1400 Independence Avenue, SW.

 Room 3071-S, STOP 0201

Washington, DC 20250-0201

TO: AMS Deputy Administrators 

FROM: Elanor Starmer, Administrator

SUBJECT: Consistency between Bioengineered Disclosure and the National Organic 

 Program 

On July 29, 2016, the President signed a bill that amends the Agricultural Marketing Act of 1946 

to include Subtitle E, the National Bioengineered Food Disclosure Standard (Pub. L. 114-216). 

The Agricultural Marketing Service (AMS) is issuing the following Policy Memorandum to 

provide clarity to AMS staff and stakeholders pursuant to the statutory requirements that the 

Secretary of Agriculture consider establishing consistency with the Organic Foods Production 

Act of 1990 (7 U.S.C. 6501 et seq.) and its implementing rules and regulations, as well as the

implementation of the National Bioengineered Food Disclosure Standard (hereafter referred to as 

the GMO disclosure program). 

To ensure consistency across AMS labeling programs and to provide clarity to AMS staff and 

stakeholders, we are issuing the attached Policy Memorandum. This policy specifies the criteria 

that AMS will use when proposing rules for mandatory bioengineered food disclosure and 

labeling in order to prevent conflicts between the future requirements of a proposed GMO 

disclosure program and the requirements of the USDA organic regulations (7 CFR 205) for the 

production, handling and labeling of organic food, feed, and fiber. The specific requirements 

of a GMO disclosure program have yet to be defined through rulemaking, whereas the 

U.S. Department of Agriculture organic regulations have been in place since 2002. This policy 

also explains how AMS views labeling options that fall outside these criteria and statutory 

authorities. 

Each Deputy Administrator with a role in implementing organic labeling requirements and/or 

bioengineered disclosure requirements, or whose programs cover products that may be produced 

as organic or through bioengineering, shall review the attached memorandum to ensure 

compliance with this policy. Any new proposed regulations or specifications must comply with 

this policy. 
1400 Independence Avenue, SW.

 Room 3071-S, STOP 0201

Washington, DC 20250-0201

2

Policy Memorandum

AMS Bioengineered Foods Disclosure Program –

Consistency with the AMS National Organic Program

1. Purpose

This policy describes the criteria used by the GMO disclosure program within the Agricultural 

Marketing Service (AMS) Livestock Poultry and Seed Program (LPS), as the basis for ensuring 

consistency with the Organic Foods Production Act and the AMS National Organic Program 

(NOP). This policy also explains how AMS views requirements that fall outside these criteria

and statutory authorities.

2. Scope

This policy applies to any current and future implementing regulations and guidance for 

mandatory disclosure of bioengineered food or food derived from bioengineering, and its 

associated labeling program. 

3. Background

The AMS NOP implements the Organic Foods Production Act of 1990. Acting upon 

recommendations from the National Organic Standards Board, a Federal Advisory Committee 

appointed by the Secretary, the NOP establishes, monitors, and enforces the USDA organic 

regulations, codified in 7 CFR 205. The organic regulations are further explained through 

guidance, instructions, and policy memorandums, all of which are published in the NOP Program 

Handbook on the AMS website. USDA’s organic regulations establish criteria for the 

production of organic crops and livestock, processing of organic products, and labeling of 

organic food, fiber and livestock feed in the U.S. With rare and defined exceptions, all products 

sold, labeled or represented as organic in the U.S. must be certified by a USDA-accredited 

certifier. 

The use of bioengineered products, also generally referred to as genetically modified organisms 

(GMOs), is prohibited in organic production and handling. The USDA organic 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.” This 

prohibition applies to any product certified and labeled as 100% organic, organic, or “made with 

organic (specified ingredients).” 

AMS LPS will implement the National Bioengineered Food Disclosure Standard, which instructs 

USDA to establish a national mandatory bioengineered food disclosure standard, with respect to 

any bioengineered food and/or any food that may be bioengineered, by July 29, 2018. AMS will 

implement this Act through rulemaking with public notice and comment. AMS also intends to 

hold public stakeholder sessions to seek input prior to rulemaking. 
3

In order to ensure consistency between organic certification and bioengineering disclosure 

programs, as instructed by statute, AMS is issuing the following policy. 

