I. National Organic Program (NOP) Information
A. Definitions
Definitions as related specifically to agricultural production and processing of crops, livestock and crop products relative to their consideration as organic production. Most of the following definitions come directly from the National Organic Program (NOP). Definitions were compiled in April 2006, for online access of NOP definitions visit: http://www.ams.usda.gov/nop/NOP/standards/DefineReg.html
§ 205.1 Meaning of Words.
For the purpose of the regulations in this subpart, words in the singular form shall be deemed to impart the plural and vice versa, as the case may demand.
§ 205.2 Terms Defined.
Accreditation- The limit 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 no represent permissible levels of contamination where it is avoidable.
Administrator- The Administrator for the Agricultural Marketing Service, United States Department of Agriculture, or the representative to whom authority has been delegated to act instead of the Administrator.
Agricultural inputs- All substances or materials used in the production or handling of organic agricultural products.
Agricultural product- Any agricultural commodity or product, whether raw or processed, including any commodity or product derived from livestock, that is marketed in the United States for human or livestock consumption.
Allowed synthetic- A substance that is included on the National List of synthetic substances allowed for use in organic production or handling.
Agricultural Marketing Service (AMS)- The Agricultural Marketing Service of the United States Department of Agriculture
Animal drug- Any drug as defined in section 201 of the Federal Food, Drug and Cosmetic Act, as amended (21 U.S.C. 321), that is intended for use in livestock, including any drug intended for use in livestock feed but not including such livestock feed.
Annual seedling- A plant grown from seed that will complete its life cycle or produce a harvestable yield within the same crop year or season in which it was planted.
Area of operation- The types of operations: crops, livestock, wild-crop harvesting or handling, or any combination thereof that a certifying agency may be accredited to certify under this part.
Audit trail- Documentation that is sufficient to determine the source, transfer of ownership and transportation of any agricultural product labeled as “100 percent organic”, the organic ingredients of any agricultural product labeled as “organic” or “made with organic (specified ingredients)” or the organic ingredients of any agricultural product containing less than 70 percent organic ingredients identified as organic in an ingredient statement.
Biodegradable- Subject to biological decomposition in to simpler biochemical or chemical components.
Biodiversity- The variety and variability among living organisms and the ecological complexes in which they occur. Diversity can be defined as the number of different items and their relative frequency. For biological diversity, these items are organized at many levels, ranging from complete ecosystems to the chemical structures that are the molecular basis of heredity. Thus, the term encompasses different ecosystems, species, genes, and their relative abundance.
Biodynamic farming- A farming system that is very similar to organic agriculture in that soil fertility is the emphasis. Biodynamic farmer utilize special plants, minerals, and animal preparations and they also have a formula for making compost that minimizes loss of nutrients. Cosmic and earth forces play a role in crop production and farmers often try to plant according to moon phases.
Biologics- All viruses, serums, toxins and analogous products of natural or synthetic origin, such as diagnostics, antitoxins, vaccines, live microorganisms, killed microorganisms, and the antigenic or immunizing components of microorganisms intended for use in the diagnosis, treatment, or prevention of diseases of animals.
Biorational pesticide- Products that are considered to be environmentally friendly because they have minimal harmful effects on non-target organisms and the environment; they are frequently more “user friendly” than traditional pesticides; examples include neem oil, insecticidal soap, horticultural oil and potassium bicarbonate.
Breeder stock- Female livestock whose offspring may be incorporated into an organic operation at the time of their birth.
Buffer zone- An area located between a certified production operation or portion of a production operation and an adjacent land area that is not maintained under organic management. A buffer zone must be sufficient in size or other features (e.g., windbreaks or a diversion ditch) to prevent the possibility of unintended contact by prohibited substances applied to adjacent land areas with an area that is part of a certified operation. *General required buffer zone is 25 foot.
Bulk- The presentation to consumers at retail sale of an agricultural product in unpackaged, loose form, enabling the consumer to determine the individual pieces, amounts, or volume of the product purchased.
Certification or certified- A determination made by a certifying agent that a production of handling operation is in compliance with the Act and the regulations in the part, which is documented by a certificate of organic operation.
Certified operation- A crop or livestock production, wild-crop harvesting or handling operation, or portion of such operation that is certified by an accredited certifying agency as utilizing a system of organic production or handling as described by the Act and the regulations in this part.
Certifying agent- Any entity accredited by the Secretary as a certifying agent for the purpose of certifying a production of handling operation as a certified production of handling operation. *States are given authority to delegate certifying agent.
Certifying agent’s operation- All sites, facilities, personnel, and records used by a certifying agent to conduct certification activities under the Act and the regulations in this part.
Claims- Oral, written, implied, or symbolic representations, statements, advertising or other forms of communication presented to the public or buyers of agricultural products that relate to the organic certification process or the term, “100 percent organic”, “organic”, or “made with organic (specified ingredients or food group(s)), “or, in the case of agricultural products containing less that 70 percent organic ingredients, the term, “organic”, on the ingredients panel.
Commercially available- The ability to obtain a production input in an appropriate form, quality, or quantity to fulfill an essential function in a system of organic production or handling, as determined by the certifying agent in the course of reviewing the organic plan.
Commingling- Physical contact between unpackaged organically produced and non-organically produced agricultural products during production, transportation, storage, handling or processing, other than during the manufacture of a multi-ingredient product containing both types of ingredients.
Compost- The product of a managed process through which microorganisms break down plant and animal materials into more available forms suitable for application to the soil. Compost must be produced through a process that combines plant and animal materials with an initial C:N ratio of between 25:1 and 40:1. Producer using an in-vessel or static aerated pile system must maintain the composting materials at a temperature between 131F and 170F for 3 days. Producers using a windrow system must maintain the composting materials at a temperature between 131F and 170F for 15 days, during which time, the materials must be turned a minimum of five times.
Compost tea- A water extract of compost is brewed, or organisms were extracted from the compost, the bacteria, fungi, protozoa and nematodes are given a change to increase in number and activity using the soluble food resources and nutrients present in the water.
Control- Any method that reduces of limits damage by populations of pests, weeds, or diseases to levels that do not significantly reduce productivity.
Conventional farming systems- A farming system that relays on intensive chemical programs and reliance on mechanized production, using specialized equipment and facilities.
Crop- A plant or part of a plant intended to be marketed as an agricultural product or fed to livestock.
Crop residues- The plant parts remaining in a field after the harvest of a crop, which include stalks, stems, leaves, roots, and weeds.
Crop rotation- The practice of alternating the annual crops grown on a specific field in a planned pattern or sequence in successive crop years so that crops of the same species or family are not grown repeatedly without interruption on the same field. Perennial cropping systems employ means such as alley cropping, intercropping, and hedgerows to introduce biological diversity in lieu of crop rotation.
Crop year- That normal growing season for a crop as determined by the Secretary.
Cultivation- Digging up or cutting the soil to prepare a seed bed; control weeds; aerate the soil; or work organic matter, crop residues, or fertilizers into the soil.
Cultivar- An unvarying variety of plant produced by selective hybridization or, sometimes found in wild populations, and maintained by vegetative propagation or by inbred seed.
Cultural methods- Methods used to enhance crop health and prevent weed, pest, or disease problems without the use of substances; examples include the selection of appropriate varieties and planting sites; proper timing and density of plantings; irrigation; and extending a growing season by manipulating the microclimate with green houses, cold frames, or wind breaks.
Detectable residues- The amount or presence of chemical residues or sample components that can be reliably observed or found in the sample matrix by current approved analytical methodology.
Disease vectors- Plants or animals that harbor or transmit disease organisms or pathogens which may attack crops or livestock.
Drift- The physical movement of prohibited substances from the intended target site onto an organic operation or portion thereof.
Emergency pest or disease treatment program- A mandatory program authorized by a Federal, State, or local agency for the purpose of controlling or eradicating a pest or disease.
