manage nutrients and soil fertility.
munication presented to the public or Crop residues. The plant parts remain-
buyers of agricultural products that re- ing in a field after the harvest of a
late to the organic certification proc- crop, which include stalks, stems,
ess or the term, ‘‘100 percent organic,’’ leaves, roots, and weeds.
‘‘organic,’’ or ‘‘made with organic Crop rotation. The practice of alter-
(specified ingredients or food nating the annual crops grown on a
group(s)),’’ or, in the case of agricul- specific field in a planned pattern or
tural products containing less than 70 sequence in successive crop years so
percent organic ingredients, the term, that crops of the same species or fam-
‘‘organic,’’ on the ingredients panel. ily are not grown repeatedly without
Class of animal. A group of livestock interruption on the same field. Peren-
that shares a similar stage of life or nial cropping systems employ means
production. The classes of animals are such as alley cropping, intercropping,
those that are commonly listed on feed and hedgerows to introduce biological
labels. diversity in lieu of crop rotation.
Crop year. That normal growing sea-
Commercially available. The ability to
son for a crop as determined by the
obtain a production input in an appro-
Secretary.
priate form, quality, or quantity to ful-
Cultivation. Digging up or cutting the
fill an essential function in a system of
soil to prepare a seed bed; control
organic production or handling, as de-
weeds; aerate the soil; or work organic
termined by the certifying agent in the
matter, crop residues, or fertilizers
course of reviewing the organic plan.
into the soil.
Commingling. Physical contact be- Cultural methods. Methods used to en-
tween unpackaged organically pro- hance crop health and prevent weed,
duced and nonorganically produced ag- pest, or disease problems without the
ricultural products during production, use of substances; examples include the
processing, transportation, storage or selection of appropriate varieties and
handling, other than during the manu- planting sites; proper timing and den-
facture of a multiingredient product sity of plantings; irrigation; and ex-
containing both types of ingredients. tending a growing season by manipu-
Compost. The product of a managed lating the microclimate with green
process through which microorganisms houses, cold frames, or wind breaks.
break down plant and animal materials Detectable residue. The amount or
into more available forms suitable for presence of chemical residue or sample
application to the soil. Compost must component that can be reliably ob-
be produced through a process that served or found in the sample matrix
combines plant and animal materials by current approved analytical meth-
with an initial C:N ratio of between odology.
25:1 and 40:1. Producers using an in-ves- Disease vectors. Plants or animals
sel or static aerated pile system must that harbor or transmit disease orga-
maintain the composting materials at nisms or pathogens which may attack
a temperature between 131 °F and 170 crops or livestock.
°F for 3 days. Producers using a wind- Drift. The physical movement of pro-
row system must maintain the hibited substances from the intended
composting materials at a temperature target site onto an organic operation
between 131 °F and 170 °F for 15 days, or portion thereof.
during which time, the materials must Dry lot. A fenced area that may be
be turned a minimum of five times. covered with concrete, but that has lit-
Control. Any method that reduces or tle or no vegetative cover.
limits damage by populations of pests, Dry matter. The amount of a feedstuff
weeds, or diseases to levels that do not remaining after all the free moisture is
significantly reduce productivity. evaporated out.
399
§ 205.2 7 CFR Ch. I (1–1–22 Edition)
Dry matter demand. The expected dry Feedlot. A dry lot for the controlled
matter intake for a class of animal. feeding of livestock.
Dry matter intake. Total pounds of all Feed supplement. A combination of
feed, devoid of all moisture, consumed feed nutrients added to livestock feed
by a class of animals over a given pe- to improve the nutrient balance or per-
riod of time. formance of the total ration and in-
Emergency pest or disease treatment tended to be:
program. A mandatory program author- (1) Diluted with other feeds when fed
ized by a Federal, State, or local agen- to livestock;
cy for the purpose of controlling or (2) Offered free choice with other
eradicating a pest or disease. parts of the ration if separately avail-
Employee. Any person providing paid able; or
or volunteer services for a certifying (3) Further diluted and mixed to
agent. produce a complete feed.
Excipients. Any ingredients that are Fertilizer. A single or blended sub-
intentionally added to livestock medi- stance containing one or more recog-
cations but do not exert therapeutic or nized plant nutrient(s) which is used
diagnostic effects at the intended dos- primarily for its plant nutrient content
age, although they may act to improve and which is designed for use or
product delivery (e.g., enhancing ab- claimed to have value in promoting
sorption or controlling release of the plant growth.
drug substance). Examples of such in- Field. An area of land identified as a
gredients include fillers, extenders, discrete unit within a production oper-
diluents, wetting agents, solvents, ation.
emulsifiers, preservatives, flavors, ab- Forage. Vegetative material in a
sorption enhancers, sustained-release fresh, dried, or ensiled state (pasture,
matrices, and coloring agents. hay, or silage), which is fed to live-
Excluded methods. A variety of meth- stock.
ods used to genetically modify orga- Governmental entity. Any domestic
nisms or influence their growth and de- government, tribal government, or for-
velopment by means that are not pos- eign governmental subdivision pro-
sible under natural conditions or proc- viding certification services.
esses and are not considered compat- Graze. (1) The consumption of stand-
ible with organic production. Such ing or residual forage by livestock.
methods include cell fusion, micro- (2) To put livestock to feed on stand-
encapsulation and macroencapsulation, ing or residual forage.
and recombinant DNA technology (in- Grazing. To graze.
cluding gene deletion, gene doubling, Grazing season. The period of time
introducing a foreign gene, and chang- when pasture is available for grazing,
ing the positions of genes when due to natural precipitation or irriga-
achieved by recombinant DNA tech- tion. Grazing season dates may vary
nology). Such methods do not include because of mid-summer heat/humidity,
the use of traditional breeding, con- significant precipitation events, floods,
jugation, fermentation, hybridization, hurricanes, droughts or winter weather
in vitro fertilization, or tissue culture. events. Grazing season may be ex-
Feed. Edible materials which are con- tended by the grazing of residual forage
sumed by livestock for their nutri- as agreed in the operation’s organic
tional value. Feed may be concentrates system plan. Due to weather, season,
(grains) or roughages (hay, silage, fod- or climate, the grazing season may or
der). The term, ‘‘feed,’’ encompasses all may not be continuous. Grazing season
agricultural commodities, including may range from 120 days to 365 days,
pasture ingested by livestock for nutri- but not less than 120 days per year.
tional purposes. Handle. To sell, process, or package
Feed additive. A substance added to agricultural products, except such
feed in micro quantities to fulfill a spe- term shall not include the sale, trans-
cific nutritional need; i.e., essential portation, or delivery of crops or live-
nutrients in the form of amino acids, stock by the producer thereof to a han-
vitamins, and minerals. dler.
400
Handler. Any person engaged in the Ingredient. Any substance used in the
business of handling agricultural prod- preparation of an agricultural product
ucts, including producers who handle that is still present in the final com-
crops or livestock of their own produc- mercial product as consumed.
tion, except such term shall not in- Ingredients statement. The list of in-
clude final retailers of agricultural gredients contained in a product shown
products that do not process agricul- in their common and usual names in
tural products. the descending order of predominance.
Handling operation. Any operation or Inspection. The act of examining and
portion of an operation (except final evaluating the production or handling
retailers of agricultural products that operation of an applicant for certifi-
do not process agricultural products) cation or certified operation to deter-
that receives or otherwise acquires ag- mine compliance with the Act and the
ricultural products and processes, regulations in this part.
packages, or stores such products. Inspector. Any person retained or
Immediate family. The spouse, minor used by a certifying agent to conduct
children, or blood relatives who reside inspections of certification applicants
in the immediate household of a certi- or certified production or handling op-
fying agent or an employee, inspector, erations.
contractor, or other personnel of the Label. A display of written, printed,
certifying agent. For the purpose of or graphic material on the immediate
this part, the interest of a spouse, container of an agricultural product or
minor child, or blood relative who is a any such material affixed to any agri-
resident of the immediate household of cultural product or affixed to a bulk
a certifying agent or an employee, in- container containing an agricultural
spector, contractor, or other personnel product, except for package liners or a
of the certifying agent shall be consid- display of written, printed, or graphic
material which contains only informa-
ered to be an interest of the certifying
tion about the weight of the product.
agent or an employee, inspector, con-
Labeling. All written, printed, or
tractor, or other personnel of the certi-
graphic material accompanying an ag-
fying agent.
ricultural product at any time or writ-
Inclement weather. Weather that is ten, printed, or graphic material about
violent, or characterized by tempera- the agricultural product displayed at
tures (high or low), or characterized by retail stores about the product.
excessive precipitation that can cause Livestock. Any cattle, sheep, goats,
physical harm to a given species of swine, poultry, or equine animals used
livestock. Production yields or growth for food or in the production of food,
rates of livestock lower than the max- fiber, feed, or other agricultural-based
imum achievable do not qualify as consumer products; wild or domes-
physical harm. ticated game; or other nonplant life,
Inert ingredient. Any substance (or except such term shall not include
group of substances with similar chem- aquatic animals for the production of
ical structures if designated by the En- food, fiber, feed, or other agricultural-
vironmental Protection Agency) other based consumer products.
than an active ingredient which is in- Lot. Any number of containers which
tentionally included in any pesticide contain an agricultural product of the
product (40 CFR 152.3(m)). same kind located in the same convey-
Information panel. That part of the ance, warehouse, or packing house and
label of a packaged product that is im- which are available for inspection at
mediately contiguous to and to the the same time.
right of the principal display panel as Manure. Feces, urine, other excre-
observed by an individual facing the ment, and bedding produced by live-
principal display panel, unless another stock that has not been composted.
section of the label is designated as the Market information. Any written,
information panel because of package printed, audiovisual, or graphic infor-
size or other package attributes (e.g., mation, including advertising, pam-
irregular shape with one usable sur- phlets, flyers, catalogues, posters, and
face). signs, distributed, broadcast, or made
401
§ 205.2 7 CFR Ch. I (1–1–22 Edition)
available outside of retail outlets that Nontoxic. Not known to cause any ad-
are used to assist in the sale or pro- verse physiological effects in animals,
motion of a product. plants, humans, or the environment.
Mulch. Any nonsynthetic material, Organic. A labeling term that refers
such as wood chips, leaves, or straw, or to an agricultural product produced in
any synthetic material included on the accordance with the Act and the regu-
National List for such use, such as lations in this part.
newspaper or plastic that serves to sup- Organic matter. The remains, resi-
press weed growth, moderate soil tem- dues, or waste products of any orga-
perature, or conserve soil moisture. nism.
Narrow range oils. Petroleum deriva-
Organic production. A production sys-
tives, predominately of paraffinic and
tem that is managed in accordance
napthenic fractions with 50 percent
with the Act and regulations in this
boiling point (10 mm Hg) between 415
°F and 440 °F. part to respond to site-specific condi-
National List. A list of allowed and tions by integrating cultural, biologi-
prohibited substances as provided for cal, and mechanical practices that fos-
in the Act. ter cycling of resources, promote eco-
National Organic Program (NOP). The logical balance, and conserve biodiver-
program authorized by the Act for the sity.
purpose of implementing its provisions. Organic system plan. A plan of man-
National Organic Standards Board agement of an organic production or
(NOSB). A board established by the handling operation that has been
Secretary under 7 U.S.C. 6518 to assist agreed to by the producer or handler
in the development of standards for and the certifying agent and that in-
substances to be used in organic pro- cludes written plans concerning all as-
duction and to advise the Secretary on pects of agricultural production or
any other aspects of the implementa- handling described in the Act and the
tion of the National Organic Program. regulations in subpart C of this part.
Natural resources of the operation. The Pasture. Land used for livestock graz-
physical, hydrological, and biological ing that is managed to provide feed
features of a production operation, in- value and maintain or improve soil,
cluding soil, water, wetlands, wood- water, and vegetative resources.
lands, and wildlife. Peer review panel. A panel of individ-
Nonagricultural substance. A sub- uals who have expertise in organic pro-
stance that is not a product of agri- duction and handling methods and cer-
culture, such as a mineral or a bac- tification procedures and who are ap-
terial culture, that is used as an ingre- pointed by the Administrator to assist
dient in an agricultural product. For in evaluating applicants for accredita-
the purposes of this part, a non- tion as certifying agents.
agricultural ingredient also includes Person. An individual, partnership,
any substance, such as gums, citric corporation, association, cooperative,
acid, or pectin, that is extracted from,
or other entity.
isolated from, or a fraction of an agri-
Pesticide. Any substance which alone,
cultural product so that the identity of
the agricultural product is unrecogniz- in chemical combination, or in any for-
able in the extract, isolate, or fraction. mulation with one or more substances
Nonsynthetic (natural). A substance is defined as a pesticide in section 2(u)
that is derived from mineral, plant, or of the Federal Insecticide, Fungicide,
animal matter and does not undergo a and Rodenticide Act (7 U.S.C. 136(u) et
synthetic process as defined in section seq).
6502(21) of the Act (7 U.S.C. 6502(21)). Petition. A request to amend the Na-
For the purposes of this part, nonsyn- tional List that is submitted by any
thetic is used as a synonym for natural person in accordance with this part.
as the term is used in the Act. Planting stock. Any plant or plant tis-
Nonretail container. Any container sue other than annual seedlings but in-
used for shipping or storage of an agri- cluding rhizomes, shoots, leaf or stem
cultural product that is not used in the cuttings, roots, or tubers, used in plant
retail display or sale of the product. production or propagation.
402
Practice standard. The guidelines and Prohibited substance. A substance the

requirements through which a produc- use of which in any aspect of organic
tion or handling operation implements production or handling is prohibited or
a required component of its production not provided for in the Act or the regu-
or handling organic system plan. A lations of this part.
practice standard includes a series of Records. Any information in written,
allowed and prohibited actions, mate- visual, or electronic form that docu-
rials, and conditions to establish a ments the activities undertaken by a
minimum level performance for plan- producer, handler, or certifying agent
ning, conducting, and maintaining a to comply with the Act and regulations
function, such as livestock health care in this part.
or facility pest management, essential Residual forage. Forage cut and left to
to an organic operation. lie, or windrowed and left to lie, in
Principal display panel. That part of a place in the pasture.
label that is most likely to be dis- Residue testing. An official or vali-
played, presented, shown, or examined dated analytical procedure that de-
under customary conditions of display tects, identifies, and measures the
for sale. presence of chemical substances, their
Private entity. Any domestic or for- metabolites, or degradation products in
eign nongovernmental for-profit or or on raw or processed agricultural
not-for-profit organization providing products.
certification services. Responsibly connected. Any person
who is a partner, officer, director, hold-
Processing. Cooking, baking, curing,
er, manager, or owner of 10 percent or
heating, drying, mixing, grinding,
more of the voting stock of an appli-
churning, separating, extracting,
cant or a recipient of certification or
slaughtering, cutting, fermenting, dis-
accreditation.
tilling, eviscerating, preserving, dehy-
Retail food establishment. A res-
drating, freezing, chilling, or otherwise
taurant; delicatessen; bakery; grocery
manufacturing and includes the pack-
store; or any retail outlet with an in-
aging, canning, jarring, or otherwise
store restaurant, delicatessen, bakery,
enclosing food in a container.
salad bar, or other eat-in or carry-out
Processing aid. (1) Substance that is service of processed or prepared raw
added to a food during the processing and ready-to-eat-food.
of such food but is removed in some Routine use of parasiticide. The reg-
manner from the food before it is pack- ular, planned, or periodic use of
aged in its finished form; parasiticides.
(2) a substance that is added to a food Secretary. The Secretary of Agri-
during processing, is converted into culture or a representative to whom
constituents normally present in the authority has been delegated to act in
food, and does not significantly in- the Secretary’s stead.
crease the amount of the constituents Sewage sludge. A solid, semisolid, or
naturally found in the food; and liquid residue generated during the
(3) a substance that is added to a food treatment of domestic sewage in a
for its technical or functional effect in treatment works. Sewage sludge in-
the processing but is present in the fin- cludes but is not limited to: domestic
ished food at insignificant levels and septage; scum or solids removed in pri-
does not have any technical or func- mary, secondary, or advanced waste-
tional effect in that food. water treatment processes; and a mate-
Producer. A person who engages in rial derived from sewage sludge. Sew-
the business of growing or producing age sludge does not include ash gen-
food, fiber, feed, and other agricul- erated during the firing of sewage
tural-based consumer products. sludge in a sewage sludge incinerator
Production lot number/identifier. Iden- or grit and screenings generated during
tification of a product based on the preliminary treatment of domestic
production sequence of the product sewage in a treatment works.
showing the date, time, and place of Shelter. Structures such as barns,
production used for quality control sheds, or windbreaks; or natural areas

purposes. such as woods, tree lines, large hedge
403
§ 205.3 7 CFR Ch. I (1–1–22 Edition)
rows, or geographic land features, that Temporary and Temporarily. Occurring

are designed or selected to provide for a limited time only (e.g., overnight,
physical protection or housing to all throughout a storm, during a period of
animals. illness, the period of time specified by
Slaughter stock. Any animal that is the Administrator when granting a
intended to be slaughtered for con- temporary variance), not permanent or
sumption by humans or other animals. lasting.
Soil and water quality. Observable in- Tolerance. The maximum legal level
dicators of the physical, chemical, or of a pesticide chemical residue in or on
biological condition of soil and water, a raw or processed agricultural com-
including the presence of environ- modity or processed food.
mental contaminants. Transplant. A seedling which has been
Split operation. An operation that pro- removed from its original place of pro-
duces or handles both organic and non- duction, transported, and replanted.
organic agricultural products. Unavoidable residual environmental
Stage of life. A discrete time period in contamination (UREC). Background lev-
an animal’s life which requires specific els of naturally occurring or synthetic
management practices different than chemicals that are present in the soil
during other periods (e.g., poultry dur- or present in organically produced ag-
ing feathering). Breeding, freshening, ricultural products that are below es-
lactation and other recurring events tablished tolerances.
are not a stage of life. Wild crop. Any plant or portion of a
State. Any of the several States of the plant that is collected or harvested
United States of America, its terri- from a site that is not maintained
tories, the District of Columbia, and under cultivation or other agricultural
the Commonwealth of Puerto Rico. management.
State certifying agent. A certifying Yards/Feeding pad. An area for feed-
agent accredited by the Secretary ing, exercising, and outdoor access for
under the National Organic Program livestock during the non-grazing sea-
and operated by the State for the pur- son and a high traffic area where ani-
poses of certifying organic production mals may receive supplemental feeding
and handling operations in the State. during the grazing season.
State organic program (SOP). A State [65 FR 80637, Dec. 21, 2000, as amended at 72
program that meets the requirements FR 70484, Dec. 12, 2007; 75 FR 7192, Feb. 17,
of section 6506 of the Act, is approved 2010; 79 FR 58662, Sept. 30, 2014; 80 FR 6429,
by the Secretary, and is designed to en- Feb. 5, 2015]
sure that a product that is sold or la-
beled as organically produced under § 205.3 Incorporation by reference.
the Act is produced and handled using (a) Certain material is incorporated
organic methods. by reference into this part with the ap-
State organic program’s governing State proval of the Director of the Federal
official. The chief executive official of a Register under 5 U.S.C. 552(a) and 1
State or, in the case of a State that CFR part 51. To enforce any edition
provides for the statewide election of other than that specified in this sec-
an official to be responsible solely for tion, we must publish notice of change
the administration of the agricultural in the FEDERAL REGISTER and the ma-
operations of the State, such official terial must be available to the public.
who administers a State organic cer- All approved material is available for
tification program. inspection at the USDA Agricultural
Synthetic. A substance that is formu- Marketing Service, National Organic
lated or manufactured by a chemical Program, 1400 Independence Avenue
process or by a process that chemically SW., Washington, DC 20250; (202) 720–
changes a substance extracted from 3252, and is available from the sources
naturally occurring plant, animal, or listed below. It is also available for in-
mineral sources, except that such term spection at the National Archives and
shall not apply to substances created Records Administration (NARA). For
by naturally occurring biological proc- information on the availability of this

esses. material at NARA, call (202) 741–6030 or
404
go to http://www.archives.gov/fed- mate aerobic biodegradability of plas-

eral_register/code_of_federal_regulations/ tic materials in soil by measuring the
ibr_locations.html. oxygen demand in a respirometer or
(b) ASTM International, 100 Barr the amount of carbon dioxide evolved,’’
Harbor Drive, PO Box C700, West August 15, 2012, IBR approved for
Conshohocken, PA 19428; phone 1–877– § 205.2.
909–2786; http://www.astm.org/.
(1) ASTM D5988–12 (‘‘ASTM D5988’’), [79 FR 58662, Sept. 30, 2014]
‘‘Standard Test Method for Deter-
mining Aerobic Biodegradation of Plas- Subpart B—Applicability
tic Materials in Soil,’’ approved May 1,
2012, IBR approved for § 205.2. § 205.100 What has to be certified.
(2) ASTM D6400–12 (‘‘ASTM D6400’’), (a) Except for operations exempt or
‘‘Standard Specification for Labeling excluded in § 205.101, each production or
of Plastics Designed to be Aerobically handling operation or specified portion
Composted in Municipal or Industrial of a production or handling operation
Facilities,’’ approved May 15, 2012, IBR that produces or handles crops, live-
approved for § 205.2.
stock, livestock products, or other ag-
(3) ASTM D6866–12 (‘‘ASTM D6866’’),
ricultural products that are intended
‘‘Standard Test Methods for Deter-
to be sold, labeled, or represented as
mining the Biobased Content of Solid,
Liquid, and Gaseous Samples Using Ra- ‘‘100 percent organic,’’ ‘‘organic,’’ or
diocarbon Analysis,’’ approved April 1, ‘‘made with organic (specified ingredi-
2012, IBR approved for § 205.2. ents or food group(s))’’ must be cer-
(4) ASTM D6868–11 (‘‘ASTM D6868’’), tified according to the provisions of
‘‘Standard Specification for Labeling subpart E of this part and must meet
of End Items that Incorporate Plastics all other applicable requirements of
and Polymers as Coatings or Additives this part.
with Paper and Other Substrates De- (b) Any production or handling oper-
signed to be Aerobically Composted in ation or specified portion of a produc-
Municipal or Industrial Facilities,’’ ap- tion or handling operation that has
proved February 1, 2011, IBR approved been already certified by a certifying
for § 205.2. agent on the date that the certifying
(c) European Committee for Stand- agent receives its accreditation under
ardization; Avenue Marnix, 17–B–1000 this part shall be deemed to be cer-
Brussels; phone 32 2 550 08 11; tified under the Act until the oper-
www.cen.eu. ation’s next anniversary date of certifi-
(1) EN 13432:2000:E (‘‘EN 13432’’), Sep- cation. Such recognition shall only be
tember, 2000, ‘‘Requirements for pack- available to those operations certified
aging recoverable through composting by a certifying agent that receives its
and biodegradation—Test scheme and accreditation within 18 months from
evaluation criteria for the final accept- February 20, 2001.
ance of packaging,’’ IBR approved for (c) Any operation that:
§ 205.2. (1) Knowingly sells or labels a prod-
(2) EN 14995:2006:E (‘‘EN 14995’’), De- uct as organic, except in accordance
cember, 2006, ‘‘Plastics—Evaluation of with the Act, shall be subject to a civil
compostability—Test scheme and spec- penalty of not more than the amount
ifications,’’ IBR approved for § 205.2. specified in § 3.91(b)(1) of this title per
(d) International Organization for violation.
Standardization, 1, ch. de la Voie-
(2) Makes a false statement under the
Creuse, CP 56, CH–1211 Geneva 20, Swit-
Act to the Secretary, a governing
zerland; phone 41 22 749 01 11;
www.iso.org. State official, or an accredited certi-
(1) ISO 17088:2012(E), (‘‘ISO 17088’’), fying agent shall be subject to the pro-
‘‘Specifications for compostable plas- visions of section 1001 of title 18,
tics,’’ June 1, 2012, IBR approved for United States Code.
§ 205.2.
[65 FR 80637, Dec. 21, 2000, as amended at 70

