Formal Recommendation 

From: National Organic Standards Board (NOSB) 

To: the National Organic Program (NOP)

Date: 

Subject: 

Chair: 

The NOSB hereby recommends to the NOP the following: 

Rulemaking Action: 

Guidance Statement: 

Other: 

Statement of Recommendation: (Motion # 1) 

 

Rationale Supporting Recommendation (including consistency with OFPA and NOP):

 

Committee Vote:

 

Moved: 

SecondĞĚ: 

Yes:EŽ͗ďƐƚĂŝŶ͗ďƐĞŶƚ͗ZĞĐƵƐĞ͗

 

 

 3DJHUHYLVHGPD

October 16, 2012

Petition to add Propylene Glycol Monolaurate (PGML) to §205.601 (e)

Barry Flamm

Petition Failed

Passed

 Motion to classify Propylene Glycol Monolaurate (PGML) as synthetic. 

 

 

 

PGML is manufactured by a process that involves chemical change.

Colehour Bondera

Jay Feldman

15 0 0 0 0
Rationale Supporting Recommendation (including consistency with OFPA and NOP):

Statement of Recommendation: (Motion # )

Committee Vote:

 

Moved: 

SecondĞĚ: 

Yes:EŽ͗ďƐƚĂŝŶ͗ďƐĞŶƚ͗ZĞĐƵƐĞ͗

 

 

 

 

3DJHUHYLVHGPD

Failed

Motion to add PGML to the National List on §205.601(e) as an acaracide. 

 

While potentially useful as an additional tool for controlling Acari pests, it is not needed as it can 

be substituted with alternatives including cultural practices and biological controls -- other 

options are available which do not have the impacts on human and environmental health. As a 

synthetic product, this material is not consistent with either organic or sustainable production 

systems. Those who supported adding PGML to the National List found that available organic 

options are not always effective. 

Colehour Bondera

John Foster

5 10 0 0 0
National Organic Standards Board

Crops Subcommittee

Petitioned Material Proposal

Propylene Glycol Monolaurate (PGML)

August 7, 2012

Introduction:

PGML has been petitioned to be added to section 205.601(e) of the National List. PGML is an 

acaricide; a pesticide that kills members of the Acari group – ticks and mites. Stated in the 

petition (pg. 5), specifically PGML is seen as, “a broad spectrum antimicrobial agent to control 

fungi and bacteria that cause decay of post-harvest fruit and vegetables.” 

Relevant areas in the Rule:

The National List includes at §205.601(e) 

As insecticides (including acaricides or mite control). 

Discussion: 

While potentially useful as an additional tool for controlling Acari pests, it is not needed as it 

can be substituted with alternatives including cultural practices and biological controls -- other 

options are available which do not have the impacts on human and environmental health. That 

the environmental impacts leave more damage overall than benefit, is of notable concern, 

when considered in regard to efficacy. As a synthetic product, this material is not consistent 

with either organic nor sustainable production systems. As a tool made for use in conventional 

agricultural systems, PGML does not serve as an organic system tool. 

Those who supported adding PGML to the National List said that while there are other organic 

options, they are very sporadic in how well they control the target pests or even under certain 

circumstances if they will control them at all. The impact on crop quality, and the potential 

environmental impact when using the alternative materials can be somewhat of a concern, as 

well. Giving organic farmers another tool that is better than those they currently rely upon is 

exactly what this process is all about if we can properly look at the risk/ benefit. 

Evaluation Criteria:

(Applicability noted for each category; Documentation attached) Criteria Satisfied? (see 

“B” below)

1. Impact on Humans and Environment ܆ Yes ܈ No ܆ N/A 

2. Essential & Availability Criteria ܆ Yes ܈ No ܆ N/A 

3. Compatibility & Consistency ܆ Yes ܈ No ܆ N/A 

4. Commercial Supply is Fragile or Potentially Unavailable ܆ Yes ܆ No ܈ N/A 

as Organic (only for § 205.606) 

Substance Fails Criteria Category: [1, 2, 3] 

Proposed Annotation (if any): 
Revised March 2012

Basis for annotation: ܆ To meet criteria above ܆ Other regulatory criteria ܆ Citation 

Notes: 

Recommended Subcommittee Action & Vote, including classification recommendation 

(state actual motion): 

Classification Motion: 

PGML is synthetic. 

Motion by: Colehour Bondera Seconded by: Zea Sonnabend 

Yes__8___ No__0__ Abstain__0__ Recuse__0__ Absent__0__ 

Listing Motion: 

Add PGML to the National List §205.601(e) as an acaracide. 

