Inspection and Testing, Reporting, and Exclusion from Sale 

This portion of subpart G sets forth the inspection and testing requirements for agricultural 

products that have been produced on organic production operations or handled through organic 

handling operations. 

Residue testing plays an important role in organic certification by providing a means for 

monitoring compliance with the National Organic Program (NOP) and by discouraging the 

mislabeling of agricultural products. This testing program provides State organic programs' (SOP) 

governing State officials and certifying agents with a tool for ensuring compliance with three areas 

for testing: (1) preharvest residue testing, (2) postharvest residue testing, and (3) testing for 

unavoidable residual environmental contamination levels. 

Description of Regulations

General Requirements

Under the residue testing requirements of the NOP, all agricultural products sold, labeled, or 

represented as organically produced must be available for inspection by the Administrator, SOP's 

governing State official, or certifying agent. Organic farms and handling operations must be made 

available for inspection under subpart E, Certification. In addition, products from the 

aforementioned organic operations may be required by the SOP's governing State official or 

certifying agent to undergo preharvest or postharvest testing when there is reason to believe that 

agricultural inputs used in organic agriculture production or agricultural products to be sold or 

labeled as organically produced have come into contact with prohibited substances or have been 

produced using excluded methods. The cost of such testing will be borne by the applicable 

certifying agent and is considered a cost of doing business. Accordingly, certifying agents should 

make provisions for the cost of preharvest or postharvest residue testing when structuring 

certification fees. 

Preharvest and Postharvest Residue Testing

The main objectives of the residue testing program are to: (1) ensure that certified organic 

production and handling operations are in compliance with the requirements set forth in this final 

rule and (2) serve as a means for monitoring drift and unavoidable residue contamination of 

agricultural products to be sold or labeled as organically produced. Any detectable residues of a 

prohibited substance or a product produced using excluded methods found in or on samples 

during analysis will serve as a warning indicator to the certifying agent. 

The Administrator, SOP's governing State official, or certifying agent may require preharvest or 

postharvest testing of any agricultural input used in organic agricultural production or any 

agricultural product to be sold or labeled as "100 percent organic," "organic," or "made with 

organic (specified ingredients or food group(s))." It is based on the Administrator's, SOP's 

governing State official's, or certifying agent's belief that an agricultural product or agricultural 

input has come into contact with one or more prohibited substances or has been produced using 

excluded methods. Certifying agents do not have to conduct residue tests if they do not have 

reason to believe that there is a need for testing. Certifying agents must ensure, however, that 

certified organic operations are operating in accordance with the Act and the regulations set forth 

in this part. 
The "reason to believe" could be triggered by various situations, for example: (1) the applicable 

authority receiving a formal, written complaint regarding the practices of a certified organic 

operation; (2) an open container of a prohibited substance found on the premises of a certified 

organic operation; (3) the proximity of a certified organic operation to a potential source of drift; 

(4) suspected soil contamination by historically persistent substances; or (5) the product from a 

certified organic operation being unaffected when neighboring fields or crops are infested with 

pests. These situations do not represent all of the possible occurrences that would trigger an 

investigation. Preharvest or postharvest residue testing will occur on a case-by-case basis. 

In each case, an inspector representing the Administrator, SOP's governing State official, or 

certifying agent or will conduct sampling. According to subpart F, Accreditation, private or State 

entities accredited as certifying agents under the NOP must ensure that its responsibly connected 

persons, employees, and contractors with inspection, analysis, and decision-making 

responsibilities have sufficient expertise to successfully perform the duties assigned. Therefore, 

all inspectors employed by certifying agents to conduct sampling must have sufficient expertise in 

methods of chain-of-custody sampling. Moreover, testing for chemical residues must be 

performed in an accredited laboratory. When conducting chemical analyses, the laboratory must 

incorporate the analytical methods described in the most current edition of the Official Methods of 

Analysis of the AOAC International or other current applicable validated methodology for 

determining the presence of contaminants in agricultural products. Results of all analyses and 

tests performed under section 205.670 must be promptly provided to the Administrator, except, 

that, where an SOP exists, all test results and analyses should be provided to the SOP's 

governing State official by the applicable certifying party that requested testing. Residue test 

results and analyses must also be, according to section 205.403(e)(2), provided to the owner of 

the certified organic operation whose product was tested. All other parities desiring to obtain such 

information must request it from the applicable certifying agent. 