(2) ISO 17556:2012(E) (‘‘ISO 17556’’), FR 29579, May 24, 2005; 80 FR 6429, Feb. 5,
‘‘Plastics—Determination of the ulti- 2015]
405
§ 205.101 7 CFR Ch. I (1–1–22 Edition)
§ 205.101 Exemptions and exclusions (b) Exclusions. (1) A handling oper-

from certification. ation or portion of a handling oper-
(a) Exemptions. (1) A production or ation is excluded from the require-
handling operation that sells agricul- ments of this part, except for the re-
tural products as ‘‘organic’’ but whose quirements for the prevention of com-
gross agricultural income from organic mingling and contact with prohibited
sales totals $5,000 or less annually is substances as set forth in § 205.272 with
exempt from certification under sub- respect to any organically produced
part E of this part and from submitting products, if such operation or portion
an organic system plan for acceptance of the operation only sells organic agri-
or approval under § 205.201 but must cultural products labeled as ‘‘100 per-
comply with the applicable organic cent organic,’’ ‘‘organic,’’ or ‘‘made
production and handling requirements with organic (specified ingredients or
of subpart C of this part and the label- food group(s))’’ that:
ing requirements of § 205.310. The prod- (i) Are packaged or otherwise en-
ucts from such operations shall not be closed in a container prior to being re-
used as ingredients identified as or- ceived or acquired by the operation;
ganic in processed products produced and
by another handling operation. (ii) Remain in the same package or
(2) A handling operation that is a re- container and are not otherwise proc-
tail food establishment or portion of a essed while in the control of the han-
retail food establishment that handles dling operation.
organically produced agricultural prod- (2) A handling operation that is a re-
ucts but does not process them is ex- tail food establishment or portion of a
empt from the requirements in this retail food establishment that proc-
part. esses, on the premises of the retail food
(3) A handling operation or portion of establishment, raw and ready-to-eat
a handling operation that only handles food from agricultural products that
agricultural products that contain less were previously labeled as ‘‘100 percent
than 70 percent organic ingredients by organic,’’ ‘‘organic,’’ or ‘‘made with or-
total weight of the finished product ganic (specified ingredients or food
(excluding water and salt) is exempt group(s))’’ is excluded from the require-
from the requirements in this part, ex- ments in this part, except:
cept: (i) The requirements for the preven-
(i) The provisions for prevention of tion of contact with prohibited sub-
contact of organic products with pro- stances as set forth in § 205.272; and
hibited substances set forth in § 205.272
(ii) The labeling provisions of
with respect to any organically pro-
§ 205.310.
duced ingredients used in an agricul-
tural product; (c) Records to be maintained by exempt
(ii) The labeling provisions of operations. (1) Any handling operation
§§ 205.305 and 205.310; and exempt from certification pursuant to
(iii) The recordkeeping provisions in paragraph (a)(3) or (a)(4) of this section
paragraph (c) of this section. must maintain records sufficient to:
(4) A handling operation or portion of (i) Prove that ingredients identified
a handling operation that only identi- as organic were organically produced
fies organic ingredients on the infor- and handled; and
mation panel is exempt from the re- (ii) Verify quantities produced from
quirements in this part, except: such ingredients.
(i) The provisions for prevention of (2) Records must be maintained for
contact of organic products with pro- no less than 3 years beyond their cre-
hibited substances set forth in § 205.272 ation and the operations must allow
with respect to any organically pro- representatives of the Secretary and
duced ingredients used in an agricul- the applicable State organic programs’
tural product; governing State official access to these
(ii) The labeling provisions of records for inspection and copying dur-
§§ 205.305 and 205.310; and ing normal business hours to determine
(iii) The recordkeeping provisions in compliance with the applicable regula-

paragraph (c) of this section. tions set forth in this part.
406
§ 205.102 Use of the term, ‘‘organic.’’ group(s)),’’ the product must be pro-
Any agricultural product that is sold, duced and handled without the use of:
labeled, or represented as ‘‘100 percent (a) Synthetic substances and ingredi-
organic,’’ ‘‘organic,’’ or ‘‘made with or- ents, except as provided in § 205.601 or
ganic (specified ingredients or food § 205.603;
group(s))’’ must be: (b) Nonsynthetic substances prohib-
(a) Produced in accordance with the ited in § 205.602 or § 205.604;
requirements specified in § 205.101 or (c) Nonagricultural substances used
§§ 205.202 through 205.207 or §§ 205.236 in or on processed products, except as
through 205.240 and all other applicable otherwise provided in § 205.605;
requirements of part 205; and (d) Nonorganic agricultural sub-
(b) Handled in accordance with the stances used in or on processed prod-
requirements specified in § 205.101 or ucts, except as otherwise provided in
§§ 205.270 through 205.272 and all other § 205.606;
applicable requirements of this part (e) Excluded methods, except for vac-
205. cines: Provided, That, the vaccines are
[65 FR 80637, Dec. 21, 2000, as amended at 75 approved in accordance with
FR 7193, Feb. 17, 2010] § 205.600(a);
(f) Ionizing radiation, as described in
§ 205.103 Recordkeeping by certified Food and Drug Administration regula-
operations.
tion, 21 CFR 179.26; and
(a) A certified operation must main- (g) Sewage sludge.
tain records concerning the production,
harvesting, and handling of agricul- §§ 205.106–205.199 [Reserved]
tural products that are or that are in-
tended to be sold, labeled, or rep-
resented as ‘‘100 percent organic,’’ ‘‘or-
Subpart C—Organic Production
ganic,’’ or ‘‘made with organic (speci- and Handling Requirements
fied ingredients or food group(s)).’’
§ 205.200 General.
(b) Such records must:
(1) Be adapted to the particular busi- The producer or handler of a produc-
ness that the certified operation is con- tion or handling operation intending to
ducting; sell, label, or represent agricultural
(2) Fully disclose all activities and products as ‘‘100 percent organic,’’ ‘‘or-
transactions of the certified operation ganic,’’ or ‘‘made with organic (speci-
in sufficient detail as to be readily un- fied ingredients or food group(s))’’ must
derstood and audited; comply with the applicable provisions
(3) Be maintained for not less than 5 of this subpart. Production practices
years beyond their creation; and implemented in accordance with this
(4) Be sufficient to demonstrate com- subpart must maintain or improve the
pliance with the Act and the regula- natural resources of the operation, in-
tions in this part. cluding soil and water quality.
(c) The certified operation must
make such records available for inspec- § 205.201 Organic production and han-
tion and copying during normal busi- dling system plan.
ness hours by authorized representa- (a) The producer or handler of a pro-
tives of the Secretary, the applicable duction or handling operation, except
State program’s governing State offi- as exempt or excluded under § 205.101,
cial, and the certifying agent. intending to sell, label, or represent ag-
§ 205.104 [Reserved] ricultural products as ‘‘100 percent or-
ganic,’’ ‘‘organic,’’ or ‘‘made with or-
§ 205.105 Allowed and prohibited sub- ganic (specified ingredients or food
stances, methods, and ingredients group(s))’’ must develop an organic
in organic production and han- production or handling system plan
dling. that is agreed to by the producer or
To be sold or labeled as ‘‘100 percent handler and an accredited certifying
organic,’’ ‘‘organic,’’ or ‘‘made with or- agent. An organic system plan must
ganic (specified ingredients or food meet the requirements set forth in this
407
§ 205.202 7 CFR Ch. I (1–1–22 Edition)
section for organic production or han- crop or contact with a prohibited sub-
dling. An organic production or han- stance applied to adjoining land that is
dling system plan must include: not under organic management.
(1) A description of practices and pro-
cedures to be performed and main- § 205.203 Soil fertility and crop nutri-
tained, including the frequency with ent management practice standard.
which they will be performed; (a) The producer must select and im-
(2) A list of each substance to be used plement tillage and cultivation prac-
as a production or handling input, indi- tices that maintain or improve the
cating its composition, source, loca- physical, chemical, and biological con-
tion(s) where it will be used, and docu- dition of soil and minimize soil ero-
mentation of commercial availability, sion.
as applicable; (b) The producer must manage crop
(3) A description of the monitoring nutrients and soil fertility through ro-
practices and procedures to be per- tations, cover crops, and the applica-
formed and maintained, including the tion of plant and animal materials.
frequency with which they will be per- (c) The producer must manage plant
formed, to verify that the plan is effec- and animal materials to maintain or
tively implemented; improve soil organic matter content in
(4) A description of the recordkeeping a manner that does not contribute to
system implemented to comply with contamination of crops, soil, or water
the requirements established in by plant nutrients, pathogenic orga-
§ 205.103; nisms, heavy metals, or residues of pro-
(5) A description of the management hibited substances. Animal and plant
practices and physical barriers estab- materials include:
lished to prevent commingling of or- (1) Raw animal manure, which must
ganic and nonorganic products on a be composted unless it is:
split operation and to prevent contact (i) Applied to land used for a crop not
of organic production and handling op- intended for human consumption;
erations and products with prohibited (ii) Incorporated into the soil not less
substances; and than 120 days prior to the harvest of a
(6) Additional information deemed product whose edible portion has direct
necessary by the certifying agent to contact with the soil surface or soil
evaluate compliance with the regula- particles; or
tions. (iii) Incorporated into the soil not
(b) A producer may substitute a plan less than 90 days prior to the harvest of
prepared to meet the requirements of a product whose edible portion does not
another Federal, State, or local gov- have direct contact with the soil sur-
ernment regulatory program for the or- face or soil particles;
ganic system plan: Provided, That, the (2) Composted plant and animal ma-
submitted plan meets all the require- terials produced though a process that:
ments of this subpart. (i) Established an initial C:N ratio of
between 25:1 and 40:1; and
§ 205.202 Land requirements. (ii) Maintained a temperature of be-
Any field or farm parcel from which tween 131 °F and 170 °F for 3 days using
harvested crops are intended to be sold, an in-vessel or static aerated pile sys-
labeled, or represented as ‘‘organic,’’ tem; or
must: (iii) Maintained a temperature of be-
(a) Have been managed in accordance tween 131 °F and 170 °F for 15 days
with the provisions of §§ 205.203 through using a windrow composting system,
205.206; during which period, the materials
(b) Have had no prohibited sub- must be turned a minimum of five
stances, as listed in § 205.105, applied to times.
it for a period of 3 years immediately (3) Uncomposted plant materials.
preceding harvest of the crop; and (d) A producer may manage crop nu-
(c) Have distinct, defined boundaries trients and soil fertility to maintain or
and buffer zones such as runoff diver- improve soil organic matter content in
sions to prevent the unintended appli- a manner that does not contribute to
cation of a prohibited substance to the contamination of crops, soil, or water
408
by plant nutrients, pathogenic orga- produced seed must be used for the pro-
nisms, heavy metals, or residues of production of edible sprouts;
hibited substances by applying: (2) Nonorganically produced seeds
(1) A crop nutrient or soil amend- and planting stock that have been
ment included on the National List of treated with a substance included on
synthetic substances allowed for use in the National List of synthetic sub-
organic crop production; stances allowed for use in organic crop
(2) A mined substance of low solu- production may be used to produce an
bility; organic crop when an equivalent or-
(3) A mined substance of high solu- ganically produced or untreated vari-
bility: Provided, That, the substance is ety is not commercially available;
used in compliance with the conditions (3) Nonorganically produced annual
established on the National List of seedlings may be used to produce an or-
nonsynthetic materials prohibited for ganic crop when a temporary variance
crop production; has been granted in accordance with
(4) Ash obtained from the burning of § 205.290(a)(2);
a plant or animal material, except as (4) Nonorganically produced planting
prohibited in paragraph (e) of this sec- stock to be used to produce a perennial
tion: Provided, That, the material crop may be sold, labeled, or rep-
burned has not been treated or com- resented as organically produced only
bined with a prohibited substance or after the planting stock has been main-
the ash is not included on the National tained under a system of organic man-
List of nonsynthetic substances prohib- agement for a period of no less than 1
ited for use in organic crop production; year; and
and (5) Seeds, annual seedlings, and
(5) A plant or animal material that planting stock treated with prohibited
has been chemically altered by a man- substances may be used to produce an
ufacturing process: Provided, That, the organic crop when the application of
material is included on the National the materials is a requirement of Fed-
List of synthetic substances allowed eral or State phytosanitary regula-
for use in organic crop production es- tions.
tablished in § 205.601. (b) [Reserved]
(e) The producer must not use:
(1) Any fertilizer or composted plant § 205.205 Crop rotation practice stand-
ard.
and animal material that contains a
synthetic substance not included on The producer must implement a crop
the National List of synthetic sub- rotation including but not limited to
stances allowed for use in organic crop sod, cover crops, green manure crops,
production; and catch crops that provide the fol-
(2) Sewage sludge (biosolids) as de- lowing functions that are applicable to
fined in 40 CFR part 503; and (3) Burn- the operation:
ing as a means of disposal for crop resi- (a) Maintain or improve soil organic
dues produced on the operation: Except, matter content;
That, burning may be used to suppress (b) Provide for pest management in
the spread of disease or to stimulate annual and perennial crops;
seed germination. (c) Manage deficient or excess plant
nutrients; and
§ 205.204 Seeds and planting stock (d) Provide erosion control.
practice standard.
(a) The producer must use organi- § 205.206 Crop pest, weed, and disease
cally grown seeds, annual seedlings, management practice standard.
and planting stock: Except, That, (a) The producer must use manage-
(1) Nonorganically produced, un- ment practices to prevent crop pests,
treated seeds and planting stock may weeds, and diseases including but not
be used to produce an organic crop limited to:
when an equivalent organically pro- (1) Crop rotation and soil and crop
duced variety is not commercially nutrient management practices, as pro-

available: Except, That, organically vided for in §§ 205.203 and 205.205;
409
§ 205.207 7 CFR Ch. I (1–1–22 Edition)
(2) Sanitation measures to remove § 205.207 Wild-crop harvesting practice

disease vectors, weed seeds, and habi- standard.
tat for pest organisms; and (a) A wild crop that is intended to be
(3) Cultural practices that enhance sold, labeled, or represented as organic
crop health, including selection of must be harvested from a designated
plant species and varieties with regard area that has had no prohibited sub-
to suitability to site-specific condi- stance, as set forth in § 205.105, applied
tions and resistance to prevalent pests, to it for a period of 3 years imme-
weeds, and diseases. diately preceding the harvest of the
(b) Pest problems may be controlled wild crop.
through mechanical or physical meth- (b) A wild crop must be harvested in
ods including but not limited to: a manner that ensures that such har-
(1) Augmentation or introduction of vesting or gathering will not be de-
predators or parasites of the pest spe- structive to the environment and will
cies; sustain the growth and production of
(2) Development of habitat for nat- the wild crop.
ural enemies of pests;
(3) Nonsynthetic controls such as §§ 205.208–205.235 [Reserved]
lures, traps, and repellents.
§ 205.236 Origin of livestock.
(c) Weed problems may be controlled
through: (a) Livestock products that are to be
(1) Mulching with fully biodegradable sold, labeled, or represented as organic
materials; must be from livestock under contin-
(2) Mowing; uous organic management from the
last third of gestation or hatching: Ex-
(3) Livestock grazing;
cept, That:
(4) Hand weeding and mechanical cul-
(1) Poultry. Poultry or edible poultry
tivation;
products must be from poultry that has
(5) Flame, heat, or electrical means; been under continuous organic man-
or agement beginning no later than the
(6) Plastic or other synthetic second day of life;
mulches: Provided, That, they are re- (2) Dairy animals. Milk or milk prod-
moved from the field at the end of the ucts must be from animals that have
growing or harvest season. been under continuous organic man-
(d) Disease problems may be con- agement beginning no later than 1 year
trolled through: prior to the production of the milk or
(1) Management practices which sup- milk products that are to be sold, la-
press the spread of disease organisms; beled, or represented as organic, Ex-
or cept,
(2) Application of nonsynthetic bio- (i) That, crops and forage from land,
logical, botanical, or mineral inputs. included in the organic system plan of
(e) When the practices provided for in a dairy farm, that is in the third year
paragraphs (a) through (d) of this sec- of organic management may be con-
tion are insufficient to prevent or consumed by the dairy animals of the farm
trol crop pests, weeds, and diseases, a during the 12-month period imme-
biological or botanical substance or a diately prior to the sale of organic
substance included on the National milk and milk products; and
List of synthetic substances allowed (ii) That, when an entire, distinct
for use in organic crop production may herd is converted to organic produc-
be applied to prevent, suppress, or con- tion, the producer may, provided no
trol pests, weeds, or diseases: Provided, milk produced under this subparagraph
That, the conditions for using the sub- enters the stream of commerce labeled
stance are documented in the organic as organic after June 9, 2007: (a) For
system plan. the first 9 months of the year, provide
(f) The producer must not use lumber a minimum of 80-percent feed that is
treated with arsenate or other prohib- either organic or raised from land in-
ited materials for new installations or cluded in the organic system plan and
replacement purposes in contact with managed in compliance with organic

soil or livestock. crop requirements; and (b) Provide feed
410
in compliance with § 205.237 for the (2) Provide feed supplements or addi-
final 3 months. tives in amounts above those needed
(iii) Once an entire, distinct herd has for adequate nutrition and health
been converted to organic production, maintenance for the species at its spe-
all dairy animals shall be under or- cific stage of life;
ganic management from the last third (3) Feed plastic pellets for roughage;
of gestation. (4) Feed formulas containing urea or
(3) Breeder stock. Livestock used as manure;
breeder stock may be brought from a (5) Feed mammalian or poultry
nonorganic operation onto an organic slaughter by-products to mammals or
operation at any time: Provided, That, poultry;
if such livestock are gestating and the
(6) Use feed, feed additives, and feed
offspring are to be raised as organic
supplements in violation of the Federal
livestock, the breeder stock must be
Food, Drug, and Cosmetic Act;
brought onto the facility no later than
the last third of gestation. (7) Provide feed or forage to which
(b) The following are prohibited: any antibiotic including ionophores
(1) Livestock or edible livestock has been added; or
products that are removed from an or- (8) Prevent, withhold, restrain, or
ganic operation and subsequently man- otherwise restrict ruminant animals
aged on a nonorganic operation may be from actively obtaining feed grazed
not sold, labeled, or represented as or- from pasture during the grazing sea-
ganically produced. son, except for conditions as described
(2) Breeder or dairy stock that has under § 205.239(b) and (c).
not been under continuous organic (c) During the grazing season, pro-
management since the last third of ges- ducers shall:
tation may not be sold, labeled, or rep- (1) Provide not more than an average
resented as organic slaughter stock. of 70 percent of a ruminant’s dry mat-
(c) The producer of an organic live- ter demand from dry matter fed (dry
stock operation must maintain records matter fed does not include dry matter
sufficient to preserve the identity of grazed from residual forage or vegeta-
all organically managed animals and tion rooted in pasture). This shall be
edible and nonedible animal products calculated as an average over the en-
produced on the operation. tire grazing season for each type and
[65 FR 80637, Dec. 21, 2000, as amended at 71 class of animal. Ruminant animals
FR 32807, June 7, 2006] must be grazed throughout the entire
grazing season for the geographical re-
§ 205.237 Livestock feed. gion, which shall be not less than 120
(a) The producer of an organic live- days per calendar year. Due to weath-
stock operation must provide livestock er, season, and/or climate, the grazing
with a total feed ration composed of season may or may not be continuous.
agricultural products, including pas- (2) Provide pasture of a sufficient
ture and forage, that are organically quality and quantity to graze through-
produced and handled by operations out the grazing season and to provide
certified to the NOP, except as pro- all ruminants under the organic sys-
vided in § 205.236(a)(2)(i), except, that, tem plan with an average of not less
synthetic substances allowed under than 30 percent of their dry matter in-
§ 205.603 and nonsynthetic substances take from grazing throughout the graz-
not prohibited under § 205.604 may be ing season: Except, That,
used as feed additives and feed supple- (i) Ruminant animals denied pasture
ments, Provided, That, all agricultural in accordance with § 205.239(b)(1)
ingredients included in the ingredients through (8), and § 205.239(c)(1) through
list, for such additives and supple- (3), shall be provided with an average of
ments, shall have been produced and not less than 30 percent of their dry
handled organically. matter intake from grazing throughout
(b) The producer of an organic oper- the periods that they are on pasture
ation must not: during the grazing season;
(1) Use animal drugs, including hor- (ii) Breeding bulls shall be exempt
mones, to promote growth; from the 30 percent dry matter intake
411
§ 205.238 7 CFR Ch. I (1–1–22 Edition)
from grazing requirement of this sec- (6) Administration of vaccines and

