[Federal Register Volume 77, Number 94 (Tuesday, May 15, 2012)]
[Rules and Regulations]
[Pages 28472-28476]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-11722]


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DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 205

[Document Number AMS-NOP-10-0078; NOP-09-03FR]
RIN 0581-AD05


National Organic Program; Amendments to the National List of 
Allowed and Prohibited Substances (Livestock)

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Final rule.

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SUMMARY: This final rule amends the U.S. Department of Agriculture's 
(USDA's) National List of Allowed and Prohibited Substances (National 
List) to enact two recommendations submitted to the Secretary of 
Agriculture (Secretary) by the National Organic Standards Board (NOSB) 
on June 20, 2008, and May 30, 2004. This final rule establishes 
exemptions (uses) for two substances, fenbendazole and moxidectin, 
along with any restrictive annotations, as parasiticides in organic 
livestock production.

DATES: Effective Date: This rule becomes effective May 16, 2012.

FOR FURTHER INFORMATION CONTACT: Melissa Bailey, Ph.D., Director, 
Standards Division, National Organic Program, (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 sections 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. 6501-6522), (OFPA), and NOP regulations, in section 
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 multiple 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 69569); December 12, 
2007 (72 FR 70479); September 18, 2008 (73 FR 54057); October 9, 2008 
(73 FR 59479); July 6, 2010 (75 FR 38693); August 24, 2010 (75 FR 
51919); December 13, 2010 (75 FR 77521); March 14, 2011 (76 FR 13501); 
August 3, 2011 (76 FR 46595); and February 14, 2012 (77 FR 8089). 
Additionally, proposed amendments to the National List were published 
on November 8, 2011 (76 FR 69141); January 12, 2012 (77 FR 1980; 77 FR 
1996); and February 6, 2012 (77 FR 5717).
    This final rule amends the National List to enact two 
recommendations submitted to the Secretary by the NOSB on June 20, 
2008, and May 30, 2004.

[[Page 28473]]

II. Overview of Amendments

    The following provides an overview of the amendments made to 
designated sections of the National List regulations:

Section 205.603 Synthetic Substances Allowed for Use in Organic 
Livestock Production

    This final rule amends Sec.  205.603(a) of the National List 
regulations by revising paragraph (a)(18) to move ivermectin to a new 
section (ii), adding fenbendazole at new section (i), and adding 
moxidectin at new section (iii) 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).
    (iii) Moxidectin (CAS 113507-06-5)--for control of 
internal parasites 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 
final 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 proposed rule published on July 17, 2006 (71 FR 40624), 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. In a final rule 
published on December 12, 2007 (72 FR 70479), USDA responded to 
comments from the proposed rule and affirmed that the NOSB recommended 
use of moxidectin is as a parasiticide, not as an antibiotic.
    The proposal to allow the emergency use of the two substances in 
this final rule was published as a proposed rule on May 5, 2011 (76 FR 
25612).

IV. Statutory and Regulatory Authority

    The OFPA, as amended (7 U.S.C. 6501-6522), 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 section 
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.

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 final 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 the OFPA 
(7 U.S.C. 6514(b)). States are also preempted under 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 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 the OFPA (7 U.S.C. 6519(f)), this final rule would not 
alter the authority of the Secretary under the Federal Meat Inspection 
Act (21 U.S.C. 601-624), the Poultry Products Inspection Act (21 U.S.C. 
451-471), or the Egg Products Inspection Act (21 U.S.C. 1031-1056), 
concerning meat, poultry, and egg products, nor any of the authorities 
of the Secretary of Health and Human Services under the Federal Food, 
Drug and Cosmetic Act (21 U.S.C. 301-399), nor the authority of the 
Administrator of the EPA under the Federal Insecticide, Fungicide and 
Rodenticide Act (7 U.S.C. 136-136(y)).
    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. 601-612) 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, 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). AMS has 
also considered the economic impact of this action on small entities. 
The impact on entities affected by this final rule would not be 
significant. The effect of this final rule is to allow the use of 
additional substances in agricultural production and handling. This 
action would modify the regulations published in the final rule to 
provide small entities with more tools to use in day-to-day operations.

