[Federal Register Volume 72, Number 238 (Wednesday, December 12, 2007)]
[Rules and Regulations]
[Pages 70479-70486]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-23915]



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  Federal Register / Vol. 72, No. 238 / Wednesday, December 12, 2007 / 
Rules and Regulations  

[[Page 70479]]



DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 205

[Docket Number AMS-TM-07-0123; TM-03-04]
RIN 0581-AC62


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

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This final rule amends the U.S. Department of Agriculture's 
(USDA) National List of Allowed and Prohibited Substances (National 
List) regulations to enact recommendations submitted to the Secretary 
of Agriculture (Secretary) by the National Organic Standards Board 
(NOSB) from October 30, 2000, through March 3, 2005. Consistent with 
the recommendations from the NOSB, this final rule adds two defined 
terms and nine substances, along with any restrictive annotations, and 
a category of substances to the National List.

DATES: Effective Dates: This final rule becomes effective December 13, 
2007.

FOR FURTHER INFORMATION CONTACT: Robert Pooler, Agricultural Marketing 
Specialist, National Organic Program, USDA/AMS/TM/NOP, Room 4008-So., 
Ag Stop 0268, 1400 Independence Ave., SW., Washington, DC 20250. Phone: 
(202) 720-3252.

SUPPLEMENTARY INFORMATION:

I. Background

    On December 21, 2000, the Secretary established, within the 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 (OFPA), as amended, (7 U.S.C. 6501 et seq.), and 
NOP regulations, in Sec.  205.105, specifically prohibit the use of any 
synthetic substance for organic production and handling unless the 
synthetic substance is on the National List. Section 205.105 also 
requires that any nonorganic agricultural, nonsynthetic nonagricultural 
substance used in organic handling must also be on the National List.
    Under the authority of the OFPA, the National List can be amended 
by the Secretary based on substance recommendations developed by the 
NOSB. This final rule amends the National List to enact recommendations 
submitted to the Secretary by the NOSB from November 15, 2000, through 
March 3, 2005.

II. Overview of Amendments

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

Section 205.2 Terms Defined

    This final rule amends Sec.  205.2 of the NOP regulations by adding 
the following terms:
    AMDUCA. The Animal Medicinal Drug Use Clarification Act of 1994 
(Pub. L. 103-396).
    Excipients. Any ingredients that are intentionally added to 
livestock medications but do not exert therapeutic or diagnostic 
effects at the intended dosage, although they may act to improve 
product delivery (e.g., enhancing absorption or controlling release of 
the drug substance). Examples of such ingredients include fillers, 
extenders, diluents, wetting agents, solvents, emulsifiers, 
preservatives, flavors, absorption enhancers, sustained-release 
matrices, and coloring agents.

Section 205.603 Synthetic Substances Allowed for Use in Organic 
Livestock Production

    This final rule amends paragraph (a) of Sec.  205.603 of the 
National List regulations by adding the following substances:
    Atropine (CAS -51-55-8)--federal law restricts this drug 
to use by or on the lawful written or oral order of a licensed 
veterinarian, in full compliance with the AMDUCA and 21 CFR part 530 of 
the Food and Drug Administration regulations. Also, for use under 7 CFR 
part 205, the NOP requires: (1) Use by or on the lawful written order 
of a licensed veterinarian, in full compliance with the AMDUCA; and (2) 
a meat withdrawal period of at least 56 days after administering to 
livestock intended for slaughter; and a milk discard period of at least 
12 days after administering to dairy animals.
    Butorphanol (CAS -42408-82-2)--federal law restricts this 
drug to use by or on the lawful written or oral order of a licensed 
veterinarian, in full compliance with the AMDUCA and 21 CFR part 530 of 
the Food and Drug Administration regulations. Also, for use under 7 CFR 
part 205, the NOP requires: (1) Use by or on the lawful written order 
of a licensed veterinarian, in full compliance with the AMDUCA; and (2) 
a meat withdrawal period of at least 42 days after administering to 
livestock intended for slaughter; and a milk discard period of at least 
8 days after administering to dairy animals.
    Flunixin (CAS -38677-85-9)--in accordance with approved 
labeling; except that for use under 7 CFR part 205, the NOP requires a 
withdrawal period of at least two-times that required by the FDA.
    Furosemide (CAS -54-31-9)--in accordance with approved 
labeling; except that for use under 7 CFR part 205, the NOP requires a 
withdrawal period of at least two-times that required by the FDA.
    Magnesium hydroxide (CAS -1309-42-8)--federal law 
restricts this drug to use by or on the lawful written or oral order of 
a licensed veterinarian, in full compliance with the AMDUCA and 21 CFR 
part 530 of the Food and Drug Administration regulations. Also, for use 
under 7 CFR part 205, the NOP requires use by or on the lawful written 
order of a licensed veterinarian, in full compliance with the AMDUCA.
    Peroxyacetic/Peracetic acid (CAS -79-21-0)--for sanitizing 
facility and processing equipment.
    Poloxalene (CAS -9003-11-6)--for use under 7 CFR part 205, 
the NOP requires that poloxalene only be used for the emergency 
treatment of bloat.

