This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

25612 

Vol. 76, No. 87 

Thursday, May 5, 2011 

DEPARTMENT OF AGRICULTURE 

Agricultural Marketing Service 

7 CFR Part 205 

[Document Number AMS–NOP–10–0078; 

NOP–09–03] 

RIN 0581–AD05 

National Organic Program; Proposed 

Amendments to the National List of 

Allowed and Prohibited Substances 

(Livestock) 

AGENCY: Agricultural Marketing Service, 

USDA. 

ACTION: Proposed rule. 

SUMMARY: This proposed rule would 

amend the U.S. Department of 

Agriculture’s (USDA) National List of 

Allowed and Prohibited Substances 

(National List) to reflect 

recommendations submitted to the 

Secretary of Agriculture (Secretary) by 

the National Organic Standards Board 

(NOSB) on June 20, 2008, and May 30, 

2004. The recommendations addressed 

in this proposed rule pertain to 

establishing exemptions (uses) for two 

substances, fenbendazole and 

moxidectin, on the National List as 

parasiticides in organic livestock 

production. Consistent with the 

recommendations from the NOSB, this 

proposed rule would amend the 

National List to add these two 

substances, along with their restrictive 

annotations. 

DATES: Comments must be received by 

July 5, 2011. 

ADDRESSES: Interested persons may 

submit written comments on this 

proposed rule using one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Toni Strother, Agricultural 

Marketing Specialist, National Organic 

Program, USDA–AMS–NOP, 1400 

Independence Ave., SW., Room 2646– 

So., Ag Stop 0268, Washington, DC 

20250–0268. 

Instructions: All submissions received 

must include the docket number AMS– 

NOP–10–0078; NOP–09–03, and/or 

Regulatory Information Number (RIN) 

0581–AD05 for this rulemaking. You 

should clearly indicate the topic and 

section number of this proposed rule to 

which your comment refers. You should 

clearly indicate whether you support 

the action being proposed for either or 

both of the substances in this proposed 

rule. You should clearly indicate the 

reason(s) for your position. You should 

also supply information on alternative 

management practices, where 

applicable, that support alternatives to 

the proposed action. You should also 

offer any recommended language 

change(s) that would be appropriate to 

your position. Please include relevant 

information and data to support your 

position (e.g. scientific, environmental, 

manufacturing, industry, impact 

information, etc.). Only relevant 

material supporting your position 

should be submitted. All comments 

received will be posted without change 

to http://www.regulations.gov. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.regulations.gov. Comments 

submitted in response to this proposed 

rule will also be available for viewing in 

person at USDA–AMS, National Organic 

Program, Room 2646–South Building, 

1400 Independence Ave., SW., 

Washington, DC, from 9 a.m. to 12 noon 

and from 1 p.m. to 4 p.m., Monday 

through Friday (except official Federal 

holidays). Persons wanting to visit the 

USDA South Building to view 

comments received in response to this 

proposed rule are requested to make an 

appointment in advance by calling (202) 

720–3252. 

FOR FURTHER INFORMATION CONTACT: 

Melissa Bailey, PhD, Director, Standards 

Division, Telephone: (202) 720–3252; 

Fax: (202) 205–7808. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On December 21, 2000, the Secretary 

established, within the National Organic 

Program (NOP) (7 CFR part 205), the 

National List regulations §§ 205.600 

through 205.607. This National List 

identifies the synthetic substances that 

may be used and the nonsynthetic 

(natural) substances that may not be 

used in organic production. The 

National List also identifies synthetic, 

nonsynthetic nonagricultural and 

nonorganic agricultural substances that 

may be used in organic handling. The 

Organic Foods Production Act of 1990, 

as amended (7 U.S.C. 6501 et seq.), 

(OFPA), and NOP regulations, in 

§ 205.105, specifically prohibit the use 

of any synthetic substance in organic 

production and handling unless the 

synthetic substance is on the National 

List. Section 205.105 also requires that 

any nonorganic agricultural and any 

nonsynthetic nonagricultural substance 

used in organic handling appear on the 

National List. 

Under the authority of the OFPA, the 

National List can be amended by the 

Secretary based on proposed 

amendments developed by the NOSB. 

Since established, the NOP has 

published fourteen amendments to the 

National List: October 31, 2003, (68 FR 

61987); November 3, 2003, (68 FR 

62215); October 21, 2005, (70 FR 61217), 

June 7, 2006, (71 FR 32803); September 

11, 2006, (71 FR 53299); June 27, 2007 

(72 FR 35137); October 16, 2007, (72 FR 

58469); December 10, 2007, (72 FR 

70479); December 12, 2007, (72 FR 

70479); September 18, 2008, (73 FR 

59479); October 9, 2008 (73 FR 59479); 

July 6, 2010 (75 FR 38693); August 24, 

2010 (75 FR 51919); and December 13, 

2010 (75 FR 77521). Additionally, 

proposed amendments to the National 

List published on November 8, 2010, (75 

FR 68505) are currently pending. 

