NOSB RECOMMENDED DECISION FORM

Form NOPLIST2. Full Board Transmittal to NOP

For NOSB Meeting: November 

2009 

Substance: Eprinomectin

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 X No  N/A 

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

B. Substance fails criteria? 

Criteria category: A.2.

Comments: There are already 

substances on the List which have 

the same properties.

C. Proposed Annotation: ______________________________________ 

___________________________________________________________ 

Basis for annotation: 

To meet criteria above: ____ Criteria: _______________ 

Other regulatory criteria: ____ Citation:_______________

D. Final Board Action & Vote (State Actual Motion): To add eprinomectin to 

7CFR205.603 as a parasiticide 

.

Motion: Hubert Karreman Second: Tracy Miedema Yes: 0 No: 13 Abstain: 0 Absent: 2

 

Provide a summary narrative here or attach a more complete narrative, and attach the original committee recommendation

that includes the evaluation criteria checklist:

1—substance voted to be added as “allowed” on National List on National List to § 205.______ with Annotation (if any): ____ __ 

__________________________________________________________________________________________________ _ 

2—substance to be added to “prohibited” paragraph of National List to § 205.______ Describe why a prohibited substance: __ ____

_____________________________________________________ ___________________________________ ____ 

 

3—substance was rejected by vote for amending National List to § 205.603 Describe why material was rejected: There exist synthetic

materials on the List having essentially the same use (ivermectin).

4-substance was recommended to be deferred § 205. ______ Describe why deferred; if any follow-up is needed. If follow-up needed, 

who conducts follow-up ________________________________ ____________________________________ 

Agricultural Nonagricultural Crops

Synthetic Not synthetic Livestock

Allowed1Prohibited2

Handling

No restriction Deferred4 Rejected3

E. Approved by NOSB Chair to transmit to NOP

 Jeff Moyer . 

Chair Date

 11/05/2009 .

F. NOP Action: Include in FR to amend National List: 

 Return to NOSB Reason: ____________________________________________________________________ 

_____________________________________ _________________________ 

 Date 
NOSB EVALUATION CRITERIA FOR SUBSTANCES ADDED TO THE NATIONAL LIST

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

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 is interaction between Eprinomectin and various species 

of avians, fish, algae and earthworms at various levels. To what 

degree this matches what would be excreted by the animal in the 

isomeric B1a form of Eprinomectin (the major isomer) isn’t 

provided.

3. Is the substance harmful to the 

environment?

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

X Tightly bound to the soil, thus persistence may be an issue i.e. 

no breakdown of product noted in petition.

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

6. Are there adverse biological and 

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

X No environmental impact statement was required by FDA 

during submittal of eprinomectin for official NADA approval.

7. Are there detrimental 

physiological effects on soil 

organisms, crops, or livestock? 

[§6518 m.5]

X No data submitted for soil or crops. A battery of studies was 

completed on various animal species during the regulatory 

approval process (mice, rats, rabbits, dogs, cattle). Tightly 

bound to soil, therefore persistence is likely

8. Is there a toxic or other adverse 

action of the material or its 

breakdown products? 

[§6518 m.2]

X Tightly bound to soil, therefore persistence is likely

9. Is there undesirable persistence or 

concentration of the material or 

breakdown products in 

environment?[§6518 m.2]

X Tightly bound to soil, therefore persistence is likely.

10. Is there any harmful effect on 

human health? 

[§6517 c (1)(A)(i) ; 6517 c(2)(A)i; 

§6518 m.4]

X Minor skin irritation was noted during clinical testing of the 

product and that person had a history or skin irritations. The

OTC directions clearly say to immediately wash any product off 

exposed skin.

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 

X
tolerances? [§205.600 b.5] 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.
Category 2. Is the Substance Essential for Organic Production? Substance - Eprinomectin

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 It is semi-synthetic, derived from soil streptomyces and 

chemically altered to create the product.

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

3. Is the substance created by 

naturally occurring biological 

processes? [6502 (21)]

X X Part of the process is via fermentation but then various chemical 

processes are undertaken to create the end product.

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 X With internal parasiticides, this is always debatable in that there 

are many studies showing various botanical compounds 

providing some measure of efficacy when tested using in vivo 

models. However, the efficiency of the synthetic products is 

extremely high and therefore very easy to use. 

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 X See answer to #5

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 X See answer to #5

10. Is there another practice that 

would make the substance 

unnecessary? [§6518 m.6]

X X Cultural management practices and excellent nutrition would 

render the need for synthetic wormers to be minimized

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

Question Yes No N/A1 Documentation

(TAP; petition; regulatory agency; other)

1. Is the substance compatible with 

organic handling? [§205.600 b.2]

X X It is when thinking about animal welfare needs; it isn’t when 

thinking about residues of synthetics in the environment.

2. Is the substance consistent with 

organic farming and handling? 

[§6517 c (1)(A)(iii); 6517 c 

(2)(A)(ii)]

X X See #1 above

3. Is the substance compatible with 

a system of sustainable 

agriculture? [§6518 m.7]

X X It depends on your philosophy.

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.
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 - ______________________________________

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? 

 

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 nonavailability 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?