OFPA requires certifying agents, to the extent of their awareness, to report violations of 

applicable laws relating to food safety to appropriate health agencies such as EPA and FDA. 

When residue testing indicates that an agricultural product contains pesticide residues or 

environmental contaminants that exceed either the EPA tolerance level or FDA action level, as 

applicable, the certifying agent must promptly report data revealing such information to the 

Federal agency whose regulatory tolerance or action level has been exceeded. 

Residue Testing and Monitoring Tools

When testing indicates that an agricultural product to be sold or labeled as organically produced 

contains residues of prohibited substances, certifying agents will compare the level of detected 

residues with 5 percent of the Environmental Protection Agency (EPA) tolerance for the specific 

residue detected on the agricultural product intended to be sold as organically produced. This 

compliance measure, 5 percent of EPA tolerance for the detected prohibited residue, will serve as 

a standard for the Administrator, SOP's governing State officials, and certifying agents to assist in 

monitoring for illegal use violations. 

In addition, we intend to establish levels of unavoidable residual environmental contamination 

(UREC) for crop-and site-specific agricultural commodities to be sold, labeled, or represented as 

"100 percent organic," "organic," or "made with..." These levels will represent limits at which 

USDA may take compliance action to suspend the use of a contaminated area for organic 

agricultural production. Currently, USDA is seeking scientifically sound principles and measures 

by which it can establish UREC levels to most effectively address issues of unavoidable residual 

environmental contamination with respect to this rule. However, in the interim, UREC will be 

defined as the Food and Drug Administration's (FDA) action levels for poisonous or deleterious 

substances in human food or animal feed. UREC levels will be initially set for persistent prohibited 

substances (aldrin, dieldrin, chlordane, DDE, etc.) in the environment. They may become more 

inclusive of prohibited residues as additional information becomes available. Unavoidable 
residual environmental contamination levels will be based on the unavoidability of the chemical 

substances and do not represent permissible levels of contamination where it is avoidable. 

Analyses and test results will be available for public access unless the residue testing is part of 

an ongoing compliance investigation. Information relative to an ongoing compliance investigation 

will be confidential and restricted to the public. 

Detection of Prohibited Substances or Products Derived from Excluded Methods

In the case of residue testing and the detection of prohibited substances in or on agricultural 

products to be sold, labeled, or represented as "100 percent organic," "organic," or "made with...," 

products with detectable residues of prohibited substances that exceed 5 percent of the EPA 

tolerance for the specific residue or UREC cannot be sold or labeled as organically produced. 

When such an agricultural crop is in violation of these requirements, the certification of that crop 

will be suspended for the period that the crop is in production. Certifying agents must follow the 

requirements specified in sections 205.662 and 205.663 of subpart G, Compliance. 

The "5 percent of EPA tolerance" standard is considered a level above which an agricultural 

product cannot be sold as organic, regardless of how the product may have come into contact 

with a potential prohibited substance. This standard has been established to: (1) satisfy consumer 

expectations that organic agricultural products will contain minimal chemical residues and (2) 

respond to the organic industry's request to implement a standard comparable to current industry 

practices. However, the "5 percent of EPA tolerance" standard cannot be used to automatically 

qualify agricultural products as organically produced, even if the level of chemical residues 

detected on an agricultural product is below 5 percent of the EPA tolerance for the respective 

prohibited substance. This final rule is a comprehensive set of standards and regulations that 

determines whether a product can or cannot be considered to carry the specified organic labeling 

terms in subpart D, Labeling. Therefore, in addition to this section of subpart G, Administrative, all 

other requirements of this part must be met by certified organic operations to have an agricultural 

product considered "organically produced." 

When residue testing detects the presence of any prohibited substance, whether above or below 

5 percent of the EPA tolerance for the specific pesticide or UREC, the SOP's governing State 

official or certifying agent may conduct an investigation of the certified organic operation to 

determine the cause of the prohibited substance or product in or on the agricultural product to be 

sold or labeled as organically produced. The same shall occur if testing detects a product 

produced using excluded methods. If the investigation reveals that the presence of the prohibited 

substance or product produced using excluded methods in or on an agricultural product intended 

to be sold as organically produced is the result of an intentional application of a prohibited 

substance or use of excluded methods, the certified organic operation shall be subject to 

suspension or revocation of its organic certification. In addition, any person who knowingly sells, 

labels, or represents an agricultural product as organically produced in violation of the Act or 

these regulations shall be subject to a civil penalty of not more than $10,000 per violation. 

