FORMAL RECOMMENDATION BY THE

NATIONAL ORGANIC STANDARDS BOARD (NOSB) 

TO THE NATIONAL ORGANIC PROGRAM (NOP) 

Date: April 29, 2010 

Subject: Inerts in Pesticides Allowed for use in Organic Production 

Chair: Daniel G. Giacomini 

Recommendation

The NOSB hereby recommends to the NOP the following: 

Rulemaking Action: 

Guidance Statement: X 

Other: 

Summary Statement of the Recommendation (including Recount of Vote): The NOSB voted 

13 yes to 1 no with one member absent to submit to the NOP a guidance recommendation on 

inerts in pesticides allowed for use in organic production. The NOSB is suggesting 6 steps to 

accomplish the changes in regulation that would allow materials on the now obsolete EPA List 3 

and 4 Inerts currently on the National List to be looked at by the NOSB, NOP, and EPA to 

determine how best to evaluate these materials for listing, maintain the list, and continue to 

evaluate new inert materials for inclusion on the List. 

NOSB Vote: Motion: Jeff Moyer Second:Jay Feldman 

Board vote: Yes - 13 No- 1 Abstain- 0 Absent - 1 

Summary Rationale Supporting Recommendation (including consistency with OFPA and 

NOP): OFPA Section 6517(b) Content of List. The list established under subsection (a) of this 

section shall contain an itemization, by specific use or application, of each synthetic substance 

permitted under subsection (c) (1) of this section or each natural substance prohibited under 

subsection (c)(2). The NOP currently maintains an outdated classification listing for inerts used in 

pesticides under the old EPA list 4 and list 3 classifications. As of 2006 this EPA classification no 

longer exists and has been replaced by the new EPA classification lists 40CFR 180. EPA has 

reassessed a number of List 4 Inert ingredients and these reassessments have resulted in a number 

of revocations. Assessments have also resulted in a number of reclassifications of List 3 intert 

ingredients to List 4 Inert ingredients. As a result, the NOP regulations must be amended to 

acknowledge the inert tolerance reassessments conducted by EPA. This recommendation is meant 

to help determine the most effective and efficient way to amend the regulations with the 

collaboration of the NOSB, NOP, and the EPA. 

Response by the NOP:
National Organic Standards Board (NOSB) 

Crops Committee 

Guidance Recommendation on 

Inerts in Pesticides Allowed for use in Organic Production 

March 1, 2010 

Introduction 

This document discusses the Crops Committee proposed guidance to the 

program (NOP) regarding the need for clarification on materials listed as inerts 

under the old EPA List 4 and List 3 classifications. 

The ORGANIC FOODS PRODUCION ACT OF 1990 states: 

Sec. 2119 

(1) REQUIREMENTS. In establishing the proposed National List or proposed 

amendments to the National List, the Board shall- 

(1) review available information from the Environmental Protection 

Agency, the National Institute of Environmental Health Studies, and 

such other sources as appropriate, concerning the potential for 

adverse human and environmental effects of substances 

considered for inclusion in the proposed National List; 

(2) work with manufacturers of substances considered for inclusion in 

the proposed National List to obtain a complete list of ingredients 

and determine whether such substances contain inert materials that 

are synthetically produced; and 

Background 

The NOP currently maintains an outdated classification listing for inerts used in 

pesticides under the old EPA list 4 and list 3 classifications. As of 2006 this EPA 

classification no longer exists and has been replaced by the new EPA 

classification lists 40CFR 180. The NOP issued the following statement on 

September 6, 2007 documenting the position of the program regarding the 

changes made by EPA to their List 3 and 4 inerts. 

The National Organic Program (NOP) regulations currently allow 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 – 

as ingredients in pesticides allowed in organic production operations. These lists 

were 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 they 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. 

• 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. 