tion and management on pasture re- other veterinary biologics.
quirement of § 205.239(c)(2); Provided, (b) When preventive practices and
That, any animal maintained under veterinary biologics are inadequate to
this exemption shall not be sold, la- prevent sickness, a producer may ad-
beled, used, or represented as organic minister synthetic medications: Pro-
slaughter stock. vided, That, such medications are al-
(d) Ruminant livestock producers lowed under § 205.603. Parasiticides al-
shall: lowed under § 205.603 may be used on:
(1) Describe the total feed ration for (1) Breeder stock, when used prior to
each type and class of animal. The de- the last third of gestation but not dur-
scription must include: ing lactation for progeny that are to be
(i) All feed produced on-farm; sold, labeled, or represented as organi-
(ii) All feed purchased from off-farm cally produced; and
sources; (2) Dairy animals, as allowed under
(iii) The percentage of each feed type, § 205.603.
including pasture, in the total ration; (3) Fiber bearing animals, as allowed
and under § 205.603.
(iv) A list of all feed supplements and (c) The producer of an organic live-
additives. stock operation must not:
(2) Document the amount of each (1) Sell, label, or represent as organic
type of feed actually fed to each type any animal or edible product derived
and class of animal. from any animal treated with anti-
(3) Document changes that are made biotics, any substance that contains a
to all rations throughout the year in synthetic substance not allowed under
response to seasonal grazing changes. § 205.603, or any substance that contains
(4) Provide the method for calcu-
a nonsynthetic substance prohibited in
lating dry matter demand and dry mat-
§ 205.604.
ter intake.
(2) Administer any animal drug,
[65 FR 80637, Dec. 21, 2000, as amended at 75 other than vaccinations, in the absence
FR 7193, Feb. 17, 2010] of illness;
(3) Administer hormones for growth
§ 205.238 Livestock health care prac-
tice standard. promotion;
(4) Administer synthetic
(a) The producer must establish and parasiticides on a routine basis;
maintain preventive livestock health (5) Administer synthetic
care practices, including: parasiticides to slaughter stock;
(1) Selection of species and types of (6) Administer animal drugs in viola-
livestock with regard to suitability for tion of the Federal Food, Drug, and
site-specific conditions and resistance Cosmetic Act; or
to prevalent diseases and parasites; (7) Withhold medical treatment from
(2) Provision of a feed ration suffi- a sick animal in an effort to preserve
cient to meet nutritional require- its organic status. All appropriate
ments, including vitamins, minerals, medications must be used to restore an
protein and/or amino acids, fatty acids, animal to health when methods accept-
energy sources, and fiber (ruminants); able to organic production fail. Live-
(3) Establishment of appropriate stock treated with a prohibited sub-
housing, pasture conditions, and sani- stance must be clearly identified and
tation practices to minimize the occur- shall not be sold, labeled, or rep-
rence and spread of diseases and resented as organically produced.
parasites;
(4) Provision of conditions which [65 FR 80637, Dec. 21, 2000, as amended at 83
allow for exercise, freedom of move- FR 66571, Dec. 27, 2018]
ment, and reduction of stress appro-
priate to the species; § 205.239 Livestock living conditions.
(5) Performance of physical alter- (a) The producer of an organic live-
ations as needed to promote the ani- stock operation must establish and
mal’s welfare and in a manner that maintain year-round livestock living

minimizes pain and stress; and conditions which accommodate the
412
health and natural behavior of ani- porary confinement or shelter for an

mals, including: animal because of:
(1) Year-round access for all animals (1) Inclement weather;
to the outdoors, shade, shelter, exer- (2) The animal’s stage of life: Except,
cise areas, fresh air, clean water for that lactation is not a stage of life that
drinking, and direct sunlight, suitable would exempt ruminants from any of
to the species, its stage of life, the cli- the mandates set forth in this regula-
mate, and the environment: Except, tion;
that, animals may be temporarily de- (3) Conditions under which the
nied access to the outdoors in accord- health, safety, or well-being of the ani-
ance with §§ 205.239(b) and (c). Yards, mal could be jeopardized;
feeding pads, and feedlots may be used (4) Risk to soil or water quality;
to provide ruminants with access to (5) Preventive healthcare procedures
the outdoors during the non-grazing or for the treatment of illness or injury
season and supplemental feeding dur- (neither the various life stages nor lac-
ing the grazing season. Yards, feeding tation is an illness or injury);
pads, and feedlots shall be large enough (6) Sorting or shipping animals and
to allow all ruminant livestock occu- livestock sales: Provided, that, the ani-
pying the yard, feeding pad, or feedlot mals shall be maintained under contin-
to feed simultaneously without crowd- uous organic management, including
ing and without competition for food. organic feed, throughout the extent of
Continuous total confinement of any their allowed confinement;
animal indoors is prohibited. Contin- (7) Breeding: Except, that, bred ani-
uous total confinement of ruminants in mals shall not be denied access to the
yards, feeding pads, and feedlots is pro- outdoors and, once bred, ruminants
hibited. shall not be denied access to pasture
(2) For all ruminants, management during the grazing season; or
on pasture and daily grazing through- (8) 4–H, Future Farmers of America
out the grazing season(s) to meet the and other youth projects, for no more
requirements of § 205.237, except as pro- than one week prior to a fair or other
vided for in paragraphs (b), (c), and (d) demonstration, through the event and
of this section. up to 24 hours after the animals have
arrived home at the conclusion of the
(3) Appropriate clean, dry bedding.
event. These animals must have been
When roughages are used as bedding,
maintained under continuous organic
they shall have been organically pro-
management, including organic feed,
duced in accordance with this part by
during the extent of their allowed con-
an operation certified under this part,
finement for the event.
except as provided in § 205.236(a)(2)(i),
(c) The producer of an organic live-
and, if applicable, organically handled
stock operation may, in addition to the
by operations certified to the NOP.
times permitted under § 205.239(b), tem-
(4) Shelter designed to allow for: porarily deny a ruminant animal pas-
(i) Natural maintenance, comfort be- ture or outdoor access under the fol-
haviors, and opportunity to exercise; lowing conditions:
(ii) Temperature level, ventilation, (1) One week at the end of a lactation
and air circulation suitable to the spe- for dry off (for denial of access to pas-
cies; and ture only), three weeks prior to partu-
(iii) Reduction of potential for live- rition (birthing), parturition, and up to
stock injury; one week after parturition;
(5) The use of yards, feeding pads, (2) In the case of newborn dairy cat-
feedlots and laneways that shall be tle for up to six months, after which
well-drained, kept in good condition they must be on pasture during the
(including frequent removal of wastes), grazing season and may no longer be
and managed to prevent runoff of individually housed: Provided, That, an
wastes and contaminated waters to ad- animal shall not be confined or teth-
joining or nearby surface water and ered in a way that prevents the animal
across property boundaries. from lying down, standing up, fully ex-
(b) The producer of an organic live- tending its limbs, and moving about
stock operation may provide tem- freely;
413
§ 205.240 7 CFR Ch. I (1–1–22 Edition)
(3) In the case of fiber bearing ani- ing must be managed in full compli-
mals, for short periods for shearing; ance with §§ 205.202 through 205.206. Irri-
and gation shall be used, as needed, to pro-
(4) In the case of dairy animals, for mote pasture growth when the oper-
short periods daily for milking. Milk- ation has irrigation available for use
ing must be scheduled in a manner to on pasture.
ensure sufficient grazing time to pro- (b) Producers must provide pasture in
vide each animal with an average of at compliance with § 205.239(a)(2) and man-
least 30 percent DMI from grazing age pasture to comply with the re-
throughout the grazing season. Milking quirements of: § 205.237(c)(2), to annu-
frequencies or duration practices can- ally provide a minimum of 30 percent
not be used to deny dairy animals pas- of a ruminant’s dry matter intake
ture. (DMI), on average, over the course of
(d) Ruminant slaughter stock, typi- the grazing season(s); § 205.238(a)(3), to
cally grain finished, shall be main- minimize the occurrence and spread of
tained on pasture for each day that the diseases and parasites; and § 205.239(e)
finishing period corresponds with the
to refrain from putting soil or water
grazing season for the geographical lo-
quality at risk.
cation: Except, that, yards, feeding
pads, or feedlots may be used to pro- (c) A pasture plan must be included
vide finish feeding rations. During the in the producer’s organic system plan,
finishing period, ruminant slaughter and be updated annually in accordance
stock shall be exempt from the min- with § 205.406(a). The producer may re-
imum 30 percent DMI requirement submit the previous year’s pasture plan
from grazing. Yards, feeding pads, or when no change has occurred in the
feedlots used to provide finish feeding plan. The pasture plan may consist of a
rations shall be large enough to allow pasture/rangeland plan developed in co-
all ruminant slaughter stock occu- operation with a Federal, State, or
pying the yard, feeding pad, or feed lot local conservation office: Provided,
to feed simultaneously without crowd- that, the submitted plan addresses all
ing and without competition for food. of the requirements of § 205.240(c)(1)
The finishing period shall not exceed through (8). When a change to an ap-
one-fifth (1⁄5) of the animal’s total life proved pasture plan is contemplated,
or 120 days, whichever is shorter. which may affect the operation’s com-
(e) The producer of an organic live- pliance with the Act or the regulations
stock operation must manage manure in this part, the producer shall seek
in a manner that does not contribute the certifying agent’s agreement on
to contamination of crops, soil, or the change prior to implementation.
water by plant nutrients, heavy met- The pasture plan shall include a de-
als, or pathogenic organisms and opti- scription of the:
mizes recycling of nutrients and must (1) Types of pasture provided to en-
manage pastures and other outdoor ac- sure that the feed requirements of
cess areas in a manner that does not § 205.237 are being met.
put soil or water quality at risk. (2) Cultural and management prac-
[65 FR 80637, Dec. 21, 2000, as amended at 75 tices to be used to ensure pasture of a
FR 7193, Feb. 17, 2010] sufficient quality and quantity is avail-
able to graze throughout the grazing
§ 205.240 Pasture practice standard. season and to provide all ruminants
The producer of an organic livestock under the organic system plan, except
operation must, for all ruminant live- exempted classes identified in
stock on the operation, demonstrate § 205.239(c)(1) through (3), with an aver-
through auditable records in the or- age of not less than 30 percent of their
ganic system plan, a functioning man- dry matter intake from grazing
agement plan for pasture. throughout the grazing season.
(a) Pasture must be managed as a (3) Grazing season for the livestock
crop in full compliance with §§ 205.202, operation’s regional location.
205.203(d) and (e), 205.204, and 205.206(b) (4) Location and size of pastures, in-
through (f). Land used for the produc- cluding maps giving each pasture its
tion of annual crops for ruminant graz- own identification.
414
(5) The types of grazing methods to ‘‘made with organic (specified ingredi-
be used in the pasture system. ents or food group(s))’’ are not subject
(6) Location and types of fences, ex- to this requirement.
cept for temporary fences, and the lo-
cation and source of shade and the lo- § 205.271 Facility pest management
cation and source of water. practice standard.
(7) Soil fertility and seeding systems. (a) The producer or handler of an or-
(8) Erosion control and protection of ganic facility must use management
natural wetlands and riparian areas practices to prevent pests, including
practices. but not limited to:
[75 FR 7194, Feb. 17, 2010] (1) Removal of pest habitat, food
sources, and breeding areas;
§§ 205.243–205.269 [Reserved] (2) Prevention of access to handling
facilities; and
§ 205.270 Organic handling require- (3) Management of environmental
ments. factors, such as temperature, light, hu-
(a) Mechanical or biological methods, midity, atmosphere, and air circula-
including but not limited to cooking, tion, to prevent pest reproduction.
baking, curing, heating, drying, mix- (b) Pests may be controlled through:
ing, grinding, churning, separating, (1) Mechanical or physical controls
distilling, extracting, slaughtering, including but not limited to traps,
cutting, fermenting, eviscerating, pre- light, or sound; or
serving, dehydrating, freezing, chilling, (2) Lures and repellents using non-
or otherwise manufacturing, and the synthetic or synthetic substances con-
packaging, canning, jarring, or other- sistent with the National List.
wise enclosing food in a container may (c) If the practices provided for in
be used to process an organically pro- paragraphs (a) and (b) of this section
duced agricultural product for the pur- are not effective to prevent or control
pose of retarding spoilage or otherwise pests, a nonsynthetic or synthetic sub-
preparing the agricultural product for stance consistent with the National
market. List may be applied.
(b) Nonagricultural substances al- (d) If the practices provided for in
lowed under § 205.605 and nonorgani- paragraphs (a), (b), and (c) of this sec-
cally produced agricultural products tion are not effective to prevent or con-
allowed under § 205.606 may be used: trol facility pests, a synthetic sub-
(1) In or on a processed agricultural stance not on the National List may be
product intended to be sold, labeled, or applied: Provided, That, the handler
represented as ‘‘organic,’’ pursuant to and certifying agent agree on the sub-
§ 205.301(b), if not commercially avail- stance, method of application, and
able in organic form. measures to be taken to prevent con-
(2) In or on a processed agricultural tact of the organically produced prod-
product intended to be sold, labeled, or ucts or ingredients with the substance
represented as ‘‘made with organic used.
(specified ingredients or food (e) The handler of an organic han-
group(s)),’’ pursuant to § 205.301(c). dling operation who applies a nonsyn-
(c) The handler of an organic han- thetic or synthetic substance to pre-
dling operation must not use in or on vent or control pests must update the
agricultural products intended to be operation’s organic handling plan to
sold, labeled, or represented as ‘‘100 reflect the use of such substances and
percent organic,’’ ‘‘organic,’’ or ‘‘made methods of application. The updated
with organic (specified ingredients or organic plan must include a list of all
food group(s)),’’ or in or on any ingredi- measures taken to prevent contact of
ents labeled as organic: the organically produced products or
(1) Practices prohibited under para- ingredients with the substance used.
graphs (e) and (f) of § 205.105. (f) Notwithstanding the practices
(2) A volatile synthetic solvent or provided for in paragraphs (a), (b), (c),
other synthetic processing aid not al- and (d) of this section, a handler may
lowed under § 205.605: Except, That, non- otherwise use substances to prevent or
organic ingredients in products labeled control pests as required by Federal,
415
§ 205.272 7 CFR Ch. I (1–1–22 Edition)
State, or local laws and regulations: variance from a standard set forth in
Provided, That, measures are taken to subpart C of this part for organic pro-
prevent contact of the organically production or handling operations be es-
duced products or ingredients with the tablished: Provided, That, such vari-
substance used. ance is based on one or more of the rea-
sons listed in paragraph (a) of this sec-
§ 205.272 Commingling and contact tion.
with prohibited substance preven- (c) The Administrator will provide
tion practice standard.
written notification to certifying
(a) The handler of an organic han- agents upon establishment of a tem-
dling operation must implement meas- porary variance applicable to the certi-
ures necessary to prevent the commin- fying agent’s certified production or
gling of organic and nonorganic prod- handling operations and specify the pe-
ucts and protect organic products from riod of time it shall remain in effect,
contact with prohibited substances. subject to extension as the Adminis-
(b) The following are prohibited for trator deems necessary.
use in the handling of any organically (d) A certifying agent, upon notifica-
produced agricultural product or ingre- tion from the Administrator of the es-
dient labeled in accordance with sub- tablishment of a temporary variance,
part D of this part: must notify each production or han-
(1) Packaging materials, and storage dling operation it certifies to which the
containers, or bins that contain a syn- temporary variance applies.
thetic fungicide, preservative, or fumi- (e) Temporary variances will not be
gant; granted for any practice, material, or
(2) The use or reuse of any bag or procedure prohibited under § 205.105.
container that has been in contact
with any substance in such a manner [65 FR 80637, Dec. 21, 2000, as amended at 75
FR 7194, Feb. 17, 2010]
as to compromise the organic integrity
of any organically produced product or §§ 205.291–205.299 [Reserved]
ingredient placed in those containers,
unless such reusable bag or container
has been thoroughly cleaned and poses Subpart D—Labels, Labeling, and
no risk of contact of the organically Market Information
produced product or ingredient with
§ 205.300 Use of the term, ‘‘organic.’’
the substance used.
(a) The term, ‘‘organic,’’ may only be
§§ 205.273–205.289 [Reserved] used on labels and in labeling of raw or
processed agricultural products, in-
§ 205.290 Temporary variances. cluding ingredients, that have been
(a) Temporary variances from the re- produced and handled in accordance
quirements in §§ 205.203 through 205.207, with the regulations in this part. The
205.236 through 205.240 and 205.270 term, ‘‘organic,’’ may not be used in a
through 205.272 may be established by product name to modify a nonorganic
the Administrator for the following ingredient in the product.
reasons: (b) Products for export, produced and
(1) Natural disasters declared by the certified to foreign national organic
Secretary; standards or foreign contract buyer re-
(2) Damage caused by drought, wind, quirements, may be labeled in accord-
flood, excessive moisture, hail, tor- ance with the organic labeling require-
nado, earthquake, fire, or other busi- ments of the receiving country or con-
ness interruption; and tract buyer: Provided, That, the ship-
(3) Practices used for the purpose of ping containers and shipping docu-
conducting research or trials of tech- ments meet the labeling requirements
niques, varieties, or ingredients used in specified in § 205.307(c).
organic production or handling. (c) Products produced in a foreign
(b) A State organic program’s gov- country and exported for sale in the
erning State official or certifying United States must be certified pursu-
agent may recommend in writing to ant to subpart E of this part and la-
the Administrator that a temporary beled pursuant to this subpart D.
416
(d) Livestock feeds produced in ac- than 70 percent organically produced

cordance with the requirements of this ingredients (by weight or fluid volume,
part must be labeled in accordance excluding water and salt) must be pro-
with the requirements of § 205.306. duced and handled pursuant to require-
ments in subpart C of this part. The
§ 205.301 Product composition.
nonorganic ingredients may be pro-
(a) Products sold, labeled, or rep- duced and handled without regard to
resented as ‘‘100 percent organic.’’ A raw the requirements of this part. Multi-
or processed agricultural product sold, ingredient agricultural product con-
labeled, or represented as ‘‘100 percent taining less than 70 percent organically
organic’’ must contain (by weight or produced ingredients may represent
fluid volume, excluding water and salt) the organic nature of the product only
100 percent organically produced ingre-
as provided in § 205.305.
dients. If labeled as organically pro-
(e) Livestock feed. (1) A raw or proc-
duced, such product must be labeled
pursuant to § 205.303. essed livestock feed product sold, la-
(b) Products sold, labeled, or rep- beled, or represented as ‘‘100 percent
resented as ‘‘organic.’’ A raw or proc- organic’’ must contain (by weight or
essed agricultural product sold, la- fluid volume, excluding water and salt)
beled, or represented as ‘‘organic’’ not less than 100 percent organically
must contain (by weight or fluid vol- produced raw or processed agricultural
ume, excluding water and salt) not less product.
than 95 percent organically produced (2) A raw or processed livestock feed
raw or processed agricultural products. product sold, labeled, or represented as
Any remaining product ingredients ‘‘organic’’ must be produced in con-
must be organically produced, unless formance with § 205.237.
not commercially available in organic (f) All products labeled as ‘‘100 per-
form, or must be nonagricultural sub- cent organic’’ or ‘‘organic’’ and all in-
stances or nonorganically produced ag- gredients identified as ‘‘organic’’ in the
ricultural products produced consistent ingredient statement of any product
with the National List in subpart G of must not:
this part. If labeled as organically pro- (1) Be produced using excluded meth-
duced, such product must be labeled ods, pursuant to § 205.105(e);
pursuant to § 205.303.
(2) Be produced using ionizing radi-
(c) Products sold, labeled, or rep-
resented as ‘‘made with organic (specified ation, pursuant to § 205.105(f);
ingredients or food group(s)).’’ Multi- (3) Be processed using sewage sludge,
ingredient agricultural product sold, pursuant to § 205.105(g);
labeled, or represented as ‘‘made with (4) Be processed using processing aids
organic (specified ingredients or food not approved on the National List of
group(s))’’ must contain (by weight or Allowed and Prohibited Substances in
fluid volume, excluding water and salt) subpart G of this part: Except, That,
at least 70 percent organically pro- products labeled as ‘‘100 percent or-
duced ingredients which are produced ganic,’’ if processed, must be processed
and handled pursuant to requirements using organically produced processing
in subpart C of this part. No ingredi- aids;
ents may be produced using prohibited (5) Contain sulfites, nitrates, or
practices specified in paragraphs (f)(1), nitrites added during the production or
(2), and (3) of § 205.301. Nonorganic in- handling process, Except, that, wine
gredients may be produced without re- containing added sulfites may be la-
gard to paragraphs (f)(4), (5), (6), and (7) beled ‘‘made with organic grapes’’;
of § 205.301. If labeled as containing or- (6) Be produced using nonorganic in-
ganically produced ingredients or food gredients when organic ingredients are
groups, such product must be labeled available; or
(7) Include organic and nonorganic
(d) Products with less than 70 percent
forms of the same ingredient.
organically produced ingredients. The or-
ganic ingredients in multiingredient [65 FR 80637, Dec. 21, 2000, as amended at 80

agricultural product containing less FR 6429, Feb. 5, 2015]
417
§ 205.302 7 CFR Ch. I (1–1–22 Edition)
§ 205.302 Calculating the percentage of (2) For products labeled ‘‘organic,’’

