National Organic Program Overview

Subpart A - Definitions

Description of Regulations

This subpart defines various terms used in this part. These definitions are intended to enhance 

conformance with the regulatory requirements through a clear understanding of the meaning of 

key terms. 

We have amended terms and definitions carried over from the proposed rule where necessary to 

make their wording consistent with the language used in this final rule. We have revised the 

definitions of the following words for greater clarity: person, practice standard, inert ingredient, 

processing, tolerance. We have removed the definitions for the following terms because the terms 

are not used in this final rule or have been determined to be unnecessary: accredited laboratory, 

estimated national mean, system of organic production and handling. We received comments on 

some of these definitions that have been deleted. We have not addressed those comments here 

because the relevant definitions have been deleted. 

Definitions - Changes Based on Comments

This subpart differs from the proposed rule in several respects as follows: 

(1) Many commenters requested changes to the definition of "excluded methods." Comments 

included requests to use the more common term, "genetically modified organisms(GMO)"; to 

include the products of excluded methods/GMO's in the definition; to more closely follow the 

NOSB definition by adding gene deletion, doubling, introduction of a foreign gene, and changing 

gene position; to include that excluded methods are prohibited by the Act and by the regulations 

in this part; to change the wording of the reference to "recombinant DNA"; and to add that the 

definition of excluded methods only covers "intentional use." 

We have accepted some of the comments and have modified the definition accordingly. 

Specifically, we have included reference to the "methods"-gene deletion, gene doubling, changing 

positions of genes, and introducing foreign genes-that were included in the original NOSB 

definition. This will make the definition even more closely parallel the NOSB recommendation. We 

also refer to recombinant DNA technology, which is technically more accurate than the proposed 

rules reference to recombinant DNA as a "method." 

We have not accepted the comments that requested adding the products of excluded methods to 

the definition. The emphasis and basis of these standards is on process, not product. We have 

specifically structured the provisions relating to excluded methods to refer to the use of methods. 

Including the products of excluded methods in the definition would not be consistent with this 

approach to organic standards as a process-based system. For the same reason, we have 

retained the term, "excluded methods," to reinforce that process-based approach. 

We have also rejected comments requesting that we include the prohibition on excluded methods 

in the definition and, likewise, those requesting that we refer to "intentional use" of excluded 

methods. The final rule maintains and clarifies the prohibition on the use of excluded methods in 

organic production systems. The prohibition is most properly addressed in the appropriate 

provisions of the regulations, particularly in Section 205.105, and not in the definition. Similarly, 

although we recognize that a distinction between intentional and unintentional use of excluded 
methods may be meaningful, particularly as it pertains to issues of drift, this is an issue that is 

best handled in the sections of the regulation governing use of excluded methods, not in the 

definition. The definition for "excluded methods" now reads: 

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 position 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." 

(2) Many commenters objected to the definition of "compost" in the proposed rule because it 

required that compost must be produced in a facility that was in compliance with the Natural 

Resource Conservation Service's (NRCS) practice standard for a composting facility. We agree 

with these commenters and removed the requirement to comply with the NRCS practice 

standard. However, the final rule incorporates new requirements for the production of compost 

that are included in the definition. The final rule requires that 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. Furthermore, producers using an in-vessel or static aerated pile system must maintain the 

composting materials at a temperature of 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. We 

developed the requirements in the final rule for producing an allowed composted material by 

integrating standards used by the Environmental Protection Agency (EPA) and USDA's Natural 

Resources Conservation Service (NRCS). The requirements for the carbon-to-nitrogen (C:N) ratio 

for composting materials is the same as that found in the NRCS practice standard for a 

composting facility. The time and temperature requirements for in-vessel, static aerated pile, and 

window composting systems are consistent with those which EPA regulates under 40 CFR 503 

for the production of Class A sewage sludge. Additionally, AMS reviewed these compost 

production requirements with USDA's Agricultural Research Service (ARS). This subject is 

discussed further under subpart C, Crop Production, Changes Based on Comment. 

(3) Some commenters stated that allowing nonagricultural or synthetic substances as feed 

supplements contradicted the definition for "feed supplement" in the proposed rule. These 

commenters stated that the definition stipulated that a feed supplement must, itself, be a feed 

material and that the proposed definition for "feed" did not include nonagricultural or synthetic 

substances. These commenters stated that the definition of "feed supplement" needed to be 

amended to accommodate nonagricultural or synthetic substances, or such substances should 

not be allowed. We agree with these commenters and amended the definition for "feed 

supplement" to read "a combination of feed nutrients added to livestock feed to improve the 

nutritional balance or performance of the total ration." One commenter recommended modifying 

the definition of "feed additive" to "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." We 

agree that this modification provides a more precise description of "feed additive" and have 

included the change. The changes to the definitions for "feed supplement" and "feed additive" are 

further discussed under item (4) of Livestock Production - Changes Based on Comments. 