Emergency Pest or Disease Treatment Programs

When a prohibited substance is applied to an organic production or handling operation due to a 

Federal or State emergency pest or disease treatment program and the organic handling or 

production operation otherwise meets the requirements of this final rule, the certification status of 

the operation shall not be affected as a result of the application of the prohibited substance, 

except that: (1) any harvested crop or plant part to be harvested that has contact with a prohibited 

substance applied as the result of a Federal or State emergency pest or disease treatment 

program cannot be sold, labeled, or represented as "100 percent organic," "organic," or "made 

with..." and (2) any livestock that are treated with a prohibited substance applied as the result of a 
Federal or State emergency pest or disease treatment program or product derived from such 

treated livestock cannot be sold, labeled, or represented as "100 percent organic," "organic," or 

"made with..." 

However, milk or milk products may be labeled or sold as organically produced beginning 12 

months following the last date that the dairy animal was treated with the prohibited substance. 

Additionally, the offspring of gestating mammalian breeder stock treated with a prohibited 

substance may be considered organic if the breeder stock was not in the last third of gestation on 

the date that the breeder stock was treated with the prohibited substance. 

Residue Testing - Changes Based on Comments

This portion of subpart G differs from our proposal in several respects as follows: 

(1) Reporting Requirements. Commenters were not satisfied with the language in section 

205.670(d)(1) that required results of all analyses and tests performed under section 205.670 to 

be provided to the Administrator promptly upon receipt. They asked that the paragraph be 

amended to include that: (1) results of all analyses and tests performed under section 205.670 be 

provided by the Administrator to the appropriate SOP's governing State official and (2) test results 

be made immediately available to the owner of the material sampled. They stated that since State 

organic certification programs are responsible for enforcement within their State, results of 

residue tests conducted by certifying agents must be provided to the SOP's governing State 

official for routine monitoring and for investigating possible violations of the Act. 

We agree with the commenters and have responded to their concerns accordingly. To ensure 

that SOP's receive results of all tests and analyses conducted under the inspection and testing 

requirements of subpart G, section 205.670(d) has been amended to include that the results of all 

analyses and residue tests must be provided to the Administrator promptly upon receipt; Except: 

That where an SOP exists, all test results and analyses should be provided to the SOP's 

governing State official. 

In regard to the commenters' request that certified organic operations be provided with a copy of 

test results from samples taken by an inspector, an additional paragraph, section 205.403(e)(2), 

has been added to subpart E, Certification, that assures that such information is provided to the 

owners of certified organic operations by the certifying agents. 

(2) Integrity Of Organic Samples. We have modified language in section 205.670(c) to clarify our 

intent regarding the maintenance of sample integrity. The proposed rule stated that "sample 

integrity must be maintained in transit, and residue testing must be performed in an accredited 

laboratory." During the final rulemaking process, we did not believe that our intent was clear on 

this subject. Our intent is to ensure that sample integrity is maintained throughout the entire chain 

of custody during the residue testing process. Proposed language only suggests that sample 

integrity be maintained in transit. Therefore, the we have changed the second sentence in section 

205.670(c) to state that "sample integrity must be maintained throughout the chain of custody, 

and residue testing must be performed in an accredited laboratory." 

(3) Reporting Residue and Other Food Safety Violations to Appropriate Health Agencies. In the 

proposed rule, section 205.671(b) under Exclusion from Organic Sale states, "If test results 

indicate a specific agricultural product contains pesticide residues or environmental contaminants 

that exceed the FDA's or the EPA's regulatory tolerances, the data must be reported promptly to 

the appropriate public health agencies." During the final rulemaking process, a group of 

commenters suggested that we move section 205.671(b) into section 205.670 as paragraph (e). 

They recommended that we move section 205.671(b) because it does not specifically address 

the sale of organically produced products, as indicated by the section heading. They 
recommended that section 205.671(b) be placed under section 205.670 as paragraph (e) 

because it dealt with the reporting of residues that exceed Federal regulatory tolerances. The 

commenters further stated that, while section 205.671(b) creates a duty to report, it is not specific 

as to who must report. 

We have accepted the suggestions of the commenters and have responded accordingly. We 

have removed section 205.671(b) and relocated it under section 205.670 as paragraph (e). We 

have also modified the regulatory text of paragraph (e) to include language that instructs 

certifying agents to report, when residue testing indicates that an agricultural product contains 

pesticide residues or environmental contaminants that exceed either the EPA tolerance level or 

FDA action level, as applicable, data reveling such information to the Federal agency whose 

regulatory tolerance or action level has been exceeded. 