This proposed rule would amend the 

National List to reflect two 

recommendations submitted to the 

Secretary by the NOSB on June 20, 

2008, and May 30, 2004. Based upon 

their evaluation of petitions submitted 

by industry participants and reviews 

prepared by Technical Advisory Panels, 

the NOSB recommended that the 

Secretary amend § 205.603 of the 

National List to add two substances 

(fenbendazole and moxidectin) for use 

as parasiticides in organic livestock 

production under the conditions 

specified in their respective 

annotations. The exemption for use of 

each substance in organic production 

was evaluated by the NOSB using the 

criteria specified in OFPA (7 U.S.C. 

6517–6518). 

II. Overview of Proposed Amendments 

The following provides an overview 

of the proposed amendments to 


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Federal Register / Vol. 76, No. 87 / Thursday, May 5, 2011 / Proposed Rules 25613 

1The petition was submitted by Intervet Inc., and 

is retrievable from the NOP Web site in the 

Petitioned Substances Database, http:// 

www.ams.usda.gov/NOPPetitioned 

SubstancesDatabase. 

2Hoechst-Roussel Agri-Vet Company. May 1995. 

Environmental Assessment NADA 128–620 

Fenbendazole Suspension 10% in Dairy Cattle of 

Breeding Age. Retrieved from FDA’s Animal and 

Veterinary area via NADA number (the FONSI is 

also available via the link to the Environmental 

Assessment): http://www.fda.gov/

AnimalVeterinary/DevelopmentApprovalProcess/

EnvironmentalAssessments/ucm072419.htm. 3Technical Advisory Panel Review on 

Parasiticides (Fenbendazole, Ivermectin and 

Levamisole). November 25,1999. Retrieved from 

National Organic Program Petitioned Substances 

Database: http://www.ams.usda.gov/NOPPetitioned

SubstancesDatabase. 

4This table does not include the FDA mandated 

limitations and restrictions on use. That 

information can be found in the referenced section 

of the CFR. This table only includes livestock 

applicable to organic production and does not list 

other types of animals, such as horses not intended 

for food, dogs and zoo animals, for which certain 

forms of oral fenbendazole are approved. 

designated sections of the National List 

regulations: 

Section 205.603 Synthetic Substances 

Allowed for Use in Organic Livestock 

Production 

This proposed rule would amend 

§ 205.603 of the National List 

Regulations by amending paragraph 

(a)(18) to move the name of the one 

listed substance (ivermectin) to a newly 

designated section (ii) and adding two 

new sections (i) and (iii) for the purpose 

of allowing the restricted use of the 

following substances in organic 

livestock production: 

Fenbendazole (CAS #43210–67–9). 

Fenbendazole was petitioned for use in 

March 2007, as a parasiticide for the 

management of specific gastrointestinal 

worms and lungworms in organic 

livestock production.1 Fenbendazole is 

a light brownish-gray, odorless 

crystalline powder which is insoluble in 

water and soluble in dimethyl sulfoxide. 

Fenbendazole is a member of the 

benzimidazole family of anthelmintics. 

It functions by blocking the 

polymerization of tubulin into 

microtubules in gastrointestinal worms 

and lungworms thereby disrupting the 

integrity and transport functions of the 

parasites’ cells. Fenbendazole is most 

effective in ruminant animals because 

the rate of passage through the digestive 

system is slowed by the rumen or 

cecum. 

When administered to livestock, 

fenbendazole and its metabolites can be 

released into the environment through 

the excretions of treated animals. 

Benzimidazole compounds demonstrate 

high chemical stability in the 

environment and fenbendazole binds 

tightly to soil particles, but rapidly 

degrades in sunlight. 

In 1995, the Food and Drug 

Administration (FDA) issued a Finding 

of No Significant Impact (FONSI) based 

upon an environmental assessment of 

the use of fenbendazole suspension in 

dairy cattle.2 The environmental 

assessment included studies on 

environmental fate of fenbendazole (e.g., 

migration/adsorption in soil, photolysis, 

water solubility, biodegradation) and its 

potential toxicity in aquatic and 

terrestrial environments including 

toxicity to earthworms and dung 

beetles. In the FONSI, the FDA 

concluded that the introduction of 

fenbendazole as suspension, paste or 

premixes for treatment of dairy cattle, 

would not have a significant effect on 

the quality of the human environment. 

According to the Technical Advisory 

Panel (TAP) review prepared for the 

NOSB, there was no convincing 

evidence associating fenbendazole with 

serious chronic or acute effects upon 

human health.3

The FDA has approved forms of 

fenbendazole to treat parasites in cattle 

(including dairy cattle), goats, sheep, 

and swine (including pregnant swine), 

and turkeys. The FDA has approved 

four oral dosage forms of fenbendazole: 

suspension, powder, paste, and blocks, 

for various species of food animals, per 

21 CFR 520.905(a)–(e). The FDA has 

also approved the use of fenbendazole 

in animal feeds for beef and dairy cattle, 

swine and turkeys, per 21 CFR 558.258. 