On September 30, 2009, EPA issued a statement that said the agency will seek 

to disclose hazardous pesticide inert ingredients (See http://epa.gov/oppfead1/

cb/csb_page/updates/2009/disclose-inerts.html). In a letter responding to 
petitions before the agency, EPA said that it is “initiating rulemaking to increase 

public availability of hazardous inert ingredient identities for specific 

formulations.” EPA continues, “In connection with the rulemaking, EPA will also 

be discussing ideas to increase the disclosure of inert ingredients to an even 

greater degree than requested by petitioners, for example, by requiring 

disclosure of all inert ingredients, including ingredients not deemed hazardous.” 

(See entire letter at http://www.epa.gov/opprd001/

inerts/petitionresponse.pdf

NOP Policy 

Parties reviewing pesticide product ingredients for compliance with the NOP are 

advised to use EPA’s August 2004 lists of approved List 4 inert ingredients, 

minus the revoked inert ingredients. These lists are provided at the end of this 

document as attachments: 

• -Inert Ingredients Ordered Alphabetically by Chemical Name - List 4A 

(Attachment 1) 

• -Inert Ingredients Ordered Alphabetically by Chemical Name - List 4B 

(Attachment 2) 

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. Certifiers and other affected parties should consult the NOP Document 

Control Masterlist for the most current guidance on this topic. 

Definitions: 

EPA Inert (other) Ingredients in Pesticide Products 

Pesticide products contain both "active" and "inert" ingredients. The terms "active 

ingredient" and "inert ingredient" have been defined by Federal law, the Federal 

Insecticide, Fungicide, and Rodenticide Act (FIFRA), since 1947. 

An active ingredient is one that prevents, destroys, repels or mitigates a pest, or 

is a plant regulator, defoliant, desiccant or nitrogen stabilizer. By law, the active 

ingredient must be identified by name on the label together with its percentage by 

weight. 
An inert ingredient means any substance (or group of structurally similar 

substances if designated by the Agency), other than an active ingredient, which 

is intentionally included in a pesticide product. Inert ingredients play a key role in 

the effectiveness of a pesticidal product. For example, inert ingredients may 

serve as a solvent, allowing the pesticide's active ingredient to penetrate a plant's 

outer surface. In some instances, inert ingredients are added to extend the 

pesticide product's shelf-life or to protect the pesticide from degradation due to 

exposure to sunlight. “Inert” ingredients can be and are frequently chemically and 

biologically active substances, as well as hazardous and toxic to the environment 

and humans. 

Pesticide products can contain more than one inert ingredient, but federal law 

does not require that these ingredients be identified by name or percentage on 

the label. Only the total percentage of inert ingredients is required to be on the 

pesticide product label. 

EPA Regulatory Statement: 

EPA’s National Organic Program Guidance 

December 20, 2007 

• The National Organic Program (NOP) is a USDA program. All matters of 

policy concerning the eligibility of Inert Ingredients for use in the NOP are 

determined by USDA. EPA’s role is to assist USDA by assuring that 

USDA’s policies are implemented with regard to organic claims made by 

registered pesticide products. 

• USDA policy regarding Inert Ingredients and List 4 is summarized in the 

following USDA document: Instructions to Certifiers for Use of EPA List 4 

Inert Ingredients 

• If an applicant has questions with regard to the policy outlined in the 

above link, or wishes to petition USDA for the addition of another Inert 

Ingredient, EPA refers the applicant to USDA's NOP office. Program and 

contact information can be found through the following link: 

http://www.ams.usda.gov/nop/indexIE.htm

• Per USDA, any applicants seeking organic designation must assure that 

their inert ingredients can be found on this posted List 4, dated August 

2004. No other Inert Ingredients (i.e. reassessed inert ingredients) will be 

considered for organic designation at this time. (Ingredients approved by 7 

CFR part 205 excepted.) 