(4) Exclusion from Organic Sale. We have reviewed section 205.671(a), removed the requirement 

to implement the Pesticide Data Program (pdp) estimated national mean as a compliance tool in 

monitoring for the presence of unacceptable levels of prohibited substances in agricultural 

products intended to be sold as organic, and added the "5 percent of EPA tolerance" standard. 

Commenters voiced the opinion that the estimated national mean would be a difficult standard in 

organic agricultural production for several reasons. Some stated that the estimated national mean 

was a new concept that would confuse producers and handlers because they would not know the 

exact definition of "estimated national mean" and how it would be determined. Others stated that 

the PDP was too limited in scope to employ an estimated national mean for all 

commodity/pesticide combinations. Commenters reasoned that PDP data were limited in terms of 

the agricultural commodities that are sampled and tested. 

Another group of commenters stated that PDP data would be unfair to use in the NOP's residue 

testing plan. They argued PDP data should not be used to set maximum residue levels for 

organic agricultural products because PDP samples its products as close to the point of 

consumption as possible. As a result, commenters believe that PDP data may not be totally 

reflective of residue levels of agricultural products at the farmgate level. Since most residue 

testing in organic agricultural production takes place at the farmgate, these commenters argued 

that it would be an inappropriate standard for organic agricultural production. 

As a result, a large number of commenters suggested that we reconsider using the estimated 

national mean as a standard for the maximum allowable residues on organically produced 

products. Instead, commenters recommended that the NOP incorporate the National Organic 

Standards Board's (NOSB) recommendation and current industry practice of using 5 percent of 

the EPA tolerance as a maximum level of pesticide residue on organic agricultural products. 

Commenters argued that using 5 percent of the EPA tolerance provides a sense of confidence to 

the consumers of organic agricultural products. 

In many respects, we agree with the commenters. We have revisited using PDP data to establish 

an estimated national mean for commodity/pesticide combinations and for setting a maximum 

level of pesticide residue that could exclude agricultural products from being sold, labeled, or 

represented as organic. As a result, we have concluded that such an approach may be somewhat 

underdeveloped to incorporate into the NOP. We have reached this conclusion based on many of 

the same arguments presented by commenters (i.e., limited scope of agricultural products tested 

under PDP, product sampling based upon market availability, testing near the point of 

consumption, etc.). Also, we estimated that there would be a considerable time lag between the 

implementation of the NOP and defining a comprehensive list of estimated national means for all 

commodity/pesticide combinations. Thus, we have decided not to use the estimated national 

mean as a tool for monitoring organic agricultural products for the presence of prohibited 

substances and as a standard to exclude agricultural products from being sold, labeled, or 

represented as organically produced. 
Instead, we have decided to follow the recommendation of the commenters by replacing the 

estimated national mean for specific commodity/pesticide pairs with 5 percent of the EPA 

tolerance for the specific pesticide. Therefore, when residue testing detects prohibited substances 

at levels that are greater than 5 percent of the EPA tolerance for the specific pesticide detected 

on the particular product samples, the agricultural product must not be sold or labeled as 

organically produced. 

We fully understand that the EPA tolerance is defined as the maximum legal level of a pesticide 

residue in or on a raw or processed agricultural commodity. We also acknowledge that the EPA 

tolerance is a health-based standard. We are not trying to employ the 5 percent standard in a 

manner similar to that of EPA. As mentioned in our proposal, the national organic standards, 

including provisions governing prohibited substances, are based on the method of production, not 

the content of the product. The primary purpose of the residue testing approach described in this 

final rule, then, is to provide an additional tool for SOP's' governing State officials and certifying 

agents to use in monitoring and ensuring compliance with the NOP. 

(5) Unavoidable Residual Environmental Contamination. We have defined, as an interim 

measure, UREC as the FDA action levels for poisonous or deleterious substances in human food 

or animal feed. 

Section 205.671 proposed the use of UREC to serve as a residue testing tool for compliance. 

Commenters believed UREC levels, as prescribed in section 205.671 of the proposed rule, would 

be problematic as a standard because they were undefined. Commenters argued that it would be 

impractical and very expensive to establish UREC levels for every organic crop and region in the 

United States. They suggested that UREC levels be managed as a practice standard or program 

manual issue. They also expressed the concern that inconsistent application of UREC levels 

could create difficulties for certifying agents and certified operations. 

