[Federal Register Volume 77, Number 247 (Wednesday, December 26, 2012)]
[Rules and Regulations]
[Pages 75885-75891]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-30723]
[[Page 75885]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 71
[Docket No. CDC-2012-0017]
RIN 0920-AA12
Control of Communicable Diseases: Foreign; Scope and Definitions
AGENCY: Centers for Disease Control and Prevention (HHS/CDC),
Department of Health and Human Services (HHS).
ACTION: Direct Final Rule and request for comments.
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SUMMARY: Through this Direct Final Rule, the Centers for Disease
Control and Prevention (CDC), located within the Department of Health
and Human Services (HHS) is updating and reorganizing the Scope and
Definitions for foreign quarantine regulations and add a new section to
contain definitions for Importations. This Direct Final Rule (DFR) will
update the scope and definitions to reflect modern terminology and
plain language used globally by industry and public health partners. As
part of the update, we are updating five existing definitions; adding
thirteen new definitions to help clarify existing provisions; creating
a new scope and definitions section for Importations under a new
section by reorganizing existing definitions into this new section; and
updating regulations to reflect the language used by the most recent
Executive Order regarding quarantinable communicable diseases.
DATES: The direct final rule is effective on February 25, 2013 unless
significant adverse comment is received by January 25, 2013. If we
receive no significant adverse comments within the specified comment
period, we intend to publish a document confirming the effective date
of the final rule in the Federal Register within 30 days after the
comment period on this DFR ends. If we receive any timely significant
adverse comment, we will withdraw this final rule in part or in whole
by publication of a document in the Federal Register within 30 days
after the comment period ends.
ADDRESSES: You may submit comments, identified by ``RIN 0920-AA12'': by
any of the following methods:
Internet: Access the Federal e-Rulemaking Portal at http://www.regulations.gov. Follow the instructions for submitting comments.
Mail: Division of Global Migration and Quarantine, Centers
for Disease Control and Prevention, 1600 Clifton Road NE., MS-03,
Atlanta, Georgia 30333, ATTN: Part 71 DFR.
Instructions: All submissions received must include the agency name
and docket number or Regulation Identifier Number (RIN) for this
rulemaking. All relevant comments will be posted without change to
http://regulations.gov, including any personal information provided.
For detailed instructions on submitting comments and additional
information on the rulemaking process, see the ``Public Participation''
heading of the SUPPLEMENTARY INFORMATION section of this document.
Docket: For access to the docket to read background documents or
comments received, please go to http://www.regulations.gov. Comments
will also be available for public inspection Monday through Friday,
except for legal holidays, from 9 a.m. until 5 p.m., Eastern Standard
Time, at 1600 Clifton Road NE., Atlanta, Georgia 30333. Please call
ahead to 1-866-694-4867 and ask for a representative in the Division of
Global Migration and Quarantine (DGMQ) to schedule your visit. To
download an electronic version of the rule, access http://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: For questions concerning this direct
final rule: Ashley A. Marrone, JD, Centers for Disease Control and
Prevention, 1600 Clifton Road NE., Mailstop E-03, Atlanta, Georgia
30333; telephone 404-498-1600.
SUPPLEMENTARY INFORMATION: HHS/CDC is publishing a direct final rule
(DFR) because it does not expect to receive any significant adverse
comments and believes that updating scope and definitions to add
clarity to the regulations is non-controversial. However, in this
Federal Register, HHS/CDC is simultaneously publishing a companion
notice of proposed rulemaking (NPRM) that proposes identical updates.
If HHS/CDC does not receive any significant adverse comments on this
DFR within the specified comment period, we will publish a document in
the Federal Register confirming the effective date of this final rule
within 30 days after the comment period on the DFR ends and withdraw
the NPRM. If HHS/CDC receives any timely significant adverse comment,
we will withdraw the DFR in part or in whole by publication of a
document in the Federal Register within 30 days after the public
comment period ends. If the DFR is withdrawn, we will carefully
consider all public comments before proceeding with any subsequent
final rule based on the NPRM. A significant adverse comment is one that
explains: (1) Why the DFR is inappropriate, including challenges to the
rule's underlying premise or approach; or (2) why the DFR will be
ineffective or unacceptable without a change.