[[Page 28474]]

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, AMS 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.
    According to USDA Economic Research Service (ERS) data based upon 
information from USDA-accredited certifying agents, the number of 
certified U.S. organic crop and livestock operations totaled nearly 
13,000 and certified organic acreage exceeded 4.8 million acres in 
2008.\1\ ERS, based upon the list of certified operations maintained by 
the National Organic Program, estimated the number of certified 
handling operations was 3,225 in 2007.\2\ AMS believes that most of the 
certified production operations would be classified as small entities 
under the criteria established by the SBA.
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    \1\ 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/.
    \2\ U.S. Department of Agriculture, Economic Research Service, 
2009. Data Sets: Procurement and Contracting by Organic Handlers, 
http://www.ers.usda.gov/Data/OrganicHandlers.
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    The U.S. sales of organic food and beverages grew from $3.6 billion 
in 1997 to nearly $21.1 billion in 2008. Between 1990 and 2008, organic 
food sales demonstrated a growth rate between 15 to 24 percent each 
year. In 2010, organic food sales grew 7.7 percent.\3\ Sales of organic 
dairy products, including milk, yogurt and cheese totaled approximately 
$3.6 billion in 2010.\4\
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    \3\ Organic Trade Association's 2010 Organic Industry Survey, 
http://www.ota.com.
    \4\ Ibid.
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    In addition, USDA has accredited 93 certifying agents who provide 
certification services to producers and handlers under the NOP. 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 final rule. Accordingly, OMB clearance is not 
required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3501, 
chapter 35).

E. Executive Order 13175

    This final rule has been reviewed in accordance with the 
requirements of Executive Order 13175, Consultation and Coordination 
with Indian Tribal Governments. The review reveals that this regulation 
will not have substantial and direct effects on Tribal governments and 
will not have significant Tribal implications.

F. Comments Received on Proposed Rule NOP-09-03

    AMS received 15 comments on the proposed rule AMS-NOP-10-0078; NOP-
09-03. Comments were received from large animal veterinarians, organic 
dairy producers and handlers, a livestock parasitologist, agricultural 
consultants, a trade association, an accredited certifying agent, a 
nonorganic beef operation, and a private citizen. Some of the comments 
supported the additions of fenbendazole and moxidectin to the National 
List as proposed. Many comments stated that fenbendazole and moxidectin 
were preferable to ivermectin, which is the only parasiticide currently 
approved for internal use in organic dairy or breeder livestock. 
Several comments supporting the use of fenbendazole and moxidectin 
asserted that under the access to pasture requirements for organic 
ruminants, which were fully implemented in June 2010, these livestock 
face an increased risk of parasite infestations which warrants greater 
access to synthetic parasiticides. Some comments emphasized that the 
restrictive annotations as proposed would ensure that use of 
fenbendazole and moxidectin would be used infrequently as a last resort 
emergency treatment when preventive practices and veterinary biologics 
are not effective. Two comments which opposed the use of both 
fenbendazole and moxidectin either disputed their necessity in organic 
livestock production or broadly opposed the use of animal drugs in 
organic production.
    A number of comments expressed support for fenbendazole by 
comparing that substance to the parasiticide ivermectin, with respect 
to ecological impacts, effectiveness and parasite resistance. Some 
comments characterized fenbendazole as more benign towards earthworms 
and dung beetles than ivermectin. Commenters described ivermectin as 
harmful to aquatic and soil plants, micro-organisms, earthworms, and 
dung beetles. Several comments indicated that ivermectin has limited 
effectiveness. One comment specifically noted that this parasiticide 
does not cover all life stages of all gastro-intestinal parasites. 
Another comment remarked that the development of resistance to 
ivermectin can be attributed to the frequency of treatment in organic 
production due to the lack of other approved treatments for internal 
parasites. Finally, one comment noted that there are no ivermectin 
products labeled for use in female cattle of breeding age, while 
fenbendazole is not subject to such restriction. Support for the use of 
moxidectin was also framed in comparison to ivermectin. Several 
comments stated that moxidectin is less toxic to important soil 
organisms and a more effective treatment for long-term control of 
certain fecal parasitic eggs.
    The Food and Drug Administration (FDA) regulations permit the use 
of topical and injectable solutions of moxidetin for both internal and 
external parasites, however, only the topical form is permitted in 
dairy cattle. In the proposed rule, AMS specifically requested comments 
on the moxidectin annotation which limits use for internal parasites 
only. One comment stated that moxidectin could be useful to treat 
external parasiticides, but the availability of fenbendazole would make 
moxidectin unnecessary for internal parasites. Some comments, however, 
suggested that a producer's ability to alternate parasiticides would 
help prevent resistance. As comments did not substantively object to 
the proposed use of moxidectin, the listing of moxidectin for internal 
parasites only has not been altered. As of this final rule, three 
parasiticides will be permitted for internal parasites in organic 
livestock production: ivermectin, fenbendazole, and moxidectin.
Changes Requested But Not Made
    Reduce the Length of the Milk Withdrawal Period. A number of 
comments which supported the use of fenbendazole objected to the 
proposed 90-day milk withholding period following treatment with 
fenbendazole. They indicated that the use of fenbendazole would not be 
feasible in organic production if milk cannot be marketed as organic 
for 90 days following treatment. The alternatives suggested by 
commenters were a 30-day withholding period or no withholding period. 
The commenters proposed that

