FORMAL RECOMMENDATION BY THE

NATIONAL ORGANIC STANDARDS BOARD (NOSB) 

TO THE NATIONAL ORGANIC PROGRAM (NOP) 

Date: ___November 30, 2007_______

Subject: __Sodium Ferric Hydroxy EDTA_____ 

Chair: __Andrea M. Caroe______________ 

 

Recommendation

The NOSB hereby recommends to the NOP the following: 

Rulemaking Action: ___X___

Guidance Statement: ________ 

Other: ________ 

Statement of the Recommendation (including Recount of Vote):

Add Sodium Ferric Hydroxy EDTA as snail and slug bait to the National List §205.601(h). 

NOSB Vote: Motion: Gerald Davis Second: Jeff Moyer 

Board vote: Yes - 0 No- 15 Abstain- 0 Absent - 0 

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

Is not consistent with environmental and compatibility with organic farming OFPA criteria 

primarily due to the behavior of EDTA in the environment and the toxic chemicals used to 

manufacture. 

Response by the NOP:
Decision Sheets 

December 2006 

NOSB COMMITTEE RECOMMENDATION 

Form NOPLIST1. Committee Transmittal to NOSB 

For NOSB Meeting: Novermber 2007 Substance: Sodium Ferric Hydroxy ETDA 

Committee: Crops X Livestock  Handling  Petition is for: adding sodium Ferric Hydroxy EDTA as snail and 

slug bait to the National List § 205.601(h)

A. Evaluation Criteria (Applicability noted for each category; Documentation attached) Criteria Satisfied? (see B below) 

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

2. Essential & Availability Criteria Yes  No X N/A 

3. Compatibility & Consistency Yes  No X N/A 

4. Commercial Supply is Fragile or Potentially Unavailable as Organic (only for 606) Yes  No  N/A X 

B. Substance Fails Criteria Category: 1,2, and 3 Comments: Ferric phosphate is already listed for this use, harm to humans and 

the environment, not consistent with organic farming and handling. 

C. Proposed Annotation (if any): _____________________________________________________________________________

________________________________________________________________________________________________________ 

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

D. Recommended Committee Action & Vote (State Actual Motion): Motion is to add Sodium Ferric Hydroxy EDTA to the 

National List on 205.601(h) as a slug and snail bait. 

 9/12/ 07 Motion by: Jeff Seconded: Tina Yes: 0 No: 6 Absent: 0 Abstain 0 

11/29/07 1st: Rigo; 2nd Tina: yes 5 No 0 Absent: 1 

 

 

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(h). Describe why material was rejected: Sodium Ferric 

Hydroxy EDTA failed categories 1, 2, and 3. 

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 

E. Approved by Committee Chair to transmit to NOSB: 

_ Gerald Davis________________________________ ______9/12/07___________________ 

 Committee Chair Date
Decision Sheets 

December 2006 

NOSB EVALUATION CRITERIA FOR SUBSTANCES ADDED TO THE NATIONAL LIST

Category 1. Adverse impacts on humans or the environment? Substance – Sodium Ferric Hydroxy EDTA

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 

2. Is there environmental contamination 

during manufacture, use, misuse, or 

disposal? [§6518 m.3] 

X Petition pg. 13—petitioner says no, but with ingredients like 

hydrogen cyanide, formaldehyde and sulfuric acid it seems 

intuitive that there would be adverse effects from the 

manufacture. 

3. Is the substance harmful to the 

environment? 

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

X Not enough information. Pg 9 of the petition only addresses iron and 

not SFH EDTA. The EDTA clearly has the potential to be harmful to 

the environment (EU Commission risk assessment on EDTA) 

4. Does the substance contain List 1, 2, 

or 3 inerts? 

[§6517 c (1)(B)(ii); 205.601(m)2] 

Not enough Info. Ferric sodium EDTA is a list 4B, but this is 

not the petitioned compound 

5. Is there potential for detrimental 

chemical interaction with other 

materials used?[§6518 m.1] 

X Pg 9 of the petition iron and only how the petitioned substance 

should react in an organic system. 

6. Are there adverse biological and 

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

X Page 15 of the petition had conclusions based on iron and ferric 

sodium EDTA. EDTA can result in the detrimental movement of 

metals in soils and river sediments (EU Commission Risk 

Assessment on EDTA) 

7. Are there detrimental physiological 

effects on soil organisms, crops, or 

livestock? [§6518 m.5] 

Insufficient information provided in the petition. Once again, the 

information in the petition are based on iron, EDTA, and ferric 

sodium EDTA, none of which are the petitioned compound. 

8. Is there a toxic or other adverse 

action of the material or its breakdown 

products? 

