Formal Recommendation 

From: National Organic Standards Board (NOSB)

To: the National Organic Program (NOP)

Date: October 29, 2015

Subject: Annotation Change - EPA List 4 on 205.601(m), and 205.603(e) 

NOSB Chair: Jean Richardson

The NOSB hereby recommends to the NOP the following: 

Rulemaking Action: X

Guidance Statement:

Other:

Statement of the Recommendation: 

The purpose for the annotation change is to remove reference in the regulation to the EPA List 

4 which is no longer in use and which the EPA requested that it be removed in 2010. In order to 

thoroughly evaluate inerts for compatibility with organic materials, the NOSB has decided to 

work with the EPA Safer Choice Program and in order to move forward with a formal 

relationship, an annotation change to recognize this collaboration is needed. The 

recommendation acknowledges the current nomenclature in use by the EPA regarding FIFRA 

25(b) and 40 CFR 180.1122, while laying a framework for some inerts to be reviewed 

individually.

205.601(m) and 205.603(e) – 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. 

(i) Substances permitted for use as inerts in minimal risk products exempt from 

pesticide registration under FIFRA section 25(b).1, 

(ii) Substances included on the EPA’s Safer Chemical Ingredient List.

(iii) Inert ingredients that are exempt from the requirement of a tolerance under 

40 CFR 180.1122 – for use only in passive pheromone dispensers. 

[Reserved] (for any other inerts individually petitioned and reviewed)]

Rationale Supporting Recommendation (including consistency with OFPA and Organic 

Regulations): 

 1 http://www.epa.gov/opprd001/inerts/section25b_inerts.pdf . EPA has published a proposed rule at FR 77:76979

to codify the list of actives and inerts eligible for minimal risk products, when finalized the NOP reference will cite 

this. 
OFPA states in section 2119 National Organic Standards Board:

(l) 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;

The information provided by the EPA indicated the need to remove the List 4 reference. The 

EPA also runs the Safer Choice Program and so working with them to evaluate inerts fulfills the 

above clauses in OFPA while providing a structure that is workable for all parties.

NOSB Vote: 

Motion to change the annotation for EPA List 4 Inerts as follows:

205.601(m) and 205.603(e) – 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. 

(iv) Substances permitted for use as inerts in minimal risk products exempt from 

pesticide registration under FIFRA section 25(b).2, 

(v) Substances included on the EPA’s Safer Chemical Ingredient List.

(vi) Inert ingredients that are exempt from the requirement of a tolerance under 

40 CFR 180.1122 – for use only in passive pheromone dispensers. 

(vii) [Reserved] (for any other inerts individually petitioned and reviewed)] 

Motion by: Zea Sonnabend

Seconded by: Harold Austin

Additional Discussion: none

Yes: 10 No: 4 Abstain: 0 Absent: 0 Recuse: 0

 2 http://www.epa.gov/opprd001/inerts/section25b_inerts.pdf . EPA has published a proposed rule at FR 77:76979

to codify the list of actives and inerts eligible for minimal risk products, when finalized the NOP reference will cite 

this. 
National Organic Standards Board

Crops and Livestock Subcommittees

Proposed Annotation Change

EPA List 4 on 205.601(m), and 205.603(e) 

August 26, 2015

Introduction

The Crops and Livestock Subcommittees are working towards a solution to reviewing the inerts 

that were formerly on EPA List 4 by collaborating with the Inerts Working Group and the EPA Safer 

Choice Program (SCP) (formerly Design for the Environment Program). The NOSB will need to vote 

on an annotation change before this project can move forward. 

Background

Current Listings:

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. 

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

205.603(e) 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.

In 2010 the EPA told the NOP that EPA List 4 was no longer being maintained and that language 

referring to it should be removed from the Federal Rule. In 2012 the NOSB passed a 

recommendation to proceed with reviewing individual inert ingredients and to change the listing 

on both 205.601(m) and 205.603(e) (Crops and Livestock respectively) to:

As synthetic other (“inert”) ingredients in pesticide formulations as classified by the 

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

substances listed in this section that are used as an active pesticide ingredient in accordance 

with any limitations on the use of such substances.

(i) Substances permitted for use in minimal risk products exempt from pesticide registration 

under FIFRA section 25(b); 

(ii) Reserved (for list of approved other (“inert”) ingredients).

