[Federal Register Volume 77, Number 247 (Wednesday, December 26, 2012)]
[Rules and Regulations]
[Pages 75885-75891]
From the Federal Register Online via the Government Publishing 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.

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

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

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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
------------------------------------------------------------------------
                                          Corresponding, new or updated
  Existing definitions in 42 CFR 71.1           definition in DFR
------------------------------------------------------------------------
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.

[[Page 75887]]

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

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

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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
------------------------------------------------------------------------
                                         Corresponding, new and modified
  Existing definitions in 42 CFR 71.1     definition in DFR Sec.   71.50
------------------------------------------------------------------------
                                         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.
------------------------------------------------------------------------

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.

0
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.
* * * * *

0
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