Motion by: Colehour Bondera Seconded by: John Foster 

Yes__2___ No__6__ Abstain__0__ Recuse__0__ Absent__0__ 

܆ 1Allowed ܆ Agricultural ܈ Crops

Livestock ܆ Non-synthetic ܆ Prohibited2 ܆

܈ 3Rejected ܈ Synthetic ܆ Handling

No restriction ܆ Commercial unavailable as 

organic

܆ 4Deferred ܆

1

Substance voted to be added as “allowed” on National List to § 205. with Annotation (if 

any): 

2

Substance to be added as “prohibited” on National List to § 205. with Annotation (if any): 

 Describe why a prohibited substance: 

3

Substance was rejected by vote for amending National List to § 205.601(e). Describe why 

material was rejected: 

Not needed and environmental impacts too costly. 

4

Substance was recommended to be deferred because 

 

 If follow-up needed, who will follow up: 

Approved by Subcommittee Chair to Transmit to NOSB

Jay Feldman, Subcommittee Chair August 7, 2012
Revised March 2012

NOSB Evaluation Criteria for Substances Added To the National List

Category 1. Adverse impacts on humans or the environment? Substance: Propylene Glycol 

 Monolaurate (PGML)

Question Yes No N/A1 Documentation (TAP; petition; regulatory 

agency; other)

1. Are there adverse effects on environment 

from manufacture, use, or disposal? 

[§205.600 b.2] 

 X 

2. Is there environmental contamination during 

manufacture, use, misuse, or disposal? 

[§6518 m.3] 

X There can be with misuse or disposal since 

beneficials can be destroyed... Human 

irritation if mis-used. Feedstock for 

manufacture comes from petroleum, natural 

gas or coal. Manufacture requires burning of 

petroleum, thus greenhouse gas production. 

See TR - line 231 onward. 

3. Is the substance harmful to the environment 

and biodiversity? 

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

X Fossil fuel dependent (234-6). 

4. Does the substance contain List 1, 2 or 3 

inerts? [§6517 c (1)(B)(ii); 205.601(m)2] 

 X List 4B. 

5. Is there potential for detrimental chemical 

interaction with other materials used? 

[§6518 m.1] 

X Can enhance toxicity of other ‘biocides’ (255). 

6. Are there adverse biological and chemical 

interactions in agro-ecosystem? [§6518 m.5] 

X Both beneficial mites (soil food web & organic 

matter decomposers) and fungi directly 

impacted; limited studies (283-299 & 309-

316)... 

7. Are there detrimental physiological effects on 

soil organisms, crops, or livestock? [§6518 

m.5] 

X Potential impact on soil food web mites (283-

299 & 309-316). 

8. Is there a toxic or other adverse action of the 

material or its breakdown products? 

[§6518 m.2] 

 Unclear/unknown. 

9. Is there undesirable persistence or 

concentration of the material or breakdown 

products in environment? [§6518 m.2] 

 X 

10. Is there any harmful effect on human health? 

[§6517 c (1)(A)(i); 6517 c(2)(A)i; §6518 m.4] 

X Minimal, but can cause short-term skin and 

eye reactions (328-335). PGML is a “Toxicity 

Category III” substance in terms of eye 

irritation (US EPA Fact Sheet, 2004). As 

listed in 40 CFR 156.62, US EPA establishes 

the four toxicity categories: I, II, III and IV. 

Toxicity category I is highly toxic and severely 

irritating, category II moderately toxic and 

moderately irritating, category III slightly toxic 

and slightly irritating, and category IV 

practically non-toxic and not an irritant. 

Toxicity category III substances cause eye 

irritation effects, but the irritation effects are 

reversible within seven days. Toxicity 

category IV substances do not cause eye 

irritation effects. 

11. Is there an adverse effect on human health 

as defined by applicable Federal regulations? 

[205.600 b.3] 

 X 

12. Is the substance GRAS when used according X 
Revised March 2012

to FDA’s good manufacturing practices? 

[§205.600 b.5] 

13. Does the substance contain residues of 

heavy metals or other contaminants in 

excess of FDA tolerances? [§205.600 b.5] 

 X 

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b) are N/A—

not applicable. 
Revised March 2012

NOSB Evaluation Criteria for Substances Added To the National List

Category 2. Is the Substance Essential for Organic Production?

Substance: Propylene Glycol Monolaurate (PGML)

Question Yes No N/A1 Documentation (TAP; petition; regulatory 

agency; other)

1. Is the substance formulated or manufactured 

by a chemical process? [6502 (21)] 

X 

2. Is the substance formulated or manufactured 

by a process that chemically changes a 

substance extracted from naturally occurring 

plant, animal, or mineral, sources? 

[6502 (21)] 

 X Manufactured from petroleum, natural gas, or 

coal by a process involving chemical change. 

3. Is the substance created by naturally 

occurring biological processes? [6502 (21)] 

 X Could be, however commercially it is not... 

4. Is there a natural source of the substance? 

[§205.600 b.1] 

 X 

5. Is there an organic substitute? [§205.600 b.1] X 

6. Is the substance essential for handling of 

organically produced agricultural products? 

[§205.600 b.6] 

 X 

7. Is there a wholly natural substitute product? 

[§6517 c (1)(A)(ii)] 

X Non-synthetic botanical and fungal-derived 

acaricides (354). 