[[Page 70480]]

    Tolazoline (CAS -59-98-3)--federal law restricts this drug 
to use by or on the lawful written or oral order of a licensed 
veterinarian, in full compliance with the AMDUCA and 21 CFR part 530 of 
the Food and Drug Administration regulations. Also, for use under 7 CFR 
part 205, the NOP requires: (1) Use by or on the lawful written order 
of a licensed veterinarian, in full compliance with the AMDUCA; (2) use 
only to reverse the effects of sedation and analgesia caused by 
Xylazine; and (3) a meat withdrawal period of at least 8 days after 
administering to livestock intended for slaughter; and a milk discard 
period of at least 4 days after administering to dairy animals.
    Xylazine (CAS -7361-61-7)--federal law restricts this drug 
to use by or on the lawful written or oral order of a licensed 
veterinarian, in full compliance with the AMDUCA and 21 CFR part 530 of 
the Food and Drug Administration regulations. Also, for use under 7 CFR 
part 205, the NOP requires: (1) Use by or on the lawful written order 
of a licensed veterinarian, in full compliance with the AMDUCA; (2) the 
existence of an emergency; and (3) a meat withdrawal period of at least 
8 days after administering to livestock intended for slaughter; and a 
milk discard period of at least 4 days after administering to dairy 
animals.
    This final rule amends Sec.  205.603 of the National List 
regulations by adding a new paragraph (f) to read as follows:
    Excipients, only for use in the manufacture of drugs used to treat 
organic livestock when the excipient is: Identified by the FDA as 
Generally Recognized As Safe; Approved by the FDA as a food additive; 
or Included in the FDA review and approval of a New Animal Drug 
Application or New Drug Application.
    This final rule also makes a technical correction to Sec.  205.603 
paragraph (e) by removing the word ``a'' from between ``or'' and 
``synthetic''.

III. Related Documents

    Six notices were published regarding the meetings of the NOSB and 
its 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) 65 FR 64657, October 30, 2000, (Calcium 
borogluconate); (2) 66 FR 10873, February 20, 2001, (Poloxalene); (3) 
67 FR 54784, August 26, 2002, (Activated charcoal, Bismuth 
subsalicylate, Butorphanol, Epinephrine, Kaolin pectin, Magnesium 
hydroxide, Potassium sorbate, Propylene glycol, Tolazoline, and 
Xylazine); (4) 67 FR 62949, October 9, 2002, (Excipients and Flunixin); 
(5) 68 FR 23277, May 1, 2003, (Atropine, Calcium propionate, 
Furosemide, and Mineral oil); and (6) 69 FR 18036, April 6, 2004, 
(Moxidectin). The proposed rule for this final rule was published on 
July 17, 2006 (71 FR 40624).

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 substance 
recommendations developed by the NOSB. Sections 6518(k)(2) and 6518(n) 
of OFPA authorize the NOSB to develop substance recommendations 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) can be accessed through the NOP Web site at http://www.ams.usda.gov/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 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 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 
final 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 and Cosmetic Act (21 U.S.C. 
301 et seq.), nor the authority of the Administrator of the 
Environmental Protection Agency (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.

[[Page 70481]]

    Pursuant to the requirements set forth in the RFA, the Agricultural 
Marketing Service (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 final rule would not be significant. The 
effect of this final rule would be to allow the use of additional 
substances in agricultural production and handling. This action would 
modify the regulations to 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 
entirely 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 $6,500,000 and small agricultural 
producers are defined as those having annual receipts of less than 
$750,000. This final rule would have an impact on a substantial number 
of small entities.
    The U.S. organic industry at the end of 2001 included nearly 6,949 
certified organic crop and livestock operations. Data on the numbers of 
certified organic handling operations (any operation that transforms 
raw product into processed products using organic ingredients) were not 
available at the time of survey in 2001; but they were estimated to be 
in the thousands. By the end of 2006, the number of certified organic 
crop, livestock, and handling operations totaled over 14,800 operations 
based on reports by certifying agents to the NOP as part of their 
annual reporting requirements. AMS believes that most of these entities 
would be considered small entities under the criteria established by 
SBA.
    U.S. sales of organic food and beverages have grown from $1 billion 
in 1990 to nearly $17 billion in 2006. Organic food sales are projected 
to reach $23.8 billion for 2010. The organic industry is viewed as the 
fastest growing sector of agriculture, currently representing nearly 3 
percent of overall food and beverage sales. Since 1990, organic retail 
sales have historically demonstrated a growth rate between 20 to 24 
percent each year including a 22 percent increase in 2006.
    In addition, 95 certifying agents are currently accredited by USDA 
to 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 NOP web site, at http://www.ams.usda.gov/nop. AMS believes that most of these entities would be considered small 
entities under the criteria established by the SBA.