We agree that UREC levels should be defined. We are seeking scientifically sound principles and 

measures by which we can establish UREC levels to most effectively address issues of 

unavoidable residual contamination with respect to this rule. However, in the interim, the ability to 

implement an undefined standard would be difficult for certifying agents. Therefore, we have 

included language in the preamble that temporarily defines UREC as the FDA action levels for 

poisonous or deleterious substances in human food or animal feed. When residue testing detects 

the presence of a prohibited substance on an agricultural product greater than such levels 

mentioned, the agricultural product cannot be sold as organic. We have decided to use FDA 

action levels for UREC because they encompass many of the toxic, persistent chemicals and 

heavy metals that are present in the environment and may be found on food and animal feed. As 

mentioned earlier, the FDA action levels are being employed in this part as temporary measures 

for compliance. We will continue to seek scientifically sound principles and measures by which to 

establish UREC levels that more appropriately satisfy the purposes of this part. 

Residue Testing - Changes Requested But Not Made

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

follows: 

(1) Residue Testing Responsibility. Commenters petitioned that we remove the requirement in 

section 205.670(b) that states residue tests must be conducted by the applicable SOP's 

governing State official or the certifying agent at the official's or certifying agent's own expense. 

The commenters expressed the opinion that we were practicing "micromanagement." They also 

said that there was no need for the proposal to be so detailed with respect to who pays for 

residue testing. Based on the commenters' responses, residue analyses are reportedly paid by 

producers, buyers, brokers, certifiers, and government residue testing programs. 
We have not adopted the suggestion of the commenters. In the proposal, we stated that 

conducting residue tests was considered a cost of doing business for certifying agents. Our 

position has not changed. Certifying agents can factor residue testing costs into certification fees. 

It is not our intention to "micromanage" the way that certifying agents conduct business. Section 

2107(a)(6) of the Act requires that certifying agents conduct residue testing of agricultural 

products that have been produced on certified organic farms and handled through certified 

organic handling operations. OFPA also requires, under section 2112(a) through (c), that 

certifying agents enforce its provisions by implementing a system of residue testing to test 

products sold or labeled as organically produced. In addition, subpart E, Certification, authorizes 

certifying agents to conduct on-site inspections, which may include residue testing, of certified 

organic operations to verify that the operation is complying with the provisions in the Act and the 

regulations in this part. Certifying agents are responsible for monitoring organic operations for the 

presence of prohibited substances; we view residue testing as a cost of doing business. 

Therefore, we believe that certifying agents should factor monitoring costs associated with 

implementing the provisions in the Act and Rule into their certification fees. 

(2) Reporting to Federal Regulatory Agencies. Commenters disagree with section 205.671(b) of 

the proposed rule which states that if test results indicate a specific agricultural product contains 

pesticide residues or environmental contaminants that exceed the FDA action level or EPA 

tolerance, the data must be reported promptly to appropriate public health agencies. Commenters 

believe that since results of all analyses and tests must be provided to the Administrator, USDA 

should be responsible for communicating such test results to other Federal agencies such as 

FDA or EPA if regulatory tolerances or action levels are exceeded. They also suggested that 

section 205.671(b) be removed from the national regulations. Commenters expressed the view 

that such a requirement is not related to organic certification. 

We do not agree with the commenters. It is not our intent to create additional responsibility for the 

certifying agent. Section 205.671(b), redesignated as section 205.670(e), is a statutory 

requirement. Section 2107(a)(6) of the Organic Food Production Act of 1990 requires certifying 

agents, to the extent of their awareness, to report violations of applicable laws relating to food 

safety to appropriate health agencies such as EPA and FDA. Therefore, due to section 2107 of 

the Act, section 205.670(e) has been included in the national regulations. 

(3) "Threshold" for Genetic Contamination. Many commenters suggested that we establish a 

"threshold" for the unintended or adventitious presence of products of excluded methods in 

organic products. Some commenters argued that a threshold is necessary because, without the 

mandatory labeling of biotechnology-derived products, organic operations and certifying agents 

could not be assured that products of excluded methods were not being used. Others argued 

that, without an established threshold, the regulations would constitute a "zero tolerance" for 

products of excluded methods, which would be impossible to achieve. 