Table 1 shows the different forms of 

fenbendazole and the animals for which 

FDA has approved its use.4

TABLE 1—FDA APPROVED FENBENDAZOLE ORAL DOSAGE FORMS AND USES 4

Fenbendazole dosage 

form 

Suspension Paste Powder Blocks Animal feed 

21 CFR 

reference 

21 CFR 520.905(a) 21 CFR 520.905(c) 21 CFR 520.905(d) 21 CFR 520.905(e) 21 CFR 558.258 

Animal species for 

which use is approved.

* Cattle—including 

dairy cattle of 

breeding age. 

* Beef cattle. 

* Non-lactating goats. 

* Cattle ....................... * Swine ...................... * Cattle—excluding 

dairy cattle of 

breeding age.

* Turkeys. 

* Swine. 

* Dairy and beef cattle—not for use in 

veal calves. 

Per the Federal Food, Drug and 

Cosmetic Act (FFDCA), as amended by 

the Food Quality Protection Act of 1996 

(FQPA), the FDA established specific 

tolerances at 21 CFR 556.275 for 

residues of fenbendazole in animal 

tissues to be used as food. The 

acceptable daily intake (ADI) and 

tolerances are listed for liver, muscle 

and milk among the livestock species 

for which FDA has approved its use. 

The NOP regulations at 

§ 205.238(b)(1) permit the use of 

synthetic parasiticides if included on 

§ 205.603 of the National List in breeder 

stock, excluding the last third of 

gestation and during lactation for 

progeny that will be sold, labeled or 

represented as organic. Section 205.2 of 

the NOP regulations defines breeder 

stock as ‘‘female livestock whose 

offspring may be incorporated into an 

organic operation at the time of their 

birth.’’ Neither the NOP regulations nor 

the NOSB recommendation restrict the 

use of parasiticides to ruminant 

animals. In effect, this proposed action 

would allow the use of the applicable 

form of fenbendazole among breeder 

stock for beef and dairy cattle, goats, 

and swine, provided it is not 

administered during the last third of 

gestation and lactation for progeny that 

will be sold as organic. The action 

would also allow the use of the 

applicable form of fenbendzole for 

turkeys. 

At its May 20–22, 2008, meeting in 

Washington, DC, the NOSB 

recommended revising the National List 

at § 205.603(a)(18) to permit the use of 

fenbendazole under the following 

conditions: ‘‘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 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
25614 Federal Register / Vol. 76, No. 87 / Thursday, May 5, 2011 / Proposed Rules 

5NOSB Recommendation on Fenbendazole. June 

20, 2008. Retrieved from National Organic Program 

Petitioned Substances Database. Transcripts from 

the NOSB May 20–22, 2008 meeting can be 

retrieved from the NOP webpage in the NOSB 

section: http://bit.ly/iemAwC. 

6The FDA regulations at 21 FR 520.905a state 

that the 10 mg fenbendazole suspension for beef 

cattle is restricted to use by or on the order of a 

licensed veterinarian. The FDA regulations do not 

stipulate that requirement for other dosage forms. 

The NOP requirement for a 90-day withdrawal 

period for milk or milk products from an animal 

treated with an allowed parasiticide also exceeds 

FDA requirements for use among nonorganic 

livestock. The 90-day milk withdrawal period was 

set based upon consumer expectations for 

organically raised animals and is only applicable to 

the use of this substance under the NOP regulations 

(65 FR 80573). 

7The petition was submitted by Fort Dodge 

Animal Health and is retrievable from the NOP Web 

site in the Petitioned Substances Database, http:// 

www.ams.usda.gov/ 

NOPPetitionedSubstancesDatabase. 

8According to the 2003 Technical Advisory Panel 

review, in a study submitted to the FDA by the 

manufacturer, less than 1% of the applied dose of 

moxidectin was found to wash off treated cattle 

when rainfall occurred within 30 minutes of 

product application. 

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.’’ 

Except for the provision, ‘‘only to be 

used upon written diagnosis of clinical 

infestation by a veterinarian,’’ the 

recommended annotation is identical to 

the National List annotation for the 

parasiticide ivermectin at § 205.603. 

These common components reiterate the 

restrictions on the use of parasiticides in 

general, as set forth in §§ 205.238(b) and 

(c)(4)–(5). 