With this goal in mind, the Inerts Working Group of the NOSB/NOP/EPA has been establishing a 

relationship with the Safer Choice Program for conducting these reviews. The steps to establishing 

this process include:

• The NOSB voting to proceed with an annotation change.
• A Federal Register Notice to notify stakeholders of the program and procedures, 

and rulemaking to amend the National List (subject to public comment). 

• The inclusion of a reasonable implementation time (3-5 years) so that 

manufacturers can apply for SCIL consideration, or petition NOSB, and/or 

reformulate their products.

• An MOU or other mechanism to finalize the agreement between NOP and SCP.

• Specific instructions and outreach developed for the SCP portion of the review 

targeted toward manufacturers of pesticide products used in organic production. 

• NOSB periodic review of the SCIL list to consider those criteria in OFPA that the SCP 

does not address (such as compatibility with organic agriculture).

Relevant areas in the Rule

See above

Discussion

The CS and LS propose the following change to 205.601(m)(1) and 205.603(e)(1), EPA List 4 – Inerts 

of Minimal Concern. 

205.601(m) and 205.603(e) – 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. 

(i) Substances permitted for use in minimal risk products exempt from pesticide 

registration under FIFRA section 25(b).1, 

(ii) Substances included on the EPA’s Safer Chemical Ingredient List.

(iii) Inert ingredients that are exempt from the requirement of a tolerance under 40 

CFR 180.1122 – for use only in passive pheromone dispensers. 

(iv) [Reserved] (for any other inerts individually petitioned and reviewed)] 

This is very similar to the recommendation by the NOSB in 2012 except that it acknowledges the 

Safer Chemical Ingredient List and it includes the listing for pheromone dispensers into the main 

inerts listing (see Appendix II). This clarifies to all stakeholders how the inerts will be reviewed, 

listed, and allowed (or not) in the future.

The timeline for this process needs to be adequate in order that all inerts currently in use may be

reviewed under SCIL, or petitioned and reviewed by NOSB. There also needs to be time for 

products to be reformulated, if necessary. The goal is to make this transition towards a new review 

of inerts as seamless for organic producers as possible, with an assurance that formulated 

 1 http://www.epa.gov/opprd001/inerts/section25b_inerts.pdf . EPA has published a proposed rule at FR 77:76979 to 

codify the list of actives and inerts eligible for minimal risk products, when finalized the NOP reference will cite this. 
products that are reviewed for inerts and effective are still available to them throughout the 

change in policy.

The proposal provides a change in the Inerts listing, without specifying a corresponding timeline. 

NOSB expects that the NOP will create an appropriate grace period for making this change, as they 

did when the rule first came out in 2000 that limited inerts to only List 4.

The Inerts Working Group has completed a comparison between the SCIL criteria and the NOSB 

criteria that are used in reviewing materials (see Appendix I). There is a lot of similarity between 

them but also some gaps that can be addressed by the NOSB in periodic review of the SCIL.

Recommendation

Proposed Motion to change the annotation for EPA List 4 Inerts as follows:

205.601(m) and 205.603(e) – 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. 

(i) Substances permitted for use in minimal risk products exempt from pesticide 

registration under FIFRA section 25(b).2, 

(ii) Substances included on the EPA’s Safer Chemical Ingredient List.

(iii) Inert ingredients that are exempt from the requirement of a tolerance under 40 

CFR 180.1122 – for use only in passive pheromone dispensers. 

(iv) [Reserved] (for any other inerts individually petitioned and reviewed)] 

Crops Subcommittee Vote

Motion by: Zea Sonnabend

Seconded by: Harold Austin

Additional Discussion: none

Yes: 5 No: 0 Abstain: 0 Absent: 0 Recuse: 0

Livestock Subcommittee Vote

Motion to accept the List 4 annotation change proposal from the Crops Subcommittee

Motion by: Tracy Favre

Seconded by: Jean Richardson/Ashley Swaffar

Yes: 5 No: 0 Abstain: 0 Absent: 1 Recuse: 0

 2 http://www.epa.gov/opprd001/inerts/section25b_inerts.pdf . EPA has published a proposed rule at FR 77:76979 to 

codify the list of actives and inerts eligible for minimal risk products, when finalized the NOP reference will cite this. 
Appendix I