We do not believe there is sufficient consensus upon which to establish such a standard at this 

time. Much of the basic, baseline information about the prevalence of genetically engineered 

products in the conventional agricultural marketplace that would be necessary to set such a 

threshold-e.g., the effects of pollen drift where it may be a factor, the extent of mixing at various 

points throughout the marketing chain, the adventitious presence of genetically engineered seed 

in nonengineered seed lots-is still largely unknown. Our understanding of how the use of 

biotechnology in conventional agricultural production might affect organic crop production is even 

less well developed. 

Also, as was pointed out in some comments, the testing methodology for the presence of 

products of excluded methods has not yet been fully validated. Testing methods for some 

biotechnology traits in some commodities are becoming commercially available. Without 

recognized methods of testing for and quantifying of all traits in a wide range of food products, 

however, it would be very difficult to establish a reliable numerical tolerance. 
There are publicly and privately funded research projects underway that may provide useful 

baseline information. Efforts of Federal agencies to clarify the marketing and labeling of 

biotechnology- and nonbiotechnology-derived crops may also help address these concerns. FDA, 

for example, is developing guidance for food producers who voluntarily chose to label 

biotechnology- and nonbiotechnology-derived foods. USDA is also preparing a Federal Register 

Notice to seek public comment on the appropriate role, if any, that it can play in facilitating the 

marketing of agricultural products through the development of "quality assurance" type programs 

that help to preserve the identity of agricultural commodities. USDA, in cooperation with the 

technology providers, is also working to validate testing procedures and laboratories for some 

commodities. 

All of these efforts may help to provide information on this issue. Practices for preserving product 

identity, including segregating genetically engineered and nongenetically engineered products, 

are evolving in some conventional markets. As we discussed in the preamble to the proposed 

rule, we anticipate that these evolving industry best practices and standards will become the 

standards for implementing the provisions in this regulation relating to the use of excluded 

methods. As was also discussed in the proposed rule, these regulations do not establish a "zero 

tolerance" standard. As with other substances not approve for use in organic production systems, 

a positive detection of a product of excluded methods would trigger an investigation by the 

certifying agent to determine if a violation of organic production or handling standards occurred. 

The presence of a detectable residue alone does not necessarily indicate use of a product of 

excluded methods that would constitute a violation of the standards. 

(4) Certification Status After Emergency Pest or Disease Treatment. We have not modified 

language in section 205.672 that would affect the certification status of a certified organic 

operation if the operation had been subjected to a Federal or State emergency pest or disease 

treatment program. 

Section 205.672 states that when a prohibited substance is applied to a certified operation due to 

a Federal or State emergency pest or disease treatment program and the certified operation 

otherwise meets the requirements of this part, the certification status of the operation shall not be 

affected as a result of the application of the prohibited substance: Provided, That, the certified 

operation adheres to certain requirements prescribed by the NOP. One group of commenters 

informed us that they did not support maintaining the organic status of an operation that has been 

directly treated with prohibited substances, regardless of the reason for treatment. They believe 

that Federal and State emergency pest or disease treatment programs should provide 

alternatives for organic operations whenever feasible. If no alternative measure is feasible, the 

organic operation should choose between voluntary surrender of their organic status on targeted 

parts of the operation or destruction of the crop to eliminate pest habitat. The commenters also 

suggested that compensation should be provided to organic producers whose crops must be 

destroyed to eliminate habitat. They feel that allowing the application of prohibited materials to 

certified organic land without affecting the certification status violates the trust consumers place in 

organic certification. 

We disagree with the position of the commenters. Historically, residues from emergency pest or 

disease treatment programs have been treated as drift cases by certifiers. In these cases, the 

specific crop may not be sold as organic, but the organic status of future crop years are not 

affected. We intend to handle such cases in a similar manner. We understand that commenters 

would like us to remove the certification of an organic operation that has been treated with a 

prohibited substance, but organic certification is a production claim, not a content claim. We, 

along with the commenters, are concerned with consumers trusting organic certification. At the 

same time, we are concerned with the welfare of certified organic operations. We have tried to 

include language in section 205.672 that would address both issues. We believe that, if a certified 

organic grower has been a good steward of his/her land and has managed the production of 

his/her product(s) in accordance with all regulations in the Act and other requirements in this part, 
the certification status of the operation should not be affected. The application of a prohibited 

substance as part of a Federal or State emergency pest or disease treatment program is outside 

the control of the certified operation. We also believe that maintaining consumer trust is 

important. Thus, section 205.672 states that any harvested crop or plant part to be harvested that 

has been treated with a prohibited substance as part of a Federal or State emergency pest or 

disease treatment program cannot be sold as organically produced. Therefore, the certified 

organic operation can retain its certification status, and the consumer can be assured that a 

product from a certified organic operation that has been in contact with a prohibited substance as 

the result of a Federal or State pest or disease treatment program will not enter the organic 

marketplace. Accordingly, we have not made the change to section 205.672 as proposed by the 

commenters. 

