[Federal Register Volume 77, Number 234 (Wednesday, December 5, 2012)]
[Proposed Rules]
[Pages 72254-72268]
[FR Doc No: 2012-29322]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 500, 520, 522, 524, 529, 556, and 558

[Docket No. FDA-2012-N-1067]
RIN 0910-AG17

New Animal Drugs; Updating Tolerances for Residues of New Animal
Drugs in Food

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to revise
the animal drug regulations regarding tolerances for residues of
approved and conditionally approved new animal drugs in food by
standardizing, simplifying, and clarifying the determination standards
and codification style. In addition, we are proposing to add
definitions for key terms. The purpose of the revision is to enhance
understanding of tolerance determination and improve the readability of
the regulations.

DATES: Submit either electronic or written comments by March 5, 2013.
See section VI of this document for the proposed effective date of a
final rule based on this proposed rule.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2012-
N-1067 and RIN number 0910-AG17, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov/.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Fax:<PHONE_NUMBER>.
     Mail/Hand Delivery/Courier (for paper or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency
name, Docket

No. FDA-2012-N-1067, and Regulatory Information Number (RIN) 0910-AG17
for this rulemaking. All comments received may be posted without change
to http://www.regulations.gov, including any personal information
provided. For additional information on submitting comments, see the
``Comments'' heading of the SUPPLEMENTARY INFORMATION section of this
document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Dong Yan, Center for Veterinary
Medicine (HFV-151), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Sections 512(b)(1)(H), 512(i), and 571(a)(2)(A) of the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360b(b)(1)(H),
360b(i), and 360ccc(a)(2)(A)) provide the authority for the Secretary
of Health and Human Services (the Secretary) to establish and publish
regulations setting tolerances for residues of approved and
conditionally approved new animal drugs. The Secretary delegated this
authority to the Commissioner of Food and Drugs. FDA's regulations
setting forth the tolerances for residues of new animal drugs in food
are codified in part 556 of Title 21 of the Code of Federal Regulations
(21 CFR part 556) (40 FR 13802 at 13942, March 27, 1975). The part 556
regulations describe general considerations regarding tolerances for
residues of new animal drugs in food in subpart A and specific
tolerances for residues of new animal drugs in subpart B. Subpart B has
been amended frequently as new animal drugs have been approved for use
in food-producing animals. Food from treated animals with new animal
drug residues that exceed established tolerances is adulterated under
section 402(a)(2)(C)(ii) of the FD&C Act (21 U.S.C. 342(a)(2)(C)(ii)).
    FDA's human food safety evaluation of residues of new animal drugs
has evolved over the past 50 years. Before the mid-1970s, FDA based
tolerances primarily on a small number of toxicity studies, typically
90-day feeding studies in laboratory animals. From the results of these
studies, FDA determined the ``no-observed-effect-level'' (NOEL). The
acceptable daily intake (ADI) for total residue of a drug was
calculated by dividing the NOEL by the appropriate safety factor to
adjust for the differences between test animals and humans. To
calculate the safe concentrations, FDA considered food consumption
values and human body weight. Consumption was estimated as a total
dietary exposure of 1,500 grams of food per day. Historically, FDA used
an average human weight of 50 or 60 kilograms. Because these toxicology
studies did not assess lifetime effects (which could only be observed
in long-term feeding studies), FDA applied a 2,000-fold safety factor
to the NOELs. FDA generally set the tolerance for ``negligible''
residues of these drugs at 0.1 part per million (ppm) in muscle and 10
parts per billion in milk, even if the computed tolerance exceeded the
calculated values.
    In later years, FDA assigned what it called ``finite tolerances.''
Finite tolerances were calculated using procedures similar to those
described previously, except, unlike tolerances set for ``negligible''
residues, finite tolerances were set at the calculated level. Finite
tolerances had to be supported, at a minimum, by lifetime feeding
studies in two rodent species, a 6-month or longer study in a non-
rodent mammalian species, and a three-generation reproduction study.
Because finite tolerances were based on more extensive studies, FDA
generally applied a lower (100-fold) safety factor in calculating the
ADI.
    The earliest established tolerances generally referred to the
parent drug. Consequently, residue chemistry studies, including residue
depletion studies that served as the basis for assigning withdrawal
periods for tissues and for milk (milk discard time), and the
analytical methods used to measure residue levels focused on the parent
drug.
    From the mid-1970s to the present, FDA's human food safety
evaluation of animal drug residues has evolved with advancements in
science. As a result, the procedures described in the existing Sec.
556.1 for setting drug tolerances no longer accurately reflect current
regulatory science. In addition, current part 556 employs a patchwork
of various styles for listing tolerances that have evolved over the
past 40 years. As a result, the listings in part 556 are not uniform in
format, and, in some instances, do not provide all relevant information
in a consistent manner. For example, the regulations provide the ADI
and safe concentrations for some, but not all, drugs. In addition, the
regulations list some tolerances as being for ``negligible'' residue,
and others as ``no residue,'' ``zero,'' or ``not required,'' but they
do not explain what these important terms mean. The proposed rule
addresses these inconsistencies by simplifying and standardizing the
determination standards and codification style and by adding
definitions for key terms.

II. Description of Proposed Rule

    FDA proposes to revise part 556 by standardizing and simplifying
the codification style and adding definitions for key terms. First,
proposed Sec.  556.1 provides a revised scope for part 556. Second,
proposed Sec.  556.3 provides definitions of key terms FDA uses in the
regulations. Third, proposed Sec.  556.5 explains the general
considerations for using the tolerance information for veterinary drug
residues. Finally, FDA proposes a uniform format for listing tolerances
in subpart B, by, among other things, removing obsolete or confusing
terms and cross-referencing tolerances to the approved conditions of
use for that new animal drug.

A. Subpart A--General Provisions

1. Scope (Proposed Sec.  556.1)
    FDA proposes to delete existing Sec.  556.1 (``General
considerations; tolerances for residues of new animal drugs in food'')
and replace it with a description of the scope. FDA proposes to discuss
general considerations for setting tolerances in new Sec.  556.5.
    Proposed Sec.  556.1 reiterates the requirement in sections
512(b)(1)(H) and 571(a)(2)(A) of the FD&C Act that applicants seeking
approval or conditional approval of new animal drugs must submit a
proposed tolerance as part of new animal drug applications when
necessary to assure that the proposed use of the new animal drug will
be safe. The proposed section states that FDA assigns tolerances for
animal drugs used in food-producing animals as part of the application
approval process and then codifies them in subpart B of part 556.
Proposed Sec.  556.1 also clarifies that compounds that have been found
to be carcinogenic are regulated under subpart E of part 500 (21 CFR
part 500).
2. Definitions (Proposed Sec.  556.3)
    FDA proposes to define in Sec.  556.3 certain key terms used in
animal drug residue chemistry and some terms frequently used in part
556. In the proposed rule, the definitions appear in alphabetical
order. In this preamble, the definitions are discussed in an order

that facilitates the explanation of the interrelated concepts the terms
represent.
    a. Terms related to determining tolerances. FDA's human food safety
evaluation focuses on residues of new animal drugs in the edible
tissues of the treated animal. FDA proposes to define ``edible
tissues'' as muscle, liver, kidney, fat, skin with fat in natural
proportions, whole eggs, whole milk, and honey. FDA proposes to define
``residue,'' as it is defined in 21 CFR 530.3, to mean any compound
present in edible tissues that results from the use of a drug, and
includes the drug, its metabolites, and any other substance formed in
or on food because of the drug's use. Under the proposed rule, the
``total residue'' includes every residue of a given drug. FDA proposes
to define total residue as the aggregate of all compounds that result
from the use of an animal drug, including the drug, its metabolites,
and any other substances formed in or on food because of such drug use.
    Under the proposal, the definition of a NOEL means the highest dose
level of a drug tested that produces no observable effects. ADI means
the amount of total residue that can safely be consumed per day over a
human's lifetime. The ADI is calculated by dividing the NOEL (from the
most appropriate toxicological study) by a safety factor. The safety
factor reflects, among other things, the extrapolation of long-term
effects from shorter-term exposures, extrapolation of animal data to
humans, and variability in sensitivity among human populations.
Sometimes, the concept of an ``acceptable single-dose intake'' or
``ASDI'' is used to calculate tolerances. FDA is proposing to define
``ASDI'' as the amount of total residue that may safely be consumed in
a single meal. The ASDI may be used to derive the tolerance for
residues of a drug at an injection site where the drug is administered
according to the label.
    Under the proposed rule, a ``tolerance'' means the maximum
concentration of a marker residue or other residue indicated for
monitoring that can legally remain in a specific edible tissue of a
treated animal. A ``marker residue'' means the residue selected for
assay by the regulatory method. In general, the marker residue is a
subset of the total residue; for example, the marker residue could be
the parent drug, a metabolite, or a combination of residues. The
concentration of the marker residue in the target tissue is in a known
relationship to the concentration of the total residue in the target
tissue. The ``regulatory method'' means the aggregate of all
experimental procedures for measuring and confirming the presence of
the marker residue in the target tissue of the target animal. The
``target tissue'' means the edible tissue selected to monitor for
residues in the target animals. When the marker residue or other
residue indicated for monitoring is at or below the tolerance in the
target tissue, the total drug residues in all the edible tissues
(excluding milk and eggs unless otherwise specified) should be at or
below the safe concentration.
    b. Terms used to characterize tolerances. In the past, FDA has used
several terms to characterize tolerances in part 556, including
``zero,'' ``no residue,'' ``not required,'' and ``not needed'' but has
not included clear definitions in part 556 for these important terms.
Because the differences in these terms has not always been evident, FDA
is proposing to amend part 556 by eliminating redundant terminology and
adding definitions for the terms that the Agency intends to continue
using to help ensure that going forward the terms will be uniformly
applied by the Agency and understood by the public.
    First, over the years, many people have mistakenly believed the
term ``zero'' with respect to tolerances to mean there could be no
residue remaining in an edible tissue. However, FDA acknowledges that
some residue will remain in the animal, even if below a detectable
level, and that a complete lack of drug residue is not achievable. In
approving certain animal drugs, FDA assigned a ``zero'' tolerance, with
``zero'' meaning that no residues could be detected using the approved
analytical method to detect residues of that drug. Often, the
analytical method chosen to determine ``zero'' represented the limit of
technology at the time. FDA no longer assigns ``zero'' tolerances for
new approvals, but instead assigns a tolerance for a drug based on a
toxicological and residue chemistry evaluation (see proposed Sec.
556.5). However, FDA is not proposing to remove the previously assigned
``zero'' tolerances from the regulations at this time.
    Second, FDA uses the term ``no residue'' to apply specifically to
compounds of carcinogenic concern. Under section 512(d)(1)(I) of the
FD&C Act, ``no residue'' of any drug that induces cancer when ingested
by man or animal is allowed in any edible tissue of a food-producing
animal, when tested using methods of examination prescribed or approved
by FDA. FDA historically has interpreted the term ``no residue'' to
mean that any residue in the target tissue must be non-detectable or
below the limit of detection of the approved regulatory method (67 FR
78172, December 23, 2002). Consistent with this interpretation, FDA is
proposing to define ``no residue'' to mean that the marker residue is
below the limit of detection using the approved regulatory method. FDA
is proposing to add this definition to Sec.  500.82 under subpart E
entitled ``Regulation of Carcinogenic Compounds Used in Food-Producing
Animals.''
    Third, FDA previously approved some animal drugs with a waiver of
the requirement for a tolerance (i.e., a tolerance was ``not required''
or ``not needed'') because they met two conditions in place at the time
they were evaluated by FDA. The first condition was an assurance that
residues would deplete to or below safe levels by zero-day withdrawal
(i.e., no withdrawal period was needed), or that an adequate withdrawal
period was inherent in the proposed conditions of drug use. The second
condition was a rapid depletion of residues, so there was no concern
about residues resulting from misuse or overdosing. Sometimes the
codified tolerance listings described these situations as ones where a
tolerance was ``not needed''; other times the phrase ``not required''
was used to convey the same meaning. To ensure consistency, FDA
proposes to revise part 556 to delete descriptions of tolerances as
``not needed'' and replace such designations with the term ``not
required.''
    Fourth, in the past, when a drug was approved with a zero
withdrawal period, FDA would not set a tolerance for the particular
drug. Historically, FDA generally recommended that a sponsor of a drug
seeking a zero withdrawal period conduct a total residue depletion
study in which target animals were dosed with 1.5 to 2 times the
recommended maximum dose of drug to simulate overdosing. If a zero
withdrawal period was approved, FDA would not set a tolerance for the
drug.
    Currently, FDA continues to recommend these total residue depletion
studies when sponsors propose zero withdrawal periods, but, when
possible, FDA sets a tolerance for these drugs. Infrequently,
circumstances preclude FDA from setting a tolerance. For example, some
drugs may be poorly absorbed and/or metabolized rapidly to such an
extent as to make selection of an analyte impractical or impossible. In
these uncommon cases, FDA proposes to use the term ``not required''
when describing the tolerance.