[§6518 m.2] 

X Also, add in the reference used in #10: Page 14 of petition, but eye irritant 

page 15, and possible chronic iron overload. EDTA is a very strong metal 

chelating agent, especially for calcium. It is poorly absorbed in mammalian 

GI tract and concerns have been raised that excessive usage in food could 

deplete the body of Ca and other minerals. It is a FDA GRAS direct food 

additive, but the maximum amounts in different foods are regulated. It is also 

added to some food systems as a Na2Ca salt rather than the Na form to 

prevent Ca depletion (O. R. Fennema 1985, Food Chemistry, 2'ed edition, pp. 

641 - 642). 

9. Is there undesirable persistence or 

concentration of the material or 

breakdown products in 

environment?[§6518 m.2] 

X EDTA is not degraded rapidly in the environment and is the most 

abundant anthropogenic chemical in some European surface waters 

http://en.wikipedia.org/wiki/EDTA#_note-1 accessed 1 August 07). Its 

strong chelating power can enhance the movement of metals such as Zn, 

Cd, Ni, Cr, Cu and Fe in soil and river sediments. EDTA is very soluble 

in water and is not sequestered in municipal sewage treatment plants 

(Frank and Rau 1990, in petition). The biodegradation rate strongly 

depends on the metal complexed to the EDTA. Ca and Mg complexes are 

easier to degrade than Cu and Fe for example (see EU Commission risk 

assessment on EDTA p 12 in petition). Photo degradation appears easier. 

However, the high solubility in water can limit the time exposed to 

sunlight. Since EDTA is inert under some environmental conditions and 

rapidly degrades under other conditions (very alkaline water - such as in 

waste water treatment from paper pulp mills (EU Commission risk 

assessment on EDTA), some environmental accumulations must occur. 

10. Is there any harmful effect on 

human health? 

[§6517 c (1)(A)(i) ; 6517 c(2)(A)i; 

§6518 m.4] 

X Page 14 of petition, but eye irritant page 15, and possible chronic iron 

overload. EDTA is a very strong metal chelating agent, especially for 

calcium. It is poorly absorbed in mammalian GI tract and concerns 

have been raised that excessive usage in food could deplete the body 

of Ca and other minerals. It is a FDA GRAS direct food additive, but 

the maximum amounts in different foods are regulated. It is also 

added to some food systems as a Na2Ca salt rather than the Na form 

to prevent Ca depletion (O. R. Fennema 1985, Food Chemistry, 2'ed 

edition, pp. 641 - 642). 
Decision Sheets 

December 2006 

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 to FDA’s good 

manufacturing practices? [§205.600 

b.5] 

X 

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. 
Decision Sheets 

December 2006 

Category 2. Is the Substance Essential for Organic Production? Substance – Sodium Ferric Hydroxy EDTA

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 Page 22, Page 8, page 13 of the petition and summarized below. 

It is commercially produced in either a single or two step process. 

The single step process is most widely used commercially. The 

synthesis starting with ethylenediamine (2-a aldehyde and sodium 

cyanide to form a Na EDTA salt and ammonia and a Na salt of NTA 

(nitrilotriacetic acid) by reaction between the ammonia and the 

starting materials. Acidification precipitates the EDTA, leaving the 

NTA in solution. Hydrochloric or sulfuric acids are used. The NTA 

is considered a waste product, although the NTA can also be used as 

a chelator in detergents. Excess ammonia is either volatilized or 

recovered (see Ullmann's Encylopedia of industrial chemistry vol. 

A10 for details). The two step process uses the same starting 

materials and forms a Na salt of EDTA, and ammonia (no NTA) 

Formaldehyde and sodium cyanide are hazardous chemicals 

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 Page 13 of the petition-tetra sodium salt is a synthetic reacted 

with ferric sulfate to give ferric sodium EDTA. 

3. Is the substance created by 

naturally occurring biological 

processes? [6502 (21)] 

X Page 13 of the petition summarized above. 

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 Page 20 of the petition-diatomaceous earth, barriers, physical 

controls. 

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 Ferric Phosphate 

10. Is there another practice that 

would make the substance 

unnecessary? [§6518 m.6] 

X Petition page 20 copper tape, diatomaceous earth, barriers, 

physical 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 –Sodium Ferric 

Hydroxy EDTA 

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 It’s a synthetic material that does not present a compelling 

need for it as well as the toxic substances necessary for its 

manufacture. 

3. Is the substance compatible 

with a system of sustainable 

agriculture? [§6518 m.7] 

X EDTA is inert under some circumstances and can build up in soil. It 

is the most abundant anthropomorphic chemical in some European 

surface waters. It can enhance the movement of metals in soil and 

river sediments.(EU commission risk assessment on EDTA) 

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 – Sodium Ferric Hydroxy EDTA

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 nonavailability 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; 

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