[Federal Register Volume 77, Number 247 (Wednesday, December 26, 2012)]
[Proposed Rules]
[Pages 75939-75946]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-30725]


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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: Notice of Proposed Rulemaking and request for comments.

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SUMMARY: Through this Notice of Proposed Rulemaking (NPRM), the Centers 
for Disease Control and Prevention (CDC), located within the Department 
of Health and Human Services (HHS) is proposing to update and 
reorganize the Scope and Definitions for foreign quarantine regulations 
and add a new section to contain definitions for Importations. This 
NPRM proposes to update the Scope and Definitions to reflect modern 
terminology and plain language used globally by industry and public 
health partners. As part of the proposed updates, 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: Submit written or electronic comments by January 25, 2013.

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 NPRM.
    Instructions: All submissions received must include the agency name 
and docket number or Regulation Identifier Number (RIN) for this 
rulemaking. All

[[Page 75940]]

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 notice 
of proposed rulemaking: 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 simultaneously publishing a 
companion direct final rule (DFR) in the Federal Register that proposes 
identical updates because we believe that these requirements are non-
controversial and unlikely to generate significant adverse comment. If 
HHS/CDC does not receive any significant adverse comments on the DFR 
within the specified comment period, we will publish a document in the 
Federal Register withdrawing this NPRM and confirming the effective 
date of the DFR within 30 days after the public comment period on the 
DFR ends. 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 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. Proposed Updates to 42 CFR 71.1, 71.32(a) and 71.50
IV. Proposed Scope and Definitions for Section 71.1
    A. Definitions Updated Under Section 71.1
    B. Definitions Added to Section 71.1
V. Proposed Update of Section 71.32(a)
VI. Proposed Scope and Definitions for Section 71.50
    A. Definitions Added to Section 71.50
VII. Alternatives Considered
VIII. 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 NPRM.

II. Authority for These Regulations

    The primary authority supporting this rulemaking is section 361 of 
the Public Health Service Act (42 U.S.C. Sec.  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 prevent the introduction, transmission, or spread of 
communicable diseases from one state into another. CDC is proposing to 
update 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. Updates to 42 CFR 71.1, 71.32(a) and 71.50

    Through this Notice of Proposed Rulemaking (NPRM), HHS/CDC proposes 
to update 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 
have decided to reorganize the existing definitions by creating a new 
section 71.50 for this subpart to contain these definitions to better 
clarify the terms for importers. We are also adding new definitions for 
section 71.50 to clarify the intent of certain provisions under subpart 
F.
    Finally, as part of the proposed changes to definitions, we are 
also updating section 71.32(a) incorporate the most recent listing of 
quarantinable communicable diseases under Executive Order 13295, of 
April 4, 2003, as amended by Executive Order 13375 of

[[Page 75941]]

April 1, 2005. These proposed changes are not substantive and will not 
affect current practices.

IV. Proposed Scope and Definitions for Section 71.1

    Proposed 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 HHS/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 
proposed scope reads: ``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 of terms 
used in the current CFR. The NPRM proposes new or updated definitions 
for clarification and to be consistent with current industry and public 
health principles and practice.
    Table 1 lists the definitions found in the current 42 CFR part 71, 
subpart A, and compares them with the updated definitions in this NPRM.

                 Table 1--Subpart A--Foreign Quarantine
    Definitions and Corresponding Changes in Definitions in the NPRM
------------------------------------------------------------------------
                                                Corresponding, new or
 Existing definitions in Part 42 CFR 71.1    updated definition in NPRM
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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.
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 NPRM 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 NPRM proposes 
to update 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 NPRM proposes to update the term ``isolation'' to 
mean 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 necessary as to prevent the spread of infection.'' Not only does 
the updated definition help to clarify the distinction between

[[Page 75942]]