This preamble is organized as follows:
I. Public Participation
II. Authority for These Regulations
III. Rationale for Direct Final Rule
IV. Updates to 42 CFR 71.1, 71.32(a) and 71.50
V. Scope and Definitions for Section 71.1
A. Definitions Updated under Section 71.1
B. Definitions Added to Section 71.1
VI. Update of Section 71.32(a)
VII. Scope and Definitions for Section 71.5
A. Definitions Added to Section 71.50
VIII. Alternatives Considered
IX. Required Regulatory Analysis
A. Required Regulatory Analyses under Executive Orders 12866 and
13563
B. Regulatory Flexibility Act
C. Small Business Regulatory Enforcement Fairness Act of 1996
D. The Paperwork Reduction Act of 1995
E. National Environmental Policy Act (NEPA)
F. Civil Justice Reform (Executive Order 12988)
G. Executive Order 13132 (Federalism)
H. Plain Language Act of 2010
I. Public Participation.
Interested persons are invited to participate in this rulemaking by
submitting written views, opinions, recommendations, and data. Comments
received, including attachments and other supporting materials, are
part of the public record and subject to public disclosure. Do not
include any information in your comment or supporting materials that
you do not wish to be disclosed publicly. Comments are invited on any
topic related to this DFR.
II. Authority for These Regulations.
The primary authority supporting this rulemaking is section 361 of
the Public Health Service Act (42 U.S.C. 264). Section 361 authorizes
the Secretary of HHS to make and enforce regulations as in the
Secretary's judgment are necessary to prevent the introduction,
transmission, or spread of communicable diseases from foreign countries
into the states or possessions of the United States and from one state
or possession into any other state or possession. Regulations that
implement federal quarantine authority are currently promulgated in 42
CFR Parts 70 and 71. Part 71 contains regulations to prevent the
introduction, transmission, and spread of communicable diseases into
the states and possessions of the United States, while Part 70 contains
regulations to
[[Page 75886]]
prevent the introduction, transmission, or spread of communicable
diseases from one state into another. CDC is updating the term
``possession'' to ``territory.'' The U.S. Department of the Interior's
Office of Insular Affairs, the lead federal agency on issues involving
the territories, no longer uses the term ``possession'' to refer to the
insular areas. Therefore, CDC is adopting the predominant term
``territory'' consistent with how other federal agencies use this term.
The Secretary has delegated to the Director of the Centers for Disease
Control and Prevention the authority for implementing these
regulations.
Authority for carrying out most of these functions has been
delegated to HHS/CDC's Division of Global Migration and Quarantine
(DGMQ). The Secretary's authority to apprehend, examine, detain, and
conditionally release individuals is limited to those quarantinable
communicable diseases published in an Executive Order of the President.
This list currently includes cholera, diphtheria, infectious
tuberculosis (TB), plague, smallpox, yellow fever, and viral
hemorrhagic fevers, such as Marburg, Ebola, and Crimean-Congo
hemorrhagic fever (CCHF), Severe Acute Respiratory Syndrome (SARS), and
influenza caused by novel or re-emergent influenza viruses that are
causing or have the potential to cause a pandemic (see Executive Order
13295, as amended by Executive Order 13375 on April 1, 2005).
III. Rationale for Direct Final Rule
Through this Direct Final Rule (DFR), HHS/CDC is updating the scope
and definitions to part 71 to reflect modern science and current
practices. HHS/CDC has chosen to publish a DFR because we view this as
a non-controversial action and anticipate no significant adverse
comment. This DFR does not create any additional requirements or burden
upon the regulated community nor does it alter current HHS/CDC
practices.
A significant adverse comment is one that explains: (1) Why the DFR
is inappropriate, including challenges to the rule's underlying premise
or approach; or (2) why the DFR will be ineffective or unacceptable
without a change. In determining whether a comment necessitates
withdrawal of this DFR, HHS/CDC will consider whether it warrants a
substantive response through a notice and comment process. If we
receive significant adverse comment on this DFR, we will publish a
timely withdrawal in the Federal Register informing the public that the
amendments in this rule will not take effect. If this DFR is withdrawn,
we will carefully consider all public comments before proceeding with
any subsequent final rule based on the NPRM which is being published
simultaneously in the Federal Register.
IV. Updates to 42 CFR 71.1, 71.32(a) and 71.50
Through this DFR, HHS/CDC is updating the Scope and Definitions for
42 CFR Part 71 under section 71.1 and adding a new section 71.50, to
reflect modern terminology and plain language commonly used by global
private sector industry and public health partners. Specifically, we
are updating five existing definitions, adding thirteen new definitions
to help clarify existing provisions, and creating a new scope and
definitions section within Part 71, under subpart F for Importations,
by reorganizing certain existing definitions. In updating the
definitions in Part 71, it became evident to us that certain
definitions pertain more directly to Importations under subpart F than
to Part 71 in general; therefore, we decided to reorganize the existing
definitions by creating a new section 71.50 for this subpart to better
clarify these terms for importers. We are also adding new definitions
that have been crafted for section 71.50 to help clarify the intent of
certain provisions under subpart F.
Finally, as part of the changes to definitions, we are also
updating section 71.32(a) to incorporate the most recent listing of
quarantinable communicable diseases under Executive Order 13295, of
April 4, 2003, as amended by Executive Order 13375 of April 1, 2005.
