National Organic Standards Board

Materials Subcommittee

Prevention Strategy Guidance for Excluded Methods

Discussion Document

February 10, 2015 

I. INTRODUCTION

The purpose of this document is to solicit input and feedback from the organic community on 

precautions that organic producers and handlers should take to prevent and minimize GMO 

contamination in organic production and processing. In an environment where GMOs are widely 

distributed throughout the food chain, it is imperative that organic producers and handlers have 

strategies and plans to prevent GMO contamination. A key tenet of "co-existence" is a shared 

responsibility for the exclusion of the methods and products of genetic engineering. The organic 

part of this shared responsibility is practiced extensively already, but it would be a stronger point 

in future policy statements and efforts against GMO contamination of organic products if it were 

spelled out thoroughly in guidance from the National Organic Program.

Some prevention strategies already exist in the organic and non-GMO community. These 

sources will be utilized to create a comprehensive set of steps and considerations that organic 

producers and handlers can use in their own operations and Accredited Certifying Agents 

(ACAs) can use to verify compliance with the contamination avoidance clause in the rule as it 

relates to GMOs.

II. BACKGROUND

The Organic Foods Production Act (OFPA) of 1990 does not mention biotechnology, genetic 

engineering or genetically modified organisms, but OFPA prohibits synthetics unless they are on 

the National List. The first NOP proposed rule (1997) did not prohibit GMOs, resulting in a huge 

public outcry against GMOs being considered for use in organic production and handling. The 

proposed rule was withdrawn and the second NOP proposed rule (2000) excluded the use of 

GMOs in organic production and handling.

The NOP regulations prohibit the use of GMOs as “excluded methods” under 7 CFR § 205.105: 

“Allowed and prohibited substances, methods, and ingredients in organic production and 

handling.” Excluded methods are defined as:

A variety of methods to genetically modify organisms or influence their growth and 

development by means that are not possible under natural conditions or processes and 

are not considered compatible with organic production. Such methods include cell 

fusion, microencapsulation and macroencapsulation, and recombinant DNA technology 

(including gene deletion, gene doubling, introducing a foreign gene, and changing the 

positions of genes when achieved by recombinant DNA technology). Such methods do 

not include the use of traditional breeding, conjugation, fermentation, hybridization, in 

vitro fertilization, or tissue culture (7 CFR § 205.2-Terms defined)

Compliance with the organic Standards requires that operations have verifiable practices in 

place to avoid contact with GMOs. Since organic certification is process-based, the presence of 

detectable GMO residues alone does not necessarily constitute a violation of the regulation. The 

organic Standards make allowances for “Unavoidable residual environmental contamination,” 

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which is defined (§ 205.2) as “Background levels of naturally occurring or synthetic chemicals 

that are present in the soil or present in organically produced agricultural products that are 

below established tolerances.”

 

The NOP relies on organic certifiers and producers to determine preventive practices that most 

effectively avoid contact with GMOs on an organic operation.

III. RELEVANT AREAS OF THE RULE AND NOP GUIDANCE/POLICY

Rule 7 CFR

§205.105 Allowed and prohibited substances, methods, and ingredients in organic 

production and handling.

To be sold or labeled as “100 percent organic,” “organic,” or “made with organic (specified 

ingredients or food group(s)),” the product must be produced and handled without the use of: 

(e) Excluded methods, except for vaccines: Provided, That, the vaccines are approved in 

accordance with §205.600(a);

§205.201 Organic production and handling system plan.

(a)...An organic production or handling system plan must include:

(3) A description of the monitoring practices and procedures to be performed and maintained, 

including the frequency with which they will be performed, to verify that the plan is effectively 

implemented;

(5) A description of the management practices and physical barriers established to prevent 

commingling of organic and nonorganic products on a split operation and to prevent contact of 

organic production and handling operations and products with prohibited substances;

(6) Additional information deemed necessary by the certifying agent to evaluate compliance with 

the regulations.

§205.272 Commingling and contact with prohibited substance prevention practice 

standard.

(a) The handler of an organic handling operation must implement measures necessary to 

prevent the commingling of organic and nonorganic products and protect organic products from

contact with prohibited substances. 

