Decision Sheets

April 2010

NOSB COMMITTEE RECOMMENDATION

Form NOPLIST1. Committee Transmittal to NOSB

For NOSB Meeting: November, 2011 Substance: Indole-3-butyric acid (IBA)__CAS#133-32-4___

Committee: Crops x Livestock  Handling  Petition is for:__IBA as a plant growth 

regulator___________________________________________

___________________________________________________ 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 X No  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  

B. Substance Fails Criteria Category: _2 and 3___Comments: __There has not been shown to be a demostrated need for IBA in organic 

production.__Synthetic materials to achieve propogation and to regulate plant growth is inconsistent with organic production._In addition, 

although #1 is checked yes, environmental__impacts my be greater than indicated in the review depending on the raw materials used and the 

manufacturing process. In addition, although the most common probable use of IBA would be point application_by dipping plant cuttings in 

powder dust or solution to promote rooting, the petition requests a broader use. Area application would present a different more complex 

risk.__________________________________________ 

___________________________________________________________________________________________________

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): 

_________________________________________________________________________________________________

Classification of the material: Synthetic ____X____ Non- synthetic_____________ Absent:_________ Abstain _________ 

Motion by: _Barry Flamm__ Seconded:__Tina Ellor______________ Yes: __6___ No: _____ Absent: ___1____ Abstain: _____

Recommended Committee Action & Vote ____Motion to list under 205.601(k)________________________________

____________________________________________________________________________________________________

 

Motion by: __Barry Flamm__________ Seconded:__Tina Ellor______________ Yes: __1___ No: ___4__ Absent: _______ Abstain: _____

 

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. _____ Describe why material was rejected: Failed Categories 2&3 and 

concerns under category 1_________ 

____________________________________________________________________________________________________

4) Substance was recommended to be deferred because _________________________________________________________

____________________________________________________________________________________________________ 

If follow-up needed, who will follow up _____________________________________________________________________

Crops Agricultural Allowed

1

 

Livestock Non-Synthetic Prohibited2 

Handling Synthetic X Rejected3 X

No restriction Commercially UnAvailable as Organic1

 

Deferred4
Decision Sheets

April 2010

E. Approved by Committee Chair to transmit to NOSB:

______________________________________ _________________________

 Committee Chair Date
Decision Sheets

April 2010

NOSB Evaluation Criteria for Substances Added To the National List

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

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]

N/A

2. Is there environmental contamination 

during manufacture, use, misuse, or 

disposal? [§6518 m.3]

X X Petitioner stated IBA is a technical grade 

synthesized substance from many 

sources.186 products containing IBA are 

available in US. IBA is manufactured 

world wide. Thus, there might be different 

manufacturing procedures. (TR 227)

3. Is the substance harmful to the 

environment and biodiversity?

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

X TR 282- IBA is biosynthesized in natural

plants and produced by soil bacteria. It is 

non-toxic to avian wildlife, plants, but 

slightly toxic to fish and aquatic, and 

invertebrates and should not cause 

adverse effects to mammalian wildlife.

EPA says IBA does not persist in the 

environment. TR 221 EPA also waved 

most tox requirements. TR 252-255 –

IBA has typical hormonal dose-response 

pattern. TR 287- PAN data base shows 

no evidence of harmful effects to 

environment, except slight toxicity to fish.

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

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

X TR 238- Indole (CAS#120-72-9) 

butyrolactone(CAS# 96-48-0) and 

Sodium Hydroxide (CAS# 1310-73-2) 

was on list 4B.

5. Is there potential for detrimental chemical 

interaction with other materials used?

[§6518 m.1]

X TR 246- potentially reacts with strong 

oxidizers. TR 249- 250 synergistic with 

other chemicals and bacteria

6. Are there adverse biological and 

chemical interactions in agro-ecosystem? 

[§6518 m.5]

X X TR 44- There are two general groups of 

application methods in terms of toxic 

effect and environmental consequence. 

1) point application: dipping 

plant cuttings in 

powder,dust or solution.