D. Paperwork Reduction Act

    Under the OFPA, no additional collection or recordkeeping 
requirements are imposed on the public by this final 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.
    AMS is committed to compliance with the Government Paperwork 
Elimination Act (GPEA), which requires Government agencies in general 
to provide the public the option of submitting information or 
transacting business electronically to the maximum extent possible.

E. Received Comments on Proposed Rule TM-03-04

    AMS received 79 comments on proposed rule TM-03-04. Comments were 
received from organic livestock producers, veterinarians, accredited 
certifying agents, consumers, retailers, trade associations, 
manufacturers of animal medications, and public interest groups. A 
number of comments expressed total opposition to all amendments 
proposed in TM-03-04 and asserted that such amendments weakened the NOP 
regulations. A few comments supported the addition of all the proposed 
amendments without changes. Many comments indicated conditional support 
for some of the proposed amendments; however, they suggested 
modifications be made to their inclusion on the National List. Such 
comments conveyed that the proposed amendments altered the original 
intent for how the NOSB recommended the substance be used in organic 
livestock production. Some of those comments proposed that if the 
substance was not to be listed as recommended by the NOSB, then the 
proposed amendment should not be added to the National List.
    Additional comments raised concern regarding USDA's decision not to 
include certain substances on the National List. These substances 
include activated charcoal, calcium borogluconate, calcium propionate, 
kaolin pectin, mineral oil, propylene glycol, and epinephrine. Comments 
also indicated that a few of the proposed amendments required further 
clarification or correction to avoid misinterpretation of the 
regulations and misapplication of the substance.
Changes Made Based On Comments
    The following changes are made based upon comments received.
    Calcium propionate as a mold inhibitor in dry formulated herbal 
products. Some comments expressed opposition to the proposed amendment 
to add Calcium propionate as a mold inhibitor in dry herbal products to 
Sec.  205.603(d). At their May 2003 meeting, the NOSB recommended 
adding Calcium propionate as a mold inhibitor in dry formulated herbal 
``remedies.'' Comments on Calcium propionate concluded that the NOSB 
did not recommend Calcium propionate to be added onto the National List 
as a livestock feed additive under Sec.  205.603(d); rather, these 
comments argued that the NOSB recommended Calcium propionate be 
included as a ``medical treatment'' and listed under Sec.  205.603(a). 
Comments further suggested that if calcium propionate could not be 
listed under Sec.  205.603(a) that it should not be included on the 
National List because the authorization for the substance could be 
misinterpreted to allow its use for organic livestock feed, which was 
not the intent of the proposal or the NOSB recommendation.
    We agree with these comments that the proposed amendment for 
Calcium propionate did not correspond with the NOSB recommendation. 
Based on the consultation between USDA and FDA, we were informed that 
``dry formulated herbal remedies'' are not recognized as a ``medical 
treatment'' for animal illness and could not be authorized as such in 
the Federal Register and under Sec.  205.603(a) of the National List 
without having been approved by FDA through a New Animal Drug 
Application (NADA).
    As a result, USDA researched the most appropriate way to include 
the substance on the National List to reflect the NOSB's 
recommendation. To that effect, we recognized that Calcium propionate 
did not have any approved uses as a medical treatment under the FDA 
regulations. However, under 21 CFR 582.3221 (Animal Drugs, Feeds, and 
Related Products), it is approved as a chemical preservative that is 
Generally Recognized as Safe. Therefore, since ``dry formulated herbal 
remedies'' are not recognized as medical treatments under the FDA's 
regulations and could not be prescribed as such in the National List, 
the USDA believed that it could implement the recommendation

[[Page 70482]]

