Inert Ingredients Discussion Document

October 11, 2011

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 need to be disclosed 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

NOTE

This Discussion Document is presented by the National Organic Standards 

Board Crops Committee on behalf of the NOSB-NOP-EPA Working Group 

on Inert Ingredients. This document has not been approved by the Crops 

Committee, but comments on this document are welcomed, and will be supplied 

to the Working Group as they develop a final recommendation. The Crops 

Committee also seeks comments in particular on the status of former List 3 inert

ingredients, which are currently permitted only in passive pheromone dispensers 

(§ 205.601(m)(2)). The allowance for former List 3 inert ingredients is scheduled 

to sunset on November 3, 2013; a vote to determine renewal is scheduled for

the May 21-24, 2012 NOSB Meeting. 
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... (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;

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

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

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

NOSB. In 1999, the NOSB recommended that ―inerts on List 4 generally be allowed 

unless explicitly recommended for prohibition.‖1in 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 2002, the NOSB recommended that the Secretary of 

Agriculture allow the use of certain EPA List 3 inert pesticide ingredients in certain 

pheromone products.3 The Secretary accepted and codified the NOSB 

recommendations accordingly. 

NOP regulation

§ 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...:

(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—for use only in passive pheromone 

dispensers.

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 

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 

 

1

1999 NOSB Recommendation available at

http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=stelprdc5058968

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 19–20, 2002 NOSB Meeting minutes available at 

http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5057498
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reclassification, the NOP regulations concerning allowed inert ingredients are out of 

date when compared with current EPA regulations. 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‖.

4

 The 

current exemption that permits former List 3 inerts in passive pheromone dispensers 

only is scheduled to sunset November 3, 2013 and will be voted on at the May 21-24, 

2012 NOSB meeting. 

A NOSB-NOP-EPA working group was established in June 2010. Members include: Jay 

Feldman (NOSB), Tracy Miedema (NOSB), Jeff Moyers (former NOSB), Chris Pfeifer 

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

Division), Emily Brown Rosen (NOP), Lisa Brines (NOP), and John Punzi (NOP, on 

detail from AMS Pesticide Data Program). The group has collected information 

regarding current classification of the former List 3 and 4 inerts and gave a brief 

presentation at the April 2011 NOSB meeting.

5

At this point, the Working Group has developed a few options for consideration and is 

requesting public comment. 

I. Some initial considerations for review of inert ingredients 

a. NOSB must be able to review any substance recommended for the National List 

according to OFPA criteria, section 6518 (m):

―Evaluation. In evaluating substances considered for inclusion in the 

proposed National List or proposed amendment to the National List, the 

Board shall consider:

1. The potential of such substances for detrimental chemical interactions with 

other materials used in organic farming systems;

2. The toxicity and mode of action of the substance and of its breakdown products 

or any contaminants, and their persistence and areas of concentration in the 

environment;

3. The probability of environmental contamination during manufacture, use, 

misuse or disposal of such substance;

4. The effect of the substance on human health;

5. The effects of the substance on biological and chemical interactions in the 

agroecosystem, including the physiological effects of the substance on soil 

organisms (including the salt index and solubility of the soil), crops and 

livestock;

6. The alternatives to using the substance in terms of practices or other available 

materials; and 

7. Its compatibility with a system of sustainable agriculture.‖

 

4 October 28, 2010 recommendation available at 

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

5 Available at http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5090591&acct=nosb
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b. This means that any EPA permitted category of ―inerts‖ used in organic 

formulations would need to be reviewed. The OFPA criteria include need for use 

(i.e. the absence of natural alternatives) and cradle-to-grave considerations, 

which are not FIFRA criteria, so no list adopted under FIFRA would be 

satisfactory without additional consideration.

c. In the interim, the NOSB could accept an EPA list (or lists) aligned with some of 

the OFPA criteria related to the potential for hazardous effects associated with 

use. The working group notes that the EPA’s criteria do not include need,

manufacture, misuse, or disposal issues.

d. If a baseline EPA category is accepted, the NOSB will need to provide other 

options for substances not covered by this list (e.g., applying OFPA criteria for 

review of petitioned inert ingredients).

e. The NOSB may need to separately consider the few former List 3 chemicals that 

are currently in use.

f. The WG on Inerts believes there are at least 120 substances in current use in

organic production as inert ingredients that are not included in EPA’s current 

25(b) list (Inerts of Minimal Concern). Most of these substances would be 

classified as synthetic and appear on the former EPA List 4B. 

II. Proposals Under Consideration by WG-Inerts

1. Relist the allowance for former List 3 inerts “as is” for use in passive 

pheromone dispensers only during the 2013 Sunset review

The NOSB could renew the current exemption for former List 3 inerts for the next 

sunset period (i.e. through 2018). In the interim, the Working Group will continue to 

determine how to apply the OFPA criteria for evaluation of individual inert 

ingredients or categories of inerts, and provide a recommendation to NOSB for 

implementation by 2017, when the exemption (allowance) for former List 4 inert 

ingredients expires.

