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7:7:3.1.1.9.32.1.343.1 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM A Subpart A—Definitions   § 205.1 Meaning of words. AMS       For the purpose of the regulations in this subpart, words in the singular form shall be deemed to impart the plural and vice versa, as the case may demand.
7:7:3.1.1.9.32.1.343.2 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM A Subpart A—Definitions   § 205.2 Terms defined. AMS     [65 FR 80637, Dec. 21, 2000, as amended at 72 FR 70484, Dec. 12, 2007; 75 FR 7192, Feb. 17, 2010; 79 FR 58662, Sept. 30, 2014; 80 FR 6429, Feb. 5, 2015; 87 FR 19772, Apr. 5, 2022; 87 FR 68027, Nov. 14, 2022; 88 FR 3620, Jan. 19, 2023; 88 FR 75444, Nov. 2, 2023; 88 FR 86259, Dec. 13, 2023; 88 FR 89539, Dec. 28, 2023; 89 FR 104392, Dec. 23, 2024] Accreditation. A determination made by the Secretary that authorizes a private, foreign, or State entity to conduct certification activities as a certifying agent under this part. Act. The Organic Foods Production Act of 1990, as amended (7 U.S.C. 6501 et seq. ). Action level. The limit at or above which the Food and Drug Administration will take legal action against a product to remove it from the market. Action levels are based on unavoidability of the poisonous or deleterious substances and do not represent permissible levels of contamination where it is avoidable. Administrator. The Administrator for the Agricultural Marketing Service, United States Departure of Agriculture, or the representative to whom authority has been delegated to act in the stead of the Administrator. Adverse action. A noncompliance decision that adversely affects certification, accreditation, or a person subject to the Act, including a proposed suspension or revocation; a denial of certification, accreditation, or reinstatement; a cease and desist notice; or a civil penalty. Agricultural inputs. All substances or materials used in the production or handling of organic agricultural products. Agricultural product. Any agricultural commodity or product, whether raw or processed, including any commodity or product derived from livestock, that is marketed in the United States for human or livestock consumption. Agricultural Marketing Service (AMS). The Agricultural Marketing Service of the United States Department of Agriculture. Allowed synthetic. A substance that is included on the National List of synthetic substances allowed for use in organic production or handling. AMDUCA. The Animal Medicinal Drug Use Clarification Act of 1994 (Pub. L. 103-396). Animal drug. Any drug as defined in section 201 of the Federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C. 321), that is intended for use in livestock, including any drug intended for use in livestock feed but not including such livestock feed. Annual seedling. …
7:7:3.1.1.9.32.1.343.3 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM A Subpart A—Definitions   § 205.3 Incorporation by reference. AMS     [79 FR 58662, Sept. 30, 2014] (a) Certain material is incorporated by reference into this part with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. To enforce any edition other than that specified in this section, we must publish notice of change in the Federal Register and the material must be available to the public. All approved material is available for inspection at the USDA Agricultural Marketing Service, National Organic Program, 1400 Independence Avenue SW., Washington, DC 20250; (202) 720-3252, and is available from the sources listed below. It is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call (202) 741-6030 or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. (b) ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428; phone 1-877-909-2786; http://www.astm.org/. (1) ASTM D5988-12 (“ASTM D5988”), “Standard Test Method for Determining Aerobic Biodegradation of Plastic Materials in Soil,” approved May 1, 2012, IBR approved for § 205.2. (2) ASTM D6400-12 (“ASTM D6400”), “Standard Specification for Labeling of Plastics Designed to be Aerobically Composted in Municipal or Industrial Facilities,” approved May 15, 2012, IBR approved for § 205.2. (3) ASTM D6866-12 (“ASTM D6866”), “Standard Test Methods for Determining the Biobased Content of Solid, Liquid, and Gaseous Samples Using Radiocarbon Analysis,” approved April 1, 2012, IBR approved for § 205.2. (4) ASTM D6868-11 (“ASTM D6868”), “Standard Specification for Labeling of End Items that Incorporate Plastics and Polymers as Coatings or Additives with Paper and Other Substrates Designed to be Aerobically Composted in Municipal or Industrial Facilities,” approved February 1, 2011, IBR approved for § 205.2. (c) European Committee for Standardization; Avenue Marnix, 17-B-1000 Brussels; phone 32 2 550 08 11; www.cen.eu. (1) EN 13432:2000:E (“EN 13432”), Sep…
7:7:3.1.1.9.32.2.343.1 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM B Subpart B—Applicability   § 205.100 What has to be certified. AMS     [65 FR 80637, Dec. 21, 2000, as amended at 70 FR 29579, May 24, 2005; 80 FR 6429, Feb. 5, 2015; 88 FR 3621, Jan. 19, 2023] (a) Except for the exempt operations described in § 205.101, each operation or portion of an operation that produces or handles agricultural products intended to be sold, labeled, or represented as “100 percent organic,” “organic,” or “made with organic (specified ingredients or food group(s))” must be certified according to the provisions of subpart E of this part and must meet all other applicable requirements of this part. (b) Any production or handling operation or specified portion of a production or handling operation that has been already certified by a certifying agent on the date that the certifying agent receives its accreditation under this part shall be deemed to be certified under the Act until the operation's next anniversary date of certification. Such recognition shall only be available to those operations certified by a certifying agent that receives its accreditation within 18 months from February 20, 2001. (c) Any person or responsibly connected person that: (1) Knowingly sells or labels a product as organic, except in accordance with the Act, shall be subject to a civil penalty of not more than the amount specified in § 3.91(b)(1) of this title per violation. (2) Makes a false statement under the Act to the Secretary, a governing State official, or an accredited certifying agent shall be subject to the provisions of section 1001 of title 18, United States Code.
7:7:3.1.1.9.32.2.343.2 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM B Subpart B—Applicability   § 205.101 Exemptions from certification. AMS     [88 FR 3621, Jan. 19, 2023] The following operations in paragraphs (a) through (h) of this section are exempt from certification under subpart E of this part and from submitting an organic system plan for acceptance or approval under § 205.201 but must comply with the applicable organic production and handling requirements of subpart C of this part, the applicable labeling requirements of subpart D of this part, and any requirements described in paragraphs (a) through (i) of this section. (a) A production or handling operation that sells agricultural products as “organic” but whose gross agricultural income from organic sales totals $5,000 or less annually. (b) A retail establishment that does not process organically produced agricultural products. (c) A retail establishment that processes, at the point of final sale, agricultural products certified under this part as “100 percent organic,” “organic,” or “made with organic (specified ingredients or food group(s)).” (d) A handling operation that only handles agricultural products that contain less than 70 percent organic ingredients (as described in § 205.301(d)) or that only identifies organic ingredients on the information panel. (e) An operation that only receives, stores, and/or prepares for shipment, but does not otherwise handle, organic agricultural products that: (1) Are enclosed in sealed, tamper-evident packages or containers prior to being received or acquired by the operation; and (2) Remain in the same sealed, tamper-evident packages or containers and are not otherwise handled while in the control of the operation. (f) An operation that only buys, sells, receives, stores, and/or prepares for shipment, but does not otherwise handle, organic agricultural products already labeled for retail sale that: (1) Are enclosed in sealed, tamper-evident packages or containers that are labeled for retail sale prior to being received or acquired by the operation; and (2) Remain in the same sealed, tamper-evident packages or containers that are labeled for retail sale and are not othe…
7:7:3.1.1.9.32.2.343.3 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM B Subpart B—Applicability   § 205.102 Use of the term, “organic.” AMS     [65 FR 80637, Dec. 21, 2000, as amended at 75 FR 7193, Feb. 17, 2010] Any agricultural product that is sold, labeled, or represented as “100 percent organic,” “organic,” or “made with organic (specified ingredients or food group(s))” must be: (a) Produced in accordance with the requirements specified in § 205.101 or §§ 205.202 through 205.207 or §§ 205.236 through 205.240 and all other applicable requirements of part 205; and (b) Handled in accordance with the requirements specified in § 205.101 or §§ 205.270 through 205.272 and all other applicable requirements of this part 205.
7:7:3.1.1.9.32.2.343.4 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM B Subpart B—Applicability   § 205.103 Recordkeeping by certified operations. AMS     [65 FR 80637, Dec. 21, 2000, as amended at 88 FR 3621, Jan. 19, 2023] (a) A certified operation must maintain records concerning the production, harvesting, and handling of agricultural products that are or that are intended to be sold, labeled, or represented as “100 percent organic,” “organic,” or “made with organic (specified ingredients or food group(s)).” (b) Such records must: (1) Be adapted to the particular business that the certified operation is conducting; (2) Fully disclose all activities and transactions of the certified operation, in sufficient detail as to be readily understood and audited; records must span the time of purchase or acquisition, through production, to sale or transport and be traceable back to the last certified operation; (3) Include audit trail documentation for agricultural products handled or produced by the certified operation and identify agricultural products on these records as “100% organic,” “organic,” or “made with organic (specified ingredients or food group(s)),” or similar terms, as applicable; (4) Be maintained for not less than 5 years beyond their creation; and (5) Be sufficient to demonstrate compliance with the Act and the regulations in this part. (c) The certified operation must make such records available for inspection and copying during normal business hours by authorized representatives of the Secretary, the applicable State program's governing State official, and the certifying agent.
7:7:3.1.1.9.32.2.343.5 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM B Subpart B—Applicability   § 205.104 [Reserved] AMS        
7:7:3.1.1.9.32.2.343.6 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM B Subpart B—Applicability   § 205.105 Allowed and prohibited substances, methods, and ingredients in organic production and handling. AMS       To be sold or labeled as “100 percent organic,” “organic,” or “made with organic (specified ingredients or food group(s)),” the product must be produced and handled without the use of: (a) Synthetic substances and ingredients, except as provided in § 205.601 or § 205.603; (b) Nonsynthetic substances prohibited in § 205.602 or § 205.604; (c) Nonagricultural substances used in or on processed products, except as otherwise provided in § 205.605; (d) Nonorganic agricultural substances used in or on processed products, except as otherwise provided in § 205.606; (e) Excluded methods, except for vaccines: Provided, That, the vaccines are approved in accordance with § 205.600(a); (f) Ionizing radiation, as described in Food and Drug Administration regulation, 21 CFR 179.26; and (g) Sewage sludge.
7:7:3.1.1.9.32.2.343.7 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM B Subpart B—Applicability   §§ 205.106-205.199 [Reserved] AMS        
7:7:3.1.1.9.32.3.343.1 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM C Subpart C—Organic Production and Handling Requirements   § 205.200 General. AMS       The producer or handler of a production or handling operation intending to sell, label, or represent agricultural products as “100 percent organic,” “organic,” or “made with organic (specified ingredients or food group(s))” must comply with the applicable provisions of this subpart. Production practices implemented in accordance with this subpart must maintain or improve the natural resources of the operation, including soil and water quality.
