Subpart C - Organic Crop, Wild Crop, Livestock, and Handling Requirements

Description of Regulations

General Requirements

This subpart sets forth the requirements with which production and handling operations must 

comply in order to sell, label, or represent agricultural products as "100 percent organic," 

"organic," or "made with organic (specified ingredients or food group(s))." The producer or 

handler of an organic production or handling operation must comply with all applicable provisions 

of subpart C. Any production practice implemented in accordance with this subpart must maintain 

or improve the natural resources, including soil and water quality, of the operation. Production 

and handling operations which sell, label, or represent agricultural products as organic in any 

manner and which are exempt or excluded from certification must comply with the requirements 

of this subpart, except for the development of an organic system plan. 

Production and Handling (General)

The Organic Food Production Act of 1990 (OFPA or Act) requires that all crop, wild crop, 

livestock, and handling operations requiring certification submit an organic system plan to their 

certifying agent and, where applicable, the State organic program (SOP). The organic system 

plan is a detailed description of how an operation will achieve, document, and sustain compliance 

with all applicable provisions in the OFPA and these regulations. The certifying agent must 

concur that the proposed organic system plan fulfills the requirements of subpart C, and any 

subsequent modification of the organic plan by the producer or handler must receive the approval 

of the certifying agent. 

The organic system plan is the forum through which the producer or handler and certifying agent 

collaborate to define, on a site-specific basis, how to achieve and document compliance with the 

requirements of certification. The organic system plan commits the producer or handler to a 

sequence of practices and procedures resulting in an operation that complies with every 

applicable provision in the regulations. Accreditation qualifies the certifying agent to attest to 

whether an organic system plan comports with the organic standard. The organic system plan 

must be negotiated, enacted, and amended through an informed dialogue between certifying 

agent and producer or handler, and it must be responsive to the unique characteristics of each 

operation. 

An organic system plan contains six components. First, the organic system plan must describe 

the practices and procedures used, including the frequency with which they will be used, in the 

certified operation. Second, it must list and characterize each substance used as a production or 

handling input, including the documentation of commercial availability, as applicable. Third, it 

must identify the monitoring techniques which will be used to verify that the organic plan is being 

implemented in a manner which complies with all applicable requirements. Fourth, it must explain 

the recordkeeping system used to preserve the identity of organic products from the point of 

certification through delivery to the customer who assumes legal title to the goods. Fifth, the 

organic system plan must describe 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. 

Finally, the organic system plan must contain the additional information deemed necessary by the 

certifying agent to evaluate site-specific conditions relevant to compliance with these or 

applicable State program regulations. Producers or handlers may submit a plan developed to 
comply with other Federal, State, or local regulatory programs if it fulfills the requirements of an 

organic system plan. 

The first element of the organic system plan requires a narrative or other descriptive format that 

identifies the practices and procedures to be performed and maintained, including the frequency 

with which they will be performed. Practices are tangible production and handling techniques, 

such as the method for applying manure, the mechanical and biological methods used to prepare 

and combine ingredients and package finished products, and the measures taken to exclude 

pests from a facility. Procedures are the protocols established for selecting appropriate practices 

and materials for use in the organic system plan, such as a procedure for locating commercially 

available, organically produced seed. Procedures reflect the decision-making process used to 

implement the organic system plan. 

By requiring information on the frequency with which production and handling practices and 

procedures will be performed, the final rule requires an organic system plan, to include an 

implementation schedule, including information on the timing and sequence of all relevant 

production and handling activities. The plan will include, for example, information about planned 

crop rotation sequences, the timing of any applications of organic materials, and the timing and 

location of soil tests. Livestock management practices might describe development of a rotational 

grazing plan or addition of mineral supplements to the feed supply. A handling operation might 

identify steps involved in locating and contracting with farmers who could produce organic 

ingredients that were in short supply. 

The second element that must be included in an organic system plan is information on the 

application of substances to land, facilities, or agricultural products. This requirement 

encompasses both natural and synthetic materials allowed for use in production and handling 

operations. For natural materials which may be used in organic operations under specific 

restrictions, the organic plan must detail how the application of the materials will comply with 

those restrictions. For example, farmers who apply manure to their fields must document in their 

organic system plans how they will prevent that application from contributing to water 

contamination. A producer and handler who bases the selection of seed and planting stock 

material under section 205.204 or an agricultural ingredient under section 205.301 on the 

commercial availability of that substance must provide documentation in the organic system plan. 

The third element of the organic system plan is a description of the methods used to evaluate its 

effectiveness. Producers and handlers are responsible for identifying measurable indicators that 

can be used to evaluate how well they are achieving the objectives of the operation. For example, 

production objectives could be measured through regular tallies of bushels or pounds of product 

sold from the farm or in numbers of cases sold from a handling operation. Indicators that can 

identify changes in quality or effectiveness of management practices could be relatively simple, 

such as the information contained in a standard soil test. The specific indicators used to evaluate 

a given organic system plan will be determined by the producer or handler in consultation with the 

certifying agent. Thus, if the organic system plan calls for improvements in soil organic matter 

content in a particular field, it would include provisions for analyzing soil organic matter levels at 

periodic intervals. If herd health improvement is an objective, factors such as somatic cell count 

or observations about changes in reproductive patterns might be used as indicators. 

The fourth element of the organic system plan is a description of the recordkeeping system used 

to verify and document an audit trail, as appropriate to the operation. For each crop or wild-crop 

harvested, the audit trail must trace the product from the field, farm parcel, or area where it is 

harvested through the transfer of legal title. A livestock operation must trace each animal from its 

entrance into through removal from the organic operation. A handling operation must trace each 

product that is handled and sold, labeled, or represented as organic from the receipt of its 

constituent ingredients to the sale of the processed product. 
The fifth element which must be included in an organic system plan pertains to split production or 

handling operations. This provision requires an operation that produces both organic and 

nonorganic products to describe the management practices and physical barriers established to 

prevent commingling of organic and nonorganic products. This requirement addresses contact of 

organic products, including livestock, organic field units, storage areas, and packaging to be used 

for organic products, with prohibited substances. 

The specific requirements to be included in an organic system plan are not listed here. The 

accreditation process provides an assurance that certifying agents are competent to determine 

the specific documentation they require to review and evaluate an operation's organic system 

plan. Section 205.200(a)(6) allows a certifying agent to request additional information needed to 

determine that an organic system plan meets the requirements of this subpart. The site-specific 

nature of organic production and handling necessitates that certifying agents have the authority to 

determine whether specific information is needed to carry out their function. 

Crop Production

Any field or farm parcel used to produce an organic crop must have been managed in 

accordance with the requirements in sections 205.203 through 205.206 and have had no 

prohibited substances applied to it for at least 3 years prior to harvest of the crop. Such fields and 

farm parcels must also have distinct, defined boundaries and buffer zones to prevent contact with 

the land or crop by prohibited substances applied to adjoining land. 

A producer of an organic crop must manage soil fertility, including tillage and cultivation practices, 

in a manner that maintains or improves the physical, chemical, and biological condition of the soil 

and minimizes soil erosion. The producer must manage crop nutrients and soil fertility through 

rotations, cover crops, and the application of plant and animal materials. 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. Plant and animal 

materials include raw animal manure, composted plant and animal materials, and uncomposted 

plant materials. Raw animal manure must either be composted, applied to land used for a crop 

not intended for human consumption, or incorporated into the soil at least 90 days before 

harvesting an edible product that does not come into contact with the soil or soil particles and at 

least 120 days before harvesting an edible product that does come into contact with the soil or 

soil particles. Composted plant or animal materials must be produced through a process that 

establishes an initial carbon-to-nitrogen (C:N) ratio of between 25:1 and 40:1 and achieves a 

temperature between 131F and 170F. Composting operations that utilize an in-vessel or static 

aerated pile system must maintain a temperature within that range for a minimum of 3 days. 

Composting operations that utilize a windrow composting system must maintain a temperature 

within that range for a minimum of 15 days, during which time the materials must be turned five 

times. 

In addition to these practices and materials, a producer may apply a crop nutrient or soil 

amendment included on the National List of synthetic substances allowed in crop production. The 

producer may apply a mined substance of low solubility. A mined substance of high solubility may 

only be applied if the substance is used in compliance with the annotation on the National List of 

nonsynthetic materials prohibited in crop production. Ashes of untreated plant or animal materials 

which have not been combined with a prohibited substance and which are not included on the 

National List of nonsynthetic substances prohibited for use in organic crop production may be 

used to produce an organic crop. A plant or animal material that has been chemically altered by a 

manufacturing process may be used only if it is included on the National List of synthetic 

substances allowed for use in organic production. The producer may not use any fertilizer or 

composted plant and animal material that contains a synthetic substance not allowed for crop 

production on the National List or use sewage sludge. Burning crop residues as a means of 
disposal is prohibited, except that burning may be used to suppress the spread of disease or to 

stimulate seed germination. 

The producer must use organically grown seeds, annual seedlings, and planting stock. The 

producer may use untreated nonorganic seeds and planting stock when equivalent organic 

varieties are not commercially available, except that organic seed must be used for the 

production of edible sprouts. Seed and planting stock treated with substances that appear on the 

National List may be used when an organically produced or untreated variety is not commercially 

available. Nonorganically produced annual seedlings may be used when a temporary variance 

has been established due to damage caused by unavoidable business interruption, such as fire, 

flood, or frost. Planting stock used to produce a perennial crop may be sold as organically 

produced planting stock after it has been maintained under a system of organic management for 

at least 1 year. Seeds, annual seedlings, and planting stock treated with prohibited substances 

may be used to produce an organic crop when the application of the substance is a requirement 

of Federal or State phytosanitary regulations. 

The producer is required to implement a crop rotation, including but not limited to sod, cover 

crops, green manure crops, and catch crops. The crop rotation must maintain or improve soil 

organic matter content, provide for effective pest management in perennial crops, manage 

deficient or excess plant nutrients, and control erosion to the extent that these functions are 

applicable to the operation. 

The producer must use preventive practices to manage crop pests, weeds, and diseases, 

including but not limited to crop rotation, soil and crop nutrient management, sanitation measures, 

and cultural practices that enhance crop health. Such cultural practices include the selection of 

plant species and varieties with regard to suitability to site-specific conditions and resistance to 

prevalent pests, weeds, and diseases. Mechanical and biological methods that do not entail 

application of synthetic substances may be used as needed to control pest, weed, and disease 

problems that may occur. Pest control practices include augmentation or introduction of pest 

predators or parasites; development of habitat for natural enemies; and nonsynthetic controls 

such as lures, traps, and repellents. Weed management practices include mulching with fully 

biodegradable materials; mowing; livestock grazing; hand weeding and mechanical cultivation; 

flame, heat, or electrical techniques; and plastic or other synthetic mulches, provided that they 

are removed from the field at the end of the growing or harvest season. Disease problems may 

be controlled through management practices which suppress the spread of disease organisms 

and the application of nonsynthetic biological, botanical, or mineral inputs. When these practices 

are insufficient to prevent or control crop pests, weeds, and diseases, a biological or botanical 

substance or a synthetic substance that is allowed on the National List may be used provided that 

the conditions for using the substance are documented in the organic system plan. The producer 

must not use lumber treated with arsenate or other prohibited materials for new installations or 

replacement purposes that comes into contact with soil or livestock. 

A wild crop that is to be sold, labeled, or represented as "100 percent organic," "organic," or 

"made with organic (specified ingredients or food group(s))" must be harvested from a designated 

area that has had no prohibited substances applied to it for a period of 3 years immediately 

preceding the harvest of the wild crop. The wild crop must also be harvested in a manner that 

ensures such harvesting or gathering will not be destructive to the environment and will sustain 

the growth and production of the wild crop. 

Livestock Production

Any livestock product to be sold, labeled, or represented as organic must be maintained under 

continuous organic management from the last third of gestation or hatching with three exceptions. 