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 NPRM, HHS/CDC is proposing to define 
``surveillance'' 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 are proposing to update 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 are proposing to update 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 are 
proposing 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 propose to update 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 NPRM 
proposes to define ``commander'' as the aircrew member with 
responsibility for the aircraft's operations and navigation.
    Quarantine. HHS/CDC is proposing to separately define 
``quarantine'' as the separation of an individual or group of 
individuals who are reasonably believed to have been exposed to a 
quarantinable communicable disease, who are not 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 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. Under the proposed definition, 
``quarantinable communicable disease'' means 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/quarantine and 
http://www.archives.gov/federal_register. If this Order is amended, 
HHS/CDC will enforce that amended order immediately and update its 
appropriate Web site. A proposed definition for ``quarantinable 
communicable disease'' is being added to Part 71 through this NPRM to 
incorporate the most recent applicable Executive Order. The addition of 
this proposed 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 propose to update the term ``possession'' to 
mean ``U.S. territory'' and define 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. Consistent with current practice, this NPRM 
includes a proposed definition of ``U.S. territory'', to mean 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 proposing to add a new definition for U.S. territory consistent with 
current federal usage.

V. Proposed Update of Section 71.32(a)

    In 2003, in response to the emergence of Severe Acute Respiratory 
Syndrome (SARS), the 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 
proposed changes to in this NPRM, 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 proposed changes are not substantive and will not affect current 
practices.

VI. Proposed Scope and Definitions for Section 71.50

    This NPRM proposes to move 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 proposed 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 also propose separate definitions for quarantine and

[[Page 75943]]

isolation to reflect current practices as they apply to individuals 
(71.1) and animals (71.50).
    Proposed 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.
    Proposed section 71.50 (b) Definitions contains updated definitions 
used in the current CFR. The NPRM 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 current 42 CFR part 71, 
subpart A, and the corresponding new or updated proposed definitions in 
this NPRM.

                                        Table 2--Subpart F--Importations
                        Definitions and Corresponding Changes in Definitions in the NPRM
----------------------------------------------------------------------------------------------------------------
                                                 Corresponding, new and modified definition in proposed 42 CFR
  Existing definitions in 42 CFR Part 71.1                                   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 or rendered noninfectious. For 
the purposes of this NPRM, ``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 proposed 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 NPRM, we are proposing to define ``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 to what is meant by this term.
    Isolation, when applied to animals. We have proposed a definition 
of ``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. We have proposed a separate definition under this subpart to 
distinguish the concept of isolation for individuals from isolation of 
animals,
    Licensed Veterinarian. We have proposed defining ``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 proposed to define ``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 CFR 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 proposed defining 
``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. In this NPRM, we have proposed ``render 
noninfectious'' to mean treating an animal product (e.g., by boiling, 
irradiating, soaking, formalin fixation, or salting) in such a manner 
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;

[[Page 75944]]

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 NPRM, HHS/CDC is proposing to 
better clarify and explain existing practices that limit limiting 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.

VII. Alternatives Considered

    Under Executive Order 13563 agencies are asked to consider all 
feasible alternatives to current practice and the rule as proposed. 
HHS/CDC notes that the main impact of the proposed rule is to clarify 
the current practices and intent of HHS/CDC 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 NPRM, HHS/CDC proposes to update 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.

VIII. 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) HHS/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 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 
NPRM enhances definitions related to control of communicable diseases 
and adds more recent medical information where appropriate. HHS/CDC has 
determined that this NPRM is an update of definitions and compliant 
with the spirit of EO 13563. Further, HHS/CDC has determined that this 
NPRM is not a significant regulatory action as defined in EO 12866 
because the NPRM 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 proposed rule under the 
Regulatory Flexibility Act (5 U.S.C. 601-612). Unless we certify that 
the proposed 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 proposed 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 
proposed 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 proposed 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.

[[Page 75945]]

G. Executive Order 13132 (Federalism)

    HHS/CDC has reviewed this proposed 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.

Proposed Text

    For the reasons discussed in the preamble, the Centers for Disease 
Control and Prevention proposes to amend 42 CFR Part 71 as follows:

PART 71--FOREIGN QUARANTINE

    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).

    2. Amend Sec.  71.1 as follows:
    a. Revise paragraph (a).
    b. In paragraph (b), add in alphabetical order definitions of 
Commander, Quarantine, Quarantinable communicable disease, and U.S. 
territory.
    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 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.
    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.
* * * * *
    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

[[Page 75946]]

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. 2012-30725 Filed 12-21-12; 4:15 pm]
BILLING CODE 4150-28-P