[Federal Register Volume 78, Number 23 (Monday, February 4, 2013)]
[Rules and Regulations]
[Pages 7674-7679]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-02391]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Docket No. CDC-2011-0007]

42 CFR Part 71

RIN 0920-AA37


Foreign Quarantine; Import Regulations for Infectious Biological 
Agents, Infectious Substances, and Vectors

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Final rule.

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SUMMARY: The Centers for Disease Control and Prevention (CDC) within 
the Department of Health and Human Services (HHS) is issuing this final 
rule amending the regulations regarding the importation of infectious 
biological agents, infectious substances, and vectors. The amendments 
improve HHS/CDC's ability to prevent the introduction, transmission, or 
spread of communicable diseases into the United States.

DATES: The final rule is effective April 5, 2013.

FOR FURTHER INFORMATION CONTACT: Robbin Weyant, Ph.D., Director, 
Division of Select Agents and Toxins, Centers for Disease Control and 
Prevention, 1600 Clifton Road NE., MS A-46, Atlanta, GA 30333. 
Telephone: 404-718-2000.

SUPPLEMENTARY INFORMATION: The preamble is organized as follows:

I. Background
II. Statutory Authority
III. Responses to Public Comments
    A. Definitions
    B. Infectious Biological Agent
    C. Biosafety
    D. Permit Exemptions
    E. Transportation
    F. Subsequent Transfer
    G. Miscellaneous
IV. Required Regulatory Analyses Under Executive Orders 13563 and 
12866 and Regulatory Flexibility Act
V. Other Administrative Requirements
    A. Paperwork Reduction Act of 1995
    B. Executive Order 12988, Civil Justice Reform and Executive 
Order 13132, Federalism
    C. Plain Language in Government Writing

I. Background

    On October 14, 2011, we published a proposed rule in the Federal 
Register (76 FR 63891) to clarify regulatory definitions, ensure 
adequate biosafety measures, increase oversight through inspections, to 
address permit exemptions and transportation requirements, and to 
describe an appeal process. The proposed rule provided a 60-day public 
comment period that ended on December 13, 2011.
    This final rule contains provisions that apply to a variety of 
entities including academic institutions and biomedical centers, 
commercial manufacturing facilities, Federal, State, and local 
laboratories, including clinical and diagnostic laboratories, research 
facilities, exhibition facilities, and educational facilities.

II. Statutory Authority

    This final rule is issued under the authority of Section 361 of the 
Public Health Service Act (PHS Act) (42 U.S.C. 264). This provision 
authorizes the Health and Human Services (HHS) Secretary to make and 
enforce such regulations as in her 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. 
For purposes of carrying out and enforcing such regulations, the HHS 
Secretary may authorize a variety of public health measures, including 
inspection, fumigation, disinfection, sanitation, pest extermination, 
destruction of animals or articles found to be sources of dangerous 
infection to human beings, and other measures.
    The Foreign Quarantine regulations (42 CFR part 71) set forth 
provisions to prevent the introduction, transmission, and spread of 
communicable disease from foreign countries into the United States. 
Part 71, Subpart F (Importations) contains provisions for importation 
of etiological agents, hosts, and vectors (42 CFR 71.54), requiring 
persons to obtain a permit issued by the CDC before importing, or 
distributing after import, any of these materials.

III. Responses to Public Comment

    We received nine comments from academic, private and government 
facilities. The comments are discussed below.