During this open meeting, the NOSB 

evaluated the use of fenbendazole 

against the evaluation criteria of 7 

U.S.C. 6517 and 6518 of the OFPA and 

received public comment. The record 

contains acknowledgement of the risks 

associated with chemical treatment of 

parasites, particularly to non-target 

organisms, human health and the food 

chain, residue accumulation and target 

organism resistance. However, the 

NOSB has considered the role of 

fenbendazole as part of an integrated 

system of animal health care, which 

includes the relief of pain and suffering 

that can be caused by parasitic 

infestation. The NOP regulations 

prohibit the routine use of synthetic 

parasiticides, per § 205.238(c)(4), and 

the infrequent use of fenbendazole in 

organic production is expected to 

mitigate its introduction to and 

persistence in the environment. The 

NOSB emphasized that the allowance of 

additional parasiticides should not be 

viewed as an indication that 

parasiticides will be approved with 

greater facility. The NOSB reiterated 

that organic livestock producers are first 

and foremost responsible for managing 

parasites through practices specified in 

their organic system plans, including 

selection of disease resistant breeds, 

rotational grazing and culling of 

susceptible animals. The NOSB 

concluded that fenbendazole had clear 

advantages over ivermectin which is the 

only parasiticide currently approved for 

use in organic production. In its 

discussion, the NOSB noted these 

comparative advantages of fenbendazole 

over ivermectin: (1) More targeted 

spectrum of activity; (2) notably benign 

to earthworms, plant life, 

microorganisms and particularly dung 

beetles, all of which are important in 

sustainable systems; (3) very few reports 

of anthelmintic resistance even in 

conventional livestock production; and, 

(4) very low toxicity.5

For the purpose of clarity, the 

Secretary is proposing that the shared 

elements of the annotation for 

ivermectin and proposed annotation for 

fenbendazole be placed as a separate 

paragraph at § 205.603(a)(18). The 

contents of that paragraph, which 

restate the requirements provided in 

§§ 205.238(b) and (c)(4)–(5), would 

apply to each parasiticide listed beneath 

including ivermectin and the new 

listings for fenbendazole and 

moxidectin as proposed below. The 

repetition of these requirements in 

§ 205.603 of the National List ensures 

that the provisions which appear in 

another section of the regulations will 

not be overlooked. 

The NOP engaged in consultations 

with the EPA and FDA. Concerning the 

use of fenbendazole, the EPA deferred to 

FDA as the appropriate regulatory body. 

The FDA informed the NOP that the 

proposed amendment to exempt 

fenbendazole for use in organic 

livestock is consistent with FDA 

regulations. The requirement that 

fenbendazole may only be used upon 

written diagnosis of clinical infestation 

by a veterinarian exceeds FDA 

requirements and is only applicable to 

the use of fenbendazole in organic 

livestock production.6

Therefore, after consultation with the 

EPA and FDA regarding the NOSB 

recommendation, the Secretary is 

proposing to accept the NOSB’s 

recommendation and amend 

§ 205.603(a) of the National List by 

removing ivermectin from (18) and 

placing ivermectin in new section (ii) 

and adding fenbendazole at new section 

(i) as follows: (a)(18) Parasiticides. 

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. 

(i) Fenbendazole (CAS #43210–67– 

9)—only for use by or on the lawful 

written order of a licensed veterinarian. 

(ii) Ivermectin (CAS #70288–86–7). 

Moxidectin was petitioned in March 

2003, for use as a topical medical 

treatment for controlling internal and 

external parasites in organic cattle 

production.7 It is a white to pale yellow 

powder that is slightly soluble in water 

and is readily soluble in various organic 

solvents. Moxidectin belongs to the 

milbemycin group of macrolides. It is 

chemically synthesized from 

nemadectin, a fermentation product of 

Streptomyces cyaneogriseus subsp. 

Noncyanogenus. Moxidectin functions 

as an endectocide (a drug effective 

against both internal and external 

parasites) and activates glutamate-gated 

chloride channels and GABA-gated 

chloride channels, causing paralysis of 

certain arthropods and nematodes. 

Moxidectin is effective against a wide 

range of adult and larval internal and 

external parasites including 

gastrointestinal roundworms, 

lungworms, cattle grubs, mites, lice and 

horn flies. 

Moxidectin and its active metabolites 

are primarily introduced into the 

environment through excretion of feces. 

In addition, a minute amount of 

topically applied moxidectin may wash 

off treated cattle when rainfall follows 

treatment.8 Moxidectin is a lipophilic 

material that breaks down under 

sunlight and binds tightly to the soil, 

which mitigates the potential for 

contamination of water sources and 

effects on aquatic organisms. Under 

aerobic conditions, the half-life of 

moxidectin in the environment was 

found to be about two months. In water, 

moxidectin breaks down fairly rapidly 

through photodegradation, and has a 

half-life of 6.8 hours. Various studies on 

the effect of moxidectin and its 

metabolites upon non-target soil 

organisms have been equivocal. Some 

studies have shown adverse effects 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
Federal Register / Vol. 76, No. 87 / Thursday, May 5, 2011 / Proposed Rules 25615 

9Retrieved from FDA’s Animal and Veterinary 

area via NADA number for 141–099 CYDECTIN®

0.5% Pour-On for Cattle (Moxidectin): http:// 

www.fda.gov/AnimalVeterinary/ 

DevelopmentApprovalProcess/ 

EnvironmentalAssessments/ucm072419.htm. 

