Doc. No: AMS-GD-2020-5

Effective Date: July 7, 2020

NBFDS Validation

Guidance

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USDA is an equal opportunity provider, employer, and lender.

The contents of this document do not have the force and effect of law and are not meant 

to bind the public in any way. The following is intended only to provide clarity to the public 

regarding existing requirements under the law or agency policies. 

National Bioengineered Food Disclosure Standard

Guidance to Ensure Acceptable Validation of a Refining Process

The regulations implementing the National Bioengineered Food Disclosure Standard (the

Standard) identify the requirements for a validated refining process at 7 CFR 66.9(b)-(c). In

the final rule, AMS indicated it would provide industry stakeholders further guidance to

validate a refining process. As described at 7 CFR 66.9(a), there are three ways to show 

modified genetic material is not detectable: (1) records to verify that the food is sourced from

a non-bioengineered crop or source; (2) records to verify that the food has been subjected to a 

refinement process validated to make the modified genetic material in the food undetectable; 

or (3) certificates of analysis or other records of testing appropriate to the specific food that

confirm the absence of modified genetic material. This guidance pertains to 7 CFR 66.9(a)(2) 

and 7 CFR 66.9(b) on how to ensure acceptable validation of a refinement process. For more

guidance on detectability testing, 7 CFR 66.9(c) Standards of performance for detectability

testing, see National Bioengineered Food Disclosure Standard Guidance on Testing Methods. 

As explained at 7 CFR 66.9(b)(2), once a refining process has been validated, additional 

testing is not necessary to confirm the absence of detectable modified genetic material in

food subsequently refined through that process, provided that no significant changes are

made to the validated process, that records are maintained to demonstrate that the refining

process has been validated, and that the validated refining process is followed. Also, a 

process only has to be validated in accordance with the regulations once, and may be 

applicable to multiple facilities or manufacturers so long as that specific process is followed 

and appropriate records are maintained. 

1. Identify raw materials, ingredients, and product-contact materials.

2. Define characteristics and intended use of end product.

For the Standard, a defined characteristic of the end product would be that modified genetic

material is undetectable.

General Steps to Validate a Refinement Process
Doc. No: AMS-GD-2020-5

Effective Date: July 7, 2020

NBFDS Validation

Guidance

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3. Define the sequence and interaction of all processing steps used to arrive at the end

product.

Utilize process map(s), written procedure(s), and/or other means to document processes stepby-step, beginning to end. Some of these items may already exist as a part of a Quality

Management System or another form of existing monitoring system.

4. Identify key step or steps in the refinement process that may influence the end

product’s characteristics and its ability to meet specified requirements.

A key step is any action or activity that can influence (prevent, reduce, or eliminate) the

ability to meet specified requirements. For the Standard, determine the step(s) in the refining

process that renders modified genetic material undetectable, or the series of steps in the

process (which may include the entire process) after which modified genetic material is

undetectable.

Define the parameters (e.g., time, temperature, content level) and decision criteria (i.e.,

limit(s)) that make it a key step. It is important to identify parameters that can be measured.

These parameters are what is studied during validation to determine if the intended end

product characteristics, such as making modified genetic material undetectable, is achieved.

If minor changes are made in the future, the refinement process would not need to be

revalidated if the key parameters are not affected.

5. Assemble relevant validation information that demonstrates the refinement process

operates as intended to meet specified requirements (end product characteristics),

conducting studies as needed.

Validation is the collection of evidence/data to demonstrate that a key step(s) consistently

and effectively meets specified requirements, such as making modified genetic material

undetectable.

The collection of evidence/data, may be achieved through a variety of approaches depending

on the product, processes/steps, and specified requirements. Approaches include testing,

reference to scientific or technical literature or previous validation studies, experimental data

applicable to in-plant operations, or applied data obtained during operational conditions.

The evidence/data needed to validate a key step (to meet the specified requirement) may be

available from other sources, so additional data may not be needed. If so, regulated entities

should maintain a copy of the other source’s evidence/data for their records. Also, the

evidence/data may be applicable to multiple facilities and/or manufacturers; each would
Doc. No: AMS-GD-2020-5

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NBFDS Validation

Guidance

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USDA is an equal opportunity provider, employer, and lender.

simply need to maintain copies as records.

Ultimately, evidence/data is needed to demonstrate that the key step(s) renders modified

genetic material undetectable. If other data sources do not exist, testing is often a means to

collect evidence and demonstrate modified genetic material is undetectable.1 

Note, non-key steps are documented within procedures and maps. It is important to ensure 

and document that steps that occur after key steps do not alter the intended end product 

characteristics, for example, do not introduce modified genetic material.

6. Continually verify the refinement process is operating as validated

Verification is the confirmation, through objective, recorded evidence, that the validated

process continues to meet the specified requirements. It requires monitoring that identified

parameters of the key step(s) are operating as intended and validated. Measurements are to

be recorded to demonstrate the key step(s) occurred as validated. Regulated entities should

establish a system, including frequency, for monitoring the parameters of the key step(s).

7. Revalidate the refinement process, as applicable, if significant changes are made to the

process.

If significant changes are made to the validated refinement process, especially the key

step(s), it will need to be revalidated, as described above, to determine if the process/step, as

changed, operates as intended to meet specified requirements. Significant changes are

changes to the defined key step(s) that could impact or affect the process’s ability to meet

specified requirements.

8. Maintain record(s) of the validation and ongoing verification.

Regulated entities must maintain records to demonstrate that the refining process has been

validated and that the validated refining process is verified/followed pursuant to 7 CFR

66.9(b)(2).

In accordance with 7 CFR 66.300 et. seq., customary or reasonable records must be

maintained to demonstrate compliance with the Standard. Regulated entities must maintain

1 Testing in this instance is conducted one-time as part of the validation process. This is not to be confused with

ongoing end-product testing, allowed by 7 CFR 66.9(a)(3), which is used in lieu of validating the refinement

process.
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USDA is an equal opportunity provider, employer, and lender.

records for at least two years beyond the date the food or food product is sold or distributed

for retail sale. Some of the examples of customary or reasonable records that could be used to

demonstrate compliance with the disclosure requirements of this part include, but are not 

limited to, third party certifications, laboratory testing results, validated process verification, 

and other records generated or maintained by the regulated entity in the normal course of 

business.