A. Definitions

    Commenters requested clarification about whether the definition of 
``vector'' should (1) include an exemption for animals meant for a zoo, 
(2) address pelts or other objects meant for museum use or (3) limit 
the definition to the importation of live animals. Prior to entry into 
the United States and regardless of the purpose for the importation, a 
permit will continue to be required for any live animal or animal 
product (e.g., a mount, rug, or other display item composed of the 
hide, hair, skull, teeth, bones, or claws of an animal) unless (1) the 
animal or animal product is not known to transfer or to be capable of 
transferring an infectious biological agent to a human or (2) the 
animal product has been rendered noninfectious. The documentation may 
include a statement from a treating veterinarian, statement from a 
medical facility, medical certificate, or in the case of an animal 
product, documentary evidence, such as a veterinary or taxidermy 
certificate, describing how the material had been treated to render it 
noninfectious. Any live animal or animal product imported for 
scientific, educational or exhibition purposes (e.g., bats and bat 
products) will also continue to require a permit, unless accompanied by 
documentation indicating that the animal or animal product is not known 
to transfer or to

[[Page 7675]]

be capable of transferring an infectious biological agent to a human or 
the product has been rendered noninfectious.
    The terms ``educational purpose,'' ``exhibition purpose'' and 
``scientific purpose'' are defined in 42 CFR 71.1. ``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.'' ``Educational purpose'' means ``use 
in the teaching of a defined educational program at the university 
level or equivalent.'' ``Exhibition purpose'' means ``use as a 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 scheduled for multiple performances each 
week and open to the general public except for reasonable vacation and 
retraining periods.''
    One commenter urged HHS/CDC to modify the definition section to 
include a new definition for the term ``infectious substance.'' The 
commenter indicated that defining the term ``infectious substance'' in 
the context of applicable transportation standards and requirements for 
dangerous goods and hazardous materials would clarify HHS/CDC's 
expectations regarding the packaging and shipping of these materials 
and help applicants to better understand and address these issues. We 
agree with the commenter and are replacing the definition of 
``infectious material'' with an ``infectious substance'' definition, 
which states ``any material that is known or reasonably expected to 
contain an infectious biological agent.'' This definition for 
``infectious substance'' is consistent with the definitions found in 
the Department of Transportation (DOT) regulations set forth at 49 CFR 
Part 171-180 (``A material known or suspected to contain a pathogen:--a 
microorganism (including bacteria, viruses, parasites, fungi) or other 
agent, that can cause disease in humans or animals'') and World Health 
Organization (WHO) Transport of Infectious Substances Standard (``For 
the purposes of transport, infectious substances are defined as 
substances which are known or are reasonably expected to contain 
pathogens. Pathogens are defined as microorganisms (including bacteria, 
viruses, rickettsiae, parasites, fungi) and other agents such as 
prions, which can cause disease in humans or animals'').
    A commenter recommended defining the term ``biosafety measures,'' 
which is used several times in the proposed regulatory language, to 
help importers prepare for use of these requirements and to assist in 
agency review of such measures before the issuance of a permit. The 
commenter recommended that ``biosafety measures'' be defined as 
``standard microbiological practices, special practices, safety 
equipment (primary and personal protective equipment) and laboratory 
facilities (secondary barriers) as noted in the current edition of 
Biosafety in Microbiological and Biomedical Laboratories (BMBL) and 
additional safeguards as provided in the NIH Guidelines for recombinant 
and synthetic DNA if appropriate for the substance or material for 
which such measures are implemented.'' We made no changes based on this 
comment. While the commenter provided excellent references, we believe 
that citing only these references is limiting since there are other 
references that provide useful recommendations for safely working with 
a variety of human pathogens (i.e., Occupational Safety and Health 
Administration (OSHA) regulations, World Health Organization guidance, 
etc.).

B. Infectious Biological Agent

    One commenter noted that she was not aware of any medically 
important fungal agents that are communicable (transmissible from 
person to person), with the possible exception of dermatophyte agents 
(Epidermophyton, Microsporum, and Trichophyton). The commenter argued 
that the hazardous characteristics of dermatophyte agents are not 
sufficiently severe to merit regulation of these agents through the 
import permit mechanism. The commenter suggested that the regulatory 
text be clarified to list the fungal agents that would be regulated. 
The commenter further reasoned that Coccidioides species, Histoplasma 
capsulatum, and Blastomyces dermatitidis should no longer require an 
import permit since they do not cause communicable disease and are not 
transmissible from person to person. We made no changes based on this 
comment. Section 71.1 (Scope and definitions) of Title 42, Code of 
Federal Regulations defines ``communicable disease'' as ``an illness 
due to a specific infectious agent or its toxic products which arises 
through transmission of that agent or its products from an infected 
person or animal or a reservoir to a susceptible host, either directly, 
or indirectly through an intermediate animal host, vector, or the 
inanimate environment.'' All examples cited by this commenter meet this 
definition of the term ``infectious biological agents'' because each of 
the fungi cited are capable of causing communicable disease.