10Technical Advisory Panel review on 

Moxidectin. April 2003. Retrieved from National 

Organic Program Petitioned Substances Database: 

http://www.ams.usda/nop; Transcripts from the 

NOSB May 28–30, 2004 meeting can be retrieved 

from the NOSB section of the NOP webpage. 11The public comments to proposed rule, TM– 

03–04, can be retrieved from the NOP Web site in 

the public comments area: http:// 

www.ams.usda.gov/AMSv1.0/NOPPublicComments. 12The table does not include the FDA mandated 

limitations and restrictions on use. That 

information can be found in the referenced section 

of the CFR. This table only includes livestock 

applicable to organic production and does not 

include dogs for which certain injectable and oral 

forms of moxidectin are approved or horses and 

ponies not intended for food for which the 

moxidectin oral gel form is approved. 

upon non-target organisms, while others 

showed moxidectin to be comparatively 

less harmful to arthropods than other 

parasiticides, notably ivermectin, and to 

have no adverse impact on earthworms, 

dung fauna, plant germination or leaves 

of growing plants. 

The FDA considered the 

environmental effects of the pour-on 

form of moxidectin for cattle and in 

1997, issued a finding of no significant 

impact (FONSI) declaring that use of the 

drug would not have a significant effect 

on the human environment. The FONSI 

noted that based upon its similarities to 

avermectins, moxidectin is not expected 

to have a significant effect on dungdependent insects as toxicity is 

mitigated by temporal and spatial 

distribution.9 The TAP review prepared 

for the NOSB stated that some parasites 

which are resistant to ivermectin have 

been effectively reduced by moxidectin 

treatment.10

At its May 28–30, 2004, meeting in 

Chicago, IL, the NOSB recommended 

adding moxidectin to the National List, 

with the annotation that it be used only 

for internal control of parasites. In this 

open meeting, the NOSB evaluated 

moxidectin against the criteria of 7 

U.S.C. 6517 and 6518 of the OFPA, 

received public comment, and 

concluded that the use of the substance 

in organic livestock production is 

consistent with the OFPA evaluation 

criteria. 

In a proposed rule published in the 

Federal Register on July 17, 2006, (71 

FR 40624), the USDA indicated that 

moxidectin would not be added to the 

National List as recommended by the 

NOSB because moxidectin is classified 

as a macrolide antibiotic. Moxidectin is 

a derivative of the antibiotic 

nemadectin, which is produced during 

the fermentation of Streptomyces 

cyaneogriseus sp. noncyanogenus. This 

decision was based upon the rationale 

that, although moxidectin was approved 

by FDA for use as a parasiticide in 

conventional livestock production, the 

substance is classified as an antibiotic 

due to its origin as a derivative of the 

antibiotic nemadectin, and, therefore, its 

use in organic livestock would be 

inconsistent with the prohibition of 

antibiotics at § 205.238(c)(1). 

In response to the July 17, 2006, 

proposed rule (71 FR 40624), a number 

of comments were submitted in support 

of the NOSB recommendation that 

moxidectin be included on the National 

List for internal control of parasites.11

The comments characterized USDA’s 

decision not to add moxidectin to the 

list as arbitrary and without scientific or 

regulatory basis. The commenters 

argued that moxidectin is a parasiticide, 

and does not act as an antibiotic when 

used as a medical treatment to eliminate 

parasites from livestock. One comment 

stated that a defining feature of an 

antibiotic is its ability to inhibit the 

growth of microorganisms or kill them 

outright. The commenter further stated 

that moxidectin does not exhibit this 

capacity when used for parasites 

because it eliminates the parasitic 

organisms, rather than bacterial 

infections. 

Based upon the evidence received 

through public comments on the July 

17, 2006, proposed rule, the NOP 

verified the information supplied by 

commenters and, subsequently, 

concurred that moxidectin, though 

categorized as a macrolide antibiotic, 

does not function as such when used as 

a parasiticide. In a final rule (72 FR 

70479) published in the Federal 

Register on December 12, 2007, USDA 

announced that moxidectin would be 

added to the National List through a 

future rulemaking action. 

The FDA has approved oral, injectable 

and topical dosage forms of moxidectin 

for treatment in beef and dairy cattle, 

and sheep. The various approved dosage 

forms of moxidectin are summarized in 

Table 2. 

TABLE 2—FDA APPROVED MOXIDECTIN FORMS AND USES 12

Moxidectin dosage form Oral—solution Injectable—solution Topical 

21 CFR reference 21 CFR 520.1454 21 CFR 522.1450 21 CFR 524.1451 

Animal species for which use is 

approved.

Sheep—excluding female sheep 

providing milk for human consumption.

Beef and non-lactating dairy cattle; no use in veal calves.Beef and dairy cattle; no use in 

veal calves. 

Per the Federal Food, Drug, and 

Cosmetic Act (FFDCA), as amended by 

the Food Quality Protection Act of 1996 

(FQPA), the FDA established tolerances 

for moxidectin in animal products to be 

used as food at 21 CFR 556.426. The 

acceptable daily intake (ADI) and 

residue tolerances are listed for liver, 

milk and meat of cattle and sheep. 