Employee- Any person providing paid or volunteer services for a certifying agent
Excluded methods- A variety of methods used to genetically modify organisms or influence their growth and development by means that are not possible under natural conditions or processes and are not considered compatible with organic production. Such methods include cell fusion, microencapsulation and macroencapsulation, and recombinant DNA technology (including gene deletion, gene doubling, introducing a foreign gene, and changing the positions of genes when achieved by recombinant DNA technology). Such methods do not include the use of traditional breeding, conjugation, fermentation, hybridization, in vitro fertilization, or tissue culture.
Feed- Edible materials which are consumed by livestock for their nutritional value. Feed may be concentrates (grains) or roughages (hay, silage, fodder). The term, "feed," encompasses all agricultural commodities, including pasture grasses or grains ingested by livestock for nutritional purposes.
Feed additive- A substance added to feed in micro quantities to fulfill a specific nutritional need; i.e., essential nutrients in the form of amino acids, vitamins, and minerals.
Feed Supplement- A combination of feed nutrients added to livestock feed to improve the nutrient balance or performance of the total ration and intended to be:
(1) Diluted with other feeds when fed to livestock;
(2) Offered free choice with other parts of the ration if separately available; or
(3) Further diluted and mixed to produce a complete feed.
Fertilizer- A single or blended substance containing one or more recognized plant nutrient(s) which is used primarily for its plant nutrient content and which is designed for use or claimed to have value in promoting plant growth.
Field- An area of land identified as a discrete unit within a production operation.
Forage- Vegetative material in a fresh, dried, or ensiled state (pasture, hay, or silage), which is fed to livestock.
Genetically modified organism (GMO)- (a) An organism that has been modified by gene technology or (b) an organism that has inherited traits from an organism (the initial organism), being traits that occurred in the initial organism because of gene technology, or (c) anything declared by the Gene Technology Regulations to be a genetically modified organism.
Governmental entity- Any domestic government, tribal government, or foreign governmental subdivision providing certification services.
Growth regulator- Products registered as pesticides that do not control pests, but change the shape or appearance of the plant, stop or start plant growth, prevent flowering and other natural functions.
Handle- To sell, process, or package agricultural products, except such term shall not include the sale, transportation, or delivery of crops or livestock by the producer thereof to a handler.
Handler- Any person engaged in the business of handling agricultural products, including producers who handle crops or livestock of their own production, except such term shall not include final retailers of agricultural products that do not process agricultural products.
Handling operation- Any operation or portion of an operation (except final retailers of agricultural products that do not process agricultural products) that receives or otherwise acquires agricultural products and processes, packages, or stores such products.
Immediate family- The spouse, minor children, or blood relatives who reside in the immediate household of a certifying agent or an employee, inspector, contractor, or other personnel of the certifying agent. For the purpose of this part, the interest of a spouse, minor child, or blood relative who is a resident of the immediate household of a certifying agent or an employee, inspector, contractor, or other personnel of the certifying agent shall be considered to be an interest of the certifying agent or an employee, inspector, contractor, or other personnel of the certifying agent.
Inert ingredient- Any substance (or group of substances with similar chemical structures if designated by the Environmental Protection Agency) other than an active ingredient which is intentionally included in any pesticide product (40 CFR 152.3(m)).
Information panel- That part of the label of a packaged product that is immediately contiguous to and to the right of the principal display panel as observed by an individual facing the principal display panel, unless another section of the label is designated as the information panel because of package size or other package attributes (e.g., irregular shape with one usable surface).
Ingredient- Any substance used in the preparation of an agricultural product that is still present in the final commercial product as consumed.
Ingredients statement- The list of ingredients contained in a product shown in their common and usual names in the descending order of predominance.
Inspector- Any person retained or used by a certifying agent to conduct inspections of certification applicants or certified production or handling operations.
Inspection- The act of examining and evaluating the production or handling operation of an applicant for certification or certified operation to determine compliance with the Act and the regulations in this part.
Label- A display of written, printed, or graphic material on the immediate container of an agricultural product or any such material affixed to any agricultural product or affixed to a bulk container containing an agricultural product, except for package liners or a display of written, printed, or graphic material which contains only information about the weight of the product.
Labeling- All written, printed, or graphic material accompanying an agricultural product at any time or written, printed, or graphic material about the agricultural product displayed at retail stores about the product.
Livestock- Any cattle, sheep, goat, swine, poultry, or equine animals used for food or in the production of food, fiber, feed, or other agricultural-based consumer products; wild or domesticated game; or other nonplant life, except such term shall not include aquatic animals or bees for the production of food, fiber, feed, or other agricultural-based consumer products.
Lot-
Manure- Feces, urine, other excrement, and bedding produced by livestock that has not been composted.
Mating disruption, insect pests- Form of insect control in which synthetic sex pheromones, usually of the female are maintained artificially at a higher level than the background, interfering with male location; sometimes referred to as male confusion.
Market information- Any written, printed, audiovisual, or graphic information, including advertising, pamphlets, flyers, catalogues, posters, and signs, distributed, broadcast, or made available outside of retail outlets that are used to assist in the sale or promotion of a product.
Mulch- Any non-synthetic material, such as wood chips, leaves, or straw, or any synthetic material included on the National List for such use, such as newspaper or plastic that serves to suppress weed growth, moderate soil temperature, or conserve soil moisture.
Narrow range oils- Petroleum derivatives, predominately of paraffinic and napthenic fractions with 50 percent boiling point (10 mm Hg) between 415F and 440F.
National List- A list of allowed and prohibited substances as provided for in the Act.
National Organic Program (NOP)- The program authorized by the Act for the purpose of implementing its provisions.
National Organic Standards Board (NOSB)- A board established by the Secretary under 7 U.S.C. 6518 to assist in the development of standards for substances to be used in organic production and to advise the Secretary on any other aspects of the implementation of the National Organic Program.
Natural resources of the operation- The physical, hydrological, and biological features of a production operation, including soil, water, wetlands, woodlands, and wildlife.
Nonagricultural substance- A substance that is not a product of agriculture, such as a mineral or a bacterial culture, that is used as an ingredient in an agricultural product. For the purposes of this part, a nonagricultural ingredient also includes any substance, such as gums, citric acid, or pectin, that is extracted from, isolated from, or a fraction of an agricultural product so that the identity of the agricultural product is unrecognizable in the extract, isolate, or fraction.
Non-synthetic (natural)- A substance that is derived from mineral, plant, or animal matter and does not undergo a synthetic process as defined in section 6502(21) of the Act (7 U.S.C. 6502(21)). For the purposes of this part, non-synthetic is used as a synonym for natural as the term is used in the Act.
Nontoxic- Not known to cause any adverse physiological effects in animals, plants, humans, or the environment.
Non-retail container- Any container used for shipping or storage of an agricultural product that is not used in the retail display or sale of the product.
Nursery stock- All field or container-grown and native trees, sod, shrubs, herbaceous perennials, vines, cuttings, grafts, scion, buds, fruit-pits and other seeds of fruit and ornamental trees and shrubs; also other plants and plant products for, or capable of, propagation, except field, vegetable, and flower seeds, bedding plants, bulbs, and roots.
Organic- A labeling term that refers to an agricultural product produced in accordance with the Act and the regulations in this part.
Organic matter- The remains, residues, or waste products of any organism.
Organic Materials Review Institute (OMRI)- An institute that provides certifiers, growers, manufacturers and suppliers with an independent review of products intended for use in certified organic production, handling and processing.
Organic production- A production system that is managed in accordance with the Act and regulations in this part to respond to site-specific conditions by integrating cultural, biological, and mechanical practices that foster cycling of resources, promote ecological balance, and conserve biodiversity.
Organic system plan- A plan of management of an organic production or handling operation that has been agreed to by the producer or handler and the certifying agent and that includes written plans concerning all aspects of agricultural production or handling described in the Act and the regulations in subpart C of this part.
Pasture-
Peer review panel- A panel of individuals who have expertise in organic production and handling methods and certification procedures and who are appointed by the Administrator to assist in evaluating applicants for accreditation as certifying agents.
Person- An individual, partnership, corporation, association, cooperative, or other entity.
Pesticide- Any substance which alone, in chemical combination, or in any formulation with one or more substances is defined as a pesticide in section 2(u) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136(u) et seq).
Petition- A request to amend the National List that is submitted by any person in accordance with this part.