7:7:3.1.1.9.32.3.343.10 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM C Subpart C—Organic Production and Handling Requirements   § 205.210 Mushroom production practice standard. AMS     [89 FR 104392, Dec. 23, 2024] (a) The producer must manage mushroom production in accordance with the provisions of §§ 205.200, 205.201, 205.202 as applicable, 205.203(e), and 205.206(a)(2) and (3) and (b) through (f). The producer may manage crop nutrients for mushroom production in accordance with the provisions of § 205.203(d). (b) The producer must manage mushroom substrate and mushroom spawn media, including spent mushroom substrate and mushroom spawn media, in a manner that does not contribute to contamination of crops, mushroom spawn, mushroom substrate, soil, or water by pathogenic organisms, heavy metals, or residues of prohibited substances. (c) Mushroom substrate may be composed of the following materials in accordance with the conditions specified in this paragraph: (1) Composted plant and animal materials. Compost used in mushroom substrate must be described in the organic system plan. It must be produced through a process that maintains a temperature of at least 131 °F for at least three days; (2) Uncomposted plant materials. Uncomposted plant materials must be organically produced: Except, that, nonorganically produced uncomposted plant materials may be used when a functionally equivalent organically produced material is not commercially available. Prohibited substances must not be applied to nonorganically produced uncomposted plant materials after harvest. Operations that use nonorganically produced uncomposted plant materials in mushroom substrate (except for wood materials allowed under paragraph (c)(3) of this section) must describe in the organic system plan: (i) The procedures used to search for organic materials and the records kept to document searches; (ii) The criteria used to evaluate if functionally equivalent organic materials are commercially available; and (iii) The recordkeeping system used to document purchases of nonorganic materials, including a summary of the type(s) and total amount of each nonorganic material used in mushroom substrate. (3) Wood chips, sawdust, logs, or other materials deriv…
7:7:3.1.1.9.32.3.343.11 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM C Subpart C—Organic Production and Handling Requirements   §§ 205.211-205.235 [Reserved] AMS        
7:7:3.1.1.9.32.3.343.12 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM C Subpart C—Organic Production and Handling Requirements   § 205.236 Origin of livestock. AMS     [87 FR 19772, Apr. 5, 2022] (a) Livestock products that are to be sold, labeled, or represented as organic must be from livestock under continuous organic management from the last third of gestation or hatching: Except, That: (1) Poultry. Poultry or edible poultry products must be from poultry that has been under continuous organic management beginning no later than the second day of life; (2) Dairy animals. Subject to the requirements of this paragraph, an operation that is not certified for organic livestock and that has never transitioned dairy animals may transition nonorganic animals to organic production only once. After the one-time transition is complete, the operation may not transition additional animals or source transitioned animals from other operations; the operation must source only animals that have been under continuous organic management from the last third of gestation. Eligible operations converting to organic production by transitioning organic animals under this paragraph must meet the following requirements and conditions: (i) Dairy animals must be under continuous organic management for a minimum of 12 months immediately prior to production of milk or milk products that are to be sold, labeled, or represented as organic. Only certified operations may represent or sell products as organic. (ii) The operation must describe the transition as part of its organic system plan. The description must include the actual or expected start date of the minimum 12-month transition, individual identification of animals intended to complete transition, and any additional information or records deemed necessary by the certifying agent to determine compliance with the regulations. Transitioning animals are not considered organic until the operation is certified. (iii) During the 12-month transition period, dairy animals and their offspring may consume third-year transitional crops from land included in the organic system plan of the operation transitioning the animals; (iv) Offspring born during or after the 12-month tran…
7:7:3.1.1.9.32.3.343.13 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM C Subpart C—Organic Production and Handling Requirements   § 205.237 Livestock feed. AMS     [65 FR 80637, Dec. 21, 2000, as amended at 75 FR 7193, Feb. 17, 2010; 87 FR 19773, Apr. 5, 2022] (a) The producer of an organic livestock operation must provide livestock with a total feed ration composed of agricultural products, including pasture and forage, that are organically produced and handled by operations certified under this part, except as provided in § 205.236(a)(2)(iii) and (a)(3), except, that, synthetic substances allowed under § 205.603 and nonsynthetic substances not prohibited under § 205.604 may be used as feed additives and feed supplements, Provided, That, all agricultural ingredients included in the ingredients list, for such additives and supplements, shall have been produced and handled organically. (b) The producer of an organic operation must not: (1) Use animal drugs, including hormones, to promote growth; (2) Provide feed supplements or additives in amounts above those needed for adequate nutrition and health maintenance for the species at its specific stage of life; (3) Feed plastic pellets for roughage; (4) Feed formulas containing urea or manure; (5) Feed mammalian or poultry slaughter by-products to mammals or poultry; (6) Use feed, feed additives, and feed supplements in violation of the Federal Food, Drug, and Cosmetic Act; (7) Provide feed or forage to which any antibiotic including ionophores has been added; or (8) Prevent, withhold, restrain, or otherwise restrict ruminant animals from actively obtaining feed grazed from pasture during the grazing season, except for conditions as described under § 205.239(b) and (c). (c) During the grazing season, producers shall: (1) Provide not more than an average of 70 percent of a ruminant's dry matter demand from dry matter fed (dry matter fed does not include dry matter grazed from residual forage or vegetation rooted in pasture). This shall be calculated as an average over the entire grazing season for each type and class of animal. Ruminant animals must be grazed throughout the entire grazing season for the geographical region, which shall be not less than 120 days per calendar year. Due to weather, season, and/or c…
7:7:3.1.1.9.32.3.343.14 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM C Subpart C—Organic Production and Handling Requirements   § 205.238 Livestock care and production practices standard. AMS     [88 FR 75445, Nov. 2, 2023; 88 FR 86259, Dec. 13, 2023; 88 FR 89539, Dec. 28, 2023] (a) Preventive health care practices. The producer must establish and maintain preventive health care practices, including: (1) Selection of species and types of livestock with regard to suitability for site-specific conditions and resistance to prevalent diseases and parasites. (2) Provision of a feed ration sufficient to meet nutritional requirements of the animal, including vitamins, minerals, proteins and/or amino acids, fatty acids, energy sources, and fiber (ruminants). (3) Establishment of appropriate housing, pasture conditions, and sanitation practices to minimize the occurrence and spread of diseases and parasites. (4) Provision of conditions which allow for exercise, freedom of movement, and reduction of stress appropriate to the species. (5) Physical alterations may be performed for identification purposes or the safety of the animal. Physical alterations must be performed: at a young age for the species, in a manner that minimizes stress and pain, and by a person that is capable of performing the physical alteration in a manner that minimizes stress and pain. (i) The following practices may not be routinely used and must be used only with documentation that alternative methods to prevent harm failed: needle teeth clipping (no more than top one-third of the tooth) in pigs and tail docking in pigs. (ii) The following practices are prohibited: de-beaking, de-snooding, caponization, dubbing, toe clipping of chickens, toe clipping of turkeys unless with infra-red at hatchery, beak trimming after 10 days of age, tail docking of cattle, wattling of cattle, face branding of cattle, tail docking of sheep shorter than the distal end of the caudal fold, and mulesing of sheep. (6) Administration of vaccines and other veterinary biologics. (7) All surgical procedures necessary to treat an illness or injury shall be undertaken in a manner that employs best management practices to promote the animal's wellbeing and to minimize pain, stress, and suffering, with the use of allowed anesthetics, analgesics, …
7:7:3.1.1.9.32.3.343.15 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM C Subpart C—Organic Production and Handling Requirements   § 205.239 Mammalian and non-avian livestock living conditions. AMS     [88 FR 75446, Nov. 6, 2023; 88 FR 86259, Dec. 13, 2023; 88 FR 89539, Dec. 28, 2023] (a) The producer of an organic livestock operation must establish and maintain year-round livestock living conditions, which accommodate the wellbeing and natural behavior of animals, including: (1) Year-round access for all animals to the outdoors, shade, shelter, exercise areas, fresh air, clean water for drinking, and direct sunlight, suitable to the species, its stage of life, the climate, and the environment: Except, that, animals may be temporarily denied access to the outdoors in accordance with paragraphs (b) and (c) of this section. Yards, feeding pads, and feedlots may be used to provide ruminants with access to the outdoors during the non-grazing season and supplemental feeding during the grazing season. Yards, feeding pads, and feedlots shall be large enough to allow all ruminant livestock occupying the yard, feeding pad, or feedlot to feed without competition for food. Continuous total confinement of any animal indoors is prohibited. Continuous total confinement of ruminants in yards, feeding pads, and feedlots is prohibited. (2) For all ruminants, management on pasture and daily grazing throughout the grazing season(s) to meet the requirements of § 205.237 of this part, except as provided for in paragraphs (b), (c), and (d) of this section. (3) Appropriate clean, dry bedding. When roughages are used as bedding, they shall have been organically produced in accordance with this part by an operation certified under this part, except as provided in § 205.236(a)(2)(iii) of this part, and, if applicable, organically handled by operations certified under this part. (4) Shelter designed to allow for: (i) Over a 24-hour period, sufficient space and freedom to lie down, turn around, stand up, fully stretch their limbs, and express normal patterns of behavior; (ii) Temperature level, ventilation, and air circulation suitable to the species; (iii) Reduction of potential for livestock injury; and (iv) Indoor housing must have areas for bedding and resting that are sufficiently large, solidly built, and c…
7:7:3.1.1.9.32.3.343.16 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM C Subpart C—Organic Production and Handling Requirements   § 205.240 Pasture practice standard. AMS     [75 FR 7194, Feb. 17, 2010] The producer of an organic livestock operation must, for all ruminant livestock on the operation, demonstrate through auditable records in the organic system plan, a functioning management plan for pasture. (a) Pasture must be managed as a crop in full compliance with §§ 205.202, 205.203(d) and (e), 205.204, and 205.206(b) through (f). Land used for the production of annual crops for ruminant grazing must be managed in full compliance with §§ 205.202 through 205.206. Irrigation shall be used, as needed, to promote pasture growth when the operation has irrigation available for use on pasture. (b) Producers must provide pasture in compliance with § 205.239(a)(2) and manage pasture to comply with the requirements of: § 205.237(c)(2), to annually provide a minimum of 30 percent of a ruminant's dry matter intake (DMI), on average, over the course of the grazing season(s); § 205.238(a)(3), to minimize the occurrence and spread of diseases and parasites; and § 205.239(e) to refrain from putting soil or water quality at risk. (c) A pasture plan must be included in the producer's organic system plan, and be updated annually in accordance with § 205.406(a). The producer may resubmit the previous year's pasture plan when no change has occurred in the plan. The pasture plan may consist of a pasture/rangeland plan developed in cooperation with a Federal, State, or local conservation office: Provided, that, the submitted plan addresses all of the requirements of § 205.240(c)(1) through (8). When a change to an approved pasture plan is contemplated, which may affect the operation's compliance with the Act or the regulations in this part, the producer shall seek the certifying agent's agreement on the change prior to implementation. The pasture plan shall include a description of the: (1) Types of pasture provided to ensure that the feed requirements of § 205.237 are being met. (2) Cultural and management practices to be used to ensure pasture of a sufficient quality and quantity is available to graze throughout the grazi…
7:7:3.1.1.9.32.3.343.17 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM C Subpart C—Organic Production and Handling Requirements   § 205.241 Avian living conditions. AMS     [88 FR 75446, Nov. 6, 2023; 88 FR 86259, Dec. 13, 2023; 88 FR 89539, Dec. 28, 2023] (a) Avian year-round living conditions. The producer of an organic poultry operation must establish and maintain year-round poultry living conditions that accommodate the health and natural behavior of poultry, including: year-round access to the outdoors; shade; shelter; exercise areas; fresh air; direct sunlight; clean water for drinking; materials for dust bathing; and adequate outdoor space to escape aggressive behaviors suitable to the species, its stage of life, the climate, and environment. Poultry may be temporarily denied access to the outdoors in accordance with paragraph (d) of this section. Continuous total confinement of poultry indoors is prohibited. (b) Indoor space requirements. (1) Poultry housing must be sufficiently spacious to allow all birds to move freely, stretch both wings simultaneously, stand normally, and engage in natural behaviors. (2) Producers must monitor ammonia levels at least weekly by taking measurements at the height of the birds' heads and implement practices to maintain ammonia levels below 20 ppm. When ammonia levels exceed 20 ppm, producers must implement additional practices and additional monitoring to reduce ammonia levels below 20 ppm. Ammonia levels must not exceed 25 ppm. (3) For layers and all other fully feathered birds, artificial light may be used to prolong the day length, to provide up to 16 hours of continuous light per 24-hour period ( i.e., minimum of 8 hours of continuous darkness per 24-hour period). Artificial light intensity should be lowered gradually to encourage hens to move to perches or settle for the night. Artificial light spectrum may not be manipulated to increase feed intake and growth rate. (4) Exit areas—poultry houses must have at least 1 linear foot of exit area for every 360 birds, measured across the base of the exit, but no less than one linear foot of exit area for flocks with fewer than 360 birds. Exit areas must be appropriately distributed and sized to ensure that all birds have ready access to the outdoors; (i) If exit are…
7:7:3.1.1.9.32.3.343.18 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM C Subpart C—Organic Production and Handling Requirements   § 205.242 Transport and slaughter. AMS     [88 FR 75446, Nov. 6, 2023; 88 FR 86259, Dec. 13, 2023; 88 FR 89539, Dec. 28, 2023] (a) Transportation. (1) Certified organic livestock must be clearly identified as organic, and this identity must be traceable for the duration of transport. (2) All livestock must be fit for transport to buyers, auction or slaughter facilities. (i) Calves must have a dry navel cord and be able to stand and walk without human assistance. (ii) Seriously crippled and non-ambulatory animals must not be transported for sale or slaughter. Such animals may be medically treated or euthanized. (3) Adequate and season-appropriate ventilation is required for all livestock trailers, shipping containers, and any other mode of transportation used to protect animals against cold and heat stresses. (4) During any transport and prior to slaughter, bedding must be provided on trailer floors and in holding pens, as needed, to keep livestock clean, dry, and comfortable. Use of bedding must be appropriate to the species and type of transport. Bedding is not required in poultry crates. When roughages are used for bedding, they must be certified organic. (5) For transport that exceeds eight hours, measured from the time all animals are loaded onto a vehicle until the vehicle arrives at its final destination, the operation must describe how organic management and animal welfare will be maintained. (i) The producer or handler of an organic livestock operation, who is responsible for overseeing the transport of organic livestock, must provide records to certifying agents during inspections or upon request that demonstrate that transport times for organic livestock are not detrimental to the welfare of the animals and meet the requirements of paragraph (a)(5) of this section. (ii) [Reserved] (6) Organic producers and handlers, who are responsible for overseeing the transport of organic livestock, must have emergency plans in place that adequately address possible animal welfare problems that might occur during transport. (b) Mammalian slaughter. (1) Producers and handlers who slaughter organic livestock must be in compliance…
7:7:3.1.1.9.32.3.343.19 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM C Subpart C—Organic Production and Handling Requirements   §§ 205.243-205.269 [Reserved] AMS        
7:7:3.1.1.9.32.3.343.2 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM C Subpart C—Organic Production and Handling Requirements   § 205.201 Organic production and handling system plan. AMS     [65 FR 80637, Dec. 21, 2000, as amended at 88 FR 3622, Jan. 19, 2023] (a) The producer or handler of a production or handling operation, except as exempt under § 205.101, intending to sell, label, or represent agricultural products as “100 percent organic,” “organic,” or “made with organic (specified ingredients or food group(s))” must develop an organic production or handling system plan that is agreed to by the producer or handler and an accredited certifying agent. An organic system plan must meet the requirements set forth in this section for organic production or handling. An organic production or handling system plan must include: (1) A description of practices and procedures to be performed and maintained, including the frequency with which they will be performed; (2) A list of each substance to be used as a production or handling input, indicating its composition, source, location(s) where it will be used, and documentation of commercial availability, as applicable; (3) A description of the monitoring practices and procedures to be performed and maintained, including the frequency with which they will be performed, to verify that the plan is effectively implemented. This must include a description of the monitoring practices and procedures to verify suppliers in the supply chain and organic status of agricultural products received, and to prevent organic fraud, as appropriate to the certified operation's activities, scope, and complexity; (4) A description of the recordkeeping system implemented to comply with the requirements established in § 205.103; (5) A description of the management practices and physical barriers established to prevent commingling of organic and nonorganic products on a split operation and to prevent contact of organic production and handling operations and products with prohibited substances; and (6) Additional information deemed necessary by the certifying agent to evaluate compliance with the regulations. (b) A producer may substitute a plan prepared to meet the requirements of another Federal, State, or local government regulatory program f…
7:7:3.1.1.9.32.3.343.20 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM C Subpart C—Organic Production and Handling Requirements   § 205.270 Organic handling requirements. AMS     [65 FR 80637, Dec. 21, 2000, as amended at 89 FR 104393, Dec. 23, 2024] (a) Mechanical or biological methods, including but not limited to cooking, baking, curing, heating, drying, mixing, grinding, churning, separating, distilling, extracting, slaughtering, cutting, fermenting, eviscerating, preserving, dehydrating, freezing, chilling, or otherwise manufacturing, and the packaging, canning, jarring, or otherwise enclosing food in a container may be used to process an organically produced agricultural product for the purpose of retarding spoilage or otherwise preparing the agricultural product for market. (b) Nonagricultural substances allowed under § 205.605 and nonorganically produced agricultural products allowed under § 205.606 may be used: (1) In or on a processed agricultural product intended to be sold, labeled, or represented as “organic,” pursuant to § 205.301(b), if not commercially available in organic form. (2) In or on a processed agricultural product intended to be sold, labeled, or represented as “made with organic (specified ingredients or food group(s)),” pursuant to § 205.301(c). (c) The handler of an organic handling operation must not use in or on agricultural products intended to be sold, labeled, or represented as “100 percent organic,” “organic,” or “made with organic (specified ingredients or food group(s)),” or in or on any ingredients labeled as organic: (1) Practices prohibited under paragraphs (e) and (f) of § 205.105. (2) A volatile synthetic solvent or other synthetic processing aid not allowed under § 205.605: Except, That, nonorganic ingredients in products labeled “made with organic (specified ingredients or food group(s))” are not subject to this requirement. (d) In addition to the substances described in paragraph (b) of this section, substances allowed under § 205.603(d)(2) and (3) may be used in or on pet food intended to be sold, labeled, or represented as “organic” or “made with organic (specified ingredients or food group(s)),” pursuant to § 205.301(b) and (c). Pet food must be labeled pursuant to subpart D of this part.
