Decision Sheets

December 2006

NOSB COMMITTEE RECOMMENDATION

Form NOPLIST1. Committee Transmittal to NOSB

For NOSB Meeting: Fall 2010__ Substance: (S, S)-Ethylenediaminedisuccinic acid (EDDS)

Committee: Crops  Livestock  Handling  Petition is for: adding (S, S)-Ethylenediaminedisuccinic acid (EDDS)

on the National List § 205.601________________________________

A. 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 as Organic (only for 606) Yes  No  N/A  

B. Substance Fails Criteria Category: 1, 2, 3 Comments: Material is synthetic with alternative materials available. There are concerns 

surrounding the environmental impact of its manufacture and use as well it’s compatibility and consistency with organic agriculture. 

See checklist for details.

C. Proposed Annotation (if any): _________________________________________________________________________ 

____________________________________________________________________________________________________

 Basis for annotation: To meet criteria above: _______ Other regulatory criteria: _______ Citation:____________________

D. Recommended Committee Action & Vote, including classification recommendation (State Actual Motion): 

EDDS be classified as a synthetic for organic crop production_____

Classification of the material: Synthetic ____5____ Non- synthetic___0_________ Absent:___2_____ Abstain __0___ 

Motion by: Kevin Englebert Seconded: Tina Ellor

Recommended Committee Action & Vote List EDDS on National List § 205.601 for use in organic crop production.

___________________________________________________________________________________________________

 

Motion by: Kevin Englebert Seconded: Jeff Moyer Yes: 0___ No: _5___ Absent: _2_____ Abstain: _0___

 

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______Describe why material was rejected: Adverse effects 

on humans and the environment,, not compatable with organic production and alternatives are available._____________________ 

___________________________________________________________________________________________________

4) Substance was recommended to be deferred because _________________________________________________________

____________________________________________________________________________________________________ 

If follow-up needed, who will follow up _____________________________________________________________________

Crops X Agricultural Allowed1 

Livestock Non-Synthetic Prohibited2 

Handling Synthetic X Rejected3 X

No restriction Commercially UnAvailable as Organic1

 

Deferred4

F. Approved by Committee Chair to transmit to NOSB:

Tina Ellor August 16, 2010

___________________________________________________

Committee Chair Date
Decision Sheets

December 2006

EVALUATION CRITERIA FOR SUBSTANCES ADDED TO THE NATIONAL LIST

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

Question Yes No N/A

1

Documentation

(TAP; petition; regulatory agency; other)

1. Are there adverse effects on 

environment from manufacture, use, or 

disposal? [§205.600 b.2]

X TR pages 7-9: One of the major reactants 

used in making EDDS is EDB, which has 

many adverse effects. “In the petition, no 

information was given whether 

dibromoethane, one of the two major 

chemicals for manufacturing (S,S)EDDS, 

would be completely converted to the endproduct of (S,S)EDDS. If the conversion is 

not 100%, no information was given whether 

the un-reacted dibromoethane would be 

mixed with the end-product of (S,S)EDDS or 

mixed with by-products.”

Lines.351-444 History on the hazards of EDB

2. Is there environmental contamination 

during manufacture, use, misuse, or 

disposal? [§6518 m.3]

X

TR page 8: “What happens to 1,2-

dibromoethane when it enters the 

environment?

It moves into the environment from 

manufacturing use and leaks at waste sites.

It moves into the environment from 

manufacturing use and leaks at waste sites.

When released, it quickly moves to air and 

will evaporate from surface water and soil to 

the air. 

It dissolves in water and will move through 

soil into the groundwater. 

Small amounts remain attached to soil 

particles. 

It breaks down slowly in air (over 4-5 

months), more quickly in surface water (2 

months), and hardly at all in groundwater. 

It is not expected to build up in plants or 

animals.”

3. Is the substance harmful to the 

environment and biodiversity? 

[§6517c(1)(A)(i);6517(c)(2)(A)i]

X TR page 10: Direct evidence/data are still 

limited. 

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

3 inerts? [§6517 c (1 ) (B)(ii); 

205.601(m)2]

X

5. Is there potential for detrimental 

chemical interaction with other 

materials used?

[§6518 m.1]

X Chelating agents interact with a wide range 

of metals and could conceivably create 

imbalances and/or deficiencies. 
Decision Sheets

December 2006

6. Are there adverse biological and 

chemical interactions in agroecosystem? [§6518 m.5]

X TR page 10: Direct evidence/data are still

limited. No TR on dibromoethane, 

breakdown products are not known.

7. Are there detrimental physiological 

effects on soil organisms, crops, or 

livestock? [§6518 m.5]

X TR page 10: Direct evidence/data are still 

limited. 

