2. o § 205.600 Evaluation criteria for applicable state program’s govern-
allowed and prohibited sub- ing official and the certifying agent
stances, methods and ingredients during normal business hours.
• Labels, labeling and market information
2) § 205.201 Organic production
o § 205.300 Use of the term
and handling system plan
“organic”
o § 205.301 Product composition a) A producer or handler of a produc-
• § 205.2 Selected defined terms tion or handling operation, except as
exempt or excluded under § 205.101,
For complete information about labeling
intending to sell, label or represent
requirements, see sections 205.302-3.11
agricultural products as “100 per-
included in ATTRA’s Organic Handling cent organic,” “organic” or “made
Standards Highlights. with organic (specified ingredients
or food groups)” must develop an
Excerpts organic production or handling
system plan that is agreed to by the
Recordkeeping and organizing producer or handler and an accred-
systems ited certifying agent. An organic
1) § 205.103 Recordkeeping by system plan must meet the require-
certified operations ments set forth in this section for
organic production or handling.”
a) A certified operation must main-
tain records concerning the pro- i) An organic production or han-
duction, harvesting and handling dling system plan must include:
of agricultural products that are 1) A description of practices
or that are intended to be sold, and procedures to be per-
labeled or represented as “100 formed and maintained, and
percent organic,” “organic” or the frequency with which they
“made with organic (specified will be performed;
ingredients or food groups).”
2) A list of each substance to
i) Such records must: be used as a production or
1) Adapt to the particular busi-
handling input, indicating
ness that the certified opera- its composition, source,
tion is conducting; location(s) where it will be
used and documentation of
2) Fully disclose all activities and commercial availability, as
transactions of the certified applicable;
operation in sufficient detail
3) A description of the monitoring
that is readily understood and
practices and procedures to
audited;
be performed and maintained,
3) Be maintained for at least 5 including the frequency with
years beyond their creation; which they will be performed,
and to verify that the plan is effec-
tively implemented;
4) Demonstrate compliance with
the Act and the regulations in 4) A description of the record-
this part. keeping system implemented to
comply with the requirements
ii) A certified operation must make
established in § 205.103;
records available for inspection
and copying by authorized rep- 5) A description of the manage-
resentatives of the secretary, the ment practices and physical
Page 2 ATTRA Highlights of the USDA’s National Organic Program Regulations
3. barriers established to pre- 2) The substance’s manufac-
vent commingling of organic ture, use and disposal do not
and non-organic products on a have adverse effects on the
split operation and to prevent environment and are done
contact of organic production in a manner compatible with
and handling operations and organic handling;
products with prohibited sub- 3) The nutritional quality of the
stances; and food is maintained when the
6) Additional information deemed substance is used and the
necessary by the certifying substance itself or its break-
agent to evaluate compliance down products do not have
with the regulations. an adverse effect on human
health as defined by applica-
b) A producer may substitute a plan ble federal regulations;
prepared to meet the requirements
of another federal, state or local 4) The substance’s primary use
government regulatory program for is not as a preservative or to
the organic system plan, provided re-create or improve flavors,
that the submitted plan meets all colors, textures or nutritive
value lost during processing,
the requirements of this subpart.
except where the replacement
of nutrients is required by law;
The National List of Allowed and
5) The substance is listed as gen-
Prohibited Substances erally recognized as safe by
1) § 205.600 Evaluation criteria the Food and Drug Adminis-
for allowed and prohibited sub- tration (FDA) when used in
stances, methods and ingredients accordance with the FDA’s
a) The following criteria will be uti- good manufacturing practices
lized in the evaluation of substances and contains no residues of
or ingredients for the organic pro- heavy metals or other contam-
duction and handling sections of inants in excess of tolerances
set by the FDA; and
the National List:
6) The substance is essential for
i) Synthetic and non-synthetic sub-
the handling of organically pro-
stances considered for inclusion
duced agricultural products.
in or deletion from the National
List will be evaluated using the iii) Non-synthetics used in organic
criteria specified in the Act (7 processing will be evaluated
U.S.C. 6517 and 6518). using the criteria specified in the
Act (7 U.S.C. 6517 and 6518).
ii) In addition to the criteria set
forth in the Act, any synthetic Editor’s note: The National List of Allowed and
substance used as a processing Prohibited Substances is subject to change as
aid or adjuvant will be evaluated a result of legal actions, petitions to add or
against the following criteria: remove materials or technical corrections.