(4) One commenter stated that the definition for "forage" inaccurately described it as "vegetable 

matter," and suggested that "vegetative matter" was a more suitable description. We agree with 

the suggestion and have incorporated the change. 

(5) Some commenters stated that the definition for "mulch" implied that all mulch materials must 

either be organic or included on the National List. These commenters maintained that, if this was 

the intent of the proposed rule, the provision was too restrictive. They recommended revising the 
definition to clarify that natural but nonorganic plant and animal materials, if managed to prevent 

contamination from prohibited substances, could be used as mulch without being added to the 

National List. This was the intent in the proposed rule, and we have modified the definition to 

make this provision clearer. 

(6) Many commenters stated that the final rule should include a definition of "organic production" 

that required that certified operations must preserve or protect biodiversity. These commenters 

stated that the preservation of biodiversity is a requirement in many existing organic certification 

standards, including the Codex guidelines. They also stated that the NOSB had included the 

requirement to preserve biodiversity in its definition of organic. We agree with the intent of these 

comments but prefer the term, "conserve," to "preserve" because it reflects a more dynamic, 

interactive relationship between the operation and biodiversity over time. We included a definition 

for organic production as "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." We deleted the definition for "organic system of production and handling" in the final 

rule. 

(7) Several commenters, including the NOSB, were concerned that the definition for "planting 

stock" as "any plant or plant tissue, including rhizomes, shoots, leaf or stem cuttings, roots, or 

tubers, used in plant production or propagation" was sufficiently broad to be applied to annual 

seedlings. We agree that it is important to establish that annual seedlings are not covered by the 

definition of "planting stock" and amended the definition to exclude them. The definition for 

planting stock in the final rule states "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." The final rule retains the definition for "annual seedling " from the proposed rule. 

(8) Several commenters recommended that the definition of "processing" should be amended to 

include "distilling" as an allowed practice. We agree with this comment and added distilling as an 

allowed processing practice. 

(9) Several commenters recommended that the final rule include a definition for "processing aid" 

that is consistent with the definition proposed by the NOSB and used by the Food and Drug 

Administration (FDA). We agree with these commenters and have included a definition for 

processing aid that is the same as the definition used by FDA and found in 21 CFR Part 

101.100(a)(3)(ii). 

(10) Many commenters questioned whether the term, "State organic certification program," in the 

proposed rule included organic programs from States that did not offer certification services. 

These commenters stated that the final rule should include provisions for all State organic 

programs regardless of whether they functioned as certifying agents. We agree with these 

commenters and have amended the final rule by incorporating the term, "State organic program," 

as "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." The term, "State organic program," encompasses 

such programs whether they offer certification services or not. 

(11) One commenter stated that the definition for "wild crop" only referred to a plant or part of a 

plant that was harvested from "an area of land." This commenter was concerned that the 

definition would preclude the certification of operations that produce wild aquatic crops, such as 

seaweed, and stated that the OFPA does allow for certifying such operations. We agree with this 

commenter and changed the definition to refer to a plant or part of a plant harvested from a "site." 
(12) Many commenters stated that the soil fertility and crop nutrient management practice 

standard lacked a definition for "manure." These commenters maintained that the different 

provisions contained in the practice standard for "manure" and "compost" would be difficult to 

enforce without clear definitions to differentiate between the two materials. We agree with these 

comments and added a definition for manure as "feces, urine, other excrement, and bedding 

produced by livestock that has not been composted." 

(13) Some commenters stated that the National List in the final rule should include an annotation 

for narrow range oils to limit their use to a specific subset of such materials recommended by the 

NOSB. We agree with this comment but, rather than add an annotation, we have included the 

specifications recommended by the NOSB in a new definition for narrow range oils. Narrow range 

oils are defined as "petroleum derivatives, predominately of paraffinic and napthenic fractions 

with a 50-percent boiling point (10 mm Hg) between 415F and 440F. 

(14) Many commenters maintained that the final rule needed a definition of the term, "pasture," to 

describe the relationship between ruminants and the land they graze. These commenters stated 

that a meaningful definition of "pasture" must incorporate the nutritional component that it 

provides livestock, as well as the necessity to manage the land in a manner that protects the 

natural resources of the operation. We agree with these commenters and have added a definition 

of "pasture" as "land used for livestock grazing that is managed to provide feed value and 

maintain or improve soil, water, and vegetative sources." 

(15) Many commenters stated that a definition for "split operation" was necessary to prevent 

commingling between organic and nonorganic commodities on operations that produced or 

handled both forms of a commodity. We agree with these comments and have included a 

definition for "split operation" as " an operation that produces or handles both organic and 

nonorganic agricultural products." 