organically produced ingredients. the percentage of organic ingredients
(a) The percentage of all organically in the product; (The size of the percent-
produced ingredients in an agricultural age statement must not exceed one-
product sold, labeled, or represented as half the size of the largest type size on
‘‘100 percent organic,’’ ‘‘organic,’’ or the panel on which the statement is
‘‘made with organic (specified ingredi- displayed and must appear in its en-
ents or food group(s)),’’ or that include tirety in the same type size, style, and
organic ingredients must be calculated color without highlighting.)
by: (3) The term, ‘‘organic,’’ to identify
(1) Dividing the total net weight (ex- the organic ingredients in multiingre-
cluding water and salt) of combined or- dient products labeled ‘‘100 percent or-
ganic ingredients at formulation by the ganic’’;
total weight (excluding water and salt) (4) The USDA seal; and/or
of the finished product. (5) The seal, logo, or other identi-
(2) Dividing the fluid volume of all fying mark of the certifying agent
organic ingredients (excluding water which certified the production or han-
and salt) by the fluid volume of the fin- dling operation producing the finished
ished product (excluding water and product and any other certifying agent
salt) if the product and ingredients are which certified production or handling
liquid. If the liquid product is identi- operations producing raw organic prod-
fied on the principal display panel or uct or organic ingredients used in the
information panel as being reconsti- finished product: Provided, That, the
tuted from concentrates, the calcula- handler producing the finished product
tion should be made on the basis of sin- maintain records, pursuant to this
gle-strength concentrations of the in- part, verifying organic certification of
gredients and finished product. the operations producing such ingredi-
(3) For products containing organi- ents, and: Provided further, That, such
cally produced ingredients in both solid seals or marks are not individually dis-
and liquid form, dividing the combined played more prominently than the
weight of the solid ingredients and the USDA seal.
weight of the liquid ingredients (ex- (b) Agricultural products in packages
cluding water and salt) by the total described in § 205.301(a) and (b) must:
weight (excluding water and salt) of (1) For products labeled ‘‘organic,’’
the finished product. identify each organic ingredient in the
(b) The percentage of all organically ingredient statement with the word,
produced ingredients in an agricultural ‘‘organic,’’ or with an asterisk or other
product must be rounded down to the reference mark which is defined below
nearest whole number. the ingredient statement to indicate
(c) The percentage must be deter- the ingredient is organically produced.
mined by the handler who affixes the Water or salt included as ingredients
label on the consumer package and cannot be identified as organic.
verified by the certifying agent of the (2) On the information panel, below
handler. The handler may use informa- the information identifying the han-
tion provided by the certified operation dler or distributor of the product and
in determining the percentage. preceded by the statement, ‘‘Certified
organic by * * *,’’ or similar phrase,
§ 205.303 Packaged products labeled identify the name of the certifying
‘‘100 percent organic’’ or ‘‘organic.’’ agent that certified the handler of the
(a) Agricultural products in packages finished product and may display the
described in § 205.301(a) and (b) may dis- business address, Internet address, or
play, on the principal display panel, in- telephone number of the certifying
formation panel, and any other panel agent in such label.
of the package and on any labeling or
market information concerning the § 205.304 Packaged products labeled
product, the following: ‘‘made with organic (specified in-
(1) The term, ‘‘100 percent organic’’ gredients or food group(s)).’’
or ‘‘organic,’’ as applicable, to modify (a) Agricultural products in packages

the name of the product; described in § 205.301(c) may display on
418
the principal display panel, informa- (c) Agricultural products in packages

tion panel, and any other panel and on described in § 205.301(c) must not dis-
any labeling or market information play the USDA seal.
concerning the product:
(1) The statement: § 205.305 Multi-ingredient packaged
(i) ‘‘Made with organic (specified in- products with less than 70 percent
gredients)’’: Provided, That, the state- organically produced ingredients.
ment does not list more than three or- (a) An agricultural product with less
ganically produced ingredients; or than 70 percent organically produced
(ii) ‘‘Made with organic (specified ingredients may only identify the or-
food groups)’’: Provided, That, the ganic content of the product by:
statement does not list more than (1) Identifying each organically pro-
three of the following food groups: duced ingredient in the ingredient
beans, fish, fruits, grains, herbs, meats, statement with the word, ‘‘organic,’’ or
nuts, oils, poultry, seeds, spices, sweet- with an asterisk or other reference
eners, and vegetables or processed milk mark which is defined below the ingre-
products; and, Provided further, That, dient statement to indicate the ingre-
all ingredients of each listed food dient is organically produced, and
group in the product must be organi-
(2) If the organically produced ingre-
cally produced; and
dients are identified in the ingredient
(iii) Which appears in letters that do
not exceed one-half the size of the larg- statement, displaying the product’s
est type size on the panel and which percentage of organic contents on the
appears in its entirety in the same type information panel.
size, style, and color without high- (b) Agricultural products with less
lighting. than 70 percent organically produced
(2) The percentage of organic ingredi- ingredients must not display:
ents in the product. The size of the per- (1) The USDA seal; and
centage statement must not exceed (2) Any certifying agent seal, logo, or
one-half the size of the largest type other identifying mark which rep-
size on the panel on which the state- resents organic certification of a prod-
ment is displayed and must appear in uct or product ingredients.
its entirety in the same type size,
style, and color without highlighting. § 205.306 Labeling of livestock feed.
(3) The seal, logo, or other identi- (a) Livestock feed products described
fying mark of the certifying agent that in § 205.301(e)(1) and (e)(2) may display
certified the handler of the finished on any package panel the following
product. terms:
(b) Agricultural products in packages (1) The statement, ‘‘100 percent or-
described in § 205.301(c) must:
ganic’’ or ‘‘organic,’’ as applicable, to
(1) In the ingredient statement, iden-
modify the name of the feed product;
tify each organic ingredient with the
word, ‘‘organic,’’ or with an asterisk or (2) The USDA seal;
other reference mark which is defined (3) The seal, logo, or other identi-
below the ingredient statement to indi- fying mark of the certifying agent
cate the ingredient is organically pro- which certified the production or han-
duced. Water or salt included as ingre- dling operation producing the raw or
dients cannot be identified as organic. processed organic ingredients used in
(2) On the information panel, below the finished product, Provided, That,
the information identifying the han- such seals or marks are not displayed
dler or distributor of the product and more prominently than the USDA seal;
preceded by the statement, ‘‘Certified (4) The word, ‘‘organic,’’ or an aster-
organic by * * *,’’ or similar phrase, isk or other reference mark which is
identify the name of the certifying defined on the package to identify in-
agent that certified the handler of the gredients that are organically pro-
finished product: Except, That, the duced. Water or salt included as ingre-
business address, Internet address, or dients cannot be identified as organic.
telephone number of the certifying (b) Livestock feed products described

agent may be included in such label. in § 205.301(e)(1) and (e)(2) must:
419
§ 205.307 7 CFR Ch. I (1–1–22 Edition)
(1) On the information panel, below port Only’’ and: Provided further, That,
the information identifying the han- proof of such container marking and
dler or distributor of the product and export must be maintained by the han-
preceded by the statement, ‘‘Certified dler in accordance with recordkeeping
organic by * * *,’’ or similar phrase, requirements for exempt and excluded
display the name of the certifying operations under § 205.101.
agent that certified the handler of the
finished product. The business address, § 205.308 Agricultural products in
Internet address, or telephone number other than packaged form at the
of the certifying agent may be included point of retail sale that are sold, la-
beled, or represented as ‘‘100 per-
in such label. cent organic’’ or ‘‘organic.’’
(2) Comply with other Federal agency
or State feed labeling requirements as (a) Agricultural products in other
applicable. than packaged form may use the term,
‘‘100 percent organic’’ or ‘‘organic,’’ as
§ 205.307 Labeling of nonretail con- applicable, to modify the name of the
tainers used for only shipping or product in retail display, labeling, and
storage of raw or processed agricul- display containers: Provided, That, the
tural products labeled as ‘‘100 per- term, ‘‘organic,’’ is used to identify the
cent organic,’’ ‘‘organic,’’ or ‘‘made
with organic (specified ingredients organic ingredients listed in the ingre-
or food group(s)).’’ dient statement.
(b) If the product is prepared in a cer-
(a) Nonretail containers used only to tified facility, the retail display, label-
ship or store raw or processed agricul- ing, and display containers may use:
tural product labeled as containing or- (1) The USDA seal; and
ganic ingredients may display the fol- (2) The seal, logo, or other identi-
lowing terms or marks: fying mark of the certifying agent that
(1) The name and contact informa- certified the production or handling op-
tion of the certifying agent which cer- eration producing the finished product
tified the handler which assembled the and any other certifying agent which
final product; certified operations producing raw or-
(2) Identification of the product as
ganic product or organic ingredients
organic;
used in the finished product: Provided,
(3) Special handling instructions
That, such seals or marks are not indi-
needed to maintain the organic integ-
vidually displayed more prominently
rity of the product;
than the USDA seal.
(4) The USDA seal;
(5) The seal, logo, or other identi- § 205.309 Agricultural products in
fying mark of the certifying agent that other than packaged form at the
certified the organic production or point of retail sale that are sold, la-
handling operation that produced or beled, or represented as ‘‘made with
handled the finished product. organic (specified ingredients or
(b) Nonretail containers used to ship food group(s)).’’
or store raw or processed agricultural (a) Agricultural products in other
product labeled as containing organic than packaged form containing be-
ingredients must display the produc- tween 70 and 95 percent organically
tion lot number of the product if appli- produced ingredients may use the
cable. phrase, ‘‘made with organic (specified
(c) Shipping containers of domesti- ingredients or food group(s)),’’ to mod-
cally produced product labeled as or- ify the name of the product in retail
ganic intended for export to inter- display, labeling, and display con-
national markets may be labeled in ac- tainers.
cordance with any shipping container (1) Such statement must not list
labeling requirements of the foreign more than three organic ingredients or
country of destination or the container food groups, and
labeling specifications of a foreign con- (2) In any such display of the prod-
tract buyer: Provided, That, the ship- uct’s ingredient statement, the organic
ping containers and shipping docu- ingredients are identified as ‘‘organic.’’
ments accompanying such organic (b) If prepared in a certified facility,

products are clearly marked ‘‘For Ex- such agricultural products labeled as
420
‘‘made with organic (specified ingredi- (3) The green or black lower half cir-
ents or food group(s))’’ in retail dis- cle may have four light lines running
plays, display containers, and market from left to right and disappearing at
information may display the certifying the point on the right horizon to re-
agent’s seal, logo, or other identifying semble a cultivated field.
mark.
§ 205.310 Agricultural products pro-

duced on an exempt or excluded op-
eration.
(a) An agricultural product organi-
cally produced or handled on an ex-
empt or excluded operation must not:
(1) Display the USDA seal or any cer-
tifying agent’s seal or other identifying
mark which represents the exempt or
excluded operation as a certified or-
ganic operation, or
(2) Be represented as a certified or-
ganic product or certified organic in-
gredient to any buyer.
(b) An agricultural product organi-
cally produced or handled on an ex- §§ 205.312–205.399 [Reserved]
empt or excluded operation may be
identified as an organic product or or- Subpart E—Certification
ganic ingredient in a multiingredient
product produced by the exempt or ex- § 205.400 General requirements for
cluded operation. Such product or in- certification.
gredient must not be identified or rep- A person seeking to receive or main-
resented as ‘‘organic’’ in a product tain organic certification under the
processed by others. regulations in this part must:
(c) Such product is subject to re- (a) Comply with the Act and applica-
quirements specified in paragraph (a) ble organic production and handling
of § 205.300, and paragraphs (f)(1) regulations of this part;
through (f)(7) of § 205.301. (b) Establish, implement, and update
annually an organic production or han-
§ 205.311 USDA Seal. dling system plan that is submitted to
(a) The USDA seal described in para- an accredited certifying agent as pro-
graphs (b) and (c) of this section may vided for in § 205.200;
be used only for raw or processed agri- (c) Permit on-site inspections with
cultural products described in para- complete access to the production or
graphs (a), (b), (e)(1), and (e)(2) of handling operation, including noncer-
§ 205.301. tified production and handling areas,
(b) The USDA seal must replicate the structures, and offices by the certi-
form and design of the example in fig- fying agent as provided for in § 205.403;
ure 1 and must be printed legibly and (d) Maintain all records applicable to
conspicuously: the organic operation for not less than
(1) On a white background with a 5 years beyond their creation and allow
brown outer circle and with the term, authorized representatives of the Sec-
‘‘USDA,’’ in green overlaying a white retary, the applicable State organic
upper semicircle and with the term, program’s governing State official, and
‘‘organic,’’ in white overlaying the the certifying agent access to such
green lower half circle; or records during normal business hours
(2) On a white or transparent back- for review and copying to determine
ground with black outer circle and compliance with the Act and the regu-
black ‘‘USDA’’ on a white or trans- lations in this part, as provided for in
parent upper half of the circle with a § 205.103;
contrasting white or transparent ‘‘or- (e) Submit the applicable fees

ganic’’ on the black lower half circle. charged by the certifying agent; and
421
ER21DE00.001</GPH>
§ 205.401 7 CFR Ch. I (1–1–22 Edition)
(f) Immediately notify the certifying to comply with the applicable require-
agent concerning any: ments of subpart C of this part;
(1) Application, including drift, of a (3) Verify that an applicant who pre-
prohibited substance to any field, pro- viously applied to another certifying
duction unit, site, facility, livestock, agent and received a notification of
or product that is part of an operation; noncompliance or denial of certifi-
and cation, pursuant to § 205.405, has sub-
(2) Change in a certified operation or mitted documentation to support the
any portion of a certified operation correction of any noncompliances iden-
that may affect its compliance with tified in the notification of noncompli-
the Act and the regulations in this ance or denial of certification, as re-
part. quired in § 205.405(e); and
(4) Schedule an on-site inspection of
the operation to determine whether the
FR 6429, Feb. 5, 2015]
applicant qualifies for certification if
§ 205.401 Application for certification. the review of application materials re-
veals that the production or handling
A person seeking certification of a operation may be in compliance with
production or handling operation under the applicable requirements of subpart
this subpart must submit an applica- C of this part.
tion for certification to a certifying (b) The certifying agent shall within
agent. The application must include a reasonable time:
the following information: (1) Review the application materials
(a) An organic production or han- received and communicate its findings
dling system plan, as required in to the applicant;
§ 205.200; (2) Provide the applicant with a copy
(b) The name of the person com- of the on-site inspection report, as ap-
pleting the application; the applicant’s proved by the certifying agent, for any
business name, address, and telephone on-site inspection performed; and
number; and, when the applicant is a (3) Provide the applicant with a copy
corporation, the name, address, and of the test results for any samples
telephone number of the person author- taken by an inspector.
ized to act on the applicant’s behalf; (c) The applicant may withdraw its
(c) The name(s) of any organic certi- application at any time. An applicant
fying agent(s) to which application has who withdraws its application shall be
previously been made; the year(s) of liable for the costs of services provided
application; the outcome of the appli- up to the time of withdrawal of its ap-
cation(s) submission, including, when plication. An applicant that volun-
available, a copy of any notification of tarily withdrew its application prior to
noncompliance or denial of certifi- the issuance of a notice of noncompli-
cation issued to the applicant for cer- ance will not be issued a notice of non-
tification; and a description of the ac- compliance. Similarly, an applicant
tions taken by the applicant to correct that voluntarily withdrew its applica-
the noncompliances noted in the notifi- tion prior to the issuance of a notice of
cation of noncompliance, including evi- certification denial will not be issued a
dence of such correction; and notice of certification denial.
(d) Other information necessary to
determine compliance with the Act and § 205.403 On-site inspections.
the regulations in this part. (a) On-site inspections. (1) A certifying
agent must conduct an initial on-site
§ 205.402 Review of application. inspection of each production unit, fa-
(a) Upon acceptance of an application cility, and site that produces or han-
for certification, a certifying agent dles organic products and that is in-
must: cluded in an operation for which cer-
(1) Review the application to ensure tification is requested. An on-site in-
completeness pursuant to § 205.401; spection shall be conducted annually
(2) Determine by a review of the ap- thereafter for each certified operation
plication materials whether the appli- that produces or handles organic prod-
cant appears to comply or may be able ucts for the purpose of determining
422
whether to approve the request for cer- by the applicant for certification or by
tification or whether the certification the certified operation;
of the operation should continue. (3) That prohibited substances have
(2)(i) A certifying agent may conduct not been and are not being applied to
additional on-site inspections of appli- the operation through means which, at
cants for certification and certified op- the discretion of the certifying agent,
erations to determine compliance with may include the collection and testing
the Act and the regulations in this of soil; water; waste; seeds; plant tis-
part. sue; and plant, animal, and processed
(ii) The Administrator or State or- products samples.
ganic program’s governing State offi- (d) Exit interview. The inspector must
cial may require that additional in- conduct an exit interview with an au-
spections be performed by the certi- thorized representative of the oper-
fying agent for the purpose of deter- ation who is knowledgeable about the
mining compliance with the Act and inspected operation to confirm the ac-
the regulations in this part. curacy and completeness of inspection
observations and information gathered
(iii) Additional inspections may be
during the on-site inspection. The in-
announced or unannounced at the dis-
spector must also address the need for
cretion of the certifying agent or as re-
any additional information as well as
quired by the Administrator or State
any issues of concern.
organic program’s governing State offi-
(e) Documents to the inspected oper-
cial.
ation. (1) At the time of the inspection,
(b) Scheduling. (1) The initial on-site the inspector shall provide the oper-
inspection must be conducted within a ation’s authorized representative with
reasonable time following a determina- a receipt for any samples taken by the
tion that the applicant appears to com- inspector. There shall be no charge to
ply or may be able to comply with the the inspector for the samples taken.
requirements of subpart C of this part: (2) A copy of the on-site inspection
Except, That, the initial inspection report and any test results will be sent
may be delayed for up to 6 months to to the inspected operation by the certi-
comply with the requirement that the fying agent.
inspection be conducted when the land,
facilities, and activities that dem- § 205.404 Granting certification.
onstrate compliance or capacity to (a) Within a reasonable time after
comply can be observed. completion of the initial on-site in-
(2) All on-site inspections must be spection, a certifying agent must re-
conducted when an authorized rep- view the on-site inspection report, the
resentative of the operation who is results of any analyses for substances
knowledgeable about the operation is conducted, and any additional informa-
present and at a time when land, facili- tion requested from or supplied by the
ties, and activities that demonstrate applicant. If the certifying agent deter-
the operation’s compliance with or ca- mines that the organic system plan
pability to comply with the applicable and all procedures and activities of the
provisions of subpart C of this part can applicant’s operation are in compliance
be observed, except that this require- with the requirements of this part and
ment does not apply to unannounced that the applicant is able to conduct
on-site inspections. operations in accordance with the plan,
(c) Verification of information. The on- the agent shall grant certification. The
site inspection of an operation must certification may include requirements
verify: for the correction of minor noncompli-
(1) The operation’s compliance or ca- ances within a specified time period as
pability to comply with the Act and a condition of continued certification.
the regulations in this part; (b) The certifying agent must issue a
(2) That the information, including certificate of organic operation which
the organic production or handling sys- specifies the:
tem plan, provided in accordance with (1) Name and address of the certified
§§ 205.401, 205.406, and 205.200, accurately operation;

reflects the practices used or to be used (2) Effective date of certification;
423
§ 205.405 7 CFR Ch. I (1–1–22 Edition)
(3) Categories of organic operation, (c) After issuance of a notification of

including crops, wild crops, livestock, noncompliance, the certifying agent
or processed products produced by the must:
certified operation; and (1) Evaluate the applicant’s correc-
(4) Name, address, and telephone tive actions taken and supporting doc-
number of the certifying agent. umentation submitted or the written
(c) Once certified, a production or rebuttal, conduct an on-site inspection
handling operation’s organic certifi- if necessary, and
cation continues in effect until surren- (i) When the corrective action or re-
dered by the organic operation or sus- buttal is sufficient for the applicant to
pended or revoked by the certifying qualify for certification, issue the ap-
agent, the State organic program’s plicant an approval of certification
governing State official, or the Admin- pursuant to § 205.404; or
istrator. (ii) When the corrective action or re-
buttal is not sufficient for the appli-
§ 205.405 Denial of certification.
cant to qualify for certification, issue
(a) When the certifying agent has the applicant a written notice of denial
reason to believe, based on a review of of certification.
the information specified in § 205.402 or (2) Issue a written notice of denial of
§ 205.404, that an applicant for certifi- certification to an applicant who fails
cation is not able to comply or is not to respond to the notification of non-
in compliance with the requirements of compliance.
this part, the certifying agent must (3) Provide notice of approval or de-
provide a written notification of non- nial to the Administrator, pursuant to
compliance to the applicant. When cor- § 205.501(a)(14).
rection of a noncompliance is not pos-
(d) A notice of denial of certification
sible, a notification of noncompliance
must state the reason(s) for denial and
and a notification of denial of certifi-
the applicant’s right to:
cation may be combined in one notifi-
cation. The notification of noncompli- (1) Reapply for certification pursuant
ance shall provide: to §§ 205.401 and 205.405(e);
(1) A description of each noncompli- (2) Request mediation pursuant to
ance; § 205.663 or, if applicable, pursuant to a
(2) The facts upon which the notifica- State organic program; or
tion of noncompliance is based; and (3) File an appeal of the denial of cer-
(3) The date by which the applicant tification pursuant to § 205.681 or, if ap-
must rebut or correct each noncompli- plicable, pursuant to a State organic
ance and submit supporting docu- program.
mentation of each such correction (e) An applicant for certification who
when correction is possible. has received a written notification of
(b) Upon receipt of such notification noncompliance or a written notice of
of noncompliance, the applicant may: denial of certification may apply for
(1) Correct noncompliances and sub- certification again at any time with
mit a description of the corrective ac- any certifying agent, in accordance
tions taken with supporting docu- with §§ 205.401 and 205.405(e). When such
mentation to the certifying agent; applicant submits a new application to
(2) Correct noncompliances and sub- a certifying agent other than the agent
mit a new application to another certi- who issued the notification of non-
fying agent: Provided, That, the appli- compliance or notice of denial of cer-
cant must include a complete applica- tification, the applicant for certifi-
tion, the notification of noncompliance cation must include a copy of the noti-
received from the first certifying fication of noncompliance or notice of
agent, and a description of the correc- denial of certification and a descrip-
tive actions taken with supporting doc- tion of the actions taken, with sup-
umentation; or porting documentation, to correct the
(3) Submit written information to noncompliances noted in the notifica-
the issuing certifying agent to rebut tion of noncompliance.
the noncompliance described in the no- (f) A certifying agent who receives a
tification of noncompliance. new application for certification,
424
which includes a notification of non- lowing receipt of the certified oper-