• NOP applicants should be aware that the tolerance exemptions for the 

following ingredients still found in the above List 4 have since been 

revoked and are no longer approved for use in pesticide products under 

USDA’s NOP: manganous oxide; polyglyceryl phthalate ester of coconut 
oil fatty acid; coumarone - indene resin; pentaerythritol monostearate; 

pentaerythritol tetrastearate; acrylic acid methyl ester, polymer with 

acrylonitrile and 1,3-butadiene (tolerance exemption is called "Nitrile 

rubber modified acrylonitrile methylacrylate [CAS Reg. No. 27012-62-0] 

conforming to 21 CFR 177.1480"); sodium fluoride; and acetylated lanolin 

alcohol. 

• For food uses, NOP applicants should cross-check their inert ingredients 

against the electronic Code of Federal Regulations (e-CFR) (40 CFR Part 

180) to assure that their proposed uses remain covered by an appropriate 

tolerance exemption. The e-CFR can be found through the following link: 

http://www.gpoaccess.gov/ecfr/ (Select Title 40, Volume 23 (parts 150-

189), and then part 180. The majority of inert ingredient tolerance 

exemptions are found in 180.910 – 160.) 

• NOP applicants are responsible for providing sufficient information on their 

inert ingredients for EPA to make an NOP determination. Simply noting an 

ingredient as List 4 is often not sufficient. The NOP has many additional 

requirements for ingredients, which are intended to assure organic 

compatibility of the formulation. EPA suggests applicants submit 

Manufacturing Process data for their product and technical data sheets 

and MSDS for their inert ingredients. 

• NOP applicants using proprietary blends in their formulations should 

check with their suppliers to assure that all the constituent ingredients in 

their blend can be found on this posted List 4, dated August 2004. The 

owner of the propriety blend must submit to EPA a complete description of 

the blend’s composition (trade name, chemical names, CAS Reg. No.s, 

and amount of each component the total of which must equal 100%). 

NOP Regulatory Citation: (This is the current listing regarding inerts under the 

NOP rule) 

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

In accordance with restrictions specified in this section, the following synthetic 

substances may be used in organic crop production: Provided, That, use of such 

substances do not contribute to contamination of crops, soil, or water. 

Substances allowed by this section, except disinfectants and sanitizers in 

paragraph (a) and those substances in paragraphs (c), (j), (k), and (l) of this 

section, may only be used when the provisions set forth in §205.206(a) through 

(d) prove insufficient to prevent or control the target pest 

(m) As synthetic inert ingredients as classified by the Environmental 

Protection Agency (EPA), for use with nonsynthetic substances or 

synthetic substances listed in this section and used as an active 
pesticide ingredient in accordance with any limitations on the use of such 

substances. 

(1) EPA List 4—Inerts of Minimal Concern. 

(2) EPA List 3—Inerts of Unknown Toxicity allowed: 

(i) Glycerine Oleate (Glycerol monooleate) (CAS #s 37220–82–

9)—for use only until December 31, 2006. 

(ii) Inerts used in passive pheromone dispensers 

Discussion 

The Crops Committee, with the input of many individuals and organizations has 

been working through the historic and current perspectives regarding the 

updating of the NOP’s classification of the inert materials. It is clear to this 

committee that the EPA definitions of inerts do not preclude them from actually 

functioning as active ingredients depending on the formulation used. We, as a 

committee, are extremely reluctant to assimilate the new 40 CFR 180 listings for 

these materials in mass into the organic materials use list thereby bringing in 

hundreds of un-reviewed materials. We also recognize that both dollars and time 

preclude individual examination of the hundreds of materials found on these lists. 

The NOSB needs to review all inert ingredient components used in current 

NOP compliant pesticide formulations for consideration for inclusion on 

the National List of Allowed Materials on 205.601. 

Proposed Guidance to the NOP: The Crops Committee is making the following 

recommendation to the NOSB: 

The NOSB requests that the NOP create and enter into a Memorandum Of 

Understanding (MOU) with the EPA to assist in the evaluation of the 

materials previously known as both EPA List 4, inerts of minimal concern 

and EPA List 3, inerts of unknown toxicity allowed. This MOU should serve 

as the platform for an implementation strategy that may include an official 

task force or some other structure to achieve the following objectives. 