C. Biosafety

    One commenter was interested in knowing specifically how HHS/CDC 
will ``work with'' entities to address safety issues. The commenter 
questioned if this will entail providing additional financing to bring 
importers into compliance, or is this ``offer to work with'' the 
importer a distinctive part of the permit issuance process. HHS/CDC's 
statement in the preamble to the proposed rule that it was willing to 
work with an entity whose biosafety measures were found to be 
inadequate was neither an offer to provide financial assistance nor a 
distinctive part of the permit issuance process. It was simply a 
statement that, rather than simply deny a permit, HHS/CDC would be 
willing to assist an applicant to achieve compliance with the import 
regulations. If an importer is unable to address the inadequate 
biosafety measures identified, the importer would not receive a permit 
to import the infectious biological agent, infectious substance, or 
vector requested.

D. Permit Exemptions

Diagnostic Specimens
    One commenter proposed to replace the term ``diagnostic specimen'' 
with the phrase, ``exempt human specimen or exempt animal specimen'', 
consistent with DOT Hazardous Materials Regulations and the 
International Air Transport Association Dangerous Goods Standards. We 
made no changes based on this comment since the proposed replacement 
language limits the specimens to human and animals and does not include 
environmental samples.
    Another commenter stated that the proposed rule leaves too much 
speculation about what is potentially infectious material. The 
commenter suggested that a standard which was more closely aligned with 
the WHO standard for biological materials and infectious substances 
would provide more clarity. We agree with the commenter and have 
replaced the definition for ``infectious material'' with an 
``infectious substance'' definition that closely aligns with 
definitions found in the DOT regulations and WHO standards.
    Even though we did not receive a comment regarding bats, we 
clarified

[[Page 7676]]

that these materials should not be exempted since people become 
infected with germs either through direct or close contact with bats or 
their droppings. Specifically, bats are known carriers of germs that 
cause disease in humans, including internal and external parasites, 
fungi, bacteria, and viruses. The most significant of these germs are 
Nipah virus and viruses that cause diseases such as Ebola, Marburg 
Hemorrhagic Fever, Sudden Acute Severe Respiratory Syndrome (SARS), and 
rabies.
Genomic Material
    One commenter requested that the importation and subsequent 
transfer of positive stranded viral RNA be considered in this Part. The 
commenter reasoned that if this material could be used to recover an 
infectious agent, its importation and subsequent transfer would be, for 
all intents and purposes, identical to the importation and subsequent 
transfer of an etiological agent. The commenter also reasoned that if 
the intent was the extraction of the genetic information only, and the 
recipient had no intention to retrieve the infectious agent from the 
nucleic acid preparation, then the need for the permit would seem not 
to be warranted. We made no changes based on this comment since 
positive stranded viral rRNA genomic material would meet our proposed 
definition as a ``component of such microorganism or prion that is 
capable of causing communicable disease in a human.'' It should be 
noted that our proposed rule already contains an exemption for genomic 
materials certified by the importer to be incapable of producing 
infectious biological agents.