and intent of the NOSB by permitting the use of Calcium propionate as a 
mold inhibitor in dry formulated ``products'' (instead of ``remedies'') 
by authorizing it as a feed. We concluded that herbs (agricultural 
products) would be fed to an animal and would therefore be considered 
part of the feed provisions of the National List.
    In addition to the general public comments received on Calcium 
propionate, we received comments from the FDA concerning the proposed 
language to authorize the use of Calcium propionate as a ``mold 
inhibitor.'' The FDA shared that Calcium propionate is not authorized 
for use as a ``mold inhibitor,'' but a ``chemical preservative.'' 
Therefore, it must only be recognized for use within the parameters for 
which it has been authorized. The FDA also commented that the AMDUCA 
does not apply to Calcium propionate and cannot be used to attempt 
broader uses than authorized by the FDA.
    As a result, based on comments received on Calcium propionate's 
proposed addition to Sec.  205.603(d) of the National List and 
information shared by the FDA, we have decided not to add Calcium 
propionate to the National List. Instead, we are referring this 
substance back to the NOSB for the purpose of reconsidering its 
placement on the National List (i.e. Sec.  205.603(d)), as it relates 
to the regulatory provisions of the FDA).
    Incorrect CAS number for Butorphanol. One commenter observed that 
the proposed rule included an incorrect CAS number for Butorphanol. The 
proposed rule listed Butorphanol's CAS number as 14887-18-9. This 
comment indicated that the proper CAS number is 42408-82-2. NOP 
research confirmed the CAS number provided within the comment is 
accurate. Therefore, we agree with this comment and have inserted the 
proper CAS number into the final rule.
    Extended Withdrawal Periods. Many commenters disagreed with USDA's 
decision to omit the NOSB's recommendations to extend the withdrawal 
periods for a number of proposed livestock medications (e.g. Atropine, 
Butorphanol, Flunixin, Furosemide, Tolazoline, and Xylazine). 
Commenters argued that the NOP has the authority to require stricter 
standards for animal drug use than those specified by the FDA. 
According to the commenters, all drugs permitted for use in organic 
farming are subject to stricter standards than those used by nonorganic 
farmers, because they are subject to certifiers' review and approval in 
an Organic System Plan (OSP). Commenters also noted that there are 
currently several livestock medications (Ivermectin, Lidocaine, and 
Procaine) on the National List whose withdrawal periods already extend 
beyond that required by FDA.
    Commenters expressed that USDA should either accept the NOSB's 
recommendation to extend the withdrawal period of the proposed 
livestock medications or not amend the National List at all. Without 
the extended withdrawal period, according to these commenters, the 
NOSB's recommendations would be weakened and the synthetic substances 
would be allowed to be used in ways that the NOSB did not intend.
    As a proposed compromise to satisfy the intent of the NOSB, many 
commenters suggested that USDA should consider amending the annotations 
of Atropine, Butorphanol, Flunixin, Furosemide, Tolazoline, and 
Xylazine by establishing extended withdrawal periods, calculated using 
withdrawal times from the Food Animal Residue Avoidance Databank 
(FARAD). The FARAD is a National Food Safety Project administered 
through the USDA Cooperative State Research, Education, and Extension 
Service. It is a system designed to provide livestock producers, 
extension specialists, and veterinarians with practical information on 
how to avoid drug, pesticide and environmental contaminant residue 
problems. FARAD is a repository of comprehensive residue avoidance 
information. It is also sanctioned to provide ``withholding period'' 
(also known as withdrawal period) estimates to the U.S. Pharmacopeia-
Drug Information (USP-DI) Veterinary Medicine Advisory Committee. 
Commenters suggested that USDA account for an extra margin of at least 
double the withdrawal times of FARAD to safely capture the intent of 
the NOSB.
    USDA agrees with the position stated in the comments. Since many of 
the aforementioned livestock medications are being authorized for use 
under AMDUCA and do not have formal FDA approved labels for the use 
recommended by the NOSB, veterinarians who are authorized to administer 
the medical treatment to organic livestock would be responsible for 
establishing a substantially extended withdrawal period prior to the 
marketing of milk, meat, eggs, or other edible products. The FDA 
requires that these withdrawal periods be supported by appropriate 
scientific information, if applicable. The FDA also requires that the 
veterinarian take appropriate measures to assure the assigned 
timeframes for withdrawal are met and that no illegal drug residues 
occur in any food-producing animal subjected to extra-label treatment 
(21 CFR 530.20(a)(2)(ii); (iv)). Therefore, in an effort to ensure 
uniformity and consistency regarding the application of withdrawal 
periods, USDA has amended the annotations of Atropine, Butorphanol, 
Tolazine, and Xylazine to reflect minimum withdrawal periods that are 
double the FARAD withdrawal period suggested for the administration of 
the referenced livestock medication.
    With respect to the withdrawal periods for Flunixin and Furosemide, 
however, these drugs do have FDA approved labels for the use 
recommended by the NOSB and were not proposed for use in organic 
livestock production under AMDUCA but rather existing FDA approved 
animal drug use and labeling, 21 CFR part 520. As a result, the 
withdrawal period associated with the use of these substances under the 
NOP would be based upon the withdrawal period established by the FDA, 
as opposed to a FARAD withdrawal period.
    Based on public comment, USDA consulted further with the FDA, 
concerning the ability to extend the withdrawal period on these 
approved drugs. Based on our consultations, USDA agreed to clarify the 
rationale for extending the FDA established withdrawal period. 
Secondly, USDA agreed to clarify the language used to authorize the use 
of the substances by indicating the extended withdrawal periods (at 
least two-times that required by the FDA) were only relevant for use of 
the substances under the NOP regulations.
    Therefore, to clarify our rationale for extending the withdrawal 
periods established by the FDA, we acknowledge that this determination 
was not based on scientific research or risk assessments. The decision 
to extend the FDA withdrawal periods (or any other withdrawal period) 
for the use of Flunixin and Furosemide (and other substances) was based 
on consumer preference and the recommendations of the NOSB. FDA 
exercises full responsibility for determining and enforcing the 
withdrawal intervals for animal drugs. No food safety arguments are 
used or implied to support the use of extended withdrawal periods 
authorized under the NOP regulations. Rather, we determined that 
extended withdrawal periods are more compatible with consumer 
expectations of organically raised animals.
    Verification of lawful order of a licensed veterinarian. Federal 
law restricts Atropine, Butorphanol, Magnesium hydroxide, Tolazine, and