compliance or a notice of denial of cer- ation’s annual update of information,
tification, must treat the application the certifying agent may allow con-
as a new application and begin a new tinuation of certification and issue an
application process pursuant to updated certificate of organic oper-
§ 205.402. ation on the basis of the information
(g) Notwithstanding paragraph (a) of submitted and the most recent on-site
this section, if a certifying agent has inspection conducted during the pre-
reason to believe that an applicant for vious 12 months: Provided, That, the
certification has willfully made a false annual on-site inspection, required pur-
statement or otherwise purposefully suant to § 205.403, is conducted within
misrepresented the applicant’s oper- the first 6 months following the cer-
ation or its compliance with the certified operation’s scheduled date of an-
tification requirements pursuant to nual update.
this part, the certifying agent may (c) If the certifying agent has reason
deny certification pursuant to para- to believe, based on the on-site inspec-
graph (c)(1)(ii) of this section without tion and a review of the information
first issuing a notification of non- specified in § 205.404, that a certified op-
compliance. eration is not complying with the re-
quirements of the Act and the regula-
§ 205.406 Continuation of certification. tions in this part, the certifying agent
(a) To continue certification, a cer- shall provide a written notification of
tified operation must annually pay the noncompliance to the operation in ac-
certification fees and submit the fol- cordance with § 205.662.
lowing information, as applicable, to (d) If the certifying agent determines
the certifying agent: that the certified operation is com-
(1) An updated organic production or plying with the Act and the regula-
handling system plan which includes: tions in this part and that any of the
(i) A summary statement, supported information specified on the certificate
by documentation, detailing any devi- of organic operation has changed, the
ations from, changes to, modifications certifying agent must issue an updated
to, or other amendments made to the certificate of organic operation pursu-
previous year’s organic system plan ant to § 205.404(b).
during the previous year; and
(ii) Any additions or deletions to the §§ 205.407–205.499 [Reserved]
previous year’s organic system plan,
intended to be undertaken in the com- Subpart F—Accreditation of
ing year, detailed pursuant to § 205.200;
(2) Any additions to or deletions from
Certifying Agents
the information required pursuant to § 205.500 Areas and duration of ac-
§ 205.401(b); creditation.
(3) An update on the correction of
minor noncompliances previously iden- (a) The Administrator shall accredit
tified by the certifying agent as requir- a qualified domestic or foreign appli-
ing correction for continued certifi- cant in the areas of crops, livestock,
cation; and wild crops, or handling or any com-
(4) Other information as deemed nec- bination thereof to certify a domestic
essary by the certifying agent to deter- or foreign production or handling oper-
mine compliance with the Act and the ation as a certified operation.
regulations in this part. (b) Accreditation shall be for a period
(b) Following the receipt of the infor- of 5 years from the date of approval of
mation specified in paragraph (a) of accreditation pursuant to § 205.506.
this section, the certifying agent shall (c) In lieu of accreditation under
within a reasonable time arrange and paragraph (a) of this section, USDA
conduct an on-site inspection of the will accept a foreign certifying agent’s
certified operation pursuant to accreditation to certify organic pro-
§ 205.403: Except, That, when it is impos- duction or handling operations if:
sible for the certifying agent to con- (1) USDA determines, upon the re-
duct the annual on-site inspection fol- quest of a foreign government, that the
425
§ 205.501 7 CFR Ch. I (1–1–22 Edition)
standards under which the foreign gov- expertise to conduct such reviews and
ernment authority accredited the for- implement measures to correct any
eign certifying agent meet the require- noncompliances with the Act and the
ments of this part; or regulations in this part that are identi-
(2) The foreign government authority fied in the evaluation;
that accredited the foreign certifying (8) Provide sufficient information to
agent acted under an equivalency persons seeking certification to enable
agreement negotiated between the them to comply with the applicable re-
United States and the foreign govern- quirements of the Act and the regula-
ment. tions in this part;
(9) Maintain all records pursuant to
§ 205.501 General requirements for ac-
creditation. § 205.510(b) and make all such records
available for inspection and copying
(a) A private or governmental entity during normal business hours by au-
accredited as a certifying agent under thorized representatives of the Sec-
this subpart must: retary and the applicable State organic
(1) Have sufficient expertise in or- program’s governing State official;
ganic production or handling tech- (10) Maintain strict confidentiality
niques to fully comply with and imple- with respect to its clients under the ap-
ment the terms and conditions of the plicable organic certification program
organic certification program estab-
and not disclose to third parties (with
lished under the Act and the regula-
the exception of the Secretary or the
tions in this part;
applicable State organic program’s
(2) Demonstrate the ability to fully
governing State official or their au-
comply with the requirements for ac-
thorized representatives) any business-
creditation set forth in this subpart;
related information concerning any cli-
(3) Carry out the provisions of the
ent obtained while implementing the
Act and the regulations in this part,
regulations in this part, except as pro-
including the provisions of §§ 205.402
vided for in § 205.504(b)(5);
through 205.406 and § 205.670;
(4) Use a sufficient number of ade- (11) Prevent conflicts of interest by:
quately trained personnel, including (i) Not certifying a production or
inspectors and certification review per- handling operation if the certifying
sonnel, to comply with and implement agent or a responsibly connected party
the organic certification program es- of such certifying agent has or has held
tablished under the Act and the regula- a commercial interest in the produc-
tions in subpart E of this part; tion or handling operation, including
(5) Ensure that its responsibly con- an immediate family interest or the
nected persons, employees, and con- provision of consulting services, within
tractors with inspection, analysis, and the 12-month period prior to the appli-
decision-making responsibilities have cation for certification;
sufficient expertise in organic produc- (ii) Excluding any person, including
tion or handling techniques to success- contractors, with conflicts of interest
fully perform the duties assigned. from work, discussions, and decisions
(6) Conduct an annual performance in all stages of the certification proc-
evaluation of all persons who review ess and the monitoring of certified pro-
applications for certification, perform duction or handling operations for all
on-site inspections, review certifi- entities in which such person has or
cation documents, evaluate qualifica- has held a commercial interest, includ-
tions for certification, make rec- ing an immediate family interest or
ommendations concerning certifi- the provision of consulting services,
cation, or make certification decisions within the 12-month period prior to the
and implement measures to correct application for certification;
any deficiencies in certification serv- (iii) Not permitting any employee,
ices; inspector, contractor, or other per-
(7) Have an annual program review of sonnel to accept payment, gifts, or fa-
its certification activities conducted vors of any kind, other than prescribed
by the certifying agent’s staff, an out- fees, from any business inspected: Ex-
side auditor, or a consultant who has cept, That, a certifying agent that is a
426
not-for-profit organization with an In- nature or qualities of products labeled

ternal Revenue Code tax exemption or, as organically produced;
in the case of a foreign certifying (15) Submit to the Administrator a
agent, a comparable recognition of not- copy of:
for-profit status from its government, (i) Any notice of denial of certifi-
may accept voluntary labor from cer- cation issued pursuant to § 205.405, noti-
tified operations; fication of noncompliance, notification
(iv) Not giving advice or providing of noncompliance correction, notifica-
consultancy services, to certification tion of proposed suspension or revoca-
applicants or certified operations, for tion, and notification of suspension or
overcoming identified barriers to cer- revocation sent pursuant to § 205.662 si-
tification; multaneously with its issuance; and
(v) Requiring all persons who review (ii) A list, on January 2 of each year,
applications for certification, perform including the name, address, and tele-
on-site inspections, review certifi- phone number of each operation grant-
cation documents, evaluate qualifica- ed certification during the preceding
tions for certification, make rec- year;
ommendations concerning certifi- (16) Charge applicants for certifi-
cation, or make certification decisions cation and certified production and
and all parties responsibly connected handling operations only those fees and
to the certifying agent to complete an charges for certification activities that
annual conflict of interest disclosure it has filed with the Administrator;
report; and (17) Pay and submit fees to AMS in
accordance with § 205.640;
(vi) Ensuring that the decision to
(18) Provide the inspector, prior to
certify an operation is made by a per-
each on-site inspection, with previous
son different from those who conducted
on-site inspection reports and notify
the review of documents and on-site in-
the inspector of its decision regarding
spection.
certification of the production or han-
(12)(i) Reconsider a certified oper- dling operation site inspected by the
ation’s application for certification inspector and of any requirements for
and, if necessary, perform a new on-site the correction of minor noncompli-
inspection when it is determined, with- ances;
in 12 months of certifying the oper- (19) Accept all production or handling
ation, that any person participating in applications that fall within its area(s)
the certification process and covered of accreditation and certify all quali-
under § 205.501(a)(11)(ii) has or had a fied applicants, to the extent of its ad-
conflict of interest involving the appli- ministrative capacity to do so without
cant. All costs associated with a recon- regard to size or membership in any as-
sideration of application, including on- sociation or group; and
site inspection costs, shall be borne by (20) Demonstrate its ability to com-
the certifying agent. ply with a State’s organic program to
(ii) Refer a certified operation to a certify organic production or handling
different accredited certifying agent operations within the State.
for recertification and reimburse the (21) Comply with, implement, and
operation for the cost of the recertifi- carry out any other terms and condi-
cation when it is determined that any tions determined by the Administrator
person covered under § 205.501(a)(11)(i) to be necessary.
at the time of certification of the ap- (b) A private or governmental entity
plicant had a conflict of interest in- accredited as a certifying agent under
volving the applicant. this subpart may establish a seal, logo,
(13) Accept the certification decisions or other identifying mark to be used by
made by another certifying agent ac- production and handling operations
credited or accepted by USDA pursuant certified by the certifying agent to in-
to § 205.500; dicate affiliation with the certifying
(14) Refrain from making false or agent: Provided, That, the certifying
misleading claims about its accredita- agent:
tion status, the USDA accreditation (1) Does not require use of its seal,
program for certifying agents, or the logo, or other identifying mark on any
427
§ 205.502 7 CFR Ch. I (1–1–22 Edition)
product sold, labeled, or represented as and documents set forth in §§ 205.503

organically produced as a condition of through 205.505 and the fees required in
certification and § 205.640 to: Program Manager, USDA–
(2) Does not require compliance with AMS–NOP, 1400 Independence Ave. SW.,
any production or handling practices Room 2648 So. Bldg., Ag Stop 0268,
other than those provided for in the Washington, DC 20250–0268.
Act and the regulations in this part as (b) Following the receipt of the infor-
a condition of use of its identifying mation and documents, the Adminis-
mark: Provided, That, certifying agents trator will determine, pursuant to
certifying production or handling oper- § 205.506, whether the applicant for ac-
ations within a State with more re- creditation should be accredited as a
strictive requirements, approved by the certifying agent.
Secretary, shall require compliance [65 FR 80637, Dec. 21, 2000, as amended at 80
with such requirements as a condition FR 6429, Feb. 5, 2015]
of use of their identifying mark by
such operations. § 205.503 Applicant information.
(c) A private entity accredited as a A private or governmental entity
certifying agent must: seeking accreditation as a certifying
(1) Hold the Secretary harmless for agent must submit the following infor-
any failure on the part of the certi- mation:
fying agent to carry out the provisions (a) The business name, primary office
of the Act and the regulations in this location, mailing address, name of the
part; person(s) responsible for the certifying
(2) Furnish reasonable security, in an agent’s day-to-day operations, contact
amount and according to such terms as numbers (telephone, facsimile, and
the Administrator may by regulation Internet address) of the applicant, and,
prescribe, for the purpose of protecting for an applicant who is a private per-
the rights of production and handling son, the entity’s taxpayer identifica-
operations certified by such certifying tion number;
agent under the Act and the regula- (b) The name, office location, mailing
tions in this part; and address, and contact numbers (tele-
(3) Transfer to the Administrator and phone, facsimile, and Internet address)
make available to any applicable State for each of its organizational units,
organic program’s governing State offi- such as chapters or subsidiary offices,
cial all records or copies of records and the name of a contact person for
concerning the person’s certification each unit;
activities in the event that the certi- (c) Each area of operation (crops,
fying agent dissolves or loses its ac- wild crops, livestock, or handling) for
creditation; Provided, That, such trans- which accreditation is requested and
fer shall not apply to a merger, sale, or the estimated number of each type of
other transfer of ownership of a certi- operation anticipated to be certified
fying agent. annually by the applicant along with a
(d) No private or governmental enti- copy of the applicant’s schedule of fees
ty accredited as a certifying agent for all services to be provided under
under this subpart shall exclude from these regulations by the applicant;
participation in or deny the benefits of (d) The type of entity the applicant is
the National Organic Program to any (e.g., government agricultural office,
person due to discrimination because of for-profit business, not-for-profit mem-
race, color, national origin, gender, re- bership association) and for:
ligion, age, disability, political beliefs, (1) A governmental entity, a copy of
sexual orientation, or marital or fam- the official’s authority to conduct cer-
ily status. tification activities under the Act and
the regulations in this part,
§ 205.502 Applying for accreditation. (2) A private entity, documentation
(a) A private or governmental entity showing the entity’s status and organi-
seeking accreditation as a certifying zational purpose, such as articles of in-
agent under this subpart must submit corporation and by-laws or ownership
an application for accreditation which or membership provisions, and its date

contains the applicable information of establishment; and
428
(e) A list of each State or foreign the Act and the regulations in this part
country in which the applicant cur- and the reporting of violations of the
rently certifies production and han- Act and the regulations in this part to
dling operations and a list of each the Administrator;
State or foreign country in which the (3) A copy of the procedures to be
applicant intends to certify production used for complying with the record-
or handling operations. keeping requirements set forth in
§ 205.501(a)(9);
§ 205.504 Evidence of expertise and
ability. (4) A copy of the procedures to be
used for maintaining the confiden-
A private or governmental entity tiality of any business-related informa-
seeking accreditation as a certifying
tion as set forth in § 205.501(a)(10);
agent must submit the following docu-
(5) A copy of the procedures to be
ments and information to demonstrate
its expertise in organic production or used, including any fees to be assessed,
handling techniques; its ability to fully for making the following information
comply with and implement the or- available to any member of the public
ganic certification program established upon request:
in §§ 205.100 and 205.101, §§ 205.201 (i) Certification certificates issued
through 205.203, §§ 205.300 through during the current and 3 preceding cal-
205.303, §§ 205.400 through 205.406, and endar years;
§§ 205.661 and 205.662; and its ability to (ii) A list of producers and handlers
comply with the requirements for ac- whose operations it has certified, in-
creditation set forth in § 205.501: cluding for each the name of the oper-
(a) Personnel. (1) A copy of the appli- ation, type(s) of operation, products
cant’s policies and procedures for produced, and the effective date of the
training, evaluating, and supervising certification, during the current and 3
personnel; preceding calendar years;
(2) The name and position description (iii) The results of laboratory anal-
of all personnel to be used in the cer- yses for residues of pesticides and other
tification operation, including admin- prohibited substances conducted during
istrative staff, certification inspectors, the current and 3 preceding calendar
members of any certification review years; and
and evaluation committees, contrac- (iv) Other business information as
tors, and all parties responsibly con- permitted in writing by the producer or
nected to the certifying agent; handler; and
(3) A description of the qualifica- (6) A copy of the procedures to be
tions, including experience, training, used for sampling and residue testing
and education in agriculture, organic pursuant to § 205.670.
production, and organic handling, for:
(c) Conflicts of interest. (1) A copy of
(i) Each inspector to be used by the
procedures intended to be implemented
applicant and
(ii) Each person to be designated by to prevent the occurrence of conflicts
the applicant to review or evaluate ap- of interest, as described in
plications for certification; and § 205.501(a)(11).
(4) A description of any training that (2) For all persons who review appli-
the applicant has provided or intends cations for certification, perform on-
to provide to personnel to ensure that site inspections, review certification
they comply with and implement the documents, evaluate qualifications for
requirements of the Act and the regu- certification, make recommendations
lations in this part. concerning certification, or make cer-
(b) Administrative policies and proce- tification decisions and all parties re-
dures. (1) A copy of the procedures to be sponsibly connected to the certifying
used to evaluate certification appli- agent, a conflict of interest disclosure
cants, make certification decisions, report, identifying any food- or agri-
and issue certification certificates; culture-related business interests, in-
(2) A copy of the procedures to be cluding business interests of imme-
used for reviewing and investigating diate family members, that cause a
certified operation compliance with conflict of interest.
429
§ 205.505 7 CFR Ch. I (1–1–22 Edition)
(d) Current certification activities. An views and implement measures to cor-

applicant who currently certifies pro- rect any noncompliances with the Act
duction or handling operations must and the regulations in this part;
submit: (1) A list of all production and (5) Pay and submit fees to AMS in ac-
handling operations currently certified cordance with § 205.640; and
by the applicant; (6) Comply with, implement, and
(2) Copies of at least 3 different in- carry out any other terms and condi-
spection reports and certification eval- tions determined by the Administrator
uation documents for production or to be necessary.
handling operations certified by the ap- (b) A private entity seeking accredi-
plicant during the previous year for tation as a certifying agent under this
each area of operation for which ac- subpart must additionally agree to:
creditation is requested; and (1) Hold the Secretary harmless for
(3) The results of any accreditation any failure on the part of the certi-
process of the applicant’s operation by fying agent to carry out the provisions
an accrediting body during the pre- of the Act and the regulations in this
vious year for the purpose of evalu- part;
ating its certification activities. (2) Furnish reasonable security, in an
(e) Other information. Any other infor- amount and according to such terms as
mation the applicant believes may as- the Administrator may by regulation
sist in the Administrator’s evaluation prescribe, for the purpose of protecting
of the applicant’s expertise and ability. the rights of production and handling
§ 205.505 Statement of agreement. operations certified by such certifying
agent under the Act and the regula-
(a) A private or governmental entity tions in this part; and
seeking accreditation under this sub- (3) Transfer to the Administrator and
part must sign and return a statement make available to the applicable State
of agreement prepared by the Adminis- organic program’s governing State offi-
trator which affirms that, if granted cial all records or copies of records
accreditation as a certifying agent concerning the certifying agent’s cer-
under this subpart, the applicant will tification activities in the event that
carry out the provisions of the Act and the certifying agent dissolves or loses
the regulations in this part, including: its accreditation; Provided, That such
(1) Accept the certification decisions transfer shall not apply to a merger,
made by another certifying agent ac- sale, or other transfer of ownership of a
credited or accepted by USDA pursuant certifying agent.
to § 205.500;
(2) Refrain from making false or mis- § 205.506 Granting accreditation.
leading claims about its accreditation
status, the USDA accreditation pro- (a) Accreditation will be granted
gram for certifying agents, or the na- when:
ture or qualities of products labeled as (1) The accreditation applicant has
organically produced; submitted the information required by
(3) Conduct an annual performance §§ 205.503 through 205.505;
evaluation of all persons who review (2) The accreditation applicant pays
applications for certification, perform the required fee in accordance with
on-site inspections, review certifi- § 205.640(c); and
cation documents, evaluate qualifica- (3) The Administrator determines
tions for certification, make rec- that the applicant for accreditation
ommendations concerning certifi- meets the requirements for accredita-
cation, or make certification decisions tion as stated in § 205.501, as deter-
and implement measures to correct mined by a review of the information
any deficiencies in certification serv- submitted in accordance with §§ 205.503
ices; through 205.505 and, if necessary, a re-
(4) Have an annual internal program view of the information obtained from
review conducted of its certification a site evaluation as provided for in
activities by certifying agent staff, an § 205.508.
outside auditor, or a consultant who (b) On making a determination to ap-

has the expertise to conduct such re- prove an application for accreditation,
430
the Administrator will notify the ap- is unsuccessful in its rebuttal, the Pro-
plicant of the granting of accreditation gram Manager will provide the appli-
in writing, stating: cant with written notification of ac-
(1) The area(s) for which accredita- creditation denial. An applicant who
tion is given; has received written notification of ac-
(2) The effective date of the accredi- creditation denial may apply for ac-
tation; creditation again at any time in ac-
(3) Any terms and conditions for the cordance with § 205.502, or appeal the
correction of minor noncompliances; denial of accreditation in accordance
and with § 205.681 by the date specified in
(4) For a certifying agent who is a the notification of accreditation de-
private entity, the amount and type of nial.
security that must be established to (d) If the certifying agent was accred-
protect the rights of production and ited prior to the site evaluation and
handling operations certified by such the certifying agent fails to correct the
certifying agent. noncompliances, fails to report the cor-
(c) The accreditation of a certifying rections by the date specified in the no-
agent shall continue in effect until tification of noncompliance, or fails to
such time as the certifying agent fails file a rebuttal of the notification of
to renew accreditation as provided in noncompliance by the date specified,
§ 205.510(c), the certifying agent volun- the Administrator will begin pro-
tarily ceases its certification activi- ceedings to suspend or revoke the cer-
ties, or accreditation is suspended or tifying agent’s accreditation. A certi-
revoked pursuant to § 205.665. fying agent who has had its accredita-
§ 205.507 Denial of accreditation. tion suspended may at any time, unless
otherwise stated in the notification of
(a) If the Program Manager has rea- suspension, submit a request to the
son to believe, based on a review of the Secretary for reinstatement of its ac-
information specified in §§ 205.503 creditation. The request must be ac-
through 205.505 or after a site evalua- companied by evidence demonstrating
tion as specified in § 205.508, that an ap- correction of each noncompliance and
plicant for accreditation is not able to corrective actions taken to comply
comply or is not in compliance with with and remain in compliance with
the requirements of the Act and the the Act and the regulations in this
regulations in this part, the Program part. A certifying agent whose accredi-
Manager shall provide a written notifi- tation is revoked will be ineligible for
cation of noncompliance to the appli-
accreditation for a period of not less
cant. Such notification shall provide:
than 3 years following the date of such
(1) A description of each noncompli-
determination.
ance;
(2) The facts upon which the notifica- § 205.508 Site evaluations.
tion of noncompliance is based; and
(3) The date by which the applicant (a) Site evaluations of accredited cer-
must rebut or correct each noncompli- tifying agents shall be conducted for
ance and submit supporting docu- the purpose of examining the certifying
mentation of each such correction agent’s operations and evaluating its
when correction is possible. compliance with the Act and the regu-
(b) When each noncompliance has lations of this part. Site evaluations
been resolved, the Program Manager shall include an on-site review of the
will send the applicant a written notifi- certifying agent’s certification proce-
cation of noncompliance resolution and dures, decisions, facilities, administra-
proceed with further processing of the tive and management systems, and
application. production or handling operations cer-
(c) If an applicant fails to correct the tified by the certifying agent. Site
noncompliances, fails to report the cor- evaluations shall be conducted by a
rections by the date specified in the no- representative(s) of the Administrator.
tification of noncompliance, fails to (b) An initial site evaluation of an
file a rebuttal of the notification of accreditation applicant shall be con-