From the date of public notice of the approval of this recommendation: 

1) Working with the EPA, the NOSB will create a sub-list from the previous list of 

inert materials used in organic pesticide formulation known as list 3 and list 4 

inerts that meet the NOSB established review criteria for non-synthetic “natural” 

materials. Nonsynthetic substances are not required to be listed on the National 

List on 205.601 or 205.603 for use in organic production and will not require 

further review in order to be allowed for use in the manufacturing of pest 

management materials. Manufacturers of organic pesticides will be directed to 
this “list” of materials as their first choice for ingredients used in the formulation of 

their products. 

2) If unable to formulate pesticide products for use in organic production relying 

on these non-synthetic “natural” ingredients, the manufacturers of pesticides 

currently allowed for use and in organic production must provide the NOP with 

the names and CAS numbers for all their product ingredients currently listed as 

inert that they intend to defend for continued use, for review by the NOSB under 

the existing petition process. Product status will remained unchanged during the 

petition process. Any ingredients not introduced for review within an established 

time frame will not be considered for inclusion on the National List of Allowed 

Materials and will Not Be Allowed for use in pesticide formulations in organic 

production. 

3) The inerts materials submitted to the NOSB as a petitioned substance will 

receive priority review by the board to determine compliance with the standards 

of OFPA under the general materials review procedures. Upon receipt of the 

petitioned product ingredients, the crops committee will solicit a technical review 

(TR) of each material. Materials not submitted for review will have a designated 

grace period, after which they will no longer be allowed. 

 

4) Following the petition process and the committee recommendation, any 

material or substance found to be incompatible with organic production will be 

given an established time period in which to reformulate or lose approved status 

and be prohibited from further use. ) Submitted materials rejected during NOSB 

review process will be prohibited after a designated grace period, unless health 

and environmental risks dictate an expedited termination of use 

5) Items: 

 1) EPA List 4 Inerts of Minimal Concern 

 2) EPA List 3 Inerts of Unknown Toxicity allowed: 

under 205.601(m) As synthetic inert ingredients as classified by the 

Environmental Protection Agency (EPA), for use with nonsynthetic substances or 

synthetic substances listed in this section and used as an active pesticide 

ingredient in accordance with any limitations on the use of such substances, will 

remain in the rule as a static list until recommendations from the Task Force 

indicate change. 

6) Based on the results of the MOU established task force the NOSB will either 

list the specific inert ingredient components recommended for inclusion on 

205.601 (m) by the NOSB subject to the current sunset process or post the list as 

a single material listing as a subset list managed by the EPA as a 

“List of inerts suitable for organic production” or other delineation. Which ever 

listing format is utilized individual materials will be subject to the sunset process 

already established under the NOSB policy manual. 
Committee Vote to recommend this document: 

Motion: Barry Flamm ; Second: Tina Ellor ; 

Yes: 6 No: 0 Absent: 1 Abstain: 0 

Respectfully submitted: 

Tina Ellor 

Crops Committee Chair 

March 1st , 2010 
Addendum 

Screen for Allowable Inerts 

[Note: This type of screen would take about 1⁄2 hour to run a chemical 

through. It would confirm that those remaining on the allowable list do not 

raise any red flags. If the ingredient turns up on one of these lists, then it 

would trigger a more indepth review.] 

(1) Toxicity Category I or II by the United States Environmental Protection 

Agency (EPA). These pesticides are identified by the words “DANGER” or 

“WARNING” on the label. 

(2) A developmental or reproductive toxicant as defined by the State of 

California Proposition 65 Chemicals Known to Developmental or 

Reproductive Harm. 