Please check the Web site www.ams.usda.gov/
1) The substance cannot be nop/NOP/standards/FullRegTextOnly.html for
produced from a natural the most current update of § 205.601-606 for
source and there are no lists of materials allowed and prohibited for
crop and livestock production or handling.
organic substitutes;
www.attra.ncat.org ATTRA Page 3
4. Labels, labeling and market b) Products sold, labeled or repre-
sented as “organic”
information
1) § 205.300 Use of the term i) A raw or processed agricultural
“organic” product sold, labeled or repre-
sented as “organic” must con-
a) The term “organic” may only be tain (by weight or fluid volume,
used on labels and in labeling of raw excluding water and salt) at least
or processed agricultural products 95 percent organically produced
and ingredients that have been pro- raw or processed agricultural
duced and handled in accordance products. Any remaining prod-
with the regulations in this part. The uct ingredients must be organi-
term “organic” may not be used in cally produced unless not com-
a product name to modify a non- mercially available in organic
organic ingredient in the product. form or must be nonagricultural
b) Products for export or produced substances or non-organically
and certified to foreign organic produced agricultural products
produced consistent with the
standards or foreign contract buyer
National List in subpart G of
requirements may be labeled in
this part. If labeled as organi-
accordance with the organic label-
cally produced, such product
ing requirements of the receiv-
must be labeled pursuant to §
ing country or contract buyer if
205.303.
the shipping containers and ship-
ping documents meet the labeling c) Products sold, labeled or repre-
requirements specified in sented as “made with organic (spec-
§ 205.307(c). ified ingredients or food groups)”
c) Products produced in a foreign i) Multi-ingredient agricultural
country and exported for sale in the product sold, labeled or repre-
United States must be certified pur- sented as “made with organic
suant to subpart E of this part and (specified ingredients or food
labeled pursuant to this subpart D. groups)” must contain (by
weight or fluid volume, exclud-
d) Livestock feeds produced in accor- ing water and salt) at least
dance with the requirements of this 70 percent organically pro-
part must be labeled in accordance duced ingredients that are pro-
with the requirements of duced and handled pursuant to
§ 205.306. requirements in subpart C of
2) § 205.301 Product composition this part. No ingredients may be
produced using prohibited prac-
a) Products sold, labeled or repre- tices specified in paragraphs one
sented as “100 percent organic” through three of § 205.301(f).
i) A raw or processed agricultural Non-organic ingredients may
product sold, labeled or repre- be produced without regard to
sented as “100 percent organic” paragraphs four through seven
must contain (by weight or fluid of § 205.301(f). If labeled as
volume, excluding water and containing organically produced
salt) 100 percent organically ingredients or food groups, such
produced ingredients. If labeled product must be labeled pursu-
as organically produced, such ant to § 205.304.
product must be labeled pursu- d) Products with less than 70 percent
ant to § 205.303. organically produced ingredients
Page 4 ATTRA Highlights of the USDA’s National Organic Program Regulations
5. i) The organic ingredients in 4) Be processed using process-
multi-ingredient agricultural ing aids not approved on the
product containing less than 70 National List in subpart G
percent organically produced of this part, however prod-
ingredients (by weight or fluid ucts labeled as “100 percent
volume, excluding water and organic,” if processed, must
salt) must be produced and be processed using organi-
handled pursuant to require- cally produced processing
ments in subpart C of this part. aids;
The non-organic ingredients 5) Contain sulfites, nitrates or
may be produced and handled nitrites added during the pro-
without regard to the require- duction or handling process.
ments of this part. Multi- However, wine containing
ingredient agricultural product added sulfites may be labeled
containing less than 70 percent “made with organic grapes”;
organically produced ingredi-
ents may represent the organic 6) Be produced using non-organic
nature of the product only as ingredients when organic
provided in § 205.305. ingredients are available; or
e) Livestock feed 7) Include organic and non-
organic forms of the same
i) A raw or processed livestock ingredient.
feed product sold, labeled or
represented as “100 percent For complete information about labeling
organic” must contain (by weight requirements, see sections 205.302-3.11
or fluid volume, excluding water included in ATTRA’s Organic Handling
and salt) not less than 100 per- Standards Highlights.
cent organically produced raw or
processed agricultural product. Selected defined terms
ii) A raw or processed livestock 1) Audit trail
feed product sold, labeled or a) Documentation that is sufficient to
represented as "organic” must determine the source, transfer of
be produced in conformance ownership and transportation of any
with § 205.237. agricultural product labeled as “100
iii) All products labeled as “100 percent organic,” the organic ingre-
percent organic” or “organic" dients of any agricultural product
and all ingredients identified as labeled as “organic” or “made with
"organic" in the ingredient state- organic (specified ingredients or
ment of any product must not: food groups)” or the organic ingredi-
ents of any agricultural product con-
1) Be produced using excluded taining less than 70 percent organic
methods, pursuant to ingredients identified as “organic” in
§ 201.105(e); an ingredients statement.