E. Transportation

    One commenter argued that the regulations should place the 
responsibility for compliance with all applicable laws and regulations 
concerning the packaging and shipment of infectious substances on the 
shipper since the only thing related to shipping that could be 
practically mandated for the recipient would be to open the shipment in 
a manner consistent with the expected hazard and report any spillage/
leakage. The commenter stated that the importer could be required to 
obtain some type of affirmation from the shipper to the effect that the 
shipment is done in compliance with applicable regulations. We agree 
with the commenter insofar as the commenter suggests that the shipper 
comply with all applicable legal requirements relating to the 
packaging, labeling, and shipment of infectious substances, such as 
those found at 49 CFR part 173 and standards issued by the 
International Civil Aviation Organization (ICAO). We disagree with the 
commenter, however, insofar as the commenter suggests that the importer 
should bear no legal responsibility under these regulations for actions 
taken by the shipper on the importer's behalf. Accordingly, under these 
regulations the importer, as the initiator of the Import Permit 
request, must implement measures to ensure that the shipper will 
package, label, and ship the requested infectious substance, infectious 
biological agent, or vector in a manner that is safe and in compliance 
with all applicable legal requirements.
    Another commenter suggested that we amend the statement ``The 
importer is in compliance with all applicable laws concerning the 
packaging and shipment of infectious substance'' to include ``and 
regulations'' in the statement. The commenter also recommended that 
guidance be provided on the HHS/CDC Web site to clarify HHS/CDC's 
expectations regarding the packaging and shipping of infectious 
substances. We agreed with the commenter that the statement should be 
revised to include all laws and regulations. Therefore, we changed the 
language to read, ``The importer takes measures to help ensure that the 
shipper complies with all applicable legal requirements concerning the 
packaging, labeling, and shipment of infectious substances.'' To 
clarify HHS/CDC's expectations regarding the packaging and shipping of 
infectious substances, we have posted guidance regarding our 
expectations on the HHS/CDC import permit Web site at: http://www.cdc.gov/od/eaipp/faq.htm.

F. Subsequent Transfer

    One commenter requested confirmation that an importer may still 
seek authorization for subsequent transfers of the items within the 
United States through the initial permit application. We confirm that 
an importer may still seek authorization for subsequent transfers of 
items within the United States in the initial permit application.

G. Miscellaneous

Cost
    One commenter believed that there would be a significant cost to 
implement the HHS/CDC inspection program. The commenter stated it 
should be an institutional responsibility to ensure that an appropriate 
biosafety plan is in place. The commenter believed if an institution 
does not have a biosafety office or plan; it should not have the permit 
to import items that may pose any kind of risk. We agree that an entity 
that does not have a biosafety plan should not have a permit to import 
items that have the potential to pose a risk to public health and 
safety.
    Since 2009, we have refined the HHS/CDC import permit database to 
include better descriptions of material being imported, the biosafety 
level of the laboratory where the work will be performed, and the type 
of work to be conducted (e.g., diagnostic, research). To estimate the 
number of facilities that would require a biosafety inspection under 
this Part; we first identified those facilities that had previously 
applied to import agents which are capable of causing serious or 
potentially lethal disease in humans via the aerosol route. From that 
list, we deleted those facilities already receiving periodic biosafety 
inspections from either HHS/CDC or the U.S. Department of Agriculture's 
Animal and Plant Health Inspection Service (USDA/APHIS) under the HHS 
or USDA Select Agent Regulations (42 CFR part 73, 9 CFR part 121, or 7 
CFR part 131) and concluded that approximately 25 facilities would need 
to be inspected per year to verify that they have in place the 
appropriate biosafety measures. Since we already review documents 
regarding biosafety and have a staff of fully trained and experienced 
biosafety inspectors, and based on our review of recent permitting 
activity, we believe the projected travel costs to perform these 
inspections will be less than 1% of the current budget for the HHS/
CDC's Division of Select Agents and Toxins. We also plan to coordinate 
these inspections with those we are already conducting under the 
Federal Select Agent Inspection Program to recognize greater 
efficiencies.
Internet Site
    One commenter suggested that HHS/CDC maintain on its internet site 
the current permit preparation guidance text so that permit applicants 
will have ready access to information regarding their responsibilities 
under the regulations, separate from the regulations themselves. We 
agree with this commenter and will review our Web site content on a 
regular ongoing basis to ensure that the content is consistent with the 
regulations and easy to find.
Alternatives Considered
    In the proposed rule we discussed the alternative approaches we 
considered in development of this rulemaking in order to reduce burden 
for clinical/diagnostic laboratories or small businesses selling 
manufactured goods.