7:7:3.1.1.9.32.3.343.21 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM C Subpart C—Organic Production and Handling Requirements   § 205.271 Facility pest management practice standard. AMS       (a) The producer or handler of an organic facility must use management practices to prevent pests, including but not limited to: (1) Removal of pest habitat, food sources, and breeding areas; (2) Prevention of access to handling facilities; and (3) Management of environmental factors, such as temperature, light, humidity, atmosphere, and air circulation, to prevent pest reproduction. (b) Pests may be controlled through: (1) Mechanical or physical controls including but not limited to traps, light, or sound; or (2) Lures and repellents using nonsynthetic or synthetic substances consistent with the National List. (c) If the practices provided for in paragraphs (a) and (b) of this section are not effective to prevent or control pests, a nonsynthetic or synthetic substance consistent with the National List may be applied. (d) If the practices provided for in paragraphs (a), (b), and (c) of this section are not effective to prevent or control facility pests, a synthetic substance not on the National List may be applied: Provided, That, the handler and certifying agent agree on the substance, method of application, and measures to be taken to prevent contact of the organically produced products or ingredients with the substance used. (e) The handler of an organic handling operation who applies a nonsynthetic or synthetic substance to prevent or control pests must update the operation's organic handling plan to reflect the use of such substances and methods of application. The updated organic plan must include a list of all measures taken to prevent contact of the organically produced products or ingredients with the substance used. (f) Notwithstanding the practices provided for in paragraphs (a), (b), (c), and (d) of this section, a handler may otherwise use substances to prevent or control pests as required by Federal, State, or local laws and regulations: Provided, That, measures are taken to prevent contact of the organically produced products or ingredients with the substance used.
7:7:3.1.1.9.32.3.343.22 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM C Subpart C—Organic Production and Handling Requirements   § 205.272 Commingling and contact with prohibited substance prevention practice standard. AMS       (a) The handler of an organic handling operation must implement measures necessary to prevent the commingling of organic and nonorganic products and protect organic products from contact with prohibited substances. (b) The following are prohibited for use in the handling of any organically produced agricultural product or ingredient labeled in accordance with subpart D of this part: (1) Packaging materials, and storage containers, or bins that contain a synthetic fungicide, preservative, or fumigant; (2) The use or reuse of any bag or container that has been in contact with any substance in such a manner as to compromise the organic integrity of any organically produced product or ingredient placed in those containers, unless such reusable bag or container has been thoroughly cleaned and poses no risk of contact of the organically produced product or ingredient with the substance used.
7:7:3.1.1.9.32.3.343.23 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM C Subpart C—Organic Production and Handling Requirements   § 205.273 Imports to the United States. AMS     [88 FR 3622, Jan. 19, 2023] Each shipment of organic agricultural products imported into the United States must be certified pursuant to subpart E of this part, labeled pursuant to subpart D of this part, be declared as organic to U.S. Customs and Border Protection, and be associated with valid NOP Import Certificate data. (a) Persons exporting organic agricultural products to the United States must request an NOP Import Certificate from a certifying agent prior to their export. Only certifying agents accredited by the USDA or foreign certifying agents authorized under an organic trade arrangement or agreement may issue an NOP Import Certificate. (b) The certifying agent must review an NOP Import Certificate request and determine whether the export complies with the USDA organic regulations. The certifying agent must have and implement a documented organic control system for intaking and approving or rejecting the validity of an NOP Import Certificate request. The certifying agent shall issue the NOP Import Certificate through the Organic Integrity Database only if the export complies with the USDA organic regulations. (c) Each compliant organic import must be declared as organic to U.S. Customs and Border Protection by entering NOP Import Certificate data into the U.S. Customs and Border Protection's Automated Commercial Environment system. Organic imports must be clearly identified and marked as organic on all import documents including but not limited to invoices, packing lists, bills of lading, and U.S. Customs and Border Protection entry data. Only NOP Import Certificate data generated by the Organic Integrity Database are valid. (d) Upon receiving a shipment with organic agricultural products, the organic importer must ensure the import is accompanied by accurate NOP Import Certificate data and must verify that the shipment has had no contact with prohibited substances pursuant to § 205.272 or exposure to ionizing radiation pursuant to § 205.105, since export. The organic importer must have a documented organic control system to c…
7:7:3.1.1.9.32.3.343.24 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM C Subpart C—Organic Production and Handling Requirements   §§ 205.274-205.289 [Reserved] AMS        
7:7:3.1.1.9.32.3.343.25 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM C Subpart C—Organic Production and Handling Requirements   § 205.290 Temporary variances. AMS     [65 FR 80637, Dec. 21, 2000, as amended at 75 FR 7194, Feb. 17, 2010] (a) Temporary variances from the requirements in §§ 205.203 through 205.207, 205.236 through 205.240 and 205.270 through 205.272 may be established by the Administrator for the following reasons: (1) Natural disasters declared by the Secretary; (2) Damage caused by drought, wind, flood, excessive moisture, hail, tornado, earthquake, fire, or other business interruption; and (3) Practices used for the purpose of conducting research or trials of techniques, varieties, or ingredients used in organic production or handling. (b) A State organic program's governing State official or certifying agent may recommend in writing to the Administrator that a temporary variance from a standard set forth in subpart C of this part for organic production or handling operations be established: Provided, That, such variance is based on one or more of the reasons listed in paragraph (a) of this section. (c) The Administrator will provide written notification to certifying agents upon establishment of a temporary variance applicable to the certifying agent's certified production or handling operations and specify the period of time it shall remain in effect, subject to extension as the Administrator deems necessary. (d) A certifying agent, upon notification from the Administrator of the establishment of a temporary variance, must notify each production or handling operation it certifies to which the temporary variance applies. (e) Temporary variances will not be granted for any practice, material, or procedure prohibited under § 205.105.
7:7:3.1.1.9.32.3.343.26 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM C Subpart C—Organic Production and Handling Requirements   §§ 205.291-205.299 [Reserved] AMS        
7:7:3.1.1.9.32.3.343.3 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM C Subpart C—Organic Production and Handling Requirements   § 205.202 Land requirements. AMS       Any field or farm parcel from which harvested crops are intended to be sold, labeled, or represented as “organic,” must: (a) Have been managed in accordance with the provisions of §§ 205.203 through 205.206; (b) Have had no prohibited substances, as listed in § 205.105, applied to it for a period of 3 years immediately preceding harvest of the crop; and (c) Have distinct, defined boundaries and buffer zones such as runoff diversions to prevent the unintended application of a prohibited substance to the crop or contact with a prohibited substance applied to adjoining land that is not under organic management.
7:7:3.1.1.9.32.3.343.4 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM C Subpart C—Organic Production and Handling Requirements   § 205.203 Soil fertility and crop nutrient management practice standard. AMS       (a) The producer must select and implement tillage and cultivation practices that maintain or improve the physical, chemical, and biological condition of soil and minimize soil erosion. (b) The producer must manage crop nutrients and soil fertility through rotations, cover crops, and the application of plant and animal materials. (c) The producer must manage plant and animal materials to maintain or improve soil organic matter content in a manner that does not contribute to contamination of crops, soil, or water by plant nutrients, pathogenic organisms, heavy metals, or residues of prohibited substances. Animal and plant materials include: (1) Raw animal manure, which must be composted unless it is: (i) Applied to land used for a crop not intended for human consumption; (ii) Incorporated into the soil not less than 120 days prior to the harvest of a product whose edible portion has direct contact with the soil surface or soil particles; or (iii) Incorporated into the soil not less than 90 days prior to the harvest of a product whose edible portion does not have direct contact with the soil surface or soil particles; (2) Composted plant and animal materials produced through a process that: (i) Established an initial C:N ratio of between 25:1 and 40:1; and (ii) Maintained a temperature of between 131 °F and 170 °F for 3 days using an in-vessel or static aerated pile system; or (iii) Maintained a temperature of between 131 °F and 170 °F for 15 days using a windrow composting system, during which period, the materials must be turned a minimum of five times. (3) Uncomposted plant materials. (d) A producer may manage crop nutrients and soil fertility to maintain or improve soil organic matter content in a manner that does not contribute to contamination of crops, soil, or water by plant nutrients, pathogenic organisms, heavy metals, or residues of prohibited substances by applying: (1) A crop nutrient or soil amendment included on the National List of synthetic substances allowed for use in organic crop pr…
7:7:3.1.1.9.32.3.343.5 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM C Subpart C—Organic Production and Handling Requirements   § 205.204 Seeds and planting stock practice standard. AMS       (a) The producer must use organically grown seeds, annual seedlings, and planting stock: Except, That, (1) Nonorganically produced, untreated seeds and planting stock may be used to produce an organic crop when an equivalent organically produced variety is not commercially available: Except, That, organically produced seed must be used for the production of edible sprouts; (2) Nonorganically produced seeds and planting stock that have been treated with a substance included on the National List of synthetic substances allowed for use in organic crop production may be used to produce an organic crop when an equivalent organically produced or untreated variety is not commercially available; (3) Nonorganically produced annual seedlings may be used to produce an organic crop when a temporary variance has been granted in accordance with § 205.290(a)(2); (4) Nonorganically produced planting stock to be used to produce a perennial crop may be sold, labeled, or represented as organically produced only after the planting stock has been maintained under a system of organic management for a period of no less than 1 year; and (5) Seeds, annual seedlings, and planting stock treated with prohibited substances may be used to produce an organic crop when the application of the materials is a requirement of Federal or State phytosanitary regulations. (b) [Reserved]
7:7:3.1.1.9.32.3.343.6 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM C Subpart C—Organic Production and Handling Requirements   § 205.205 Crop rotation practice standard. AMS       The producer must implement a crop rotation including but not limited to sod, cover crops, green manure crops, and catch crops that provide the following functions that are applicable to the operation: (a) Maintain or improve soil organic matter content; (b) Provide for pest management in annual and perennial crops; (c) Manage deficient or excess plant nutrients; and (d) Provide erosion control.
7:7:3.1.1.9.32.3.343.7 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM C Subpart C—Organic Production and Handling Requirements   § 205.206 Crop pest, weed, and disease management practice standard. AMS       (a) The producer must use management practices to prevent crop pests, weeds, and diseases including but not limited to: (1) Crop rotation and soil and crop nutrient management practices, as provided for in §§ 205.203 and 205.205; (2) Sanitation measures to remove disease vectors, weed seeds, and habitat for pest organisms; and (3) Cultural practices that enhance crop health, including selection of plant species and varieties with regard to suitability to site-specific conditions and resistance to prevalent pests, weeds, and diseases. (b) Pest problems may be controlled through mechanical or physical methods including but not limited to: (1) Augmentation or introduction of predators or parasites of the pest species; (2) Development of habitat for natural enemies of pests; (3) Nonsynthetic controls such as lures, traps, and repellents. (c) Weed problems may be controlled through: (1) Mulching with fully biodegradable materials; (2) Mowing; (3) Livestock grazing; (4) Hand weeding and mechanical cultivation; (5) Flame, heat, or electrical means; or (6) Plastic or other synthetic mulches: Provided, That, they are removed from the field at the end of the growing or harvest season. (d) Disease problems may be controlled through: (1) Management practices which suppress the spread of disease organisms; or (2) Application of nonsynthetic biological, botanical, or mineral inputs. (e) When the practices provided for in paragraphs (a) through (d) of this section are insufficient to prevent or control crop pests, weeds, and diseases, a biological or botanical substance or a substance included on the National List of synthetic substances allowed for use in organic crop production may be applied to prevent, suppress, or control pests, weeds, or diseases: Provided, That, the conditions for using the substance are documented in the organic system plan. (f) The producer must not use lumber treated with arsenate or other prohibited materials for new installations or replacement purposes in contact with soil or…
7:7:3.1.1.9.32.3.343.8 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM C Subpart C—Organic Production and Handling Requirements   § 205.207 Wild-crop harvesting practice standard. AMS       (a) A wild crop that is intended to be sold, labeled, or represented as organic must be harvested from a designated area that has had no prohibited substance, as set forth in § 205.105, applied to it for a period of 3 years immediately preceding the harvest of the wild crop. (b) A wild crop must be harvested in a manner that ensures that such harvesting or gathering will not be destructive to the environment and will sustain the growth and production of the wild crop.
7:7:3.1.1.9.32.3.343.9 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM C Subpart C—Organic Production and Handling Requirements   §§ 205.208-205.209 [Reserved] AMS        
7:7:3.1.1.9.32.4.343.1 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM D Subpart D—Labels, Labeling, and Market Information   § 205.300 Use of the term, “organic.” AMS     [65 FR 80637, Dec. 21, 2000, as amended at 88 FR 3622, Jan. 19, 2023] (a) The term, “organic,” may only be used on labels and in labeling of raw or processed agricultural products, including ingredients, that have been produced and handled in accordance with the regulations in this part. The term, “organic,” may not be used in a product name to modify a nonorganic ingredient in the product. (b) Products for export, produced and certified to foreign national organic standards or foreign contract buyer requirements, may be labeled in accordance with the organic labeling requirements of the receiving country or contract buyer: Provided, That, the shipping containers and shipping documents meet the labeling requirements specified in § 205.307(c). (c) Products produced in a foreign country and exported for sale in the United States must be certified pursuant to subpart E of this part, labeled pursuant to this subpart D, and must comply with the requirements in § 205.273. (d) Livestock feeds produced in accordance with the requirements of this part must be labeled in accordance with the requirements of § 205.306.