The NOSB recommended the use of 

moxidectin for control of internal 

parasites only. The FDA approved 

indications for use of the topical and 

injectable solutions include internal and 

external parasites, therefore, this 

recommended limitation is only for the 

purposes of organic livestock 

production. Organic producers using 

moxidectin to treat infection would 

need to demonstrate that any use of 

moxidectin is for control of internal 

parasites only. Such information should 

be available as part of their animal 

health records. 

In considering the NOSB 

deliberations on moxidectin and the 

TAP review, the NOP identified an 

inconsistency between the TAP review’s 

data on persistence of moxidectin in the 

environment and the data reported as 

part of the recommendation from the 

NOSB Livestock Committee. The TAP 

review stated that moxidectin has a halflife of two months in aerobic soil 

conditions, but the NOSB Livestock 

Committee inadvertently recorded the 

half-life of moxidectin as six months in 

the soil on the committee 

recommendation submitted to the 

NOSB. Based upon the six month halflife, the Livestock Committee proposed 

an annotation restricting use of 

moxidectin to control for internal 

parasites as an effort to minimize the 

environmental impact of its use. While 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
25616 Federal Register / Vol. 76, No. 87 / Thursday, May 5, 2011 / Proposed Rules 

13Technical Advisory Report on Moxidectin. 

April 2003. Retrieved from National Organic 

Program Petitioned Substances Database: http:// 

www.ams.usda/nop; Transcripts from the NOSB 

May 28–30, 2004, meeting can be retrieved from the 

NOSB section of the NOP webpage. 

14The FDA regulations, at 21 CFR 522.1450, 

require that cattle not be slaughtered within 21 days 

of treatment with the injectable form of moxidectin 

solution. 

the discrepancy between the TAP 

review and the Livestock Committee 

recommendation was discussed at their 

May 28–30, 2004, meeting, the NOSB 

opted to recommended moxidectin with 

an annotation to limit its use for the 

treatment of internal parasites.13

The NOP regulations permit the use of 

synthetic parasiticides in breeder stock, 

excluding the last third of gestation and 

during lactation for progeny that will be 

sold, labeled or represented as organic, 

§ 205.238(b)(1). The NOP regulations, at 

§ 205.2, define breeder stock as ‘‘female 

livestock whose offspring may be 

incorporated into an organic operation 

at the time of their birth.’’ In effect, this 

proposed action would allow the use of 

the applicable form of moxidectin 

among breeder stock for beef and dairy 

cattle, and sheep, provided it is not 

administered during the last third of 

gestation and during lactation for 

progeny that will be sold as organic. In 

accordance with the portions of the 

NOP regulations which pertain to the 

use of any approved parasiticide, 

§§ 205.238(b) and (c)(4)–(5), moxidectin 

must not be administered on a routine 

basis and must not be administered to 

slaughter stock. Per § 205.238(b), 

moxidectin may only be administered to 

dairy stock, a minimum of 90 days prior 

to the production of milk or milk 

products that are to be labeled as 

organic when preventive practices and 

veterinary biologics have failed. 

The NOP engaged in consultations 

with the FDA and EPA concerning the 

approved use of the substance. The EPA 

deferred to FDA as the appropriate 

regulatory body. Based upon 

consultations with the FDA, the NOP 

was informed that moxidectin is 

approved for use by the FDA for 

treatment and control of internal and 

external parasites in beef and dairy 

cattle (21 CFR 524.1452). Further, the 

FDA regulations do not require a 

withdrawal time following the 

application of topical moxidectin to 

nonorganic beef and dairy cattle.14

Therefore, the limitation on the use of 

moxidectin for control of internal 

parasites only, and the 90-day 

withdrawal period for organic milk/milk 

products following treatment with 

moxidectin are only applicable to the 

use of moxidectin among livestock 

under organic management. 

After consulting with EPA and FDA 

and assessing public comments on the 

proposed rule (71 FR 40624), the 

Secretary proposes to accept NOSB’s 

recommendation to amend 

§ 205.603(a)(18) of the National List by 

adding newly designated section (iii), 

under the existing restrictions at 

§ 205.603(a)(18) as follows: (iii) 

Moxidectin (CAS #113507–06–5)—for 

control of internal parasites only. 

Because of the discrepancy between the 

TAP review and the NOSB 

recommendation on the issue of 

persistence of the substance in the 

environment, the AMS invites specific 

comments on the need for the proposed 

annotation to limit the use of the 

moxidectin as an internal parasiticide 

only. 

III. Related Documents 

Two notices were published regarding 

the meetings of the NOSB and 

deliberations on recommendations and 

substances petitioned for amending the 

National List. Substances and 

recommendations included in this 

proposed rule were announced for 

NOSB deliberation in the following 

Federal Register notices: (1) 73 FR 

18491, April 4, 2008 (Fenbendazole); 

(2) 69 FR 18036, April 6, 2004 

(Moxidectin). 

