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[Federal Register Volume 76, Number 87 (Thursday, May 5, 2011)]
[Proposed Rules]
[Pages 25612-25617]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-11045]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

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.

========================================================================


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

[[Page 25612]]

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.

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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 Sec. Sec.  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 Sec.  
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 Sec.  
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

[[Page 25613]]

designated sections of the National List regulations:

Section 205.603 Synthetic Substances Allowed for Use in Organic 
Livestock Production

    This proposed rule would amend Sec.  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.
---------------------------------------------------------------------------

    \1\ The petition was submitted by Intervet Inc., and is 
retrievable from the NOP Web site in the Petitioned Substances 
Database, http://www.ams.usda.gov/NOPPetitionedSubstancesDatabase SubstancesDatabase.
---------------------------------------------------------------------------

    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\
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    \2\ Hoechst-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.
    \3\ Technical 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/NOPPetitionedSubstancesDatabase.
---------------------------------------------------------------------------

    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\
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    \4\ This 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.

                                             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      * Cattle--including     * Cattle..............  * Swine..............  * Cattle--excluding    * Turkeys.
 approved.                            dairy cattle of                                                        dairy cattle of       * Swine.
                                      breeding age.                                                          breeding age.         * Dairy and beef
                                     * Beef cattle.........                                                                         cattle--not for use
                                     * Non-lactating goats.                                                                         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 Sec.  205.238(b)(1) permit the use of 
synthetic parasiticides if included on Sec.  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 Sec.  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

[[Page 25614]]

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 Sec.  205.603. These 
common components reiterate the restrictions on the use of 
parasiticides in general, as set forth in Sec. Sec.  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 
Sec.  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\
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    \5\ NOSB 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.
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    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 Sec.  
205.603(a)(18). The contents of that paragraph, which restate the 
requirements provided in Sec. Sec.  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 Sec.  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\
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    \6\ The 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).
---------------------------------------------------------------------------

    Therefore, after consultation with the EPA and FDA regarding the 
NOSB recommendation, the Secretary is proposing to accept the NOSB's 
recommendation and amend Sec.  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.
---------------------------------------------------------------------------

    \7\ The 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.
---------------------------------------------------------------------------

    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

[[Page 25615]]

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.
---------------------------------------------------------------------------

    \8\ According 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.
---------------------------------------------------------------------------

    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 dung-dependent 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\
---------------------------------------------------------------------------

    \9\ Retrieved from FDA's Animal and Veterinary area via NADA 
number for 141-099 CYDECTIN[supreg] 0.5% Pour-On for Cattle 
(Moxidectin): http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/EnvironmentalAssessments/ucm072419.htm.
    \10\ Technical 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.
---------------------------------------------------------------------------

    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 Sec.  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.
---------------------------------------------------------------------------

    \11\ The 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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \12\ The 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.

                              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      Sheep--excluding        Beef and non-lactating       Beef and dairy cattle;
 approved.                            female sheep            dairy cattle; no use in      no use in veal
                                      providing milk for      veal calves.                 calves.
                                      human consumption.
----------------------------------------------------------------------------------------------------------------

    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 half-life 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 half-life, 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

[[Page 25616]]

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\
---------------------------------------------------------------------------

    \13\ Technical 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.
---------------------------------------------------------------------------

    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, Sec.  205.238(b)(1). The NOP regulations, at Sec.  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, Sec. Sec.  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 Sec.  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.
---------------------------------------------------------------------------

    \14\ The 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.
---------------------------------------------------------------------------

    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 Sec.  205.603(a)(18) of the National 
List by adding newly designated section (iii), under the existing 
restrictions at Sec.  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 Sec.  
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 Sec.  
2115(b) of the OFPA (7 U.S.C. 6514(b)). States are also preempted under 
Sec. Sec.  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 Sec.  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 Sec.  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

[[Page 25617]]

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.
---------------------------------------------------------------------------

    \15\ U.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/.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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.
    \17\ Organic Trade Association's 2010 Organic Industry Survey, 
http://www.ota.com.
---------------------------------------------------------------------------

    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 Sec.  205.603, paragraph (a)(18) is revised to read as 
follows:

Sec.  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
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