National Organic Standards Board

Crops Committee

2012 Sunset Recommendation

List 3 Inert Ingredients in Passive Pheromone Dispensers

March 20, 2012

List: 205.601 Synthetic substances allowed for use in organic crop production.

(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. 

(2) EPA List 3—Inerts of unknown toxicity—for use only in passive pheromone 

dispensers.

Background

Inert ingredients are defined in the National Organic Program (NOP) regulations, with 

reference to the Environmental Protection Agency (EPA) definition, to include any 

ingredient other than active ingredients used in pesticide products. The Federal 

Insecticide, Fungicide, and Rodenticide Act (FIFRA) provides that inert ingredients used 

in pesticides do not require disclosure on product labels. 

NOP 7 CFR §205.2 Terms Defined

Inert ingredient. Any substance (or group of substances with similar chemical 

structures if designated by the Environmental Protection Agency) other than an 

active ingredient which is intentionally included in any pesticide product (40 CFR 

152.3(m)).

EPA 40 CFR 152.3 Definitions 

Active ingredient means any substance (or group of structurally similar 

substances if specified by the Agency) that will prevent, destroy, repel or mitigate 

any pest, or that functions as a plant regulator, desiccant, or defoliant within the 

meaning of FIFRA sec. 2(a), except as provided in §174.3 of this chapter

Section 6517(c)(1)(B)(ii) of the Organic Foods Production Act of 1990 (OFPA) 

authorizes the National Organic Standards Board (NOSB) to establish a National List of 

approved and prohibited substances that may include synthetic inert ingredients that are 

not classified by the Administrator of the EPA as “inerts of toxicological concern.” 

OFPA

7 USC 6517(c)(1) Exemption for Prohibited Substances. 

The National List may provide for the use of substances in an organic farming or 

handling operation that are otherwise prohibited under this chapter only if

...(B) the substance

CC 1 List 3 Inerts
... (ii) is used in production and contains synthetic inert ingredients that are not 

classified by the Administrator of the Environmental Protection Agency as inerts 

of toxicological concern;

Summary

OFPA, Regulations, and Previous NOSB Action

OFPA, in establishing the National List (§2118, 7 U.S.C. 6517), creates a list of 

exemptions for prohibited substances in organic production and handling and in so 

doing lists the categories of substances that must be reviewed by the NOSB if they are 

to be listed: “(B) the substance (i) is used in production and contains an active synthetic 

ingredient in the following categories: ........; (ii) is used in production and contains 

synthetic inert ingredients that are not classified by the Administrator of the 

Environmental Protection Agency as inerts of toxicological concern; or...” Tracking the 

U.S. Environmental Protection Agency (EPA) categorization of active and inert 

ingredients in pesticide formulations, OFPA subjects all allowed substances to the 

underlying statutory standards of health and safety, essentiality, and compatibility in this 

section of the law. Section 2118(c)(1)(B)(i) creates a category of active ingredients

that may be allowed, which is parallel to Section 2118(c)(1)(B)(ii) creating the category 

of inerts that may be allowed --those found by EPA to not be “inerts of toxicological 

concern.” In summary, the categories of active and inert ingredients in Section 2118 

establish an NOSB duty to review these substances.

The fact that OFPA uses the language the “substance...contains synthetic inert 

ingredients...” is somewhat confusing. The confusion is amplified by the fact that inert 

ingredients are themselves “substances.”1 The language in OFPA is clarified in the 

Conference Report, which states: “The Conference substitute adopts the House 

provision with an amendment that adds production aids to the category of synthetic 

active ingredients and the category of synthetic inert ingredients not of toxicological 

concern to the Administrator of EPA as possible exemptions on the National List.” 

[Emphasis added.]

The language of the Conference Report thus makes it clear that “synthetic inert 

ingredients not of toxicological concern to the Administrator of EPA” is a category of 

substances that may be considered for listing on the National List.

1 §205.2

Inert ingredient. Any substance (or group of substances with similar chemical structures if designated by 

the Environmental Protection Agency) other than an active ingredient which is intentionally included in 

any pesticide product (40 CFR 152.3(m)).

Classification of Materials November 2009: “Substance”: “An element, molecular species, or chemical 

compound that possesses a distinct identity (For example, a distinct identity may be demonstrated 

through the material having a separate Chemical Abstract Service (CAS) number (in some cases the 

same material may have multiple CAS numbers), Codex International Numbering System (INS) number, 

or FDA or other agency standard of identity).” 

CC 2 List 3 Inerts
However, even if we take the interpretation that it is “substances containing synthetic 

inert ingredients not of toxicological concern to the Administrator of EPA” that may be 

listed on the National List, §6517(c)(1)(B) only allows such substances to be listed on 

the National List if the requirements of §6517(b), §6517(c)(1)(A), and §6517(d) are met. 

This requires that the “substance” undergo review according to the criteria of OFPA. If 

the inert is regarded as a component of the substance and not a substance itself, it still 

must be reviewed as part of the review of the substance.

The NOSB responsibility has its roots in both the Senate Report and the Preamble to 

OFPA and the subsequent action by the NOSB. 