(5) Emergency Pest or Disease Treatment Programs. Commenters suggested that the 

Department add a new paragraph to section 205.672 that states "the certifying agent must 

monitor production operations that have been subjected to a Federal or State emergency pest or 

disease treatment program, and may require testing of following crops, or an extended transition 

period for affected production sites, if residue test results indicate the presence of a prohibited 

substance." Commenters said the language in the proposed rule did not clearly establish that a 

transition period could be needed after contamination of a certified organic operation by a 

government-mandated spray program. They felt that there may be a need for a case-by-case 

determination by the certifying agent as to when it would be best for a certified organic operation 

to begin selling its products as organically produced after it has been subject to a government 

mandated spray program. 

We understand that commenters would like USDA to mandate certifying agents to monitor 

operations that have been subject to Federal or State emergency pest or disease treatment 

programs; however, we do not see a need to prescribe such a provision. Based on the 

responsibilities of being a USDA-accredited certifier, it is our belief that certifying agents would 

monitor a certified organic operation that has been subjected to a Federal or State emergency 

pest or disease treatment program to make sure that product being produced for organic sale is 

actually being produced in accordance with the Act and the regulations in this part. Certifying 

agents have been granted the authority to conduct additional on-site inspections of certified 

organic operations to determine compliance with the Act and national standards under subpart E, 

section 205.403. Commenters requested that we include language that would allow certifying 

agents to recommend an extended transition period for affected production sites if residue tests 

indicate the presence of a prohibited substance. Again, we understand the commenters' concern, 

but we are not aware of comprehensive soil residue data that could guide certifying agents in 

determining appropriate withdrawal intervals for operations that have been subjected to 

emergency pest or disease treatment programs. 

Residue Testing - Clarifications

Clarification is given on the following issues raised by commenters as follows: 

(1) Sampling and Testing. Commenters stated that the purpose of residue testing under the Act is 

to assure that organically produced agricultural products that are sold as organic do not contain 

pesticide residues or residues of other prohibited substances that exceed levels as specified by 

the NOP. Based on language in section 205.670(b) of the proposed rule, commenters expressed 

the opinion that the Agricultural Marketing Service (AMS) was, not only requiring residue testing 

of organic agricultural products, but also of "any" agricultural input used or agricultural product 

intended to be sold as "100 percent organic," "organic," or "made with..." when there is reason to 

believe that the agricultural input or product has come into contact with a prohibited substance. 

Commenters believe that organic certifying agents may be required to test many nonorganic 

agricultural inputs (such as seeds, compost, straw, sawdust, and plastic) and nonorganic 

agricultural products and ingredients used in products labeled as "made with...". They also 
argued that such testing would be unnecessary, burdensome, and expensive because such 

materials are more likely to have come into contact with a prohibited substance. Therefore, 

commenters suggested that we amend section 205.670(b) by deleting "agricultural inputs" and 

replacing "agricultural product" with "organically produced agricultural product." They also 

recommended that we replace the second occurrence of "product" with "organic product." Thus 

section 205.670(b) would suggest that only organic agricultural products could be required to be 

tested by the certifying agent. 

We understand the concerns of the commenters but believe that the commenters have 

misinterpreted the intent of section 205.670(b). It is not our intent to mandate residue testing of all 

inputs and ingredients used in the production of organic agricultural products. Neither is it our 

intent for certifying agents to abuse residue testing responsibility by conducting residue tests of 

certified organic operations without reason to believe that the agricultural input or product 

intended to be sold as organic has come into contact with prohibited substances. Our intent is to 

make it clear that certifying agents have the authority to test any agricultural input used or 

agricultural product intended to be sold as organically produced when there is reason to believe 

that the agricultural input or product has come into contact with a prohibited substance. Section 

205.670(b) allows for testing of inputs and agricultural products, but it does not require that all 

inputs of a product intended to be sold as organically produced must be tested. However, 

certifying agents must be able to ensure that certified organic operations are operating in 

accordance with the Act and the regulations set forth in this part. To assure that certifying agents 

have established fair and effective procedures for enforcing residue testing requirements, section 

205.504(b)(6) provides that they must submit to USDA a copy of the procedures to be used for 

sampling and residue testing pursuant to section 205.670. 