noncompliance by the date specified, or ducted before or within a reasonable
431
§ 205.509 7 CFR Ch. I (1–1–22 Edition)
period of time after issuance of the ap- tation or notice of renewal of accredi-
plicant’s ‘‘notification of accredita- tation;
tion.’’ A site evaluation shall be con- (4) The results of the most recent
ducted after application for renewal of performance evaluations and annual
accreditation but prior to the issuance program review and a description of ad-
of a notice of renewal of accreditation. justments to the certifying agent’s op-
One or more site evaluations will be eration and procedures implemented or
conducted during the period of accredi- to be implemented in response to the
tation to determine whether an accred- performance evaluations and program
ited certifying agent is complying with review; and
the general requirements set forth in (5) The fees required in § 205.640(a).
§ 205.501. (b) Recordkeeping. Certifying agents
must maintain records according to
§ 205.509 Peer review panel. the following schedule:
The Administrator shall establish a (1) Records obtained from applicants
peer review panel pursuant to the Fed- for certification and certified oper-
eral Advisory Committee Act (FACA) ations must be maintained for not less
(5 U.S.C. App. 2 et seq.). The peer review than 5 years beyond their receipt;
(2) Records created by the certifying
panel shall be composed of not less
agent regarding applicants for certifi-
than 3 members who shall annually
cation and certified operations must be
evaluate the National Organic Pro-
maintained for not less than 10 years
gram’s adherence to the accreditation
beyond their creation; and
procedures in this subpart F and ISO/
(3) Records created or received by the
IEC Guide 61, General requirements for
certifying agent pursuant to the ac-
assessment and accreditation of certifi-
creditation requirements of this sub-
cation/registration bodies, and the Na-
part F, excluding any records covered
tional Organic Program’s accreditation
by § 205.510(b)(2), must be maintained
decisions. This shall be accomplished
for not less than 5 years beyond their
through the review of accreditation creation or receipt.
procedures, document review and site (c) Renewal of accreditation. (1) The
evaluation reports, and accreditation Administrator shall send the accred-
decision documents or documentation. ited certifying agent a notice of pend-
The peer review panel shall report its ing expiration of accreditation approxi-
finding, in writing, to the National Or- mately 1 year prior to the scheduled
ganic Program’s Program Manager. date of expiration.
(2) An accredited certifying agent’s
§ 205.510 Annual report, record-
keeping, and renewal of accredita- application for accreditation renewal
tion. must be received at least 6 months
prior to the fifth anniversary of
(a) Annual report and fees. An accred- issuance of the notification of accredi-
ited certifying agent must submit an- tation and each subsequent renewal of
nually to the Administrator, on or be- accreditation. The accreditation of cer-
fore the anniversary date of the tifying agents who make timely appli-
issuance of the notification of accredi- cation for renewal of accreditation will
tation, the following reports and fees: not expire during the renewal process.
(1) A complete and accurate update of The accreditation of certifying agents
information submitted pursuant to who fail to make timely application for
§§ 205.503 and 205.504; renewal of accreditation will expire as
(2) Information supporting any scheduled unless renewed prior to the
changes being requested in the areas of scheduled expiration date. Certifying
accreditation described in § 205.500; agents with an expired accreditation
(3) A description of the measures im- must not perform certification activi-
plemented in the previous year and any ties under the Act and the regulations
measures to be implemented in the of this part.
coming year to satisfy any terms and (3) Following receipt of the informa-
conditions determined by the Adminis- tion submitted by the certifying agent
trator to be necessary, as specified in in accordance with paragraph (a) of

the most recent notification of accredi- this section and the results of a site
432
evaluation, the Administrator will de- (b) In addition to the criteria set
termine whether the certifying agent forth in the Act, any synthetic sub-
remains in compliance with the Act stance used as a processing aid or adju-
and the regulations of this part and vant will be evaluated against the fol-
should have its accreditation renewed. lowing criteria:
(d) Notice of renewal of accreditation. (1) The substance cannot be produced
Upon a determination that the certi- from a natural source and there are no
fying agent is in compliance with the organic substitutes;
Act and the regulations of this part, (2) The substance’s manufacture, use,
the Administrator will issue a notice of and disposal do not have adverse ef-
renewal of accreditation. The notice of fects on the environment and are done
renewal will specify any terms and con- in a manner compatible with organic
ditions that must be addressed by the handling;
certifying agent and the time within (3) The nutritional quality of the
which those terms and conditions must food is maintained when the substance
be satisfied. is used, and the substance, itself, or its
(e) Noncompliance. Upon a determina- breakdown products do not have an ad-
tion that the certifying agent is not in verse effect on human health as defined
compliance with the Act and the regu- by applicable Federal regulations;
lations of this part, the Administrator (4) The substance’s primary use is
will initiate proceedings to suspend or not as a preservative or to recreate or
revoke the certifying agent’s accredi- improve flavors, colors, textures, or
tation. nutritive value lost during processing,
(f) Amending accreditation. Amend- except where the replacement of nutri-
ment to scope of an accreditation may ents is required by law;
be requested at any time. The applica- (5) The substance is listed as gen-
tion for amendment shall be sent to erally recognized as safe (GRAS) by
the Administrator and shall contain in- Food and Drug Administration (FDA)
formation applicable to the requested when used in accordance with FDA’s
change in accreditation, a complete good manufacturing practices (GMP)
and accurate update of the information and contains no residues of heavy met-
submitted pursuant to §§ 205.503 and als or other contaminants in excess of
205.504, and the applicable fees required tolerances set by FDA; and
in § 205.640. (6) The substance is essential for the
[65 FR 80637, Dec. 21, 2000, as amended at 80 handling of organically produced agri-
FR 6429, Feb. 5, 2015] cultural products.
(c) Nonsynthetics used in organic
§§ 205.511–205.599 [Reserved] processing will be evaluated using the
criteria specified in the Act (7 U.S.C.
Subpart G—Administrative 6517 and 6518).
THE NATIONAL LIST OF ALLOWED AND § 205.601 Synthetic substances allowed

PROHIBITED SUBSTANCES for use in organic crop production.
In accordance with restrictions speci-
§ 205.600 Evaluation criteria for al- fied in this section, the following syn-
lowed and prohibited substances, thetic substances may be used in or-
methods, and ingredients.
ganic crop production: Provided, That,
The following criteria will be utilized use of such substances do not con-
in the evaluation of substances or in- tribute to contamination of crops, soil,
gredients for the organic production or water. Substances allowed by this
and handling sections of the National section, except disinfectants and sani-
List: tizers in paragraph (a) and those sub-
(a) Synthetic and nonsynthetic substances in paragraphs (c), (j), (k), and
stances considered for inclusion on or (l) of this section, may only be used
deletion from the National List of al- when the provisions set forth in
lowed and prohibited substances will be § 205.206(a) through (d) prove insuffi-
evaluated using the criteria specified cient to prevent or control the target
in the Act (7 U.S.C. 6517 and 6518). pest.
433
§ 205.601 7 CFR Ch. I (1–1–22 Edition)
(a) As algicide, disinfectants, and (iii) Biodegradable biobased mulch

sanitizer, including irrigation system film as defined in § 205.2. Must be pro-
cleaning systems. duced without organisms or feedstock
(1) Alcohols. derived from excluded methods.
(i) Ethanol. (c) As compost feedstocks—News-
(ii) Isopropanol. papers or other recycled paper, without
(2) Chlorine materials—For pre-har- glossy or colored inks.
vest use, residual chlorine levels in the (d) As animal repellents—Soaps, am-
water in direct crop contact or as monium—for use as a large animal re-
water from cleaning irrigation systems pellant only, no contact with soil or
applied to soil must not exceed the edible portion of crop.
maximum residual disinfectant limit (e) As insecticides (including
under the Safe Drinking Water Act, ex- acaricides or mite control).
cept that chlorine products may be
(1) Ammonium carbonate—for use as
used in edible sprout production ac-
bait in insect traps only, no direct con-
cording to EPA label directions.
tact with crop or soil.
(i) Calcium hypochlorite.
(ii) Chlorine dioxide. (2) Aqueous potassium silicate (CAS
(iii) Hypochlorous acid—generated #–1312–76–1)—the silica, used in the
from electrolyzed water. manufacture of potassium silicate,
(iv) Sodium hypochlorite. must be sourced from naturally occur-
(3) Copper sulfate—for use as an ring sand.
algicide in aquatic rice systems, is lim- (3) Boric acid—structural pest con-
ited to one application per field during trol, no direct contact with organic
any 24-month period. Application rates food or crops.
are limited to those which do not in- (4) Copper sulfate—for use as tadpole
crease baseline soil test values for cop- shrimp control in aquatic rice produc-
per over a timeframe agreed upon by tion, is limited to one application per
the producer and accredited certifying field during any 24-month period. Ap-
agent. plication rates are limited to levels
(4) Hydrogen peroxide. which do not increase baseline soil test
(5) Ozone gas—for use as an irrigation values for copper over a timeframe
system cleaner only. agreed upon by the producer and ac-
(6) Peracetic acid—for use in dis- credited certifying agent.
infecting equipment, seed, and (5) Elemental sulfur.
asexually propagated planting mate- (6) Lime sulfur—including calcium
rial. Also permitted in hydrogen per- polysulfide.
oxide formulations as allowed in (7) Oils, horticultural—narrow range
§ 205.601(a) at concentration of no more oils as dormant, suffocating, and sum-
than 6% as indicated on the pesticide mer oils.
product label. (8) Soaps, insecticidal.
(7) Soap-based algicide/demossers. (9) Sticky traps/barriers.
(8) Sodium carbonate peroxyhydrate (10) Sucrose octanoate esters (CAS
(CAS #–15630–89–4)—Federal law re- #s—42922–74–7; 58064–47–4)—in accord-
stricts the use of this substance in food ance with approved labeling.
crop production to approved food uses
(f) As insect management.
identified on the product label.
Pheromones.
(b) As herbicides, weed barriers, as
(g) As rodenticides. Vitamin D3.
applicable.
(1) Herbicides, soap-based—for use in (h) As slug or snail bait.
farmstead maintenance (roadways, (1) Ferric phosphate (CAS # 10045–86–
ditches, right of ways, building perim- 0).
eters) and ornamental crops. (2) Elemental sulfur.
(2) Mulches. (i) As plant disease control.
(i) Newspaper or other recycled (1) Aqueous potassium silicate (CAS
paper, without glossy or colored inks. #–1312–76–1)—the silica, used in the
(ii) Plastic mulch and covers (petro- manufacture of potassium silicate,
leum-based other than polyvinyl chlo- must be sourced from naturally occur-
ride (PVC)). ring sand.
434
(2) Coppers, fixed—copper hydroxide, shall not exceed the minimum needed
copper oxide, copper oxychloride, in- to lower the pH to 3.5.
cludes products exempted from EPA (9) Vitamins, B1, C, and E.
tolerance, Provided, That, copper-based (10) Squid byproducts—from food
materials must be used in a manner waste processing only. Can be pH ad-
that minimizes accumulation in the justed with sulfuric, citric, or phos-
soil and shall not be used as herbicides. phoric acid. The amount of acid used
(3) Copper sulfate—Substance must shall not exceed the minimum needed
be used in a manner that minimizes ac- to lower the pH to 3.5.
cumulation of copper in the soil. (11) Sulfurous acid (CAS # 7782–99–2)
(4) Hydrated lime. for on-farm generation of substance
(5) Hydrogen peroxide. utilizing 99% purity elemental sulfur
(6) Lime sulfur. per paragraph (j)(2) of this section.
(7) Oils, horticultural, narrow range (k) As plant growth regulators.
oils as dormant, suffocating, and sum- Ethylene gas—for regulation of pine-
mer oils. apple flowering.
(8) Peracetic acid—for use to control (l) As floating agents in postharvest
fire blight bacteria. Also permitted in handling. Sodium silicate—for tree
hydrogen peroxide formulations as al- fruit and fiber processing.
lowed in § 205.601(i) at concentration of (m) As synthetic inert ingredients as
no more than 6% as indicated on the classified by the Environmental Pro-
pesticide product label. tection Agency (EPA), for use with
(9) Potassium bicarbonate. nonsynthetic substances or synthetic
(10) Elemental sulfur. substances listed in this section and
(11) Polyoxin D zinc salt. used as an active pesticide ingredient
(j) As plant or soil amendments. in accordance with any limitations on
(1) Aquatic plant extracts (other than the use of such substances.
hydrolyzed)—Extraction process is lim- (1) EPA List 4—Inerts of Minimal
ited to the use of potassium hydroxide Concern.
or sodium hydroxide; solvent amount (2) EPA List 3—Inerts of unknown
used is limited to that amount nec- toxicity—for use only in passive
essary for extraction. pheromone dispensers.
(2) Elemental sulfur. (n) Seed preparations. Hydrogen chlo-
(3) Humic acids—naturally occurring ride (CAS # 7647–01–0)—for delinting
deposits, water and alkali extracts cotton seed for planting.
only. (o) As production aids. Microcrys-
(4) Lignin sulfonate—chelating agent, talline cheesewax (CAS #’s 64742–42–3,
dust suppressant. 8009–03–08, and 8002–74–2)–for use in log
(5) Magnesium oxide (CAS # 1309–48– grown mushroom production. Must be
4)—for use only to control the viscosity made without either ethylene-pro-
of a clay suspension agent for humates. pylene co-polymer or synthetic colors.
(6) Magnesium sulfate—allowed with (p)–(z) [Reserved]
a documented soil deficiency. [65 FR 80637, Dec. 21, 2000, as amended at 68
(7) Micronutrients—not to be used as FR 61992, Oct. 31, 2003; 71 FR 53302 Sept. 11,
a defoliant, herbicide, or desiccant. 2006; 72 FR 69572, Dec. 10, 2007; 75 FR 38696,
Those made from nitrates or chlorides July 6, 2010; 75 FR 77524, Dec. 13, 2010; 77 FR
are not allowed. Micronutrient defi- 8092, Feb. 14, 2012; 77 FR 33298, June 6, 2012; 77
FR 45907, Aug. 2, 2012; 78 FR 31821, May 28,
ciency must be documented by soil or 2013; 79 FR 58663, Sept. 30, 2014; 80 FR 77234,
tissue testing or other documented and Dec. 14, 2015; 82 FR 31243, July 6, 2017; 83 FR
verifiable method as approved by the 66571, Dec. 27, 2018; 84 FR 56677, Oct. 23, 2019]
certifying agent.
(i) Soluble boron products. § 205.602 Nonsynthetic substances pro-
(ii) Sulfates, carbonates, oxides, or hibited for use in organic crop pro-
silicates of zinc, copper, iron, man- duction.
ganese, molybdenum, selenium, and co- The following nonsynthetic sub-
balt. stances may not be used in organic
(8) Liquid fish products—can be pH crop production:
adjusted with sulfuric, citric or phos- (a) Ash from manure burning.
phoric acid. The amount of acid used (b) Arsenic.
435
§ 205.603 7 CFR Ch. I (1–1–22 Edition)
(c) Calcium chloride, brine process is part 530 of the Food and Drug Adminis-
natural and prohibited for use except tration regulations. Also, for use under
as a foliar spray to treat a physio- 7 CFR part 205, the NOP requires:
logical disorder associated with cal- (i) Use by or on the lawful written
cium uptake. order of a licensed veterinarian; and
(d) Lead salts. (ii) A meat withdrawal period of at
(e) Potassium chloride—unless de- least 42 days after administering to
rived from a mined source and applied livestock intended for slaughter; and a
in a manner that minimizes chloride milk discard period of at least 8 days
accumulation in the soil. after administering to dairy animals.
(f) Rotenone (CAS # 83–79–4). (6) Activated charcoal (CAS # 7440–
(g) Sodium fluoaluminate (mined). 44–0)—must be from vegetative sources.
(h) Sodium nitrate—unless use is re- (7) Calcium borogluconate (CAS #
stricted to no more than 20% of the 5743–34–0)—for treatment of milk fever
crop’s total nitrogen requirement; use only.
in spirulina production is unrestricted (8) Calcium propionate (CAS # 4075–
until October 21, 2005. 81–4)—for treatment of milk fever only.
(i) Strychnine. (9) Chlorhexidine (CAS # 55–56–1)—for
(j) Tobacco dust (nicotine sulfate). medical procedures conducted under
[68 FR 61992, Oct. 31, 2003, as amended at 83 the supervision of a licensed veteri-
FR 66572, Dec. 27, 2018] narian. Allowed for use as a teat dip
when alternative germicidal agents
§ 205.603 Synthetic substances allowed and/or physical barriers have lost their
for use in organic livestock produc- effectiveness.
tion. (10) Chlorine materials—disinfecting
In accordance with restrictions speci- and sanitizing facilities and equip-
fied in this section the following syn- ment. Residual chlorine levels in the
thetic substances may be used in or- water shall not exceed the maximum
ganic livestock production: residual disinfectant limit under the
(a) As disinfectants, sanitizer, and Safe Drinking Water Act.
medical treatments as applicable. (i) Calcium hypochlorite.
(1) Alcohols. (ii) Chlorine dioxide.
(i) Ethanol—disinfectant and sani- (iii) Hypochlorous acid—generated
tizer only, prohibited as a feed addi- from electrolyzed water.
tive. (iv) Sodium hypochlorite
(ii) Isopropanol-disinfectant only. (11) Electrolytes—without anti-
(2) Aspirin-approved for health care biotics.
use to reduce inflammation. (12) Flunixin (CAS #-38677–85–9)—in
(3) Atropine (CAS #-51–55–8)—federal accordance with approved labeling; ex-
law restricts this drug to use by or on cept that for use under 7 CFR part 205,
the lawful written or oral order of a li- the NOP requires a withdrawal period
censed veterinarian, in full compliance of at least two-times that required by
with the AMDUCA and 21 CFR part 530 the FDA.
of the Food and Drug Administration (13) Glucose.
regulations. Also, for use under 7 CFR (14) Glycerin—allowed as a livestock
part 205, the NOP requires: teat dip, must be produced through the
(i) Use by or on the lawful written hydrolysis of fats or oils.
order of a licensed veterinarian; and (15) Hydrogen peroxide.
(ii) A meat withdrawal period of at (16) Iodine.
least 56 days after administering to (17) Kaolin pectin—for use as an ad-
livestock intended for slaughter; and a sorbent, antidiarrheal, and gut protect-
milk discard period of at least 12 days ant.
after administering to dairy animals. (18) Magnesium hydroxide (CAS #-
(4) Biologics—Vaccines. 1309–42–8)—federal law restricts this
(5) Butorphanol (CAS #-42408–82–2)— drug to use by or on the lawful written
federal law restricts this drug to use by or oral order of a licensed veterinarian,
or on the lawful written or oral order in full compliance with the AMDUCA
of a licensed veterinarian, in full com- and 21 CFR part 530 of the Food and
pliance with the AMDUCA and 21 CFR Drug Administration regulations. Also,
436
for use under 7 CFR part 205, the NOP (27) Propylene glycol (CAS #57–55–6)—
requires use by or on the lawful writ- only for treatment of ketosis in
ten order of a licensed veterinarian. ruminants.
(19) Magnesium sulfate. (28) Sodium chlorite, acidified—al-
(20) Mineral oil—for treatment of in- lowed for use on organic livestock as a
testinal compaction, prohibited for use teat dip treatment only.
as a dust suppressant. (29) Tolazoline (CAS #59–98–3)—fed-
(21) Nutritive supplements— eral law restricts this drug to use by or
injectable supplements of trace min- on the lawful written or oral order of a
erals per paragraph (d)(2) of this sec- licensed veterinarian, in full compli-
tion, vitamins per paragraph (d)(3), and ance with the AMDUCA and 21 CFR
electrolytes per paragraph (a)(11), with part 530 of the Food and Drug Adminis-
excipients per paragraph (f), in accord- tration regulations. Also, for use under
ance with FDA and restricted to use by 7 CFR part 205, the NOP requires:
or on the order of a licensed veteri- (i) Use by or on the lawful written
narian. order of a licensed veterinarian;
(22) Oxytocin—use in postparturition (ii) Use only to reverse the effects of
therapeutic applications. sedation and analgesia caused by
(23) Parasiticides—prohibited in Xylazine; and,
slaughter stock, allowed in emergency (iii) A meat withdrawal period of at
treatment for dairy and breeder stock least 8 days after administering to live-
when organic system plan-approved stock intended for slaughter; and a
preventive management does not pre- milk discard period of at least 4 days
vent infestation. In breeder stock, after administering to dairy animals.
treatment cannot occur during the last (30) Xylazine (CAS #7361–61–7)—fed-
third of gestation if the progeny will be eral law restricts this drug to use by or
sold as organic and must not be used on the lawful written or oral order of a
during the lactation period for breed- licensed veterinarian, in full compli-
ing stock. Allowed for fiber bearing ance with the AMDUCA and 21 CFR
animals when used a minimum of 36 part 530 of the Food and Drug Adminis-
days prior to harvesting of fleece or tration regulations. Also, for use under
wool that is to be sold, labeled, or rep- 7 CFR part 205, the NOP requires:
resented as organic. (i) Use by or on the lawful written
(i) Fenbendazole (CAS #43210–67–9)— order of a licensed veterinarian; and,
milk or milk products from a treated (ii) A meat withdrawal period of at
animal cannot be labeled as provided least 8 days after administering to live-
for in subpart D of this part for: 2 days stock intended for slaughter; and a
following treatment of cattle; 36 days milk discard period of at least 4 days
following treatment of goats, sheep, after administering to dairy animals.
and other dairy species. (b) As topical treatment, external
(ii) Moxidectin (CAS #113507–06–5)— parasiticide or local anesthetic as ap-
milk or milk products from a treated plicable.
animal cannot be labeled as provided (1) Copper sulfate.
for in subpart D of this part for: 2 days (2) Elemental sulfur—for treatment
following treatment of cattle; 36 days of livestock and livestock housing.
following treatment of goats, sheep, (3) Formic acid (CAS # 64–18–6)—for
and other dairy species. use as a pesticide solely within hon-
(24) Peroxyacetic/peracetic acid (CAS eybee hives.
#-79–21–0)—for sanitizing facility and (4) Iodine.
processing equipment. (5) Lidocaine—as a local anesthetic.
(25) Phosphoric acid—allowed as an Use requires a withdrawal period of 8
equipment cleaner, Provided, That, no days after administering to livestock
direct contact with organically man- intended for slaughter and 6 days after
aged livestock or land occurs. administering to dairy animals.
(26) Poloxalene (CAS #-9003–11–6)—for (6) Lime, hydrated—as an external
use under 7 CFR part 205, the NOP re- pest control, not permitted to cau-
quires that poloxalene only be used for terize physical alterations or deodorize
the emergency treatment of bloat. animal wastes.
437
§ 205.604 7 CFR Ch. I (1–1–22 Edition)
(7) Mineral oil—for topical use and as (g)–(z) [Reserved]