Planting stock- Any plant or plant tissue other than annual seedlings but including rhizomes, shoots, leaf or stem cuttings, roots, or tubers, used in plant production or propagation.
Practice standard- The guidelines and requirements through which a production or handling operation implements a required component of its production or handling organic system plan. A practice standard includes a series of allowed and prohibited actions, materials, and conditions to establish a minimum level performance for planning, conducting, and maintaining a function, such as livestock health care or facility pest management, essential to an organic operation.
Principal display panel- That part of a label that is most likely to be displayed, presented, shown, or examined under customary conditions of display for sale.
Private entity- Any domestic or foreign nongovernmental for-profit or not-for-profit organization providing certification services.
Processing- Cooking, baking, curing, heating, drying, mixing, grinding, churning, separating, extracting, slaughtering, cutting, fermenting, distilling, eviscerating, preserving, dehydrating, freezing, chilling, or otherwise manufacturing and includes the packaging, canning, jarring, or otherwise enclosing food in a container.
Processing aid- (a) substance that is added to a food during the processing of such food but is removed in some manner from the food before it is packaged in its finished form; (b) a substance that is added to a food during processing, is converted into constituents normally present in the food, and does not significantly increase the amount of the constituents naturally found in the food; and (c) a substance that is added to a food for its technical or functional effect in the processing but is present in the finished food at insignificant levels and does not have any technical or functional effect in that food.
Producer- A person who engages in the business of growing or producing food, fiber, feed, and other agricultural-based consumer products.
Production lot number/identifier- Identification of a product based on the production sequence of the product showing the date, time, and place of production used for quality control purposes.
Prohibited substance- A substance the use of which in any aspect of organic production or handling is prohibited or not provided for in the Act or the regulations of this part.
Records- Any information in written, visual, or electronic form that documents the activities undertaken by a producer, handler, or certifying agent to comply with the Act and regulations in this part.
Residue testing- An official or validated analytical procedure that detects, identifies, and measures the presence of chemical substances, their metabolites, or degradations products in or on raw or processed agricultural products.
Responsibly connected- Any person who is a partner, officer, director, holder, manager, or owner of 10 percent or more of the voting stock of an applicant or a recipient of certification or accreditation.
Retail food establishment- A restaurant; delicatessen; bakery; grocery store; or any retail outlet with an in-store restaurant, delicatessen, bakery, salad bar, or other eat-in or carry-out service of processed or prepared raw and ready-to-eat-food.
Routine use of parasiticide- The regular, planned, or periodic use of parasiticides.
Secretary- The Secretary of Agriculture or a representative to whom authority has been delegated to act in the Secretary's stead.
Sewage sludge- A solid, semisolid, or liquid residue generated during the treatment of domestic sewage in a treatment works. Sewage sludge includes but is not limited to: domestic septage; scum or solids removed in primary, secondary, or advanced wastewater treatment processes; and a material derived from sewage sludge. Sewage sludge does not include ash generated during the firing of sewage sludge in a sewage sludge incinerator or grit and screenings generated during preliminary treatment of domestic sewage in a treatment works.
Slaughter stock- Any animal that is intended to be slaughtered for consumption by humans or other animals.
Split
Soil and water quality- Observable indicators of the physical, chemical, or biological condition of soil and water, including the presence of environmental contaminants.
State- Any of the several States of the United States of America, its territories, the District of Columbia, and the Commonwealth of Puerto Rico.
State certifying agent- A certifying agent accredited by the Secretary under the National Organic Program and operated by the State for the purposes of certifying organic production and handling operations in the State.
State organic program (SOP)- A State program that meets the requirements of section 6506 of the Act, is approved by the Secretary, and is designed to ensure that a product that is sold or labeled as organically produced under the Act is produced and handled using organic methods.
State organic program's governing State official- The chief executive official of a State or, in the case of a State that provides for the statewide election of an official to be responsible solely for the administration of the agricultural operations of the State, such official who administers a State organic certification program.
Synthetic- A substance that is formulated or manufactured by a chemical process or by a process that chemically changes a substance extracted from naturally occurring plant, animal, or mineral sources, except that such term shall not apply to substances created by naturally occurring biological processes.
Tolerance- The maximum legal level of a pesticide chemical residue in or on a raw or processed agricultural commodity or processed food.
Transplant- A seedling which has been removed from its original place of production, transported, and replanted.
Unavoidable residual environmental contamination (UREC)- Background levels of naturally occurring or synthetic chemicals that are present in the soil or present in organically produced agricultural products that are below established tolerances.
Wild crop- Any plant or portion of a plant that is collected or harvested from a site that is not maintained under cultivation or other agricultural management.
B. National Organic
Program Certification
These requirements for organic certification come directly from the National Organic Program (NOP) as of April 2006. For up to date requirements visit the NOP online at: http://www.ams.usda.gov/nop/NOP/
§ 205.400 General requirements for certification
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 systems plan that is submitted to an accredited certifying agent as provided in §205.200
C. Permit on-site inspections with complete access to the production or handling operation, including non-certified 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 review and copying to determine compliance with the Act and the regulations in this past, as provided for in §205.104;
E. Submit the applicable fees charged by the certifying agent; and
F. Immediately notify the certifying agent concerning any;
1. Application, including drift, of a prohibited substance to any field, production unit, site, facility, livestock, or product that is part of any operation; and
2. Change in a certified operation or any portion of a certified operation that may affect its compliance with the Act and the regulations in this part.
§ 205.401 Application for Certification
A person seeking certification of a production or handling operation under this subpart must submit an application for certification to a certifying agent. The application must include the following information:
A. An organic production or handling system plan, as required in §205.200;
B. The name of the person completing the application; the applicant’s business name, address and telephone number; and, when the applicant is a corporation, the name, address, and telephone number of the person authorized to act on the applicant’s behalf;
C. The name(s) of any organic certifying agent(s) to which application has previously been made; the year(s) of application; the outcome of the application(s) submission, including, when available, a copy of any notification of non-compliance or denial of certification issued to the applicant for certification; and a description of the actions taken by the applicant to correct the non-compliances noted in the notification of non-compliance, including evidence of such correction; and
D. Other information necessary to determine compliance with the Act and the regulations in this part.
§ 205.402 Review of Application
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 non-compliance or denial certification, pursuant to §205.405, has submitted documentation to support the correction of any non-compliances identified in the notification of non-compliance 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 requirement of subpart C of this part.
B. There 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, s 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 non-compliance will not be issued a notice of non-compliance. Similarly, an applicant that voluntarily withdrew its application prior to the issuance of a notice of certification denial will not be issued a notice of certification denial.
§ 205.403 On-site inspection
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 operation should continue.
i. A certifying agent may conduct additional on-site inspection of applicants for certification and certified operations to determine compliance with the Act and the regulations in this part.
ii. The Administrator of 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 inspection may be announced or unannounced at the discretion of the certifying agent or as required by the Administrator or State organic program’s governing State official.
B. Scheduling
1. The initial on-site inspection must be conduced within a reasonable time following a determination that the applicant appears to comply or may be able to comply with the requirements of subpart C of this part: Except, that, the initial inspection may be delayed for up to 6 months to comply with the requirements that the inspection be conducted when the land, facilities, and activities that demonstrate compliance or capacity to comply can be observed.
C. Verification of information. The on-site inspection of an operation must verify:
1. The operation’s compliance or capacity to comply with the Act and the regulations in this part;
2. That the information, including the organic production or handling system plan, provided in accordance with §205.401, 205.406, and 205,200, accurately reflects the practice used or to be used by the applicant for certification or by the certified operation;
3. That prohibited substances have not been and are not being applied to the operation through means which, at the discretion of the certifying agent, may include the collection and testing of soil; water; waste; seeds; plant tissue; and plant, animal and processed products samples.
D. Exit interview. The inspector must conduct an exit interview with an authorized representative of the operation who is knowledgeable about the inspected operation to confirm the accuracy and completeness of inspection observations and information gathered during the on-site inspection. The inspector must also address the need for any additional information as well as any issues of concern.
E. Documents to the inspected operation
1. At the time of the inspection, the inspector shall provide the operation’s authorized representative with a receipt for any samples taken by the inspector. There shall be no charge to the inspector for samples taken.