4. Policy

When proposing standards for a national bioengineered food disclosure program, AMS’ policy 

will be as follows: 

No certified organic products will require disclosure as bioengineered; and 

No proposed rules for bioengineered food disclosure will require that modifications be 

made to the USDA organic regulations. 

4.1 Scope

Proposed rules for the GMO disclosure program will cover only food for human consumption, as 

defined by the authorizing legislation, whereas the organic regulations cover human food, 

livestock feed, feed inputs, and fiber. 

4.2 Terms Defined

Both the USDA organic regulations and the National Bioengineered Food Disclosure Standard

include definitions related to products of bioengineering. When proposing regulations to 

implement the GMO disclosure program, AMS will seek comment on further definitions of 

bioengineered foods requiring mandatory disclosure. The current definitions under the two 

programs are as follows. 

National Bioengineered Food Disclosure Standard: “The term bioengineering, and 

any similar term, as determined by the Secretary, with respect to a food, refers to a food 

that contains genetic material that has been modified through in vitro recombinant 

deoxyribonucleic acid (DNA) techniques; and for which the modification could not 

otherwise be obtained through conventional breeding or found in nature.”

USDA Organic Regulations: “Excluded methods. A variety of methods used to 

genetically modify organisms or influence their growth and development by means that 

are not possible under natural conditions or processes and are not considered compatible 

with organic production. Such methods include cell fusion, microencapsulation and 

macroencapsulation, and recombinant DNA technology (including gene deletion, gene 

doubling, introducing a foreign gene, and changing the 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).
4

4.3 Thresholds 

Some markets have established tolerance levels or thresholds for the presence of a bioengineered

substance in food, both for mandatory disclosure requirements or for absence claims, such as 

non-GMO. USDA has not established mandatory tolerances for either positive or negative 

bioengineered label claims. The statute instructs AMS to propose regulations which determine 

the amounts of a bioengineered substance that may be present in food, as appropriate, in order 

for the food to require disclosure as a bioengineered food. These proposed regulations will be 

open for public comment.

USDA organic regulations do not establish GMO tolerance levels. Organic standards are process 

based, and the regulations prohibit the use of GMOs, prohibit commingling or contamination 

during processing and handling, and require preventative practices to avoid contact with GMOs. 

Organic agricultural products should have minimal if any GMO presence.

As a part of its voluntary, user-fee-funded verification services provided under 7 CFR 62, AMS 

currently allows a company to label and market a product as “USDA Process Verified” to a 

claim of meeting a 99.1% threshold of Non-GMO/Non-GE traits. The USDA Process Verified 

Program (PVP) is a verification service that offers applicants a unique way to market their 

products to customers using clearly defined, implemented, and transparent process points that are 

independently verified by AMS auditors. PVP programs verify the process used to meet 

standards that companies set for themselves, and AMS can and does establish policies related to 

which marketing claims the Agency wishes to be associated with the PVP. However, with 

limited exceptions such as the “Organic” claim, AMS does not have statutory authority to 

establish regulations dictating standards behind marketing claims. 

4.4 Absence Claims

As instructed by statute, USDA shall consider organic certification sufficient to make a claim 

regarding the absence of bioengineering in the food, such as “not bioengineered,” “non-GMO,” 

or another similar claim. However, products that do not require mandatory disclosure as 

bioengineered foods or foods that contain bioengineered ingredients may not automatically 

qualify for absence claims. 

5. References

Organic Foods Production Act of 1990 (7 U.S.C. 6501 et seq.) -

USDA Organic Regulations (7 CFR 205)

National Organic Program Policy Memo 11-13: Genetically Modified Organisms

National Bioengineered Food Disclosure Standard (Pub. L. 114-216)

[Signature on file] 9/19/2016

Elanor Starmer, Administrator Date