These changes are not substantive and will not affect current
practices.
V. Scope and Definitions for Part 71.1
Section 71.1(a) has been updated to include the current interstate
quarantine regulations administered by HHS/CDC found at ``42 CFR part
70'' to the existing cross-reference citing ``21 CFR parts 1240 and
1250.''
On August 16, 2000, the Secretary transferred certain authority for
interstate control of communicable disease, including the authority to
apprehend, examine, detain, and conditionally release individuals
moving from one state into another from HHS/Food and Drug
Administration (FDA) to CDC, which became 42 CFR Part 70. As part of
this transfer, FDA retained regulatory authority over animals and other
products that may transmit or spread communicable disease. These other
regulations may be found at 21 CFR parts 1240 and 1250. This rule has
no effect upon FDA's regulatory authority. Accordingly, the new scope
will read: ``The provisions of this part contain the regulations to
prevent the introduction, transmission, and spread of communicable
disease from foreign countries into the States or territories (also
known as possessions) of the United States. Regulations pertaining to
preventing the interstate spread of communicable diseases are contained
in 21 CFR parts 1240 and 1250 and 42 CFR part 70.''
Current section 71.1 (b) Definitions contains definitions used in
the current CFR. This DFR adds new definitions and updates certain
definitions for clarification and to be consistent with current
industry and public health principles and practice.
Table 1 list the definitions found in the current 42 CFR part 71,
subpart A, and compares them with the updated definitions in this DFR.
Table 1--Subpart A--Foreign Quarantine
Definitions and Corresponding Changes in Definitions in the DFR
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Corresponding, new or updated
Existing definitions in 42 CFR 71.1 definition in DFR
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Carrier................................ No Change.
Commander.
Communicable disease................... No Change.
Contamination.......................... No Change.
Controlled Free Pratique............... No Change.
Deratting Certificate.................. No Change.
Deratting Exemption Certificate........ No Change.
Detention.............................. No Change.
Director............................... No Change.
Disinfection........................... No Change.
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Disinfestation......................... No Change.
Disinsection........................... No Change.
Educational Purpose.................... Moved to new 71.50.
Exhibition Purpose..................... Moved to new 71.50.
Ill person............................. No Change.
International Health Regulations....... Updated.
International voyage................... No Change.
Isolation.............................. Updated.
Military Services...................... No Change.
Quarantine.
Quarantinable Communicable
disease.
Possession.
Scientific Purpose..................... Moved to new 71.50.
Surveillance........................... Updated.
U.S. port.............................. No Change.
U.S. Territory.
United States.......................... Updated.
Vector................................. Updated.
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A. Definitions Updated Under Section 71.1
International Health Regulations or IHR. This DFR defines
International Health Regulations or IHR as the International Health
Regulations of the World Health Organization (WHO), adopted by the 58th
World Health Assembly in 2005, as may be further amended, and subject
to the United States' reservation and understandings. The DFR updates
the current CFR's definition to reflect that the 1969 IHR, as amended
in 1973 and 1981 by the World Health Assembly, has been superseded by
the 2005 IHR currently in place. This definition also reflects that the
United States accepted the IHR with the reservation that it will
implement them in line with U.S. principles of federalism. In addition,
the United States submitted three understandings, setting forth its
views that: (1) Incidents that involve the natural, accidental or
deliberate release of chemical, biological or radiological materials
are notifiable under the IHR; (2) countries that accept the IHR are
obligated to report potential public health emergencies that occur
outside their borders to the extent possible; and (3) the IHR do not
create any separate private right to legal action against the federal
government.
Isolation. The DFR defines the term ``isolation'' as the separation
of an individual or group of individuals who are reasonably believed to
be infected with a quarantinable communicable disease from others who
are healthy in such a manner as to prevent the spread of the
quarantinable communicable disease. The current definition of
``isolation,'' when applied to an individual or group of individuals,
is stated as ``the separation of that person or group of persons from
other persons, except the health staff on duty, in such a manner as to
prevent the spread of infection.'' Not only does the updated definition
help to clarify the distinction between quarantine and isolation, but
it removes the current reference to ``health staff on duty'' to which
the separation does not apply. HHS/CDC believes that the reference to
``health staff on duty'' is unnecessary and outmoded because, in
practice, a patient may have his or her needs attended to by a variety
of individuals. The new definition focuses on the measures used to
prevent the spread of infection and not on the types of individuals who
may attend to the patient. This is not a substantive change from
current practice.