In a July 17, 2006, proposed rule (71 

FR 40624), the USDA announced its 

decision that moxidectin would not be 

proposed for inclusion on the National 

List, because of its macrolide antibiotic 

classification, which was inconsistent 

with NOP policy prohibiting the use of 

antibiotics in organic livestock 

production. On December 12, 2007, in a 

final rule (72 FR 70479), the USDA 

responded to comments from the 

proposed rule (71 FR 40624) and 

affirmed that the NOSB recommended 

use of moxidectin is as a parasiticide, 

not as an antibiotic. 

IV. Statutory and Regulatory Authority 

The OFPA, as amended [7 U.S.C. 6501 

et seq.], authorizes the Secretary to 

make amendments to the National List 

based on proposed amendments 

developed by the NOSB. Sections 6518 

(k) and 6518 (n) of the OFPA authorize 

the NOSB to develop proposed 

amendments to the National List for 

submission to the Secretary and 

establish a petition process by which 

persons may petition the NOSB for the 

purpose of having substances evaluated 

for inclusion on or deletion from the 

National List. The National List petition 

process is implemented under § 205.607 

of the NOP regulations. The current 

petition process (72 FR 2167, January 

18, 2007) can be accessed through the 

NOP Web site at http:// 

www.ams.usda.gov/AMSv1.0/nop. 

A. Executive Order 12866. 

This action has been determined not 

significant for purposes of Executive 

Order 12866, and therefore, has not 

been reviewed by the Office of 

Management and Budget. 

B. Executive Order 12988. 

Executive Order 12988 instructs each 

executive agency to adhere to certain 

requirements in the development of new 

and revised regulations in order to avoid 

unduly burdening the court system. 

This proposed rule is not intended to 

have a retroactive effect. 

States and local jurisdictions are 

preempted under the OFPA from 

creating programs of accreditation for 

private persons or State officials who 

want to become certifying agents of 

organic farms or handling operations. A 

governing State official would have to 

apply to USDA to be accredited as a 

certifying agent, as described in 

§ 2115(b) of the OFPA (7 U.S.C. 

6514(b)). States are also preempted 

under §§ 2104 through 2108 of the 

OFPA (7 U.S.C. 6503 through 6507) 

from creating certification programs to 

certify organic farms or handling 

operations unless the State programs 

have been submitted to, and approved 

by, the Secretary as meeting the 

requirements of the OFPA. 

Pursuant to § 2108(b)(2) of the OFPA 

(7 U.S.C. 6507(b)(2)), a State organic 

certification program may contain 

additional requirements for the 

production and handling of organically 

produced agricultural products that are 

produced in the State and for the 

certification of organic farm and 

handling operations located within the 

State under certain circumstances. Such 

additional requirements must: (a) 

Further the purposes of the OFPA, (b) 

not be inconsistent with the OFPA, (c) 

not be discriminatory toward 

agricultural commodities organically 

produced in other States, and (d) not be 

effective until approved by the 

Secretary. 

Pursuant to § 2120(f) of the OFPA (7 

U.S.C. 6519(f)), this proposed rule 

would not alter the authority of the 

Secretary under the Federal Meat 

Inspection Act (21 U.S.C. 601 et seq.), 

the Poultry Products Inspections Act (21 

U.S.C. 451 et seq.), or the Egg Products 

Inspection Act (21 U.S.C. 1031 et seq.), 

concerning meat, poultry, and egg 

products, nor any of the authorities of 

the Secretary of Health and Human 

Services under the Federal Food, Drug 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
Federal Register / Vol. 76, No. 87 / Thursday, May 5, 2011 / Proposed Rules 25617 

15U.S. Department of Agriculture, Economic 

Research Service, 2009. Data Sets: U.S. Certified 

Organic Farmland Acreage, Livestock Numbers and 

Farm Operations, 1992–2008. http:// 

www.ers.usda.gov/Data/Organic/. 

16 Dimitri, C., and L. Oberholtzer. 2009. Marketing 

U.S. Organic Foods: Recent Trends from Farms to 

Consumers, Economic Information Bulletin No. 58, 

U.S. Department of Agriculture, Economic Research 

Service, http://www.ers.usda.gov/Publications/ 

EIB58. 

17Organic Trade Association’s 2010 Organic 

Industry Survey, http://www.ota.com. 

and Cosmetic Act (21 U.S.C. 301 et 

seq.), nor the authority of the 

Administrator of the EPA under the 

Federal Insecticide, Fungicide and 

Rodenticide Act (7 U.S.C. 136 et seq.). 

Section 2121 of the OFPA (7 U.S.C. 

6520) provides for the Secretary to 

establish an expedited administrative 

appeals procedure under which persons 

may appeal an action of the Secretary, 

the applicable governing State official, 

or a certifying agent under this title that 

adversely affects such person or is 

inconsistent with the organic 

certification program established under 

this title. The OFPA also provides that 

the U.S. District Court for the district in 

which a person is located has 

jurisdiction to review the Secretary’s 

decision. 