    FDA is proposing to define ``not required'' with respect to
tolerances as indicating that at the time of approval, the drug met one
of the following conditions: (1) No withdrawal period (i.e., zero
withdrawal) was necessary for residues of the drug to deplete to or
below the concentrations considered to be safe or an adequate
withdrawal period was inherent in the proposed drug use, and there was
no concern about residues resulting from misuse or overdosing; or (2)
the drug qualified for a zero withdrawal period because it was poorly
absorbed or metabolized rapidly to such an extent as to make selection
of an analyte impractical or impossible.
3. General Considerations (Proposed Sec.  556.5)
    Proposed Sec.  556.5(a) states that tolerances published in subpart
B of part 556 pertain only to the species and production classes of the
animal for which the drug use has been approved or conditionally
approved. The proposed rule provides the approved use and conditionally
approved use conditions, including species and production classes, in
each tolerance listing under ``(c) Related conditions of use.''
Tolerances are not provided for extralabel (e.g., use in species or
production classes in which the drug is not approved for use.)
Extralabel use resulting in any residue above an established safe level
or tolerance is unlawful and renders the drug product adulterated under
section 501(a)(5) of the FD&C Act (21 U.S.C. 351(a)(5)), in that it is
unsafe within the meaning of section 512 of the FD&C Act.
    Proposed Sec.  556.5(b) states that all tolerances refer to the
concentrations of a marker residue, or other residue indicated for
monitoring, permitted in uncooked tissues.
    Proposed Sec.  556.5(c) states that a finding that the
concentration of a marker residue is at or below the tolerance in the
target tissue from a tested animal indicates that all edible tissues
(excluding milk and eggs unless otherwise specified) from that animal
are safe. In the proposed listing format, if a listed tolerance is
linked to a target tissue, the phrase ``target tissue'' will appear in
parentheses immediately after the identified tissue. If a listed
tolerance is not expressly linked to a target tissue, then the
tolerance is meant to apply only to the named edible tissue, and
inferences cannot be made about the safety of the other edible tissues
from the target animal.
    Proposed Sec.  556.5(d) states that FDA requires that a drug
sponsor develop a regulatory method to measure drug residues in edible
tissues of approved target species at concentrations around the
tolerance as provided in Sec.  514.1(b)(7) of this chapter. The
tolerance is directly tied to the approved regulatory method because
FDA determines the tolerance using data collected with that method.

B. Subpart B--Specific Tolerances for Residues of Approved and
Conditionally Approved New Animal Drugs

    FDA proposes a uniform format for the individual drug tolerance
listings in subpart B. FDA would list the ADI and ASDI if they are
available. If the ADI and ASDI are both unavailable, FDA would reserve
paragraph (a) for future use. FDA would list tolerances in paragraph
(b) for each edible tissue for each species, as appropriate. When a
tolerance listing states ``edible tissues,'' it would mean all edible
tissues of that species unless otherwise specified. FDA intends the
revised paragraph (c) to help readers locate approved or conditionally
approved uses of each drug and to identify the form of the drug (e.g.,
free acid or base, salt, hydrate).
    FDA proposes to revise subpart B by deleting tolerances for certain
drugs (or species of animals) whose approvals have been withdrawn, but
the corresponding tolerances were not removed from the part 556
listing; and adding tolerances for approved drugs not previously listed
in this subpart. Specifically, FDA proposes to delete the tolerances
for clopidol for all species other than chickens and turkeys (Sec.
556.160) and nystatin for swine (Sec.  556.470). FDA proposes to add
tolerance listings for: Azaperone, bambermycins, coumaphos,
efrotomycin, fenprostalene (swine), fenthion, flurogestone, and
poloxalene.
    Note that some listings provide more than one tolerance. For
example, tilmicosin in cattle (Sec.  556.735(b)(1)) includes the
following information: A marker residue (tilmicosin), a target tissue
(liver), a tolerance of 1.2 ppm for tilmicosin in liver of cattle, and
a tolerance of 0.1 ppm for tilmicosin in muscle of cattle.
    This means that if the concentration of tilmicosin in the liver of
a treated animal is at or below 1.2 ppm, all the edible tissues
(excluding milk and eggs unless otherwise specified) from the animal
are considered to be safe if ingested daily by humans over a lifetime.
If the concentration of tilmicosin is assayed for only the muscle
tissue and the concentration is at or below 0.1 ppm, the muscle tissue
from the animal is considered to be safe if ingested daily by humans
over a lifetime. Because muscle is not the target tissue, the
tilmicosin concentration in muscle alone does not predict residue
safety for the other edible tissues.

C. Other Proposed Changes to Part 556

    This proposal includes other changes to the current part 556
regulations. First, FDA proposes to delete salt designations from the
tolerance listings in subpart B. For example, maduramicin ammonium,
morantel tartrate, and sulfabromomethazine sodium will be listed as
maduramicin, morantel, and sulfabromomethazine, respectively. FDA
proposes this change for several reasons. The residues derived from
salt formulations and hydrated forms of a given drug are the same. In
addition, the approved regulatory methods ordinarily measure the free
drug, a metabolite, or some combination of residues, not the salts. FDA
also believes such a simplification of tolerance listings will improve
their readability. However, when FDA lists the ADI for a compound, the
specific compound that was administered in the pivotal toxicological
feeding study will be indicated, as toxicological outcome could be
affected by salt formulation.
    Second, FDA proposes to cross-reference drug tolerances in part 556
to the approved or conditionally approved conditions of use listed in
21 CFR parts 516, 520, 522, 524, 526, 529, and 558. These listings
specify the drug, salt, dosage form, and indications for use (amount,
animal species/production class, and limitations) of approved or
conditionally approved animal drug products. In conjunction with adding
these cross-references, FDA proposes to remove references to production
classes from tolerance listings in subpart B. In a few past instances,
FDA codified tolerances specifying the production class (e.g., beef or
dairy cattle) of food-producing species. This was done in an effort to
be consistent with the listed approved conditions of use, but for only
a few animal drugs listed in part 556.
    FDA also proposes to delete safe concentrations from the tolerance
listings in part 556. Although tolerances have been codified using the
total residue, target tissue, and marker residue concepts for about 25
years, the particular types of information codified have varied. For
some drugs, FDA listed only tolerances. For other drugs, FDA listed
safe concentrations as well as tolerances, leading some readers to
misinterpret the safe concentrations as tolerances. Because a tolerance
can be a small fraction of the safe concentration, such a
misunderstanding could lead to referencing an incorrect residue safety
standard for a specific drug. FDA

tentatively concludes that removing safe concentrations from the
codified listings will reduce the potential for this confusion. The
Agency invites comment on this removal.
    Further, FDA proposes to remove the word ``negligible'' from
tolerance citations, because the word is outdated. A tolerance is the
maximum concentration of a new animal drug residue that can legally
remain in an edible tissue of a treated animal and raise no concern for
human food safety. In other words, by definition, a tolerance
essentially represents the negligible level of residue. Therefore, FDA
no longer uses the word ``negligible'' to characterize residues.
    Finally, FDA is proposing to delete the word ``uncooked'' from the
individual listings in subpart B. Because the general considerations
and the proposed definition of tolerance clarifies that all tolerances
refer to the concentrations of the marker residue, or other residues
indicated for monitoring, permitted in uncooked edible tissues,
including the word ``uncooked'' in individual listings is no longer
necessary.
    FDA seeks comment on the proposed changes to part 556. In
particular, the Agency is interested to know if the reorganization and
standardization of content enhances the clarity and utility of part 556
and if the definitions of terms are clear and understandable. FDA does
not, however, seek comment on the numerical drug residue tolerance
values listed in subpart B as these values were determined by FDA in
conjunction with the approval or conditional approval of each new
animal drug application and, as such, are not the subject of public
comment. An exception would be the notation of a technical error where
the numerical value cited in the published document does not conform to
an approved application or application for conditional approval.

III. Environmental Impact

    The Agency has determined under 21 CFR 25.30(i) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IV. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). The Agency believes that this proposed rule is not a
significant regulatory action as defined by the Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because this proposed rule would not impose
compliance costs on the current or future sponsors of any approved and
conditionally approved new animal drugs, the Agency proposes to certify
that the final rule will not have a significant economic impact on a
substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $139 million, using the most current (2011) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
proposed rule to result in any 1-year expenditure that would meet or
exceed this amount.

V. Federalism

    FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. FDA has determined that
the proposed rule, if finalized, would not contain policies that would
have substantial direct effects on the States, on the relationship
between the National Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
Accordingly, the Agency tentatively concludes that the proposed rule
does not contain policies that have federalism implications as defined
in the Executive order and, consequently, a federalism summary impact
statement is not required.

VI. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no new
collections of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 (44
U.S.C. 3501-3520) is not required.

VII. Proposed Effective Date

    FDA is proposing that any final rule that may issue based on this
proposal be effective 60 days after the date of its publication in the
Federal Register.

VIII. Comments

    Interested persons may submit either written comments regarding
this document to the Division of Dockets Management (see ADDRESSES) or
electronic comments to http://www.regulations.gov. It is only necessary
to send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

List of Subjects

21 CFR Part 500

    Animal drugs, Animal feeds, Cancer, Labeling, Packaging and
containers, Polychlorinated biphenyls (PCBs).

21 CFR Parts 520, 522, 524, and 529

    Animal drugs.

21 CFR Part 556

    Animal drugs, Foods.

21 CFR Part 558

    Animal drugs, Animal feeds.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR chapter I, subchapter E, be amended as follows:

PART 500--GENERAL

    1. The authority citation for 21 CFR part 500 continues to read as
follows:

    Authority:  21 U.S.C. 321, 331, 342, 343, 348, 351, 352, 353,
360b, 371, 379e.

    2. Amend Sec.  500.82, in paragraph (b), by alphabetically adding a
definition for ``no residue'' to read as follows:

Sec.  500.82  Definitions.

* * * * *
    (b) * * *
    No residue means the marker residue is below the limit of detection
using the approved regulatory method. The ``no residue'' designation
applies only to compounds of carcinogenic concern.
* * * * *

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

    3. The authority citation for 21 CFR part 520 continues to read as
follows:

    Authority:  21 U.S.C. 360b.

    4. In Sec.  520.1840, revise paragraph (c) to read as follows:

Sec.  520.1840  Poloxalene.