Poultry or edible poultry products must be from animals that have been under continuous organic 

management beginning no later than the second day of life. 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 such products, except for the conversion of an entire, distinct herd to 

organic production. For the first 9 months of the year of conversion, the producer may provide the 

herd with a minimum of 80-percent feed that is either organic or produced from land included in 

the organic system plan and managed in compliance with organic crop requirements. During the 

final 3 months of the year of conversion, the producer must provide the herd feed in compliance 

with section 205.237. Once the herd has been converted to organic production, all dairy animals 

shall be under organic management from the last third of gestation. Livestock used as breeder 

stock may be brought from a nonorganic operation into an organic operation at any time, provided 

that, if such livestock are gestating and the offspring are to be organically raised from birth, the 

breeder stock must be brought into the organic operation prior to the last third of gestation. 

Should an animal be brought into an organic operation pursuant to this section and subsequently 

moved to a nonorganic operation, neither the animal nor any products derived from it may be 

sold, labeled, or represented as organic. Breeder or dairy stock that has not been under 

continuous organic management from the last third of gestation may not be sold, labeled, or 

represented as organic slaughter stock. The producer of an organic livestock operation must 

maintain records sufficient to preserve the identity of all organically managed livestock and all 

edible and nonedible organic livestock products produced on his or her operation. 

Except for nonsynthetic substances and synthetic substances included on the National List that 

may be used as feed supplements and additives, the total feed ration for livestock managed in an 

organic operation must be composed of agricultural products, including pasture and forage, that 

are organically produced. Any portion of the feed ration that is handled must comply with organic 

handling requirements. The producer must not use animal drugs, including hormones, to promote 

growth in an animal or provide feed supplements or additives in amounts above those needed for 

adequate growth and health maintenance for the species at its specific stage of life. The producer 

must not feed animals under organic management plastic pellets for roughage or formulas 

containing urea or manure. The feeding of mammalian and poultry slaughter by-products to 

mammals or poultry is prohibited. The producer must not supply animal feed, feed additives, or 

feed supplements in violation of the Federal Food, Drug, and Cosmetic Act. 

The producer of an organic livestock operation must establish and maintain preventive animal 

health care practices. The producer must select species and types of livestock with regard to 

suitability for site-specific conditions and resistance to prevalent diseases and parasites. The 

producer must provide a feed ration including vitamins, minerals, protein, and/or amino acids, 

fatty acids, energy sources, and, for ruminants, fiber. The producer must establish appropriate 

housing, pasture conditions, and sanitation practices to minimize the occurrence and spread of 

diseases and parasites. Animals in an organic livestock operation must be maintained under 

conditions which provide for exercise, freedom of movement, and reduction of stress appropriate 

to the species. Additionally, all physical alterations performed on animals in an organic livestock 

operation must be conducted to promote the animals' welfare and in a manner that minimizes 

stress and pain. 

The producer of an organic livestock operation must administer vaccines and other veterinary 

biologics as needed to protect the well-being of animals in his or her care. When preventive 

practices and veterinary biologics are inadequate to prevent sickness, the producer may 

administer medications included on the National List of synthetic substances allowed for use in 

livestock operations. The producer may not administer synthetic parasiticides to breeder stock 

during the last third of gestation or during lactation if the progeny is to be sold, labeled, or 

represented as organically produced. After administering synthetic parasiticides to dairy stock, 

the producer must observe a 90-day withdrawal period before selling the milk or milk products 

produced from the treated animal as organically produced. Every use of a synthetic medication or 

parasiticide must be incorporated into the livestock operation's organic system plan subject to 

approval by the certifying agent. 
The producer of an organic livestock operation must not treat an animal in that operation with 

antibiotics, any synthetic substance not included on the National List of synthetic substances 

allowed for use in livestock production, or any substance that contains a nonsynthetic substance 

included on the National List of nonsynthetic substances prohibited for use in organic livestock 

production. The producer must not administer any animal drug, other than vaccinations, in the 

absence of illness. The use of hormones for growth promotion is prohibited in organic livestock 

production, as is the use of synthetic parasiticides on a routine basis. The producer must not 

administer synthetic parasiticides to slaughter stock or administer any animal drug in violation of 

the Federal Food, Drug, and Cosmetic Act. The producer must not withhold medical treatment 

from a sick animal to maintain its organic status. All appropriate medications and treatments must 

be used to restore an animal to health when methods acceptable to organic production standards 

fail. Livestock that are treated with prohibited materials must be clearly identified and shall not be 

sold, labeled, or represented as organic. 

A livestock producer must document in his or her organic system plan the preventative measures 

he or she has in place to deter illness, the allowed practices he or she will employ if illness 

occurs, and his or her protocol for determining when a sick animal must receive a prohibited 

animal drug. These standards will not allow an organic system plan that envisions an acceptable 

level of chronic illness or proposes to deal with disease by sending infected animals to slaughter. 

The organic system plan must reflect a proactive approach to health management, drawing upon 

allowable practices and materials. Animals with conditions that do not respond to this approach 

must be treated appropriately and diverted to nonorganic markets. 

The producer of an organic livestock operation must establish and maintain livestock living 

conditions for the animals under his or her care which accommodate the health and natural 

behavior of the livestock. The producer must provide 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. This requirement includes access to pasture for ruminant animals. 

The producer must also provide appropriate clean, dry bedding, and, if the bedding is typically 

consumed by the species, it must comply with applicable organic feed requirements. The 

producer must provide shelter designed to allow for the natural maintenance, comfort level, and 

opportunity to exercise appropriate to the species. The shelter must also provide the temperature 

level, ventilation, and air circulation suitable to the species and reduce the potential for livestock 

injury. The producer may provide temporary confinement of an animal because of inclement 

weather; the animal's stage of production; conditions under which the health, safety, or well-being 

of the animal could be jeopardized; or risk to soil or water quality. The producer of an organic 

livestock operation is required to 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 nutrient recycling. 

Handling

Mechanical or biological methods can be used to process an agricultural product intended to be 

sold, labeled, or represented as "100 percent organic," "organic," or "made with organic 

ingredients" for the purpose of retarding spoilage or otherwise preparing the agricultural product 

for market. Processed multiingredient products labeled "100 percent organic," may only use 

wholly organic ingredients, pursuant to paragraph (a) of section 205.301. Nonagricultural 

substances that are allowed for use on the National List and nonorganically produced agricultural 

products may be used in or on "organic" and "made with..." products pursuant to paragraphs (b) 

and (c) of section 205.301, respectively. Documentation of commercial availability of each 

substance to be used as a nonorganic ingredient in products labeled "organic" must be listed in 

the organic handling system plan in accordance with section 205.201. 

Handlers are prohibited from using: (1) ionizing radiation for the treatment or processing of foods; 

(2) ingredients produced using excluded methods; or (3) volatile synthetic solvents in or on a 
processed product or any ingredient which is sold, labeled, or represented as organic. The 

prohibition on ionizing radiation for the treatment or processing of foods is discussed under 

Applicability, section 205.105. This rule does not prohibit an organic handling operation from 

using Food and Drug Administration (FDA)-approved X-rays for inspecting packaged foods for 

foreign objects that may be inadvertently commingled in the packaged product. 

The two paragraphs on excluded methods and ionizing radiation in section 205.270(c) of the 

proposed rule are replaced with new paragraph (c)(1) which cross-references those practices 

under paragraphs (e) and (f) of section 205.105. New section 205.105 clearly specifies that 

ionizing radiation and excluded methods are two practices that handlers must not use in 

producing organic agricultural products and ingredients. The prohibition on the use of volatile 

synthetic solvents, also included under paragraph (c) of section 205.270 does not apply to 

nonorganic ingredients in "made with..." products. 

The practice standard for facility pest management under section 205.271 requires the producer 

or handler operating a facility to use management practices to control and prevent pest 

infestations. Prevention practices in paragraph (a) include removing pest habitats, food sources, 

and breeding areas; preventing access to handling facilities; and controlling environmental 

factors, such as temperature, light, humidity, atmosphere, and air circulation, to prevent pest 

reproduction. Permitted pest control methods in paragraph (b) include mechanical or physical 

controls, such as traps, light, or sound. Lures and repellents using nonsynthetic substances may 

be used as pest controls. Lures and repellents with synthetic substances that are allowed on the 

National List also may be used. Prevention and control practices in paragraphs (a) and (b) may 

be used concurrently. 

If the practices in paragraphs (a) and (b) are not effective, amended paragraph (c) provides that 

handlers may then use a nonsynthetic or synthetic substance consistent with National List. If the 

measures and substances provided under paragraphs (a), (b), and (c) are not effective, synthetic 

substances not on the National List may be used to control pest infestations. Under new 

paragraph (d), the handler and the operation's certifying agent, prior to using such a substance, 

must agree on the substance to be used to control the pest, measures to be taken to prevent 

contact with organically produced product, and ingredients that may be in the handling facility. 

This rule recognizes that certain local, State, and Federal laws or regulations may require 

intervention with prohibited substances before or at the same time substances allowed in 

paragraphs (b) and (c) are used. To the extent that this occurs, this rule permits the handler to 

follow such laws and regulations to market a product as organically handled, provided that the 

product does not come into contact with the pest control substance used. 

The extent of pest infestation cannot be foreseen when an organic plan is submitted by the 

certified operation and approved by the certifying agent. A handler who uses any nonsynthetic or 

synthetic substance to control facility pests must update its organic handling system plan to 

address all measures taken or intended to be taken to prevent contact between the substance 

and any organically produced ingredient or finished product. 

Section 205.272 provides additional practice standards that must be followed by an organic 

handling operation to prevent the commingling of organic and nonorganic products and to protect 

organic products from contact with prohibited substances. An organic handling operation must not 

use packaging materials and storage containers or bins that contain a synthetic fungicide, 

preservative, or fumigant in handling an organic product. The operation also must not use or 

reuse any storage bin or container that was previously in contact with any prohibited substance 

unless the reusable bin or container has been thoroughly cleaned and poses no risk of prohibited 

materials contacting the organic product. 
Temporary Variances

This subpart establishes conditions under which certified organic operations may receive 

temporary variances from the production and handling provisions of this subpart. The 

Administrator may establish temporary variances due to: (1) Natural disasters declared by the 

Secretary; (2) unavoidable business interruption caused by natural catastrophes such as drought, 

wind, fire, flood, excessive moisture, hail, tornado, or earthquake; or (3) to conduct research on 

organic production and handling techniques or inputs. An SOP's governing State official or a 

certifying agent may recommend that the Administrator establish a temporary variance for various 

reasons including an unavoidable business interruption. The Administrator will determine how 

long a temporary variance will be in effect at the time it is established, subject to such extension 

as the Administrator deems necessary. Temporary variances may not be issued to allow use of 

any practice, material, or procedure which is prohibited under section 205.105. 

The proposed rule inadvertently omitted the SOP's governing State official as having authority to 

recommend a temporary variance to the Administrator. We have added that authority in 

paragraph (b) of section 205.290. 

Upon notification by the Administrator that a temporary variance has been established, the 

certifying agent must inform each production and handling operation it certifies that may be 

affected by the temporary variance. For example, if a drought causes a severe shortage of 

organically produced hay, a dairy operation may be permitted to substitute some nonorganic hay 

for a portion of the herd's diet to prevent liquidation of the herd. The producer must keep records 

showing the source and amount of the nonorganic hay used and the timeframe needed to restore 

the total feed ration to organic sources. The certifying agent may require that the next organic 

plan include contingency measures to avoid the need to resort to nonorganic feed in case of a 

future shortage. 

General - Changes Based on Comments

This subpart differs from the proposal in several respects as follows: (1) Maintain or Improve 

Provision for Production Operations Only. A number of commenters questioned whether the 

requirement in the proposed rule that an operation must "maintain or improve the natural 

resources of the operation, including soil and water quality" applied to handling as well as 

production operations. They stated that handling operations are not integrated into natural 

systems the way that production systems are. As a result, these commenters were uncertain how 

handlers could fulfill the "maintain or improve" requirement. 

The "maintain or improve" requirement addresses the impact of a production operation on the 

natural resource base that sustains it and, as such, does not apply to handling operations. We 

have modified the final rule in section 205.200 by limiting the "maintain or improve" requirement 

to production practices. 