a lubricant.
(8) Oxalic acid dihydrate—for use as a FR 54059, Sept. 18, 2008; 75 FR 51924, Aug. 24,
pesticide solely for apiculture. 2010; 77 FR 28745, May 15, 2012; 77 FR 45907,
(9) Procaine—as a local anesthetic. Aug. 2, 2012; 77 FR 57989, Sept. 19, 2012; 80 FR
Use requires a withdrawal period of 8 6429, Feb. 5, 2015; 82 FR 31243, July 6, 2017; 83
days after administering to livestock FR 66572, Dec. 27, 2018; 84 FR 18136, Apr. 30,
intended for slaughter and 6 days after 2019; 86 FR 33484, June 25, 2021]
administering to dairy animals.
§ 205.604 Nonsynthetic substances pro-
(10) Sodium chlorite, acidified—al- hibited for use in organic livestock
lowed for use on organic livestock as production.
teat dip treatment only.
The following nonsynthetic sub-
(11) Sucrose octanoate esters (CAS
stances may not be used in organic
#s–42922–74–7; 58064–47–4)—in accordance
livestock production:
with approved labeling.
(a) Strychnine.
(12) Zinc sulfate—for use in hoof and
(b)–(z) [Reserved]
foot treatments only.
(c) As feed supplements—None. § 205.605 Nonagricultural (nonorganic)
(d) As feed additives. substances allowed as ingredients
(1) DL-Methionine, DL-Methionine— in or on processed products labeled
hydroxy analog, and DL-Methionine— as ‘‘organic’’ or ‘‘made with organic
hydroxy analog calcium (CAS #’s 59–51– (specified ingredients or food
group(s)).’’
8, 583–91–5, 4857–44–7, and 922–50–9)—for
use only in organic poultry production The following nonagricultural sub-
at the following pounds of synthetic 100 stances may be used as ingredients in
percent methionine per ton of feed in or on processed products labeled as
the diet, maximum rates as averaged ‘‘organic’’ or ‘‘made with organic (spec-
per ton of feed over the life of the ified ingredients or food group(s))’’
flock: Laying chickens—2 pounds; only in accordance with any restric-
broiler chickens—2.5 pounds; turkeys tions specified in this section.
and all other poultry—3 pounds. (a) Nonsynthetics allowed:
(2) Trace minerals, used for enrich- Acids (Citric—produced by microbial
ment or fortification when FDA ap- fermentation of carbohydrate sub-
proved. stances; and Lactic).
(3) Vitamins, used for enrichment or Agar-agar.
fortification when FDA approved. Animal enzymes—(Rennet—animals
(e) As synthetic inert ingredients as derived; Catalase—bovine liver; Animal
classified by the Environmental Pro- lipase; Pancreatin; Pepsin; and
tection Agency (EPA), for use with Trypsin).
nonsynthetic substances or synthetic Attapulgite—as a processing aid in
substances listed in this section and the handling of plant and animal oils.
used as an active pesticide ingredient Bentonite.
in accordance with any limitations on Calcium carbonate.
the use of such substances. Calcium chloride.
(1) EPA List 4—Inerts of Minimal Calcium sulfate—mined.
Concern. Carrageenan.
(2) [Reserved] Dairy cultures.
(f) Excipients—only for use in the Diatomaceous earth—food filtering
manufacture of drugs and biologics aid only.
used to treat organic livestock when Enzymes—must be derived from edi-
the excipient is: (1) Identified by the ble, nontoxic plants, nonpathogenic
FDA as Generally Recognized As Safe; fungi, or nonpathogenic bacteria.
(2) Approved by the FDA as a food addi- Flavors—nonsynthetic flavors may
tive; (3) Included in the FDA review be used when organic flavors are not
and approval of a New Animal Drug commercially available. All flavors
Application or New Drug Application; must be derived from organic or non-
or (4) Approved by APHIS for use in synthetic sources only and must not be
veterinary biologics. produced using synthetic solvents and
438
carrier systems or any artificial pre- Cellulose (CAS #9004–34–6)—for use in

servative. regenerative casings, powdered cel-
Gellan gum (CAS # 71010–52–1)—high- lulose as an anti-caking agent (non-
acyl form only. chlorine bleached) and filtering aid.
Glucono delta-lactone—production Microcrystalline cellulose is prohib-
by the oxidation of D-glucose with bro- ited.
mine water is prohibited. Chlorine materials—disinfecting and
Kaolin. sanitizing food contact surfaces, equip-
L-Malic acid (CAS # 97–67–6). ment and facilities may be used up to
Magnesium chloride. maximum labeled rates. Chlorine ma-
Magnesium sulfate, nonsynthetic terials in water used in direct crop or
sources only. food contact are permitted at levels ap-
Microorganisms—any food grade bac- proved by the FDA or EPA for such
teria, fungi, and other microorganism. purpose, provided the use is followed by
Nitrogen—oil-free grades. a rinse with potable water at or below
Oxygen—oil-free grades. the maximum residual disinfectant
Perlite—for use only as a filter aid in limit for the chlorine material under
food processing. the Safe Drinking Water Act. Chlorine
Potassium chloride. in water used as an ingredient in or-
Potassium iodide. ganic food handling must not exceed
Pullulan—for use only in tablets and the maximum residual disinfectant
capsules for dietary supplements la- limit for the chlorine material under
beled ‘‘made with organic (specified in- the Safe Drinking Water Act.
gredients or food group(s)). i. Calcium hypochlorite.
Sodium bicarbonate. ii. Chlorine dioxide.
Sodium carbonate. iii. Hypochlorous acid—generated
Tartaric acid—made from grape wine. from electrolyzed water.
Waxes—nonsynthetic (Wood resin). iv. Sodium hypochlorite.
Yeast—When used as food or a fer- Collagen gel—as casing, may be used
mentation agent in products labeled as only when organic collagen gel is not
‘‘organic,’’ yeast must be organic if its commercially available.
end use is for human consumption; Ethylene—allowed for postharvest
nonorganic yeast may be used when or- ripening of tropical fruit and
ganic yeast is not commercially avail- degreening of citrus.
able. Growth on petrochemical sub- Ferrous sulfate—for iron enrichment
strate and sulfite waste liquor is pro- or fortification of foods when required
hibited. For smoked yeast, nonsyn- by regulation or recommended (inde-
thetic smoke flavoring process must be pendent organization).
documented. Glycerides (mono and di)—for use
(b) Synthetics allowed: only in drum drying of food.
Acidified sodium chlorite—Secondary Hydrogen peroxide.
direct antimicrobial food treatment Magnesium stearate—for use only in
and indirect food contact surface sani- agricultural products labeled ‘‘made
tizing. Acidified with citric acid only. with organic (specified ingredients or
Activated charcoal (CAS #s 7440–44–0; food group(s)),’’ prohibited in agricul-
64365–11–3)—only from vegetative tural products labeled ‘‘organic’’.
sources; for use only as a filtering aid. Nutrient vitamins and minerals, in
Alginates. accordance with 21 CFR 104.20, Nutri-
Alginic acid (CAS #9005–32–7) tional Quality Guidelines For Foods.
Ammonium bicarbonate—for use Ozone.
only as a leavening agent. Peracetic acid/Peroxyacetic acid
Ammonium carbonate—for use only (CAS # 79–21–0)—for use in wash and/or
as a leavening agent. rinse water according to FDA limita-
Ascorbic acid. tions. For use as a sanitizer on food
Calcium citrate. contact surfaces.
Calcium hydroxide. Phosphoric acid—cleaning of food-
Calcium phosphates (monobasic, di- contact surfaces and equipment only.
basic, and tribasic). Potassium carbonate.

Carbon dioxide. Potassium citrate.
439
§ 205.606 7 CFR Ch. I (1–1–22 Edition)
Potassium hydroxide—prohibited for (d) Colors derived from agricultural

use in lye peeling of fruits and vegeta- products—Must not be produced using
bles except when used for peeling synthetic solvents and carrier systems
peaches. or any artificial preservative.
Potassium lactate—for use as an (1) Beet juice extract color—derived
antimicrobial agent and pH regulator from Beta vulgaris L., except must not
only. be produced from sugarbeets.
Potassium phosphate—for use only in (2) Beta-carotene extract color—de-
agricultural products labeled ‘‘made rived from carrots (Daucus carota L.) or
with organic (specific ingredients or algae (Dunaliella salina).
food group(s)),’’ prohibited in agricul- (3) Black currant juice color—derived
tural products labeled ‘‘organic’’. from Ribes nigrum L.
Silicon dioxide—Permitted as a (4) Black/purple carrot juice color—
defoamer. Allowed for other uses when derived from Daucus carota L.
organic rice hulls are not commer- (5) Blueberry juice color—derived
cially available. from blueberries (Vaccinium spp.).
Sodium acid pyrophosphate (CAS # (6) Carrot juice color—derived from
7758–16–9)—for use only as a leavening Daucus carota L.
agent. (7) Cherry juice color—derived from
Sodium citrate. Prunus avium (L.) L. or Prunus cerasus
Sodium hydroxide—prohibited for use L.
in lye peeling of fruits and vegetables. (8) Chokeberry, aronia juice color—
Sodium lactate—for use as an anti- derived from Aronia arbutifolia (L.)
microbial agent and pH regulator only. Pers. or Aronia melanocarpa (Michx.)
Sodium phosphates—for use only in Elliott.
dairy foods. (9) Elderberry juice color—derived
from Sambucus nigra L.
Sulfur dioxide—for use only in wine
(10) Grape juice color—derived from
labeled ‘‘made with organic grapes,’’
Vitis vinifera L.
Provided, That, total sulfite concentra-
(11) Grape skin extract color—derived
tion does not exceed 100 ppm.
from Vitis vinifera L.
Tocopherols—derived from vegetable
(12) Paprika color—derived from
oil when rosemary extracts are not a
dried powder or vegetable oil extract of
suitable alternative.
Capsicum annuum L.
Xanthan gum.
(13) Pumpkin juice color—derived
(c)–(z) [Reserved] from Cucurbita pepo L. or Cucurbita
[68 FR 61993, Oct. 31, 2003] maxima Duchesne.
EDITORIAL NOTE: For FEDERAL REGISTER ci-
(14) Purple sweet potato juice color—
tations affecting § 205.605, see the List of CFR derived from Ipomoea batatas L. or
Sections Affected, which appears in the Solanum tuberosum L.
Finding Aids section of the printed volume (15) Red cabbage extract color—de-
and at www.govinfo.gov. rived from Brassica oleracea L.
(16) Red radish extract color—derived
§ 205.606 Nonorganically produced ag- from Raphanus sativus L.
ricultural products allowed as in- (17) Saffron extract color—derived
gredients in or on processed prod- from Crocus sativus L.
ucts labeled as ‘‘organic.’’
(18) Turmeric extract color—derived
Only the following nonorganically from Curcuma longa L.
produced agricultural products may be (e) Fish oil (Fatty acid CAS #’s:
used as ingredients in or on processed 10417–94–4, and 25167–62–8)—stabilized
products labeled as ‘‘organic,’’ only in with organic ingredients or only with
accordance with any restrictions speci- ingredients on the National List,
fied in this section, and only when the §§ 205.605 and 205.606.
product is not commercially available (f) Fructooligosaccharides (CAS #
in organic form. 308066–66–2).
(a) Carnauba wax (g) Gelatin (CAS # 9000–70–8).
(b) Casings, from processed intes- (h) Glycerin (CAS # 56–81–5)—pro-
tines. duced from agricultural source mate-

(c) Celery powder. rials and processed using biological or
440
mechanical/physical methods as de- §§ 205.608–205.619 [Reserved]

scribed under § 205.270(a).
(i) Gums—water extracted only (Ara- STATE ORGANIC PROGRAMS
bic; Guar; Locust bean; and Carob
bean). § 205.620 Requirements of State or-
ganic programs.
(j) Inulin-oligofructose enriched (CAS
# 9005–80–5). (a) A State may establish a State or-
(k) Kelp—for use only as a thickener ganic program for production and han-
and dietary supplement. dling operations within the State
(l) Konjac flour (CAS # 37220–17–0). which produce and handle organic agri-
(m) Lecithin—de-oiled. cultural products.
(n) Orange pulp, dried. (b) A State organic program must
(o) Orange shellac-unbleached (CAS # meet the requirements for organic pro-
9000–59–3). grams specified in the Act.
(p) Pectin (non-amidated forms only). (c) A State organic program may
(q) Potassium acid tartrate. contain more restrictive requirements
(r) Seaweed, Pacific kombu. because of environmental conditions or
(s) Starches. the necessity of specific production or
(1) Cornstarch (native). handling practices particular to the
(2) Sweet potato starch—for bean State or region of the United States.
thread production only. (d) A State organic program must as-
(t) Tamarind seed gum. sume enforcement obligations in the
(u) Tragacanth gum (CAS #–9000–65– State for the requirements of this part
1). and any more restrictive requirements
(v) Turkish bay leaves. approved by the Secretary.
(e) A State organic program and any
(w) Wakame seaweed (Undaria
amendments to such program must be
pinnatifida).
approved by the Secretary prior to
(x) Whey protein concentrate.
being implemented by the State.
[72 FR 35140, June 27, 2007, as amended at 75
FR 77524, Dec. 13, 2010; 77 FR 8092, Feb. 14, § 205.621 Submission and determina-
2012; 77 FR 33299, June 6, 2012; 77 FR 44429, tion of proposed State organic pro-
July 30, 2012; 78 FR 31821, May 28, 2013; 79 FR grams and amendments to ap-
58663, Sept. 30, 2014; 80 FR 77234, Dec. 12, 2015; proved State organic programs.
82 FR 31244, July 6, 2017; 83 FR 66571, Dec. 27, (a) A State organic program’s gov-
2018; 84 18136, Apr. 30, 2019; 85 FR 70435, Nov.
erning State official must submit to
5, 2020]
the Secretary a proposed State organic
§ 205.607 Amending the National List. program and any proposed amendments
to such approved program.
(a) Any person may petition the Na- (1) Such submission must contain
tional Organic Standards Board for the supporting materials that include stat-
purpose of having a substance evalu- utory authorities, program description,
ated by the Board for recommendation documentation of the environmental
to the Secretary for inclusion on or de- conditions or specific production and
letion from the National List in ac- handling practices particular to the
cordance with the Act. State which necessitate more restric-
(b) A person petitioning for amend- tive requirements than the require-
ment of the National List should re- ments of this part, and other informa-
quest a copy of the petition procedures tion as may be required by the Sec-
from the USDA at the address in retary.
§ 205.607(c). (2) Submission of a request for
(c) A petition to amend the National amendment of an approved State or-
List must be submitted to: Program ganic program must contain sup-
Manager, USDA–AMS–NOP, 1400 Inde- porting materials that include an ex-
pendence Ave. SW., Room 2648 So. planation and documentation of the en-
Bldg., Ag Stop 0268, Washington, DC vironmental conditions or specific pro-
20250–0268. duction and handling practices par-
ticular to the State or region, which

FR 61993, Oct. 31, 2003; 80 FR 6429, Feb. 5, necessitates the proposed amendment.
2015] Supporting material also must explain
441
§ 205.622 7 CFR Ch. I (1–1–22 Edition)
how the proposed amendment furthers required to prepare reports and any
and is consistent with the purposes of other documents in connection with
the Act and the regulations of this the performance of service. The hourly
part. rate shall be the same as that charged
(b) Within 6 months of receipt of sub- by the Agricultural Marketing Service,
mission, the Secretary will: Notify the through its Quality Systems Certifi-
State organic program’s governing cation Program, to certification bodies
State official of approval or dis- requesting conformity assessment to
approval of the proposed program or the International Organization for
amendment of an approved program Standardization ‘‘General Require-
and, if disapproved, the reasons for the ments for Bodies Operating Product
disapproval. Certification Systems’’ (ISO Guide 65).
(c) After receipt of a notice of dis- (2) Applicants for initial accredita-
approval, the State organic program’s tion and accredited certifying agents
governing State official may submit a submitting annual reports or seeking
revised State organic program or renewal of accreditation during the
amendment of such a program at any first 18 months following the effective
time. date of subpart F of this part shall re-
ceive service without incurring an
§ 205.622 Review of approved State or-
ganic programs. hourly charge for service.
(3) Applicants for initial accredita-
The Secretary will review a State or- tion and renewal of accreditation must
ganic program not less than once dur- pay at the time of application, effec-
ing each 5-year period following the tive 18 months following February 20,
date of the initial program approval. 2001, a nonrefundable fee of $500.00
The Secretary will notify the State or- which shall be applied to the appli-
ganic program’s governing State offi- cant’s fees-for-service account.
cial of approval or disapproval of the (b) Travel charges. When service is
program within 6 months after initi- requested at a place so distant from
ation of the review. the evaluator’s headquarters that a
§§ 205.623–205.639 [Reserved] total of one-half hour or more is re-
quired for the evaluator(s) to travel to
FEES such place and back to the head-
quarters or at a place of prior assign-
§ 205.640 Fees and other charges for ment on circuitous routing requiring a
accreditation. total of one-half hour or more to travel
Fees and other charges equal as near- to the next place of assignment on the
ly as may be to the cost of the accredi- circuitous routing, the charge for such
tation services rendered under the reg- service shall include a mileage charge
ulations, including initial accredita- administratively determined by the
tion, review of annual reports, and re- U.S. Department of Agriculture and
newal of accreditation, shall be as- travel tolls, if applicable, or such trav-
sessed and collected from applicants el prorated among all the applicants
for initial accreditation and accredited and certifying agents furnished the
certifying agents submitting annual re- service involved on an equitable basis
ports or seeking renewal of accredita- or, when the travel is made by public
tion in accordance with the following transportation (including hired vehi-
provisions: cles), a fee equal to the actual cost
(a) Fees-for-service. (1) Except as oth- thereof. Travel charges shall become
erwise provided in this section, fees- effective for all applicants for initial
for-service shall be based on the time accreditation and accredited certifying
required to render the service provided agents on February 20, 2001. The appli-
calculated to the nearest 15-minute pe- cant or certifying agent will not be
riod, including the review of applica- charged a new mileage rate without no-
tions and accompanying documents tification before the service is ren-
and information, evaluator travel, the dered.
conduct of on-site evaluations, review (c) Per diem charges. When service is
of annual reports and updated docu- requested at a place away from the
ments and information, and the time evaluator’s headquarters, the fee for
442
such service shall include a per diem (c) The Administrator shall assess in-
charge if the employee(s) performing terest, penalties, and administrative
the service is paid per diem in accord- costs on debts not paid by the due date
ance with existing travel regulations. shown on a bill for collection and col-
Per diem charges to applicants and cer- lect delinquent debts or refer such
tifying agents will cover the same pe- debts to the Department of Justice for
riod of time for which the evaluator(s) litigation.
receives per diem reimbursement. The
per diem rate will be administratively [65 FR 80637, Dec. 21, 2000, as amended at 80
determined by the U.S. Department of FR 6429, Feb. 5, 2015]
Agriculture. Per diem charges shall be-
§ 205.642 Fees and other charges for
come effective for all applicants for certification.
initial accreditation and accredited
certifying agents on February 20, 2001. Fees charged by a certifying agent
The applicant or certifying agent will must be reasonable, and a certifying
not be charged a new per diem rate agent shall charge applicants for cer-
without notification before the service tification and certified production and
is rendered. handling operations only those fees and
(d) Other costs. When costs, other charges that it has filed with the Ad-
than costs specified in paragraphs (a), ministrator. The certifying agent shall
(b), and (c) of this section, are associ- provide each applicant with an esti-
ated with providing the services, the mate of the total cost of certification
applicant or certifying agent will be and an estimate of the annual cost of
charged for these costs. Such costs in- updating the certification. The certi-
clude but are not limited to equipment fying agent may require applicants for
rental, photocopying, delivery, fac- certification to pay at the time of ap-
simile, telephone, or translation plication a nonrefundable fee which
charges incurred in association with shall be applied to the applicant’s fees-
accreditation services. The amount of for-service account. The certifying
the costs charged will be determined agent may set the nonrefundable por-
administratively by the U.S. Depart- tion of certification fees; however, the
ment of Agriculture. Such costs shall nonrefundable portion of certification
become effective for all applicants for fees must be explained in the fee sched-
initial accreditation and accredited ule submitted to the Administrator.
certifying agents on February 20, 2001. The fee schedule must explain what fee
§ 205.641 Payment of fees and other amounts are nonrefundable and at
charges. what stage during the certification
process fees become nonrefundable.
(a) Applicants for initial accredita- The certifying agent shall provide all
tion and renewal of accreditation must
persons inquiring about the application
remit the nonrefundable fee, pursuant
process with a copy of its fee schedule.
to § 205.640(a)(3), along with their appli-
cation. Remittance must be made pay- §§ 205.643–205.649 [Reserved]
able to the USDA, AMS Livestock Pro-
gram and mailed to: USDA, AMS Live- COMPLIANCE
stock, Poultry and Seed Program,
QAD, P.O. Box 790304 St. Louis, MO § 205.660 General.
63179–0304 or such other address as re-
(a) The National Organic Program’s
quired by the Program Manager.
Program Manager, on behalf of the
(b) Payments for fees and other
Secretary, may inspect and review cer-
charges not covered under paragraph
(a) of this section must be: tified production and handling oper-
ations and accredited certifying agents
(1) Received by the due date shown
on the bill for collection; for compliance with the Act or regula-
tions in this part.
(2) Made payable to the Agricultural
Marketing Service, USDA; and (b) The Program Manager may ini-
(3) Mailed to the address provided on tiate suspension or revocation pro-

the bill for collection. ceedings against a certified operation:
443
§ 205.661 7 CFR Ch. I (1–1–22 Edition)
(1) When the Program Manager has (2) The facts upon which the notifica-
reason to believe that a certified oper- tion of noncompliance is based; and
ation has violated or is not in compli- (3) The date by which the certified
ance with the Act or regulations in operation must rebut or correct each
this part; or noncompliance and submit supporting
(2) When a certifying agent or a State documentation of each such correction
organic program’s governing State offi- when correction is possible.
cial fails to take appropriate action to (b) Resolution. When a certified oper-
enforce the Act or regulations in this ation demonstrates that each non-
part. compliance has been resolved, the cer-
(c) The Program Manager may ini- tifying agent or the State organic pro-
tiate suspension or revocation of a cer- gram’s governing State official, as ap-
tifying agent’s accreditation if the cer- plicable, shall send the certified oper-
tifying agent fails to meet, conduct, or ation a written notification of non-
maintain accreditation requirements compliance resolution.
pursuant to the Act or this part. (c) Proposed suspension or revocation.
(d) Each notification of noncompli- When rebuttal is unsuccessful or cor-
ance, rejection of mediation, non- rection of the noncompliance is not
compliance resolution, proposed sus- completed within the prescribed time
pension or revocation, and suspension period, the certifying agent or State
or revocation issued pursuant to
organic program’s governing State offi-
§ 205.662, § 205.663, and § 205.665 and each
cial shall send the certified operation a
response to such notification must be
written notification of proposed sus-
sent to the recipient’s place of business
pension or revocation of certification
via a delivery service which provides
of the entire operation or a portion of
dated return receipts.
the operation, as applicable to the non-
§ 205.661 Investigation of certified op- compliance. When correction of a non-
erations. compliance is not possible, the notifi-
cation of noncompliance and the pro-
(a) A certifying agent may inves-
posed suspension or revocation of cer-
tigate complaints of noncompliance
tification may be combined in one no-
with the Act or regulations of this part
tification. The notification of proposed
concerning production and handling
suspension or revocation of certifi-
operations certified as organic by the
cation shall state:
certifying agent. A certifying agent
must notify the Program Manager of (1) The reasons for the proposed sus-
all compliance proceedings and actions pension or revocation;
taken pursuant to this part. (2) The proposed effective date of
(b) A State organic program’s gov- such suspension or revocation;
erning State official may investigate (3) The impact of a suspension or rev-
complaints of noncompliance with the ocation on future eligibility for certifi-
Act or regulations in this part con- cation; and
cerning organic production or handling (4) The right to request mediation
operations operating in the State. pursuant to § 205.663 or to file an appeal
§ 205.662 Noncompliance procedure (d) Willful violations. Notwithstanding
for certified operations. paragraph (a) of this section, if a certi-
(a) Notification. When an inspection, fying agent or State organic program’s
review, or investigation of a certified governing State official has reason to
operation by a certifying agent or a believe that a certified operation has
State organic program’s governing willfully violated the Act or regula-
State official reveals any noncompli- tions in this part, the certifying agent
ance with the Act or regulations in or State organic program’s governing
this part, a written notification of non- State official shall send the certified
compliance shall be sent to the cer- operation a notification of proposed
tified operation. Such notification suspension or revocation of certifi-
shall provide: cation of the entire operation or a por-
(1) A description of each noncompli- tion of the operation, as applicable to

ance; the noncompliance.
444
(e) Suspension or revocation. (1) If the § 205.663 Mediation.

