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Organic Standards for
                                             All Organic Operations
ATTRA                                        Highlights of the USDA’s National Organic Program Regulations
   A Publication of ATTRA—National Sustainable Agriculture Information Service • 1-800-346-9140 • www.attra.ncat.org

By Ann H. Baier                              This collection of excerpts from the USDA’s National Organic Program provides the reader with key
NCAT Agriculture                             standards relevant to all certified organic operations. This publication should be used as needed with
Specialist                                   excerpts for crop production, livestock production or handling.
© 2008 NCAT
                                              Highlights of the USDA’s National Organic Program Regulations include key standards for:
                                              1) All certified organic operations
                                              2) Crop production
                                              3) Livestock production
Contents                                      4) Handling (including processing)
                                              Use this publication for all certified organic operations, in combination with one or more of publications
Introduction ..................... 1          two, three or four as relevant to organic crop production, livestock production or handling.
Excerpts ............................. 2
   Recordkeeping
   and organizing
   systems .......................... 2      Introduction                                           found under the USDA’s Agricultural Marketing
                                                                                                    Service 7 CFR Part 205. CFR stands for Code


                                             T
   The National List
   of Allowed and
                                                    his publication provides easy refer-            of Federal Regulations.
   Prohibited                                       ence to the standards relevant to all
   Substances .................. 3                  organic operations. These excerpts              Part 205 of the regulations, found under
   Labels, labeling                          from the USDA’s National Organic Program               Title 7: Agriculture, is the National Organic
   and market
                                             Final Rule contain the general requirements            Program.
   information .................. 4
   Selected defined
                                             for an organic system plan, recordkeeping,             The Organic Foods Production Act was
   terms ............................... 5   product labeling and preventing commin-                enacted under the 1990 Farm Bill. The Act,
                                             gling and contamination.                               as it is referred to in the text, authorized
                                             This is not a complete collection of organic           creation of the USDA National Organic
                                             standards. It must be used in conjunction              Program to set national standards for the
                                             with standards for crops production, live-             production, handling and processing of
                                             stock production or handling of agricultural           organically grown agricultural products.
                                             products, as applicable.                               The National Organic Program over-
                                                                                                    sees mandatory certification of organic
                                             This set of excerpts is not a substitute for           production. Producers who meet National
                                             reading the entire set of standards, which             Organic Program standards may label their
                                             can be found online at www.ams.usda.gov/               products as “USDA Certified Organic.”
                                             NOP. This set of excerpts should also not              The subparts reference organizational
                                             be used for verifying points of compliance             levels in each excerpt.
                                             for organic production and handling activi-
ATTRA—National Sustainable
Agriculture Information Service              ties with an accredited organic certifier. For          The following sections of the National
(www.ncat.attra.org) is managed
by the National Center for Appro-
                                             a list of these, go to the List of Accredited          Organic Program are excerpted:
priate Technology (NCAT) and is              Certifying Agents on the National Organic               • Recordkeeping and organic system plan
funded under a grant from the
United States Department of
                                             Program Web site, www.ams.usda.gov.                       o § 205.103 Recordkeeping by
Agriculture’s Rural Business-                                                                              certified operations
Cooperative Service. Visit the
NCAT Web site (www.ncat.org/
                                             Using this guide:                                         o § 205.201 Organic production and
sarc_current.php) for                        This is a collection of verbatim excerpts                     handling system plan
more information on
our sustainable agri-
                                             from key parts of the National Organic                  • The National List of Allowed and
culture projects.                            Program’s Final Rule. Organic regulations are              Prohibited Substances
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
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
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
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
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
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
Organic Standards for All Organic Operations:
                 Highlights of the USDA’s National Organic
                 Program Regulations
                 By Ann H. Baier
                 NCAT Agriculture Specialist
                 © 2008 NCAT
                 Holly Michels, Editor
                 Amy Smith, Production
                 This publication is available on the Web at:
                 www.attra.ncat.org/attra-pub/nopstandard_organic.html
                 or
                 www.attra.ncat.org/attra-pub/PDF/nopstandard_organic.pdf
                 IP325
                 Slot 319
                 Version 070108


Page 8   ATTRA

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Organic Standards for All Organic Operations: Highlights of the USDA's National Organic Program Regulations

  • 1. Organic Standards for All Organic Operations ATTRA Highlights of the USDA’s National Organic Program Regulations A Publication of ATTRA—National Sustainable Agriculture Information Service • 1-800-346-9140 • www.attra.ncat.org By Ann H. Baier This collection of excerpts from the USDA’s National Organic Program provides the reader with key NCAT Agriculture standards relevant to all certified organic operations. This publication should be used as needed with Specialist excerpts for crop production, livestock production or handling. © 2008 NCAT Highlights of the USDA’s National Organic Program Regulations include key standards for: 1) All certified organic operations 2) Crop production 3) Livestock production Contents 4) Handling (including processing) Use this publication for all certified organic operations, in combination with one or more of publications Introduction ..................... 1 two, three or four as relevant to organic crop production, livestock production or handling. Excerpts ............................. 2 Recordkeeping and organizing systems .......................... 2 Introduction found under the USDA’s Agricultural Marketing Service 7 CFR Part 205. CFR stands for Code T The National List of Allowed and his publication provides easy refer- of Federal Regulations. Prohibited ence to the standards relevant to all Substances .................. 3 organic operations. These excerpts Part 205 of the regulations, found under Labels, labeling from the USDA’s National Organic Program Title 7: Agriculture, is the National Organic and market Final Rule contain the general requirements Program. information .................. 4 Selected defined for an organic system plan, recordkeeping, The Organic Foods Production Act was terms ............................... 5 product labeling and preventing commin- enacted under the 1990 Farm Bill. The Act, gling and contamination. as it is referred to in the text, authorized This is not a complete collection of organic creation of the USDA National Organic standards. It must be used in conjunction Program to set national standards for the with standards for crops production, live- production, handling and processing of stock production or handling of agricultural organically grown agricultural products. products, as applicable. The National Organic Program over- sees mandatory certification of organic This set of excerpts is not a substitute for production. Producers who meet National reading the entire set of standards, which Organic Program standards may label their can be found online at www.ams.usda.gov/ products as “USDA Certified Organic.” NOP. This set of excerpts should also not The subparts reference organizational be used for verifying points of compliance levels in each excerpt. for organic production and handling activi- ATTRA—National Sustainable Agriculture Information Service ties with an accredited organic certifier. For The following sections of the National (www.ncat.attra.org) is managed by the National Center for Appro- a list of these, go to the List of Accredited Organic Program are excerpted: priate Technology (NCAT) and is Certifying Agents on the National Organic • Recordkeeping and organic system plan funded under a grant from the United States Department of Program Web site, www.ams.usda.gov. o § 205.103 Recordkeeping by Agriculture’s Rural Business- certified operations Cooperative Service. Visit the NCAT Web site (www.ncat.org/ Using this guide: o § 205.201 Organic production and sarc_current.php) for This is a collection of verbatim excerpts handling system plan more information on our sustainable agri- from key parts of the National Organic • The National List of Allowed and culture projects. Program’s Final Rule. Organic regulations are Prohibited Substances
  • 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
  • 8. Organic Standards for All Organic Operations: Highlights of the USDA’s National Organic Program Regulations By Ann H. Baier NCAT Agriculture Specialist © 2008 NCAT Holly Michels, Editor Amy Smith, Production This publication is available on the Web at: www.attra.ncat.org/attra-pub/nopstandard_organic.html or www.attra.ncat.org/attra-pub/PDF/nopstandard_organic.pdf IP325 Slot 319 Version 070108 Page 8 ATTRA