8. Is there a toxic or other adverse action of 

the material or its breakdown products?

 [§6518 m.2]

X TR page 10: Direct evidence/data are still 

limited. 

9. Is there undesirable persistence or 

concentration of the material or 

breakdown products in 

environment?[§6518 m.2]

X TR page 11: “Although the labeled part of 

(S,S)EDDS decomposed to CO2 gas, that did 

not necessarily assure that the unlabeled part 

also decomposed to CO2 gas since that part 

was not directly measured. Therefore, 

(S,S)EDDS as a whole compound might 

decompose rapidly, but the breakdown 

products might not be totally inorganic. The 

breakdown products of the unlabeled part of 

(S,S)EDDS may still need to be clarified. 

The potentially unbroken part is originated 

from 1,2-dibromoethane, a substance 

banned by US EPA in 1984 for most kinds of 

uses.”

10. Is there any harmful effect on human 

health? [§6517 c (1)(A) (i) ; 6517 

c(2)(A)I; §6518 m.4]

X TR page 11: “(S,S)-EDDS is considered to 

be of low toxicity by US EPA. US FDA 

approved the use of (S,S)-EDDS in foodcontacting paper or paperboards.”

However, it is unknown how much unreacted 

EDB might be present.

MSDS page 3: Slightly irritating to skin, 

eyes, and respiratory system.

11. Is there an adverse effect on human 

health as defined by applicable Federal 

regulations? [205.600 b.3]

X TR page 4: The U.S. Environmental 

Protection Agency (EPA) established the 

exemption from the requirement of a 

tolerance for residues of (S,S)-EDDS when 

used as an inert ingredient sequestrant or 

chelating agent in pesticide formulations 

applied to growing crops only under 40 CFR 

Part 180.920 (EPA-HQ-OPP-2008-0250; 

FRL-8362-4; effective November 14, 2008).

TR page 11: US FDA approved the use of 

(S,S)-EDDS in food-contacting paper or 

paperboards.

Petition p 8: The agency’s [FDA’s] final ruling 

was a “Finding of No Significant Impact” 

(FONSI) when EDDS was present at no more 

than 0.31% b weight of the dry fiber of foodcontact paper and paperboard.”

12. Is the substance GRAS when used 

according to FDA’s good 

manufacturing practices? [§205.600 

b.5]

X TR page 11: US FDA approved the use of 

(S,S)-EDDS in food-contacting paper or 

paperboards.

13. Does the substance contain residues of 

heavy metals or other contaminants in 

excess of FDA tolerances? [§205.600 

b.5]

X TR, Petition (exempt from tolerance)

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.
Decision Sheets

December 2006

Category 2. Is the Substance Essential for Organic Production? Substance: EDDS

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 TR lines 278-292

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 TR lines 299-302. Not extracted from naturally occurring 

plant, animal, or mineral sources.

3. Is the substance created by 

naturally occurring biological 

processes? [6502 (21)]

X X The chemical process is noted above; however, lines 307-

313 describes production from bacteria as an alternative.

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 Jay Feldman: Could be considered? Use of distilled or 

deionized water to eliminate interference of metals in the 

mixture.

TR page 6. “In a laboratory experiment, EDDS was 

produced by bacteria at a rate of 20 grams per liter in 

fermentations of Amycolatopsis orientalis with feeding 

solution of glycerol (major component), glutamic acid an 

urea (major component), phosphates (minor) an 

Fe(III)citric acid (trace).”

8. Is the substance used in 

handling, not synthetic, but 

not organically produced? 

[§6517 c (1)(B)(iii)]

X

9. Are there any alternative 

substances? [§6518 m.6]

X TR page 11: as a chelating agent, EDTA not as an active 

ingredient but still as an inert.

10. Is there another practice 

that would make the 

substance unnecessary? 

[§6518 m.6]

X TR page 11: Several alternative cultural methods to using 

pesticides (or the petitioned material) were cited in the 

petition (page 20 – 21 of the petition): biological controls, 

barrier controls, repellent controls, traps, hand picking, 

and cultural controls.

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. 
Decision Sheets

December 2006

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

Substance: EDDS 

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, 

and biodiversity? [§6517 c 

(1)(A)(iii); 6517 c (2)(A)(ii)] 

X TR: Manufacture involves highly toxic reactants. No 

need established.

3. Is the substance compatible with 

a system of sustainable 

agriculture? [§6518 m.7] 

X TR page 11: breakdown products not all known. 

Unknown interactions with desirable metals in soils.

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

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. 
Decision Sheets

December 2006

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 - EDDS

Question Yes No N/A Comments on Information Provided 

(sufficient, plausible, reasonable, 

thorough, complete, unknown)

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