[[Page 70483]]

Xylazine to use by or on the lawful written or oral order of a licensed 
veterinarian, in full compliance with the AMDUCA and 21 CFR part 530 of 
the Food and Drug Administration regulations. For use under 7 CFR part 
205, the NOP is requiring use by or on the lawful written order of a 
licensed veterinarian. Further, under the NOP, a written order is 
necessary for the livestock producer to prove compliance with paragraph 
(b) of Sec.  205.238 Livestock health care practice standard. Written 
orders will also facilitate compliance with the recordkeeping 
provisions of Sec.  205.103.
    Other use restrictions for Tolazine and Xylazine. In addition to 
the use restrictions noted above, in response to comments, the NOP has 
added the following use restrictions. For Tolazine, the NOP has added 
the requirement that Tolazine only be used to reverse the effects of 
sedation and analgesia caused by Xylazine as originally recommended by 
the NOSB at its September 17-19, 2002, meeting in Washington, DC. For 
Xylazine, the NOP has added the requirement for the existence of an 
emergency as originally recommended by the NOSB at its September 17-19, 
2002, meeting in Washington, DC.
    Excipients. Commenters suggested that the proposed amendment to 
include excipients onto the National List was too broad or needed 
further clarification to reduce possible confusion for producers, 
certifying agents, and consumers. Commenters asserted that the proposed 
language could lead readers to believe that excipients are permitted 
for use in livestock feed or feed supplements.
    We do not agree that the proposed language is so misleading to 
readers. However, we do believe that a definition of excipients would 
help clarify its meaning. Therefore, we have amended the regulations to 
include the following definition for excipients: ``any ingredients 
intentionally added to livestock medications but that do not exert 
therapeutic or diagnostic effects at the intended dosage, although they 
may act to improve product delivery (e.g., enhancing absorption or 
controlling release of the drug substance). Examples include fillers, 
extenders, diluents, wetting agents, solvents, emulsifiers, 
preservatives, flavors, absorption enhancers, sustained-release 
matrices, and coloring agents.''
    Poloxalene annotation. A number of comments objected to USDA 
omitting the NOSB's recommendation to authorize the use of Poloxalene 
with the annotation ``only be used for emergency treatment of bloat.'' 
With regard to Poloxalene and the proposed language in TM-03-04, 
commenters expressed concern that the proposed language would allow 
routine use of Poloxalene. As a result, commenters believed the 
proposed language for Poloxalene represents the use of a substance that 
was not approved by the NOSB.
    We agree that the proposed language in TM-03-04, authorizing the 
use of Poloxalene, did not restrict its use for only the ``emergency 
treatment of bloat,'' as the NOSB had recommended. Based on our initial 
consultations with the FDA, we originally proposed the use of the 
substance as follows ``in accordance with approved labeling.'' However, 
after reviewing the comments and further consultation with the FDA, we 
have modified the authorizing language to (1) reflect the intent of the 
NOSB and (2) clarify the language used to authorize the use of the 
substance by indicating that the restricted use of Poloxalene (only for 
the emergency treatment of bloat) is only relevant for use of the 
substance under the NOP.
    Exclusion of Moxidectin. A number of commenters requested that USDA 
include Moxidectin on the National List, as the NOSB had recommended 
(to control internal parasites). We did not propose to add Moxidectin 
to the National List because the substance is a macrolide antibiotic 
and does not comply with the April 22, 2005, NOP policy statement on 
antibiotic use in livestock production. The statement provides that the 
use of antibiotics and other prohibited substances is not allowed for 
organically produced livestock or their edible products once a producer 
is certified organic. Commenters stated that USDA's rationale for not 
adding Moxidectin to the National List was arbitrary and without 
scientific or regulatory basis. Commenters argued that Moxidectin 
should not be considered an antibiotic, but a parasiticide, and 
therefore should be allowed for use as medication to treat organic 
livestock. One commenter presented information that attempted to 
delineate the difference between an antibiotic and a parasiticide. The 
comment argued that the defining feature of an antibiotic is its 
ability to inhibit the growth of microorganisms or kill them outright. 
It included that Moxidectin does not have this capacity. Instead, 
Moxidectin targets parasites, rather than bacterial infections.
    We have verified the information shared through public comment and 
agree that Moxidectin, even though an animal drug that is a macrolide 
antibiotic, does not function as an antibiotic (targeting bacterial 
infections), but as a parasiticide (targeting parasites/helminthes, 
e.g., roundworms, lungworms, hookworms, flatworms, etc.). As a result, 
we will initiate proposed rulemaking to authorize Moxidectin as a 
livestock medication to control internal parasites.
    Removal of Bismuth subsalicylate (CAS #-14887-18-9). Bismuth 
subsalicylate was proposed for inclusion on the National List. It was 
proposed for use as a drug restricted to use by or on the lawful 
written or oral order of a licensed veterinarian, in full compliance 
with the AMDUCA and 21 CFR part 530 of the FDA regulations. In the 
proposed rule, the NOP shared that consultations with the FDA revealed 
that Bismuth subsalicylate is approved as a drug for use in humans 
(FDA, ``Approved Drug Products with Therapeutic Equivalence 
Evaluations, 2005'') and that New Animal Drug Application (NADA) 
approvals for Bismuth subsalicylate were not identified. The NOP 
further stated that despite the absence of a NADA approval for Bismuth 
subsalicylate, the substance could be permitted for use in livestock 
production if used in full compliance with the AMDUCA and 21 CFR part 
530 of the FDA regulations, ``Provision permitting extra-label use of 
animal drugs.'' This action was based on the rationale that Bismuth 
subsalicylate was an approved human drug and qualified for use under 
the provisions of AMDUCA.
    However, in response to the proposed rule, the FDA informed the NOP 
that Bismuth subsalicylate could not be authorized for use in livestock 
production under the AMDUCA and 21 CFR part 530 of the FDA regulations, 
because Bismuth subsalicylate is not approved as an independent, active 
ingredient for use as a human drug, but only in combination with 
Metronidazole and Tetracycline hydrochloride. The FDA further commented 
that over-the-counter medications do not qualify for use under the 
provisions of AMDUCA and 21 CFR part 530. As a result, they advised the 
NOP to remove Bismuth subsalicylate from the proposed amendments to the 
National List; Bismuth subsalicylate has been removed from inclusion.
Other Changes Made
    Several of the new substance listings contain the term ``AMDUCA.'' 
For the convenience of persons using the NOP regulations we have added 
a definition of AMDUCA to Sec.  205.2. That definition reads: ``AMDUCA. 
The Animal Medicinal Drug Use Clarification Act of 1994 (Pub. L. 103-
396).''
    While preparing this final rule, we noted a technical error in the 
wording of Sec.  205.603(e). Accordingly, this final