Surveillance. Under this DFR, ``surveillance'' is defined as the
temporary supervision by a public health official (or designee) of an
individual or group, who may have been exposed to a quarantinable
communicable disease, to determine the risk of disease spread. We have
updated the term ``surveillance'' to more accurately reflect current
practice and to clarify that, just as with quarantine and isolation,
this public health measure is applicable to individuals and groups of
individuals.
United States. We have updated the definition of ``United States''
to mean the 50 States, the District of Columbia, and the territories
(also known as possessions) of the United States, including American
Samoa, Guam, the Northern Mariana Islands, the Commonwealth of Puerto
Rico, and the U.S. Virgin Islands. We have taken this action to better
clarify the authority of provisions within Part 71. The current
definition includes the Trust Territory of the Pacific Islands, which
have not been administered by the United States since 1986.
Vector. We have updated the term ``vector'' to be defined as any
animals (vertebrate or invertebrate) including arthropods or any
noninfectious self-replicating system (e.g., plasmids or other
molecular vector) or animal products that are known to transfer, or are
capable of transferring, an infectious biological agent to a human. To
provide further clarity, we have defined the term ``animal products''
in subpart F. This revision more adequately reflects modern science and
current practice which are focused on protecting public health.
B. Definitions Added to Section 71.1
Commander. Consistent with current industry practice, this DFR
defines ``commander'' as the aircrew member with responsibility for the
aircraft's operations and navigation.
Quarantine. ``Quarantine'' is defined as the separation of an
individual or group of individuals who are reasonably believed to have
been exposed to a quarantinable communicable disease, but who are not
yet ill, from others who have not been so exposed, in such a manner as
to prevent the possible spread of the quarantinable communicable
disease. HHS/CDC is separately defining quarantine, isolation, and
surveillance, and is using these terms in a manner that is consistent
with public health practice. In current practice, quarantine,
isolation, and surveillance may apply either to individuals or groups
of individuals. Indeed, the current definition of Isolation in 42 CFR
71.1
[[Page 75888]]
applies to ``a person or group of persons.'' HHS/CDC is clarifying that
quarantine and surveillance are public health practices that may also
be applied to groups of individuals. This is not a substantive change,
but rather consistent with CDC's current practice.
Quarantinable communicable disease. ``Quarantinable communicable
disease'' is defined as any of the communicable diseases listed in an
Executive Order, as provided under section 361 of the Public Health
Service Act (42 U.S.C. 264). Executive Order 13295, of April 4, 2003,
as amended by Executive Order 13375 of April 1, 2005, contains the
current revised list of quarantinable communicable diseases, and may be
obtained at http://www.cdc.gov and http://www.archives.gov/federal--
register. If this Order is amended, HHS will enforce that amended order
immediately and update the appropriate Web site. A new definition for
``quarantinable communicable disease'' is being added to part 71
through this DFR to incorporate the most recent Executive Order. The
addition of this new definition will also be reflected in section
71.32(a), Persons, carriers and things.
Possession. To best add clarity to part 71 and to align this part
with 42 CFR part 70, we have updated the term ``possession'' to mean
``U.S. territory'' and defined U.S. territory to include American
Samoa, Guam, the Commonwealth of the Northern Mariana Islands, the
Commonwealth of Puerto Rico, and the U.S. Virgin Islands. Currently,
only Puerto Rico and the Virgin Islands are explicitly listed in the
definition. Thus, CDC is updating this provision to explicitly list the
other U.S. jurisdictions to which this part applies.
U.S. territory. Under this DFR, ``U.S. territory'' means any
territory (also known as possessions) of the United States including
American Samoa, Guam, the Commonwealth of the Northern Mariana Islands,
the Commonwealth of Puerto Rico, and the U.S. Virgin Islands. The
Department of the Interior's Office of Insular Affairs, the federal
government's lead agency for U.S. territories, no longer uses the term
``possession'' to refer to these jurisdictions. Consequently, HHS/CDC
is adding a new definition for U.S. territory consistent with current
federal usage.
VI. Update of Section 71.32(a)
In 2003, in response to the emergence of Severe Acute Respiratory
Syndrome (SARS), HHS amended 42 CFR 70.6 and 71.32 to incorporate by
reference the Executive Order listing the quarantinable communicable
diseases subject to detention, isolation, quarantine, or conditional
release, thereby eliminating the administrative delay involved in
separately publishing the list of diseases through rulemaking.
Section 71.32(a), Persons, carriers, and things, contains the
general authority for the Director to take measures to protect public
health against ``any of the communicable diseases listed in an
Executive Order, as provided under section 361(b) of the Public Health
Service Act.'' The current Sec. 71.32(a) lists Executive Order (E.O.)
13295, of April 4, 2003. The subpart states that ``If this Order is
amended, HHS will enforce that amended order.''