The Senate Report makes it clear that inert ingredient review was to be subject to the 

National List process:

Until such time as FIFRA is altered to require the full disclosure of inert 

ingredients, organic farmers should be allowed to continue using compounded 

substances if the active ingredient is natural and if use of the substance is 

recommended by the National Organic Standards Board and approved by the 

Secretary for inclusion on the National List. However, in order for the National 

Organic Standards Board to evaluate whether certain compounds should be 

listed, the Board will need some information about the inert ingredients in 

question. The Committee directs the Board to seek the advice of the 

Administrator of the EPA, who has information on inert ingredients submitted as 

part of registration, as to whether such inert material would be appropriate for 

organic production. EPA's response will not limit its regulatory responsibility for 

such material.

In the Preamble to the Final Rule, December 21, 2000, USDA said,

In this final rule, only EPA List 4 Inerts are allowed as ingredients in formulated 

pesticide products used in organic crop and livestock production. The allowance 

for EPA List 4 Inerts only applies to pesticide formulations. Synthetic ingredients 

in any formulated products used as organic production inputs, including 

pesticides, fertilizers, animal drugs, and feeds, must be included on the National 

List. As sanctioned by OFPA, synthetic substances can be used in organic 

production and handling as long as they appear on the National List. The organic 

industry should clearly understand that NOSB evaluation of the wide variety of 

inert ingredients and other nonactive substances will require considerable 

coordination between the NOP, the NOSB, and industry.

In February, 1999, the NOSB recommended: 

Inert ingredients on EPA Lists 1 and 2 shall be prohibited for use in organic 

production and handling effective on the date of implementation of the final rule 

of NOP. Synthetic inerts on EPA List 3 shall be prohibited if not specifically 

approved by the NOSB. This approval process will be completed and published 

CC 3 List 3 Inerts
by January 1, 2002. Any inert currently in use in organic production that is not 

approved by the NOSB will be banned within 18 months after the review is 

completed and published. To that goal, inerts on EPA List 3 used in products that 

have active ingredients approved for organic production shall be reviewed by the 

NOSB on a case-by-case basis for possible inclusion on the National List. 

Thus, the board voted that the consideration of individual List 3 materials was to be 

completed by January 1, 2002 –more than 10 years ago.

In October 2002, the Board passed the motion to list pheromones, which resulted in the 

current listing for List 3 inerts. 

Pheromones—includes only EPA-exempt pheromone products, EPA registered 

pheromone products with no additional synthetic toxicants unless listed in this 

section and any inert ingredients used in such pheromone formulations that are 

not on EPA List 1, that is inerts of toxicological concern or EPA List 2, that is 

potentially toxic inerts, provided the pheromone products are limited to passive 

dispensers, pheromone products containing only pheromone active ingredients 

listed in this section and List 4 inerts may be applied without restriction.

At the same meeting, the Board also passed a motion temporarily allowing the 

continued listing of certain List 3 inerts:

The NOSB recommends that any list 3 inert material forwarded for a technical 

review be allowed for use until that material is approved or prohibited by the 

Secretary of Agriculture.

When the List 3 inerts came up for sunset in November 2007, the summary of the 

recommendation said, 

Future petitions to add, remove or renew an inert ingredient to the National List 

will need to reference a specific inert ingredient. A petition may be submitted to 

the NOSB using the National List petition procedures. Individually petitioned 

substances must be recommended by the NOSB and added to the National List 

through notice and comment rulemaking before use in organic agriculture.

That recommendation was reaffirmed in February 2008. And, in presenting the 

discussion paper on List 4 inerts in November 2008, Gerald Davis said, “[Discussion 

paper point number] Five concerns the list 3 inerts currently used in passive pheromone 

dispensers. The current policy is that they need to be petitioned individually and are 

subject to regular sunset reevaluations, that that has already been in place as an NOP 

policy for a couple years now, since we were first notified about the EPA change.”

Consultations with USDA and EPA

The NOSB, in conjunction with USDA, consulted with EPA during the development and 

subsequent amendments of the National List. The NOSB recommended in 1999 

CC 4 List 3 Inerts
prohibiting List 1 and 2 inerts, and List 3 inerts that are not specifically approved by the 

NOSB, in spite of the fact that the EPA had by that time distinguished Lists 4A and 4B 

as those ingredients that were not of toxicological concern (4A), and those regarded as 

not causing adverse effects based on their use patterns (4B).

2

 

In 2006, EPA reassessed all inert ingredients used in pesticide formulations allowed on 

food crops, including former Lists 3, 4A, and 4B inerts, to ensure that they met the 

tolerance reassessment requirements of the Food Quality Protection Act. Inerts allowed 

for use in EPA registered pesticides applied to food now must either have a residue 

tolerance level or an exemption from tolerance level codified at 40 CFR Part 180. As a 

result of this reclassification, NOP regulations concerning allowed inert ingredients are 

out-of-date when compared with current EPA regulations, since EPA eliminated its list 

categories when it completed its tolerance reassessment. The NOSB recommended in 

April 2010 that NOP establish a task force in collaboration with EPA to examine this 

problem and provide a recommendation to the board for re-evaluation of former List 3 

and List 4 inerts. In October 2010, the NOSB recommended that the current exemption 

on the National List that permits former List 4 inerts through October 2012 should be 

renewed “pending review by the program of inerts individually and as a class of 

materials”.3

 The current exemption that permits former List 3 inerts in passive 

pheromone dispensers only is scheduled to sunset November 3, 2013. 