7:7:3.1.1.9.32.4.343.10 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM D Subpart D—Labels, Labeling, and Market Information   § 205.309 Agricultural products in other than packaged form at the point of retail sale that are sold, labeled, or represented as “made with organic (specified ingredients or food group(s)).” AMS       (a) Agricultural products in other than packaged form containing between 70 and 95 percent organically produced ingredients may use the phrase, “made with organic (specified ingredients or food group(s)),” to modify the name of the product in retail display, labeling, and display containers. (1) Such statement must not list more than three organic ingredients or food groups, and (2) In any such display of the product's ingredient statement, the organic ingredients are identified as “organic.” (b) If prepared in a certified facility, such agricultural products labeled as “made with organic (specified ingredients or food group(s))” in retail displays, display containers, and market information may display the certifying agent's seal, logo, or other identifying mark.
7:7:3.1.1.9.32.4.343.11 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM D Subpart D—Labels, Labeling, and Market Information   § 205.310 Agricultural products produced or processed by an exempt operation. AMS     [65 FR 80637, Dec. 21, 2000, as amended at 88 FR 3623, Jan. 19, 2023] (a) An agricultural product organically produced or processed by an exempt operation must not: (1) Display the USDA seal or any certifying agent's seal or other identifying mark which represents the exempt operation as a certified organic operation; or (2) Be represented as a certified organic product or certified organic ingredient to any buyer. (b) An agricultural product organically produced or processed by an exempt operation may be identified as an organic product or organic ingredient in a multi-ingredient product produced by the exempt operation. Such product or ingredient must not be identified or represented as “organic” in a product processed by others. (c) Such product is subject to requirements specified in paragraph (a) of § 205.300, and paragraphs (f)(1) through (f)(7) of § 205.301.
7:7:3.1.1.9.32.4.343.12 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM D Subpart D—Labels, Labeling, and Market Information   § 205.311 USDA Seal. AMS       (a) The USDA seal described in paragraphs (b) and (c) of this section may be used only for raw or processed agricultural products described in paragraphs (a), (b), (e)(1), and (e)(2) of § 205.301. (b) The USDA seal must replicate the form and design of the example in figure 1 and must be printed legibly and conspicuously: (1) On a white background with a brown outer circle and with the term, “USDA,” in green overlaying a white upper semicircle and with the term, “organic,” in white overlaying the green lower half circle; or (2) On a white or transparent background with black outer circle and black “USDA” on a white or transparent upper half of the circle with a contrasting white or transparent “organic” on the black lower half circle. (3) The green or black lower half circle may have four light lines running from left to right and disappearing at the point on the right horizon to resemble a cultivated field.
7:7:3.1.1.9.32.4.343.13 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM D Subpart D—Labels, Labeling, and Market Information   §§ 205.312-205.399 [Reserved] AMS        
7:7:3.1.1.9.32.4.343.2 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM D Subpart D—Labels, Labeling, and Market Information   § 205.301 Product composition. AMS     [65 FR 80637, Dec. 21, 2000, as amended at 80 FR 6429, Feb. 5, 2015; 88 FR 3621, Jan. 19, 2023] (a) Products sold, labeled, or represented as “100 percent organic.” A raw or processed agricultural product sold, labeled, or represented as “100 percent organic” must contain (by weight or fluid volume, excluding water and salt) 100 percent organically produced ingredients. If labeled as organically produced, such product must be labeled pursuant to § 205.303. (b) Products sold, labeled, or represented as “organic.” A raw or processed agricultural product sold, labeled, or represented as “organic” must contain (by weight or fluid volume, excluding water and salt) not less than 95 percent organically produced raw or processed agricultural products. Any remaining product ingredients must be organically produced, unless not commercially available in organic form, or must be nonagricultural substances or nonorganically produced agricultural products produced consistent with the National List in subpart G of this part. If labeled as organically produced, such product must be labeled pursuant to § 205.303. (c) Products sold, labeled, or represented as “made with organic (specified ingredients or food group(s)).” Multiingredient agricultural product sold, labeled, or represented as “made with organic (specified ingredients or food group(s))” must contain (by weight or fluid volume, excluding water and salt) at least 70 percent organically produced ingredients which are produced and handled pursuant to requirements in subpart C of this part. No ingredients may be produced using prohibited practices specified in paragraphs (f)(1), (2), and (3) of § 205.301. Nonorganic ingredients may be produced without regard to paragraphs (f)(4), (5), (6), and (7) of § 205.301. If labeled as containing organically produced ingredients or food groups, such product must be labeled pursuant to § 205.304. (d) Products with less than 70 percent organically produced ingredients. The organic ingredients in multiingredient agricultural product containing less than 70 percent organically produced ingredients (by weight or fluid volu…
7:7:3.1.1.9.32.4.343.3 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM D Subpart D—Labels, Labeling, and Market Information   § 205.302 Calculating the percentage of organically produced ingredients. AMS     [65 FR 80637, Dec. 21, 2000, as amended at 88 FR 3622, Jan. 19, 2023] (a) The percentage of all organically produced ingredients in an agricultural product sold, labeled, or represented as “100 percent organic,” “organic,” or “made with organic (specified ingredients or food group(s)),” or that include organic ingredients must be calculated by: (1) Dividing the total net weight of the combined organic ingredients at formulation by the total weight of all ingredients of the product at formulation. Water and salt added as ingredients at formulation are excluded from the calculation. (2) Dividing the total fluid volume of the combined organic ingredients at formulation by the total fluid volume of all ingredients of the product at formulation if the product and ingredients are liquid. Water and salt added as ingredients at formulation are excluded from the calculation. If the liquid product is identified on the principal display panel or information panel as being reconstituted from concentrates, the calculation should be made based on single-strength concentrations of all ingredients. (3) For products containing organically produced ingredients in both solid and liquid form, dividing the combined net weight of the solid organic ingredients and the net weight of the liquid organic ingredients at formulation by the total weight of all ingredients of the product at formulation. Water and salt added as ingredients at formulation are excluded from the calculation. (b) The percentage of all organically produced ingredients in an agricultural product must be rounded down to the nearest whole number. (c) The percentage must be determined by the handler who affixes the label on the consumer package and verified by the certifying agent of the handler. The handler may use information provided by the certified operation in determining the percentage.
7:7:3.1.1.9.32.4.343.4 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM D Subpart D—Labels, Labeling, and Market Information   § 205.303 Packaged products labeled “100 percent organic” or “organic.” AMS       (a) Agricultural products in packages described in § 205.301(a) and (b) may display, on the principal display panel, information panel, and any other panel of the package and on any labeling or market information concerning the product, the following: (1) The term, “100 percent organic” or “organic,” as applicable, to modify the name of the product; (2) For products labeled “organic,” the percentage of organic ingredients in the product; (The size of the percentage statement must not exceed one-half the size of the largest type size on the panel on which the statement is displayed and must appear in its entirety in the same type size, style, and color without highlighting.) (3) The term, “organic,” to identify the organic ingredients in multiingredient products labeled “100 percent organic”; (4) The USDA seal; and/or (5) The seal, logo, or other identifying mark of the certifying agent which certified the production or handling operation producing the finished product and any other certifying agent which certified production or handling operations producing raw organic product or organic ingredients used in the finished product: Provided, That, the handler producing the finished product maintain records, pursuant to this part, verifying organic certification of the operations producing such ingredients, and: Provided further, That, such seals or marks are not individually displayed more prominently than the USDA seal. (b) Agricultural products in packages described in § 205.301(a) and (b) must: (1) For products labeled “organic,” identify each organic ingredient in the ingredient statement with the word, “organic,” or with an asterisk or other reference mark which is defined below the ingredient statement to indicate the ingredient is organically produced. Water or salt included as ingredients cannot be identified as organic. (2) On the information panel, below the information identifying the handler or distributor of the product and preceded by the statement, “Certified organic by * * *,” or similar …
7:7:3.1.1.9.32.4.343.5 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM D Subpart D—Labels, Labeling, and Market Information   § 205.304 Packaged products labeled “made with organic (specified ingredients or food group(s)).” AMS       (a) Agricultural products in packages described in § 205.301(c) may display on the principal display panel, information panel, and any other panel and on any labeling or market information concerning the product: (1) The statement: (i) “Made with organic (specified ingredients)”: Provided, That, the statement does not list more than three organically produced ingredients; or (ii) “Made with organic (specified food groups)”: Provided, That, the statement does not list more than three of the following food groups: beans, fish, fruits, grains, herbs, meats, nuts, oils, poultry, seeds, spices, sweeteners, and vegetables or processed milk products; and, Provided further, That, all ingredients of each listed food group in the product must be organically produced; and (iii) Which appears in letters that do not exceed one-half the size of the largest type size on the panel and which appears in its entirety in the same type size, style, and color without highlighting. (2) The percentage of organic ingredients in the product. The size of the percentage statement must not exceed one-half the size of the largest type size on the panel on which the statement is displayed and must appear in its entirety in the same type size, style, and color without highlighting. (3) The seal, logo, or other identifying mark of the certifying agent that certified the handler of the finished product. (b) Agricultural products in packages described in § 205.301(c) must: (1) In the ingredient statement, identify each organic ingredient with the word, “organic,” or with an asterisk or other reference mark which is defined below the ingredient statement to indicate the ingredient is organically produced. Water or salt included as ingredients cannot be identified as organic. (2) On the information panel, below the information identifying the handler or distributor of the product and preceded by the statement, “Certified organic by * * *,” or similar phrase, identify the name of the certifying agent that certified the handler of the f…
7:7:3.1.1.9.32.4.343.6 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM D Subpart D—Labels, Labeling, and Market Information   § 205.305 Multi-ingredient packaged products with less than 70 percent organically produced ingredients. AMS       (a) An agricultural product with less than 70 percent organically produced ingredients may only identify the organic content of the product by: (1) Identifying each organically produced ingredient in the ingredient statement with the word, “organic,” or with an asterisk or other reference mark which is defined below the ingredient statement to indicate the ingredient is organically produced, and (2) If the organically produced ingredients are identified in the ingredient statement, displaying the product's percentage of organic contents on the information panel. (b) Agricultural products with less than 70 percent organically produced ingredients must not display: (1) The USDA seal; and (2) Any certifying agent seal, logo, or other identifying mark which represents organic certification of a product or product ingredients.
7:7:3.1.1.9.32.4.343.7 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM D Subpart D—Labels, Labeling, and Market Information   § 205.306 Labeling of livestock feed. AMS       (a) Livestock feed products described in § 205.301(e)(1) and (e)(2) may display on any package panel the following terms: (1) The statement, “100 percent organic” or “organic,” as applicable, to modify the name of the feed product; (2) The USDA seal; (3) The seal, logo, or other identifying mark of the certifying agent which certified the production or handling operation producing the raw or processed organic ingredients used in the finished product, Provided, That, such seals or marks are not displayed more prominently than the USDA seal; (4) The word, “organic,” or an asterisk or other reference mark which is defined on the package to identify ingredients that are organically produced. Water or salt included as ingredients cannot be identified as organic. (b) Livestock feed products described in § 205.301(e)(1) and (e)(2) must: (1) On the information panel, below the information identifying the handler or distributor of the product and preceded by the statement, “Certified organic by * * *,” or similar phrase, display the name of the certifying agent that certified the handler of the finished product. The business address, Internet address, or telephone number of the certifying agent may be included in such label. (2) Comply with other Federal agency or State feed labeling requirements as applicable.
7:7:3.1.1.9.32.4.343.8 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM D Subpart D—Labels, Labeling, and Market Information   § 205.307 Labeling of nonretail containers. AMS     [88 FR 3622, Jan. 19, 2023] (a) Nonretail containers used to ship or store certified organic agricultural products must display: (1) Identification of the product as organic; and (2) The production lot number, shipping identification, or other unique information that links the container to audit trail documentation. (b) Audit trail documentation for nonretail containers must identify the last certified operation that handled the agricultural product. (c) Paragraph (a)(1) of this section does not apply to nonretail containers used to ship or store agricultural products packaged for retail sale with organic identification visible on the retail label. (d) Shipping containers of domestically produced product labeled as organic intended for export to international markets may be labeled in accordance with any shipping container labeling requirements of the foreign country of destination or the container labeling specifications of a foreign contract buyer: Provided, that, the shipping containers and shipping documents accompanying such organic products are clearly marked “For Export Only” and: Provided further, that proof of such container marking and export must be maintained by the handler in accordance with recordkeeping requirements for exempt operations under § 205.101.
7:7:3.1.1.9.32.4.343.9 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM D Subpart D—Labels, Labeling, and Market Information   § 205.308 Agricultural products in other than packaged form at the point of retail sale that are sold, labeled, or represented as “100 percent organic” or “organic.” AMS       (a) Agricultural products in other than packaged form may use the term, “100 percent organic” or “organic,” as applicable, to modify the name of the product in retail display, labeling, and display containers: Provided, That, the term, “organic,” is used to identify the organic ingredients listed in the ingredient statement. (b) If the product is prepared in a certified facility, the retail display, labeling, and display containers may use: (1) The USDA seal; and (2) The seal, logo, or other identifying mark of the certifying agent that certified the production or handling operation producing the finished product and any other certifying agent which certified operations producing raw organic product or organic ingredients used in the finished product: Provided, That, such seals or marks are not individually displayed more prominently than the USDA seal.