[[Page 7677]]

    First, we noted that, from HHS/CDC's Select Agent inspection 
program, specific biosafety measure implementation issues were 
identified in 81 of the 316 entities inspected by CDC since 2003. Some 
of the biosafety measure implementation issues were serious enough to 
require the suspension of registration or other restrictions on 
biological work at these facilities. We noted that USDA/APHIS had 
identified similar biosafety issues. Because of these issues, we 
proposed to require specific biosafety measures to be implemented by 
the applicant.
    Second, we considered proposing a requirement that applicants 
develop and maintain a written biosafety plan commensurate with the 
hazard posed by the infectious biological agent, infectious material, 
and/or vector to be imported, and the level of risk given the intended 
use including what elements of the plan are essential to prevent 
exposures and dramatically reduce the incidence of laboratory acquired 
infections and protect the public health and the environment. We 
acknowledged that most, if not all, importers of etiological agents 
already have such biosafety plans. We based this on our experience with 
import permit submissions that address Section G (Receiving Laboratory 
Capabilities) of the permit application. We specifically sought comment 
from the public concerning the cost and burden of requiring a formal a 
written biosafety plan. We did not receive any comments specifically 
addressing the cost and burden of requiring a formal written biosafety 
plan.
    Finally, we proposed exemptions to allow importers to import 
certain material that is already approved or authorized by another 
Federal agency or material that has been determined not to be an 
infectious biological agent.

IV. Required Regulatory Analyses Under Executive Orders 12866 and 13563

    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). Executive 
Order 13563 emphasizes the importance of quantifying both costs and 
benefits, of reducing costs, of harmonizing rules, and of promoting 
flexibility. This rule is being treated as ``not significant'' under EO 
12866. It clarifies regulatory definitions, insures adequate biosafety 
measures, increases oversight through inspections, addresses permit 
exemptions and transportation requirements, and describes an appeal 
process when the permit request is denied. Thus, the rule has not been 
reviewed by the Office of Management and Budget (OMB).
    Based on past experience, we estimate that there will be 
approximately 2,000 applications for both import and distribution 
permit requests each year and that the average response time to 
complete the application is 20 minutes. We believe that the burden has 
been limited to requesting only essential information on the 
application, verifying information, when required, by telephone, and 
mailing information to the appropriate parties.
    With regard to the new requirement to have biosafety measures in 
place, our current experience from reviewing the information submitted 
for the import permit applications addressing Section G (Receiving 
Laboratory Capabilities) (e.g., detailed description of any required 
personal protective equipment (PPE)), and laboratory equipment (i.e., 
biosafety cabinets, autoclaves) that ensures materials are properly 
handled and contained indicates that the vast majority of importers of 
etiological agents already have instituted such biosafety measures. 
Based on our review of applications received between March 2011 and 
January 2012, we estimate that 98% (632 out of 644) of the applicants 
possess written biosafety plans and already follow standard biosafety 
practices and procedures.
    With regard to whether HHS/CDC will inspect an import facility, as 
noted above, HHS/CDC will use the following specific criteria to 
determine which entities are to be inspected: (1) facilities that 
request to perform research with imported agents that would need to be 
conducted in a biosafety level (BSL) 3, BSL-4, animal biosafety level 
(ABSL) 3, ABSL-4 or BSL-3 Agriculture laboratory as described in the 
BMBL (e.g., Mycobacterium tuberculosis used in aerosol studies required 
at BSL-3), and (2) facilities that have not been inspected by either 
HHS/CDC or USDA/APHIS under the Federal Select Agent Regulations.
    Since 2009, we have refined the HHS/CDC import permit database to 
include better descriptions of material being imported, the biosafety 
level of the facility where the work would be performed, and the type 
of work to be conducted (e.g., diagnostic, research). To estimate the 
number of facilities that would require a biosafety inspection, we 
first identified those facilities that applied to import agents to use 
in research, which may cause serious or potentially lethal disease 
after inhalation. From that list, we removed those facilities already 
subject to periodic biosafety inspections under the Federal Select 
Agent Regulations. We concluded that approximately 25 facilities would 
need to be inspected per year to verify that they have in place the 
appropriate biosafety measures. To minimize additional burdens on 
inspected facilities, we will be contacting those facilities that 
received a permit in 2012, and would meet the criteria for requiring an 
inspection, 3 months prior to the expiration of the facility's import 
permit to initiate the renewal process. We plan to inspect these 
facilities once in a two year timeframe, assuming that no significant 
biosafety problems are identified.
    We also anticipate that there will be minimal increased cost to 
HHS/CDC to implement these changes since we already review documents 
regarding biosafety and have a staff of fully trained and experienced 
biosafety inspectors. Based on our review of recent permitting 
activity, we believe the projected travel costs to perform these 
inspections will be less than 1% of the current budget for the HHS/
CDC's Division of Select Agents and Toxins. We also plan to coordinate 
these inspections with those we are already conducting under the 
Federal Select Agent Inspection Program to recognize greater 
efficiencies.