(2) Management Practices and Physical Barriers to Prevent Commingling. Many commenters, 

including numerous certifying agents, stated that the proposed provisions for an organic system 

plan were not adequate for the task of certifying an operation that produces both organic and 

nonorganic products. The commenters requested that the final rule incorporate the provisions 

established in the OFPA for certifying these split operations. These provisions include separate 

recordkeeping for the organic and nonorganic operations and the implementation of protective 

practices to prevent the commingling of product and the unintentional contact of organic product 

with prohibited substances. We have amended the provisions for an organic system plan in 

section 205.201(a)(5) to require greater accountability regarding the segregation of organic and 

nonorganic products in a split operation. The changes we made incorporate language from the 

OFPA ("physical facilities, management practices") to provide clear criteria for producers, 
handlers and certifying agents to agree upon an organic system plan that protects the integrity of 

organic product. 

(3) Commercial Availability. The proposed rule required that a raw or processed agricultural 

product sold, labeled, or represented as organic must contain not less than 95 percent organically 

produced raw or processed agricultural product. Additionally, section 205.606 of the proposed 

rule allowed any nonorganically produced agricultural product to be used in the 5 percent 

nonorganic component of an agricultural product sold, labeled, or represented as organic. Many 

commenters objected to these provisions and recommended that nonorganically produced 

agricultural products should only be allowed in an organic product when the organically produced 

form was not commercially available. Commenters stated that allowing nonorganically produced 

agricultural products within the 5 percent would significantly weaken demand for many organically 

produced commodities, especially herbs and spices. These commenters stated that herbs and 

spices often constitute less than 5 percent of the ingredients in a raw or processed agricultural 

product and that handlers producing an organic product would instinctively seek out the less 

expensive nonorganic variety. They also indicated that the 5 percent component is an important 

market for many products produced from organically produced livestock, such as milk derivatives 

and meat by-products, that are not typically marketed directly to consumers. Commenters stated 

that the preponderance of current certification programs use the commercial availability criterion 

when determining whether a nonorganically produced agricultural product may be used within the 

5 percent component. Commenters cited the National Organic Standards Board's (NOSB) 

recommendation that organic agricultural products be used in this 5 percent component unless 

they are commercially unavailable and requested that the final rule incorporate the criteria for 

determining commercial availability that accompanied that NOSB recommendation. 

We agree with commenters that a preference for organically produced agricultural commodities, 

when commercially available, can benefit organic producers, handlers, and consumers in a 

variety of ways. We believe that the commercial availability requirement may allow consumers to 

have confidence that processed products labeled as "organic" contain the highest feasible 

percentage of organic ingredients. Some producers may benefit from any market incentive to 

supply organically produced minor ingredients that handlers need for their processed products. 

We recognize that the provision does impose an additional requirement on handlers who must 

ascertain whether the agricultural ingredients they use are commercially available in organic form. 

The NOSB recommended that the final rule contain a commercial availability provision based 

upon the guidelines developed by the American Organic Standards project of the Organic Trade 

Association. For these reasons, we have amended the final rule to require that an agricultural 

commodity used as an ingredient in a raw or processed product labeled as organic must be 

organic when the ingredient is commercially available in an organic form. 

While recognizing the potential benefits of applying the commercial availability standard to all 

agricultural ingredients in a processed product, we are concerned that enforcing this provision 

could impose an excessive burden on handlers. Although many commenters stated that some 

existing certifying agents apply a commercial availability standard, we do not have complete 

information on the criteria used by these certifying agents, and we are unsure whether a 

consensus exists on criteria for commercial availability within the organic community. Additionally, 

we are concerned that, unless the standard is clearly articulated and consistently interpreted and 

enforced, it will not be effective. Disagreement among certifying agents regarding when and 

under what circumstances an ingredient is commercially available would undermine our intent to 

create an equitable and enforceable standard. 

AMS is soliciting additional comment and information on a number of issues concerning the 

development of standards for the commercial availability of organically produced agricultural 

commodities used in processed products labeled as "organic." On the basis of these comments 

and information and additional recommendations that the NOSB may develop, AMS will develop 

a commercial availability standard for use in implementing the final rule. AMS intends to develop 
the commercial availability standard and incorporate it within the final rule prior to the 

commencement of certification activities by accredited certifying agents. This approach will 

provide organic handlers and certifying agents the standard necessary to incorporate the 

consideration of commercial availability of ingredients in an organic system plan at the time that 

the USDA organic standard comes into use. Specifically, AMS requests comments and 

information addressing the following questions: 

What factors, such as quantity, quality, consistency of supply, and expense of different sources of 

an ingredient, should be factored into the consideration of commercial availability? What relative 

importance should each of these factors possess, and are there circumstances under which the 

relative importance can change? 

What activities and documentation are sufficient to demonstrate that a handler has taken 

appropriate and adequate measures to ascertain whether an ingredient is commercially 

available? 

How can AMS ensure the greatest possible degree of consistency in the application of the 

commercial availability standard among multiple certifying agents? 

Could potentially adverse effects of a commercial availability standard, such as uncertainty over 

the cost and availability of essential ingredients, impact or impede the development of markets for 

organically processed products? 

What economic and administrative burdens are imposed by the commercial availability standards 

found in existing organic certification programs? 

How would producers benefit from market incentives to increase use of organic ingredients that 

result from a commercial availability standard? 

Would lack of a commercial availability standard provide a disincentive for handlers of products 

labeled "organic" to seek out additional organic minor ingredients? What impacts could this have 

on producers of minor ingredients? 

AMS welcomes any new or unpublished research results or information that exists concerning a 

commercial availability standard. AMS specifically invites comment from establishments which 

currently operate using commercial availability or a comparable provision in the conduct of their 

business. AMS will receive comment on this issue until 90 days after publication of the final rule. 

(4) Conservation of Biodiversity. Many commenters recommended amending the definition of 

organic production to include the requirement that an organic production system must promote or 

enhance biological diversity (biodiversity). Commenters stated that the definitions for organic 

production developed by the NOSB and the Codex Commission include this requirement. We 

agree with these commenters and have amended the definition of organic production to require 

that a producer must conserve biodiversity on his or her operation. The use of "conserve" 

establishes that the producer must initiate practices to support biodiversity and avoid, to the 

extent practicable, any activities that would diminish it. Compliance with the requirement to 

conserve biodiversity requires that a producer incorporate practices in his or her organic system 

plan that are beneficial to biodiversity on his or her operation. 

General - Changes Requested But Not Made

This subpart retains from the proposed rule regulations on which we received comments as 

follows: 
Organic Plan Excessively Restrictive. One organic inspector was concerned that the 

requirements of the organic system plan were too prescriptive and would create an excessive 

paper work burden for producers and handlers. The commenter stated that the excessive 

specificity of certain requirements (composition and source of every substance used), combined 

with the ambiguity of others (soil and tissue testing required but with no mention of the 

frequency), would confuse the working relationship between a producer or handler and his or her 

certifying agent. The commenter was concerned that strict adherence to the specifications in the 

organic system plan would compromise the ability of producers and handlers to run their 

businesses. While agreeing that flexibility in the development of the organic system plan was 

valuable, the commenter stated that producers and handlers, not the certifying agent, must retain 

the primary managerial role for their operation. Other commenters maintained that the organic 

system plan requirements were too ambiguous and would inhibit certifying agents' efforts to 

review necessary information. For example, a trade association commented that the absence of 

specific recordkeeping requirements for livestock feed materials, medications, and health care 

activities would impair compliance monitoring. 

The provisions for an organic system plan were one of the most significantly revised components 

of the proposed rule, and, with minor changes related to split operations, we have retained them 

in the final rule. These provisions provide ample discretion for producers, handlers, and certifying 

agents to perform their duties while recognizing that mutual consent is a prerequisite for them to 

meet their responsibilities. The organic system plan enables producers and handlers to propose 

and certifying agents to approve site and operation-specific practices that fulfill all applicable 

program requirements. Producers and handlers retain the authority to manage their operations as 

they deem necessary, but any actions they undertake that modify their organic system plan must 

be approved by the certifying agent. With regard to recordkeeping, certifying agents are 

authorized to require the additional information, such as the livestock records mentioned in the 

comment, that they deem necessary to evaluate compliance with the regulations. 

One certifying agent stated that the requirement to maintain or improve the natural resources of 

the operation was worthy in principle but unreasonable to achieve. This commenter stated that 

the long-term consequences of an organic system plan could not be foreseen and recommended 

requiring that producers "must endeavor" to maintain or improve the operation's natural 

resources. We have not changed this requirement because the vast majority of commenters 

supported an organic system plan that mandated the "maintain or improve" principle. A good 

working relationship between the producer and his or her certifying agent, including the annual 

inspection and accompanying revisions to the organic system plan, can rectify the unforeseen 

and unfavorable conditions that arise. 

Crop Production - Changes Based on Comments

This subpart differs from the proposal in several respects as follows: 

(1) Crop nutrient management. The fundamental requirement of the soil fertility and crop nutrient 

management practice standard, that tillage, cultivation, and nutrient management practices 

maintain or improve the physical, chemical, and biological condition of the soil and minimize 

erosion, remains unaltered. The proposed rule required that a producer budget crop nutrients by 

properly utilizing manure or other animal and plant materials, mined substances of low or high 

solubility, and allowed synthetic amendments. Many commenters disagreed with using the term, 

"budget," which they considered too limiting to characterize nutrient management in organic 

systems. These commenters recommended that the practice standard instead emphasize the 

diverse practices used in organic systems to cycle nutrients over extended periods of time. 

We agree with these commenters and have amended the final rule to require that producers 

manage crop nutrients and soil fertility through the use of crop rotations and cover crops in 

addition to plant and animal materials. Additionally, we clarified that producers may manage crop 
nutrients and soil fertility by applying mined substances if they are used in compliance with the 

conditions established in the National List. Finally, we removed the word, "waste," from our 

description of animal and plant materials in the proposed rule to emphasize the importance of 

these resources in organic soil fertility management. 

(2) Compost Practice Standard. The proposed rule required that a composted material used on 

an organic operation must be produced at a facility in compliance with the Natural Resource 

Conservation Service (NRCS) practice standard. While many commenters agreed with the need 

for greater oversight of the feedstocks and procedures used to produce compost, most stated that 

the NRCS practice standard would not be suitable for this purpose. Commenters stated that the 

requirements in the NRCS practice standard were not designed for organic operations and would 

prohibit many established, effective composting systems currently used by organic producers. For 

example, adoption of the NRCS practice standard would prevent producers from using nonfarm 

wastes as compost feedstocks. Materials such as food processing by-products and leaves from 

curbside collection programs have long been used with beneficial results. 

Commenters also stated that the minimum acceptable requirements for the design, construction, 

and operation of a composting facility contained in the practice standard were appropriate for a 

voluntary cost share program but were excessive as a compliance requirement for organic 

certification. Commenters questioned whether producers could justify the investment of time and 

resources needed to comply with the multiple design and operation criteria specified in the NRCS 

practice standard. 

We agree with commenters who stated that, given the diversity of composting systems covered 

by a national organic standard, requiring full compliance with the NRCS practice standard would 

be overly prescriptive. We maintain, however, that implementation of the OFPA requires a 

rigorous, quantitative standard for the production of compost. The OFPA contains significant 

restrictions on applying raw manure that are reflected in the soil fertility and crop nutrient 

management practice standard. These restrictions pertain to raw manure and do not apply once 

fresh animal materials are transformed into a composted material. An organic producer using a 

composted material containing manure must comply with the nutrient cycling and soil and water 

conservation provisions in his or her organic system plan but is not constrained by the restrictions 

that apply to raw manure. Therefore, producers intending to apply soil amendments will require 

clear and verifiable criteria to differentiate raw manure from composted material. 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 are 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 windrow 

composting systems are consistent with that EPA regulates under 40 CFR Part 503 for the 

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

requirements with USDA's Agricultural Research Service (ARS). 