* * * * *
    (c) Related tolerances. See Sec.  556.517 of this chapter.
* * * * *
    5. In Sec.  520.2640, revise paragraph (c) to read as follows:

Sec.  520.2640  Tylosin.

* * * * *
    (c) Related tolerances. See Sec.  556.746 of this chapter.
* * * * *

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

    6. The authority citation for 21 CFR part 522 continues to read as
follows:

    Authority:  21 U.S.C. 360b.

    7. In Sec.  522.770, revise paragraph (c) to read as follows:

Sec.  522.770  Doramectin.

* * * * *
    (c) Related tolerances. See Sec.  556.222 of this chapter.
* * * * *
    8. In Sec.  522.2640, revise paragraph (d) to read as follows:

Sec.  522.2640  Tylosin.

* * * * *
    (d) Related tolerances. See Sec.  556.746 of this chapter.
* * * * *

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

    9. The authority citation for 21 CFR part 524 continues to read as
follows:

    Authority:  21 U.S.C. 360b.

    10. In Sec.  524.920, revise paragraph (c)(4) to read as follows:

Sec.  524.920  Fenthion.

* * * * *
    (c) * * *
    (4) Related tolerances. See Sec.  556.280 of this chapter.
* * * * *

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

    11. The authority citation for 21 CFR part 529 continues to read as
follows:

    Authority:  21 U.S.C. 360b.

    12. In Sec.  529.1003, add paragraph (d) to read as follows:

Sec.  529.1003  Flurogestone acetate-impregnated vaginal sponge.

* * * * *
    (d) Related tolerances. See Sec.  556.290 of this chapter.

PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

    13. The authority citation for 21 CFR part 556 is revised to read
as follows:

    Authority:  21 U.S.C. 342, 360b, 360ccc, 371.

    14. Revise part 556 to read as follows:
Subpart A--General Provisions
Sec.
556.1 Scope.
556.3 Definitions.
556.5 General considerations.
Subpart B--Specific Tolerances for Residues of Approved and
Conditionally Approved New Animal Drugs
Sec.
556.34 Albendazole.
556.36 Altrenogest.
556.38 Amoxicillin.
556.40 Ampicillin.
556.50 Amprolium.
556.52 Apramycin.
556.60 Arsenic.
556.68 Azaperone.
556.70 Bacitracin.
556.75 Bambermycins.
556.100 Carbadox.
556.110 Carbomycin.
556.113 Ceftiofur.
556.115 Cephapirin.
556.120 Chlorhexidine.
556.150 Chlortetracycline.
556.160 Clopidol.
556.163 Clorsulon.
556.165 Cloxacillin.
556.167 Colistimethate.
556.168 Coumaphos.
556.169 Danofloxacin.
556.170 Decoquinate.
556.180 Dichlorvos.
556.185 Diclazuril.
556.200 Dihydrostreptomycin.
556.222 Doramectin.
556.224 Efrotomycin.
556.226 Enrofloxacin.
556.227 Eprinomectin.
556.230 Erythromycin.
556.240 Estradiol and related esters.
556.260 Ethopabate.
556.273 Famphur.
556.275 Fenbendazole.
556.277 Fenprostalene.
556.280 Fenthion.
556.283 Florfenicol.
556.286 Flunixin.
556.290 Flurogestone.
556.292 Gamithromycin.
556.300 Gentamicin.
556.304 Gonadotropin.
556.308 Halofuginone.
556.310 Haloxon.
556.330 Hygromycin B.
556.344 Ivermectin.
556.346 Laidlomycin.
556.347 Lasalocid.
556.350 Levamisole.
556.360 Lincomycin.
556.375 Maduramicin.
556.380 Melengestrol.
556.410 Metoserpate.
556.420 Monensin.
556.425 Morantel.
556.426 Moxidectin.
556.428 Narasin.
556.430 Neomycin.
556.440 Nequinate.
556.445 Nicarbazin.
556.460 Novobiocin.
556.470 Nystatin.
556.480 Oleandomycin.
556.490 Ormetoprim.
556.495 Oxfendazole.
556.500 Oxytetracycline.
556.510 Penicillin.
556.513 Piperazine.
556.515 Pirlimycin.
556.517 Poloxalene.
556.540 Progesterone.
556.560 Pyrantel.
556.570 Ractopamine.
556.580 Robenidine.
556.592 Salinomycin.
556.597 Semduramicin.
556.600 Spectinomycin.
556.610 Streptomycin.
556.620 Sulfabromomethazine.
556.625 Sulfachloropyrazine.
556.630 Sulfachlorpyridazine.
556.640 Sulfadimethoxine.
556.650 Sulfaethoxypyridazine.
556.660 Sulfamerazine.
556.670 Sulfamethazine.
556.685 Sulfaquinoxaline.
556.690 Sulfathiazole.
556.700 Sulfomyxin.
556.710 Testosterone.
556.720 Tetracycline.
556.730 Thiabendazole.
556.733 Tildipirosin.
556.735 Tilmicosin.
556.738 Tiamulin.
556.739 Trenbolone.
556.741 Tripelennamine.
556.745 Tulathromycin.
556.746 Tylosin.
556.748 Tylvalosin.
556.750 Virginiamycin.
556.760 Zeranol.
556.765 Zilpaterol.
556.770 Zoalene.

Subpart A--General Provisions

Sec.  556.1  Scope.

    (a) The Federal Food, Drug, and Cosmetic Act requires an applicant
seeking approval or conditional approval of a new animal drug to submit
a proposed tolerance as part of its new animal drug application when
such a tolerance is needed to assure that the proposed use of the new
animal drug will be safe (see sections 512(b)(1)(H) and 571(a)(2)(A) of
the Federal Food, Drug, and Cosmetic Act). FDA assigns tolerances for
animal drugs used in

food-producing animals as part of the application approval process.
Tolerances for approved and conditionally approved new animal drugs are
codified in subpart B of this part.
    (b) Compounds that have been found to be carcinogenic are regulated
under subpart E of part 500 of this chapter.

Sec.  556.3  Definitions.

    As used in this part:
    Acceptable daily intake (ADI) means the amount of total residue
that can safely be consumed per day over a human's lifetime without
adverse health effect. The ADI is calculated by dividing the no-
observed-effect-level (NOEL) (from the most appropriate toxicological
study) by a safety factor. The safety factor reflects, among other
things, the extrapolation of long-term effects from shorter-term
exposures, extrapolation of animal data to humans, and variability in
sensitivity among human populations.
    Acceptable single-dose intake (ASDI) means the amount of total
residue that may safely be consumed in a single meal. The ASDI may be
used to derive the tolerance for residue of the drug at the injection
site where the drug is administered according to the label.
    Edible tissues means muscle, liver, kidney, fat, skin with fat in
natural proportions, whole eggs, whole milk, and honey.
    Marker residue means the residue selected for assay by the
regulatory method whose concentration in the target tissue is in a
known relationship to the concentration of the total residue in the
target tissue. A finding that the concentration of marker residue is at
or below the tolerance in the target tissue from a tested animal
indicates that all edible tissues (excluding milk and eggs unless
otherwise specified) from that animal are safe.
    mg/kg means milligrams per kilogram.
    No-Observed-Effect Level (NOEL) means the highest dose level of a
drug tested that produces no observable effects.
    Not required, in reference to tolerances in this part, means that
at the time of approval, the drug met one of the following conditions:
    (1) No withdrawal period (i.e. zero withdrawal) was necessary for
residues of the drug to deplete to or below the concentrations
considered to be safe or an adequate withdrawal period was inherent in
the proposed drug use, and there was no concern about residues
resulting from misuse or overdosing; or
    (2) The drug qualified for a zero withdrawal period because it was
poorly absorbed or metabolized rapidly so as to make selection of an
analyte impractical or impossible.
    ppb means parts per billion (equivalent to nanograms per gram (ng/
g) or [mu]g/kg).
    ppm means parts per million (equivalent to micrograms per gram
([mu]g/g) or mg/kg).
    ppt means parts per trillion (equivalent to picograms per gram (pg/
g) or nanograms per kilogram (ng/kg)).
    Regulatory method means the aggregate of all experimental
procedures for measuring and confirming the presence of the marker
residue in the target tissue of the target animal.
    Residue means any compound present in edible tissues that results
from the use of a drug, and includes the drug, its metabolites, and any
other substance formed in or on food because of the drug's use.
    Target tissue means the edible tissue selected to monitor for
residues in the target animals.
    Tolerance means the maximum concentration of a marker residue, or
other residue indicated for monitoring, that can legally remain in a
specific edible tissue of a treated animal. (A finding, using the
approved regulatory method, that the concentration of the marker
residue or other residue indicated for monitoring is present in the
target tissue at a concentration at or below the tolerance, indicates
that all edible tissues (excluding milk and eggs unless otherwise
specified) from the tested animal are safe. All tolerances refer to the
concentrations of a marker residue, or other residue indicated for
monitoring, permitted in uncooked tissues.)
    Total residue means the aggregate of all compounds that results
from the use of an animal drug, including the drug, its metabolites,
and any other substances formed in or on food because of such drug use.
    [mu]g/kg means microgram per kilogram.
    Zero, in reference to tolerances in this part, means no detectable
residues are allowed when using a method of detection prescribed or
approved by FDA. Any residue detectable using the prescribed or
approved method renders the tissue unsafe.

Sec.  556.5  General considerations.

    (a) The tolerances listed in subpart B of this part pertain only to
the species and production classes of the animal for which the drug use
has been approved or conditionally approved. Approved use and
conditionally approved use conditions, including the species and
production classes of the animals, are cited under paragraph (c)
Related conditions of use for each tolerance listing of subpart B of
this part.
    (b) All tolerances refer to the concentrations of a marker residue,
or other residue indicated for monitoring, permitted in uncooked
tissues.
    (c) After a tolerance is listed, the finding that the concentration
of the marker residue in the target tissue from a tested animal is at
or below the tolerance indicates that all edible tissues (excluding
milk and eggs unless otherwise indicated) from that tested animal are
safe for human consumption. If a listed tolerance is not expressly
linked to a target tissue, then the tolerance is specific only for the
named edible tissue and inferences cannot be made about the safety of
the other edible tissues from the tested animal.
    (d) FDA requires that a drug sponsor develop a regulatory method to
measure drug residues in edible tissues of approved target species at
concentrations around the tolerance as provided in Sec.  514.1(b)(7) of
this chapter. Because FDA determines the tolerance for the marker
residue using data collected with the approved regulatory method, the
tolerance is directly tied to that method. Approved regulatory methods
are available from the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD
20852.

Subpart B--Specific Tolerances for Residues of Approved and
Conditionally Approved New Animal Drugs

Sec.  556.34  Albendazole.

    (a) Acceptable daily intake (ADI). The ADI for total residue of
albendazole is 5 [mu]g/kg of body weight per day.
    (b) Tolerances. The tolerances for albendazole 2-aminosulfone
(marker residue) are:
    (1) Cattle--(i) Liver (target tissue): 0.2 ppm.
    (ii) Muscle: 0.05 ppm.
    (2) Sheep--(i) Liver (target tissue): 0.25 ppm.
    (ii) Muscle: 0.05 ppm.
    (3) Goat--(i) Liver (target tissue): 0.25 ppm.
    (ii) [Reserved]
    (c) Related conditions of use. See Sec.  520.45 of this chapter.

Sec.  556.36  Altrenogest.

    (a) Acceptable daily intake (ADI). The ADI for total residue of
altrenogest is 0.04 [mu]g/kg of body weight per day.
    (b) Tolerances. The tolerance for altrenogest (the marker residue)
is:
    (1) Swine--(i) Liver (target tissue): 4 ppb.