7:7:3.1.1.9.32.5.343.1 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM E Subpart E—Certification   § 205.400 General requirements for certification. AMS     [65 FR 80637, Dec. 21, 2000, as amended at 80 FR 6429, Feb. 5, 2015; 88 FR 3623, Jan. 19, 2023] A person seeking to receive or maintain organic certification under the regulations in this part must: (a) Comply with the Act and applicable organic production and handling regulations of this part; (b) Establish, implement, and update annually an organic production or handling system plan that is submitted to an accredited certifying agent as provided for in § 205.201; (c) Permit on-site inspections with complete access to the production or handling operation, including noncertified production and handling areas, structures, and offices by the certifying agent as provided for in § 205.403; (d) Maintain all records applicable to the organic operation for not less than 5 years beyond their creation and allow authorized representatives of the Secretary, the applicable State organic program's governing State official, and the certifying agent access to such records during normal business hours for review and copying to determine compliance with the Act and the regulations in this part, as provided for in § 205.103; (e) Submit the applicable fees charged by the certifying agent; and (f) Immediately notify the certifying agent concerning any: (1) Application, including drift, of a prohibited substance to any field, production unit, site, facility, livestock, or product that is part of an operation; and (2) Change in a certified operation or any portion of a certified operation that may affect its compliance with the Act and the regulations in this part. (g) In addition to paragraphs (a) through (f) of this section, a producer group operation must: (1) Be organized as a person; (2) Use centralized processing, distribution, and marketing facilities and systems; (3) Be organized into producer group production units; (4) Maintain an internal control system to implement the practices described in § 205.201(c) and ensure compliance with this part; (5) Ensure that all agricultural products sold, labeled, or represented as organic are produced only by producer group members using land and facilities within the …
7:7:3.1.1.9.32.5.343.2 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM E Subpart E—Certification   § 205.401 Application for certification. AMS     [65 FR 80637, Dec. 21, 2000, as amended at 88 FR 3623, Jan. 19, 2023] A person seeking certification of a production or handling operation under this subpart must submit an application for certification to a certifying agent. The application must include the following information: (a) An organic production or handling system plan, as required in § 205.201; (b) The name of the person completing the application; the applicant's business name, address, and telephone number; and, when the applicant is a corporation, the name, address, and telephone number of the person authorized to act on the applicant's behalf; (c) The name(s) of any organic certifying agent(s) to which application has previously been made; the year(s) of application; the outcome of the application(s) submission, including, when available, a copy of any notification of noncompliance or denial of certification issued to the applicant for certification; and a description of the actions taken by the applicant to correct the noncompliances noted in the notification of noncompliance, including evidence of such correction; and (d) Other information necessary to determine compliance with the Act and the regulations in this part.
7:7:3.1.1.9.32.5.343.3 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM E Subpart E—Certification   § 205.402 Review of application. AMS       (a) Upon acceptance of an application for certification, a certifying agent must: (1) Review the application to ensure completeness pursuant to § 205.401; (2) Determine by a review of the application materials whether the applicant appears to comply or may be able to comply with the applicable requirements of subpart C of this part; (3) Verify that an applicant who previously applied to another certifying agent and received a notification of noncompliance or denial of certification, pursuant to § 205.405, has submitted documentation to support the correction of any noncompliances identified in the notification of noncompliance or denial of certification, as required in § 205.405(e); and (4) Schedule an on-site inspection of the operation to determine whether the applicant qualifies for certification if the review of application materials reveals that the production or handling operation may be in compliance with the applicable requirements of subpart C of this part. (b) The certifying agent shall within a reasonable time: (1) Review the application materials received and communicate its findings to the applicant; (2) Provide the applicant with a copy of the on-site inspection report, as approved by the certifying agent, for any on-site inspection performed; and (3) Provide the applicant with a copy of the test results for any samples taken by an inspector. (c) The applicant may withdraw its application at any time. An applicant who withdraws its application shall be liable for the costs of services provided up to the time of withdrawal of its application. An applicant that voluntarily withdrew its application prior to the issuance of a notice of noncompliance will not be issued a notice of noncompliance. Similarly, an applicant that voluntarily withdrew its application prior to the issuance of a notice of certification denial will not be issued a notice of certification denial.
7:7:3.1.1.9.32.5.343.4 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM E Subpart E—Certification   § 205.403 On-site inspections. AMS     [65 FR 80637, Dec. 21, 2000, as amended at 88 FR 3623, Jan. 19, 2023] (a) On-site inspections. (1) A certifying agent must conduct an initial on-site inspection of each production unit, facility, and site that produces or handles organic products and that is included in an operation for which certification is requested. An on-site inspection shall be conducted annually thereafter for each certified operation that produces or handles organic products for the purpose of determining whether to approve the request for certification or whether the certification of the operation should continue. (2) Inspections of a producer group operation must: (i) Assess the internal control system's compliance, or ability to comply, with the requirements of § 205.400(g)(8). This must include review of the internal inspections conducted by the internal control system. (ii) Conduct witness audits of internal control system inspectors performing inspections of the producer group operation. (iii) Individually inspect at least 1.4 times the square root or 2% of the total number of producer group members, whichever is higher. All producer group members determined to be high risk by the certifying agent must be inspected. At least one producer group member in each producer group production unit must be inspected. (iv) Inspect each handling facility. (3)(i) A certifying agent may conduct additional on-site inspections of applicants for certification and certified operations to determine compliance with the Act and the regulations in this part. (ii) The Administrator or State organic program's governing State official may require that additional inspections be performed by the certifying agent for the purpose of determining compliance with the Act and the regulations in this part. (iii) Additional inspections may be announced or unannounced at the discretion of the certifying agent or as required by the Administrator or State organic program's governing State official. (b) Unannounced inspections. (1) A certifying agent must, on an annual basis, conduct unannounced inspections of a minimum of fiv…
7:7:3.1.1.9.32.5.343.5 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM E Subpart E—Certification   § 205.404 Granting certification. AMS     [65 FR 80637, Dec. 21, 2000, as amended of 88 FR 3623, Jan. 19, 2023] (a) Within a reasonable time after completion of the initial on-site inspection, a certifying agent must review the on-site inspection report, the results of any analyses for substances conducted, and any additional information requested from or supplied by the applicant. If the certifying agent determines that the organic system plan and all procedures and activities of the applicant's operation are in compliance with the requirements of this part and that the applicant is able to conduct operations in accordance with the plan, the agent shall grant certification. The certification may include requirements for the correction of minor noncompliances within a specified time period as a condition of continued certification. (b) The certifying agent must issue a certificate of organic operation. The certificate of organic operation must be generated from the Organic Integrity Database and may be provided to certified operations electronically. (c) In addition to the certificate of organic operation provided for in paragraph (b) of this section, a certifying agent may issue its own addenda to the certificate of organic operation. If issued, any addenda must include: (1) Name, address, and contact information for the certified operation; (2) The certified operation's unique ID number/code that corresponds to the certified operation's ID number/code in the Organic Integrity Database; (3) A link to the Organic Integrity Database or a link to the certified operation's profile in the Organic Integrity Database, along with a statement, “You may verify the certification of this operation at the Organic Integrity Database,” or a similar statement; (4) Name, address, and contact information of the certifying agent; and (5) “Addendum issue date.” (d) Once certified, a production or handling operation's organic certification continues in effect until surrendered by the organic operation or suspended or revoked by the certifying agent, the State organic program's governing State official, or the Administrator.
7:7:3.1.1.9.32.5.343.6 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM E Subpart E—Certification   § 205.405 Denial of certification. AMS     [65 FR 80637, Dec. 21, 2000, as amended at 88 FR 3624, Jan. 19, 2023] (a) When the certifying agent has reason to believe, based on a review of the information specified in § 205.402 or § 205.404, that an applicant for certification is not able to comply or is not in compliance with the requirements of this part, the certifying agent must provide a written notification of noncompliance to the applicant. When correction of a noncompliance is not possible, a notification of noncompliance and a notification of denial of certification may be combined in one notification. The notification of noncompliance shall provide: (1) A description of each noncompliance; (2) The facts upon which the notification of noncompliance is based; and (3) The date by which the applicant must rebut or correct each noncompliance and submit supporting documentation of each such correction when correction is possible. (b) Upon receipt of such notification of noncompliance, the applicant may: (1) Correct noncompliances and submit a description of the corrective actions taken with supporting documentation to the certifying agent; (2) Correct noncompliances and submit a new application to another certifying agent: Provided, That, the applicant must include a complete application, the notification of noncompliance received from the first certifying agent, and a description of the corrective actions taken with supporting documentation; or (3) Submit written information to the issuing certifying agent to rebut the noncompliance described in the notification of noncompliance. (c) After issuance of a notification of noncompliance, the certifying agent must: (1) Evaluate the applicant's corrective actions taken and supporting documentation submitted or the written rebuttal, conduct an on-site inspection if necessary, and (i) When the corrective action or rebuttal is sufficient for the applicant to qualify for certification, issue the applicant an approval of certification pursuant to § 205.404; or (ii) When the corrective action or rebuttal is not sufficient for the applicant to qualify for certification, …
7:7:3.1.1.9.32.5.343.7 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM E Subpart E—Certification   § 205.406 Continuation of certification. AMS     [65 FR 80637, Dec. 21, 2000, as amended at 88 FR 3624, Jan. 19, 2023] (a) To continue certification, a certified operation must annually pay the certification fees and submit the following information to the certifying agent: (1) A summary statement, supported by documentation, detailing any deviations from, changes to, modifications to, or other amendments made to the organic system plan submitted during the previous year; (2) Any additions or deletions to the previous year's organic system plan, intended to be undertaken in the coming year, detailed pursuant to § 205.201; (3) Any additions to or deletions from the information required pursuant to § 205.401(b); and (4) Other information as deemed necessary by the certifying agent to determine compliance with the Act and the regulations in this part. (b) The certifying agent must arrange and conduct an on-site inspection, pursuant to § 205.403, of the certified operation at least once per calendar year. (c) If the certifying agent has reason to believe, based on the on-site inspection and a review of the information specified in § 205.404, that a certified operation is not complying with the requirements of the Act and the regulations in this part, the certifying agent shall provide a written notification of noncompliance to the operation in accordance with § 205.662. (d) If the certifying agent determines that the certified operation is complying with the Act and the regulations in this part and that any of the information specified on the certificate of organic operation has changed, the certifying agent must issue an updated certificate of organic operation pursuant to § 205.404(b).
7:7:3.1.1.9.32.5.343.8 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM E Subpart E—Certification   §§ 205.407-205.499 [Reserved] AMS        
7:7:3.1.1.9.32.6.343.1 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM F Subpart F—Accreditation of Certifying Agents   § 205.500 Areas and duration of accreditation. AMS     [65 FR 80637, Dec. 21, 2000, as amended at 88 FR 3624, Jan. 19, 2023] (a) The Administrator shall accredit a qualified domestic or foreign applicant in the areas of crops, livestock, wild crops, or handling or any combination thereof to certify a domestic or foreign production or handling operation as a certified operation. (b) Accreditation shall be for a period of 5 years from the date of approval of accreditation pursuant to § 205.506.
7:7:3.1.1.9.32.6.343.10 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM F Subpart F—Accreditation of Certifying Agents   § 205.509 Peer review panel. AMS       The Administrator shall establish a peer review panel pursuant to the Federal Advisory Committee Act (FACA) (5 U.S.C. App. 2 et seq. ). The peer review panel shall be composed of not less than 3 members who shall annually evaluate the National Organic Program's adherence to the accreditation procedures in this subpart F and ISO/IEC Guide 61, General requirements for assessment and accreditation of certification/registration bodies, and the National Organic Program's accreditation decisions. This shall be accomplished through the review of accreditation procedures, document review and site evaluation reports, and accreditation decision documents or documentation. The peer review panel shall report its finding, in writing, to the National Organic Program's Program Manager.