The conditions in the final rule for producing an allowed composted material begin with the 

selection of appropriate feedstocks. The producer's first responsibility is to identify the source of 

the feedstocks used in the composting system. This requirement ensures that only allowed plant 

and animal materials are included in the composting process, that they are not contaminated with 

prohibited materials, and that they are incorporated in quantities suitable to the design of the 

composting system. Certifying agents will exercise considerable discretion for evaluating the 

appropriateness of potential feedstock materials and may require testing for prohibited 

substances before allowing their use. For example, a certifying agent could require a producer to 

monitor off-farm inputs such as leaves collected through a municipal curbside program or organic 

wastes from a food processing facility. Monitoring may be necessary to protect against 

contamination from residues of prohibited substances, such as motor oil or heavy metals, or 

gross inert materials such as glass shards that can enter the organic waste stream. 
The final rule further requires that the producer adhere to quantitative criteria when combining 

and managing the plant and animal materials that are being composted. When combining 

feedstocks to initiate the process, producers must establish a C:N ratio of between 25:1 and 40:1. 

This range allows for very diverse combinations of feedstock materials while ensuring that, when 

properly managed, the composting process will yield high quality material. While some 

commenters maintained that specifying any C:N ratio in the final rule would be too restrictive, it 

would be far more problematic not to establish a range. The 25:1 to 40:1 range ensures that 

producers will establish appropriate conditions under which the additional requirements in this 

practice standard, most notably the time and temperature criteria, can be achieved with minimal 

producer oversight. Composting operations using a C:N ratio lower than 25:1 require increasingly 

intensive management as the ratio drops due to the risk of putrefaction. Operations in excess of 

the 40:1 range may achieve the minimum temperature but are likely to drop off quickly and result 

in a finished material that is inadequately mature and deficient in nitrogen. The producer is not 

required to perform a physical analysis of each feedstock component if he or she can 

demonstrate that an estimated value is reliable. For example, estimates of the carbon and 

nitrogen content in specific manures and plant materials are generally recognized. Other 

feedstocks of consistent quality may be tested once and assumed to approximate that value. 

The producer must develop in his or her organic system plan the management strategies and 

monitoring techniques to be used in his or her composting system. To produce an allowed 

composted material, the producer must use an in-vessel, static aerated pile, or windrow 

composting system. Producers using an in-vessel or static aerated pile system must document 

that the composting process achieved a temperature between 131F and 170F and maintained 

that level for a minimum of 3 days. Producers using a windrow composting system must 

document that the composting process achieved a temperature between 131F and 170F and 

maintained that level for a minimum of 15 days. Compost produced using a windrow system must 

be turned five times during the process. These time and temperature requirements are designed 

to minimize the risk from human pathogens contained in the feedstocks, degrade plant pathogens 

and weed seeds, and ensure that the plant nutrients are sufficiently stabilized for land application. 

The final rule does not contain provisions for the use of materials commonly referred to as 

"compost teas." A compost tea is produced by combining composted plant and animal materials 

with water and a concentrated nutrient source such as molasses. The moisture and nutrient 

source contribute to a bloom in the microbial population in the compost, which is then applied in 

liquid form as a crop pest or disease control agent. The microbial composition of compost teas 

are difficult to ascertain and control and we are concerned that applying compost teas could 

impose a risk to human health. Regulation of compost teas was not addressed in the proposed 

rule. The National Organic Program (NOP) will request additional input from the NOSB and the 

agricultural research community before deciding whether these materials should be prohibited in 

organic production or whether restrictions on their use are appropriate. 

In addition to managing crop nutrients with raw manure and composted plant and animal 

materials, a producer may use uncomposted plant materials. These are materials derived 

exclusively from plant sources that a producer manages in a manner that makes them suitable for 

application in a cropping system. For example, plant materials that are degraded and stabilized 

through a vermicomposting process may be used as a soil fertility and crop nutrient amendment. 

(3) Mined Substances of High Solubility. The proposed rule treated mined substances of high 

solubility as a single category of soil amendment and allowed their use where warranted by soil 

and crop tissue testing. Many commenters objected to the general allowance for this category of 

substances and were particularly disappointed that the NOSB annotations on two such materials, 

sodium (Chilean) nitrate and potassium chloride, were not included. Commenters cited the 

potential detrimental effects of these highly soluble and saline substances on soil quality and 

stated that several international organic certification programs severely prescribe or prohibit their 

use. One certifying agent recommended that natural substances of high solubility and salinity be 
handled comparably to similar synthetic materials such as liquid fish products and humic acids 

that appear on the National List, complete with their original NOSB annotations. 

At its June 2000 meeting, the NOSB recommended that the NOP delete general references to 

mined substances of high solubility from the final rule, and incorporate the NOSB's specific 

annotations for materials of this nature. We have adopted this recommendation by retaining a 

place for mined substances of high solubility in the soil fertility and crop nutrient management 

practice standard but restricting their use to the conditions established for the material as 

specified on the National List of prohibited natural substances. Under this approach, mined 

substances of high solubility are prohibited unless used in accordance with the annotation 

recommended by the NOSB and added by the Secretary to the National List. We deleted the 

provision from the proposed rule that use of the substance be "justified by soil or crop tissue 

analysis." The final rule contains two materials--sodium nitrate and potassium chloride--that may 

be used in organic crop production with the annotations developed the NOSB. 

While "mined substances of high solubility" is not a discrete, recognized category such as crop 

nutrients, the proposed rule mentioned sodium nitrate, potassium chloride, potassium nitrate 

(niter), langbeinite (sulfate of potash magnesia), and potassium sulfate in this context. Based on 

the recommendation of the NOSB, the final rule would prohibit use of these materials, unless the 

NOSB developed recommendations on conditions for their use and the Secretary added them to 

the National List. The NOP would welcome further guidance from the NOSB on these materials. 

(4) Burning crop residues. The proposed rule prohibited burning as a means of crop disposal, 

except for burning prunings from perennial crops to suppress the spread of disease. Many 

commenters supported the principle behind the prohibition but maintained that the proposed 

language was too restrictive and would preclude certain beneficial agronomic practices. Several 

producers stated that the proposed rule would prevent them from collecting and burning residues 

from diseased annual crops, which they felt was an effective and beneficial practice. Other 

producers cited their use of prescriptive burning as a management practice for certain native or 

wild crops. As evidenced by the allowance for burning to suppress disease with perennial crops, 

the proposed rule was not designed to preclude the selective use of fire in organic production. We 

agree with the commenters that a more flexible allowance for the practice is warranted, and we 

have amended the provision to allow burning of annual and perennial crop residues for the 

suppression of disease and to stimulate seed germination. Producers must establish their need 

and procedures for burning in their organic system plan, and the practice cannot be used solely to 

remove crop debris from fields. (5) Requirement for Organic Seed in Sprout Production. The 

proposed rule allowed nonorganically produced seeds for all purposes, including sprout 

production, when the certifying agent concurred with the producer that organically produced 

seeds were not commercially available. While commenters predominately supported this 

approach with seed used for planting, they were virtually unanimous in stating that it is never 

appropriate to allow nonorganically produced and handled seeds in organic sprout production. 

Commenters cited the NOSB's June 1994 recommendation that seed used for the production of 

edible sprouts shall be organically produced and stated that existing certification standards do not 

provide an exemption based on commercial availability. We agree with these commenters and 

have modified the final rule to require that organic seed must be used for the production of edible 

sprouts. 

(6) Mitigating the Effects of a Biological, Botanical, or Synthetic Substance. The proposed rule 

required that producers who used a biological or botanical substance or an allowed synthetic 

substance to control crop pests, weeds, or disease evaluate and mitigate the effects of repetitive 

use of the same or similar substances. While agreeing that pest resistance and shifts in pest 

populations were important considerations, commenters stated that managing these issues was 

beyond the ability of individual operations. Commenters recommended that the NOP develop 

principles and practices for managing pest resistance and shifts in pest types that would apply to 

all production operations. We agree with these comments and have deleted the requirement to 
evaluate and mitigate the effects of using the same or similar crop pest, weed, or disease control 

substances. The final rule requires that producers document the use of such substances in their 

organic systems plans, subject to the approval of their certifying agent. 

(7) Prohibition on Use of Treated Lumber. The proposed rule did not specifically address the use 

of lumber that had been treated with a prohibited substance, such as arsenic, in organic 

production. Citing the explicit prohibition on these substances in existing organic standards, many 

commenters felt that treated lumber should be excluded in the final rule. Commenters also cited 

the NOSB's recommendation to prohibit the use of lumber treated with a prohibited substance for 

new construction and replacement purposes effective upon publication of the final rule. We have 

included a modified version of the NOSB's recommendation within the crop pest, weed, and 

disease management practice standard. This provision prohibits the use of lumber treated with 

arsenate or other prohibited materials for new installations or replacement purposes in contact 

with an organic production site. We included this modification to clarify that the prohibition applies 

to lumber used in direct contact with organically produced and handled crops and livestock and 

does not include uses, such as lumber for fence posts or building materials, that are isolated from 

production. The prohibition applies to lumber used in crop production, such as the frames of a 

planting bed, and for raising livestock, such as the boards used to build a farrowing house. (8) 

Greater Rigor in the Wild Harvest Production Organic System Plan. A number of commenters 

stated that the wild-crop harvesting practice standard was insufficiently descriptive and that the 

proposed rule failed to apply the same oversight to wild harvest operations as it did to those 

producing crops and livestock. Some commenters maintained that the proposed rule did not 

require a wild harvest producer to operate under an approved organic system plan. These 

commenters proposed specific items, including maps of the production area that should be 

required in a wild harvest operation's organic system plan. One commenter recommended that 

the definition for "wild crop" be modified to allow the harvest of plants from aquatic environments. 

We amended the practice standard for wild-crop harvesting to express the compliance 

requirements more clearly. Wild-crop producers must comply with the same organic system plan 

requirements and conditions, as applicable to their operation, as their counterparts who produce 

crops and livestock. Wild harvest operations are production systems, and they must satisfy the 

general requirement that all practices included in their organic system plan must maintain or 

improve the natural resources of the operation, including soil and water quality. We modified the 

practice standard to emphasize that wild harvest production is linked to a designated site and 

expect that a certifying agent would incorporate mapping and boundary conditions into the 

organic system plan requirements. Finally, we changed the definition of "wild crop" to specify that 

harvest takes place from a "site" instead of "from land," thereby allowing for aquatic plant 

certification. 

Crop Production - Changes Requested But Not Made

This subpart retains from the proposed rule regulations on which we received comments as 

follows: 

(1) Application of Raw Manure. The soil fertility and crop nutrient management practice standard 

in the proposed rule permitted the application of raw manure to crops not intended for human 

consumption and established restrictions for applying it to crops used for human food. For human 

food crops, the proposed rule required a 120-day interval between application and harvest of 

crops whose edible portion had direct contact with the soil or soil particles, and a 90-day interval 

for crops that did not. These provisions reflected the recommendations developed by the NOSB 

at its June 1999 meeting. The practice standard also required that raw manure must be applied in 

a manner that did not contribute to the contamination of crops, soil, or water by plant nutrients, 

pathogenic organisms, heavy metals, or residues of prohibited substances. 
The majority of commenters supported the provisions for applying raw manure. Some 

commenters stated that the provisions effectively balanced the benefits of applying raw manure to 

the soil with the environmental and human health risks associated with its use. These 

commenters stated that the lengthy intervals between application and harvest would not impose 

an unreasonable or unfeasible burden on organic producers. The NOSB strongly supported the 

provisions in the proposed rule, emphasizing that raw manure contributed significant benefits to 

soil nutrient, structure, and biological activity that other soil fertility practices and materials do not 

provide. Other commenters stated that the provisions were consistent with the requirements in 

existing organic standards and added that the restrictions were justifiable because they reflected 

responsible management practices. 

For differing reasons, a number of commenters disagreed with the proposed provisions. Some 

commenters cited the human health risks associated with pathogenic organisms found in raw 

manure and stated that the proposed intervals between application and harvest were not 

adequately protective. These commenters recommended that the NOP conduct more extensive 

risk assessment procedures before determining what, if any, intervals between application and 

harvest would adequately protect human health. Some of these commenters identified the risk 

assessment methodology and pathogen treatment procedures governing the production and use 

of sewage sludge as the most suitable precedent for guiding the additional work required in this 

area. Conversely, a number of commenters stated that the provisions in the proposed rule were 

excessive because they exceeded the minimum 60-day interval between application and harvest 

established in the OFPA. Many of these commenters recommended eliminating the distinction 

between crops that come into contact with soil or soil particles and those that don't and applying a 

uniform 60-day interval between harvest and application for any crop to which raw manure had 

been applied. Some commenters stated that the 120-day interval severely limited the flexibility of 

producers who operated in regions such as the Northeast where the growing season lasted only 

slightly longer. Other commenters maintained that the practice standard did not address specific 

practices, such as applying raw manure to frozen fields, that they maintained should be expressly 

prohibited. 