(b) The following are prohibited for use in the handling of any organically produced agricultural 

product or ingredient labeled in accordance with subpart D of this part: 

(1) Packaging materials, and storage containers, or bins that contain a synthetic fungicide, 

preservative, or fumigant; 

(2) The use or reuse of any bag or container that has been in contact with any substance in 

such a manner as to compromise the organic integrity of any organically produced product or 

ingredient placed in those containers, unless such reusable bag or container has been 

thoroughly cleaned and poses no risk of contact of the organically produced product or 

ingredient with the substance used. 

§205.600 Evaluation criteria for allowed and prohibited substances, methods, and 

ingredients. 

(a) Synthetic and nonsynthetic substances considered for inclusion on or deletion from the 

National List of allowed and prohibited substances will be evaluated using the criteria specified 

in the Act (7 U.S.C. 6517 and 6518).

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§205.670 Inspection and testing of agricultural products to be sold or labeled as “100 

percent organic,” “organic,” or “made with organic (specified ingredients or food 

group(s)).”

(a) All agricultural products that are to be sold, labeled, or represented as “100 percent organic,” 

“organic,” or “made with organic (specified ingredients or food group(s))” must be made 

accessible by certified organic production or handling operations for examination by the 

Administrator, the applicable State organic program's governing State official, or the certifying 

agent.

(b) The Administrator, applicable State organic program's governing State official, or the 

certifying agent may require pre-harvest or postharvest testing of any agricultural input used or 

agricultural product to be sold, labeled, or represented as “100 percent organic,” “organic,” or 

“made with organic (specified ingredients or food group(s))” when there is reason to believe that 

the agricultural input or product has come into contact with a prohibited substance or has been 

produced using excluded methods. Samples may include the collection and testing of soil; 

water; waste; seeds; plant tissue; and plant, animal, and processed products samples. Such 

tests must be conducted by the applicable State organic program's governing State official or 

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

(c) A certifying agent must conduct periodic residue testing of agricultural products to be sold, 

labeled, or represented as “100 percent organic,” “organic,” or “made with organic (specified 

ingredients or food group(s)).” Samples may include the collection and testing of soil; water; 

waste; seeds; plant tissue; and plant, animal, and processed products samples. Such tests must 

be conducted by the certifying agent at the certifying agent's own expense.

(d) A certifying agent must, on an annual basis, sample and test from a minimum of five percent 

of the operations it certifies, rounded to the nearest whole number. A certifying agent that 

certifies fewer than thirty operations on an annual basis must sample and test from at least one 

operation annually. Tests conducted under paragraphs (b) and (c) of this section will apply to 

the minimum percentage of operations.

NOP Guidance

• NOP 5025 Commingling and Contamination Prevention in Organic Production and 

Handling (Effective date: 7/22/2011)

NOP Policy

• Policy Memo 11-13 Genetically modified organisms (Issue date: 4/15/11)

NOP Fact Sheets

• Can GMOs be Used in Organic Products? (Published May 2013)

IV. DISCUSSION

Best Management Practices

Because GMOs are widely used in conventional food and feed systems, they are nearly 

ubiquitous in our environment, and there are many potential opportunities for GMOs to 

contaminate organic food and feed. The following is a summary of management practices 

recommended to help prevent GMO contamination, drawn from the references listed at the end 

of this document and other sources.

Best Management Practices for seed and crop production 

• Assess farm site and crops to be grown for potential sources of contamination.

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• Identify at-risk crops* and potential points of contamination for each, including knowing 

what GMO crops are expected to be grown in the area. 

• Communicate with neighboring farmers about what at-risk crops you will grow, if they will 

grow GMO varieties of those crops, and what might be done to help reduce the GMO 

contamination potential on your farm.

• Be certain that non-organic seeds that are used come with non-GMO verification from 

seed supplier.

• Test at-risk seed, or get verification of clean seed from supplier, before planting.

• Avoid using bee pollinators that have been used in proximity to GMO fields and 

determine if neighboring feral hives exist that could carry GMO pollen to your farm.

• Know the life cycles of crops being planted, if the crops are self- or cross-pollinating, if 

the pollen is transported by wind or insects, etc.

• Isolate at-risk organic crops from GMO crops with suitable distances and/or planting 

timing, conferring with neighbors as needed.

• Control plants that could contaminate your crops, including volunteers, feral populations 

and wild relatives in proximity to your fields.

• Verify that all inputs, such as fertility and pest control materials, are non-GMO.

• Clean all equipment and facilities prior to use.

• Document equipment cleanout and keep records of all practices used to limit 

contamination. 

• Inspect and clean storage facilities and be sure they are isolated from GMO storage.