2. A copy of the on-site inspection report and any test results will be sent to the inspected operation by the certifying agent.
§ 205.404 Granting certification
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 operations are in compliance with the plan, the agent shall
grant certification. The certification
may include requirements for the correction of minor non-compliances within a
specified time period as a condition of continued certification.
B.
The certifying agent must issue a certificate of
organic operation which specifies the:
1.
Name and address of the certified operation;
2.
Effective date of certification;
3.
Categories of organic operation, including crops,
wild crops, livestock, or processed products produced by the certified
operation; and
4.
Name, address, and telephone number of the
certifying agent.
C.
Once certified, a production or handling operation’s
organic certification continues in effect until it surrendered by the organic
operation or suspended or revoked by the certifying agent, the State organic
program’s governing State official, or the Administrator.
§ 205.405 Denial of certification
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 non-compliance to the
applicant. When correction of
non-compliance is not possible, a notification of non-compliance and a
notification of denial of certification may be combined in one notification. The notification of non-compliance shall
provide:
1.
A description of each non-compliance;
2.
The facts upon which the notification of
non-compliance, is based, and
3.
The date by which the applicant must rebut or
correct each non-compliance and submit supporting documentation of each such correction
when correction is possible.
B.
Correct the non-compliances and submit a description
of the corrective actions taken with supporting documentation to the certifying
agent;
1.
Correct non-compliances and submit a description of
the corrective actions taken with supporting documentation to the certifying
agent;
2.
Correct non-compliances and submit a new application
to another certifying agent: Provided, that, the applicant must include a
complete application, the notification of non-compliance 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 non-compliance described in the notification of
non-compliance.
C.
After issuance of a notification of non-compliance,
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 non
sufficient for the applicant to qualify for certification, issue the applicant
a written notice of denial of certification.
2.
Issue
a written notice of denial of certification to an applicant who fails to
respond to the notification of non-compliance.
3.
Provide
notice of approval or denial to the Administrator, pursuant to §205.501
(a)(14).
D.
A notice of denial of certification must
state the reason(s) for denial and the applicant’s right to:
1.
Reapply for certification pursuant to §205.401
and §205.405(e).
2.
Request
mediation pursuant §205.663 or, if applicable, pursuant to a
State organic program, or
3.
File
an appeal of the denial of certification pursuant to §205.681
or, if applicable, pursuant to a State organic program
E.
An
applicant for certification who has received a written notification of
non-compliance or a written notice of denial of certification may apply for
certification again at any time with any certifying agent, in accordance with §205.401
and §205.405(e). When
such applicant submits a new application to a certifying agent other than the
agent who issued the notification of non-compliance or notice of denial of
certification, the applicant for certification must include a copy of the
notification of non-compliance or notice of denial of certification and a
description of the actions taken, with supporting documentation, to correct the
non-compliance noted in the notification of non-compliance.
F.
A
certifying agent who receives a new application for certification, which
includes a notification of non-compliance or notice of denial of certification,
must treat the application as a new application and begin a new application
process pursuant to §205.402.
G.
Notwithstanding paragraph (a) of this
section, if a certifying agent has reason to believe that an applicant for
certification has willfully made a false statement or otherwise purposefully
misrepresented the applicant’s operation or it compliance with the
certification requirement pursuant to this part, the certifying agent may deny
certification pursuant to paragraph (c)(1)(ii) of this section without first issuing a
notification of non-compliance.
§ 205.406 Continuation of certification
A.
To
continue certification, a certified operation must annually pay the
certification fees and submit the following information, as applicable, to the
certifying agent:
1.
An updated organic production or handling
system plan which includes:
i.
A
summary statement, support by documentation, detailing and deviations from,
changes to, modifications to, or other amendments made to the previous year’s
organic system plan during the previous year, and
ii.
Any
additions or deletions to the previous year’s organic system plan, intended to
be undertaken in the coming year, detailed pursuant to §205.200;Any
deviations to or deletions from the information required to pursuant to §205.401(b);
2.
An
update on the corrections of minor non-compliances previously identified by the
certifying agent as requiring correction for continued certification; and
3.
Other
information as deemed necessary by the certifying agent to determine compliance
with the Act and the regulations in this part.
B.
Following
the receipt of the information specified in paragraph (a) of this section, the
certifying agent shall within a reasonable time arrange and conduct an on-site
inspection of the certified operation
pursuant to §205.403: Except, that, when it is impossible for
the certifying agent to conduct the annual on-site inspection following receipt
of the certified operation’s annual update certificate of organic operation on
the basis of the information submitted and the most recent on-site inspection,
required pursuant to §205.403, is conducted within the first 6
months following the certified operation’s scheduled date of annual update.
C.
If
the certifying agent has reason to believe, based on the on-site inspection and
a review of the information specified in §205.404, that a
certified operation is not complying with the requirements of the Act and the
regulations in this part, the certifying agent shall provide a written
notification of non-compliance 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).
C.
Production and Handling Requirements
These requirements for organic production and handling come directly from the National Organic Program (NOP) as of April 2006. For up to date requirements visit the NOP online at: http://www.ams.usda.gov/nop/NOP/standards/ProdHandReg.html
§ 205.200 General.
The producer or handler of a production or handling operation intending to sell, label, or represent agricultural products as "100 percent organic," "organic," or "made with organic (specified ingredients or food group(s))" must comply with the applicable provisions of this subpart. Production practices implemented in accordance with this subpart must maintain or improve the natural resources of the operation, including soil and water quality.
§ 205.201 Organic
Production and Handling System Plan.
A. The producer or handler of a production or handling operation, except as exempt or excluded under § 205.101, intending to sell, label, or represent agricultural products as "100 percent organic," "organic," or "made with organic (specified ingredients or food group(s))" must develop an organic production or handling system plan that is agreed to by the producer or handler and an accredited certifying agent. An organic system plan must meet the requirements set forth in this section for organic production or handling. An organic production or handling system plan must include:
1. A description of practices and procedures to be performed and maintained, including the frequency with which they will be performed;
2. A list of each substance to be used as a production or handling input, indicating its composition, source, location(s) where it will be used, and documentation of commercial availability, as applicable;
3. A description of the monitoring practices and procedures to be performed and maintained, including the frequency with which they will be performed, to verify that the plan is effectively implemented;
4. A description of the recordkeeping system implemented to comply with the requirements established in § 205.103;
5. A description of the management practices and physical barriers established to prevent commingling of organic and nonorganic products on a split operation and to prevent contact of organic production and handling operations and products with prohibited substances; and
6. Additional information deemed necessary by the certifying agent to evaluate compliance with the regulations.
B. A producer may substitute a plan prepared to meet the requirements of another Federal, State, or local government regulatory program for the organic system plan: Provided, That, the submitted plan meets all the requirements of this subpart.
§ 205.202 Land
Requirements.
Any field or farm parcel from which harvested crops are intended to be sold, labeled, or represented as "organic," must:
A. Have been managed in accordance with the provisions of §205.203 through §205.206;
B. Have had no prohibited substances, as listed in §205.105, applied to it for a period of 3 years immediately preceding harvest of the crop; and
C. Have distinct, defined boundaries and buffer zones such as runoff diversions to prevent the unintended application of a prohibited substance to the crop or contact with a prohibited substance applied to adjoining land that is not under organic management.
§ 205.203 Soil
Fertility and Crop Nutrient Management Practice Standard.
A. The producer must select and implement tillage and cultivation practices that maintain or improve the physical, chemical, and biological condition of soil and minimize soil erosion.
B. The producer must manage crop nutrients and soil fertility through rotations, cover crops, and the application of plant and animal materials.