    (ii) Muscle: 1 ppb.
    (2) [Reserved]
    (c) Related conditions of use. See Sec.  520.48 of this chapter.

Sec.  556.38  Amoxicillin.

    (a) [Reserved]
    (b) Tolerances. The tolerances for amoxicillin are:
    (1) Cattle--Edible tissues: 0.01 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. Sec.  520.88, 522.88, and
526.88 of this chapter.

Sec.  556.40  Ampicillin.

    (a) [Reserved]
    (b) Tolerances. The tolerances for ampicillin are:
    (1) Cattle--Edible tissues: 0.01 ppm.
    (2) Swine--Edible tissues: 0.01 ppm.
    (c) Related conditions of use. See Sec. Sec.  520.90e, 520.90f, and
522.90 of this chapter.

Sec.  556.50  Amprolium.

    (a) [Reserved]
    (b) Tolerances. The tolerances for amprolium are:
    (1) Cattle--(i) Liver, kidney, and muscle: 0.5 ppm.
    (ii) Fat: 2.0 ppm.
    (2) Chickens and turkeys--(i) Liver and kidney: 1 ppm.
    (ii) Muscle: 0.5 ppm.
    (iii) Eggs:
    (A) Egg yolks: 8 ppm.
    (B) Whole eggs: 4 ppm.
    (3) Pheasants--(i) Liver: 1 ppm.
    (ii) Muscle: 0.5 ppm.
    (c) Related conditions of use. See Sec. Sec.  520.100, 558.55, and
558.58 of this chapter.

Sec.  556.52  Apramycin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of
apramycin is 25 [mu]g/kg of body weight per day.
    (b) Tolerance. The tolerance for apramycin (marker residue) is:
    (1) Swine--Kidney (target tissue): 0.1 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. Sec.  520.110 and 558.59 of
this chapter.

Sec.  556.60  Arsenic.

    (a) [Reserved]
    (b) Tolerances. The tolerances for total residue of combined
arsenic (calculated as As) are:
    (1) Chickens and turkeys--(i) Muscle and eggs: 0.5 ppm.
    (ii) Other edible tissues: 2 ppm.
    (2) Swine--(i) Liver and kidney: 2 ppm.
    (ii) Muscle and fat: 0.5 ppm.
    (c) Related conditions of use. See Sec. Sec.  520.2087, 520.2088,
520.2089, 558.62, 558.120, 558.369, and 558.530 of this chapter.

Sec.  556.68  Azaperone.

    (a) Acceptable daily intake (ADI). The ADI for total residues of
azaperone is 0.63 [mu]g/kg of body weight per day.
    (b) Tolerances. The tolerances for azaperone are:
    (1) Swine--(i) Edible tissues: Not required.
    (2) [Reserved]
    (c) Related conditions of use. See Sec.  522.150 of this chapter.

Sec.  556.70  Bacitracin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of
bacitracin is 0.05 mg/kg of body weight per day.
    (b) Tolerances. The tolerances for bacitracin are:
    (1) Cattle--Edible tissues: 0.5 ppm.
    (2) Chickens, turkeys, pheasants, quail--Edible tissues: 0.5 ppm.
    (3) Swine--Edible tissues: 0.5 ppm.
    (c) Related conditions of use. See Sec. Sec.  520.154, 558.76, and
558.78 of this chapter.

Sec.  556.75  Bambermycins.

    (a) [Reserved]
    (b) Tolerances. The tolerances for bambermycins are:
    (1) Cattle--Edible tissues (excluding milk): Not required.
    (2) Chickens and turkeys--Edible tissues (excluding eggs): Not
required.
    (3) Swine--Edible tissues: Not required.
    (c) Related conditions of use. See Sec.  558.95 of this chapter.

Sec.  556.100  Carbadox.

    (a) [Reserved]
    (b) Tolerance. The tolerance for quinoxaline-2-carboxylic acid
(marker residue) is:
    (1) Swine--Liver (target tissue): 30 ppb.
    (2) [Reserved]
    (c) Related conditions of use. See Sec.  558.115 of this chapter.

Sec.  556.110  Carbomycin.

    (a) [Reserved]
    (b) Tolerances. The tolerances for carbomycin are:
    (1) Chickens--Edible tissues (excluding eggs): Zero.
    (2) [Reserved]
    (c) Related conditions of use. See Sec.  520.1660a of this chapter.

Sec.  556.113  Ceftiofur.

    (a) Acceptable daily intake and acceptable single-dose intake--(1)
Acceptable daily intake (ADI). The ADI for total residue of ceftiofur
is 30 [mu]g/kg of body weight per day.
    (2) Acceptable single-dose intake (ASDI). The ASDI total residue
for ceftiofur is 0.830 mg/kg of body weight. The ASDI is the amount of
total residue of ceftiofur that may safely be consumed in a single
meal.
    (b) Tolerances. The tolerances for desfuroylceftiofur (marker
residue) are:
    (1) Cattle--(i) Kidney (target tissue): 0.4 ppm.
    (ii) Liver: 2 ppm.
    (iii) Muscle: 1 ppm.
    (iv) Milk: 0.1 ppm.
    (2) Chickens and turkeys--Edible tissues (excluding eggs): Not
required.
    (3) Goats--(i) Kidney (target tissue): 8 ppm.
    (ii) Liver: 2 ppm.
    (iii) Muscle: 1 ppm.
    (iv) Milk: 0.1 ppm.
    (4) Sheep--Edible tissues (excluding milk): Not required.
    (5) Swine--(i) Kidney (target tissue): 0.25 ppm.
    (ii) Liver: 3 ppm.
    (iii) Muscle: 2 ppm.
    (c) Related conditions of use. See Sec. Sec.  522.313 and 526.313
of this chapter.

Sec.  556.115  Cephapirin.

    (a) [Reserved]
    (b) Tolerances. The tolerances for cephapirin are:
    (1) Cattle--(i) Edible tissues (excluding milk): 0.1 ppm.
    (ii) Milk: 0.02 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. Sec.  526.363 and 526.365
of this chapter.

Sec.  556.120  Chlorhexidine.

    (a) [Reserved]
    (b) Tolerances. The tolerances for chlorhexidine are:
    (1) Cattle--Edible tissues (excluding milk): Zero.
    (2) [Reserved]
    (c) Related conditions of use. See Sec.  529.400 of this chapter.

Sec.  556.150  Chlortetracycline.

    (a) Acceptable daily intake (ADI). The ADI for total residue of
tetracyclines including chlortetracycline, oxytetracycline, and
tetracycline is 25 [mu]g/kg of body weight per day.
    (b) Tolerances. The tolerances for the sum of tetracycline residues
are:
    (1) Cattle--(i) Liver: 6 ppm.
    (ii) Kidney and fat: 12 ppm.
    (iii) Muscle: 2 ppm.
    (2) Chickens, turkeys, and ducks--(i) Liver: 6 ppm.
    (ii) Kidney and fat: 12 ppm.
    (iii) Muscle: 2 ppm.
    (iv) Eggs: 0.4 ppm for chlortetracycline only.
    (3) Sheep--(i) Liver: 6 ppm.
    (ii) Kidney and fat: 12 ppm.
    (iii) Muscle: 2 ppm.
    (4) Swine--(i) Liver: 6 ppm.
    (ii) Kidney and fat: 12 ppm.
    (iii) Muscle: 2 ppm.

    (c) Related conditions of use. See Sec. Sec.  520.445, 558.128,
558.145, and 558.155 of this chapter.

Sec.  556.160  Clopidol.

    (a) [Reserved]
    (b) Tolerances. The tolerances for clopidol are:
    (1) Chickens and turkeys--(i) Liver and kidney: 15 ppm.
    (ii) Muscle: 5 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec.  558.175 of this chapter.

Sec.  556.163  Clorsulon.

    (a) Acceptable daily intake (ADI). The ADI for total residue of
clorsulon is 8 [mu]g/kg of body weight per day.
    (b) Tolerances. The tolerances for clorsulon (marker residue) are:
    (1) Cattle--(i) Kidney (target tissue): 1.0 ppm.
    (ii) Muscle: 0.1 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. Sec.  520.462 and 522.1193
of this chapter.

Sec.  556.165  Cloxacillin.

    (a) [Reserved]
    (b) Tolerances. The tolerances for cloxacillin are:
    (1) Cattle--Edible tissues: 0.01 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec.  526.464 of this chapter.

Sec.  556.167  Colistimethate.

    (a) [Reserved]
    (b) Tolerances. The tolerances for colistimethate are:
    (1) Chickens--Edible tissues (excluding eggs): Not required.
    (2) [Reserved]
    (c) Related conditions of use. See Sec.  522.468 of this chapter.

Sec.  556.168  Coumaphos.

    (a) [Reserved]
    (b) Tolerances. The tolerances for coumaphos (measured as coumaphos
and its oxygen analog, O,O-diethyl O-3-chloro-4-methyl-2-oxo-2 H-1-
benzopyran-7-yl phosphate) are:
    (1) Cattle--(i) Edible tissues (excluding milk): 1 ppm.
    (ii) Milk fat: 0.5 ppm.
    (2) Chickens--(i) Edible tissues (excluding eggs): 1 ppm.
    (ii) Eggs: 0.1 ppm.
    (c) Related conditions of use. See Sec.  558.185 of this chapter.

Sec.  556.169  Danofloxacin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of
danofloxacin is 2.4 [mu]g/kg of body weight per day.
    (b) Tolerances. The tolerances for danofloxacin (marker residue)
are:
    (1) Cattle--(i) Liver (target tissue): 0.2 ppm.
    (ii) Muscle: 0.2 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec.  522.522 of this chapter.

Sec.  556.170  Decoquinate.

    (a) Acceptable daily intake (ADI). The ADI for total residue of
decoquinate is 75 [mu]g/kg of body weight per day.
    (b) Tolerances. The tolerances for decoquinate are:
    (1) Cattle--(i) Muscle: 1 ppm.
    (ii) Other edible tissues (excluding milk): 2 ppm.
    (2) Chickens--(i) Muscle: 1 ppm.
    (ii) Other edible tissues (excluding eggs): 2 ppm.
    (3) Goats--(i) Muscle: 1 ppm.
    (ii) Other edible tissues (excluding milk): 2 ppm.
    (c) Related conditions of use. See Sec.  558.195 of this chapter.

Sec.  556.180  Dichlorvos.

    (a) [Reserved]
    (b) Tolerances. The tolerances for dichlorvos are:
    (1) Swine--Edible tissues: 0.1 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec.  558.205 of this chapter.

Sec.  556.185  Diclazuril.

    (a) Acceptable daily intake (ADI). The ADI for total residue of
diclazuril is 25 [mu]g/kg of body weight per day.
    (b) Tolerances. The tolerances for diclazuril are:
    (1) Chickens and turkeys--(i) Liver: 3 ppm.
    (ii) Muscle: 0.5 ppm.
    (iii) Skin/fat: 1 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec.  558.198 of this chapter.

Sec.  556.200  Dihydrostreptomycin.

    (a) [Reserved]
    (b) Tolerances. The tolerances for dihydrostreptomycin are:
    (1) Cattle--(i) Kidney: 2.0 ppm.
    (ii) Other edible tissues (excluding milk): 0.5 ppm.
    (iii) Milk: 0.125 ppm.
    (2) Swine--(i) Kidney: 2.0 ppm.
    (ii) Other edible tissues: 0.5 ppm.
    (c) Related conditions of use. See Sec. Sec.  520.2158b, 520.2158c,
522.650, and 526.1696b of this chapter.