On April 1, 2005, the existing Executive Order was amended by
Executive Order 13375. Therefore, as part of the non-controversial
changes in this DFR, we are also updating section 71.32(a) to reflect
the most recent Executive Order that lists the ``Quarantinable
Communicable Diseases,'' which we have also defined. These changes are
not substantive and will not affect current practices.
VII. Scope and Definitions for Section 71.50
This DFR moves certain definitions from section 71.1 to new section
71.50, because these definitions only apply to the regulations found in
subpart F, Importations. Subpart F, Importations, contains the
restrictions on importations of nonhuman primates; certain kinds of
animals; etiological agents, hosts, and vectors; and dead bodies. The
addition of Sec. 71.50 Scope and Definitions is not a substantive
change. To clarify the regulations for the reader, the terms used only
in subpart A through subpart G are found in Sec. 71.1, while the terms
used only in subpart F, have been moved to new Sec. 71.50. We have
also separated definitions for quarantine and isolation to reflect
current practices as they apply to individuals (Sec. 71.1) and animals
(Sec. 71.50).
Section 71.50(a) Scope under subpart F--Importations, clarifies
that HHS/CDC also has the statutory authority to prevent the
introduction, transmission, and spread of communicable human diseases
resulting from importations of various animal hosts, product, vectors,
or other etiological agents that pose a threat to human health.
Section 71.50(b) Definitions contains updated definitions used in
the current CFR. The DFR promulgates new and updated definitions to be
consistent with current medical and public health principles and
practice.
Table 2 lists the definitions found in the 42 CFR part 71, subpart
A, prior to the DFR and the definitions retained in this final rule.
Table 2--Subpart F--Importations
Definitions and Corresponding Changes in Definitions in the DFR
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Corresponding, new and modified
Existing definitions in 42 CFR 71.1 definition in DFR Sec. 71.50
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Animal product or Product.
Educational purpose.................... No Change.
Exhibition purpose..................... No Change.
In transit.
Isolation, when applied to
animals.
Licensed Veterinarian.
Person.
Quarantine, when applied to
animals.
Rendered Noninfectious.
Scientific purpose..................... No Change.
You or Your.
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A. Definitions Added to Section 71.50
Animal Product or Product. We have defined the term ``animal
product'' or ``product'' to describe those items that are known to
transfer, or are capable of transferring, an infectious biological
agent to a human and that are prohibited from entering the United
States unless accompanied by a permit
[[Page 75889]]
or rendered noninfectious. For the purposes of this DFR, ``animal
product'' or ``product'' means the hide, hair, skull, teeth, bones,
claws, blood, tissue, or other biological samples from an animal,
including trophies, mounts, rugs, or other display items. We have added
this definition, which is used in subpart F, to best describe the
current prohibition on animal products that are known to transfer, or
are capable of transferring, an infectious biological agent to a human
and that as a condition of entry into the United States must be
accompanied by a permit or rendered noninfectious.
In transit. In this DFR, we have defined ``in transit'' as animals
that are located within the United States, including animals whose
presence is anticipated, scheduled, or otherwise, as part of the
movement of those animals between a foreign country of departure and
foreign country of final destination without clearing customs and
officially entering the United States. As part of modern global trade
and travel practices, animals commonly pass through the United States
without being formally admitted into this country. These animals pose a
potential risk to U.S. public health where the improper handling of
these shipments during exchange of cargo could introduce zoonotic
diseases into the United States. We note that the term ``in-transit''
is currently only found in section 71.51 relating to the importation of
dogs and cats and we believe it is useful to add clarity to this
section by defining what is meant by this term.
Isolation, when applied to animals. To distinguish the concept of
isolation for individuals from isolation of animals, we have defined
``isolation'' under this subpart to mean the separation of an ill
animal or ill group of animals from individuals, other animals, or
vectors of disease in such a manner as to prevent the spread of
infection.
Licensed Veterinarian. We have defined ``licensed veterinarian'' to
mean an individual who has obtained both an advanced degree and a valid
license to practice animal medicine. This new definition best describes
the intent of provisions of this subpart.
Person. We have defined ``person'' to mean any individual or
partnership, firm, company, corporation, association, organization, or
similar legal entity, including those that are not-for-profit. With the
exception of 42 C.F.R. section 71.55, which refers to the imported
remains of a natural person, this definition is intended to clarify the
relevant import prohibitions applicable to individuals and
organizations under this subpart.
Quarantine, when applied to animals. We have defined ``quarantine''
as it applies to animals as the practice of separating live animals
that are reasonably believed to have been exposed to a communicable
disease, but are not yet ill, in a setting where the animal can be
observed for evidence of disease, and where measures are in place to
prevent transmission of infection to humans or animals. This new
definition best clarifies the current public health measure of
quarantining animals, and it distinguishes it from public health
practice of isolation when applied to animals.