[[Page 70484]]

rule also makes a technical correction to Sec.  205.603 paragraph (e) 
by removing the word ``a'' from between ``or'' and ``synthetic''. 
Section 205.603(e) now reads: ``As synthetic inert ingredients as 
classified by the Environmental Protection Agency (EPA), for use with 
nonsynthetic substances or synthetic substances listed in this section 
and used as an active pesticide ingredient in accordance with any 
limitations on the use of such substances.''
Changes Requested But Not Made
    A number of commenters opposed the addition of any of the proposed 
amendments to the National List. The majority of these comments did not 
provide any evidence under the OFPA and NOP regulations that would 
support the position stated. Instead, these commenters stated the 
addition of any of the proposed amendments weakened the NOP regulations 
and compromised the integrity of organic foods. We considered these 
comments but have determined that the record supports the need for 
livestock medications in the interest of humane treatment of livestock. 
We believe commenters' concerns have been addressed by including double 
withdrawal periods and other use restrictions.
    Six non-accepted substances. Several comments, including a number 
from organic dairy farmers, supported adding Activated charcoal, 
Calcium borogluconate, Calcium propionate (as a medical treatment for 
milk fever), Kaolin pectin, Mineral oil, and Propylene glycol onto 
Sec.  205.603(a) as substances that should be allowed for use as 
medical treatments in organic livestock production. These substances 
were not included as amendments to the National List in the proposed 
rule. The NOSB recommended that the Secretary include these substances 
onto the National List, in Sec.  205.603, as veterinary treatments in 
organic livestock production. Comments in support of including these 
substances onto the National List argued that these substances were 
essential tools for dairy farmers, effective in restoring animal 
health, and widely available and commonly used by livestock producers 
and veterinarians, with no significant environmental impacts. 
Additionally, a few of these commenters argued that FDA considers these 
drugs to be a low regulatory priority or ``allowed by regulatory 
discretion.''
    As stated in the proposed rule, consultation with the FDA revealed 
that Activated charcoal, Calcium borogluconate, Calcium propionate, 
Kaolin pectin, Mineral oil, and Propylene glycol have not received 
approval through the FDA drug approval process to be authorized as 
medical treatments for livestock. Consultation also revealed that the 
proposed substances could not qualify for extra-label use by a licensed 
veterinarian under AMDUCA. As a result, the synthetic forms of these 
substances remain prohibited for use in organic livestock production.
    One commenter asserted that USDA should have not stated that the 
six substances could not be used in organic livestock production, 
because some of the substances could be sourced and used in 
nonsynthetic form. USDA agrees that nonsynthetic forms of the 
medication would not be prohibited from use in organic livestock 
production. The proposed rule did not address the nonsynthetic forms of 
the medications because the NOSB's recommendations only addressed the 
synthetic forms. As a result, we reiterate that the prohibited use of 
the six substances was made in the context of the synthetic form of the 
substances, not the nonsynthetic form.
    Epinephrine as a prohibited nonsynthetic substance. A few comments 
were received concerning USDA's decision not to include Epinephrine as 
a prohibited nonsynthetic substance on the National List. Some comments 
were in favor of the proposed action on Epinephrine, while a few did 
not favor USDA's decision to exclude the substance from the National 
List. We also received one comment that recommended USDA, with respect 
to the FDA restriction on the use of Epinephrine, consult with the NOSB 
to see if there is still a need to identify the substance as a 
prohibited nonsynthetic on the National List.
    The proposed rule acknowledged that Epinephrine is a nonsynthetic 
substance; and it emphasized that nonsynthetic substances are allowed 
in organic production, unless prohibited. For instance, under the NOP 
regulations, a livestock producer may not administer animal drugs in 
violation of the Federal Food, Drug and Cosmetic Act. The proposed rule 
also noted that the FDA regulations currently restrict the use of the 
medication to the emergency treatment of anaphylactic shock in cattle, 
horses, sheep, and swine, which is what the NOSB had recommended. As a 
result, we did not see a clear need to include the substance on the 
National List. USDA will consult with the NOSB to see if there is still 
a need to identify Epinephrine as a prohibited nonsynthetic on the 
National List.