Sec.  556.222  Doramectin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of
doramectin is 0.75 [mu]g/kg of body weight per day.
    (b) Tolerances. The tolerances for doramectin (marker residue) are:
    (1) Cattle--(i) Liver (target tissue): 100 ppb.
    (ii) Muscle: 30 ppb.
    (2) Swine--Liver (target tissue): 160 ppb.
    (c) Related conditions of use. See Sec. Sec.  522.770 and 524.770
of this chapter.

Sec.  556.224  Efrotomycin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of
efrotomycin is 10 [mu]g/kg of body weight per day.
    (b) Tolerances. The tolerances for efrotomycin are:
    (1) Swine--Edible tissues: Not required.
    (2) [Reserved]
    (c) Related conditions of use. See Sec.  558.235 of this chapter.

Sec.  556.226  Enrofloxacin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of
enrofloxacin is 3 [mu]g/kg of body weight per day.
    (b) Tolerances. The tolerances for enrofloxacin are:
    (1) Cattle--Liver (target tissue): 0.1 ppm desethylene
ciprofloxacin (marker residue).
    (2) Swine--Liver (target tissue): 0.5 ppm enrofloxacin (marker
residue).
    (c) Related conditions of use. See Sec.  522.812 of this chapter.

Sec.  556.227  Eprinomectin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of
eprinomectin is 10 [mu]g/kg of body weight per day.
    (b) Tolerances. The tolerances for eprinomectin B1a
(marker residue) are:
    (1) Cattle--(i) Liver (target tissue): 1.5 ppm.
    (ii) Muscle: 100 ppb.
    (iii) Milk: 12 ppb.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. Sec.  522.814 and 524.814
of this chapter.

Sec.  556.230  Erythromycin.

    (a) [Reserved]
    (b) Tolerances. The tolerances for erythromycin are:
    (1) Cattle--(i) Edible tissues (excluding milk): 0.1 ppm.
    (ii) Milk: Zero.
    (2) Chickens and turkeys--(i) Edible tissues (excluding eggs):
0.125 ppm.
    (ii) Eggs: 0.025 ppm.
    (3) Swine--Edible tissues: 0.1 ppm.
    (c) Related conditions of use. See Sec. Sec.  520.823, 522.820,
526.820, and 558.248 of this chapter.

Sec.  556.240  Estradiol and related esters.

    (a) [Reserved]
    (b) Tolerances. Residues of estradiol are not permitted in excess
of the following increments above the concentrations of estradiol
naturally present in untreated animals:
    (1) Cattle--(i) Muscle: 120 ppt.
    (ii) Fat: 480 ppt.
    (iii) Kidney: 360 ppt.
    (iv) Liver: 240 ppt.
    (2) [Reserved]

    (c) Related conditions of use. See Sec. Sec.  522.840, 522.842,
522.850, 522.1940, 522.2477, and 522.2478 of this chapter.

Sec.  556.260  Ethopabate.

    (a) [Reserved]
    (b) Tolerances. The tolerances for ethopabate, measured as
metaphenetidine, are:
    (1) Chickens--(i) Liver: 1.5 ppm.
    (ii) Kidney: 1.5 ppm.
    (iii) Muscle: 0.5 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec.  558.58 of this chapter.

Sec.  556.273  Famphur.

    (a) [Reserved]
    (b) Tolerances. The tolerances for famphur including its oxygen
analog are:
    (1) Cattle--Edible tissues (excluding milk): 0.1 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. Sec.  520.1242g, 524.900,
and 558.254 of this chapter.

Sec.  556.275  Fenbendazole.

    (a) Acceptable daily intake (ADI). The ADI for total residue of
fenbendazole is 40 [mu]g/kg of body weight per day.
    (b) Tolerances. The tolerances for fenbendazole are:
    (1) Cattle--(i) Liver (target tissue): 0.8 ppm fenbendazole (marker
residue).
    (ii) Muscle: 0.4 ppm fenbendazole.
    (iii) Milk: 0.6 ppm fenbendazole sulfoxide.
    (2) Goats--(i) Liver (target tissue): 0.8 ppm fenbendazole (marker
residue).
    (ii) Muscle: 0.4 ppm fenbendazole.
    (3) Swine--(i) Liver (target tissue): 6 ppm fenbendazole (marker
residue).
    (ii) Muscle: 2 ppm fenbendazole.
    (4) Turkeys--(i) Liver (target tissue): 6 ppm fenbendazole sulfone
(marker residue).
    (ii) Muscle: 2 ppm fenbendazole sulfone.
    (c) Related conditions of use. See Sec. Sec.  520.905 and 558.258
of this chapter.

Sec.  556.277  Fenprostalene.

    (a) Acceptable daily intake (ADI). The ADI for total residue of
fenprostalene is 0.08 [mu]g/kg of body weight per day.
    (b) Tolerances. The tolerances for fenprostalene are:
    (1) Cattle--Edible tissues (excluding milk): Not required.
    (2) Swine--Edible tissues: Not required.
    (c) Related conditions of use. See Sec.  522.914 of this chapter.

Sec.  556.280  Fenthion.

    (a) [Reserved]
    (b) Tolerance. The tolerances for fenthion are:
    (1) Cattle--Edible tissues (excluding milk): 0.1 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec.  524.920 of this chapter.

Sec.  556.283  Florfenicol.

    (a) Acceptable daily intake (ADI). The ADI for total residue of
florfenicol is 10 [mu]g/kg of body weight per day.
    (b) Tolerances. The tolerances for florfenicol amine (marker
residue) are:
    (1) Cattle--(i) Liver (target tissue): 3.7 ppm.
    (ii) Muscle: 0.3 ppm.
    (2) Swine--(i) Liver (target tissue): 2.5 ppm.
    (ii) Muscle: 0.2 ppm.
    (3) Catfish--Muscle (target tissue): 1 ppm.
    (4) Freshwater-reared warmwater finfish (other than catfish) and
salmonids--Muscle/skin (target tissue): 1 ppm.
    (c) Related conditions of use. See Sec. Sec.  520.955, 522.955,
522.956, and 558.261 of this chapter.

Sec.  556.286  Flunixin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of
flunixin is 0.72 [mu]g/kg of body weight per day.
    (b) Tolerances. The tolerances for flunixin are:
    (1) Cattle--(i) Liver (target tissue): 125 ppb flunixin free acid
(marker residue).
    (ii) Muscle: 25 ppb flunixin free acid.
    (iii) Milk: 2 ppb 5-hydroxy flunixin (marker residue).
    (2) Swine--(i) Liver (target tissue): 30 ppb flunixin free acid
(marker residue).
    (ii) Muscle: 25 ppb flunixin free acid.
    (c) Related conditions of use. See Sec. Sec.  522.956 and 522.970
of this chapter.

Sec.  556.290  Flurogestone.

    (a) [Reserved]
    (b) Tolerances. The tolerances for flurogestone are:
    (1) Sheep--Edible tissues (excluding milk): Not required.
    (2) [Reserved]
    (c) Related conditions of use. See Sec.  529.1003 of this chapter.

Sec.  556.292  Gamithromycin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of
gamithromycin is 10 [mu]g/kg of body weight per day.
    (b) Tolerances. The tolerances for gamithromycin (marker residue)
are:
    (1) Cattle--(i) Liver (target tissue): 500 ppb.
    (ii) Muscle: 150 ppb.
    (2) [Reserved]
    (c) Related conditions of use. See Sec.  522.1014 of this chapter.

Sec.  556.300  Gentamicin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of
gentamicin is 60 [mu]g/kg of body weight per day.
    (b) Tolerances. The tolerances for gentamicin are:
    (1) Chickens and turkeys--Edible tissues (excluding eggs): 0.1 ppm.
    (2) Swine--(i) Liver: 0.3 ppm.
    (ii) Kidney (target tissue): 0.4 ppm gentamicin (marker residue).
    (iii) Fat: 0.4 ppm.
    (iv) Muscle: 0.1 ppm.
    (c) Related conditions of use. See Sec. Sec.  522.1044, 524.1044e,
and 529.1044b of this chapter.

Sec.  556.304  Gonadotropin.

    (a) Acceptable daily intake (ADI). The ADI for residues of total
gonadotropins (human chorionic gonadotropin and pregnant mare serum
gonadotropin) is 42.25 International Units per kilogram of body weight
per day.
    (b) Tolerances. The tolerances for gonadotropin are:
    (1) Cattle--Edible tissues (excluding milk): Not required.
    (2) Fish--Edible tissues: Not required.
    (3) Swine--Edible tissues: Not required.
    (c) Related conditions of use. See Sec. Sec.  522.1077, 522.1078,
522.1079, and 522.1081 of this chapter.

Sec.  556.308  Halofuginone.

    (a) Acceptable daily intake (ADI). The ADI for total residue of
halofuginone hydrobromide is 0.7 [mu]g/kg of body weight per day.
    (b) Tolerances. The tolerances for halofuginone (marker residue)
are:
    (1) Chickens--Liver (target tissue): 0.16 ppm.
    (2) Turkeys--Liver (target tissue): 0.13 ppm.
    (c) Related conditions of use. See Sec.  558.265 of this chapter.

Sec.  556.310  Haloxon.

    (a) [Reserved]
    (b) Tolerances. The tolerances for haloxon are:
    (1) Cattle--Edible tissues (excluding milk): 0.1 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec.  520.1120 of this chapter.

Sec.  556.330  Hygromycin B.

    (a) [Reserved]
    (b) Tolerances. The tolerances for hygromycin B are:
    (1) Chickens--Edible tissues: Zero.
    (2) Swine--Edible tissues: Zero.
    (c) Related conditions of use. See Sec.  558.274 of this chapter.

Sec.  556.344  Ivermectin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of
ivermectin is 1 [mu]g/kg of body weight per day.
    (b) Tolerances. The tolerances for 22,23-dihydroavermectin
B1a (marker residue) are:

    (1) American bison--Liver (target tissue): 15 ppb.
    (2) Cattle--(i) Liver (target tissue): 100 ppb.
    (ii) Muscle: 10 ppb.
    (3) Reindeer--Liver (target tissue): 15 ppb.
    (4) Sheep-- Liver (target tissue): 30 ppb.
    (5) Swine--(i) Liver (target tissue): 20 ppb.
    (ii) Muscle: 20 ppb.
    (c) Related conditions of use. See Sec. Sec.  520.1192, 520.1195,
520.1197, 522.1192, 522.1193, 524.1193, and 558.300 of this chapter.

Sec.  556.346  Laidlomycin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of
laidlomycin is 7.5 [mu]g/kg of body weight per day.
    (b) Tolerance. The tolerance for laidlomycin (marker residue) is:
    (1) Cattle--Liver (target tissue): 0.2 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec.  558.305 of this chapter.

Sec.  556.347  Lasalocid.

    (a) Acceptable daily intake (ADI). The ADI for total residue of
lasalocid is 10 [mu]g/kg of body weight per day.
    (b) Tolerances. The tolerances for lasalocid (marker residue) are:
    (1) Cattle--Liver (target tissue): 0.7 ppm.
    (2) Chickens--(i) Skin with adhering fat (target tissue): 1.2 ppm.
    (ii) Liver: 0.4 ppm.
    (3) Rabbits--Liver (target tissue): 0.7 ppm.
    (4) Sheep--Liver (target tissue): 1.0 ppm.
    (5) Turkeys--(i) Liver (target tissue): 0.4 ppm.
    (ii) Skin with adhering fat: 0.4 ppm.
    (c) Related conditions of use. See Sec.  558.311 of this chapter.

Sec.  556.350  Levamisole.

    (a) [Reserved]
    (b) Tolerances. The tolerances for levamisole are:
    (1) Cattle--Edible tissues (excluding milk): 0.1 ppm.
    (2) Sheep--Edible tissues (excluding milk): 0.1 ppm.
    (3) Swine--Edible tissues: 0.1 ppm.
    (c) Related conditions of use. See Sec. Sec.  520.1242, 522.1244,
and 524.1240 of this chapter.