C. The producer must manage plant and animal materials to maintain or improve soil organic matter content in a manner that does not contribute to contamination of crops, soil, or water by plant nutrients, pathogenic organisms, heavy metals, or residues of prohibited substances. Animal and plant materials include:
1. Raw animal manure, which must be composted unless it is:
i. Applied to land used for a crop not intended for human consumption;
ii. Incorporated into the soil not less than 120 days prior to the harvest of a product whose edible portion has direct contact with the soil surface or soil particles; or
iii. Incorporated into the soil not less than 90 days prior to the harvest of a product whose edible portion does not have direct contact with the soil surface or soil particles;
2. Composted plant and animal materials produced though a process that
i. established an initial C:N ratio of between 25:1 and 40:1; and
ii. maintained a temperature of between 131 F and 170 F for 3 days using an in-vessel or static aerated pile system; or
iii. maintained a temperature of between 131F and 170F for 15 days using a windrow composting system, during which period, the materials must be turned a minimum of five times.
3. Uncomposted plant materials.
D. A producer may manage crop nutrients and soil fertility to maintain or improve soil organic matter content in a manner that does not contribute to contamination of crops, soil, or water by plant nutrients, pathogenic organisms, heavy metals, or residues of prohibited substances by applying:
1. A crop nutrient or soil amendment included on the National List of synthetic substances allowed for use in organic crop production;
2. A mined substance of low solubility;
3. A mined substance of high solubility, Provided, That, the substance is used in compliance with the conditions established on the National List of non-synthetic materials prohibited for crop production;
4. Ash obtained from the burning of a plant or animal material, except as prohibited in paragraph (e) of this section: Provided, That, the material burned has not been treated or combined with a prohibited substance or the ash is not included on the National List of nonsynthetic substances prohibited for use in organic crop production; and
5. A plant or animal material that has been chemically altered by a manufacturing process: Provided, that, the material is included on the National List of synthetic substances allowed for use in organic crop production established in § 205.601.
E. The producer must not use:
1. Any fertilizer or composted plant and animal material that contains a synthetic substance not included on the National List of synthetic substances allowed for use in organic crop production;
2. Sewage sludge (biosolids) as defined in 40 CFR Part 503; and
3. Burning as a means of disposal for crop residues produced on the operation: Except, that, burning may be used to suppress the spread of disease or to stimulate seed germination.
§ 205.204 Seed and
Planting Stock Practice Standard.
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.
§ 205.205 Crop
Rotation Practice Standard.
The producer must implement a crop rotation including but not limited to sod, cover crops, green manure crops, and catch crops that provide the following functions that are applicable to the operation:
A. Maintain or improve soil organic matter content;
B. Provide for pest management in annual and perennial crops;
C. Manage deficient or excess plant nutrients; and
D. Provide erosion control.
§ 205.206 Crop
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.
4.
B.
1. Augmentation or introduction of predators or parasites of the pest species;
2. Development of habitat for natural enemies of pests;
3. Non-synthetic 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 non-synthetic biological, botanical, or mineral inputs.
E. When the practices provided for in paragraphs (a) through (d) of this section are insufficient to prevent or control crop pests, weeds, and diseases, a biological or botanical substance or a substance included on the National List of synthetic substances allowed for use in organic crop production may be applied to prevent, suppress, or control pests, weeds, or diseases: Provided, That, the conditions for using the substance are documented in the organic system plan.
F. The producer must not use lumber treated with arsenate or other prohibited materials for new installations or replacement purposes in contact with soil or livestock.
§ 205.207 Wild-crop
Harvesting Practice Standard.
A. A wild crop that is intended to be sold, labeled, or represented as organic must be harvested from a designated area that has had no prohibited substance, as set forth in § 205.105, applied to it for a period of 3 years immediately preceding the harvest of the wild crop.
B. A wild crop must be harvested in a manner that ensures that such harvesting or gathering will not be destructive to the environment and will sustain the growth and production of the wild crop.
§ 205.236 Origin of
Livestock.
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. (1) Poultry. Poultry or edible poultry products must be from poultry that has been under continuous organic management beginning no later than the second day of life;
2. Dairy animals. Milk or milk products must be from animals that have been under continuous organic management beginning no later than 1 year prior to the production of the milk or milk products that are to be sold, labeled, or represented as organic, Except, That, when an entire, distinct herd is converted to organic production, the producer may:
i. For the first 9 months of the year, provide a minimum of 80-percent feed that is either organic or raised from land included in the organic system plan and managed in compliance with organic crop requirements; and
ii. provide feed in compliance with § 205.237 for the final 3 months.
iii. Once an entire, distinct herd has been converted to organic production, all dairy animals shall be under organic management from the last third of gestation.
3. Breeder stock. Livestock used as breeder stock may be brought from a non-organic operation onto an organic operation at any time: Provided, That, if such livestock are gestating and the offspring are to be raised as organic livestock, the breeder stock must be brought onto the facility no later than the last third of gestation.
B. The following are prohibited:
1. Livestock or edible livestock products that are removed from an organic operation and subsequently managed on a non-organic operation may be not sold, labeled, or represented as organically produced.
2. Breeder or dairy stock that has not been under continuous organic management since the last third of gestation may not be sold, labeled, or represented as organic slaughter stock.
3. The producer of an organic livestock operation must maintain records sufficient to preserve the identity of all organically managed animals and edible and non-edible animal products produced on the operation.
§ 205.237 Livestock
Feed.
A. The producer of an organic livestock operation must provide livestock with a total feed ration composed of agricultural products, including pasture and forage, that are organically produced and, if applicable, organically handled: Except, That, non-synthetic substances and synthetic substances allowed under § 205.603 may be used as feed additives and supplements.
B. The producer of an organic operation must not:
1. Use animal drugs, including hormones, to promote growth;
2. Provide feed supplements or additives in amounts above those needed for adequate nutrition and health maintenance for the species at its specific stage of life;
3. Feed plastic pellets for roughage;
4. Feed formulas containing urea or manure;
5. Feed mammalian or poultry slaughter by-products to mammals or poultry; or
6. Use feed, feed additives, and feed supplements in violation of the Federal Food, Drug, and Cosmetic Act.
§ 205.238 Livestock
Health Care Practice Standard.
A. The producer must establish and maintain preventive livestock health care practices, including:
1. Selection of species and types of livestock with regard to suitability for site-specific conditions and resistance to prevalent diseases and parasites;
2. Provision of a feed ration sufficient to meet nutritional requirements, including vitamins, minerals, protein and/or amino acids, fatty acids, energy sources, and fiber (ruminants);
3. Establishment of appropriate housing, pasture conditions, and sanitation practices to minimize the occurrence and spread of diseases and parasites;
4. Provision of conditions which allow for exercise, freedom of movement, and reduction of stress appropriate to the species;
5. Performance of physical alterations as needed to promote the animal's welfare and in a manner that minimizes pain and stress; and
6. Administration of vaccines and other veterinary biologics.
B. When preventive practices and veterinary biologics are inadequate to prevent sickness, a producer may administer synthetic medications: Provided, that, such medications are allowed under § 205.603. Parasiticides allowed under § 205.603 may be used on
1. Breeder stock, when used prior to the last third of gestation but not during lactation for progeny that are to be sold, labeled, or represented as organically produced; and
2. Dairy stock, when used a minimum of 90 days prior to the production of milk or milk products that are to be sold, labeled, or represented as organic.
C. The producer of an organic livestock operation must not:
1. Sell, label, or represent as organic any animal or edible product derived from any animal treated with antibiotics, any substance that contains a synthetic substance not allowed under § 205.603, or any substance that contains a non-synthetic substance prohibited in § 205.604.
2. Administer any animal drug, other than vaccinations, in the absence of illness
3. Administer hormones for growth promotion;
4. Administer synthetic parasiticides on a routine basis;
5. Administer synthetic parasiticides to slaughter stock;
6. Administer animal drugs in violation of the Federal Food, Drug, and Cosmetic Act; or
7. Withhold medical treatment from a sick animal in an effort to preserve its organic status. All appropriate medications must be used to restore an animal to health when methods acceptable to organic production fail. Livestock treated with a prohibited substance must be clearly identified and shall not be sold, labeled, or represented as organically produced.
§ 205.239 Livestock
Living Conditions.