The responsibility to use raw manure in a manner that is protective of human health applies to all 

producers, whether organic or not, who apply such materials. We acknowledge the commenters 

who noted that the OFPA cites food safety concerns relative to manure use and, therefore, that 

food safety considerations should be reflected in the practice standard for applying raw manure in 

the final rule. Some of the commenters favored more extensive risk assessment procedures or 

lengthening the interval between application and harvest. We have not, however, changed the 

provisions for applying raw manure. 

Although public health officials and others have identified the use of raw manure as a potential 

food safety concern, at the present time, there is no science-based, agreed-upon standard for 

regulating the use of raw manure in crop production. The standard in this rule is not a public 

health standard. The determination of food safety demands a complex risk assessment 

methodology, involving extensive research, peer review, and field testing for validation of results. 

The only comparable undertaking in Federal rulemaking has been EPA's development of 

treatment and application standards for sewage sludge, an undertaking that required years of 

dedicated effort. The NOP does not have a comparable capacity with which to undertake a 

comprehensive risk assessment of the safety of applying raw manure to human food crops. To 

delegate the authority to determine what constitutes safe application of raw manure to certifying 

agents would be even more problematic. A certifying agent cannot be responsible for establishing 

a Federal food safety standard. Therefore, the standard in this rule is a reflection of AMS' view 

and of the public comments that this standard is reasonable and consistent with current organic 

industry practices and NOSB recommendations for organic food crop production. Should 

additional research or Federal regulation regarding food safety requirements for applying raw 

manure emerge, AMS will ensure that organic production practice standards are revised to reflect 

the most up-to-date food safety standard. 
Neither the identification of food safety as a consideration in the OFPA nor the inclusion of this 

practice standard in the final rule should be construed to suggest that organically produced 

agricultural products are any safer than nonorganically produced ones. USDA has consistently 

stated that certification is a process claim, not a product claim, and, as such, cannot be used to 

differentiate organic from nonorganic commodities with regard to food safety. National organic 

standards for manure use cannot be used to establish a food safety standard for certified 

commodities in the absence of as uniform Federal regulation to ensure the safety of all human 

food crops to which raw manure has been applied. The OFPA was designed to certify a process 

for informational marketing purposes. 

Neither have we changed the practice standard in response to comments that the requirement in 

the final rule should not exceed the 60-day interval contained in the OFPA. The OFPA clearly 

establishes that the interval must be no less than 60 days and does not preclude a longer 

standard. The NOSB has strongly supported the proposed 90- and 120-day intervals, and the 

vast majority of commenters indicated that these provisions would be feasible for virtually all 

organic cropping systems. The requirement in the practice standard that raw manure must be 

applied in a manner that does not contribute to the contamination of crops, soil, or water by plant 

nutrients, pathogenic organisms, heavy metals, or residues of prohibited substances provides 

certifying agents the discretion to prohibit specific practices that would not be in compliance. With 

this discretion, a certifying agent could prohibit practices, such as applying manure to frozen 

ground or too close to water resources, that many commenters stated were not appropriate for 

organic production. 

(2) No Prohibition on Manure from Nonorganic Operations. The proposed rule identified animal 

and plant waste materials as important components in soil fertility and crop nutrient management 

without providing criteria for distinguishing allowed and prohibited sources. A large number of 

commenters objected to this provision and stated that manure from nonorganic sources may 

contain residues from prohibited substances, including animal medications. These commenters 

maintained that some of these residues, such as antibiotics, may remain active for extended 

intervals, and others, such as heavy metals, could accumulate on the organic operation. 

Commenters stated that if either or both conditions prevailed, the integrity of the organic 

operation would be jeopardized. Many producers and certifying agents emphasized that the 

proposed rule conflicted with the Codex guidelines that prohibit the use of manure from factory 

farms. These commenters were concerned that failure to restrict the use of manure from 

nonorganic operations would put their products at a competitive disadvantage, particularly in 

European markets. When raising this issue, most commenters requested that the final rule either 

prohibit the use of manure from factory farms or state that certifying agents could regulate the 

practice by requiring residue testing and restrictions on application. 

We have not changed the provisions for using manure from nonorganic operations in the final 

rule. In many discussions on the subject throughout the years, the NOSB has never 

recommended that manure from nonorganic farms be prohibited. Existing organic certification 

standards routinely permit the use of manure from nonorganic operations with appropriate 

oversight, and the final rule incorporates a similar approach. Under the final rule, a certifying 

agent can require residue testing when there is reasonable concern that manure, either raw or as 

a component of compost, contains sufficient quantities of prohibited materials to violate the 

organic integrity of the operation. Providing certifying agents the discretion to require screening 

for prohibited materials will minimize the risk of introducing contaminants while maintaining the 

ecologically important practice of recycling organic material from nonorganic operations. 

Additionally, the final rule requires that producers apply manure and compost in a manner that 

maintains or improves the soil and water quality of their operation. This provision provides an 

additional safeguard that certifying agents may use to ensure that the application of any form of 

manure protects the natural resources of the operation. 
(3) Rotating a Field in and out of Organic Production. Some commenters stated that a producer 

should not be allowed to rotate fields on their operation in and out of organic production. These 

commenters were concerned that producers could apply prohibited substances that persisted for 

many years, such as soil fumigants, and begin harvesting organically produced crops after 3 

years. They stated that, without a prohibition on the rotation of fields in this manner, organic 

producers could effectively use a prohibited substance on their operation. 

We have not amended the final rule to prohibit the rotation of a field on an operation in and out of 

organic production. The statutory prohibition on the application of a prohibited substance is 3 

years, and this requirement is contained in section 205.202(b). This prohibition restricts the 

application of a prohibited substance, not its residual activity. If AMS receives evidence that the 

rotation of fields in this manner threatens to compromise organic production, the NOP and NOSB 

will collaborate on developing standards to remedy it. (4) Use of Seed Treatments on the National 

List. The seed and planting stock practice standard in the proposed rule generated a very diverse 

array of responses that, while largely favorable, highlighted a potentially disruptive impact on 

organic producers. The practice standard favored organic seed and planting stock over 

nonorganically produced but untreated varieties and nonorganically produced, untreated seed 

and planting stock over nonorganically produced seeds and planting stock treated with an 

allowed synthetic substance. Producers could use the less preferable seed or planting stock 

variety if they demonstrated to their certifying agent that an equivalent variety in the preferred 

form was not commercially available. Most commenters endorsed the principle of requiring 

organic seed and planting stock and agreed that the proposed provisions were a workable 

approach to enforcement. They stated that the provisions created an incentive for seed and 

planting stock providers to develop supplies for organic markets, yet enabled producers who 

made a good faith effort but failed to locate seed or planting stock in the preferred form the ability 

to continue producing organically. Most commenters indicated that this approach would support 

the existing market for organic seed and planting stock while fostering its continued development. 

A number of commenters, however, stated that the seed and planting stock practice standard 

was unreasonable and unworkable and would adversely affect organic producers. These effects 

would include significantly reduced planting options due to the nonavailability of seed in any 

allowed form and higher seed costs, which represent a significant percentage of the total 

production cost for some commodities. These commenters maintained that the three categories 

of seed and planting stock allowed in the order of preference could not reliably provide producers 

with many commercial varieties currently being planted. They pointed out that there were no 

synthetic seed treatments on the National List in the proposed rule, thereby eliminating the use of 

treated seed in organic production. Commenters stated that producers often rely upon seed and 

planting stock varieties that are uniquely well adapted for their growing conditions or marketing 

requirements and that these particular varieties would very often not be available in untreated 

form. These commenters concluded that the proposed practice standard would compel many 

producers to abandon many tried and true varieties of seed and planting stock and perhaps 

phase out organic production entirely. One commenter maintained that the proposed rule's stated 

intention of using the practice standard to stimulate production of organic seed and planting stock 

was not within the purpose of the OFPA. 

We have not changed the seed and planting stock practice standard in response to these 

commenters because the prohibition on using synthetic materials not on the National List is a 

requirement of the OFPA. The final rule cannot allow producers to use synthetic seed treatments 

that have not been reviewed, favorably recommended by the NOSB, and added to the National 

List by the Secretary. The practice standard creates incentives for producers to seek out seed 

and planting stock inputs that are the most compatible with organic production, yet includes 

allowances when preferred forms are not commercially available. While no seed treatments are 

included on the National List in the final rule, individuals may petition the NOSB for review of such 

substances. Additionally, the practice standard creates an incentive for seed and planting stock 

producers and suppliers to develop natural treatments suitable for organic systems that would not 
need to appear on the National List. The objectives of spurring production of organically grown 

seed and promoting research in natural seed treatments are compatible with the OFPA's purpose 

of facilitating commerce in organically produced and processed food. We designed the practice 

standard to pursue these objectives while preventing the disruption that an ironclad requirement 

for organically produced seed and planting stock may have caused. (5) Practice Standard for 

Maple Syrup. Many commenters stated that the proposed rule lacked production and handling 

standards for operations that produce maple syrup. Commenters stated that maple syrup 

production is a significant enterprise for many organic producers and that the absence of a 

practice standard in the final rule would adversely affect existing markets for organic products. 

Many commenters recommended that the final rule incorporate the maple syrup practice standard 

from an existing certification program or the American Organic Standards. 

We have not included a practice standard for the production and handling of maple syrup 

because the final rule contains sufficient provisions for the certification of these types of 

operations. After reviewing existing practice standards for maple syrup, we determined that the 

standards in the final rule for crop production, handling operations, and allowed and prohibited 

materials on the National List provided comparable guidance. 

Crop Production - Clarifications

Clarification is given on the following issues raised by commenters: 

(1) Applicability of Crop Rotation Requirement to all Operations. One State program commented 

that the crop rotation practice standard in the proposed rule was unreasonable for producers who 

operated in regions where limited rainfall and irrigation resources or unique soil conditions made 

cover cropping impractical. This commenter stated that certain dryland cropping systems, such as 

aloe vera production, function as "semi-perennial" systems that do not include rotations, yet fulfill 

the objectives of the crop rotation practice standard. A certifying agent expressed a similar 

concern by suggesting that the crop rotation practice standard be changed by adding "may 

include, but is not limited to" prior to the list of allowed management practices. This commenter 

felt that the "may include" clause afforded individual growers greater discretion by acknowledging 

that not every allowed management practice would be applicable to all operations. 

We have retained the language from the proposed rule because it already provides the flexibility 

to develop site-specific crop rotation practices requested by these commenters. The regulation as 

originally written includes the " but not limited to" clause that allows producers to include 

alternative management practices in their organic system plan. Additionally, the regulation states 

that the producer must implement a crop rotation that provides the required functions "that are 

applicable to the operation." This further establishes that the crop rotation component of an 

organic system plan must be considered within the context of site-specific environmental 

conditions including climate, hydrology, soil conditions, and the crops being produced. The final 

rule requires implementation of a crop rotation, but the producer and certifying agent will 

determine the specific crops and the frequency and sequencing of their use in that rotation. Crop 

rotations must fulfill the requirements of this practice standard--to maintain or improve soil organic 

matter content, provide for pest management, manage deficient or excess plant nutrients, and 

control erosion--and are not obligated to use any specific management practice. We structured 

this and other practice standards, as well as the requirements of the organic system plan, to 

enable producers and certifying agents to develop organic system plans adapted to natural 

variation in environmental conditions and production systems. 