Sec.  556.360  Lincomycin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of
lincomycin is 25 [mu]g/kg of body weight per day.
    (b) Tolerances. The tolerances for lincomycin are:
    (1) Chickens--Edible tissues (excluding eggs): Not required.
    (2) Swine--(i) Liver: 0.6 ppm.
    (ii) Muscle: 0.1 ppm.
    (c) Related conditions of use. See Sec. Sec.  520.1263b, 520.1263c,
522.1260, and 558.325 of this chapter.

Sec.  556.375  Maduramicin.

    (a) [Reserved]
    (b) Tolerance. The tolerance for maduramicin (marker residue) is:
    (1) Chickens--Fat (target tissue): 0.38 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec.  558.340 of this chapter.

Sec.  556.380  Melengestrol.

    (a) [Reserved]
    (b) Tolerance. The tolerance for melengestrol is:
    (1) Cattle--Fat: 25 ppb.
    (2) [Reserved]
    (c) Related conditions of use. See Sec.  558.342 of this chapter.

Sec.  556.410  Metoserpate.

    (a) [Reserved]
    (b) Tolerances. The tolerances for metoserpate are:
    (1) Chickens--Edible tissues (excluding eggs): 0.02 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec.  520.1422 of this chapter.

Sec.  556.420  Monensin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of
monensin is 12.5 [mu]g/kg of body weight per day.
    (b) Tolerances. The tolerances for monensin are:
    (1) Cattle--(i) Liver: 0.10 ppm.
    (ii) Muscle, kidney, and fat: 0.05 ppm.
    (iii) Milk: Not required.
    (2) Chickens and turkeys--Edible tissues (excluding eggs): Not
required.
    (3) Goats--Edible tissues (excluding milk): 0.05 ppm.
    (4) Quail--Edible tissues (excluding eggs): Not required.
    (c) Related conditions of use. See Sec.  558.355 of this chapter.

Sec.  556.425  Morantel.

    (a) Acceptable daily intake (ADI). The ADI for total residue of
morantel tartrate is 10 [mu]g/kg of body weight per day.
    (b) Tolerances. The tolerances for N-methyl-1,3-propanediamine
(marker residue) are:
    (1) Cattle--(i) Liver (target tissue): 0.7 ppm.
    (ii) Milk: Not required.
    (2) Goats--(i) Liver (target tissue): 0.7 ppm.
    (ii) Milk: Not required.
    (c) Related conditions of use. See Sec. Sec.  520.1450 and 558.360
of this chapter.

Sec.  556.426  Moxidectin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of
moxidectin is 4 [mu]g/kg of body weight per day.
    (b) Tolerances. The tolerances for moxidectin (marker residue) are:
    (1) Cattle--(i) Fat (target tissue): 900 ppb.
    (ii) Liver: 200 ppb.
    (iii) Muscle: 50 ppb.
    (iv) Milk: 40 ppb.
    (2) Sheep--(i) Fat (target tissue): 900 ppb.
    (ii) Liver: 200 ppb.
    (iii) Muscle: 50 ppb.
    (c) Related conditions of use. See Sec. Sec.  520.1454, 522.1450,
and 524.1450 of this chapter.

Sec.  556.428  Narasin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of
narasin is 5 [mu]g/kg of body weight per day.
    (b) Tolerance. The tolerance for narasin (marker residue) is:
    (1) Chickens--Abdominal fat (target tissue): 480 ppb.
    (2) [Reserved]
    (c) Related conditions of use. See Sec.  558.363 of this chapter.

Sec.  556.430  Neomycin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of
neomycin is 6 [mu]g/kg of body weight per day.
    (b) Tolerances. The tolerances for neomycin are:
    (1) Cattle--(i) Kidney (target tissue): 7.2 ppm.
    (ii) Liver: 3.6 ppm.
    (iii) Muscle: 1.2 ppm.
    (iv) Fat: 7.2 ppm.
    (v) Milk: 0.15 ppm.
    (2) Sheep and Goats--(i) Kidney (target tissue): 7.2 ppm.
    (ii) Liver: 3.6 ppm.
    (iii) Muscle: 1.2 ppm.
    (iv) Fat: 7.2 ppm.
    (v) Milk: 0.15 ppm.
    (3) Swine--(i) Kidney (target tissue): 7.2 ppm.
    (ii) Liver: 3.6 ppm.
    (iii) Muscle: 1.2 ppm.
    (iv) Fat: 7.2 ppm.
    (4) Turkeys--(i) Skin with adhering fat: 7.2 ppm.
    (ii) Liver: 3.6 ppm.
    (iii) Muscle: 1.2 ppm.
    (c) Related conditions of use. See Sec. Sec.  520.1484, 524.1600b,
and 558.364 of this chapter.

Sec.  556.440  Nequinate.

    (a) [Reserved]
    (b) Tolerances. The tolerances for nequinate are:
    (1) Chickens--Edible tissues (excluding eggs): 0.1 ppm.
    (2) [Reserved]

    (c) Related conditions of use. See Sec.  558.365 of this chapter.

Sec.  556.445  Nicarbazin.

    (a) [Reserved]
    (b) Tolerances. The tolerances for nicarbazin are:
    (1) Chickens--(i) Muscle: 4 ppm.
    (ii) Liver: 4 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec.  558.366 of this chapter.

Sec.  556.460  Novobiocin.

    (a) [Reserved]
    (b) Tolerances. The tolerances for novobiocin are:
    (1) Cattle--(i) Edible tissues (excluding milk): 1 ppm.
    (ii) Milk: 0.1 ppm.
    (2) Chickens, turkeys, ducks--Edible tissues (excluding eggs): 1
ppm.
    (c) Related conditions of use. See Sec. Sec.  526.1590, 526.1696d,
and 558.415 of this chapter.

Sec.  556.470  Nystatin.

    (a) [Reserved]
    (b) Tolerances. The tolerances for nystatin are:
    (1) Cattle--Edible tissues (excluding milk): Zero.
    (2) Chickens and turkeys--Edible tissues: Zero.
    (c) Related conditions of use. See Sec. Sec.  524.1600b and 558.430
of this chapter.

Sec.  556.480  Oleandomycin.

    (a) [Reserved]
    (b) Tolerances. The tolerances for oleandomycin are:
    (1) Chickens and turkeys--Edible tissues (excluding eggs): 0.15
ppm.
    (2) Swine--Edible tissues: 0.15 ppm.
    (c) Related conditions of use. See Sec.  558.435 of this chapter.

Sec.  556.490  Ormetoprim.

    (a) [Reserved]
    (b) Tolerances. The tolerances for ormetoprim are:
    (1) Chickens, turkeys, ducks, and chukar partridges--Edible tissues
(excluding eggs): 0.1 ppm.
    (2) Salmonids and catfish--Edible tissues: 0.1 ppm.
    (c) Related conditions of use. See Sec.  558.575 of this chapter.

Sec.  556.495  Oxfendazole.

    (a) Acceptable daily intake (ADI). The ADI for total residue of
oxfendazole is 7 [mu]g/kg of body weight per day.
    (b) Tolerance. The tolerance for fenbendazole (marker residue) is:
    (1) Cattle--Liver (target tissue): 0.8 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. Sec.  520.1629 and 520.1630
of this chapter.

Sec.  556.500  Oxytetracycline.

    (a) Acceptable daily intake (ADI). The ADI for total tetracycline
residues (chlortetracycline, oxytetracycline, and tetracycline) is 25
[mu]g/kg of body weight per day.
    (b) Tolerances. The tolerances for the sum of tetracycline residues
are:
    (1) Cattle--(i) Muscle: 2 ppm.
    (ii) Liver: 6 ppm.
    (iii) Fat and kidney: 12 ppm.
    (iv) Milk: 0.3 ppm.
    (2) Chickens and turkeys--(i) Muscle: 2 ppm.
    (ii) Liver: 6 ppm.
    (iii) Fat and kidney: 12 ppm.
    (3) Finfish--Muscle (with adhering skin when edible): 2 ppm.
    (4) Lobster--Muscle: 2 ppm.
    (5) Swine and Sheep--(i) Muscle: 2 ppm.
    (ii) Liver: 6 ppm.
    (iii) Fat and kidney: 12 ppm.
    (c) Related conditions of use. See Sec. Sec.  520.1660, 522.1660,
522.1662, 524.1662b, 529.1660, and 558.450 of this chapter.

Sec.  556.510  Penicillin.

    (a) [Reserved]
    (b) Tolerances. The tolerances for penicillin are:
    (1) Cattle--(i) Edible tissues (excluding milk): 0.05 ppm.
    (ii) Milk: Zero.
    (2) Chickens--Edible tissues: Zero.
    (3) Pheasants and quail--Edible tissues: Zero.
    (4) Sheep and Swine--Edible tissues: Zero.
    (5) Turkeys--Edible tissues (excluding eggs): 0.01 ppm.
    (c) Related conditions of use. See Sec. Sec.  520.1696, 522.1696,
526.1696, and 558.460 of this chapter.

Sec.  556.513  Piperazine.

    (a) [Reserved]
    (b) Tolerances. The tolerances for piperazine are:
    (1) Chickens and turkeys--Edible tissues (excluding eggs): 0.1 ppm.
    (2) Swine--Edible tissues: 0.1 ppm.
    (c) Related conditions of use. See Sec.  520.1807 of this chapter.

Sec.  556.515  Pirlimycin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of
pirlimycin is 0.01 mg/kg of body weight per day.
    (b) Tolerances. The tolerances for pirlimycin (marker residue) are:
    (1) Cattle--(i) Liver (target tissue): 0.5 ppm.
    (ii) Muscle: 0.3 ppm.
    (iii) Milk: 0.4 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec.  526.1810 of this chapter.

Sec.  556.517  Poloxalene.

    (a) [Reserved]
    (b) Tolerances. The tolerances for poloxalene are:
    (1) Cattle--Edible tissues (excluding milk): Not required.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. Sec.  520.1840, 558.464,
and 558.465 of this chapter.

Sec.  556.540  Progesterone.

    (a) [Reserved]
    (b) Tolerances. Residues of progesterone are not permitted in
excess of the following increments above the concentrations of
progesterone naturally present in untreated animals:
    (1) Cattle and sheep--(i) Muscle: 5 ppb.
    (ii) Liver: 15 ppb.
    (iii) Kidney: 30 ppb.
    (iv) Fat: 30 ppb.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. Sec.  522.1940 and 529.1940
of this chapter.

Sec.  556.560  Pyrantel.

    (a) [Reserved]
    (b) Tolerances. The tolerances for pyrantel are:
    (1) Swine--(i) Liver and kidney: 10 ppm.
    (ii) Muscle: 1 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. Sec.  520.2045 and 558.485
of this chapter.

Sec.  556.570  Ractopamine.

    (a) Acceptable daily intake (ADI). The ADI for total residue of
ractopamine hydrochloride is 1.25 [mu]g/kg of body weight per day.
    (b) Tolerances. The tolerances for ractopamine (marker residue)
are:
    (1) Cattle--(i) Liver (target tissue): 0.09 ppm.
    (ii) Muscle: 0.03 ppm.
    (2) Swine--(i) Liver (target tissue): 0.15 ppm.
    (ii) Muscle: 0.05 ppm.
    (3) Turkeys--(i) Liver (target tissue): 0.45 ppm.
    (ii) Muscle: 0.1 ppm.
    (c) Related conditions of use. See Sec.  558.500 of this chapter.

Sec.  556.580  Robenidine.