7:7:3.1.1.9.32.6.343.11 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM F Subpart F—Accreditation of Certifying Agents   § 205.510 Annual report, recordkeeping, and renewal of accreditation. AMS     [65 FR 80637, Dec. 21, 2000, as amended at 80 FR 6429, Feb. 5, 2015] (a) Annual report and fees. An accredited certifying agent must submit annually to the Administrator, on or before the anniversary date of the issuance of the notification of accreditation, the following reports and fees: (1) A complete and accurate update of information submitted pursuant to §§ 205.503 and 205.504; (2) Information supporting any changes being requested in the areas of accreditation described in § 205.500; (3) A description of the measures implemented in the previous year and any measures to be implemented in the coming year to satisfy any terms and conditions determined by the Administrator to be necessary, as specified in the most recent notification of accreditation or notice of renewal of accreditation; (4) The results of the most recent performance evaluations and annual program review and a description of adjustments to the certifying agent's operation and procedures implemented or to be implemented in response to the performance evaluations and program review; and (5) The fees required in § 205.640(a). (b) Recordkeeping. Certifying agents must maintain records according to the following schedule: (1) Records obtained from applicants for certification and certified operations must be maintained for not less than 5 years beyond their receipt; (2) Records created by the certifying agent regarding applicants for certification and certified operations must be maintained for not less than 10 years beyond their creation; and (3) Records created or received by the certifying agent pursuant to the accreditation requirements of this subpart F, excluding any records covered by § 205.510(b)(2), must be maintained for not less than 5 years beyond their creation or receipt. (c) Renewal of accreditation. (1) The Administrator shall send the accredited certifying agent a notice of pending expiration of accreditation approximately 1 year prior to the scheduled date of expiration. (2) An accredited certifying agent's application for accreditation renewal must be received at least 6 months p…
7:7:3.1.1.9.32.6.343.12 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM F Subpart F—Accreditation of Certifying Agents   § 205.511 Accepting foreign conformity assessment systems. AMS     [88 FR 3625, Jan. 19, 2023] (a) Foreign product may be certified under the USDA organic regulations by a USDA-accredited certifying agent and imported for sale in the United States. Foreign product that is produced and handled under another country's organic certification program may be sold, labeled, or represented in the United States as organically produced if the U.S. Government determines that such country's organic certification program provides technical requirements and a conformity assessment system governing the production and handling of such products that are at least equivalent to the requirements of the Act and the regulations in this part. (b) Countries desiring to establish eligibility of product certified under that country's organic certification program to be sold, labeled, or represented in the United States as organically produced may request equivalence determinations from AMS. A foreign government must maintain compliance and enforcement mechanisms to ensure that its organic certification program is fully meeting the terms and conditions of any equivalence determination provided by the U.S. Government pursuant to this section. To request an equivalence determination, the requesting country must submit documentation that fully describes its technical requirements and conformity assessment system. If the U.S. Government determines it can proceed, AMS will assess the country's organic certification program to evaluate if it is equivalent. (c) USDA, working with other Federal agencies, will describe the scope of an equivalence determination. (d) AMS will conduct regular reviews and reassessments of countries deemed equivalent to verify that the foreign government's technical requirements and conformity assessment system continue to be at least equivalent to the requirements of the Act and the regulations of this part, and will determine if the equivalence determination should be continued, amended, or terminated. AMS will determine the timing and scope of reviews and re-assessments based on, but not limited to, factors…
7:7:3.1.1.9.32.6.343.13 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM F Subpart F—Accreditation of Certifying Agents   §§ 205.512-205.599 [Reserved] AMS        
7:7:3.1.1.9.32.6.343.2 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM F Subpart F—Accreditation of Certifying Agents   § 205.501 General requirements for accreditation. AMS     [65 FR 80637, Dec. 21, 2000, as amended at 88 FR 3624, Jan. 19, 2023] (a) A private or governmental entity accredited as a certifying agent under this subpart must: (1) Have sufficient expertise in organic production or handling techniques to fully comply with and implement the terms and conditions of the organic certification program established under the Act and the regulations in this part; (2) Demonstrate the ability to fully comply with the requirements for accreditation set forth in this subpart; (3) Carry out the provisions of the Act and the regulations in this part, including the provisions of §§ 205.402 through 205.406 and § 205.670; (4) Continuously use a sufficient number of qualified and adequately trained personnel, including inspectors and certification review personnel, to comply with and implement the USDA organic standards. (i) Certifying agents must demonstrate that all inspectors, including staff, volunteers, and contractors, have the relevant knowledge, skills, and experience required to inspect operations of the scope and complexity assigned and to evaluate compliance with the applicable regulations of this part. (A) Certifying agents must demonstrate that inspectors continuously maintain adequate knowledge and skills about the current USDA organic standards, production and handling practices, certification and inspection, import and/or export requirements, traceability audits, mass-balance audits, written and oral communication skills, sample collection, investigation techniques, and preparation of technically accurate inspection documents. (B) All inspectors must demonstrate successful completion of training that is relevant to inspection. Inspectors with less than one year of inspection experience must complete at least 50 hours of training within their first year and prior to performing inspections independently. Inspectors with one or more years of inspection experience must annually complete at least 10 hours of training if inspecting one area of operation (as defined at § 205.2) and an additional 5 hours of training for each additional area of op…
7:7:3.1.1.9.32.6.343.3 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM F Subpart F—Accreditation of Certifying Agents   § 205.502 Applying for accreditation. AMS     [65 FR 80637, Dec. 21, 2000, as amended at 80 FR 6429, Feb. 5, 2015] (a) A private or governmental entity seeking accreditation as a certifying agent under this subpart must submit an application for accreditation which contains the applicable information and documents set forth in §§ 205.503 through 205.505 and the fees required in § 205.640 to: Program Manager, USDA-AMS-NOP, 1400 Independence Ave. SW., Room 2648 So. Bldg., Ag Stop 0268, Washington, DC 20250-0268. (b) Following the receipt of the information and documents, the Administrator will determine, pursuant to § 205.506, whether the applicant for accreditation should be accredited as a certifying agent.
7:7:3.1.1.9.32.6.343.4 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM F Subpart F—Accreditation of Certifying Agents   § 205.503 Applicant information. AMS       A private or governmental entity seeking accreditation as a certifying agent must submit the following information: (a) The business name, primary office location, mailing address, name of the person(s) responsible for the certifying agent's day-to-day operations, contact numbers (telephone, facsimile, and Internet address) of the applicant, and, for an applicant who is a private person, the entity's taxpayer identification number; (b) The name, office location, mailing address, and contact numbers (telephone, facsimile, and Internet address) for each of its organizational units, such as chapters or subsidiary offices, and the name of a contact person for each unit; (c) Each area of operation (crops, wild crops, livestock, or handling) for which accreditation is requested and the estimated number of each type of operation anticipated to be certified annually by the applicant along with a copy of the applicant's schedule of fees for all services to be provided under these regulations by the applicant; (d) The type of entity the applicant is (e.g., government agricultural office, for-profit business, not-for-profit membership association) and for: (1) A governmental entity, a copy of the official's authority to conduct certification activities under the Act and the regulations in this part, (2) A private entity, documentation showing the entity's status and organizational purpose, such as articles of incorporation and by-laws or ownership or membership provisions, and its date of establishment; and (e) A list of each State or foreign country in which the applicant currently certifies production and handling operations and a list of each State or foreign country in which the applicant intends to certify production or handling operations.
7:7:3.1.1.9.32.6.343.5 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM F Subpart F—Accreditation of Certifying Agents   § 205.504 Evidence of expertise and ability. AMS     [65 FR 80637, Dec. 21, 2000, as amended at 88 FR 3625, Jan. 19, 2023] A private or governmental entity seeking accreditation as a certifying agent must submit the following documents and information to demonstrate its expertise in organic production or handling techniques; its ability to fully comply with and implement the organic certification program established in §§ 205.100 and 205.101, 205.201 through 205.203, 205.300 through 205.303, 205.400 through 205.406, and 205.661 through 205.663; and its ability to comply with the requirements for accreditation set forth in § 205.501: (a) Personnel. (1) A copy of the applicant's policies and procedures for training, evaluating, and supervising personnel; (2) The name and position description of all personnel to be used in the certification operation, including administrative staff, certification inspectors, members of any certification review and evaluation committees, contractors, and all parties responsibly connected to the certifying agent; (3) A description of the qualifications, including experience, training, and education in agriculture, organic production, and organic handling, for: (i) Each inspector to be used by the applicant and (ii) Each person to be designated by the applicant to review or evaluate applications for certification; and (4) A description of any training that the applicant has provided or intends to provide to personnel to ensure that they comply with and implement the requirements of the Act and the regulations in this part. (b) Administrative policies and procedures. (1) A copy of the procedures to be used to evaluate certification applicants, make certification decisions, and issue certification certificates; (2) A copy of the procedures to be used for reviewing and investigating certified operation compliance with the Act and the regulations in this part and the reporting of violations of the Act and the regulations in this part to the Administrator; (3) A copy of the procedures to be used for complying with the recordkeeping requirements set forth in § 205.501(a)(9); (4) A copy of the proce…
7:7:3.1.1.9.32.6.343.6 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM F Subpart F—Accreditation of Certifying Agents   § 205.505 Statement of agreement. AMS       (a) A private or governmental entity seeking accreditation under this subpart must sign and return a statement of agreement prepared by the Administrator which affirms that, if granted accreditation as a certifying agent under this subpart, the applicant will carry out the provisions of the Act and the regulations in this part, including: (1) Accept the certification decisions made by another certifying agent accredited or accepted by USDA pursuant to § 205.500; (2) Refrain from making false or misleading claims about its accreditation status, the USDA accreditation program for certifying agents, or the nature or qualities of products labeled as organically produced; (3) Conduct an annual performance evaluation of all persons who review applications for certification, perform on-site inspections, review certification documents, evaluate qualifications for certification, make recommendations concerning certification, or make certification decisions and implement measures to correct any deficiencies in certification services; (4) Have an annual internal program review conducted of its certification activities by certifying agent staff, an outside auditor, or a consultant who has the expertise to conduct such reviews and implement measures to correct any noncompliances with the Act and the regulations in this part; (5) Pay and submit fees to AMS in accordance with § 205.640; and (6) Comply with, implement, and carry out any other terms and conditions determined by the Administrator to be necessary. (b) A private entity seeking accreditation as a certifying agent under this subpart must additionally agree to: (1) Hold the Secretary harmless for any failure on the part of the certifying agent to carry out the provisions of the Act and the regulations in this part; (2) Furnish reasonable security, in an amount and according to such terms as the Administrator may by regulation prescribe, for the purpose of protecting the rights of production and handling operations certified by such certifying agent under the A…
7:7:3.1.1.9.32.6.343.7 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM F Subpart F—Accreditation of Certifying Agents   § 205.506 Granting accreditation. AMS       (a) Accreditation will be granted when: (1) The accreditation applicant has submitted the information required by §§ 205.503 through 205.505; (2) The accreditation applicant pays the required fee in accordance with § 205.640(c); and (3) The Administrator determines that the applicant for accreditation meets the requirements for accreditation as stated in § 205.501, as determined by a review of the information submitted in accordance with §§ 205.503 through 205.505 and, if necessary, a review of the information obtained from a site evaluation as provided for in § 205.508. (b) On making a determination to approve an application for accreditation, the Administrator will notify the applicant of the granting of accreditation in writing, stating: (1) The area(s) for which accreditation is given; (2) The effective date of the accreditation; (3) Any terms and conditions for the correction of minor noncompliances; and (4) For a certifying agent who is a private entity, the amount and type of security that must be established to protect the rights of production and handling operations certified by such certifying agent. (c) The accreditation of a certifying agent shall continue in effect until such time as the certifying agent fails to renew accreditation as provided in § 205.510(c), the certifying agent voluntarily ceases its certification activities, or accreditation is suspended or revoked pursuant to § 205.665.
7:7:3.1.1.9.32.6.343.8 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM F Subpart F—Accreditation of Certifying Agents   § 205.507 Denial of accreditation. AMS       (a) If the Program Manager has reason to believe, based on a review of the information specified in §§ 205.503 through 205.505 or after a site evaluation as specified in § 205.508, that an applicant for accreditation is not able to comply or is not in compliance with the requirements of the Act and the regulations in this part, the Program Manager shall provide a written notification of noncompliance to the applicant. Such notification shall provide: (1) A description of each noncompliance; (2) The facts upon which the notification of noncompliance is based; and (3) The date by which the applicant must rebut or correct each noncompliance and submit supporting documentation of each such correction when correction is possible. (b) When each noncompliance has been resolved, the Program Manager will send the applicant a written notification of noncompliance resolution and proceed with further processing of the application. (c) If an applicant fails to correct the noncompliances, fails to report the corrections by the date specified in the notification of noncompliance, fails to file a rebuttal of the notification of noncompliance by the date specified, or is unsuccessful in its rebuttal, the Program Manager will provide the applicant with written notification of accreditation denial. An applicant who has received written notification of accreditation denial may apply for accreditation again at any time in accordance with § 205.502, or appeal the denial of accreditation in accordance with § 205.681 by the date specified in the notification of accreditation denial. (d) If the certifying agent was accredited prior to the site evaluation and the certifying agent fails to correct the noncompliances, fails to report the corrections by the date specified in the notification of noncompliance, or fails to file a rebuttal of the notification of noncompliance by the date specified, the Administrator will begin proceedings to suspend or revoke the certifying agent's accreditation. A certifying agent who has had its accredi…
7:7:3.1.1.9.32.6.343.9 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM F Subpart F—Accreditation of Certifying Agents   § 205.508 Site evaluations. AMS       (a) Site evaluations of accredited certifying agents shall be conducted for the purpose of examining the certifying agent's operations and evaluating its compliance with the Act and the regulations of this part. Site evaluations shall include an on-site review of the certifying agent's certification procedures, decisions, facilities, administrative and management systems, and production or handling operations certified by the certifying agent. Site evaluations shall be conducted by a representative(s) of the Administrator. (b) An initial site evaluation of an accreditation applicant shall be conducted before or within a reasonable period of time after issuance of the applicant's “notification of accreditation.” A site evaluation shall be conducted after application for renewal of accreditation but prior to the issuance of a notice of renewal of accreditation. One or more site evaluations will be conducted during the period of accreditation to determine whether an accredited certifying agent is complying with the general requirements set forth in § 205.501.
7:7:3.1.1.9.32.7.343.1 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM G Subpart G—Administrative   § 205.600 Evaluation criteria for allowed and prohibited substances, methods, and ingredients. AMS       The following criteria will be utilized in the evaluation of substances or ingredients for the organic production and handling sections of the National List: (a) Synthetic and nonsynthetic substances considered for inclusion on or deletion from the National List of allowed and prohibited substances will be evaluated using the criteria specified in the Act (7 U.S.C. 6517 and 6518). (b) In addition to the criteria set forth in the Act, any synthetic substance used as a processing aid or adjuvant will be evaluated against the following criteria: (1) The substance cannot be produced from a natural source and there are no organic substitutes; (2) The substance's manufacture, use, and disposal do not have adverse effects on the environment and are done in a manner compatible with organic handling; (3) The nutritional quality of the food is maintained when the substance is used, and the substance, itself, or its breakdown products do not have an adverse effect on human health as defined by applicable Federal regulations; (4) The substance's primary use is not as a preservative or to recreate or improve flavors, colors, textures, or nutritive value lost during processing, except where the replacement of nutrients is required by law; (5) The substance is listed as generally recognized as safe (GRAS) by Food and Drug Administration (FDA) when used in accordance with FDA's good manufacturing practices (GMP) and contains no residues of heavy metals or other contaminants in excess of tolerances set by FDA; and (6) The substance is essential for the handling of organically produced agricultural products. (c) Nonsynthetics used in organic processing will be evaluated using the criteria specified in the Act (7 U.S.C. 6517 and 6518).
