United States Department of Agriculture 1400 Independence Avenue S.W. Policy Memo 15-2

Agricultural Marketing Service Room 2648 South Building Page 1 of 2

National Organic Program Washington, DC 20250

PM 15-2 Nanotechnology Rev03 03 20 24 Authorized Distribution: Public 

Policy Memorandum

To:

From:

Subject:

Date:

Stakeholders and Other Interested Parties

Miles V. McEvoy, Deputy Administrator 

Nanotechnology 

Approved on March, 24 2015 

Links Updated: March 20, 2024 

This memorandum clarifies the status of nanotechnology in organic production and handling 

under the U.S. Department of Agriculture (USDA) organic regulations at 7 CFR Part 205. 

Issue: 

The National Organic Program (NOP) has received questions about the use of nanotechnology in 

organic production and handling. 

Nanotechnology is science, engineering, and technology conducted at the nanoscale, which is 

about 1 to 100 nanometers. Nanomaterials are commonly associated with a size range

(nanoscale) of 1 to 100 nanometers along at least one dimension. They may, however, exceed 

that size, and be defined by physical or chemical characteristics or behavior that distinguish them 

from bulk, or non-nanomaterial. Nanomaterials can occur naturally, for example in volcanic ash 

and ocean spray, and may also be incidental byproducts of human activity, such as 

homogenization or milling. They can also be produced intentionally with specific properties

through certain chemical or physical processes. Nanomaterials have many commercial 

applications spanning different fields, such as medicine, electronics, and energy, as well as 

agricultural production and food processing. We use the term “engineered nanomaterials” to 

refer to substances specifically designed and manufactured to have unique properties or behavior 

attributable to particle size. We use the term “incidental nanomaterials” to refer to substances 

that are incidental byproducts of other manufacturing (e.g., homogenization, milling) or that

occur naturally. 

Policy: 

In 2010, the National Organic Standards Board (NOSB) recommended that engineered 

nanomaterials1

 be considered synthetic and prohibited in organic production and processing. The 

NOSB proposed defining engineered nanomaterials as “substances deliberately designed, 

engineered, and produced by human activity to be in the nanoscale range of 1-300 nanometers, 

1 October 2010 NOSB recommendation, Guidance Document— Engineered Nanomaterials in Organic Production, Processing and Packaging. 
United States Department of Agriculture 1400 Independence Avenue S.W. Policy Memo 15-2

Agricultural Marketing Service Room 2648 South Building Page 2 of 2

National Organic Program Washington, DC 20250

PM 15-2 Nanotechnology Rev03 03 20 24 Authorized Distribution: Public 

because of very specific properties or composition (e.g., shape, surface properties, chemistry) 

that result only in that nanoscale.” The NOSB-recommended definition would include all 

nanomaterials containing capping agents or other synthetic components, but not incidental 

particles created during traditional food processing, or naturally occurring nanomaterials. 

The NOP does not consider nanotechnology to be intrinsically benign or harmful. This 

memorandum clarifies that the statutory framework for the review of substances intended for use 

in organic production and handling would also apply to engineered nanomaterials. 

The Organic Foods Production Act of 1990 (OFPA) authorizes the Secretary of Agriculture to 

establish the National List of Allowed and Prohibited Substances. The National List specifies 

which synthetic substances may be used in organic production as well as any substances 

prohibited for use in organic production. Section 205.605 of the USDA organic regulations 

includes the list of synthetic and nonsynthetic substances that may be used in or on processed 

products labeled as “organic” or “made with organic (specified ingredients or food group(s)).” 

Under 7 U.S.C. 6517, the National List established by the Secretary at 7 CFR 205.605 shall be 

based upon a proposed National List or proposed amendments to the National List developed by 

the NOSB. The statute further requires that any amendments to the National List must undergo a 

public notice and comment period before changes are made. 

As with other substances, no engineered nanomaterial will be allowed for use in organic 

production and handling unless the substance has been: 1) petitioned for use; 2) reviewed and 

recommended by the NOSB; and 3) added to the National List through notice and comment 

rulemaking. The OFPA provides criteria that the NOSB must use to evaluate substances 

requested for use in organic production and handling. Individuals or organizations petitioning to 

add an engineered nanomaterial to the National List must provide information to address the 

OFPA criteria.2

 

To avoid conflicts about the presence of nanomaterials in substances regulated by other Federal 

agencies, the NOP is not establishing a separate definition for engineered nanomaterials, such as 

the definition recommended by the NOSB. The descriptions in the U.S. Food and Drug 

Administration’s Guidance for Industry Considering Whether an FDA-Regulated Product 

Involves the Application of Nanotechnology3 and the U.S. Environmental Protection Agency’s 

policies on Regulating Pesticides that Use Nanotechnology4 and Control of Nanoscale Materials 

Under the Toxic Substances Control Act5 should be used as applicable. 

2 Refer to https://www.ams.usda.gov/rules-regulations/organic/national-list/filing-petition 3 U.S. Food and Drug Administration, Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology, 

http://www.fda.gov/RegulatoryInformation/Guidances/ucm257698.htm. 4 U.S. Environmental Protection Agency, Regulating Pesticides that Use Nanotechnology. 

http://www.epa.gov/pesticides/regulating/nanotechnology.html

5 U.S. Environmental Protection Agency, Control of Nanoscale Materials Under the Toxic Substances Control Act.

https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/control-nanoscale-materials-under