(2) Excluding Annual Seedlings from Planting Stock. The proposed rule allowed a producer to 

use nonorganically produced seeds and planting stock if organically produced equivalent varieties 

were not commercially available. Several commenters, including the NOSB, were concerned that 

the definition of 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. While many commenters, including the NOSB, supported the 

commercial availability exemption in the case of seeds and planting stock, they objected to 

extending it to annual seedlings. The proposed rule did not intend to include annual seedling 

within the definition of planting stock and included a separate definition of "annual seedling" as "a 

plant grown from seed that will complete its life cycle or produce a harvestable crop yield within 

the same crop your or season in which it is planted." The proposed rule addressed annual 

seedlings as a distinct category within the seed and planting stock practice standard. There was 

no allowance for using nonorganically produced annual seedlings based on commercial 

availability, and such seedlings can only be used when a temporary variance has been issued 

due to a catastrophic business interruption. The growth of markets for organically produced 

annual seedlings, unlike those for seeds and planting stock, obviates the need for the commercial 

availability provision. We have retained this approach in the final rule. 

Livestock Production - Changes Based on Comments

This subpart differs from the proposal in several respects as follows: 

(1) Whole Herd Conversion. The proposed rule required that livestock receive 1 year of 

continuous organic management prior to the milk or milk products they produce being labeled as 

organic. Based on the feed provisions in that proposal, producers would be required to provide a 

100-percent organic feed ration (exclusive of National List substances allowed as feed 

supplements and additives) for that entire year. Many producers, consumers, State certification 

programs, and certifying agents commented that the full year organic feed requirement created 

an insurmountable barrier for small and medium-size dairy operations wishing to convert to 

organic production. They maintained that the added expense of a full year, 100-percent organic 

feed requirement was economically prohibitive. These commenters stated that "new entry" or 

"whole herd" conversion provisions in existing certification standards have been instrumental in 

enabling established nonorganic dairies to make the transition to organic production. 

Commenters stated that these provisions typically allow producers to provide livestock 80-percent 

organic or self-raised feed for the first 9 months of a herd's transition, before requiring 100-

percent organic feed for the final 3 months. Some commenters stated that many current organic 

dairies had capitalized on this whole herd conversion provision and that the consistent growth in 

demand for organic milk and milk products reflected consumer acceptance of the principle. 

At its June 2000 meeting, the NOSB reiterated its prior endorsement of the conversion principle 

for operations that jointly convert dairy herds and the land on which they are raised. The NOSB 

recommended allowing a producer managing an entire, distinct herd to provide 80-percent 

organic or self-raised feed during the first 9 months of the final year of conversion, and 100-

percent organic feed for the final 3 months. The recommendation further required that dairy 

animals brought onto an organic dairy must be organically raised form the last third of gestation, 

except that feed produced on land managed under an organic system plan could be fed to young 

stock up to 12 months prior to milk production. 

While the preponderance of comments supported the whole herd conversion provision, a 

significant number of individuals, certifying agents, and State certification programs opposed it. 

Some commenters felt that requiring less than 1 full year of 100-percent organic feed would not 

satisfy consumer expectations for an organically managed dairy. Other commenters stated that 

the whole herd conversion merely favored one segment of organic producers over another. They 

maintained that the full year, 100-percent organic feed requirement would stimulate markets for 

organically produced hay and grain, thereby rewarding good row crop rotation. One certifying 

agent was concerned that the conversion provision would create a permanent exemption and that 

split operation dairies could use it repeatedly to bring nonorganic animals into the organic 

operation. 
The final rule contains a provision for whole herd conversion that closely resembles those found 

in the NOSB recommendation and the existing certification standards. The final rule requires that 

an entire, distinct dairy herd must be under organic management for 1 year prior to the production 

of organic milk. During the first 9 months of that year, the producer must provide a feed ration 

containing a minimum of 80-percent organic feed or feed that is raised from land included in the 

organic system plan and managed in compliance with organic crop requirements. The balance of 

the feed ration may be nonorganically produced, but it must not include prohibited substances 

including antibiotics or hormones. The producer must provide the herd 100-percent organic feed 

for the final 3 months before the production of organic milk. The producer must comply with the 

provisions in the livestock health and living conditions practice standard during the entire year of 

conversion. After the dairy operation has been certified, animals brought on to the operation must 

be organically raised from the last third of gestation. We did not incorporate the NOSB's 

recommendation to provide young stock with nonorganic feed up to 12 months prior to the 

production of certified milk. By creating an ongoing allowance for using nonorganic feed on a 

certified operation, this provision would have undermined the principle that a whole herd 

conversion is a distinct, one-time event. 

We anticipate that the provisions added to the final rule will address the concerns of commenters 

who objected to the conversion principle. Consumers have embraced milk and milk products from 

dairies certified under private whole herd conversion provisions essentially identical to that in the 

final rule. While the conversion provision may temporarily reduce demand for organic feed 

materials, it encourages producers to develop their own supplies of organic feed. The conversion 

provision also rewards producers for raising their own replacement animals while still allowing for 

the introduction of animals from off the farm that were organically raised from the last third of 

gestation. This should protect existing markets for organically raised heifers while not 

discriminating against closed herd operations. Finally, the conversion provision cannot be used 

routinely to bring nonorganically raised animals into an organic operation. It is a one-time 

opportunity for producers working with a certifying agent to implement a conversion strategy for 

an established, discrete dairy herd in conjunction with the land resources that sustain it. 

(2) Organic Management for Livestock from the Last Third of Gestation. The proposed rule 

required that organically managed breeder and dairy stock sold, labeled, or represented as 

organic slaughter stock must be under continuous organic management from birth. Many 

commenters stated that this requirement was an inappropriate relaxation of most existing organic 

standards, which require organic management for all slaughter stock from the last third of 

gestation. These commenters cited the NOSB's 1994 recommendation that all slaughter stock 

must be the progeny of breeder stock under organic management from the last third of gestation 

or longer. Commenters also recommended extending the organic management provision to cover 

the last third of gestation to make it consistent with the requirements in section 205.236(a)(4) for 

the organically raised offspring of breeder stock. We agree with the argument presented by 

commenters and have changed the final rule to require that breeder or dairy stock be organically 

raised from the last third of gestation to be sold as organic slaughter stock. 

(3) Conversion Period for Nonedible Livestock Products. The proposed rule required that 

livestock must be under continuous organic management for a period not less than 1 year before 

the nonedible products produced from them could be sold as organic. Several commenters 

questioned the basis for creating different origin of livestock requirements based on whether the 

operation intended to produce edible or nonedible products. These commenters stated that the 

OFPA does not sanction such a distinction, nor is it contained in existing certification standards. 

They questioned why the proposed rule created such a provision in the absence of a favorable 

NOSB recommendation. We agree that the creation of a separate origin of livestock requirement 

for animals intended to provide nonedible products could be confusing. We have changed this 

provision in the final rule to require that nonedible products be produced from livestock that have 

been organically managed from the last third of gestation. 
(4) Provisions for Feed Supplements and Feed Additives. The proposed rule provided that 

nonagricultural products and synthetic substances included on the National List could be used as 

feed additives and supplements. Many commenters stated that allowing nonagricultural products 

and synthetic substances as feed supplements contradicted the definition for "feed supplement" 

found in the proposed rule. That definition stipulated that a feed supplement must, itself, be a 

feed material, and the definition for "feed" in the proposed rule precluded using nonagricultural 

products and synthetic substances. These commenters requested that either the definition of 

"feed supplement" be changed to make it consistent with the allowance for nonagricultural 

products and synthetic substances or else that the term be dropped from the final rule. The Food 

and Drug Administration (FDA) recommended modifying the definitions for "feed additive" and 

"feed supplement" and further specifying the components required in a feed ration under the 

livestock health care practice standard. 

We amended the definition in the final rule to state that a feed supplement is "a combination of 

feed nutrients added to livestock feed to improve the nutritional balance or performance of the 

total ration." We retained the second component of the proposed definition, which described how 

a feed supplement could be offered to livestock. We amended 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." The definitions for "feed 

supplement" and "feed additive" in the proposed rule were originally recommended by the NOSB. 

While our intent in the proposed rule was to codify as fully as possible the recommendations of 

the NOSB, we agree with commenters that the proposed definitions were was incompatible with 

the overall provisions for livestock feed. The definitions in the final rule are consistent with the 

NOSB's objective to create clear distinctions between feed, feed supplements, and feed additives 

while clarifying the role for each within an organic livestock ration. We also incorporated FDA's 

recommendation to include protein and/or amino acids, fatty acids, energy sources, and fiber for 

ruminants as required elements of a feed ration in the livestock health care practice standard. 

These additions make the livestock health care practice standard more consistent with the 

National Research Council's Committee on Animal Nutrition's Nutrient Requirement series, which 

we cited in the proposed rule as the basis for feed requirements. 

Many commenters addressed provisions in the proposed rule to allow or prohibit specific 

materials and categories of materials used in livestock feed. Among these, some commenters 

questioned whether enzymes were defined as a feed additive and, therefore, allowed. One 

certifying agent requested guidance on the status of supplementing livestock feed with amino 

acids. At its October 1999 meeting, the NOSB discussed the Technical Advisory Panel (TAP) 

reviews on the use of enzymes and amino acids in livestock feed. The NOSB determined that 

natural sources of enzymes exist and that their use should be allowed in organic production. 

Their discussion of natural sources of enzymes concluded that enzymes derived from edible, 

nontoxic plants and nonpathogenic bacteria or fungi that had not been genetically engineered 

should be allowed as a nonorganic feed additive. The NOSB did not take a position on amino 

acids during this meeting but indicated that it would revisit the subject in the near future. Based 

on these recommendations, the final rule allows the use of natural enzymes but not amino acids 

as nonorganic feed additives. The NOSB's recommendation that natural sources of enzymes 

existed and were compatible with organic livestock production supports allowing them without 

adding them to the National List. Some commenters discussed the animal welfare and 

environmental benefits associated with providing amino acids in livestock feed and supported 

allowing them. However, without a recommendation from the NOSB that amino acids are natural 

or should be added to the National List as a synthetic, the final rule does not allow their use. 

Commenters questioned whether nonsynthetic but nonagricultural substances, such as ground 

oyster shells and diatomaceous earth, would be allowed in agricultural feed. In 1994, the NOSB 

recommended that natural feed additives can be from any source, provided that the additive is 

not classified as a prohibited natural on the National List. We agree with this recommendation 

and have amended the final rule to allow such materials as feed additives and supplements. The 
only additional constraint on these materials is that every feed, feed additive, and feed 

supplement be used in compliance with the Federal Food, Drug, and Cosmetic Act, as stated in 

section 205.237(b)(6). 

The NOSB recommended that ruminants maintained under temporary confinement must have 

access to dry, unchopped hay. Although this position was an NOSB recommendation and not 

part of the proposed rule, several commenters responded to it. Most of these commenters stated 

that the language was too restrictive and could preclude the use of many suitable forage 

products. One dairy producer stated that the requirement would not be practical for operations 

that mix hay with other feed components. We agree that the NOSB's proposed language is too 

prescriptive and have not included it in the final rule. 

(5) Provisions for Confinement. The proposed rule established the health, nutritional, and 

behavioral needs of the particular species and breed of animal as the primary considerations for 

determining livestock living conditions. The proposed rule also identified essential components of 

the practice standard, including access to shade, shelter, exercise areas, fresh air, and direct 

sunlight, while stating that species-specific guidelines would be developed in conjunction with 

future NOSB recommendations and public comment. Finally, the proposed rule outlined the 

conditions pertaining to animal welfare and environmental protection under which producers 

could temporarily confine livestock. 

While supportive of the underlying principles of this practice standard, the vast majority of 

commenters stated that the actual provisions suffered from a lack of clarity and specificity. Many 

commenters were concerned that the proposed rule did not adequately ensure access to the 

outdoors for all animals. While supportive of the access to pasture requirement for ruminant 

production, commenters stated that the final rule needed a clear definition of pasture to make the 

provision meaningful. Conversely, some commenters supported the less prescriptive approach 

adopted in the proposed rule. The NOSB added considerably to its earlier recommendations on 

livestock living conditions during its June 2000 meeting. 