2. Allow the List 3 listing to sunset; former List 3 inert ingredients would need 

to be individually petitioned to be allowed for continued use

Guidelines for applying OFPA criteria for review of inert ingredients are still in 

development within the working group.

The WGI is unclear of essentiality of the approximately four former List 3 materials 

known to be in use. There may be alternatives to the use of these substances. This 

option would mean that manufacturers would need to bring forward information on 

lack of alternatives, safety, and environmental impacts. 

The working group notes that it would be difficult for the board to review petitions in 

time for them to be reviewed before the November 3, 2013 sunset date for List 3 

inerts. At a minimum, the NOSB may need to extend expiration date to allow 
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additional time for petitions and rulemaking. A channel of trade provision would also 

be needed.

3. Replace/amend the current listing for former List 3 inert ingredients, 

limiting to pheromone products.

Replacement options under consideration include the following:

a) Inert ingredients of semiochemical dispenser products that are exempt from the 

requirement of a tolerance under 40 CFR 180.1122.6

b) Inert ingredients for use in retrievable polymeric pheromone dispensers:7

a. Butylated hydroxytoluene (CAS # 128-37-0)

b. 2-Hydroxy-4-n-octyloxybenzophenone (CAS # 1843-05-6)

c. 2-(2-Hydroxy-3-tert-butyl-5-methylphenyl)-chlorobenzotriazole (CAS 

#3896-11-5)

c) Inert ingredients for use in passive pheromone dispensers

d) Inert ingredients for use in retrievable polymeric pheromone dispensers8.

4. Replace both former List 4 and List 3 references:9

a) Inert ingredients eligible for FIFRA 25(b) Pesticide Products.10,11

 

6

eCFR available at http://ecfr.gpoaccess.gov/cgi/t/text/textidx?c=ecfr&sid=8e1e539122b1034803f22bdbdc391ecc&rgn=div8&view=text&node=40:24.0.1.1.28.4.19.70&idno

=40

7 Or, alternatively, “Inert ingredients for use in for use in passive pheromone dispensers.”

8 Defined as a “solid matrix dispenser” delivering pheromones “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. (http://frwebgate2.access.gpo.gov/cgibin/TEXTgate.cgi?WAISdocID=9xi50t/3/1/0&WAISaction=retrieve) The notice says, “First, the proposal 

incorporates features that would limit the direct dietary exposure to the arthropod pheromones used as pesticides by 

requiring the formulation to be restricted to larger dispensers. This formulation restriction will limit exposure to an 

active ingredient resulting from the small amount that volatilizes from the dispenser and subsequently may deposit 

on food crops. Due to its size, the dispenser itself, with or without any remaining active ingredient, is not likely to 

become incorporated into food. Second, the Agency believes that an annual rate limitation of 150 grams AI/acre and 

a restriction to retrievably sized dispensers are likely to limit the dietary exposure to what is no greater than that 

found naturally in food as a result of heavy infestations of the pest arthropods. An arthropod species becomes a pest 

only if its populations reach levels that impede economic returns. The Agency believes there already has been 

dietary exposure to the arthropod pheromones deposited after volatilization from natural heavy pest infestations that 

could be shown to control such pest species.”

9

Inert ingredients not included would need to be individual petitioned, pending additional criteria adopted by 

NOSB.

10 http://www.epa.gov/opprd001/inerts/section25b_inerts.pdf

11 Does not include synthetic former List 3 inerts known to be in use in pheromone products.
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b) Inert ingredients exempt from the requirement of a tolerance under 40 CFR 

180.910, 180.920, 180.930, 180.940, 180.950, 180.960 and/or 180.1122.12

c) Individual listings of inerts.

d) Inert ingredients as permitted by the Environmental Protection Agency.13

e) Hybrid approach – Class(es) of inerts plus individual listings.

f) Classes of inerts, minus specific ones.

III. Issues and Discussion

1. Consider inert ingredients eligible for use in minimal risk pesticide products 

under FIFRA Section 25(b) 

Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 25(b)(2), 

EPA may exempt from the requirements of FIFRA any pesticide that is ―of a 

character unnecessary to be subject to [FIFRA]‖. Regulations at §152.25(f) 

implement 25(b). 

Restrictions on which ingredients may be used in minimum risk pesticide 

products are key aspects of the exemption, since the properties of these specific 

ingredients are the reason EPA exempted minimum risk pesticide products from 

FIFRA regulatory requirements.

The federal register notice establishing this list (61 FR 8876; Mar. 6, 1996) also 

noted the following:

In developing its list of exempted substances, EPA applied certain factors. 

Consideration was given to such factors as, (1) whether the pesticidal 

substance is widely available to the general public for other uses; (2) if it is 

a common food or constituent of a common food; (3) if it has a nontoxic 

mode of action; (4) if it is recognized by the Food and Drug Administration 

(FDA) as safe; (5) if there is no information showing significant adverse 

effects; (6) if its use pattern will result in significant exposure, and (7) if it is 

likely to be persistent in the environment.