A. The producer of an organic livestock operation must establish and maintain livestock living conditions which accommodate the health and natural behavior of animals, including:
1. Access to the outdoors, shade, shelter, exercise areas, fresh air, and direct sunlight suitable to the species, its stage of production, the climate, and the environment;
2. Access to pasture for ruminants;
3. Appropriate clean, dry bedding. If the bedding is typically consumed by the animal species, it must comply with the feed requirements of § 205.237;
4. Shelter designed to allow for:
i. Natural maintenance, comfort behaviors, and opportunity to exercise;
ii. Temperature level, ventilation, and air circulation suitable to the species; and
iii. Reduction of potential for livestock injury;
B. The producer of an organic livestock operation may provide temporary confinement for an animal because of:
1. Inclement weather;
2. The animal's stage of production;
3. Conditions under which the health, safety, or well being of the animal could be jeopardized; or
4. Risk to soil or water quality.
C. The producer of an organic livestock operation must manage manure in a manner that does not contribute to contamination of crops, soil, or water by plant nutrients, heavy metals, or pathogenic organisms and optimizes recycling of nutrients.
§ 205.270 Organic
Handling Requirements.
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 non-organically produced agricultural products allowed under § 205.606 may be used:
1. In or on a processed agricultural product intended to be sold, labeled, or represented as "organic," pursuant to § 205.301(b), if not commercially available in organic form.
2. In or on a processed agricultural product intended to be sold, labeled, or represented as "made with organic (specified ingredients or food group(s))," pursuant to § 205.301(c).
C. The handler of an organic handling operation must not use in or on agricultural products intended to be sold, labeled, or represented as "100 percent organic," "organic," or "made with organic (specified ingredients or food group(s))," or in or on any ingredients labeled as organic:
1. Practices prohibited under paragraphs (e) and (f) of § 205.105.
2. A volatile synthetic solvent or other synthetic processing aid not allowed under § 205.605, Except, That, nonorganic ingredients in products labeled "made with organic (specified ingredients or food group(s))" are not subject to this requirement.
§ 205.271 Facility
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 non-synthetic 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 non-synthetic or synthetic substance consistent with the National List may be applied.
D. If the practices provided for in paragraphs (a), (b), and © 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 non-synthetic or synthetic substance to prevent or control pests must update the operation's organic handling plan to reflect the use of such substances and methods of application. The updated organic plan must include a list of all measures taken to prevent contact of the organically produced products or ingredients with the substance used.
F. Notwithstanding the practices provided for in paragraphs (a), (b), (c), and (d) of this section, a handler may otherwise use substances to prevent or control pests as required by Federal, State, or local laws and regulations, Provided, that, measures are taken to prevent contact of the organically produced products or ingredients with the substance used.
§ 205.272 Commingling
and Contact with Prohibited Substance Prevention Practice Standard.
A. The handler of an organic handling operation must implement measures necessary to prevent the commingling of organic and non-organic products and protect organic products from contact with prohibited substances.
B. The following are prohibited for use in the handling of any organically produced agricultural product or ingredient labeled in accordance with subpart D of this part:
1. Packaging materials, and storage containers, or bins that contain a synthetic fungicide, preservative, or fumigant;
2. The use or reuse of any bag or container that has been in contact with any substance in such a manner as to compromise the organic integrity of any organically produced product or ingredient placed in those containers, unless such reusable bag or container has been thoroughly cleaned and poses no risk of contact of the organically produced product or ingredient with the substance used.
§ 205.290 Temporary
Variances.
A. Temporary variances from the requirements in §§ 205.203 through 205.207, 205.236 through 205.239, and 205.270 through 205.272 may be established by the Administrator for the following reasons:
1. Natural disasters declared by the Secretary;
2. Damage caused by drought, wind, flood, excessive moisture, hail, tornado, earthquake, fire, or other business interruption; and
3. Practices used for the purpose of conducting research or trials of techniques, varieties, or ingredients used in organic production or handling.
B. A State organic program's governing State official or certifying agent may recommend in writing to the Administrator that a temporary variance from a standard set forth in subpart C of this part for organic production or handling operations be established: Provided, that, such variance is based on one or more of the reasons listed in paragraph (a) of this section.
C. The Administrator will provide written notification to certifying agents upon establishment of a temporary variance applicable to the certifying agent's certified production or handling operations and specify the period of time it shall remain in effect, subject to extension as the Administrator deems necessary.
D. A certifying agent, upon notification from the Administrator of the establishment of a temporary variance, must notify each production or handling operation it certifies to which the temporary variance applies.
Temporary variances will not be granted for any practice, material, or procedure prohibited under § 205.105.
D. National List of Allowed and Prohibited Substances
This list of allowable substances comes directly from the National Organic Program (NOP) as of April 2006. For online access visit of most up to date lists visit: http://www.ams.usda.gov/nop/NOP/standards/ ListReg.html
§ 205.600 Evaluation criteria for allowed and
prohibited substances, methods, and ingredients.
The following criteria will be used in the evaluation of substances or ingredients for the organic production and handling section of the National List:
A. Synthetic and non-synthetic 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 USC 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 effect 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 contaminates in excess of tolerances set by FDA; and
6. The substance is essential for the handling of organically produced agricultural products.
Non-synthetic
used in organic processing will be evaluated using the criteria specified in
the Act (7
§ 205.601 Synthetic
substances allowed for use in organic crop production.
In accordance with restrictions specified in this section, the following synthetic substances may be used in organic crop production: Provided that, use of such substances do not contribute to contamination of crops, soil, or water. Substances allowed by this section, except disinfectants and sanitizers in paragraph (a) and those substances in paragraphs (c), (j), (k), and (l) of this section, may only be used when the provisions set forth in §205.206 (a) through (d) prove insufficient to prevent or control the target pest.
As Algicide, Disinfectant, and Sanitizer- including irrigation system cleaning systems.
a.
Alcohols
i.
Ethanol
ii.
Isopropanol
b. Chlorine materials- Except, that, residual chlorine levels in the water shall not exceed the maximum residual disinfectant limit under the Safe Drinking Water Act.
i.
Calcium
hypochlorite
ii.
Chlorine
dioxide
iii.
Sodium
hypochlorite
c. 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.
d. Hydrogen peroxide
e. Ozone gas- for use as an irrigation system cleaner only.
f. Peracetic acid- for the use in disinfecting equipment, seed, and asexually propagated planting material.
B. As Herbicides, Weed Barriers, as applicable.
a. Herbicides, soap-based – for use in farmstead maintenance (roadways, ditches, right of ways, building perimeters) and ornamental crops.
b.
Mulches
i.
Newspaper
or other recycled paper without glossy or colored inks
ii.
Plastic
mulch and covers (petroleum-based other than polyvinyl chloride (PVC).
C. As Compost Feed Stocks
a. Newspapers or other recycled paper, without glossy or colored inks
D. As Animal Repellents
a. Soaps, ammonium- for use as a large animal repellant only, no contact with soil or edible portion of crop
E. As Insecticides (including acaricides or mite control).
a. Ammonium carbonate- for use as bait in insect traps only, no direct contact with crop or soil.
b. Boric Acid- structural pest control, no direct contact with organic food or crops
c. Copper sulfate- for use as tadpole shrimp control in aquatic rice production, is limited to one application per field during any 24-month period. Application rates are limited to levels with do not increase baseline soil test values for copper over a timeframe agreed upon by the producer and accredited certifying agent.
d. Elemental sulfur
e. Lime sulfur- including calcium polysulfide
f. Oils, horticultural- narrow range oils as dormant, suffocating and summer oils.
g. Soaps, insecticidal
h. Sticky traps/ barriers
F. As Insect Management
a.
Phermones
G. As Rodenticides
a. Sulfur dioxide- underground rodent control only (smoke bombs)
b. Vitamine D3
H. As Slug or snail bait- None
I. As Plant Disease Controls
a. Coppers, fixed- copper hydroxide, copper oxide, copper oxychloride, includes products exempted from EPA tolerance, Provided that, copper-based materials must be used in a manner that minimizes accumulation in the soil and shall not be used as herbicides.
b. Copper sulfate- Substances must be used in a manner that minimizes accumulation of copper in the soil.
c.
Hydrated lime
d.
Hydrogen peroixide
e.
Lime sulfur
f. Oils, horticultural, narrow range oils as dormant, suffocating and summer oils
g. Peracetic acid- for use to control fire blight bacteria
h.