Many commenters stated that the criteria identified as required elements in the provisions for 

livestock living conditions did not specifically include access to the outdoors. One commenter 

stated that the requirement that animals receive direct sunlight could be interpreted to simply 

require windows in livestock confinement facilities. Commenters were virtually unanimous that, 

except for the limited exceptions for temporary confinement, all animals of all species must be 

afforded access to the outdoors. Commenters also maintained that the outdoor area must 

accommodate natural livestock behavior, such as dust wallows for poultry and, in the case of 

ruminants, provide substantial nutrition. Many commenters specifically opposed dry lots as an 

allowable outdoor environment. The NOSB recommended that the final rule state that all livestock 

shall have access to the outdoors. As a result of these comments, we have revised the final rule 

to establish that access to the outdoors is a required element for all organically raised livestock. 

We further amended the final rule to include a definition of "pasture." The definition of "pasture" 

we included emphasizes that livestock producers must manage their land to provide nutritional 

benefit to grazing animals while maintaining or improving the soil, water, and vegetative 

resources of the operation. The producer must establish and maintain forage species-appropriate 

for the nutritional requirements of the species using the pasture. 

Numerous commenters requested clarification on species-specific living conditions, such as the 

use of cages for poultry and confinement systems for veal production. The use of continuous 

confinement systems including cages for poultry and veal production is incompatible with the 

requirement that organically raised livestock receive access to the outdoors and the ability to 

engage in physical activity appropriate to their needs. There will be times when producers must 

temporarily confine livestock under their care, but these instances must be supported by the 

exemptions to the outdoor access requirement included in the final rule. Other commenters 
requested additional guidance on whether confinement for the purpose of finishing slaughter 

stock would be allowed, and, if so, how long that confinement could last. Commenters who 

supported an allowance for finishing most often recommended that, in the case of cattle, 

confinement should not exceed 90 days. The final rule does not include a specific length of time 

that cattle or other species may be confined prior to slaughter. We will seek additional input from 

the NOSB and public comment before developing such standards. 

Several commenters questioned whether a Federal, State, or local regulation that required 

confinement would supersede the requirement for outdoor access. These commenters were 

aware of county ordinances that prohibited free ranging livestock production to protect water 

quality. Organic operations must comply with all Federal, State, and local regulations. At the 

same time, to sell, label, or represent an agricultural commodity as "100 percent organic," 

"organic," or "made with...," the producer or handler must comply with the all applicable 

requirements set forth in this regulation. Federal, State, or local regulations that prohibit a 

required practice or require a prohibited one will essentially preclude organic certification of the 

affected commodity within that jurisdiction. 

(6) Prohibition on Parasiticides During Lactation. The proposed rule provided that breeder stock 

could receive synthetic parasiticides included on the National List, provided that the treatment 

occurred prior to the last third of gestation for progeny that were to be organically managed. Many 

commenters supported this principle but were concerned that the wording would allow producers 

to administer parasiticides to lactating breeder stock while the offspring were still nursing. These 

commenters felt that such an allowance violated the intent of the provision because offspring 

could be exposed to systemic parasiticides or their residues through their mother's milk. The 

NOSB recommended a prohibition on using allowed synthetic parasiticides during lactation for 

progeny that are organically managed. We agree with these commenters and have modified the 

final rule to prohibit the treatment of organically managed breeder stock with allowed synthetic 

parasiticides during the last third of gestation or lactation. 

Livestock Production - Changes Requested But Not Made

This subpart retains from the proposed rule regulations on which we received comments as 

follows: 

(1) Prohibition on Factory Farms. Many commenters requested that the final rule prohibit the 

certification of "factory farms." These commenters stated that factory farms are dependent upon 

practices and materials that are inconsistent with or expressly prohibited in the OFPA. The final 

rule does not contain such a prohibition because commenters did not provide a clear, enforceable 

definition of "factory farm" for use in the final rule. All organic operations, regardless of their size 

or other characteristics, must develop and adhere to an approved organic system plan that 

complies with these regulations in order to be certified. (2) Nonorganic Feed Protocol. The 

proposed rule required that, except for nonagricultural products and synthetic substances 

included on the National List, a producer must provide livestock with a total feed ration composed 

of agricultural feed products, including pasture and forage, that is organically produced and, if 

applicable, handled. It also included provisions for temporary variances that, under very limited 

circumstances and with the approval of the certifying agent and the Administrator, would provide 

an exemption from specific production and handling standards. The preamble of the proposed 

rule described an emergency resulting in the unavailability of organic agricultural feed products as 

an example of a situation in which a temporary variance could be issued. Many commenters 

recommended that the final rule require a producer who received a temporary variance for a feed 

emergency to follow the order of preference for noncertified organic feed developed by the 

NOSB. This order of preference requires a producer to procure agricultural feed products from 

sources that are as close to complying with the standards for organic certification as possible. 

Commenters stated that adherence to the order of preference would most closely conform with 
the expectation of consumers that organically raised livestock received organic feed and would 

create an incentive for livestock feed producers to pursue certification. 

We have not included the NOSB's feed emergency order of preference in the final rule because it 

would be too prescriptive and difficult to enforce during an emergency. Receiving a temporary 

variance categorically exempts a producer from the provision for which it was issued, although 

that producer may not substitute any practice, material, or procedure that is otherwise prohibited, 

although that producer may not substitute any practice, material, or procedure that is otherwise 

prohibited under section 205.105 . Additionally, certified organic feed is far more available in 

terms of quantity and affordability than when the NOSB developed its order of preference in 1994. 

We anticipate that producers whose original supply of organic agricultural feed products is 

interrupted will be able to fill the shortfall through the marketplace. 

(3) Prohibition on Physical Alterations. The proposed rule required that producers perform 

physical alterations as needed to promote animal welfare and in a manner that minimizes pain 

and stress. This provision was one component of the health care practice standard that required 

producers to establish and maintain preventive livestock health care practices. We stated in the 

preamble that there was insufficient consensus from previous public comment to designate 

specific physical alterations as allowed or prohibited and envisioned working with producers, 

certifying agents, and consumers to achieve that goal. We requested comment on techniques to 

measure animal stress that could be used to evaluate whether specific physical alterations were 

consistent with the conditions established in the proposed rule. 

We received significant numbers of comments both opposing and supporting the provision in the 

proposed rule for performing physical alterations. Many commenters opposed any allowance for 

physical alterations and argued that such practices are cruel and debilitating to animals. These 

commenters maintained that modifications in breed selection, stocking densities, and the 

configuration of living conditions could achieve results similar to physical alterations without 

harming the animal. They stated that by adapting their production systems to promote the 

physical and psychological welfare of animals, producers could obviate the need for physical 

alterations. In particular, commenters cited physical alterations to the beaks and feet of poultry as 

unnecessary due to the availability of alternative production systems. Many commenters 

expressed concern that the allowance for physical alterations would facilitate the certification of 

large confinement operations. Commenters also stated that performing physical alterations was 

inconsistent with Codex guidelines and objected to the allowance before full public deliberation on 

the subject through the NOSB process. 

A large number of commenters stated that, if reasonable guidelines could be established, the 

allowance for physical alterations would be a beneficial, and even necessary, condition for 

organic livestock production. These commenters maintained that producers engage in physical 

alterations for the overall welfare of the flock or herd and that the pain and stress of performing 

them must be weighed against the pain and stress of not doing so. For example, these 

commenters cited the traumatic effect of cannibalism on poultry flocks that had not undergone 

beak trimming or the injuries caused by animals whose horns had not been removed. Many of 

these commenters stated that producers could reduce but not eliminate the need for physical 

alterations through alternative production practices such as breed selection and stocking 

densities. The NOSB supported the provision as written in the proposed rule, stating that it met 

the animal welfare requirements while allowing practices necessary for good animal husbandry. 

We have retained the proposed provision for physical alterations without taking any further 

position on whether specific practices are allowed or prohibited. We did not receive substantial 

new guidance on techniques to measure stress in animals due to physical alterations and have 

made no revisions in that regard. The final rule establishes that, when appropriately performed 

and within the context of an overall management system, specific physical alterations are 
allowed. It also mandates that, as an element of a preventative health care program, physical 

alterations must benefit the ultimate physical and psychological welfare of the affected animal. 

(4) Withdrawal for Synthetic Parasiticides in Lactating Livestock. The proposed rule required a 

90-day withdrawal period before milk and milk products produced from livestock treated with an 

allowed synthetic parasiticide could be labeled as organic. Referencing the statement in the 

preamble to the proposed rule that the 90-day withdrawal period was attributable to "consumer 

expectations of organically raised animals," a dairy producer commented that the provision 

ignored animal welfare and farm economic sustainability considerations. The commenter 

considered the 90-day withdrawal period capricious and problematic since, for bovine dairy 

operations, it would compel producers to either shorten an animal's natural drying off period, or 

lose 30 days of organic milk production. The commenter stated that the optimal extended 

withdrawal period for this situation would be 60 days since this is the approximate duration of a 

dairy cow's natural dry period. Under this approach, livestock requiring treatment could receive an 

allowed synthetic parasiticide at the time of drying off, thus allowing the withdrawal period to 

coincide with the natural 60-day period when the livestock were not lactating. Livestock could 

complete the withdrawal period prior to the birth of their offspring in approximately 60 days, at 

which time the mother's milk could again be sold as organic. The commenter maintained that the 

60-day period would satisfy consumer expectation for an extended withdrawal period after 

treatment with an allowed synthetic parasiticide without imposing an unnecessary constraint on 

the producer. 

We have retained the 90-day withdrawal period in the final rule. The provisions in the final rule for 

treating livestock with an allowed synthetic parasiticide reflect the 90-day withdrawal period 

recommended by the NOSB at its October 1999 meeting. The NOSB has the authority to 

reconsider this issue and propose an alternative annotation for the Secretary's consideration. 

(5) Delineation of Space Requirements for Animal Confinement. The proposed rule did not 

establish space requirements for livestock living conditions but stated that a producer must 

accommodate the health and natural behavior of animals under his or her care. Some 

commenters stated their preference for space requirements because they are more uniform and 

enforceable. These commenters stated that some existing certification standards include space 

requirements in standards for livestock living conditions and that Codex guidelines support this 

approach. While not disagreeing that space requirements could be an effective certification tool 

for organic livestock production systems, we have not incorporated any such provisions in the 

final rule. We anticipate that additional NOSB recommendations and public comment will be 

necessary for the development of space requirements. At its June 2000 meeting, the NOSB 

agreed that it would be premature to include space requirements in the final rule. 

(6) Access to pasture versus pasture-based. Commenters stated that the proposed rule's 

requirement that ruminants receive "access to pasture" did not sufficiently characterize the 

relationship that should exist between ruminants and the land they graze. Many of these 

commenters recommended that the final rule require that ruminant production be "pasturebased." Many commenters stated that the final rule needed a more explicit description of the 

relationship between livestock and grazing land. The NOSB shared this perspective and 

recommended that the final rule require that ruminant production systems be "pasture-based." In 

contrast, an organic dairy producer maintained that a uniform, prescriptive definition of pasture 

would not be appropriate in a final rule. This commenter stated that the diversity of growing 

seasons, environmental variables, and forage and grass species could not be captured in a single 

definition and that certifying agents should define pasture on a case-by-case basis. This 

commenter also disagreed with the "pasture-based" requirement, stating that pasture should be 

only one of several components of balanced livestock nutrition. Singling out pasture as the 

foundation for ruminant management would distort this balance and deprive other producers of 

the revenue and rotation benefits they generate by growing livestock feed. 
We retained the "access to pasture" requirement because the term, "pasture-based," has not 

been sufficiently defined to use for implementing the final rule. The final rule does include a 

definition for pasture, and retention of the "access to pasture" provision provides producers and 

certifying agents with a verifiable and enforceable standard. The NOP will work with the NOSB to 

develop additional guidance for managing ruminant production operations. 

(7) Stage of Production. The proposed rule contained provisions for temporary confinement, 

during which time livestock would not receive access to the outdoors. Many commenters were 

concerned that the stage-of-production justification for temporary confinement could be used to 

deny animals access to the outdoors during naturally occurring life stages, including lactation. 