Render Noninfectious. For purposes of this DFR, to ``render
noninfectious'' means ``treating an animal product (e.g., by boiling,
irradiating, soaking, formalin fixation, or salting) in such a manner
that renders the product incapable of transferring an infectious
biological agent to a human.''
Acceptable methods of rendering a product noninfectious typically
include the following:
(1) Boiling in water to ensure that any matter other than bone,
horns, hooves, claws, antlers, or teeth is removed,
(2) Irradiating with gamma irradiation at a dose of at least 20
kilogray at room temperature (20[deg] C or higher),
(3) Soaking, with agitation, in a 4 percent (weight/volume)
solution of washing soda (sodium carbonate,
Na2CO3) maintained at pH 11.5 or above for at
least 48 hours,
(4) Soaking, with agitation, in a formic acid solution (100 kg salt
[sodium chloride, NaCl] and 12 kg formic acid per 1,000 liters water)
maintained at below pH 3.0 for at least 48 hours; wetting and dressing
agents may be added.
(5) In the case of raw hides, salting for at least 28 days with sea
salt containing 2 percent washing soda (sodium carbonate,
Na2CO3).
(6) Formalin fixation.
(7) Another method approved by HHS/CDC.
Through this definition within the DFR, HHS/CDC is better
clarifying and explaining existing practices that limit the importation
of animal products that are known to transfer, or are capable of
transferring, an infectious biological agent to a human. Such products
must be accompanied by an HHS/CDC import permit or rendered
noninfectious as a condition of entry into the United States. Items
that have been rendered noninfectious, as described in this subpart,
may be imported without an HHS/CDC permit.
You or your. To best identify and assign responsibilities under
this subpart, we have defined the terms ``you'' or ``your'' to mean an
importer, owner, or an applicant.
VIII. Alternatives Considered
Under Executive Order 13563 agencies are asked to consider all
feasible alternatives to current practice and the rulemaking. HHS/CDC
notes that the main impact of the DFR is to clarify the current
practices and intent of HHS/CDC by updating and defining terms used in
the existing 42 CFR Part 71. As explained in Section III. ``Rationale
for Updates to 42 CFR 71.1, 71.32(a) and 71.50,'' through this DFR,
HHS/CDC is also updating the Scope and Definitions for 42 CFR Part 71
under sections 71.1 and add new section 71.50, to reflect modern
terminology and plain language commonly used by global private sector
industry and public health partners. By clarifying and explaining the
provisions within part 71, HHS/CDC hopes to assist the regulated
community in complying with the provisions to best protect public
health. HHS/CDC believes that this rulemaking complies with the spirit
of the Executive Order; updating definition and clarifying language
provides good alternatives to the current regulation.
IX. Required Regulatory Analyses
A. Required Regulatory Analyses under Executive Orders 12866 and 13563
Under Executive Order 12866 (EO 12866), Regulatory Planning and
Review (58 FR 51735, October 4, 1993) CDC is required to determine
whether this regulatory action would be ``significant'' and therefore
subject to review by the Office of Management and Budget (OMB) and the
requirements of the Executive Orders. This order defines ``significant
regulatory action'' as any regulatory action that is likely to result
in a rule that may:
Have an annual effect on the economy of $100 million or
more or adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or state, local, or tribal governments or
communities;
Create a serious inconsistency or otherwise interfere with
an action taken or planned by another agency;
Materially alter the budgetary impact of entitlements,
grants, user fees, or loan programs or the rights and obligations of
recipients; or,
Raise novel legal or policy issues arising out of legal
mandates, the
[[Page 75890]]
President's priorities, or the principles set forth in EO 12866.
Executive Order 13563 (EO 13563), Improving Regulation and
Regulatory Review, (76 FR 3821, January 21, 2011), updates some of the
provisions of EO 12866 in order to promote more streamlined regulatory
actions. This EO charges, in part, that, while protecting ``public
health, welfare, safety, and our environment'' that regulations must
also ``promote predictability and reduce uncertainty'' in order to
promote economic growth. Further, regulations must be written in common
language and be easy to understand. In the spirit of EO 13563, this DFR
enhances definitions related to control of communicable diseases and
adds more recent medical information where appropriate. CDC has
determined that this DFR is an update of definitions and compliant with
the spirit of EO 13563. Further, CDC has determined that this DFR is
not a significant regulatory action as defined in EO 12866 because the
DFR is definitional and does not change the baseline costs for any of
the primary stakeholders.
B. Regulatory Flexibility Act
We have examined the impacts of the rule under the Regulatory
Flexibility Act (5 U.S.C. 601-612). Unless we certify that the rule is
not expected to have a significant economic impact on a substantial
number of small entities, the Regulatory Flexibility Act (RFA), as
amended by the Small Business Regulatory Enforcement Fairness Act
(SBREFA), requires agencies to analyze regulatory options that would
minimize any significant economic impact of a rule on small entities.