Definitions - Changes Requested But Not Made

This subpart retains from the proposed rule terms and their definitions on which we received 

comments as follows: 

(1) Many commenters objected to the definition of "sewage sludge" because it excluded ash 

generated in a sewage sludge incinerator and grit and screenings generated during preliminary 

treatment of domestic sewage in treatment works. We have not changed the definition for 

"sewage sludge" because it provides the most comprehensive and enforceable description of the 

types of materials that commenters wanted to prohibit. The definition for "sewage sludge" in the 

proposed rule arose in response to significant public comment on the first proposed rule for 

national organic standards (62 Federal Register, No. 241) that recommended prohibiting biosolids 

in organic production. When incorporating those comments into the proposed rule, we did not use 

the term, "biosolids," because it does not have a standardized definition under Federal 

regulations. The term, "biosolids," is commonly used to refer to "sewage sludge," which is the 

regulatory term established in 40 CFR Part 503. We incorporated the precise definition from 40 

CFR Part 503, even though it does not include ash, grit, or screenings, because it provided the 

clearest description of the types of materials identified in public comment. 

While commenters are correct that ash, grit, or screenings from the production of sewage sludge 

are not prohibited by this definition, these materials are prohibited elsewhere in the regulation. 

The soil fertility and crop nutrient management practice standard in section 205.203 establishes 

the universe of allowed materials and practices. These allowed materials and practices are crop 

rotations, cover crops, plant and animal materials (including their ash), nonagricultural, natural 

materials, and, under appropriate conditions, mined substances of low and high solubility and 

synthetic materials included on the National List. Ash, grit, or screenings from the production of 
sewage sludge cannot be included in any of these categories and, therefore, cannot be used in 

organic production. We retained the definition of "sewage sludge" because it most clearly 

conveys the wide array of commercially available soil amendments that might be considered for 

organic production but that the final rule expressly prohibits. We have not added specific 

exclusions for sewage sludge, ash, grit, or screenings because these materials are prohibited 

through other provisions in the practice standard. 

(2) The proposed rule prohibited the handler of an organic handling operation from using ionizing 

radiation for any purpose. The vast majority of commenters agreed with this prohibition and 

further recommended that the term, "ionizing radiation," should be defined to identify the specific 

applications that are prohibited. Most commenters supported a definition based on the FDA 

requirements in 21 CFR part 179.26 for the treatment or processing of food using ionizing 

radiation. While agreeing with the prohibition on ionizing radiation, these commenters favored 

allowing certain forms of irradiation such as the use of X-rays to inspect for debris such as stones 

that were inadvertently commingled with organically handled food. Other commenters 

recommended a prohibition on all forms of irradiation, which would include X-rays for inspection 

purposes, ultraviolet light, and microwaves in addition to ionizing radiation. Finally, a number of 

commenters stated that ionizing radiation is a safe and effective process for handling food and, 

therefore, should not be prohibited in organic handling. 

We have not added a definition for "ionizing radiation" to the final rule because we have 

incorporated specific references to the applications that are prohibited in the regulatory text. The 

final rule prohibits the handler of an organic handling operation from using ionizing radiation as 

specified under 21 CFR part 179.26. These are the FDA-approved uses of ionizing radiation that 

commenters most frequently recommended that we prohibit in organic handling operations. They 

include the use of cobalt-60, cesium-137, and other sources of radiation for the purpose of 

controlling microbial contaminants, pathogens, and pests in food or to inhibit the growth and 

maturation of fresh foods. At its June 2000 meeting, the NOSB recommended prohibiting ionizing 

radiation for the purpose of controlling microbial contaminants, pathogens, parasites, and pests in 

food, preserving a food, or inhibiting physiological processes such as sprouting or ripening. The 

final rule does not prohibit the handler of an organic handling operation from using the FDAapproved applications of X-rays for inspecting food. The prohibition on ionizing radiation in the 

final rule is based solely on consumer preference as reflected in the overwhelming public 

comment stating that organically handled foods should not be treated in that manner. 

(3) Some commenters recommend that the final rule incorporate definitions for the terms, "food 

additives," "extraction methods," "incidental additive," and "substantially transform." However, 

these terms are not used in the final rule and do not require a definition. 

Definitions - Clarifications

Following our review of the definitions provisions in the proposed rule, we decided to further 

clarify the following provision in the final rule: 

We were concerned that "State entity," the meaning of which encompasses both domestic and 

foreign political subdivisions, may be confused with "State," the meaning of which is limited to the 

States of the United States, its territories, the District of Columbia, and Puerto Rico. To avoid any 

possible confusion as to which provisions in this final rule apply to States and which apply to the 

broader political subdivisions, we have replaced the term, "State entity," with the term, 

"governmental entity," while retaining the same definition language in the proposed rule.