certified operation fails to correct the
Any dispute with respect to denial of
noncompliance, to resolve the issue
through rebuttal or mediation, or to certification or proposed suspension or
file an appeal of the proposed suspen- revocation of certification under this
sion or revocation of certification, the part may be mediated at the request of
certifying agent or State organic pro- the applicant for certification or cer-
gram’s governing State official shall tified operation and with acceptance by
send the certified operation a written the certifying agent. Mediation shall
notification of suspension or revoca- be requested in writing to the applica-
tion. ble certifying agent. If the certifying
(2) A certifying agent or State or- agent rejects the request for medi-
ganic program’s governing State offi- ation, the certifying agent shall pro-
cial must not send a notification of vide written notification to the appli-
suspension or revocation to a certified cant for certification or certified oper-
operation that has requested mediation ation. The written notification shall
pursuant to § 205.663 or filed an appeal advise the applicant for certification or
pursuant to § 205.681, while final resolu- certified operation of the right to re-
tion of either is pending. quest an appeal, pursuant to § 205.681,
(f) Eligibility. (1) A certified operation within 30 days of the date of the writ-
whose certification has been suspended ten notification of rejection of the re-
under this section may at any time, quest for mediation. If mediation is ac-
unless otherwise stated in the notifica- cepted by the certifying agent, such
tion of suspension, submit a request to mediation shall be conducted by a
the Secretary for reinstatement of its qualified mediator mutually agreed
certification. The request must be ac- upon by the parties to the mediation. If
companied by evidence demonstrating a State organic program is in effect,
correction of each noncompliance and the mediation procedures established
corrective actions taken to comply in the State organic program, as ap-
with and remain in compliance with proved by the Secretary, will be fol-
the Act and the regulations in this lowed. The parties to the mediation
part. shall have no more than 30 days to
(2) A certified operation or a person reach an agreement following a medi-
responsibly connected with an operation session. If mediation is unsuc-
ation whose certification has been re- cessful, the applicant for certification
voked will be ineligible to receive cer- or certified operation shall have 30
tification for a period of 5 years fol- days from termination of mediation to
lowing the date of such revocation, Ex- appeal the certifying agent’s decision
cept, That, the Secretary may, when in pursuant to § 205.681. Any agreement
the best interest of the certification reached during or as a result of the me-
program, reduce or eliminate the pe- diation process shall be in compliance
riod of ineligibility. with the Act and the regulations in
(g) Violations of Act. In addition to this part. The Secretary may review
suspension or revocation, any certified any mediated agreement for con-
operation that: formity to the Act and the regulations
(1) Knowingly sells or labels a prod- in this part and may reject any agree-
uct as organic, except in accordance ment or provision not in conformance
with the Act, shall be subject to a civil with the Act or the regulations in this
penalty of not more than the amount part.
specified in § 3.91(b)(1) of this title per
violation. § 205.664 [Reserved]
(2) Makes a false statement under the
Act to the Secretary, a State organic § 205.665 Noncompliance procedure
program’s governing State official, or a for certifying agents.
certifying agent shall be subject to the (a) Notification. When an inspection,
provisions of section 1001 of title 18, review, or investigation of an accred-
United States Code. ited certifying agent by the Program
[65 FR 80637, Dec. 21, 2000, as amended at 75 Manager reveals any noncompliance
FR 17560, Apr. 7, 2010; 79 FR 6430, Feb. 5, 2015] with the Act or regulations in this
445
§§ 205.666–205.667 7 CFR Ch. I (1–1–22 Edition)
part, a written notification of non- revocation of accreditation, the Pro-

compliance shall be sent to the certi- gram Manager shall send a written no-
fying agent. Such notification shall tice of suspension or revocation of ac-
provide: creditation to the certifying agent.
(1) A description of each noncompli- (f) Cessation of certification activities.
ance; A certifying agent whose accreditation
(2) The facts upon which the notifica- is suspended or revoked must:
tion of noncompliance is based; and (1) Cease all certification activities
(3) The date by which the certifying in each area of accreditation and in
agent must rebut or correct each non- each State for which its accreditation
compliance and submit supporting doc- is suspended or revoked.
umentation of each correction when (2) Transfer to the Secretary and
correction is possible. make available to any applicable State
(b) Resolution. When the certifying organic program’s governing State offi-
agent demonstrates that each non- cial all records concerning its certifi-
compliance has been resolved, the Pro- cation activities that were suspended
gram Manager shall send the certifying or revoked.
agent a written notification of non- (g) Eligibility. (1) A certifying agent
compliance resolution. whose accreditation is suspended by
(c) Proposed suspension or revocation. the Secretary under this section may
When rebuttal is unsuccessful or cor- at any time, unless otherwise stated in
rection of the noncompliance is not the notification of suspension, submit
completed within the prescribed time a request to the Secretary for rein-
period, the Program Manager shall statement of its accreditation. The re-
send a written notification of proposed quest must be accompanied by evi-
suspension or revocation of accredita- dence demonstrating correction of each
tion to the certifying agent. The notifi- noncompliance and corrective actions
cation of proposed suspension or rev- taken to comply with and remain in
ocation shall state whether the certi- compliance with the Act and the regu-
fying agent’s accreditation or specified lations in this part.
areas of accreditation are to be sus- (2) A certifying agent whose accredi-
pended or revoked. When correction of tation is revoked by the Secretary
a noncompliance is not possible, the shall be ineligible to be accredited as a
notification of noncompliance and the certifying agent under the Act and the
proposed suspension or revocation may regulations in this part for a period of
be combined in one notification. The not less than 3 years following the date
notification of proposed suspension or of such revocation.
revocation of accreditation shall state:
(1) The reasons for the proposed sus- §§ 205.666–205.667 [Reserved]
pension or revocation;
(2) The proposed effective date of the § 205.668 Noncompliance procedures
suspension or revocation; under State organic programs.
(3) The impact of a suspension or rev- (a) A State organic program’s gov-
ocation on future eligibility for accred- erning State official must promptly
itation; and notify the Secretary of commencement
(4) The right to file an appeal pursu- of any noncompliance proceeding
ant to § 205.681. against a certified operation and for-
(d) Willful violations. Notwithstanding ward to the Secretary a copy of each
paragraph (a) of this section, if the notice issued.
Program Manager has reason to believe (b) A noncompliance proceeding,
that a certifying agent has willfully brought by a State organic program’s
violated the Act or regulations in this governing State official against a cer-
part, the Program Manager shall send tified operation, shall be appealable
a written notification of proposed sus- pursuant to the appeal procedures of
pension or revocation of accreditation the State organic program. There shall
to the certifying agent. be no subsequent rights of appeal to
(e) Suspension or revocation. When the the Secretary. Final decisions of a
accredited certifying agent fails to file State may be appealed to the United
an appeal of the proposed suspension or States District Court for the district in
446
which such certified operation is lo- State official or the certifying agent at
cated. the official’s or certifying agent’s own
(c) A State organic program’s gov- expense.
erning State official may review and (c) A certifying agent must conduct
investigate complaints of noncompli- periodic residue testing of agricultural
ance with the Act or regulations con- products to be sold, labeled, or rep-
cerning accreditation of certifying resented as ‘‘100 percent organic,’’ ‘‘or-
agents operating in the State. When ganic,’’ or ‘‘made with organic (speci-
such review or investigation reveals fied ingredients or food group(s)).’’
any noncompliance, the State organic Samples may include the collection
program’s governing State official and testing of soil; water; waste; seeds;
shall send a written report of nonplant tissue; and plant, animal, and
compliance to the Program Manager. processed products samples. Such tests
The report shall provide a description must be conducted by the certifying
of each noncompliance and the facts agent at the certifying agent’s own ex-
upon which the noncompliance is pense.
based. (d) A certifying agent must, on an
§ 205.669 [Reserved] annual basis, sample and test from a
minimum of five percent of the oper-
INSPECTION AND TESTING, REPORTING, ations it certifies, rounded to the near-
AND EXCLUSION FROM SALE est whole number. A certifying agent
that certifies fewer than thirty oper-
§ 205.670 Inspection and testing of ag- ations on an annual basis must sample
ricultural products to be sold or la- and test from at least one operation
beled as ‘‘100 percent organic,’’ ‘‘or- annually. Tests conducted under para-
ganic,’’ or ‘‘made with organic
(specified ingredients or food graphs (b) and (c) of this section will
group(s)).’’ apply to the minimum percentage of
operations.
(a) All agricultural products that are
(e) Sample collection pursuant to
to be sold, labeled, or represented as
paragraphs (b) and (c) of this section
‘‘100 percent organic,’’ ‘‘organic,’’ or
must be performed by an inspector rep-
‘‘made with organic (specified ingredi-
ents or food group(s))’’ must be made resenting the Administrator, applica-
accessible by certified organic produc- ble State organic program’s governing
tion or handling operations for exam- State official, or certifying agent.
ination by the Administrator, the ap- Sample integrity must be maintained
plicable State organic program’s gov- throughout the chain of custody, and
erning State official, or the certifying residue testing must be performed in
agent. an accredited laboratory. Chemical
(b) The Administrator, applicable analysis must be made in accordance
State organic program’s governing with the methods described in the most
State official, or the certifying agent current edition of the Official Methods
may require preharvest or postharvest of Analysis of the AOAC International or
testing of any agricultural input used other current applicable validated
or agricultural product to be sold, la- methodology for determining the pres-
beled, or represented as ‘‘100 percent ence of contaminants in agricultural
organic,’’ ‘‘organic,’’ or ‘‘made with or- products.
ganic (specified ingredients or food (f) Results of all analyses and tests
group(s))’’ when there is reason to be- performed under this section will be
lieve that the agricultural input or available for public access, unless the
product has come into contact with a testing is part of an ongoing compli-
prohibited substance or has been pro- ance investigation.
duced using excluded methods. Sam- (g) If test results indicate a specific
ples may include the collection and agricultural product contains pesticide
testing of soil; water; waste; seeds; residues or environmental contami-
plant tissue; and plant, animal, and nants that exceed the Food and Drug
processed products samples. Such tests Administration’s or the Environmental
must be conducted by the applicable Protection Agency’s regulatory toler-

State organic program’s governing ances, the certifying agent must
447
§ 205.671 7 CFR Ch. I (1–1–22 Edition)
promptly report such data to the Fed- (2) The offspring of gestating mam-
eral health agency whose regulatory malian breeder stock treated with a
tolerance or action level has been ex- prohibited substance may be consid-
ceeded. Test results that exceed federal ered organic: Provided, That, the breed-
regulatory tolerances must also be re- er stock was not in the last third of
ported to the appropriate State health gestation on the date that the breeder
agency or foreign equivalent. stock was treated with the prohibited
[77 FR 67251, Nov. 9, 2012] substance.
§ 205.671 Exclusion from organic sale. §§ 205.673–205.679 [Reserved]

When residue testing detects prohib-
ited substances at levels that are ADVERSE ACTION APPEAL PROCESS
greater than 5 percent of the Environ-
§ 205.680 General.
mental Protection Agency’s tolerance
for the specific residue detected or un- (a) Persons subject to the Act who
avoidable residual environmental con- believe they are adversely affected by a
tamination, the agricultural product noncompliance decision of the National
must not be sold, labeled, or rep- Organic Program’s Program Manager
resented as organically produced. The may appeal such decision to the Ad-
Administrator, the applicable State or- ministrator.
ganic program’s governing State offi- (b) Persons subject to the Act who
cial, or the certifying agent may con- believe that they are adversely affected
duct an investigation of the certified
by a noncompliance decision of a State
operation to determine the cause of the
organic program may appeal such deci-
prohibited substance.
sion to the State organic program’s
§ 205.672 Emergency pest or disease governing State official who will ini-
treatment. tiate handling of the appeal pursuant
When a prohibited substance is ap- to appeal procedures approved by the
plied to a certified operation due to a Secretary.
Federal or State emergency pest or dis- (c) Persons subject to the Act who
ease treatment program and the cer- believe that they are adversely affected
tified operation otherwise meets the by a noncompliance decision of a certi-
requirements of this part, the certifi- fying agent may appeal such decision
cation status of the operation shall not to the Administrator, Except, That,
be affected as a result of the applica- when the person is subject to an ap-
tion of the prohibited substance: Pro- proved State organic program, the ap-
vided, That: peal must be made to the State organic
(a) Any harvested crop or plant part program.
to be harvested that has contact with a
(d) All written communications be-
prohibited substance applied as the re-
tween parties involved in appeal pro-
sult of a Federal or State emergency
pest or disease treatment program can- ceedings must be sent to the recipient’s
not be sold, labeled, or represented as place of business by a delivery service
organically produced; and which provides dated return receipts.
(b) Any livestock that are treated (e) All appeals shall be reviewed,
with a prohibited substance applied as heard, and decided by persons not in-
the result of a Federal or State emer- volved with the decision being ap-
gency pest or disease treatment pro- pealed.
gram or product derived from such
treated livestock cannot be sold, la- § 205.681 Appeals.
beled, or represented as organically (a) Certification appeals. An applicant
produced: Except, That: for certification may appeal a certi-
(1) Milk or milk products may be fying agent’s notice of denial of certifi-
sold, labeled, or represented as organi- cation, and a certified operation may
cally produced beginning 12 months fol- appeal a certifying agent’s notification
lowing the last date that the dairy ani-
of proposed suspension or revocation of

mal was treated with the prohibited
substance; and
448
Agricultural Marketing Service, USDA §§ 205.691–205.699
certification to the Administrator, Ex- in the time period provided in the let-
cept, That, when the applicant or cer- ter of notification or within 30 days
tified operation is subject to an ap- from receipt of the notification, which-
proved State organic program the ap- ever occurs later. The appeal will be
peal must be made to the State organic considered ‘‘filed’’ on the date received
program which will carry out the ap- by the Administrator or by the State
peal pursuant to the State organic pro- organic program. A decision to deny,
gram’s appeal procedures approved by suspend, or revoke certification or ac-
the Secretary. creditation will become final and non-
(1) If the Administrator or State or- appealable unless the decision is ap-
ganic program sustains a certification pealed in a timely manner.
applicant’s or certified operation’s ap- (d) Where and what to file. (1) Appeals
peal of a certifying agent’s decision, to the Administrator must be filed in
the applicant will be issued organic writing and addressed to: Adminis-
certification, or a certified operation trator, USDA, AMS, c/o NOP Appeals
will continue its certification, as appli- Team, 1400 Independence Avenue SW.,
cable to the operation. The act of sus- Room 2648–So., Stop 0268, Washington,
taining the appeal shall not be an ad- DC 20250–0268.
verse action subject to appeal by the (2) Appeals to the State organic pro-
affected certifying agent. gram must be filed in writing to the
(2) If the Administrator or State or- address and person identified in the let-
ganic program denies an appeal, a for- ter of notification.
mal administrative proceeding will be (3) All appeals must include a copy of
initiated to deny, suspend, or revoke the adverse decision and a statement of
the certification. Such proceeding shall the appellant’s reasons for believing
be conducted pursuant to the U.S. De- that the decision was not proper or
partment of Agriculture’s Uniform made in accordance with applicable
Rules of Practice, 7 CFR part 1, sub- program regulations, policies, or proce-
part H, or the State organic program’s dures.
rules of procedure.
(b) Accreditation appeals. An applicant [65 FR 80637, Dec. 21, 2000, as amended at 71
for accreditation and an accredited cer- FR 53303, Sept. 11, 2006; 80 FR 6430, Feb. 4,
tifying agent may appeal the Program 2015]
Manager’s denial of accreditation or
§§ 205.682–205.689 [Reserved]
proposed suspension or revocation of
accreditation to the Administrator. MISCELLANEOUS
(1) If the Administrator sustains an
appeal, an applicant will be issued ac- § 205.690 OMB control number.
creditation, or a certifying agent will
The control number assigned to the
continue its accreditation, as applica-
information collection requirements in
ble to the operation.
this part by the Office of Management
(2) If the Administrator denies an ap-
and Budget pursuant to the Paperwork
peal, a formal administrative pro-
Reduction Act of 1995, 44 U.S.C. Chap-
ceeding to deny, suspend, or revoke the
ter 35, is OMB number 0581–0191.
accreditation will be initiated. Such
proceeding shall be conducted pursuant [65 FR 80637, Dec. 21, 2000, as amended at 75
to the U.S. Department of Agri- FR 7195, Feb. 17, 2010]
culture’s Uniform Rules of Practice, 7
CFR part 1, Subpart H. §§ 205.691–205.699 [Reserved]
(c) Filing period. An appeal of a non-
compliance decision must be filed with- PARTS 206–209 [RESERVED]
449

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SUBCHAPTER M—ORGANIC FOODS PRODUCTION ACT

PART 205—NATIONAL ORGANIC 205.301 Product composition.

Information 205.510 Annual report, recordkeeping, and

Subpart G—Administrative ‘‘made with organic (specified ingredi-

205.670 Inspection and testing of agricul-

marketed in the United States for or ASTM D5988 (both incorporated by

by a certifying agent to conduct cer- Crop. Pastures, cover crops, green

Practice standard. The guidelines and Prohibited substance. A substance the

production used for quality control sheds, or windbreaks; or natural areas

rows, or geographic land features, that Temporary and Temporarily. Occurring

by naturally occurring biological proc- information on the availability of this

go to http://www.archives.gov/fed- mate aerobic biodegradability of plas-

[65 FR 80637, Dec. 21, 2000, as amended at 70

§ 205.101 Exemptions and exclusions (b) Exclusions. (1) A handling oper-

(iii) The recordkeeping provisions in compliance with the applicable regula-

duced variety is not commercially nutrient management practices, as pro-

(2) Sanitation measures to remove § 205.207 Wild-crop harvesting practice

replacement purposes in contact with managed in compliance with organic

from grazing requirement of this sec- (6) Administration of vaccines and

mal’s welfare and in a manner that maintain year-round livestock living

health and natural behavior of ani- porary confinement or shelter for an

(d) Livestock feeds produced in ac- than 70 percent organically produced

ganic ingredients in multiingredient [65 FR 80637, Dec. 21, 2000, as amended at 80

§ 205.302 Calculating the percentage of (2) For products labeled ‘‘organic,’’

or ‘‘organic,’’ as applicable, to modify (a) Agricultural products in packages

the principal display panel, informa- (c) Agricultural products in packages

telephone number of the certifying (b) Livestock feed products described

ments accompanying such organic (b) If prepared in a certified facility,

§ 205.310 Agricultural products pro-

contrasting white or transparent ‘‘or- (e) Submit the applicable fees

§§ 205.401, 205.406, and 205.200, accurately operation;

(3) Categories of organic operation, (c) After issuance of a notification of

which includes a notification of non- lowing receipt of the certified oper-

not-for-profit organization with an In- nature or qualities of products labeled

product sold, labeled, or represented as and documents set forth in §§ 205.503

an application for accreditation which or membership provisions, and its date

(d) Current certification activities. An views and implement measures to cor-

outside auditor, or a consultant who (b) On making a determination to ap-

file a rebuttal of the notification of accreditation applicant shall be con-

trator to be necessary, as specified in in accordance with paragraph (a) of

THE NATIONAL LIST OF ALLOWED AND § 205.601 Synthetic substances allowed

(a) As algicide, disinfectants, and (iii) Biodegradable biobased mulch

(7) Mineral oil—for topical use and as (g)–(z) [Reserved]

carrier systems or any artificial pre- Cellulose (CAS #9004–34–6)—for use in

basic, and tribasic). Potassium carbonate.

Potassium hydroxide—prohibited for (d) Colors derived from agricultural

tines. duced from agricultural source mate-

mechanical/physical methods as de- §§ 205.608–205.619 [Reserved]

[65 FR 80637, Dec. 21, 2000, as amended at 68

(3) Mailed to the address provided on tiate suspension or revocation pro-

(1) A description of each noncompli- tion of the operation, as applicable to

(e) Suspension or revocation. (1) If the § 205.663 Mediation.

part, a written notification of non- revocation of accreditation, the Pro-

must be conducted by the applicable Protection Agency’s regulatory toler-

§ 205.671 Exclusion from organic sale. §§ 205.673–205.679 [Reserved]

of proposed suspension or revocation of

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