We certify that this rule will not have a significant economic impact
on a substantial number of small entities within the meaning of the
RFA.
C. Small Business Regulatory Enforcement Fairness Act of 1996
This regulatory action is not a major rule as defined by Sec. 804
of the Small Business Regulatory Enforcement Fairness Act of 1996. This
rule will not result in an annual effect on the economy of $100,000,000
or more; a major increase in cost or prices; or significant adverse
effects on competition, employment, investment, productivity,
innovation, or on the ability of United States-based companies to
compete with foreign-based companies in domestic and export markets.
D. The Paperwork Reduction Act of 1995
HHS/CDC has determined that the Paperwork Reduction Act does apply
to the date collection and record keeping requirements of 42 CFR Part
71 and has obtained approval by the Office of Management and Budget
(OMB) under OMB Control No. 0920-0134, expiration 07/31/2015. The
updates in this rule do not impact the data collection and record
keeping requirements already approved by OMB.
E. National Environmental Policy Act (NEPA)
Pursuant to 48 FR 9374 (list of HHS/CDC program actions that are
categorically excluded from the NEPA environmental review process),
HHS/CDC has determined that this action does not qualify for a
categorical exclusion. In the absence of an applicable categorical
exclusion, the Director, HHS/CDC, has determined that provisions
amending 42 CFR Part 71 will not have a significant impact on the human
environment. Therefore, neither an environmental assessment nor an
environmental impact statement is required.
F. Civil Justice Reform (Executive Order 12988)
This rule has been reviewed under Executive Order 12988, Civil
Justice Reform. Under this rule: (1) All State and local laws and
regulations that are inconsistent with this rule will be preempted; (2)
no retroactive effect will be given to this rule; and (3)
administrative proceedings will not be required before parties may file
suit in court challenging this rule.
G. Executive Order 13132 (Federalism)
HHS/CDC has reviewed this rule in accordance with Executive Order
13132 regarding Federalism, and has determined that it does not have
``federalism implications.'' The rule does not ``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.''
H. Plain Language Act of 2010
Under Public Law 111-274 (October 13, 2010), executive Departments
and Agencies are required to use plain language in documents that
explain to the public how to comply with a requirement the Federal
Government administers or enforces. HHS/CDC has attempted to use plain
language in promulgating this rule consistent with the Federal Plain
Writing Act and requests public comment on this effort.
List of Subjects in 42 CFR Part 71
Communicable diseases, Isolation, In transit, Public health,
Quarantine, Quarantinable communicable disease, Render noninfectious.
Amended Text
For the reasons discussed in the preamble, the Centers for Disease
Control and Prevention amends 42 CFR part 71 as follows:
PART 71--FOREIGN QUARANTINE
0
1. The authority citation for part 71 continues to read as follows:
Authority: Secs. 215 and 311 of Public Health Service (PHS) Act,
as amended (42 U.S.C. 216, 243); secs. 361-369, PHS Act, as amended
(42 U.S.C. 264-272).
0
2. Amend Sec. 71.1 as follows:
0
a. Revise paragraph (a).
0
b. In paragraph (b), add in alphabetical order definitions of
Commander, Quarantine, Quarantinable communicable disease, and U.S.
territory.
0
c. In paragraph (b), revise definitions of International Health
Regulations, Isolation, Surveillance, United States, and Vector.
The revisions and additions read as follows:
Sec. 71.1 Scope and definitions.
* * * * *
(a) The provisions of this part contain the regulations to prevent
the introduction, transmission, and spread of communicable disease from
foreign countries into the States or territories (also known as
possessions) of the United States. Regulations pertaining to preventing
the interstate spread of communicable diseases are contained in 21 CFR
parts 1240 and 1250 and 42 CFR part 70.
(b) * * *
* * * * *
Commander means the aircrew member with responsibility for the
aircraft's operations and navigation.
* * * * *
International Health Regulations or IHR means the International
Health Regulations of the World Health Organization, adopted by the
Fifty-Eighth World Health Assembly in 2005, as may be further amended,
and subject to the United States' reservation and understandings.
* * * * *
Isolation means the separation of an individual or group who is
reasonably believed to be infected with a quarantinable communicable
disease
[[Page 75891]]
from those who are healthy to prevent the spread of the quarantinable
communicable disease.
* * * * *
Possession means U.S. territory.
Quarantine means the separation of an individual or group
reasonably believed to have been exposed to a quarantinable
communicable disease, but who is not yet ill, from others who have not
been so exposed, to prevent the possible spread of the quarantinable
communicable disease.