F. Effective Date.

    This final rule reflects recommendations submitted to the Secretary 
by the NOSB. The substances being added to the National List were based 
on petitions from the industry and evaluated by the NOSB using criteria 
in the Act and the regulations. Because these substances are crucial to 
organic livestock production operations, producers should be able to 
use them in 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.

0
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. Section 205.2 is amended by adding two new terms in alphabetical 
order to read as follows:


Sec.  205.2  Terms defined.

* * * * *
    AMDUCA. The Animal Medicinal Drug Use Clarification Act of 1994 
(Pub. L. 103-396).
* * * * *
    Excipients. Any ingredients that are intentionally added to 
livestock medications but do not exert therapeutic or diagnostic 
effects at the intended dosage, although they may act to improve 
product delivery (e.g., enhancing absorption or controlling release of 
the drug substance). Examples of such ingredients include fillers, 
extenders, diluents, wetting agents, solvents, emulsifiers, 
preservatives, flavors, absorption enhancers, sustained-release 
matrices, and coloring agents.
* * * * *

0
3. Section 205.603 is revised to read as follows:


Sec.  205.603  Synthetic substances allowed for use in organic 
livestock production.

    In accordance with restrictions specified in this section the 
following

[[Page 70485]]

synthetic substances may be used in organic livestock production:
    (a) As disinfectants, sanitizer, and medical treatments as 
applicable.
    (1) Alcohols.
    (i) Ethanol-disinfectant and sanitizer only, prohibited as a feed 
additive.
    (ii) Isopropanol-disinfectant only.
    (2) Aspirin-approved for health care use to reduce inflammation.
    (3) Atropine (CAS -51-55-8)--federal law restricts this 
drug to use by or on the lawful written or oral order of a licensed 
veterinarian, in full compliance with the AMDUCA and 21 CFR part 530 of 
the Food and Drug Administration regulations. Also, for use under 7 CFR 
Part 205, the NOP requires:
    (i) Use by or on the lawful written order of a licensed 
veterinarian; and
    (ii) A meat withdrawal period of at least 56 days after 
administering to livestock intended for slaughter; and a milk discard 
period of at least 12 days after administering to dairy animals.
    (4) Biologics--Vaccines.
    (5) Butorphanol (CAS -42408-82-2)--federal law restricts 
this drug to use by or on the lawful written or oral order of a 
licensed veterinarian, in full compliance with the AMDUCA and 21 CFR 
part 530 of the Food and Drug Administration regulations. Also, for use 
under 7 CFR Part 205, the NOP requires:
    (i) Use by or on the lawful written order of a licensed 
veterinarian; and
    (ii) A meat withdrawal period of at least 42 days after 
administering to livestock intended for slaughter; and a milk discard 
period of at least 8 days after administering to dairy animals.
    (6) Chlorhexidine--Allowed for surgical procedures conducted by a 
veterinarian. Allowed for use as a teat dip when alternative germicidal 
agents and/or physical barriers have lost their effectiveness.
    (7) Chlorine materials--disinfecting and sanitizing facilities and 
equipment. Residual chlorine levels in the water shall not exceed the 
maximum residual disinfectant limit under the Safe Drinking Water Act.
    (i) Calcium hypochlorite.
    (ii) Chlorine dioxide.
    (iii) Sodium hypochlorite.
    (8) Electrolytes--without antibiotics.
    (9) Flunixin (CAS -38677-85-9)--in accordance with 
approved labeling; except that for use under 7 CFR Part 205, the NOP 
requires a withdrawal period of at least two-times that required by the 
FDA.
    (10) Furosemide (CAS -54-31-9)--in accordance with 
approved labeling; except that for use under 7 CFR Part 205, the NOP 
requires a withdrawal period of at least two-times that required that 
required by the FDA.
    (11) Glucose.
    (12) Glycerine--Allowed as a livestock teat dip, must be produced 
through the hydrolysis of fats or oils.
    (13) Hydrogen peroxide.
    (14) Iodine.
    (15) Magnesium hydroxide (CAS -1309-42-8)--federal law 