Potassium bicarbonate kjhar
i.
Elemental sulfur
j. Streptomycin, for fire blight control in apples and pears only.
k. Tetracycline (oxytetracycline calcium complex), for fire blight control only.
J. As Plant or Soil Amendments
a. Aquatic plant extracts (other than hydrolyzed) – Extraction process is limited to the use of potassium hydroxide or sodium hydroxide; solvent amount used is limited to that amount necessary for extraction.
b.
Elemental sulfur
c. Humic acids- naturally occurring deposits, water and alkalie extracts only.
d. Lignin sulfonate- chelateing agent, dust suppressant, floatation agent.
e. Magnesium sulfate- allowed with a documented soil deficiency
f. Micronutrients- not to be used as defoliant, herbicide or desiccant. Those made from nitrates or chlorides are not allowed. Soil deficiency must be documented by testing.
i.
Soluble
boron products
ii.
Sulfates,
carbonates, oxides or silicates of zinc, copper, iron, manganese, molybdenum,
selenium and cobalt.
g. Liquid fish products- can be pH adjusted with sulfuric, citric or phosphoric acid. The amount of acid used shall not exceed the minimum need to lower the pH to 3.5
h.
Vitamins, B1, C and E
K. As Plant Growth Regulators
a. Ethylene gas- for regulation of pineapple flowering
L. As Floating Agents in Post Harvest Handling
a.
Lignin sulfonate
b. Sodium silicate- for tree fruit and fiber processing
M.
As Synthetic Inert Ingredients as
classified by the Environmental Protection
Agency (EPA), for use with non-synthetic substances or synthetic substances
listed in this section and used as an active pesticide ingredient in accordance
with any limitations on the use of such substances
a. EPA list 4- Inert of minimal concerns
b. EPA list 3- Inerts of unknown toxicity- for use only in passive pheromone dispensers
§ 205.602 Non-synthetic
substances prohibited for use in organic crop production.
The following non-synthetic substances may not be used in organic crop production:
A.
Ash from
manure burning
B.
Aresenic
C. Calcium chloride, brine process is natural and prohibited for use except as a foliar spray to treat a physiological disorder associated with calcium uptake
D.
Lead
salts
E. Potassium chloride- unless derived from a mined source and applied in a manner that minimizes chloride accumulation in the soil
F. Sodium fluoaluminate (mined)
G. Sodium nitrate- unless use is restricted to no more than 20% of the crops total nitrogen requirement; use in spirulina production was unrestricted until October 21, 2005.
H. Tobacco dust (nicotine sulfate)
§ 205.603 Synthetic
substances allowed for use in organic livestock production.
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
a.
Alcohols
i.
Ethanol-disinfectant
and sanitizer only, prohibited as a feed additive
ii.
Isopropanol-disinfectant
only
b. Aspirin-approved for health care use to reduce inflammation
c. Biologics-Vaccines
d. Chlorhexidine- Allowed for surgical procedures conducted by a veterinarian. Allowed for use as a test dip when alternative germicidal agents and/or physical barriers have lost their effectiveness.
e. Chlorine materials- disinfecting and sanitizing facilities and equipment. Residual chlorine levels in the water shall not exceed the maximum residual disinfectant limit under the Safe Drinking Water Act
i.
Calcium
hypochlorite
ii.
Chlorine
dioxide
iii.
Sodium
hypoclorite
f. Electrolytes- without antibiotics
g.
Glucose
h. Glycerine- allowed as a livestock teat dip, must be produced through the hydrolysis of fats or oils
i.
Hydrogen peroxide
j.
Iodine
k.
Magnesium sulfate
l. Oxytocin- use in post-parturition therapeutic applications
m. Paraciticides. Ivermectin- prohibited in slaughter stock, allowed in emergency treatment for dairy and breeder stock when organic system plan-approved preventive management does not prevent infestation. Milk or milk products for a treated animal cannot be labeled as provided for in subpart D of this part for 90 days following the treatment. In breeder stock, treatment cannot be occur during the last third of gestation if the progeny will be sold as organic and must not be used during the lactation period for breeding stock.
n. Phosphoric acid- allowed as equipment cleaner. Provided that, no direct contact with organically managed livestock or land occurs.
B. As Topical Treatment, External Parasiticide or Local Anesthetic as applicable.
a.
Copper sulfate
b.
Iodine
c. Lidocaine- as a local anesthetic. Use requires a withdrawal period of 90 days after administering to livestock intended for slaughter and 7 days after administering to dairy animals.
d. Lime, hydrated- as an external pest control, not permitted to cauterized physical alterations or deodorized animal waste
e. Mineral oil- for topical use and as a lubricant
f. Procaine- as a local anesthetic, use requires a withdrawal period of 90 days after administering to livestock intended for slaughter and 7 days after administering to dairy animals.
C. As Feed Supplements
a. Milk replacers without antibiotic, as emergency use only, no non-milk products or products from BST treated animals
D. As Feed Additives
a. DL- Methionine, DL- Methionine - hydroxyl analog, and DL-Methionine – hydroxyl analog calcium- for use only in organic poultry production until October 21, 2005.
b. Trace minerals, used for enrichment or fortification when FDA approved
c. Vitamins, used for enrichment or fortification when FDA approved
E. As Synthetic Inert Ingredients as classified by the Environmental Protection Agency (EPA), for use with non-synthetic substances or a synthetic substances listed in this section and use as an active pesticide ingredient in accordance with any limitations on the use of such substances.
a. EPA list 4- Inerts of minimal concern
§ 205.604 Non-synthetic substances prohibited for use
in organic livestock production.
The following non-synthetic substances may not be used in organic livestock production:
A.
Strychnine
§ 205.605 Nonagricultural (non-organic) substances
allowed as ingredients in or on processed products labeled as “organic” or
“made with organic (specified ingredients or food groups)”.
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 groups(s))” only in accordance with any restrictions specified in this section.
A.
Non-synthetics
allowed
a. Acids (Alginic; Citric- produced by microbial fermentation of carbohydrate substances; and Lactic)
b.
Agar-agar
c. Animal enzymes- (Rennet- animal derived; Catalase-bovine liver; Animal lipase; Pancreatin; Pepsin; and Trypsin)
d.
Bentonite
e.
Calcium
carbonate
f.
Calcium chloride
g. Calcium sulfate- mined
h.
Carageenan
i. Colors, non-synthetic sources only
j.
Dairy cultures
k. Diatomaceous earth- food filtering aid only
l. Enzymes- must be derived from edible, nontoxic plants, nonpathogenic fungi or nonpathogenic bacteria)
m. Flavors, non-synthetic sources only and must not be produced using synthetic solvents and carrier systems or any artificial preservative.
n. Glucono delta-lactone- production by the oxidation of D-glucose with bromine water is prohibited
o.
Kaolin
p. Magnesium sulfate, non-synthetic sources only
q. Nitrogen- oil free grades
r. Oxygen- oil free grades
s. Perlite- for use only as a filter aid in food processing
t.
Potassium chloride
u.
Potsassium
iodine
v.
Sodium
bicarbonate
w.
Sodium
carbonate
x.
Tartaric
acid
y. Waxes- non-synthetic (Carnauba wax; and wood resin)
z. Yeast- non-synthetic, growth on petrochemical substrate and sulfite waste liquor is prohibited (Autolysate; Bakers; Brewers; Nutritional; and Smoked- non-synethic smoke flavoring process must be documented)
B.
Synthetics
allowed
a.
Alginates
b. Ammonium bicarbonate- for use only as a leavening agent
c. Ammonium carbonate- for use only as a leavening agent
d.
Ascorbic
acid
e.
Calcium
citrate
f.
Calcium hydroxide
g. Calcium phosphates (monobasic, dibasic and tribasic)
h.
Carbon
dioxide
i. Cellulose- for use in regenerative casings, as an anti-caking agent (non-chlorine bleached) and filtering aid
j. Chlorine materials- disinfecting and sanitizing food contact surfaces, Except that residual chlorine levels in the water shall not exceed the maximum residual disinfectant limit under the Safe Drinking Water Act (Calcium hypochlorite; Chlorine dioxide; and Sodium hypochlorite)
k. Ethylene- allowed for post harvest ripening of tropical fruit and degreening of citrus
l. Ferrous sulfate- for iron enrichment or fortification of foods when required by regulation or recommended (independent organization)
m. Glycerides (mono and di) –for use only in drum drying of food
n. Glycerin- produced by hydrolysis of fats and oils
o.
