United States Department of Agriculture 1400 Independence Avenue SW. NOP 5008

Agricultural Marketing Service Room 2646-South Building Effective Date: July 22, 2011

National Organic Program Washington, DC 20250 Page 1 of 2

Original Issue Date: 09/30/10 Authorized Distribution: Public

File Name: NOP5008 Reassessed Inert Ingredients Rev03 08 31 18

Guidance 

Reassessed Inert Ingredients

Links Update: August 31, 2018

1. Purpose 

This guidance provides information to certifying agents, organic producers and handlers regarding the 

allowance of inert ingredients used in pesticide products.

2. Scope

This guidance applies to National Organic Program (NOP) certifying agents, all certified and exempt 

organic producers, handlers and input suppliers.

3. Background

The National Organic Program (NOP) regulations currently allow use of inert ingredients which appear 

on the Environmental Protection Agency (EPA) List 4A – Minimal Risk Inert Ingredients and List 4B –

Other ingredients for which EPA has sufficient information to reasonably conclude that the current use 

pattern in pesticide products will not adversely affect the public health or the environment – in a variety 

of applications, primarily as pesticides in organic production operations. These lists are maintained and 

managed by EPA.

EPA has been reassessing exemptions from tolerances for inert ingredients in pesticide products to 

ensure that they meet the safety standard established by the Food Quality Protection Act (FQPA). 

FQPA requires the reassessment of inert ingredient tolerances and tolerance exemptions that were in 

place prior to August 3, 1996. EPA completed their reassessments in 2006.

EPA reassessments resulted in the revocation of a few List 4 inert ingredients, and are therefore 

prohibited under NOP. List 4 inert ingredients that have been revoked for use in pesticide formulations 

and are now prohibited under NOP are as follows:

- Acetylated lanolin alcohol (CAS Reg. No. 91994-94-4); Revoked in 70 FR 31401, June 1, 2005.

- Acrylic acid methyl ester, polymer with acrylonitrile and 1,3-butadiene 

(CAS Reg. No. 27012-62-0); Revoked in 71 FR 14411, March 22, 2006; the tolerance exemption 

is called “Nitrile rubber modified acrylonitrile methylacrylate conforming to 21 CFR 177.1480.

- Coumarone – indene resin (CAS Reg. No. 63393-89-5); Revoked in 71 FR 14411, 

March 22, 2006.

- Manganous oxide (CAS Reg. No. 1344-43-0); Revoked in 71 FR 45415, August 9, 2006.

- Pentaerythritol monostearate (CAS Reg. No. 78–23–9); Revoked in 71 FR 14411, 

March 22, 2006.

- Pentaerythritol tetrastearate CAS Reg. No. 115–83–3); Revoked in 71 FR 14411, March 22, 

2006.
United States Department of Agriculture 1400 Independence Avenue SW. NOP 5008

Agricultural Marketing Service Room 2646-South Building Effective Date: July 22, 2011

National Organic Program Washington, DC 20250 Page 2 of 2

Original Issue Date: 09/30/10 Authorized Distribution: Public

File Name: NOP5008 Reassessed Inert Ingredients Rev03 08 31 18

- Polyglyceryl phthalate ester of coconut oil fatty acid (CAS Reg. No. 66070-87-9); Revoked in 

71 FR 45415, August 9, 2006.

- Sodium fluoride (CAS Reg. No. 7681-49-4); Revoked in 70 FR 31401, June 1, 2005.

EPA has also reclassified a number of List 3 inert ingredients (inerts of unknown toxicity) as List 4 inert 

ingredients. Those materials have not been added to EPA’s published List 4 documents but appear 

through individual approvals issued by EPA and posted on their website.

EPA has informed USDA that the “Inerts List” system may no longer be effective or available for the 

NOP to reference in the Regulations. Also impacted is the EPA review and labeling program for 

determining the compatibility of pesticides with the Regulations. As a result, the NOP regulations must 

be amended to acknowledge the inert tolerance reassessments conducted by EPA. NOP will collaborate 

with EPA and the National Organic Standards Board (NOSB) to determine the most effective and 

efficient way to amend the regulations.

4. Policy

Parties reviewing pesticide product ingredients for compliance with the NOP are advised to use EPA’s 

August 2004 list, minus the revoked inert ingredients, to verify that inert ingredients are listed as List 

No. 4A or 4B. The EPA August 2004 list of inert ingredients is available on their website.

The NOSB has requested that inert ingredients reassessed by EPA, but not previously authorized for use 

under the NOP remain prohibited in organic agriculture. Until the NOP and NOSB can determine the 

best course to take in response to EPA’s reassessment decisions, NOP will concur with the NOSB’s 

request and grant that use of such ingredients must be petitioned. A petition may be submitted to the 

NOSB using the National List petition procedures. Petitioned substances must be recommended by the 

NOSB and added to the National List through notice and comment rulemaking before use in organic 

agriculture.

This policy will remain in effect until superseded by regulatory changes or new guidance.

5. References

NOP Regulations (as amended to date)

7 CFR § 205.601 Synthetic substances allowed for use in organic crop production.

7 CFR § 205.603 Synthetic substances allowed for use in organic livestock production.

Other Laws and Regulations

United States. Cong. Food Quality Protection Act of 1996. 104th Cong. Washington: GPO, 1996. Print.

Approved on July 22, 2011