    (a) [Reserved]
    (b) Tolerances. The tolerances for robenidine are:
    (1) Chickens--(i) Skin and fat: 0.2 ppm.
    (ii) Other edible tissues (excluding eggs): 0.1 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec.  558.515 of this chapter.

Sec.  556.592  Salinomycin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of
salinomycin is 5 [mu]g/kg of body weight per day.
    (b) Tolerances. The tolerances for salinomycin are:
    (1) Chickens--Edible tissues (excluding eggs): Not required.
    (2) Quail--Edible tissues (excluding eggs): Not required.
    (c) Related conditions of use. See Sec.  558.550 of this chapter.

Sec.  556.597  Semduramicin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of
semduramicin is 3 [mu]g/kg of body weight per day.
    (b) Tolerances. The tolerances for semduramicin are:
    (1) Chickens--(i) Liver: 400 ppb.
    (ii) Muscle: 130 ppb.
    (2) [Reserved]
    (c) Related conditions of use. See Sec.  558.555 of this chapter.

Sec.  556.600  Spectinomycin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of
spectinomycin is 25 [mu]g/kg of body weight per day.
    (b) Tolerances. The tolerances for spectinomycin are:
    (1) Cattle--(i) Kidney (target tissue): 4 ppm spectinomycin (marker
residue).
    (ii) Muscle: 0.25 ppm.
    (2) Chickens and turkeys--Edible tissues (excluding eggs): 0.1 ppm.
    (3) Swine--Edible tissues: Not required.
    (c) Related conditions of use. See Sec. Sec.  520.1265, 520.2123b,
520.2123c, 522.2120, and 522.2121 of this chapter.

Sec.  556.610  Streptomycin.

    (a) [Reserved]
    (b) Tolerances. The tolerances for streptomycin are:
    (1) Cattle and Swine--(i) Kidney: 2.0 ppm.
    (ii) Other edible tissues (excluding milk): 0.5 ppm.
    (2) Chickens--(i) Kidney: 2.0 ppm.
    (ii) Other edible tissues (excluding eggs): 0.5 ppm.
    (c) Related conditions of use. See Sec.  520.2158 of this chapter.

Sec.  556.620  Sulfabromomethazine.

    (a) [Reserved]
    (b) Tolerances. The tolerances for sulfabromomethazine are:
    (1) Cattle--(i) Edible tissues (excluding milk): 0.1 ppm.
    (ii) Milk: 0.01 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec.  520.2170 of this chapter.

Sec.  556.625  Sulfachloropyrazine.

    (a) [Reserved]
    (b) Tolerances. The tolerances for sulfachloropyrazine are:
    (1) Chickens--Edible tissues (excluding eggs): Zero.
    (2) [Reserved]
    (c) Related conditions of use. See Sec.  520.2184 of this chapter.

Sec.  556.630  Sulfachlorpyridazine.

    (a) [Reserved]
    (b) Tolerances. The tolerances for sulfachlorpyridazine are:
    (1) Cattle and Swine--Edible tissues (excluding milk): 0.1 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. Sec.  520.2200 and 522.2200
of this chapter.

Sec.  556.640  Sulfadimethoxine.

    (a) [Reserved]
    (b) Tolerances. The tolerances for sulfadimethoxine are:
    (1) Catfish and salmonids--Edible tissues: 0.1 ppm.
    (2) Cattle--(i) Edible tissues (excluding milk): 0.1 ppm.
    (ii) Milk: 0.01 ppm.
    (3) Chickens, turkeys, ducks and chukar partridges--Edible tissues
(excluding eggs): 0.1 ppm.
    (c) Related conditions of use. See Sec. Sec.  520.2220, 522.2220,
and 558.575 of this chapter.

Sec.  556.650  Sulfaethoxypyridazine.

    (a) [Reserved]
    (b) Tolerances. The tolerances for sulfaethoxypyridazine are:
    (1) Cattle--(i) Edible tissues (excluding milk): 0.1 ppm.
    (ii) Milk: Zero.
    (2) Swine--Edible tissues: Zero.
    (c) Related conditions of use. See Sec. Sec.  520.2240 and 522.2240
of this chapter.

Sec.  556.660  Sulfamerazine.

    (a) [Reserved]
    (b) Tolerances. The tolerances for sulfamerazine are:
    (1) Trout--Edible tissues: Zero.
    (2) [Reserved]
    (c) Related conditions of use. See Sec.  558.582 of this chapter.

Sec.  556.670  Sulfamethazine.

    (a) [Reserved]
    (b) Tolerances. The tolerances for sulfamethazine are:
    (1) Cattle--Edible tissues (excluding milk): 0.1 ppm.
    (2) Chickens and turkeys--Edible tissues (excluding eggs): 0.1 ppm.
    (3) Swine--Edible tissues: 0.1 ppm.
    (c) Related conditions of use. See Sec. Sec.  520.2260, 520.2261,
522.2260, 558.145, and 558.630 of this chapter.

Sec.  556.685  Sulfaquinoxaline.

    (a) [Reserved]
    (b) Tolerances. The tolerances for sulfaquinoxaline are:
    (1) Cattle--Edible tissues (excluding milk): 0.1 ppm.
    (2) Chickens and turkeys--Edible tissues (excluding eggs): 0.1 ppm.
    (c) Related conditions of use. See Sec. Sec.  520.2325 and 558.586
of this chapter.

Sec.  556.690  Sulfathiazole.

    (a) [Reserved]
    (b) Tolerances. The tolerances for sulfathiazole are:
    (1) Swine--Edible tissues: 0.1 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec.  558.155 of this chapter.

Sec.  556.700  Sulfomyxin.

    (a) [Reserved]
    (b) Tolerances. The tolerances for sulfomyxin are:
    (1) Chickens and turkeys--Edible tissues (excluding eggs): Zero.
    (2) [Reserved]
    (c) Related conditions of use. See Sec.  522.2340 of this chapter.

Sec.  556.710  Testosterone.

    (a) [Reserved]
    (b) Tolerances. Residues of testosterone are not permitted in
excess of the following increments above the concentrations of
testosterone naturally present in untreated animals:
    (1) Cattle--(i) Fat: 2.6 ppb.
    (ii) Kidney: 1.9 ppb.
    (iii) Liver: 1.3 ppb.
    (iv) Muscle: 0.64 ppb.
    (2) [Reserved]
    (c) Related conditions of use. See Sec.  522.842 of this chapter.

Sec.  556.720  Tetracycline.

    (a) Acceptable daily intake (ADI). The ADI for total tetracycline
residues (chlortetracycline, oxytetracycline, and tetracycline) is 25
[mu]g/kg of body weight per day.
    (b) Tolerances. The tolerances for the sum of tetracycline residues
are:
    (1) Cattle and Sheep--(i) Kidney and fat: 12 ppm.
    (ii) Liver: 6 ppm.
    (iii) Muscle: 2 ppm.
    (2) Chickens and turkeys--(i) Kidney and fat: 12 ppm.
    (ii) Liver: 6 ppm.
    (iii) Muscle: 2 ppm.
    (3) Swine--(i) Kidney and fat: 12 ppm.
    (ii) Liver: 6 ppm.
    (iii) Muscle: 2 ppm.
    (c) Related conditions of use. See Sec. Sec.  520.2345c and
520.2345d of this chapter.

Sec.  556.730  Thiabendazole.

    (a) [Reserved]
    (b) Tolerances. The tolerances for thiabendazole are:
    (1) Cattle--(i) Edible tissues (excluding milk): 0.1 ppm.

    (ii) Milk: 0.05 ppm.
    (2) Swine--Edible tissues: 0.1 ppm.
    (3) Sheep and Goats--(i) Edible tissues (excluding milk): 0.1 ppm.
    (ii) Milk: 0.05 ppm.
    (4) Pheasants--Edible tissues (excluding eggs): 0.1 ppm.
    (c) Related conditions of use. See Sec. Sec.  520.2380a, 520.2380b,
520.2380c, and 558.615 of this chapter.

Sec.  556.733  Tildipirosin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of
tildipirosin is 10 [mu]g/kg of body weight per day.
    (b) Tolerances. The tolerances for tildipirosin (the marker
residue) are:
    (1) Cattle--(i) Liver (the target tissue): 10 ppm.
    (ii) [Reserved]
    (2) [Reserved]
    (c) Related conditions of use. See Sec.  522.2460 of this chapter.

Sec.  556.735  Tilmicosin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of
tilmicosin is 25 [mu]g/kg of body weight per day.
    (b) Tolerances. The tolerances for tilmicosin (marker residue) are:
    (1) Cattle--(i) Liver (target tissue): 1.2 ppm.
    (ii) Muscle: 0.1 ppm.
    (2) Sheep--(i) Liver (target tissue): 1.2 ppm.
    (ii) Muscle: 0.1 ppm.
    (3) Swine--(i) Liver (target tissue): 7.5 ppm.
    (ii) Muscle: 0.1 ppm.
    (c) Related conditions of use. See Sec. Sec.  522.2471 and 558.618
of this chapter.

Sec.  556.738  Tiamulin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of
tiamulin is 25 [mu]g/kg of body weight per day.
    (b) Tolerance. The tolerance for 8-alpha-hydroxymutilin (marker
residue) is:
    (1) Swine--Liver (target tissue): 0.6 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. Sec.  520.2455 and 558.600
of this chapter.

Sec.  556.739  Trenbolone.

    (a) Acceptable daily intake (ADI). The ADI for total residue of
trenbolone is 0.4 [mu]g/kg of body weight per day.
    (b) Tolerances. The tolerances for trenbolone are:
    (1) Cattle--Edible tissues (excluding milk): Not required.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. Sec.  522.2476, 522.2477,
and 522.2478 of this chapter.

Sec.  556.741  Tripelennamine.

    (a) [Reserved]
    (b) Tolerances. The tolerances for tripelennamine are:
    (1) Cattle--(i) Edible tissues (excluding milk): 200 ppb.
    (ii) Milk: 20 ppb.
    (2) [Reserved]
    (c) Related conditions of use. See Sec.  522.2615 of this chapter.

Sec.  556.745  Tulathromycin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of
tulathromycin is 15 [mu]g/kg of body weight per day.
    (b) Tolerances. The tolerances for CP-60,300 (marker residue) are:
    (1) Cattle--Liver (target tissue): 5.5 ppm.
    (2) Swine--Kidney (target tissue): 15 ppm.
    (c) Related conditions of use. See Sec.  522.2630 of this chapter.

Sec.  556.746  Tylosin.

    (a) [Reserved]
    (b) Tolerances. The tolerances for tylosin are:
    (1) Cattle--(i) Liver, kidney, fat, and muscle: 0.2 ppm.
    (ii) Milk: 0.05 ppm.
    (2) Chickens and turkeys--(i) Liver, kidney, fat, and muscle: 0.2
ppm.
    (ii) Eggs: 0.2 ppm.
    (3) Swine--Liver, kidney, fat, and muscle: 0.2 ppm.
    (c) Related conditions of use. See Sec. Sec.  520.2640, 522.2640,
558.625, and 558.630 of this chapter.

Sec.  556.748  Tylvalosin.

    (a) Acceptable daily intake (ADI). The ADI for total residues of
tylvalosin is 47.7 [mu]g/kg of body weight per day.
    (b) Tolerances. A tolerance for tylvalosin in edible tissues of
swine is not required.
    (c) Related conditions of use. See Sec.  520.2645 of this chapter.