Comparison of Review Criteria

Organic Foods Production Act Criteria for 

Review of Substances Used in Organic Production and 

EPA Safer Choice Program, Safer Chemical Ingredient List Criteria 

Review Criteria for Substances/Chemical Ingredients

USDA 

Organic Foods Production Act (7 USC 6501)

EPA – Safer Choice Program

http://www2.epa.gov/saferchoice

7 USC 6518 National Organic Standards Board

(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; 

SCP considers potential biotic and abiotic interactions 

when information is made available; however, such 

information is not commonly provided with chemical 

submissions. SCP does review potential negative 

chemical reactions within products that are reviewed 

for Safer Chemical label program. 

(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;

(1) SCP has established criteria to evaluate toxicity to 

mammalian and aquatic organism receptors. 

Importantly, all data are considered even if receptor 

specific SCP criteria are not established. 

(2) SCP evaluates breakdown products and metabolites 

of potential concern for all chemicals.

(3) SCP evaluates bioaccumulation potential and fate 

(environmental persistence) in the environment.

More details available at: 

http://www2.epa.gov/saferchoice/standard

(3) the probability of environmental 

contamination during manufacture, use, 

misuse or disposal of such substance;

SCP considers intended use of products during 

evaluation and limits the permissible use/application 

method.
(4) the effect of the substance on human 

health;

SCP evaluates human health using criteria for 

(1) acute and chronic exposures (criteria for oral, 

dermal and inhalation routes of exposure) 

(2) dermal and respiratory sensitization

(3) carcinogenicity and mutagenicity

(4) Reproductive and Developmental effects

See SCIL Master criteria

(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;

(1) SCP considers potential biotic and abiotic 

interactions when information is made available 

(although not specific to agroecosystems). 

(2) If provided with toxicity data on soil dwelling 

organisms SCP would consider these data when 

evaluating the chemical.

(6) the alternatives to using the substance in 

terms of practices or other available materials; 

and

SCP evaluates each chemical ingredient against the 

appropriate functional use criteria. Chemicals meeting 

criteria are considered to be safer than comparable 

chemicals within the functional class. 

(7) its compatibility with a system of 

sustainable agriculture

No comparable SCP criteria, however SCP evaluates 

impacts on environment, wildlife, and human health, 

and considers intended use of products during 

evaluation and limits the permissible use/application 

method.

Proposed Additional Screening for Inerts, 

(NOSB recommendation, Oct 2012 ):

Authoritative Lists Used in SCIL Review

1. Toxicity category from EPA :I or II 

(“danger” or “warning”) 

2. CA Prop 65 list- as a developmental or 

reproductive toxicant

3. Carcinogen on EPA’s List of Chemicals 

Evaluate for Carcinogenic Potential (known/ 

likely, probable, or possible human 

carcinogen)

4. Carcinogen on IARC, U.S. NTP, CA Prop 

65 (known, likely, probable, possible, 

reasonably anticipated to be)

5. Nervous system toxicants including 

cholinesterase inhibitors or chemicals 

associated with neurotoxicity by other 

Authoritative Sources Indicating Carcinogenicity 

Mutagenicity and Reproductive Toxicity: 

• International Agency for Research on 

Cancer (IARC). Agents Classified by the 

IARC Monographs, Designated Group 1, 

2A, or 2B.

• US EPA. Integrated Risk Information System 

(IRIS), Chemicals carcinogenic to humans, 

likely to be carcinogenic to humans, or 

suggestive evidence of carcinogenic 

potential (2005 Guidelines).

• California Office of Environmental Health 

Hazard Assessment (OEHHA). Proposition 

65 List of Chemicals Known to the State to 

Cause Cancer or Reproductive Toxicity.

• European Commission Hazard Phrases 
mechanism, or listed on Toxic Release 

Inventory or IRAC or CDPR as similar class 

6. Endocrine disruptors – based on EC list 

7. Adverse effect on environment, 

wildlife

based on label precautionary statements, 

including toxic or extremely toxic to bees, 

birds, fish , aquatic invertebrates, wildlife, 

other non-target organisms 

8. Moderate or high mobility in soil, or 

soil half-life of 30 days or more, using 

Groundwater Ubiquity Score (GUS), or 

calculated using soil aerobic half life and soil 

binding coefficient. 