In 2006, EPA classified 13 additional substances having tolerance exemptions 

under 40 CFR 180.910 and/or 180.920 as minimal risk under 40 CFR 

180.950(e). The proposed rule also clarified that EPA was shifting existing 

tolerance exemptions for the ―inert‖ ingredients that appear on former List 4A 

 

12 Includes all inert ingredients allowed for food use which are exempt from tolerance by EPA.

13 Would include inert ingredients for both food use and non-food use.
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from that list to 40 CFR 180.950(e). 40 CFR 180.950 also includes exemptions 

from tolerance for certain foods, animal foods, and edible fats and oils. The 

current compiled list of all inerts that qualify for 25(b) exemption may be found at: 

http://www.epa.gov/opprd001/inerts/section25b_inerts.pdf. 

The working group is aware of at least 120 inerts allowed for use in organic 

products that are former EPA List 4B substances that are currently in use and 

are not included on the 25(b) list. The majority of these substances would be 

classified as synthetic. If the baseline for allowance in organic products is limited 

to 25(b) substances, there will need to be development of an approach to apply 

the OFPA criteria to inert ingredients, and a phase in time to allow for 

reformulation and for review of petitions for substances currently allowed under 

the exemption for former EPA List 3 and List 4 inert ingredients. 

2. Other lists of substances exempt from tolerance have been considered.

a. EPA residue tolerance exemptions under 40 CFR 180.910 and 180.920 are 

established for ―inert‖ ingredients used pre-harvest or post-harvest on crops. 

Exemptions under 180.930 are established for inert ingredients applied to 

animals. Exemptions provided under 180.940 are established for active and 

inert ingredients used in food-contact surface sanitizing for processing 

equipment solutions.

b. 40 CFR 180.950 lists the pesticide chemicals that are exempted from the 

requirement of a tolerance based on the Agency's determination that these 

chemicals are of ―minimal risk.'' The pesticide chemicals listed include both 

active and inert ingredients.

c. 40 CFR 180.960 lists the pesticide chemicals that are exempt from the 

requirement of a tolerance because they meet the criteria established by the 

Agency to identify certain polymers that are of low risk. This section contains 

those polymers whose tolerance exemptions were established post-Food 

Quality Protection Act (FQPA) of 1996 and are based on the polymer’s 

meeting the criteria described in 40 CFR 723.250.These compounds have 

been determined to present little risk to the environment because of their size, 

they are too large to be active in biological systems. 

d. Inerts used in Pheromones – 40 CFR 180.1122 indicates the following:

i. All inert ingredients of semiochemical dispenser products formulated 

with, and/or contained in, dispensers made of polymeric matrix 

materials (the monomers, plasticizers, dispersing agents, antioxidants, 

UV protectants, stabilizers, and other inert ingredients) are exempted 

from the requirement of a tolerance when used as carriers in pesticide 

formulations for application to growing crops only.
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3. List 3 Inerts permitted for use in passive pheromone products.

NOP regulation:

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

pheromone dispensers.

The NOSB received petitions for several List 3 specific inerts for use in 

pheromones and voted in 2002 to add a general allowance for List 3 substances, 

only in passive dispensers, rather than add these specific chemicals to the 

National List. At this time the Working Group (including EPA) is only aware of 4 

List inerts that are currently in use in pheromone dispensers used in organic 

production, three of them have been disclosed via petition to the NOSB: 

 2-(2-Hydroxy-3-tert-butyl-5-methylphenyl)-5-chlorobenzotriazole 14

(CAS # 3896-11-5)

 2, 2-Hydroxy-4-n-octyloxybenzophenone (CAS # 1843-05-6)

 Butylated hydroxytoluene (BHT)15 (CAS # 128-37-0)

 one other surfactant

At this time the Working Group invites manufacturers to provide information on 

additional substances that may be used in passive pheromone dispensers, 

particularly any inert ingredients that are not specifically listed above, or that are 

not included on the EPA 25(b) list for inerts of minimal risk.

IV. Comments Requested

The NOSB Crops Committee and NOSB-NOP-EPA Working Group on Inerts 

specifically invite comments on the following topics at this time:

 What are the preferred options for replacing / amending the current allowance for 

List 3 inert ingredients in pheromone products?

 Is the list of former List 3 inert ingredients that are currently used in NOPcompliant pheromone products accurate, or are there others in use?

 The NOP regulation uses the term ―passive pheromone dispensers.‖ Has this 

terminology been problematic? Is the term ―retrievable polymeric pheromone 

dispensers‖ a better fit?

 Provide suggestions regarding the process by which alternatives to the use of

synthetic inert ingredients may be considered and implemented.

 What are the barriers to the development or use of alternative natural inert 

ingredients for use in pesticide formulations?

 What timelines for implementation are appropriate?

 What are preferred replacement options for both List 3 and List 4 references?

Include any that may not have been discussed above.

 

14 TAP review available at http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5094039

15 TAP review available at http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5057586