NOSB RECOMMENDED DECISION FORM

Form NOPLIST2. Full Board Transmittal to NOP 

 

For NOSB Meeting: MAY 2008 Substance: FENBENDAZOLE

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 X No  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 X 

B. Substance fails criteria? 

Criteria category: _________ 

 

Comments: 

 C. Proposed Annotation: Only to be used upon written diagnosis of clinical 

infestation by a veterinarian; prohibited in slaughter stock, allowed in emergency treatment 

for dairy and breeder stock when organic system plan-approved preventive management 

does not prevent infestation. Milk or milk products from a treated animal cannot be labeled 

as provided for in subpart D of this part for 90 days following treatment. In breeder stock, 

treatment cannot occur during the last third of gestation if the progeny will be sold as 

organic and must not be used during the lactation period for breeding stock. 

 

Basis for annotation: 

To meet criteria above: _X_ Criteria: _______________ 

 Other regulatory criteria: ____ Citation:_______________

D. Final Board Action & Vote (State Actual Motion): inclusion of FENBENDAZOLE on the National List § 205.603 

Parasiticides (with the annotation as shown in C directly above 

Motion: HJK Second: KE Yes: 14 No: 0 Abstain: Absent: 1 

 

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._603_____ with Annotation (if any): Only 

to be used upon written diagnosis of clinical infestation by a veterinarian; prohibited in slaughter stock, allowed in emergency 

treatment for dairy and breeder stock when organic system plan-approved preventive management does not prevent infestation. Milk 

or milk products from a treated animal cannot be labeled as provided for in subpart D of this part for 90 days following treatment. In 

breeder stock, treatment cannot occur during the last third of gestation if the progeny will be sold as organic and must not be used 

during the lactation period for breeding stock. 

__________________________________________________________________________________________________ _ 

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. ______ Describe why material was rejected: _____ 

_ ___________________________________________________ _ 

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 √

Allowed1

√ Prohibited2 Handling 

No restriction Deferred4 Rejected3

E. Approved by NOSB Chair to transmit to NOP 

Rigoberto Delgado June 20, 2008 

 . .

Chair Date

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 - FENBENDAZOLE

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 Fenbendazole is produced by petrochemicals involving the use of 

benzene and amines considered to be carcinogenic compounds. 

3. Is the substance harmful to the 

environment?§6517c(1)(A)(i);6517(c

)(2)(A)i] 

X X The product decomposes into fenbendazole sulfone, that is 

considered to be biologically inactive; but it can accumulate and 

be persistent, however, it is expected to be used infrequently. 

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 Parasiticides have the potential to chemically interact with other 

chemicals used in organic farming when excreted by the treated 

animals. The benzimidizoles exhibit a high degree of chemical 

stability 

6. Are there adverse biological and 

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

X The risks associated with chemical treatment of parasites include 

(1) immediate non-target effects, (2) obligation for repeat 

treatments, (3) potential risk to domestic animals and human 

health, (4) target organism resistance to the treatment, (5) potential 

residue buildup and (6) potential food chain contamination (Rudd, 

1985). 

7. Are there detrimental physiological 

effects on soil organisms, crops, or 

livestock? [§6518 m.5] 

X Fenbendazole can break into albendazole. However, there is a low 

likelihood of physiologic effects. (pg 5 TAP) 

8. Is there a toxic or other adverse 

action of the material or its 

breakdown products? [§6518 m.2] 

X X See #7 

9. Is there undesirable persistence or 

concentration of the material or 

breakdown products in 

environment?[§6518 m.2] 

X X See #3 

10. Is there any harmful effect on 

human health? [§6517 c (1)(A)(i) ; 

6517 c(2)(A)i; §6518 m.4] 

X Fenbendazole has no known teratogenic effects. In adverse drug 

experiences reported on the FDA's Center for Veterinary Medicine 

(CVM) website from 1987 to 1997 and considered at least 

possibly related to the drug by FDA, there were only 6 humans 

treated for exposure to veterinary fenbendazole with no deaths 

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. 
Category 2. Is the Substance Essential for Organic Production? Substance - FENBENDAZOLE

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 Fenbendazole is produced by petrochemicals involving the use 

of benzene and amines considered to be carcinogenic 

compounds. 

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 Derived from petrochemicals. 

3. Is the substance created by 

naturally occurring biological 

processes? [6502 (21)] 

x See #2 

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 There are claims about natural products but no efficacy studies 

yet. 

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 Yes, but the current allowed product is more harmful to the 

environment than the petitioned one. 

10. Is there another practice that 

would make the substance 

unnecessary? [§6518 m.6] 

X While we strongly encourage preventive strategies, at times 

there may be needed emergency treatment. The most promising 

alternatives to internal parasiticides require methods that disrupt 

the life cycle of the target organism outside the host (Waller and 

Faedo, 1996). Rotational grazing, fecal examination, culling 

heavily infected animals, selection of resistant breeds, biological 

control at susceptible (usually free-living) stages in the lifecycle. While some non-synthetic herbal remedies, botanicals, 

and mined 

minerals are claimed to have anthelmintic properties, most of 

these materials have not had their efficacy substantiated in 

controlled experimental trials. 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? FENBENDAZOLE

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 Yes, if only used in emergencies to relieve animal pain and 

suffering. NOTE: Routine use of parasiticides should be 

prohibited. Routine use should be defined as use not specified in 

an annual Farm Plan, or use not at the direction of a veterinarian, 

or any use in the same livestock species/production type for the 

same parasite as detailed in the Farm Plan that exceeds two 

consecutive years. 

3. Is the substance compatible with 

a system of sustainable 

agriculture? [§6518 m.7] 

X Parasiticide use has been tolerated in organic livestock 

production on a limited basis to alleviate animal suffering. This 

has almost without exception been part of an integrated system 

of animal health management and requires 

documentation of a number of approaches other than 

intervention, as well as an extended withdrawal 

period well beyond the minimum allowed by the FDA label. 

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 Yes 

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 - FENBENDAZOLE

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; 

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