2) Be produced using sewage 2) Certified operation
sludge, pursuant to
§ 201.105(f); a) A crop or livestock production, wild-
crop harvesting or handling opera-
3) Be processed using ionizing tion or portion of such operations,
radiation, pursuant to that is certified by an accredited
§ 201.105(g); certifying agent as utilizing a
www.attra.ncat.org ATTRA Page 5
6. system of organic production or applicants or certified production
handling as described by the Act or handling operations.
and the regulations in this part.
7) Inspection
3) Certifying agent
a) The act of examining and evalu-
a) Any entity accredited by the ating the production or handling
secretary as a certifying agent for operation of an applicant for cer-
the purpose of certifying a produc- tification or certified operation to
tion or handling operation. determine compliance with the Act
and the regulations in this part.
4) Claims
8) Label
a) Oral, written, implied or symbolic
representations, statements, advertis- a) A display of written, printed or
ing or other forms of communication graphic material on the immediate
presented to the public or buyers of container of an agricultural prod-
agricultural products that relate to uct or any such material affi xed to
the organic certification process or any agricultural product or affi xed
the terms “100 percent organic,” to a bulk container holding an agri-
“organic” or “made with organic cultural product, except for pack-
(specified ingredients or food age liners or a display of written,
groups),” or, in the case of agricul- printed or graphic material which
tural products containing less than contains only information about the
70 percent organic ingredients, weight of the product.
the term “organic” on the ingredi-
9) Labeling
ents panel.
a) All written, printed or graphic
5) Excluded methods
material accompanying an agricul-
a) A variety of methods used to geneti- tural product at any time or written,
cally modify organisms or influence printed or graphic material about
their growth and development by the agricultural product displayed
means that are not possible under at retail stores.
natural conditions or processes and
10) Market information
are not considered compatible with
organic production. Such methods a) Any written, printed, audiovisual
include cell fusion, microencap- or graphic information, includ-
sulation and macroencapsulation ing advertising, pamphlets, flyers,
and recombinant DNA technology catalogues, posters and signs, that
(including gene deletion, gene dou- are distributed, broadcast or made
bling, introducing a foreign gene available outside of retail outlets
and changing the positions of genes and used to assist in the sale or
when achieved by recombinant promotion of a product.
DNA technology). Such methods do
11) National List of Allowed and
not include the use of traditional
Prohibited Substances (National List)
breeding, conjugation, fermentation,
hybridization, in vitro fertilization a) A list of allowed and prohibited sub-
or tissue culture. stances as provided for in the Act.
6) Inspector 12) National Organic Program
a) Any person retained or used a) The program authorized by the Act
by a certifying agent to conduct for the purpose of implementing its
inspections of certification provisions.
Page 6 ATTRA Highlights of the USDA’s National Organic Program Regulations
7. 13) National Organic Standards Board 18) Practice standard
a) A board established by the secre- a) The guidelines and requirements
tary under 7 U.S.C. 6518 to assist through which a production or
in the development of standards handling operation implements a
for substances to be used in organic required component of its produc-
production and to advise the tion or handling organic system
secretary on any other aspects plan. A practice standard includes
of the implementation of the a series of allowed and prohibited
National Organic Program. actions, materials and conditions to
14) Non-synthetic. establish a minimum performance
level for planning, conducting and
a) A substance that is derived from maintaining a function, such as
mineral, plant or animal matter and livestock health care or facility
does not undergo a synthetic pro- pest management, essential to an
cess as defined in section 6502(21) organic operation.
of the Act (7 U.S.C. 6502(21)). For
the purposes of this part, non-syn- 19) Prohibited substance
thetic is used as a synonym for nat- a) A substance that is prohibited or not
ural as the term is used in the Act. provided for in the Act or the regula-
15) Organic production tions of this part for use in any aspect
of organic production or handling.
a) A production system that is man-
aged in accordance with the Act 20) Records
and regulations in this part to
a) Any information in written, visual
respond to site-specific conditions
or electronic form that documents
by integrating cultural, biological
the activities of a producer, han-
and mechanical practices that foster
the cycling of resources, promote dler or certifying agent to comply
ecological balance and conserve with the Act and regulations
biodiversity. in this part.
16) Organic system plan 21) Split operation
a) A plan of management of an a) An operation that produces or han-
organic production or handling dles both organic and non-organic
operation that has been agreed to agricultural products.
by the producer or handler and the 22) Synthetic
certifying agent and includes writ-
ten plans concerning all aspects of a) A substance that is formulated
agricultural production or handling or manufactured by a chemi-
described in the Act and the regu- cal process or by a process that
lations in subpart C of this part. chemically changes a substance
extracted from naturally occurring
17) Person plant, animal or mineral sources.
a) An individual, partnership, corpo- The term shall not apply to
ration, association, cooperative or substances created by naturally
other entity. occurring biological processes.
www.attra.ncat.org ATTRA Page 7