7:7:3.1.1.9.32.7.343.2 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM G Subpart G—Administrative   § 205.601 Synthetic substances allowed for use in organic crop production. AMS     [65 FR 80637, Dec. 21, 2000] In accordance with restrictions specified in this section, the following synthetic substances may be used in organic crop production: Provided, That, use of such substances do not contribute to contamination of crops, soil, or water. Substances allowed by this section, except disinfectants and sanitizers in paragraph (a) and those substances in paragraphs (c), (j), (k), (l), and (o) of this section, may only be used when the provisions set forth in § 205.206(a) through (d) prove insufficient to prevent or control the target pest. (a) As algicide, disinfectants, and sanitizer, including irrigation system cleaning systems. (1) Alcohols. (i) Ethanol. (ii) Isopropanol. (2) Chlorine materials—For pre-harvest use, residual chlorine levels in the water in direct crop contact or as water from cleaning irrigation systems applied to soil must not exceed the maximum residual disinfectant limit under the Safe Drinking Water Act, except that chlorine products may be used in edible sprout production according to EPA label directions. (i) Calcium hypochlorite. (ii) Chlorine dioxide. (iii) Hypochlorous acid—generated from electrolyzed water. (iv) Potassium hypochlorite—for use in water for irrigation purposes. (v) Sodium hypochlorite. (3) Copper sulfate—for use as an algicide in aquatic rice systems, is limited to one application per field during any 24-month period. Application rates are limited to those which do not increase baseline soil test values for copper over a timeframe agreed upon by the producer and accredited certifying agent. (4) Hydrogen peroxide. (5) Ozone gas—for use as an irrigation system cleaner only. (6) Peracetic acid—for use in disinfecting equipment, seed, and asexually propagated planting material. Also permitted in hydrogen peroxide formulations as allowed in § 205.601(a) at concentration of no more than 6% as indicated on the pesticide product label. (7) Soap-based algicide/demossers. (8) Sodium carbonate peroxyhydrate (CAS #-15630-89-4)—Federal law restricts the use of this substance…
7:7:3.1.1.9.32.7.343.3 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM G Subpart G—Administrative   § 205.602 Nonsynthetic substances prohibited for use in organic crop production. AMS     [68 FR 61992, Oct. 31, 2003, as amended at 83 FR 66572, Dec. 27, 2018] The following nonsynthetic substances may not be used in organic crop production: (a) Ash from manure burning. (b) Arsenic. (c) Calcium chloride, brine process is natural and prohibited for use except as a foliar spray to treat a physiological disorder associated with calcium uptake. (d) Lead salts. (e) Potassium chloride—unless derived from a mined source and applied in a manner that minimizes chloride accumulation in the soil. (f) Rotenone (CAS # 83-79-4). (g) Sodium fluoaluminate (mined). (h) Sodium nitrate—unless use is restricted to no more than 20% of the crop's total nitrogen requirement; use in spirulina production is unrestricted until October 21, 2005. (i) Strychnine. (j) Tobacco dust (nicotine sulfate).
7:7:3.1.1.9.32.7.343.4 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM G Subpart G—Administrative   § 205.603 Synthetic substances allowed for use in organic livestock production. AMS     [72 FR 70484, Dec. 12, 2007, as amended at 73 FR 54059, Sept. 18, 2008; 75 FR 51924, Aug. 24, 2010; 77 FR 28745, May 15, 2012; 77 FR 45907, Aug. 2, 2012; 77 FR 57989, Sept. 19, 2012; 80 FR 6429, Feb. 5, 2015; 82 FR 31243, July 6, 2017; 83 FR 66572, Dec. 27, 2018; 84 FR 18136, Apr. 30, 2019; 86 FR 33484, June 25, 2021; 87 FR 10938, Feb. 28, 2022] In accordance with restrictions specified in this section the following synthetic substances may be used in organic livestock production: (a) As disinfectants, sanitizer, and medical treatments as applicable. (1) Alcohols. (i) Ethanol—disinfectant and sanitizer only, prohibited as a feed additive. (ii) Isopropanol-disinfectant only. (2) Aspirin-approved for health care use to reduce inflammation. (3) Atropine (CAS #-51-55-8)—federal law restricts this drug to use by or on the lawful written or oral order of a licensed veterinarian, in full compliance with the AMDUCA and 21 CFR part 530 of the Food and Drug Administration regulations. Also, for use under 7 CFR part 205, the NOP requires: (i) Use by or on the lawful written order of a licensed veterinarian; and (ii) A meat withdrawal period of at least 56 days after administering to livestock intended for slaughter; and a milk discard period of at least 12 days after administering to dairy animals. (4) Biologics—Vaccines. (5) Butorphanol (CAS #-42408-82-2)—federal law restricts this drug to use by or on the lawful written or oral order of a licensed veterinarian, in full compliance with the AMDUCA and 21 CFR part 530 of the Food and Drug Administration regulations. Also, for use under 7 CFR part 205, the NOP requires: (i) Use by or on the lawful written order of a licensed veterinarian; and (ii) A meat withdrawal period of at least 42 days after administering to livestock intended for slaughter; and a milk discard period of at least 8 days after administering to dairy animals. (6) Activated charcoal (CAS # 7440-44-0)—must be from vegetative sources. (7) Calcium borogluconate (CAS # 5743-34-0)—for treatment of milk fever only. (8) Calcium propionate (CAS # 4075-81-4)—for treatment of milk fever only. (9) Chlorhexidine (CAS # 55-56-1)—for medical procedures conducted under the supervision of a licensed veterinarian. Allowed for use as a teat dip when alternative germicidal agents and/or physical barriers have lost their effectiveness. (10) Chlorine m…
7:7:3.1.1.9.32.7.343.5 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM G Subpart G—Administrative   § 205.604 Nonsynthetic substances prohibited for use in organic livestock production. AMS       The following nonsynthetic substances may not be used in organic livestock production: (a) Strychnine. (b)-(z) [Reserved]
7:7:3.1.1.9.32.7.343.6 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM G Subpart G—Administrative   § 205.605 Nonagricultural (nonorganic) substances allowed as ingredients in or on processed products labeled as “organic” or “made with organic (specified ingredients or food group(s)).” AMS     [68 FR 61993, Oct. 31, 2003] The following nonagricultural substances may be used as ingredients in or on processed products labeled as “organic” or “made with organic (specified ingredients or food group(s))” only in accordance with any restrictions specified in this section. (a) Nonsynthetics allowed. (1) Acids (Citric—produced by microbial fermentation of carbohydrate substances; and Lactic). (2) Agar-agar. (3) Animal enzymes—(Rennet—animals derived; Catalase—bovine liver; Animal lipase; Pancreatin; Pepsin; and Trypsin). (4) Attapulgite—as a processing aid in the handling of plant and animal oils. (5) Bentonite. (6) Calcium carbonate. (7) Calcium chloride. (8) Calcium sulfate—mined. (9) Carrageenan. (10) Diatomaceous earth—food filtering aid only. (11) Enzymes—must be derived from edible, nontoxic plants, nonpathogenic fungi, or nonpathogenic bacteria. (12) Flavors—nonsynthetic flavors may be used when organic flavors are not commercially available. All flavors must be derived from organic or nonsynthetic sources only and must not be produced using synthetic solvents and carrier systems or any artificial preservative. (13) Gellan gum (CAS # 71010-52-1)—high-acyl form only. (14) Glucono delta-lactone—production by the oxidation of D-glucose with bromine water is prohibited. (15) Kaolin. (16) L-Malic acid (CAS # 97-67-6). (17) Magnesium chloride. (18) Magnesium sulfate, nonsynthetic sources only. (19) Microorganisms—any food grade bacteria, fungi, and other microorganism. (20) Nitrogen—oil-free grades. (21) Oxygen—oil-free grades. (22) Perlite—for use only as a filter aid in food processing. (23) Potassium chloride. (24) Potassium iodide. (25) Pullulan—for use only in tablets and capsules for dietary supplements labeled “made with organic (specified ingredients or food group(s)). (26) Sodium bicarbonate. (27) Sodium carbonate. (28) Tartaric acid—made from grape wine. (29) Waxes—nonsynthetic (Wood rosin). (30) Yeast—When used as food or a fermentation agent in products labeled as “organic,” yeast must be organ…
7:7:3.1.1.9.32.7.343.7 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM G Subpart G—Administrative   § 205.606 Nonorganically produced agricultural products allowed as ingredients in or on processed products labeled as “organic.” AMS     [72 FR 35140, June 27, 2007, as amended at 75 FR 77524, Dec. 13, 2010; 77 FR 8092, Feb. 14, 2012; 77 FR 33299, June 6, 2012; 77 FR 44429, July 30, 2012; 78 FR 31821, May 28, 2013; 79 FR 58663, Sept. 30, 2014; 80 FR 77234, Dec. 12, 2015; 82 FR 31244, July 6, 2017; 83 FR 66571, Dec. 27, 2018; 84 18136, Apr. 30, 2019; 85 FR 70435, Nov. 5, 2020; 87 FR 10938, Feb. 28, 2022; 88 FR 33816, May 25, 2023] Only the following nonorganically produced agricultural products may be used as ingredients in or on processed products labeled as “organic,” only in accordance with any restrictions specified in this section, and only when the product is not commercially available in organic form. (a) Carnauba wax (b) Casings, from processed intestines. (c) Celery powder. (d) Colors derived from agricultural products—Must not be produced using synthetic solvents and carrier systems or any artificial preservative. (1) Beet juice extract color—derived from Beta vulgaris L., except must not be produced from sugarbeets. (2) Beta-carotene extract color—derived from carrots ( Daucus carota L.) or algae ( Dunaliella salina ). (3) Black/purple carrot juice color—derived from Daucus carota L. (4) Chokeberry, aronia juice color—derived from Aronia arbutifolia (L.) Pers. or Aronia melanocarpa (Michx.) Elliott. (5) Elderberry juice color—derived from Sambucus nigra L. (6) Grape skin extract color—derived from Vitis vinifera L. (7) Purple sweet potato juice color—derived from Ipomoea batatas L. or Solanum tuberosum L. (8) Red cabbage extract color—derived from Brassica oleracea L. (9) Red radish extract color—derived from Raphanus sativus L. (10) Saffron extract color—derived from Crocus sativus L. (e) Cornstarch (native). (f) Fish oil (Fatty acid CAS #'s: 10417-94-4, and 25167-62-8)—stabilized with organic ingredients or only with ingredients on the National List, §§ 205.605 and 205.606. (g) Fructooligosaccharides (CAS # 308066-66-2). (h) Gelatin (CAS # 9000-70-8). (i) Glycerin (CAS # 56-81-5)—produced from agricultural source materials and processed using biological or mechanical/physical methods as described under § 205.270(a). (j) Gums—water extracted only (Arabic; Guar; Locust bean; and Carob bean). (k) Inulin—oligofructose enriched (CAS # 9005-80-5). (l) Lecithin—de-oiled. (m) Orange pulp, dried. (n) Orange shellac—unbleached (CAS # 9000-59-3). (o) Pectin (non-amidated forms only). (p) P…
7:7:3.1.1.9.32.7.343.8 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM G Subpart G—Administrative   § 205.607 Amending the National List. AMS     [65 FR 80637, Dec. 21, 2000, as amended at 68 FR 61993, Oct. 31, 2003; 80 FR 6429, Feb. 5, 2015] (a) Any person may petition the National Organic Standards Board for the purpose of having a substance evaluated by the Board for recommendation to the Secretary for inclusion on or deletion from the National List in accordance with the Act. (b) A person petitioning for amendment of the National List should request a copy of the petition procedures from the USDA at the address in § 205.607(c). (c) A petition to amend the National List must be submitted to: Program Manager, USDA-AMS-NOP, 1400 Independence Ave. SW., Room 2648 So. Bldg., Ag Stop 0268, Washington, DC 20250-0268.
7:7:3.1.1.9.32.7.343.9 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM G Subpart G—Administrative   §§ 205.608-205.619 [Reserved] AMS        
7:7:3.1.1.9.32.7.344.10 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM G Subpart G—Administrative   § 205.620 Requirements of State organic programs. AMS       (a) A State may establish a State organic program for production and handling operations within the State which produce and handle organic agricultural products. (b) A State organic program must meet the requirements for organic programs specified in the Act. (c) A State organic program may contain more restrictive requirements because of environmental conditions or the necessity of specific production or handling practices particular to the State or region of the United States. (d) A State organic program must assume enforcement obligations in the State for the requirements of this part and any more restrictive requirements approved by the Secretary. (e) A State organic program and any amendments to such program must be approved by the Secretary prior to being implemented by the State.
7:7:3.1.1.9.32.7.344.11 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM G Subpart G—Administrative   § 205.621 Submission and determination of proposed State organic programs and amendments to approved State organic programs. AMS       (a) A State organic program's governing State official must submit to the Secretary a proposed State organic program and any proposed amendments to such approved program. (1) Such submission must contain supporting materials that include statutory authorities, program description, documentation of the environmental conditions or specific production and handling practices particular to the State which necessitate more restrictive requirements than the requirements of this part, and other information as may be required by the Secretary. (2) Submission of a request for amendment of an approved State organic program must contain supporting materials that include an explanation and documentation of the environmental conditions or specific production and handling practices particular to the State or region, which necessitates the proposed amendment. Supporting material also must explain how the proposed amendment furthers and is consistent with the purposes of the Act and the regulations of this part. (b) Within 6 months of receipt of submission, the Secretary will: Notify the State organic program's governing State official of approval or disapproval of the proposed program or amendment of an approved program and, if disapproved, the reasons for the disapproval. (c) After receipt of a notice of disapproval, the State organic program's governing State official may submit a revised State organic program or amendment of such a program at any time.
7:7:3.1.1.9.32.7.344.12 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM G Subpart G—Administrative   § 205.622 Review of approved State organic programs. AMS       The Secretary will review a State organic program not less than once during each 5-year period following the date of the initial program approval. The Secretary will notify the State organic program's governing State official of approval or disapproval of the program within 6 months after initiation of the review.
7:7:3.1.1.9.32.7.344.13 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM G Subpart G—Administrative   §§ 205.623-205.639 [Reserved] AMS        
7:7:3.1.1.9.32.7.345.14 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM G Subpart G—Administrative   § 205.640 Fees and other charges for accreditation. AMS       Fees and other charges equal as nearly as may be to the cost of the accreditation services rendered under the regulations, including initial accreditation, review of annual reports, and renewal of accreditation, shall be assessed and collected from applicants for initial accreditation and accredited certifying agents submitting annual reports or seeking renewal of accreditation in accordance with the following provisions: (a) Fees-for-service. (1) Except as otherwise provided in this section, fees-for-service shall be based on the time required to render the service provided calculated to the nearest 15-minute period, including the review of applications and accompanying documents and information, evaluator travel, the conduct of on-site evaluations, review of annual reports and updated documents and information, and the time required to prepare reports and any other documents in connection with the performance of service. The hourly rate shall be the same as that charged by the Agricultural Marketing Service, through its Quality Systems Certification Program, to certification bodies requesting conformity assessment to the International Organization for Standardization “General Requirements for Bodies Operating Product Certification Systems” (ISO Guide 65). (2) Applicants for initial accreditation and accredited certifying agents submitting annual reports or seeking renewal of accreditation during the first 18 months following the effective date of subpart F of this part shall receive service without incurring an hourly charge for service. (3) Applicants for initial accreditation and renewal of accreditation must pay at the time of application, effective 18 months following February 20, 2001, a nonrefundable fee of $500.00 which shall be applied to the applicant's fees-for-service account. (b) Travel charges. When service is requested at a place so distant from the evaluator's headquarters that a total of one-half hour or more is required for the evaluator(s) to travel to such place and back to the headquar…
7:7:3.1.1.9.32.7.345.15 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM G Subpart G—Administrative   § 205.641 Payment of fees and other charges. AMS     [65 FR 80637, Dec. 21, 2000, as amended at 80 FR 6429, Feb. 5, 2015] (a) Applicants for initial accreditation and renewal of accreditation must remit the nonrefundable fee, pursuant to § 205.640(a)(3), along with their application. Remittance must be made payable to the USDA, AMS Livestock Program and mailed to: USDA, AMS Livestock, Poultry and Seed Program, QAD, P.O. Box 790304 St. Louis, MO 63179-0304 or such other address as required by the Program Manager. (b) Payments for fees and other charges not covered under paragraph (a) of this section must be: (1) Received by the due date shown on the bill for collection; (2) Made payable to the Agricultural Marketing Service, USDA; and (3) Mailed to the address provided on the bill for collection. (c) The Administrator shall assess interest, penalties, and administrative costs on debts not paid by the due date shown on a bill for collection and collect delinquent debts or refer such debts to the Department of Justice for litigation.