An NOSB-NOP-EPA working group was established in June 2010. Current members 

include: Jay Feldman (NOSB), Zea Sonnabend (NOSB), Chris Pfeifer (EPA 

Biopesticides and Pollution Prevention Division), Kerry Leifer (EPA Registration 

Division), Emily Brown Rosen (NOP), and Lisa Brines (NOP). The group has collected 

information regarding current classification of the former List 3 and 4 inerts and 

presented a discussion document at the November 2011 NOSB meeting.4 

This NOSB policy recommendation phases out former EPA List 3 inerts in passive 

pheromone dispensers from a general approval provision to full review under the 

National List standards. Currently, based on information from EPA, OMRI, and WSDA, 

we believe that there are three formerly List 3 inerts in use under this provision, three of 

which were the subject of petitions filed to the NOSB. It is understood that the former 

List 3 inerts requiring review are limited to the following substances: (i) Butylated 

2 In the notice 54 FR 48314 (11/22/89), EPA said (emphasis added), 

“To accommodate revision of the lists, EPA has decided to subdivide List 4 into two parts. The previous 

list 4, representing inerts generally recorded as safe, has become List 4A, and a new List 4B has been 

created. List 4B is composed of inerts for which EPA has sufficient information to reasonably conclude 

that the current use patterns in pesticide products will not adversely affect public health and the 

environment. List 4B inerts in formulations proposed for new use patterns which cause significant 

increases in exposure will receive further scrutiny.” In notice 59 FR 49400 (6/28/94), EPA said, “In 

reviewing List 4 inert ingredients for the proposed section 25(b) rule, many inerts on the original List 4 

were moved from List 4A to List 4B. In particular, acutely toxic inerts were moved to 4B because, 

although the testing of products for acute toxicity ensures low concern for these inerts in registered 

products, without such regulatory oversight there may be unacceptable acute risks.”

3 October 28, 2010 recommendation available at 

http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5087999&acct=nosb

4 Available at http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5094901&acct=nosb

CC 5 List 3 Inerts
hydroxytoluene (CAS # 128-37-0); (ii) 2-Hydroxy-4-n-octyloxybenzophenone (CAS # 

1843-05-6); (iii) 2-(2-Hydroxy-3-tert-butyl-5-methylphenyl)-chlorobenzotriazole (CAS 

#3896-11-5)]. It is also understood that there may be a fourth inert in this category that 

has been identified by the Washington State Department of Agriculture.

The proposed annotation creates a timeframe for evaluation of these formerly List 3 

inerts in passive pheromone dispensers: a review and board action is set for Dec. 31, 

2015. This gives the board two years to review the petitions and act, and it provides the 

NOP a year to go to rulemaking. If for some reason the timeframes are delayed, the 

backup sunset provision allows the former List 3 uses to continue until Board action and 

rulemaking are complete. If the NOP adopts a policy by December 31, 2015 that covers 

former List 3 as well as other inerts, then that policy will prevail.

Committee Recommendation

The italicized text is new proposed language. Deleted text is indicated with a strikethrough line.

List: 205.601 Synthetic substances allowed for use in organic crop production.

(m) As synthetic inert other ingredients not as classified by the Environmental Protection 

Agency (EPA) as active ingredients, 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.

2) Inert ingredients exempt from the requirement of a tolerance under 40 CFR 180.1122 

that were formerly on EPA List 3 in passive polymeric dispenser products may be used 

until December 31, 2015, after which point they are subject to individual review under 

205.601, unless already covered by a policy adopted by the NOP for all other inert 

ingredients.

Committee Vote

Moved: Jay Feldman Second: Nick Maravell

Yes__8___ No__0__ Abstain__0__ Absent__0__ Recuse__0__

Committee Backup Vote to Relist: 

List: 205.601 Synthetic substances allowed for use in organic crop production.

(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.

(2) EPA List 3—Inerts of unknown toxicity—for use only in passive pheromone 

dispensers.

CC 6 List 3 Inerts
Committee Vote: 

Moved: Zea Sonnabend Second: Jay Feldman

Yes__8__ No__0__ Abstain__0__ Absent__0__ Recuse___0___

§ 205.2 Terms defined.

Passive polymeric dispenser products. Solid matrix dispensers delivering 

pheromones through volatilization only at rates less than or equal to 150 grams active 

ingredient (AI)/acre/year that is placed by hand in the field and is of such size and 

construction that it is readily recognized and retrievable. [59 FR 7368, March 30, 1994.] 

To be removed as a definition when 205.601(m)2(a) and (b) expire.] 

Moved: Jay Feldman Second: Zea Sonnabend

Yes__8___ No__0___ Abstain__0__ Absent__0___ Recuse ___0__

CC 7 List 3 Inerts