Sec.  556.750  Virginiamycin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of
virginiamycin is 250 [mu]g/kg of body weight per day.
    (b) Tolerances. The tolerances for virginiamycin are:
    (1) Cattle--Edible tissues (excluding milk): Not required.
    (2) Chickens--Edible tissues (excluding eggs): Not required.
    (3) Swine--(i) Kidney, skin, and fat: 0.4 ppm.
    (ii) Liver: 0.3 ppm.
    (iii) Muscle: 0.1 ppm.
    (4) Turkeys--Edible tissues (excluding eggs): Not required.
    (c) Related conditions of use. See Sec.  558.635 of this chapter.

Sec.  556.760  Zeranol.

    (a) Acceptable daily intake (ADI). The ADI for total residue of
zeranol is 1.25 [mu]g/kg of body weight per day.
    (b) Tolerances. The tolerances for zeranol are:
    (1) Cattle--Edible tissues (excluding milk): Not required.
    (2) Sheep--Edible tissues (excluding milk): 20 ppb.
    (c) Related conditions of use. See Sec.  522.2680 of this chapter.

Sec.  556.765  Zilpaterol.

    (a) Acceptable daily intake (ADI). The ADI for total residue of
zilpaterol is 0.083 [mu]g/kg of body weight per day.
    (b) Tolerances. The tolerances for zilpaterol freebase (marker
residue) are:
    (1) Cattle--Liver (target tissue): 12 ppb.
    (2) [Reserved]
    (c) Related conditions of use. See Sec.  558.665 of this chapter.

Sec.  556.770  Zoalene.

    (a) [Reserved]
    (b) Tolerances. The tolerances for zoalene and its metabolite 3-
amino-5-nitro-o-toluamide are:
    (1) Chickens--(i) Liver and kidney: 6 ppm.
    (ii) Muscle: 3 ppm.
    (iii) Fat: 2 ppm.
    (2) Turkeys--Liver and muscle: 3 ppm.
    (c) Related conditions of use. See Sec.  558.680 of this chapter.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

    15. The authority citation for 21 CFR part 558 continues to read as
follows:

    Authority:  21 U.S.C. 360b, 371.

    16. In Sec.  558.95, add paragraph (c) to read as follows:

Sec.  558.95  Bambermycins.

* * * * *
    (c) Related tolerances. See Sec.  556.75 of this chapter.
* * * * *
    17. In Sec.  558.185, revise paragraph (c) to read as follows:

Sec.  558.185  Coumaphos.

* * * * *
    (c) Related tolerances. See Sec.  556.168 of this chapter.
* * * * *
    18. In Sec.  558.235, add paragraph (c) to read as follows:

Sec.  558.235  Efrotomycin.

* * * * *
    (c) Related tolerances. See Sec.  556.224 of this chapter.
    19. In Sec.  558.464, add paragraph (c) to read as follows:

Sec.  558.464  Poloxalene.

* * * * *

    (c) Related tolerances. See Sec.  556.517 of this chapter.
    20. In Sec.  558.465, add paragraph (c) to read as follows:

Sec.  558.465  Poloxalene free-choice liquid Type C feed.

* * * * *
    (c) Related tolerances. See Sec.  556.517 of this chapter.
    21. In Sec.  558.625, revise paragraph (e) to read as follows:

Sec.  558.625  Tylosin.

* * * * *
    (e) Related tolerances. See Sec.  556.746 of this chapter.
* * * * *
    22. In Sec.  558.630, revise paragraph (d) to read as follows:

Sec.  558.630  Tylosin and sulfamethazine.

* * * * *
    (d) Related tolerances. See Sec. Sec.  556.670 and 556.746 of this
chapter.
* * * * *

    Dated: November 26, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-29322 Filed 12-4-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 77, Number 245 (Thursday, December 20, 2012)]
[Notices]
[Pages 75466-75468]
[FR Doc No: 2012-30689]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-68445; File No. SR-OCC-2012-19]

Self-Regulatory Organizations; Options Clearing Corporation;
Order Approving Proposed Rule Change To Revise the Method for
Determining the Minimum Clearing Fund Size To Include Consideration of
the Amount Necessary To Draw on Secured Credit Facilities

December 14, 2012.

I. Introduction

    On October 18, 2012, The Options Clearing Corporation (``OCC'')
filed with the Securities and Exchange Commission (``SEC'' or
``Commission'') the proposed rule change SR-OCC-2012-19 pursuant to
Section 19(b)(1) of the Securities Exchange Act of 1934 (``Act'') \1\
and Rule 19b-4 thereunder.\2\ The proposed rule change was published
for comment in the Federal Register on November 7, 2012.\3\ The
Commission received no comment letters. This order approves the
proposed rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Securities Exchange Act Release No. 68130 (November 1,
2012), 77 FR 66900 (November 7, 2012). OCC also filed an advance
notice relating to these proposed changes. See Securities Exchange
Act Release No. 68225 (November 14, 2012), 77 FR 69668 (November 20,
2012). The Commission did not receive any comments on this
publication.

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II. Description of the Proposed Rule Change

A. Background

    On September 23, 2011, the Commission approved a proposed rule
change by OCC to establish the size of OCC's clearing fund as the
amount that is required, within a confidence level selected by OCC, to
sustain the maximum anticipated loss under a defined set of scenarios
as determined by OCC, subject to a minimum clearing fund size of $1
billion.\4\ OCC implemented this change in May 2012. Until that time,
the size of OCC's clearing fund was calculated each month as a fixed
percentage of the average total daily margin requirement for the
preceding month, provided that the calculation resulted in a clearing
fund of $1 billion or more.\5\
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    \4\ Securities Exchange Act Release No. 34-65386 (September 23,
2011), 76 FR 60572 (September 29, 2011) (SR-OCC-2011-10).
    \5\ If the calculation did not result in a clearing fund size of
$1 billion or more, then the percentage of the average total daily
margin requirement for the preceding month that resulted in a fund
level of at least $1 billion would be applied. However, in no event
was the percentage permitted to exceed 7%. With the rule change
approved in September 2011, this 7% limiting factor on the minimum
clearing fund size was eliminated.
---------------------------------------------------------------------------

    Under the formula that is implemented for determining the size of
the clearing fund as a result of the May 2012 change, OCC's Rules
provide that the amount of the fund is equal to the larger of the
amount of the charge to the fund that would result from (i) a default
by the single ``clearing member group'' \6\ whose default would be
likely to result in the largest draw against the clearing fund or (ii)
an event involving the near-simultaneous default of two randomly-
selected ``clearing member groups'' in each case as calculated by OCC
with a confidence level selected by OCC.\7\ The size of the clearing
fund continues to be recalculated monthly, based on a monthly averaging
of daily calculations for the previous month, and it is subject to a
requirement that its minimum size may not be less than $1 billion.
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    \6\ The term ``clearing member group'' is defined in OCC's By-
Laws to mean a clearing member and any member affiliates of the
clearing member.
    \7\ The confidence levels employed by OCC in calculating the
charge likely to result from a default by OCC's largest ``clearing
member group'' and the default of two randomly-selected ``clearing
member groups'' were approved by the Commission at 99% and 99.9%,
respectively. However, the Commission approval order notes that OCC
retains discretion to employ different confidence levels in these
calculations provided that OCC will not employ confidence levels of
less than 99% without first filing a proposed rule change.
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B. Proposed Rule Change

    The proposed rule change will implement a minimum clearing fund
size equal to 110% of the amount of committed credit facilities secured
by the clearing fund so that the amount of the clearing fund likely
will exceed the required collateral value that would be necessary for
OCC to be able to draw in full on such credit facilities. OCC's
clearing fund is primarily intended to provide a high degree of
assurance that market integrity will be maintained in the event that
one or more clearing members, settlement banks, or banks that issue
letters of credit on behalf of clearing members as a form of margin
fails to meet its obligations.\8\ This includes the potential use of
the clearing fund as a source of liquidity should it ever be the case
that OCC is unable to obtain prompt delivery of, or convert promptly to
cash, any asset credited to the account of a suspended clearing member.
---------------------------------------------------------------------------

    \8\ Under Article VIII, Section 1 of OCC's By-Laws, the clearing
fund may be used to pay losses suffered by OCC: (1) As a result of
the failure of a clearing member to perform its obligations with
regard to any exchange transaction accepted by OCC; (2) as a result
of a clearing member's failure to perform its obligations in respect
of an exchange transaction or an exercised/assigned options
contract, or any other contract or obligations in respect of which
OCC is liable; (3) as a result of the failure of a clearing member
to perform its obligations in respect of stock loan or borrow
positions; (4) as a result of a liquidation of a suspended clearing
member's open positions; (5) in connection with protective
transactions of a suspended clearing member; (6) as a result of a
failure of any clearing member to make any other required payment or
to render any other required performance; or (7) as a result of a
failure of any bank or securities or commodities clearing
organization to perform its obligations to OCC.
---------------------------------------------------------------------------

    OCC's committed credit facilities are secured by assets in the
clearing fund and certain margin deposits of the suspended clearing
member. In light of the uncertainty regarding the amount of margin
assets of a suspended clearing member that might be eligible at any
given point to support borrowing under the secured credit facilities,
OCC has considered the availability of funds based on a consideration
of the amount of the clearing fund deposits available as collateral. As
an example, for OCC to draw on the full amount of its current credit
facilities secured by the clearing fund, the size of the clearing fund
likely would need to be approximately $2.2 billion. The $2.2 billion
figure reflects a 10% increase above the total size of such credit
facilities, which is meant to account for the percentage discount
applied to collateral pledged by OCC in determining the amount
available for borrowing.
    Based on monthly recalculation information, the size of OCC's
clearing fund during the period from July 2011 to July 2012 was less
than $2.2 billion on eight occasions. Therefore, to reduce the risk
that the assets in the clearing fund might at any time be insufficient
to enable OCC to meet potential liquidity needs by accessing the full
amount of its committed credit facilities that are secured by the
clearing fund, OCC is amending the current minimum clearing fund size
requirement of $1 billion by providing instead that the minimum
clearing fund size is the greater of either $1 billion or 110% of the
amount of such committed credit facilities. OCC is denoting the credit
facility component of the minimum clearing fund requirement as a
percentage of the total amount of the credit facilities that OCC
actually secures with clearing fund assets because OCC negotiates these
credit facility agreements, including size and other terms, on an
annual basis and the total size is therefore subject to change.

III. Discussion

    Section 17A(b)(3)(F) of the Act \9\ requires that, among other
things, that the rules of a clearing agency are designed to promote the
prompt and accurate clearance and settlement of securities transactions
and, to the extent applicable, derivative agreements, contracts, and
transactions, and to safeguard securities and funds in its custody or
control or for which it is responsible. The proposed rule change will
further these ends by requiring a minimum clearing fund size that is
designed to enable OCC to draw in full on its committed credit
facilities that are secured by the clearing fund.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

IV. Conclusion

    On the basis of the foregoing, the Commission finds that the
proposal is consistent with the requirements of the Act and in
particular with the requirements of Section 17A of the Act \10\ and the
rules and regulations thereunder.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78q-1.
---------------------------------------------------------------------------

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\11\ that the proposed rule change (File No. SR-OCC-2012-19) be and
hereby is approved \12\ as of the date of this order or the date of the
``Notice of No Objection to Advance Notice Filing to Revise the Method
for Determining the Minimum Clearing Fund Size to Include Consideration
of the Amount Necessary to Draw on Secured Credit Facilities''

(File No. AN-OCC-2012-04), whichever is later.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(2).
    \12\ In approving the proposed rule change, the Commission
considered the proposal's impact on efficiency, competition, and
capital formation. 15 U.S.C. 78c(f).
    \13\ 17 CFR 200.30-3(a)(12).

    For the Commission by the Division of Trading and Markets,
pursuant to delegated authority.\13\
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-30689 Filed 12-19-12; 8:45 am]
BILLING CODE 8011-01-P