7:7:3.1.1.9.32.7.345.16 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM G Subpart G—Administrative   § 205.642 Fees and other charges for certification. AMS       Fees charged by a certifying agent must be reasonable, and a certifying agent shall charge applicants for certification and certified production and handling operations only those fees and charges that it has filed with the Administrator. The certifying agent shall provide each applicant with an estimate of the total cost of certification and an estimate of the annual cost of updating the certification. The certifying agent may require applicants for certification to pay at the time of application a nonrefundable fee which shall be applied to the applicant's fees-for-service account. The certifying agent may set the nonrefundable portion of certification fees; however, the nonrefundable portion of certification fees must be explained in the fee schedule submitted to the Administrator. The fee schedule must explain what fee amounts are nonrefundable and at what stage during the certification process fees become nonrefundable. The certifying agent shall provide all persons inquiring about the application process with a copy of its fee schedule.
7:7:3.1.1.9.32.7.345.17 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM G Subpart G—Administrative   §§ 205.643-205.649 [Reserved] AMS        
7:7:3.1.1.9.32.7.346.18 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM G Subpart G—Administrative   § 205.660 General. AMS     [65 FR 80637, Dec. 21, 2000, as amended at 88 FR 3625, Jan. 19, 2023] (a) The National Organic Program's Program Manager, on behalf of the Secretary, may inspect and review certified production and handling operations and accredited certifying agents for compliance with the Act or regulations in this part. (b) The Program Manager may initiate suspension or revocation proceedings against a certified operation: (1) When the Program Manager has reason to believe that a certified operation has violated or is not in compliance with the Act or regulations in this part; or (2) When a certifying agent or a State organic program's governing State official fails to take appropriate action to enforce the Act or regulations in this part. (c) The Program Manager may initiate enforcement action against any person who sells, labels, or provides other market information concerning an agricultural product if such label or information implies that such product is produced or handled using organic methods, if the product was produced or handled in violation of the Organic Foods Production Act or the regulations in this part. (d) The Program Manager may initiate suspension or revocation of a certifying agent's accreditation if the certifying agent fails to meet, conduct, or maintain accreditation requirements pursuant to the Act or this part. (e) Each notification of noncompliance, rejection of mediation, noncompliance resolution, proposed suspension or revocation, and suspension or revocation issued pursuant to §§ 205.662, 205.663, and 205.665 and each response to such notification must be sent to the recipient's place of business via a delivery service which provides dated return receipts.
7:7:3.1.1.9.32.7.346.19 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM G Subpart G—Administrative   § 205.661 Investigation. AMS       (a) A certifying agent may investigate complaints of noncompliance with the Act or regulations of this part concerning production and handling operations certified as organic by the certifying agent. A certifying agent must notify the Program Manager of all compliance proceedings and actions taken pursuant to this part. (b) A State organic program's governing State official may investigate complaints of noncompliance with the Act or regulations in this part concerning organic production or handling operations operating in the State.
7:7:3.1.1.9.32.7.346.20 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM G Subpart G—Administrative   § 205.662 Noncompliance procedure for certified operations. AMS     [65 FR 80637, Dec. 21, 2000, as amended at 75 FR 17560, Apr. 7, 2010; 79 FR 6430, Feb. 5, 2015; 88 FR 3626, Jan. 19, 2023] (a) Notification. When an inspection, review, or investigation of a certified operation by a certifying agent or a State organic program's governing State official reveals any noncompliance with the Act or regulations in this part, a written notification of noncompliance shall be sent to the certified operation. Such notification shall provide: (1) A description of each noncompliance; (2) The facts upon which the notification of noncompliance is based; and (3) The date by which the certified operation must rebut or correct each noncompliance and submit supporting documentation of each such correction when correction is possible. (b) Resolution. When a certified operation demonstrates that each noncompliance has been resolved, the certifying agent or the State organic program's governing State official, as applicable, shall send the certified operation a written notification of noncompliance resolution. (c) Proposed suspension or revocation. When rebuttal is unsuccessful or correction of the noncompliance is not completed within the prescribed time period, the certifying agent or State organic program's governing State official shall send the certified operation a written notification of proposed suspension or revocation of certification of the entire operation or a portion of the operation, as applicable to the noncompliance. When correction of a noncompliance is not possible, the notification of noncompliance and the proposed suspension or revocation of certification may be combined in one notification. The notification of proposed suspension or revocation of certification shall state: (1) The reasons for the proposed suspension or revocation; (2) The proposed effective date of such suspension or revocation; (3) The impact of a suspension or revocation on future eligibility for certification; and (4) The right to request mediation pursuant to § 205.663 or to file an appeal pursuant to § 205.681. (d) Willful violations. Notwithstanding paragraph (a) of this section, if a certifying agent or Stat…
7:7:3.1.1.9.32.7.346.21 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM G Subpart G—Administrative   § 205.663 Mediation. AMS     [88 FR 3626, Jan. 19, 2023] (a) A certifying agent must submit with its administrative policies and procedures: decision criteria for acceptance of mediation, and a process for identifying personnel conducting mediation and setting up mediation sessions per § 205.504(b)(8). (b) A certified operation or applicant for certification may request mediation to resolve a denial of certification or proposed suspension or proposed revocation of certification issued by a certifying agent or State organic program. (1) A certified operation or applicant for certification must submit any request for mediation in writing to the applicable certifying agent or State organic program within 30 calendar days of receipt of the notice of proposed suspension or proposed revocation of certification or denial of certification. (2) A certifying agent or State organic program may accept or reject a request for mediation based on the decision criteria required in paragraph (a) of this section. Certifying agents must document these criteria and how the certifying agent applied the criteria to the request. (3) If a certifying agent rejects a mediation request, it must provide this rejection, and the justification for the rejection, in writing to the applicant for certification or certified operation. The rejection must include the right to request an appeal, pursuant to § 205.681, within 30 calendar days of the date of receipt of the written notification of rejection of the request for mediation. (4) When an operation appeals a rejection of mediation, the adverse action which is contested must not be finalized during the appeal proceeding. (c) Both parties must agree on the person conducting the mediation. (d) If a State organic program is in effect, the parties must follow the mediation procedures established in the State organic program and approved by the Secretary. (e) The parties to the mediation have a maximum of 30 calendar days from the start of mediation to reach an agreement. Successful mediation results in a settlement agreement agreed to in writing …
7:7:3.1.1.9.32.7.346.22 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM G Subpart G—Administrative   § 205.664 [Reserved] AMS        
7:7:3.1.1.9.32.7.346.23 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM G Subpart G—Administrative   § 205.665 Noncompliance procedure for certifying agents. AMS     [65 FR 80637, Dec. 21, 2000, as amended at 88 FR 3626, Jan. 19, 2023] (a) Notification. (1) A written notification of noncompliance will be sent to the certifying agent when: (i) An inspection, review, or investigation of an accredited certifying agent by the Program Manager reveals any noncompliance with the Act or regulations in this part; or (ii) The Program Manager determines that the certification activities of the certifying agent, or any person performing certification activities on behalf of the certifying agent, are not compliant with the Act or the regulations in this part; or (iii) The Program Manager determines that the certification activities at a certification office, and/in specific countries, are not compliant with the Act or the regulations in this part. (2) Such notification must provide: (i) A description of each noncompliance; (ii) The facts upon which the notification of noncompliance is based; and (iii) The date by which the certifying agent must rebut or correct each noncompliance and submit supporting documentation of each correction when correction is possible. (b) Resolution. When the certifying agent demonstrates that each noncompliance has been resolved, the Program Manager shall send the certifying agent a written notification of noncompliance resolution. (c) Proposed suspension or revocation. When rebuttal is unsuccessful or correction of the noncompliance is not completed within the prescribed time period, the Program Manager shall send a written notification of proposed suspension or revocation of accreditation to the certifying agent. The notification of proposed suspension or revocation shall state whether the certifying agent's accreditation or specified areas of accreditation are to be suspended or revoked. When correction of a noncompliance is not possible, the notification of noncompliance and the proposed suspension or revocation may be combined in one notification. The notification of proposed suspension or revocation of accreditation shall state: (1) The reasons for the proposed suspension or revocation; (2) The proposed ef…
7:7:3.1.1.9.32.7.346.24 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM G Subpart G—Administrative   §§ 205.666-205.667 [Reserved] AMS        
7:7:3.1.1.9.32.7.346.25 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM G Subpart G—Administrative   § 205.668 Noncompliance procedures under State organic programs. AMS       (a) A State organic program's governing State official must promptly notify the Secretary of commencement of any noncompliance proceeding against a certified operation and forward to the Secretary a copy of each notice issued. (b) A noncompliance proceeding, brought by a State organic program's governing State official against a certified operation, shall be appealable pursuant to the appeal procedures of the State organic program. There shall be no subsequent rights of appeal to the Secretary. Final decisions of a State may be appealed to the United States District Court for the district in which such certified operation is located. (c) A State organic program's governing State official may review and investigate complaints of noncompliance with the Act or regulations concerning accreditation of certifying agents operating in the State. When such review or investigation reveals any noncompliance, the State organic program's governing State official shall send a written report of noncompliance to the Program Manager. The report shall provide a description of each noncompliance and the facts upon which the noncompliance is based.
7:7:3.1.1.9.32.7.346.26 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM G Subpart G—Administrative   § 205.669 [Reserved] AMS        
7:7:3.1.1.9.32.7.347.27 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM G Subpart G—Administrative   § 205.670 Inspection and testing of agricultural products to be sold or labeled as “100 percent organic,” “organic,” or “made with organic (specified ingredients or food group(s)).” AMS     [77 FR 67251, Nov. 9, 2012] (a) All agricultural products that are to be sold, labeled, or represented as “100 percent organic,” “organic,” or “made with organic (specified ingredients or food group(s))” must be made accessible by certified organic production or handling operations for examination by the Administrator, the applicable State organic program's governing State official, or the certifying agent. (b) The Administrator, applicable State organic program's governing State official, or the certifying agent may require preharvest or postharvest testing of any agricultural input used or agricultural product to be sold, labeled, or represented as “100 percent organic,” “organic,” or “made with organic (specified ingredients or food group(s))” when there is reason to believe that the agricultural input or product has come into contact with a prohibited substance or has been produced using excluded methods. Samples may include the collection and testing of soil; water; waste; seeds; plant tissue; and plant, animal, and processed products samples. Such tests must be conducted by the applicable State organic program's governing State official or the certifying agent at the official's or certifying agent's own expense. (c) A certifying agent must conduct periodic residue testing of agricultural products to be sold, labeled, or represented as “100 percent organic,” “organic,” or “made with organic (specified ingredients or food group(s)).” Samples may include the collection and testing of soil; water; waste; seeds; plant tissue; and plant, animal, and processed products samples. Such tests must be conducted by the certifying agent at the certifying agent's own expense. (d) A certifying agent must, on an annual basis, sample and test from a minimum of five percent of the operations it certifies, rounded to the nearest whole number. A certifying agent that certifies fewer than thirty operations on an annual basis must sample and test from at least one operation annually. Tests conducted under paragraphs (b) and (c) of this section will apply…
7:7:3.1.1.9.32.7.347.28 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM G Subpart G—Administrative   § 205.671 Exclusion from organic sale. AMS       When residue testing detects prohibited substances at levels that are greater than 5 percent of the Environmental Protection Agency's tolerance for the specific residue detected or unavoidable residual environmental contamination, the agricultural product must not be sold, labeled, or represented as organically produced. The Administrator, the applicable State organic program's governing State official, or the certifying agent may conduct an investigation of the certified operation to determine the cause of the prohibited substance.
7:7:3.1.1.9.32.7.347.29 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM G Subpart G—Administrative   § 205.672 Emergency pest or disease treatment. AMS       When a prohibited substance is applied to a certified operation due to a Federal or State emergency pest or disease treatment program and the certified operation otherwise meets the requirements of this part, the certification status of the operation shall not be affected as a result of the application of the prohibited substance: Provided, That: (a) Any harvested crop or plant part to be harvested that has contact with a prohibited substance applied as the result of a Federal or State emergency pest or disease treatment program cannot be sold, labeled, or represented as organically produced; and (b) Any livestock that are treated with a prohibited substance applied as the result of a Federal or State emergency pest or disease treatment program or product derived from such treated livestock cannot be sold, labeled, or represented as organically produced: Except, That: (1) Milk or milk products may be sold, labeled, or represented as organically produced beginning 12 months following the last date that the dairy animal was treated with the prohibited substance; and (2) The offspring of gestating mammalian breeder stock treated with a prohibited substance may be considered organic: Provided, That, the breeder stock was not in the last third of gestation on the date that the breeder stock was treated with the prohibited substance.
7:7:3.1.1.9.32.7.347.30 7 Agriculture I M 205 PART 205—NATIONAL ORGANIC PROGRAM G Subpart G—Administrative   §§ 205.673-205.679 [Reserved] AMS        

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