8. Is the substance used in handling, not 

synthetic, but not organically produced? 

[§6517 c (1)(B)(iii)] 

 X 

9. Is there any alternative substances? 

[§6518 m.6] 

X Horticultural oils (petroleum distillates), 

soaps, sulfur and sucrose octanoate esters 

(SOE) also appear on the National List and 

are used to control mites in organic 

production (360-1). 

10. Is there another practice that would make the 

substance unnecessary? [§6518 m.6] 

X Rotation, nutrient management, selection of 

mite-resistant varieties, and the release of 

predators and parasites (342), dust 

management, resistant varieties and 

biological controls (370-398). Water 

management is a viable practice as well. 

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b) are N/A—

not applicable. 

 
Revised March 2012

NOSB Evaluation Criteria for Substances Added To the National List

Category 3. Is the substance compatible with organic production practices? 

Substance: Propylene Glycol Monolaurate (PGML)

Question Yes No N/A1 Documentation (TAP; petition; regulatory 

agency; other)

1. Is the substance compatible with organic 

handling? [§205.600 b.2] 

 X 

2. Is the substance consistent with organic 

farming and handling? [§6517 c (1)(A)(iii); 

6517 c (2)(A)(ii)] 

 X Toxic to aquatic life. 

3. Is the substance compatible with a system of 

sustainable agriculture? [§6518 m.7] 

 X No, petroleum based. 

4. Is the nutritional quality of the food 

maintained with the substance? [§205.600 

b.3] 

 X 

5. Is the primary use as a preservative? 

[§205.600 b.4] 

 X 

6. Is the primary use to recreate or improve 

flavors, colors, textures, or nutritive values 

lost in processing (except when required by 

law, e.g., vitamin D in milk)? [205.600 b.4] 

 X 

7. Is the substance used in production, and 

does it contain an active synthetic ingredient 

in the following categories: 

a. copper and sulfur compounds; 

 X 

b. toxins derived from bacteria; X 

c. pheromones, soaps, horticultural oils, fish 

emulsions, treated seed, vitamins and 

minerals? 

 X Glycol esters do not appear in an OFPA 

category. In evaluating the petition for 

sucrose octanoate esters (SOE), the NOSB 

determined that esters are equivalent in their 

manufacture and mode of action to ‘soap,’ 

which appears as a category of synthetic 

authorized for use in production on the 

National List at 7 U.S.C. §6517(c)(1)(B)(i) 

(NOSB, 2005) (116-119). However, the 

PGML molecule does not have the 

hydrophilic-lipophilic structure of a soap (27-

28), as also seen by its solubility in organic 

solvents, low water solubility, high 

saponification value, and low hydrophiliclipophilic balance value, all of which indicate a 

substance that is lipophilic, but does not have 

the hydrophilic-lipophilic structure of a soap 

(38-44). 

d. livestock parasiticides and medicines? X 

e. production aids including netting, tree 

wraps and seals, insect traps, sticky 

barriers, row covers, and equipment 

cleaners? 

 X 

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b) are N/A—

not applicable. 

 
Revised March 2012

NOSB Evaluation Criteria for Substances Added To the National List

Category 4. Is the commercial supply of an agricultural substance as organic, fragile or potentially 

unavailable? [§6610, 6518, 6519, 205.2, 205.105 (d), 205.600 (c) 205.2, 205.105 (d), 205.600 (c)] Substance: 

Propylene Glycol Monolaurate (PGML)

Question Yes No N/A1 Documentation (TAP; petition; regulatory 

agency; other)

1. Is the comparative description provided as to 

why the non-organic form of the material 

/substance is necessary for use in organic 

handling? 

 X 

2. Does the current and historical industry 

information, research, or evidence provided 

explain how or why the material /substance 

cannot be obtained organically in the 

appropriate form to fulfill an essential 

function in a system of organic handling? 

 X 

3. Does the current and historical industry 

information, research, or evidence provided 

explain how or why the material /substance 

cannot be obtained organically in the 

appropriate quality to fulfill an essential 

function in a system of organic handling? 

 X 

4. Does the current and historical industry 

information, research, or evidence provided 

explain how or why the material /substance 

cannot be obtained organically in the 

appropriate quantity to fulfill an essential 

function in a system of organic handling? 

 X 

5. Does the industry information provided on 

material / substance non-availability as 

organic, include ( but not limited to) the 

following: 

a. Regions of production (including factors 

such as climate and number of regions); 

 X 

b. Number of suppliers and amount 

produced; 

 X 

c. Current and historical supplies related to 

weather events such as hurricanes, 

floods, and droughts that may temporarily 

halt production or destroy crops or 

supplies; 

 X 

d. Trade-related issues such as evidence of 

hoarding, war, trade barriers, or civil 

unrest that may temporarily restrict 

supplies; or 

 X 

e. Are there other issues which may present 

a challenge to a consistent supply? 

 X 

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b) are N/A—

not applicable.