9. Has data gaps or missing information in 

EPA documents

10. Contains any contaminants, 

metabolites that violate these criteria

11. The substance is a known groundwater 

contaminate, as identified by state of CA or 

from historic ground water monitoring 

records.

(Annex VI to the CLP Regulation) or Risk 

Phrases (Annex VI to the DSD Regulation) 

indicating possible carcinogenic, 

mutagenic, or reproductive toxicity: H350, 

H350i, H351, H340, H341, H360, H361, 

H362, R45, R49, R40, R46, R68, R33, R60, 

R61, R62, R63, R64.

Adverse effect on environment, wildlife, including 

toxicity to non-target ecological receptors is 

currently not included in our criteria but may be 

built in to the review.

Authoritative Sources Indicating Persistence 

Bioaccumulation and Toxicity: 

• US EPA. Toxic Release Inventory (TRI). 

Designated PBT.

• EU REACH. Substances of Very High 

Concern due to PBT, vPvB, or vPvT.

• Stockholm Convention Persistent Organic 

Pollutants (POPs).

• OSPAR List of Substances of Possible 

Concern. Hazardous Substances List -

Sections A-D.

• Chemicals determined to exceed Safer 

Choice’s thresholds for persistence, 

bioaccumulation, and aquatic toxicity

when addressed through the TSCA Work 

Plan Chemical process.

Respiratory Sensitizers: 

• European Commission Hazard Phrases 

(Annex VI to the CLP Regulation) or Risk 

Phrases (Annex VI to the DSD Regulation) 

indicating possible respiratory 

sensitization: H334, R42.

Dermal Sensitizers: 

• Dermal Sensitizers from Annex III of the EU 

Cosmetics Regulation. 
http://ec.europa.eu/enterprise/sectors/ch

emicals/files/legislation/allergenic_subst_e

n.pdf Additional substances may be added 

this year. 

• European Commission Hazard Phrases 

(Annex VI to the CLP Regulation) or Risk 

Phrases (Annex VI to the DSD Regulation) 

indicating dermal sensitization: H317 or 

R43

Other Authoritative Lists:

• Environment Canada Domestic Substances 

List, designated PBT

• US EPA Toxic Release Inventory (TRI)

• US EPA Work Plan Chemicals

• US EPA Ozone Depleting Substances (Class 

I and II)

• US EPA Hazardous Air Pollutant (HAP)

• ChemSec, Substitute it Now! (SIN) List, 

designated PBT

• Association of Occupational and 

Environmental Clinics (AOEC), Exposure 

Codes

• IFRA Labeling Manual and IFRA 

Transparency List

• TEDX – The Endocrine Disruptor Exchange, 

List of Potential Endocrine Disruptors

• European Commission Endocrine Priority 

List

• Safer Chemicals, Healthy Families, Mind 

the Store

• California Department of Public Health, 

Safe Cosmetics Program, Chemicals Known 

or Suspected to Cause Cancer or 

Reproductive Toxicity. 
Appendix II

EPA regulation

40 CFR §180.1122 Inert ingredients of semiochemical dispensers; exemptions from the 

requirement of a tolerance.

(a) All inert ingredients of semiochemical dispenser products formulated with, and/or contained in, 

dispensers made of polymeric matrix materials (including 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. These dispensers shall conform to the following specifications:

(1) Exposure must be limited to inadvertent physical contact only. The design of the dispenser 

must be such as to preclude any contamination by its components of the raw agricultural 

commodity (RAC) or processed foods/feeds derived from the commodity by virtue of its 

proximity to the RAC or as a result of its physical size.

(2) The dispensers must be applied discretely. This exemption does not apply to components of 

semiochemical formulations applied in a broadcast manner either to a crop field plot or to 

individual plants.

(b) A semiochemical dispenser is a single enclosed or semi-enclosed unit that releases 

semiochemical(s) into the surrounding atmosphere via volatilization and is applied in a manner to 

provide discrete application of the semiochemical(s) into the environment.

(c) Semiochemicals are chemicals that are emitted by plants or animals and modify the behavior of 

receiving organisms. These chemicals must be naturally occurring or substantially identical to 

naturally occurring semiochemicals.

[58 FR 64494, Dec. 8, 1993]