(3) A carcinogen, as designated by EPA’s List of Chemicals Evaluated for 

Carcinogenic Potential (chemicals classified as a human carcinogen, likely 

to be carcinogenic to humans, a known/likely carcinogen, a probable human 

carcinogen, or a possible human carcinogen), the International Agency for 

Research on Cancer (IARC), U.S. National Toxicology Program (NTP), and 

the state of California's Proposition 65 list. Any of the following 

classifications shall deem the chemical a carcinogen and unacceptable: 

Known to the State of California to Cause Cancer (California) 

Group A: Human Carcinogen (US EPA 1986 category) 

Group B: Probably Human Carcinogen (US EPA 1986 category) 

Group C: Possible Human Carcinogen (US EPA 1986 category) 

Known Carcinogen (US EPA 1996 category) 

Likely Carcinogen (US EPA 1996 category) 

Carcinogenic to Humans (US EPA 1999 category) 

Likely to be Carcinogenic to Humans (US EPA 1999 category) 

Suggestive Evidence of Carcinogenicity (US EPA 1999 category) 

Known to be Human Carcinogens (NTP) 

Reasonably Anticipated to be Human Carcinogens (NTP) 

Group 1: Carcinogenic to Humans (IARC) 

Group 2A: Probably Carcinogenic to Humans (IARC) 

Group 2B: Possibly Carcinogenic to Humans (IARC) 

(4) Neurotoxic cholinesterase inhibitors, as designated by California Department 

of Pesticide Regulation or the Materials Safety Data Sheet (MSDS) for the 

particular chemical, 

(5) (5). Known groundwater contaminants, as designated by the state of 

California (for actively registered pesticides) or from historic groundwater 

monitoring records (for banned pesticides). 
(6) Pesticides formulated as dusts, powder or aerosols, unless used in a way that 

virtually eliminates inhalation hazard (for example, applied to cracks or 

crevices and sealed after the application, or as a directed spray into the 

entrance of an insect nest). 

(7) Nervous system toxicants, including chemicals such as cholinesterase 

inhibitors or chemicals associated with neurotoxicity by a mechanism other 

than cholinesterase inhibition, or listed on: 

Toxics Release Inventory (TRI), EPA EPCRA Section 313 (Identified as 

"NEUR" on Table 1) 

EPA Reregistration Eligibility Decisions (RED) 

Insecticide Resistance Action Committee (IRAC) Mode of Action 

Classification: 

Acetylcholine esterase inhibitors; 

GABA-gated chloride channel antagonists; 

Sodium channel modulators; 

Nicotinic Acetylcholine receptor agonists /antagonists; 

Nicotinic Acetylcholine receptor agonists; 

Chloride channel activators; 

Octopaminergic agonists; 

Voltage-dependent sodium channel blockers; or 

Neuronal inhibitors (unknown mode of action). 

(8) Endocrine disruptors, which include chemicals that are known to or likely to 

interfere with the endocrine system in humans or wildlife, based on the 

European Commission (EC) List of 146 substances with endocrine 

disruption classifications, Annex 13 (and/or any subsequent lists issued as 

follow-up, revisions, or extensions). 

(9) (Regarding outdoor use) Adversely affects the environment/wildlife, based 

on: 

a. Label precautionary statements including “toxic” or “extremely toxic” to 

bees, birds, fish, aquatic invertebrates, wildlife or other non-target 

organisms, unless these organisms are the target pest and/or 

environmental exposure can be virtually eliminated. 

b. Pesticides with ingredients with moderate or high mobility in soil, 

according to the Groundwater Ubiquity Score (GUS), or with a soil halflife of 30 days or more (except for mineral products). Persistence and 

Soil Mobility procedures appear below. 

i. If GUS (Groundwater Ubiquity Score) cannot be found, we search for 

the aerobic soil half-life and soil-binding coefficient Koc. GUS is then 

calculated from the formula: GUS = log10(half-life)*(4 – log10 (Koc)). 

(10) Has data gap or missing information in EPA registration documents, 

including pesticide fact sheets, or EPA reregistration eligibility decisions, 

which EPA is requiring the registrant to fulfill. 
(11) Contaminants and metabolites recognized by EPA that violate any of the 

above criteria. 

(12) Inert or active ingredients that are Chemicals Included on EPA’s List 1 

(Inerts of Toxicological Concern) or EPA List 2: (Potentially Toxic, High 

Priority for Testing).