[[Page 28475]]

a 30-day withholding period would be a disincentive to routine use, but 
would not be excessively punitive. Other commenters argued for no 
withholding period to be consistent with FDA approved fenbendazole 
labels for use in dairy cattle.
    Several commenters who supported the use of fenbendazole cited 
economic factors for opposing the 90-day withholding period for milk. 
They explained that recent amendments to the NOP regulations at section 
205.239, which requires pasturing of ruminants during the grazing 
season, will increase livestock exposure to parasites.\5\ The comments 
also explained that cows are at the greatest risk of parasite infection 
during the first 100 days of lactation which can decrease milk 
production, and consequently, financial returns. Other commenters 
argued that the risk of parasite infestation is greatest during the 
first year of any animal's life, when the animal is not sufficiently 
mature to have developed the immune responses that protect mature 
animals from parasites. One of these comments explained that lactating 
mature animals do not normally need parasiticides due to fully 
developed immune mechanisms, and that administration of parasiticides 
in early lactation could be used to increase milk production.
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    \5\ Commenters were referencing amendments codified through the 
NOP Access to Pasture final rule. This rule was published in the 
Federal Register on February 17, 2010 (75 FR 7154).
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    A number of comments cited research to assert that fenbandazole is 
rapidly metabolized and does not leave residues in milk. The studies 
cited indicated that fenbendazole degrades quickly after 48 hours and 
residues were undetectable after 72 hours to six days.
    Under the existing NOP regulations at Sec.  205.238(b), a 90-day 
milk withholding period is required after use of any synthetic 
parasiticide treatment approved for organic dairy animals. This has 
been a requirement since the NOP regulations were established in 2000. 
Despite objections at that time, which asserted that the provision 
ignored animal welfare and farm economics, the 90-day withholding 
period was retained in the NOP final rule. The preamble to the NOP 
final rule explained that the 90-day timeframe was based on a NOSB 
recommendation and the NOSB has the authority to reconsider this 
requirement (65 FR 80573).
    The NOSB has the authority to recommend a change to the 90-day milk 
withholding period. The OFPA restricts the Secretary from adding an 
exemption for the use of a synthetic substance unless this has been 
proposed by the NOSB. A reduction in the withholding period would relax 
the use restrictions on a synthetic substance and would, therefore, 
require NOSB consideration. Any NOSB recommendation to change a 
withholding period for parasiticides would need to address section 
205.238(b) in the Livestock Health Care practice standards as well as 
the listing for parasiticides at section 205.603(a)(18). AMS 
understands that producers may occasionally need to withhold milk from 
the organic market when fenbendazole is administered to lactating dairy 
animals that are suffering from parasite infestation. However, the 
routine use of parasiticides is prohibited under the NOP regulations 
and therefore AMS does not expect that use of fenbendazole will be 
widespread or frequent. Furthermore, rotating pastures and maintaining 
suitable stocking rates are preventative practices that can interrupt 