Quarantinable communicable disease means any of the communicable
diseases listed in an Executive Order, as provided under Sec. 361 of
the Public Health Service Act (42 U.S.C. Sec. 264). Executive Order
13295, of April 4, 2003, as amended by Executive Order 13375 of April
1, 2005, contains the current revised list of quarantinable
communicable diseases, and may be obtained at http://www.cdc.gov and
http://www.archives.gov/federal--register. If this Order is amended,
HHS will enforce that amended order immediately and update that Web
site.
Surveillance means the temporary supervision by a public health
official (or designee) of an individual or group, who may have been
exposed to a quarantinable communicable disease, to determine the risk
of disease spread.
* * * * *
U.S. territory means any territory (also known as possessions) of
the United States, including American Samoa, Guam, the Northern Mariana
Islands, the Commonwealth of Puerto Rico, and the U.S. Virgin Islands.
United States means the 50 States, District of Columbia, and the
territories (also known as possessions) of the United States, including
American Samoa, Guam, the Northern Mariana Islands, the Commonwealth of
Puerto Rico, and the U.S. Virgin Islands.
Vector means any animals (vertebrate or invertebrate) including
arthropods or any noninfectious self-replicating system (e.g., plasmids
or other molecular vector) or animal products that are known to
transfer, or are capable of transferring, an infectious biological
agent to a human.
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3. Revise Sec. 71.32(a) to read as follows:
Sec. 71.32 Persons, carriers, and things.
(a) Whenever the Director has reason to believe that any arriving
person is infected with or has been exposed to any of the communicable
diseases listed in an Executive Order, as provided under section 361(b)
of the Public Health Service Act, he/she may isolate, quarantine, or
place the person under surveillance and may order disinfection or
disinfestation, fumigation, as he/she considers necessary to prevent
the introduction, transmission or spread of the listed communicable
diseases. Executive Order 13295, of April 4, 2003, as provided under
section 361 of the Public Health Service Act (42 U.S.C. 264), and as
amended by Executive Order 13375 of April 1, 2005, contains the current
revised list of quarantinable communicable diseases, and may be
obtained at http://www.cdc.gov and http://www.archives.gov/federal-
register. If this Order is amended, HHS will enforce that amended order
immediately and update this reference.
* * * * *
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4. Add Sec. 71.50 to subpart F to read as follows:
Sec. 71.50--Scope and definitions.
(a) The purpose of this subpart is to prevent the introduction,
transmission, and spread of communicable human disease resulting from
importations of various animal hosts or vectors or other etiological
agents from foreign countries into the United States.
(b) In addition to terms in Sec. 71.1, the terms below, as used in
this subpart, shall have the following meanings:
Animal product or Product means the hide, hair, skull, teeth,
bones, claws, blood, tissue, or other biological samples from an
animal, including trophies, mounts, rugs, or other display items.
Educational purpose means use in the teaching of a defined
educational program at the university level or equivalent.
Exhibition purpose means use as part of a display in a facility
comparable to a zoological park or in a trained animal act. The animal
display must be open to the general public at routinely scheduled hours
on 5 or more days of each week. The trained animal act must be
routinely schedule for multiple performances each week and open to the
general public except for reasonable vacation and retraining periods.
In transit means animals that are located within the United States,
whether their presence is anticipated, scheduled, or not, as part of
the movement of those animals between a foreign country of departure
and foreign country of final destination without clearing customs and
officially entering the United States.
Isolation when applied to animals means the separation of an ill
animal or ill group of animals from individuals, or other animals, or
vectors of disease in such a manner as to prevent the spread of
infection.
Licensed veterinarian means an individual who has obtained both an
advanced degree and valid license to practice animal medicine.
Person means any individual or partnership, firm, company,
corporation, association, organization, or similar legal entity,
including those that are not-for-profit.
Quarantine when applied to animals means the practice of separating
live animals that are reasonably believed to have been exposed to a
communicable disease, but are not yet ill, in a setting where the
animal can be observed for evidence of disease, and where measures are
in place to prevent transmission of infection to humans or animals.
Render noninfectious means treating an animal product (e.g., by
boiling, irradiating, soaking, formalin fixation, or salting) in such a
manner that renders the product incapable of transferring an infectious
biological agent to a human.
Scientific purpose means use for scientific research following a
defined protocol and other standards for research projects as normally
conducted at the university level. The term also includes the use for
safety testing, potency testing, and other activities related to the
production of medical products.
You or your means an importer, owner, or an applicant.
Dated: December 13, 2012.
Kathleen Sebelius,
Secretary, Department of Health and Human Services.
[FR Doc. 2012-30723 Filed 12-21-12; 4:15 pm]
BILLING CODE 4163-18-P