• Avoid mixing during harvest, cleaning, storage, transport and sales.

• Be aware that GMO-laden dust from neighboring fields may require more thorough 

cleaning and protection of organic products than just removing GMO seeds from 

equipment.

• Know the organic regulations for excluding GMOs and know your certifier’s requirements

• Know your buyers’ GMO requirements and testing protocols.

Best Management Practices for livestock

• Assess farm site and facilities for potential sources of contamination.

• Maintain separate, isolated facilities for feed storage of organic and GMO feeds (if a split 

operation).

• Inspect and clean storage facilities before use.

• Receiving practices: quarantine incoming product and do not release until all supporting 

non-GMO paperwork and labels are reviewed. Make sure the product received is the 

product approved in the OSP. Check lot numbers. Non-GMO documentation must be 

collected and maintained on-file. 

• Thoroughly clean and purge feed processing and handling equipment if used for GMO 

products.

• Document and maintain records of cleanout of equipment and facilities used for GMO 

products.

Best Management Practices for handling

• Assess the site, facilities and organic products/inputs for possible sources of GMO 

contact.

• Receiving practices: quarantine incoming product and do not release until all supporting 

non-GMO paperwork and labels are reviewed. Make sure the product received is the 

* High risk crops include alfalfa, canola, corn, cotton, soy, sugar beets, zucchini and yellow summer squash.

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product approved in the OSP. Check lot numbers. Non-GMO documentation must be 

collected and maintained on-file.

• All inputs must be traceable and must be of non-GMO source, even the nonorganic 

inputs contained in “made with organic” products.

• Organic and non-GMO materials must be strictly segregated from any GMO materials.

• Equipment must be thoroughly cleaned and purged if used for processing and handling 

GMO materials.

• Know which ingredients pose a GMO-contamination risk and what, if any, contamination 

levels are present in them. 

• Determine minimum thresholds of GMO contamination for rejecting inputs in at-risk 

inputs.

• Create quality assurance and quality control procedures and practices for traceability, 

segregation, sampling and testing lots of inputs for GMO content, with adequate training 

of personnel to assure routine adherence to those procedures and practices.

The Role of ACAs and Oversight

o On-site inspections (observation), review of the OSP and records, and periodic testing 

verify that farmers and handlers are following their organic system plan and that the 

measures described are effective.

o Role of testing (by ACAs) as a tool for verifying adequate contact prevention measures 

• Certifying agents may conduct residue testing to determine if these preventive 

practices are adequate to avoid contact with substances such as prohibited 

pesticides, antibiotics, and GMOs

• If GMOs are suspected or detected, certifiers must conduct an investigation to 

determine if a violation of organic farming or processing standards occurred.

• Note: Certifiers may need additional guidance from NOP on GMO testing (sampling 

procedures, testing options, choosing labs). Guidance is also needed to address 

positive results given that there aren’t specific threshold levels in the USDA organic 

regulations. See Appendix A

o Any certified organic operation found to use GMOs may face enforcement actions, 

including loss of certification and financial penalties. 

Seed Purity Requirement for Non-organic Seed

The longer we wait to set limits for controlling contamination in organic seed, feed and crops, 

the further we fall behind market demand, and the longer organic farmers are subject to the 

variability of the private market vs. the requirements of the organic regulations. A first step of 

action to protect organic seeds and crops from GMO contamination could be to require the 

evaluation of the non-GMO status of nonorganic seeds intended for use in organic production.

• The regulations require that non-organic seed be non-GMO. Organic producers must 

provide ACAs with supporting evidence that non-organic seed is non-GMO. To address 

this requirement, NOP could in guidance request that ACAs collect a seed purity 

declaration for high risk crops made (preferably on the seed tag of each bag of seed with 

a lot number) by the seed supplier or organic operation to verify the non-GMO status of 

non-organic seed. 

• Since organic seed must comply with the organic standards and is subject to residue 

sampling by ACAs, requiring seed purity declaration for organic seed could undermine 

confidence in the process-based standards. For organic seed, an organic certificate is 

adequate. However, requiring a seed purity declaration on non-organic seed would 

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obligate seed suppliers or organic operations to test non-organic seed for GMOs and to 

withhold seeds that were contaminated from entering the organic supply chain. A 

suggested threshold for planting seed is 0.1%, a figure in common use.