Commenters overwhelmingly opposed such an allowance and stated that the stage of production 

exemption should be narrowly applied. One commenter stated that a dairy operation, for 

example, might have seven or eight distinct age groups of animals, with each group requiring 

distinct living conditions. Under these circumstances, the commenter maintained that a producer 

should be allowed to temporarily house one of these age groups indoors to maximize use of the 

whole farm and the available pasture. At its June 2000 meeting, the NOSB stated that the 

allowance for temporary confinement should be restricted to short-term events such as birthing of 

newborn or finish feeding for slaughter stock and should specifically exclude lactating dairy 

animals. 

We have not changed the provision in the final rule for the stage-of-production allowance in 

response to these comments. The NOSB has supported the principle of a stage-of-production 

allowance but has not provided sufficient guidance for determining, on a species-specific basis, 

what conditions would warrant such an allowance. Without a clearer foundation for evaluating 

practices, we have not identified any specific examples of practices that would or would not 

warrant a stage-of-production allowance. We will continue to explore with the NOSB specific 

conditions under which certain species could be temporarily confined to enhance their well-being. 

In the final rule, temporary confinement refers to the period during which livestock are denied 

access to the outdoors. The length of temporary confinement will vary according to the conditions 

on which it is based, such as the duration of inclement weather. The conditions for implementing 

temporary confinement for livestock do not minimize the producer's ability to restrain livestock in 

the performance of necessary production practices. For example, it is allowable for a producer to 

restrain livestock during the actual milking process or under similar circumstances, such as the 

administration of medication, when the safety and welfare of the livestock and producer are 

involved. 

Handling - Changes Based on Comments

The following changes are made based on comments received. 

(1) Commercial Availability. A large number of commenters, including organic handlers and 

certifying agents, stated that "commercial availability" must be included as a requirement for the 5 

percent of nonorganic ingredients that are used in products labeled "organic." 

We agree and have added a commercial availability requirement as part of a handler's organic 

system plan under section 205.201 of this subpart. Up to 5 percent (less water and salt) of a 

product labeled "organic," may be nonorganic agricultural ingredients. However, handlers must 

document that organic forms of the nonorganic ingredients are not commercially available before 

using the nonorganic ingredients. 

(2) Prohibited Practices. Commenters were unclear about the extent of the prohibition on use of 

excluded methods and ionizing radiation. To make that prohibition clear, we have moved the 

handling prohibitions in proposed rule sections 205.270 (c) to 205.105, Applicability, subpart B. 
Paragraphs (c)(1) and (c)(2) which listed excluded methods and ionizing radiation in the proposed 

rule are combined into paragraph (c)(1) that cross-references new section 205.105. 

(3) Use of Predator Pests and Parasites. Paragraph (b)(1) of section 205.271 proposed that 

predator pests and parasites may be used to control pests in handling facilities. Under FDA's 

Good Manufacturing Practice, 21 CFR part section 110.35(c), it states that "No pests shall be 

allowed in any area of a food plant." Some commenters believed use of predator pests in 

handling facilities is prohibited by the FDA regulation. Other commenters stated that predator 

pests could be used in certain handling facilities under the FDA regulation. One commenter 

claimed that the FDA regulation in 21 CFR part 110.19 allows exemptions for certain 

establishments that only harvest, store, or distribute raw agricultural product. Another commenter 

suggested that use of predator pests should be allowed when FDA does not prohibit their use. 

We do not intend to be inconsistent with the FDA requirement and, thus, have removed proposed 

paragraph (b)(1) of section 205.271. Use of predator pests in various organic handling and 

storage areas is subject to FDA's Good Manufacturing Practice. Paragraphs (b)(2) and (b)(3) are 

redesignated. 

(4) Use of Synthetic Pheromone Lures. Proposed paragraph (b)(3) provided for use of 

nonsynthetic lures and repellant. A few handlers and certifying agents commented that nearly all 

pheromone lures use synthetic substances. Because pheromone lures do not come into contact 

with products in a handling facility, commenters argued that such lures should be allowed, 

provided that the synthetic substance used is on the National List. 

We agree and have added "synthetic substances" to redesignated paragraph (b)(2) for use in 

lures and repellents. The synthetic substances used must be consistent with the National List. (5) 

Restrict Initial Use of Synthetics to National List Substances. Paragraph (c) in the proposed rule 

provided for use of any synthetic substance to prevent or control pests. Several handlers and 

certifying agents stated that use of nonsynthetic and synthetic substances should initially be 

limited first to substances which are allowed on the National List. This would mean that 

substances not allowed for use on the National List could not be used initially to control or prevent 

pest infestations. 

We agree with these comments. Use of allowed substance before use of other substances is a 

fundamental principle of organic agriculture. Therefore, if preferred practices under paragraphs 

(a) and (b) are not successful in preventing or controlling pest infestations, handlers may then 

use, under amended paragraph (c), only nonsynthetic or synthetic substances which are allowed 

for use on the National List. 

We have removed the proviso that applications of a pest control substance must be consistent 

with the product's label instructions. This requirement is readily understood and does not need to 

be explicitly stated in the regulations. 

Because paragraph (c) now provides for use only of allowed National List substances, a new 

paragraph (d) is added to allow for use of other synthetic substances, including synthetic 

substances not on the National List, to prevent or control pest infestations. These substances 

may be used only if the practices in paragraphs (a), (b), and (c) are ineffective. Before the 

substance is used, the handler and the operation's certifying agent must agree on the synthetic 

substance to be used and the measures to be taken to prevent contact of the substance with 

organic products and ingredients in the facility. We expect that this communication can be 

accomplished with telephone calls or by electronic means. 

This regulation does not preempt Federal, State, or local health and sanitation requirements. We 

recognize that inspectors who monitor compliance with those regulations may require immediate 
intervention and use of synthetic substances, not on the National List, before or at the same time 

as the methods specified in paragraphs (b) and (c). Therefore, to make this clear, we have added 

a new paragraph (f). To ensure that the use of the substances does not destroy a product's 

organic integrity, we are requiring that the handler take appropriate measures to prevent contact 

of the product with the pest control substance used. 

(6) Preventing Contact with Prohibited Substances. Commenters recommended that, if prohibited 

substances are applied by fogging or fumigation, the organic product and packaging material 

must be required to be completely removed from the facility and reentry of the product or 

packaging be delayed for a period three times longer than that specified on the pesticide label. 

Commenters believed removal and reentry should be mandatory, regardless of the organic 

product or container. 

We understand the commenters' concerns. However, their recommendations are not appropriate 

for all pest infestations. We believe that measures needed to be taken to prevent contact with a 

synthetic substance must be determined on a case-by-case basis by the handler and certifying 

agent. As stated earlier, new paragraph (d) of section 205.271 requires a handler and certifying 

agent to agree on control and prevention measures prior to application of a synthetic substance. 

We believe that such an agreement will help safeguard a product's organic integrity. Use of a 

synthetic substance in fogging or fumigation should be based on, among other things, location of 

the pest relative to the organic products in the facility; the extent of the pest infestation; the 

substance and application method to be used; the state of the organically produced product or 

ingredient (raw, unpackaged bulk, canned, or otherwise sealed); and health and sanitation 

requirements of local, State, and Federal authorities. 

Paragraph (e) is changed to clarify that an operation's organic handling plan must be updated to 

document all measures taken to prevent contact between synthetic pest control substances and 

organically produced products and ingredients. 

(7) Repetitive Use of Pest Control Measures. One commenter suggested a change in the 

paragraph (e) requirement that handlers' organic plans must include "an evaluation of the effects 

of repetitive use" of pest prevention and control materials. The commenter believed that the 

requirement was excessive and beyond what should be expected of handlers. The commenter 

indicated that handlers' organic plans should address the "techniques that will be used to 

minimize" the negative effects of repetitive use of pest control materials. 

We agree that "an evaluation of the effects of repetitive use" is more than what is reasonable to 

expect of handlers in their organic plans. We do not agree, however, that an organic plan should 

be required to address the "techniques" used to minimize the effects of repetitive use of pest 

control materials. However, we believe that handlers should update their organic handling plans 

to account for the use of pest control or prevention substances, particularly if the substances are 

prohibited substances. The update should include a description of the application methods used 

and the measures taken to prevent contact between the substance used and the organic product. 

We have added these requirements in redesignated paragraph (e). Proposed paragraph (e) of 

section 205.271 is removed. 

Handling - Changes Requested But Not Made

(1) Exceptions to Handling Processes. A commenter stated that many herbal products are 

extracted from organically produced herbs but that the extraction of those products "can employ 

significantly different methods than those used in the manufacture of more traditional foods." To 

be labeled as "organic" ingredients, substances such as herbs, spices, flavorings, colorings, and 

other similar substances, must be derived from a certified organic source and be extracted 

without the use of prohibited substances. 
(2) Allowed Synthetics Used in Packaging Materials and Storage Containers. A State department 

of agriculture commented that section 205.272(b)(1) prohibits use of synthetic fungicides, 

preservatives, or fumigants in packaging materials and storage containers or bins. The comment 

stated that it is inconsistent to permit use of allowed substances as ingredients in processed 

products but prohibit their use as a preservative or fumigant in the packaging materials and 

storage containers and bins. The commenter suggested that paragraph (b)(1) be amended to 

permit use of National List-allowed substances in section 205.605, particularly carbon dioxide and 

ozone, in packaging materials and storage containers or bins. 

We understand the commenter's concern. However, section 6510(a)(5) of the Act specifically 

prohibits use of any packaging materials, storage containers, or bins that contain synthetic 

fungicides, preservatives, or fumigants. 

(3) Additional Measures to Prevent Product Contamination. A few commenters suggested 

changing paragraph (e) of section 205.271 to require that handlers' organic handling plans 

specify measures that would be taken to prevent contact between a pest control substance and 

"packaging materials." This would be in addition to measures preventing contamination of "any 

ingredient or finished product" in the handling facility. 

We understand the commenters' objective. However, for the reasons stated earlier in regard to 

commenters' request that mandatory removal of product during pest control treatment be 

required, we believe that such a requirement should not be mandatory for all packaging materials. 

Measures to prevent contamination of packaging material should be left to the handler and 

certifying agent to specify in the handling plan. 

Handling - Clarifications

Clarification is given on the following issues raised by commenters. 

(1) Use of Nonorganic Ingredients in Processed Products. We have corrected paragraph (c) of 

section 205.270 to clarify what must not be used in or on organically produced ingredients and 

nonorganically produced ingredients used in processed organic products. The prohibition on use 

of ionizing radiation, excluded methods, and volatile synthetic solvents applies to all organically 

produced ingredients. The 5 percent of nonorganic ingredients in products labeled "organic," also 

are subject to the three prohibited practices. The nonorganic ingredients in products labeled 

"made with organic ingredients" must not be produced using ionizing radiation or excluded 

methods but may be produced using volatile synthetic solvents. The nonorganic ingredients in 

products containing less than 70 percent organically produced ingredients may be produced and 

processed using ionizing radiation, excluded methods, and synthetic solvents. 

(2) Water Quality Used in Processing. A handler questioned whether public drinking water 

containing approved levels of chlorine, pursuant to the Safe Drinking Water Act, is acceptable for 

use in processing products labeled "100 percent organic." Water meeting the Safe Drinking Water 

Act may be used in processing any organically produced products. 

Temporary Variances - Changes Based on Comments

Additional Causes for Issuing Temporary Variance. A few State department of agriculture 

commenters suggested that "drought" should be added to the regulatory text as a natural disaster 

warranting a temporary variance from regulations. 

We agree and have added drought to the regulatory text in paragraph (a)(2) of section 205.290. 

We have also added "hail" as a natural disaster warranting a temporary variance. Both drought 
and hail were mentioned in the preamble of the proposed rule but were unintentionally left out of 

the regulatory text. 

Temporary Variances - Changes Requested But Not Made

Allowance of Temporary Variances. A few commenters suggested that SOP's governing State 

officials should be able to authorize temporary variances due to local natural disasters which may 

occur in a State. We do not agree that with these comments. For consistency of application, we 

believe that only the Administrator should have the authority to grant a temporary variance. Citing 

local conditions, an SOP's governing State official and certifying agents may recommend a 

temporary variance to the Administrator. We are committed to providing quick responses to such 

recommendations.