restricts this drug to use by or on the lawful written or oral order of 
a licensed veterinarian, in full compliance with the AMDUCA and 21 CFR 
part 530 of the Food and Drug Administration regulations. Also, for use 
under 7 CFR part 205, the NOP requires use by or on the lawful written 
order of a licensed veterinarian.
    (16) Magnesium sulfate.
    (17) Oxytocin--use in postparturition therapeutic applications.
    (18) Paraciticides. Ivermectin--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.
    (19) Peroxyacetic/peracetic acid (CAS -79-21-0)--for 
sanitizing facility and processing equipment.
    (20) Phosphoric acid--allowed as an equipment cleaner, Provided, 
That, no direct contact with organically managed livestock or land 
occurs.
    (21) Poloxalene (CAS -9003-11-6)--for use under 7 CFR Part 
205, the NOP requires that poloxalene only be used for the emergency 
treatment of bloat.
    (22) Tolazoline (CAS -59-98-3)--federal law restricts this 
drug to use by or on the lawful written or oral order of a licensed 
veterinarian, in full compliance with the AMDUCA and 21 CFR part 530 of 
the Food and Drug Administration regulations. Also, for use under 7 CFR 
Part 205, the NOP requires:
    (i) Use by or on the lawful written order of a licensed 
veterinarian;
    (ii) Use only to reverse the effects of sedation and analgesia 
caused by Xylazine; and
    (iii) A meat withdrawal period of at least 8 days after 
administering to livestock intended for slaughter; and a milk discard 
period of at least 4 days after administering to dairy animals.
    (23) Xylazine (CAS -7361-61-7)--federal law restricts this 
drug to use by or on the lawful written or oral order of a licensed 
veterinarian, in full compliance with the AMDUCA and 21 CFR part 530 of 
the Food and Drug Administration regulations. Also, for use under 7 CFR 
Part 205, the NOP requires:
    (i) Use by or on the lawful written order of a licensed 
veterinarian;
    (ii) The existence of an emergency; and
    (iii) A meat withdrawal period of at least 8 days after 
administering to livestock intended for slaughter; and a milk discard 
period of at least 4 days after administering to dairy animals.
    (b) As topical treatment, external parasiticide or local anesthetic 
as applicable.
    (1) Copper sulfate.
    (2) Iodine.
    (3) Lidocaine--as a local anesthetic. Use requires a withdrawal 
period of 90 days after administering to livestock intended for 
slaughter and 7 days after administering to dairy animals.
    (4) Lime, hydrated--as an external pest control, not permitted to 
cauterize physical alterations or deodorize animal wastes.
    (5) Mineral oil--for topical use and as a lubricant.
    (6) Procaine--as a local anesthetic, use requires a withdrawal 
period of 90 days after administering to livestock intended for 
slaughter and 7 days after administering to dairy animals.
    (7) Sucrose octanoate esters (CAS s-42922-74-7; 58064-47-
4)--in accordance with approved labeling.
    (c) As feed supplements--None.
    (d) As feed additives.
    (1) DL-Methionine, DL-Methionine--hydroxy analog, and DL-
Methionine--hydroxy analog calcium (CAS -59-51-8; 63-68-3; 
348-67-4)--for use only in organic poultry production until October 1, 
2008.
    (2) Trace minerals, used for enrichment or fortification when FDA 
approved.
    (3) Vitamins, used for enrichment or fortification when FDA 
approved.
    (e) As synthetic inert ingredients as classified by the 
Environmental Protection Agency (EPA), for use with nonsynthetic 
substances or synthetic substances listed in this section and used as 
an active pesticide ingredient in accordance with any limitations on 
the use of such substances.
    (1) EPA List 4--Inerts of Minimal Concern.
    (2) [Reserved]
    (f) Excipients, only for use in the manufacture of drugs used to 
treat organic livestock when the excipient is: Identified by the FDA as 
Generally Recognized As Safe; Approved by the FDA as a food additive; 
or Included in

[[Page 70486]]

the FDA review and approval of a New Animal Drug Application or New 
Drug Application.
    (g)-(z) [Reserved]

    Dated: December 5, 2007.
Lloyd C. Day,
Administrator, Agricultural Marketing Service.
[FR Doc. E7-23915 Filed 12-11-07; 8:45 am]
BILLING CODE 3410-02-P