2) Area appliction/ broad 

cast: foliar spray, turf, and 

adding to springler system.

The risks are greater under group 2.

7. Are there detrimental physiological 

effects on soil organisms, crops, or 

livestock? [§6518 m.5]

X See # 3 above

8. Is there a toxic or other adverse action of 

the material or its breakdown products?

[§6518 m.2]

X See # 3 above

9. Is there undesirable persistence or 

concentration of the material or 

breakdown products in environment? 

[§6518 m.2]

X See # 3 above
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April 2010

10. Is there any harmful effect on human 

health? [§6517 c (1)(A)(i); 6517 c(2)(A)i; 

§6518 m.4]

X X EPA says no known risks to human 

health and has granted an exemption for 

tolerance of residue.

IBA is an ―acute health hazard‖ under 

Section 311/312 Hazard class of

SARA Title III Rules (MSDA-IBA,2007)

11. Is there an adverse effect on human 

health as defined by applicable Federal 

regulations? [205.600 b.3]

N/A

12. Is the substance GRAS when used 

according to FDA’s good manufacturing 

practices? [§205.600 b.5]

N/A

13. Does the substance contain residues of 

heavy metals or other contaminants in 

excess of FDA tolerances? [§205.600 

b.5]

N/A

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

April 2010

NOSB Evaluation Criteria for Substances Added To the National List

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

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 Petitioner stated IBA is a technical grade 

synthesized substance

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 Petitioner/TR

3. Is the substance created by naturally 

occurring biological processes? [6502 (21)]

X However, IBA does occurTr naturally in a 

variety of plants.

4. Is there a natural source of the substance? 

[§205.600 b.1]

N/A

5. Is there an organic substitute? [§205.600 b.1] N/A

6. Is the substance essential for handling of 

organically produced agricultural products? 

[§205.600 b.6]

N/A

7. Is there a wholly natural substitute product?

[§6517 c (1)(A)(ii)]

X X IBA occurs naturally, but there is not any 

commercially available extraction 

process. The most commonly used auxin 

for inducing adventitious rooting is IAA, 

but the availability of natural sources is 

unclear.

8. Is the substance used in handling, not 

synthetic, but not organically produced?

[§6517 c (1)(B)(iii)]

N/A

9. Is there any alternative substances? 

[§6518 m.6]

X TR 392- 398 Researchers have 

evaluated the effects of several

alternative materials containing growth 

hormones.( Not clear if these would 

provide the same response as an auxin.)

10. Is there another practice that would make the 

substance unnecessary? [§6518 m.6]

X TR 499 Successful rooting from stem 

cuttings depend on many factors: timing, 

types of cutting, light, temperature, 

moisture and 10 other factors including 

plant hormones.( which may be produced 

naturally by the plant tissues- BF)

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

April 2010

NOSB Evaluation Criteria for Substances Added To the National List

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

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

regulatory agency; other)

1. Is the substance compatible with organic 

handling? [§205.600 b.2]

N/A

2. Is the substance consistent with organic 

farming and handling? [§6517 c 

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

X TR 381- European and N. American 

regulations do not allow synthetic 

products to obtain organic propogation. It 

does not fit any of the allowed categories 

for approving synthetic inputs: 6517c1(B)

3. Is the substance compatible with a 

system of sustainable agriculture? 

[§6518 m.7]

X X IBA is biosynthesized in natural plants 

and produced by soil bacteria. There is 

no evidence that chemical properties of 

synthetic IBA are different from natural

sources, but the manufactured IBA 

contains impurities.

4. Is the nutritional quality of the food 

maintained with the substance? 

[§205.600 b.3]

N/A

5. Is the primary use as a preservative? 

[§205.600 b.4]

N/A

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]

N/A

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

April 2010

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: Name

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? 

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? 

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? 

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?

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);

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; 

d. Trade-related issues such as 

evidence of hoarding, war, trade 

barriers, or civil unrest that may 

temporarily restrict supplies; or

e. Are there other issues which may 

present a challenge to a consistent 

supply?

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.