(2) Chain Of Custody Training. A commenter suggested that section 205.670(c) address chain of 

custody training for inspectors that will be performing preharvest or postharvest tissue test 

sample collection on behalf of the Administrator, SOP's governing State official, or certifying 

agent. The commenter proposed that all inspectors should be trained to handle chain of custody 

samples in order to maintain the integrity of the samples. 

We agree that inspectors should be appropriately trained to handle chain-of-custody samples in 

order to maintain the integrity of the samples taken from a certified organic operation. However, 

we do not believe that the language in section 205.670(c) must be modified to address such an 

issue. As a USDA-accredited body, a private or State entity operating as a certifying agent must 

ensure that its responsibly connected persons, employees, and contractors with inspection, 

analysis, and decision-making responsibilities have sufficient expertise in organic production or 

handling techniques to successfully perform the duties assigned. The certifying agent must also 

submit a description of the training that has been provided or intends to be provided to personnel 

to ensure that they comply with and implement the requirements of the Act and the regulations in 

this part. In addition, certifying agents must submit a copy of the procedure to be used for 

sampling and residue testing for approval by the Administrator. Through the accreditation 

process, therefore, we will be able to assess the expertise of the individuals employed by the 

certifying agent and provide guidance in areas where additional training is needed to comply with 

the requirements of the Act and the regulations in this part. 

(3) Exclusion from Organic Sale. Commenters expressed that section 205.671(a) could be easily 

misinterpreted. They said that section 205.671(a) did not make clear that residue testing may not 

be used to qualify crops to be sold as organic if a direct application of prohibited materials 

occurred. Commenters suggested that section 205.671(a) include: "Any crop or product to which 

prohibited materials have been directly applied shall not be sold, labeled, or represented as 

organically produced." 

We do not believe this additional language is necessary. Residue testing cannot be used to 

qualify any agricultural crop or product to which a prohibited material has been 
purposefully/directly applied. The presence of any prohibited substance on an agricultural product 

to be sold as organic warrants an investigation as to why the detected prohibited substance is 

present on the agricultural product. It does not matter if the product has come into contact with a 

prohibited substance through means of drift or intentional application. If the outcome of the 

investigation reveals that the presence of the detected prohibited substance is the result of an 

intentional application, the certified operation will be subject to suspension or revocation of its 

organic certification and/or a civil penalty of not more than $10,000 if he/she knowingly sells the 

product as organic. The use of prohibited substances is not allowed in the Act or this final rule. 

Residue testing is not a means of qualifying a crop or product as organic if a prohibited substance 

has been intentionally/directly applied. It is a tool for monitoring compliance with the regulations 

set forth in the Act and in this part. 

(4) Emergency Pest or Disease Treatment Programs. Commenters requested that we make a 

clear distinction between crops or agricultural products that have had prohibited substances 

directly applied to them and those that have come into contact with prohibited substances through 

chemical drift. They have proposed that we amend section 205.672(a) to address this issue. 

Section 205.672(a) of the proposal states that any harvested crop or plant part to be harvested 

that has had contact with a prohibited substance applied as the result of a Federal or State 

emergency pest or disease treatment program cannot be sold as organically produced. 

Commenters did not find this language acceptable because it did not distinguish between the two 

types of ways that products can come into contact with prohibited substances (drift and 

direct/intentional application) and how each situation would be addressed with respect to the 

national organic standards. Commenters believed that section 205.672(a) was fairly ambiguous 

and open for misinterpretation. Commenters requested that we amend language in section 

205.672(a) to include that "Any harvested crop or plant part to be harvested that has contact with 

a prohibited substance directly applied to the crop as the result of a Federal or State emergency 

pest or disease treatment program cannot be sold, labeled, or represented as organically 

produced." 

We do not accept the commenters' request and believe that the commenters have misinterpreted 

section 205.672 of the proposed rule. Section 205.672 specifically addresses certified organic 

operations that have had prohibited substances applied to them due to a Federal or State pest or 

disease treatment program. Section 205.672 does not include those organic operations that may 

have been drifted upon by prohibited substances that have been applied to a neighboring farm as 

a result of a Federal or State emergency pest or disease treatment program. Any potential drift 

from a mandatory pest and disease treatment program will be treated in the same manner as drift 

from any other source.