the host-parasite cycle and reduce susceptibility of livestock to 
infection.
    Requirement for the Written Order from a Veterinarian for 
Fenbendazole. A comment speculated that the requirement to obtain a 
written veterinarian's order to administer fenbendazole may encourage 
the use of ivermectin and moxidectin because these do not require a 
veterinarian's written order in organic production. FDA requires the 
order of a licensed veterinarian only for the administration of 10 mg. 
fenbendazole suspension to beef cattle, per 21 CFR Section 
520.905(2)(iii). FDA regulations do not stipulate that requirement for 
other fenbendazole dosage forms. The annotation requiring a 
veterinarian's written order for any administration of fenbendazole was 
recommended by NOSB to prevent non-emergency use and is only applicable 
to the use of the fenbendazole in organic production. AMS concurs with 
the NOSB's intent that organic producers have limitations on access to 
a synthetic parasiticide to discourage routine or indiscriminate use.
    Removing the Prohibition of Parasiticide Use in Slaughter Stock. 
Several comments urged that parasiticides on the National List be 
permitted for use in both dairy and beef animals during the first year 
of life when an animal's immune system is more susceptible to 
parasites. The existing NOP regulations at section 205.238(c)(5) 
prohibit the administration of synthetic parasiticides to slaughter 
stock. A comment characterized the prohibition on parasites in meat 
producing animals (i.e. slaughter stock) as irrational since both meat 
and dairy animals can suffer from parasite infections. In addition, one 
comment noted that several years may pass from parasiticide treatment 
until slaughter.
    Expanding the use of parasiticides to organic slaughter stock is 
broader than the scope of proposed actions considered in this 
rulemaking. Lifting the prohibition on the use of parasiticides in 
slaughter stock would merit full consideration by the NOSB since such a 
change would establish new uses for synthetic substances in organic 
livestock production.

G. Effective Date

    This final rule reflects recommendations submitted to the Secretary 
by the NOSB. The substances being added to the National List were based 
upon petitions from the industry and were evaluated by the NOSB using 
criteria in the Act and the regulations. One of these recommendations 
was first made by the NOSB in 2004, and the substance was discussed in 
two subsequent Federal Register publications (71 FR 40624 and 72 FR 
70479) prior to the recent proposed rule (76 FR 25612). Because these 
substances have been subject to such extensive discussion and comment 
and these parasiticides are considered vital as an emergency treatment 
in organic livestock production, AMS believes that livestock producers 
should be able to use them on their operations as soon as possible. 
Accordingly, AMS finds that good cause exists under 5 U.S.C. 553(d)(3) 
for not postponing the effective date of this rule until 30 days after 
publication in the Federal Register.

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 amended as follows:

PART 205--NATIONAL ORGANIC PROGRAM

0
1. The authority citation for 7 CFR part 205 continues to read as 
follows:

    Authority: 7 U.S.C. 6501-6522.


0
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.

* * * * *

[[Page 28476]]

    (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: May 10, 2012.
David R. Shipman,
Administrator, Agricultural Marketing Service.
[FR Doc. 2012-11722 Filed 5-14-12; 8:45 am]
BILLING CODE 3410-02-P