C. Regulatory Flexibility Act. 

The Regulatory Flexibility Act (RFA) 

(5 U.S.C. 601 et seq.) requires agencies 

to consider the economic impact of each 

rule on small entities and evaluate 

alternatives that would accomplish the 

objectives of the rule without unduly 

burdening small entities or erecting 

barriers that would restrict their ability 

to compete in the market. The purpose 

is to fit regulatory actions to the scale of 

businesses subject to the action. Section 

605 of the RFA allows an agency to 

certify a rule, in lieu of preparing an 

analysis, if the rulemaking is not 

expected to have a significant economic 

impact on a substantial number of small 

entities. 

Pursuant to the requirements set forth 

in the RFA, the AMS performed an 

economic impact analysis on small 

entities in the final rule published in the 

Federal Register on December 21, 2000 

(65 FR 80548). The AMS has also 

considered the economic impact of this 

action on small entities. The impact on 

entities affected by this proposed rule 

would not be significant. The effect of 

this proposed rule would be to allow the 

use of additional substances in 

agricultural production and handling. 

This action would relax the regulations 

published in the final rule and would 

provide small entities with more tools to 

use in day-to-day operations. The AMS 

concludes that the economic impact of 

this addition of allowed substances, if 

any, would be minimal and beneficial to 

small agricultural service firms. 

Accordingly, USDA certifies that this 

rule will not have a significant 

economic impact on a substantial 

number of small entities. 

Small agricultural service firms, 

which include producers, handlers, and 

accredited certifying agents, have been 

defined by the Small Business 

Administration (SBA) (13 CFR 121.201) 

as those having annual receipts of less 

than $7,000,000 and small agricultural 

producers are defined as those having 

annual receipts of less than $750,000. 

Based on USDA data from the 

Economic Research Service (ERS), the 

U.S. organic sector included nearly 

13,000 certified organic crop and 

livestock operations at the end of 2008. 

These operations contained more than 

4.8 million certified acres consisting of 

2,665,382 acres of cropland and 

2,160,577 acres of pasture and 

rangeland. The total acreage under 

organic management represents a twelve 

percent increase from 2007.15 AMS 

believes that most of the certified 

production and handling operations 

would be classified as small entities 

under the criteria established by the 

SBA. 

The U.S. sales of organic food and 

beverages have grown from $3.6 billion 

in 1997 to nearly $21.1 billion in 

2008.16 Between 1990 and 2008, organic 

food sales have historically 

demonstrated a growth rate between 15 

to 24 percent each year. In 2009, organic 

food sales grew 5.1 percent.17

In addition, USDA has accredited 94 

certifying agents who provide 

certification services to producers and 

handlers. A complete list of names and 

addresses of accredited certifying agents 

may be found on the AMS NOP Web 

site, at http://www.ams.usda.gov/nop. 

AMS believes that most of these 

accredited certifying agents would be 

considered small entities under the 

criteria established by the SBA. 

D. Paperwork Reduction Act. 

No additional collection or 

recordkeeping requirements are 

imposed on the public by this proposed 

rule. Accordingly, OMB clearance is not 

required by section 350(h) of the 

Paperwork Reduction Act of 1995, 44 

U.S.C. 3501 et seq., or OMB’s 

implementing regulation at 5 CFR part 

1320. 

The AMS is committed to complying 

with the E-Government Act to promote 

the use of the Internet and other 

information technologies to provide 

increased opportunities for citizen 

access to Government information and 

services, and for other purposes. 

E. General Notice of Public Rulemaking. 

This proposed rule reflects 

recommendations submitted by the 

NOSB to the Secretary to list two 

parasiticides on the National List. A 60- 

day period for interested persons to 

comment on this rule is provided and is 

deemed appropriate. 

List of Subjects in 7 CFR Part 205 

Administrative practice and 

procedure, Agriculture, Animals, 

Archives and records, Imports, Labeling, 

Organically produced products, Plants, 

Reporting and recordkeeping 

requirements, Seals and insignia, Soil 

conservation. 

For the reasons set forth in the 

preamble, 7 CFR part 205, Subpart G is 

proposed to be amended as follows: 

PART 205—NATIONAL ORGANIC 

PROGRAM 

1. The authority citation for 7 CFR 

part 205 continues to read as follows: 

Authority: 7 U.S.C. 6501–6522. 

2. In § 205.603, paragraph (a)(18) is 

revised to read as follows: 

§ 205.603 Synthetic substances allowed 

for use in organic livestock production. 

* * * * * 

(a) * * * 

(18) Parasiticides. 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. 

(i) Fenbendazole (CAS #43210–67– 

9)—only for use by or on the lawful 

written order of a licensed veterinarian. 

(ii) Ivermectin (CAS #70288–86–7). 

(iii) Moxidectin (CAS #113507–06– 

5)—for control of internal parasites 

only. 

* * * * * 

Dated: April 29, 2011. 

David R. Shipman, 

Associate Administrator, Agricultural 

Marketing Service. 

[FR Doc. 2011–11045 Filed 5–4–11; 8:45 am] 

BILLING CODE 3410–02–P 


emcdonald on DSK2BSOYB1PROD with PROPOSALS