Hydrogen
peroxide
p. Lecithin- bleached
q. Magnesium carbonate- for use only in agricultural products labeled “made with organic (specified ingredients or food groups)” prohibited in agricultural products labeled “organic”
r. Magnesium chloride- derived from sea water
s. Magnesium stearate- for use only in agricultural products labeled “made with organic (specified ingredients or food groups)” prohibited in agricultural products labeled “organic”
t. Nutrient vitamins and minerals, in accordance with 21 CFR 104.20, Nutritional Quality Guidelines for Foods
u.
Ozone
v. Pectine (low-methoxy)
w. Phosphoric acid- cleaning of food-contact surfaces and equipment only
x.
Potassium
acid tartrate
y. Potassium tartrate made from tartaric acid
z.
Potassium
carbonate
aa.
Potassium
citrate
bb. Potassium hydroxide- prohibited for use in lye peeling of fruits and vegetables except when used for peeling peaches during the Individually Quick Frozen (IQF) production process
cc. Potassium iodide- for use only in agricultural products labeled “made with organic (specified ingredients or food groups)” prohibited in agricultural products labeled “organic
dd. Potassium phosphate- for use only in agricultural products labeled “made with organic (specified ingredients or food groups)” prohibited in agricultural products labeled “organic
ee.
Silicon
dioxide
ff.
Sodium
citrate
gg. Sodium hydroxide-prohibited for use in lye peeling of fruits and vegetables
hh. Sodium phosphates- for use only in dairy foods
ii. Sodium dioxide- for use only in wine labeled “made with organic grapes”, provided that , total sulfite concentration does not exceed 100 ppm
jj.
Tartaric
acid
kk. Tocopherols- derived from vegetable oil when rosemary extracts are not a suitable alternative
ll.
Xanthan
gum
§ 205.606 Non-organically produced agricultural
products allowed as ingredients in or on processed products labeled as
“organic” or “made with organic (specified ingredients or food groups)”.
The following non-organically produced agricultural products may be used as ingredients in or on processed products labeled as “organic” or “made with organic (specified ingredients or food groups)” only in accordance with any restrictions specified in this section
Any non-organically produced agricultural product may be used in accordance with the restrictions specified in this section and when the product is not commercially available in organic form.
A.
Cornstarch
B. Gums- water extracted only (Arabic, guar, locust bean, carob bean)
C. Kelp- for use only as a thickener and dietary supplement
D. Lecithin- unbleached
Pectin (high-methoxy)
E.
Labeling and Marketing
These requirements for organic labeling and marketing come directly from the National Organic Program (NOP) as of April 2006. For up to date requirements visit the NOP online at: http://www.ams.usda.gov/nop/NOP/
The Organic Foods Production Act and the National Organic Program (NOP) are intended to assure consumers that the organic foods they purchase are produced, processed, and certified to consistent natural organic standards. The labeling requirements of the new program apply to raw, fresh products and processed foods that contain organic ingredients. Food that are sold, labeled, or represented as organic will have to be produced and processed in accordance with the NOP standards.
Except for operations whose gross agricultural income from organic sales totals $5,000 or less, farm and processing operation that grow and process organic foods must be certified by USDA accredited certifying agents. A certified operation may label its products or ingredients as organic and may use the “USDA Organic” seal.
Labeling requirements are based on the percentage of organic ingredients in a product.
Foods labeled “100 percent organic”
and “organic”
Products labeled as “100 percent organic” must contain (excluding water and salt) only organically produced ingredients.
Products labeled “organic” must consist of at least 95 percent organically produced ingredients (excluding water and salt). Any remaining product ingredients must consist of non-agricultural substances approved by the National List or non-organically produced agricultural products that are not commercially available in organic form.
Products meeting the requirements for “100 percent organic” and “organic” may display these terms and the percentage of organic content on their principal display panel.
The USDA seal and the seal or mark of involved certifying agents may appear on product packages and in advertisements.
Foods labeled “100 percent organic” and “organic” cannot be produced using excluded methods, sewage sludge, or ionizing radiation.
Processed products labeled “made with
organic ingredients”
Processed products that contain at least 70 percent organic ingredients can use the phrase “made with organic ingredients” and list up to three of the organic ingredients or food groups on the principal display panel. For example, soup made with at least 70 percent organic ingredients and only organic vegetables may be labeled either “soup made with organic peas, potatoes and carrots” or “soup made with organic vegetables”.
Processed products labeled “made with organic ingredients” cannot be produced using excluded methods, sewage sludge, or ionizing radiation.
The percentage of organic content and the certifying agent seal or mark may be used on the principal display panel. However, the USDA seal cannot be used anywhere on the package.
Processed products that contain less
than 70 percent organic ingredients
These products cannot use the term organic anywhere on the principal display panel. However, they may identify the specific ingredients that are organically produced on the ingredients statement on the information panel.
Other labeling provisions
Any product labeled as organic must identify each organically produced ingredient in the ingredients statement on the information panel.
The name and address of the certifying agent of the final product must be displayed on the information panel.
There are no restrictions in this final rule on the use of other truthful labeling claims such as “no drugs or growth hormones used”, “free range”, or sustainable harvested”.
Penalties for misuse of labels
A civil penalty of up to $10,000 can be levied on any person who knowingly sells or labels as organic a product that is not produce and handled in accordance with the National Organic Program’s regulations.
F. Organic Rules of Thumb
All of these rules of thumb are simplified versions of the National Organic Program standards as of April 2006. Several sections come directly from the National Organic Program website. For up to date requirements visit the NOP online at: http://www.ams.usda.gov/nop/NOP/
Agricultural operations affected by the standards:
Organic Production and Handling System Plan
Land Requirements
Synthetic and Non-synthetic Substances
Additions of Animal and Plant Materials
Crop Standards
Livestock standards
Handling standards
II. Organic Certification
A. Certification Agencies
Below is a list of NOP approved certification agencies that as
of April 2006 are approved by the Arkansas State Plant Board to certify within
8364 SSR 39
Contact: Cissy Bowman
317-539-4317
cvof@iquest.net
http://members.iquest.net/~cvof/ico/
Scope: crop, livestock, wild crop,
handling
Accredited: 4/29/02
Oklahoma Department of Agriculture
Contact:
405-522-5898
cbgoss@oda.state.ok.us
Scope: crop, livestock, handling
Accredited: 12/6/02
Contact: Chris Schreiner
503-378-0690
organic@tilth.org
www.tilth.org
Scope: crop, livestock, wild crop,
handling
Accredited: 4/29/02
Organic Crop Improvement Association
6400 Cornhusker,
Contact: Jeff See
402-477-2323
JSee@ocia.org
www.ocia.org
Scope: crop, livestock, wild crop,
handling
Accredited: 4/29/02
Stellar Certification Services
Contact: Jim Fullmer
541-998-5691
stellar@demeter-usda.org
Scope: crop, livestock, wild crop,
handling
Accredited: 4/29/02
Quality Certified Services
Contact: Angela Caudle
352-377-0133
qcs@qcsinfo.org
www.QCSinfo.org
Scope: crop, livestock, wild crop,
handling
Accredited: 4/29/02
B. Organic Consultants
Ag Organics Inc.
John Turner
Gentry, AR 72734
479-736-9977
Bio-Ag Consultants & Distributors
710 South Columbia
800-363-5278
Livestock
Regional Manager at Large
3855 Wieuca Terrace
404-467-0243
Food Solutions, Inc.
Dr. Craig Bair
336-851-0206
Crossley Consulting
Rod Crossley
818-248-8323
JCL Consulting
Jim Lathers
5807
720-205-1832
SuperGro of
Keith Cuvelier
1311 Circle Dr.
319-347-6155
SeaBorn/ Lane Inc.
Warren Dunkel
Charles
800-457-5013