Requiring a seed purity declaration for non-organic seed would:

• Shift the financial burden of routine GMO testing from organic seed producers to 

suppliers of non-organic seed;

• Significantly reduce the inadvertent introduction of GMOs into organic crops through 

seed; 

• Show confidence in the processed based standards that have proved successful in 

preventing pesticide contamination on organic products; and

• Incentivize the expansion of the organic seed industry

• However, such a requirement might reduce crop seed and variety options for organic 

producers if seed suppliers were unwilling to test non-organic seeds for GMOs.

V. REQUEST FOR PUBLIC COMMENT 

The Materials Subcommittee would like input from the public on the concepts presented in this 

discussion document and particularly asks the following questions to help inform a 

subcommittee proposal:

1. Do you agree with the preventive management strategies described in this document or 

have suggestions for improvement? If not, why? Please be specific.

2. Do you have suggestions for improvement on any of the preventive practices included in 

this discussion document? Please be specific.

3. Are there other preventive management strategies that should be included? Please 

describe.

4. Do you agree that a seed purity standard should be established for non-organic seed

when used under the commercial availability clause of the regulations (organic seed is 

not available)? If yes, do you think there should be a threshold level established? Why or 

why not? What should the threshold level be?

5. Are there existing resources that are not listed here that NOSB should review and/or 

include in the proposal?

Subcommittee Vote

Motion to accept the Prevention Strategy Guidance for Excluded Methods Discussion Document

Motion by: Francis Thicke 

Seconded by: Zea Sonnabend

Yes: 5 No: 0 Absent: 2 Abstain: 0 Recuse: 0 

Approved by C. Reuben Walker, Subcommittee Chair, to transmit to NOSB February 25, 

2015

Sources/References

Blue River Hybrids - www.blueriverorgseed.com/docs/PuraMaize-Fact Sheet.pdf

Non-GMO Project Standard, 2013. Non GMO 

Project. http://www.nongmoproject.org/?attachment_id=8561

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OSGATA, 2014. Protecting Organic Seed Integrity. http://www.osgata.org/organic-seedintegrity/

Riddle, Jim 2012. GMO Contamination Prevention - What Does it Take? University of Minnesota 

Southwest Research and Outreach Center.

The Organic Center - http://www.organic-center.org

USDA/APHIS Biotech Regulatory Services (BRS) - http://www.aphis.usda.gov/biotechnology/

USDA National Organic Program - http://www.ams.usda.gov/AMSv1.0/nop

Appendix A

Guidance and training for ACAs on GMO testing

On November 9, 2012, NOP published a Final Rule on Periodic Residue Testing. The rule 

clarifies a provision of the Organic Foods Production Act (OFPA) of 1990 and the regulations 

issued that require periodic residue testing of organically produced agricultural products by 

ACAs. NOP received several comments regarding types of residues that would be considered 

acceptable targets for testing under the rule. Four commenters requested clarification on testing 

for GMOs.

NOP responded by saying that it does not intend for the testing conducted under section 

205.670 to be limited to pesticides residues. Under the existing regulations, certifying agents 

have the flexibility to test for a range of prohibited materials and excluded methods, including, 

but not limited to, pesticides, hormones, antibiotics, and GMOs. 

Given the regulatory requirements and NOP clarification, ACAs are required to test if there is 

reason to believe that an organic product has come into contact with GMOs. ACAs may also 

test for GMOs under the periodic residue testing requirements. To date, however, NOP has not 

issued any instruction or guidance on GMO testing.

The Materials/GMO Subcommittee could draft a recommendation to NOP to create guidance 

and provide training to ACAs on conducting GMO sampling and testing under the residuetesting rule. Providing NOP with a recommendation that includes further guidance on testing 

falls directly under the specific responsibilities outlined in the OFPA starting at section 2119(k):

5. PRODUCT RESIDUE TESTING.—The Board shall advise the Secretary concerning 

the testing of organically produced agricultural products for residues caused by 

unavoidable residual environmental contamination. 

Although NOP guidance on pesticide residue testing is available and USDA resources for GMO 

testing in organic feed do exist, further guidance on GMO testing of other crops for human 

consumption is greatly needed. It is extremely important that guidance offer clear and consistent 

sampling and testing protocols so ACAs may accurately assess the efficacy of an organic 

operation’s system for ensuring that GMOs do not come in contact with organic product. Testing 

is one of the most definite and effective tools ACAs can use to evaluate whether an organic 

operation has adequate measures in place to prevent commingling with non-organic GMO crops 

as well as intentional or unintentional contact with GMOs.

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