Regulatory Flexibility Act

    Under the Regulatory Flexibility Act, as amended by the Small 
Business Regulatory Enforcement Fairness Act (SBREFA) (5 U.S.C. 601 et 
seq.), agencies must consider the impact of regulations on small 
entities and analyze regulatory options that would minimize a rule's 
impacts on these entities. Alternatively, the agency head may certify 
that the proposed rule will not have a significant economic impact on a 
substantial number of small entities. The U.S. Small Business 
Administration defines a small business concern as one that is 
independently owned and operated, is organized for profit, and is not 
dominant in its field. Depending on the industry, eligibility for 
classification as a small business is based on the average number of 
employees for the preceding twelve months or on sales volume averaged 
over a three-year period. For example, a business is considered small 
if its annual revenue ranges between $2.5 to $21.5 million for services 
provided or the number of its employees range from 100 to 500 depending 
on the particular product being provided. Based on this

[[Page 7678]]

definition, HHS/CDC does not anticipate that these regulatory changes 
will have a significant economic impact on a substantial number of 
small businesses or other small entities. HHS/CDC estimates that only 
100 applications out of the approximately 2,000 applications that we 
receive each year will be from small businesses. We received no 
comments to the proposed rule concerning the cost and burden of the 
proposed rule on small businesses.

V. Other Administrative Requirements

A. Paperwork Reduction Act of 1995

    In accordance with section 3507(d) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), HHS/CDC has determined that the 
Paperwork Reduction Act does apply to information collection and 
recordkeeping requirements included in this rule. We note that the 
information collection and recordkeeping requirements are already 
approved by OMB under OMB Control Number 0920-0199, expiration 1/31/
2014. There are no new information collection or recordkeeping 
requirements in this rule.
    Since 2003, HHS/CDC has denied 2 applications for permits. HHS/CDC 
proposes to provide applicants with an opportunity for a written appeal 
in the event that the HHS/CDC denies a request for a permit to import 
infectious biological agents, infectious substances, or vectors under 
this part. Under the proposal, an applicant who wishes to make such an 
appeal would have 30 calendar days after receiving the denial to submit 
the appeal in writing to the HHS/CDC Director. The appeal must state 
the factual basis for the appeal and provide any supporting 
documentations to justify the appeal (e.g., documents that demonstrate 
the facility has the appropriate biosafety measures in place for 
working safely with requested imported material). HHS/CDC would then 
issue a written response, which would constitute final agency action. 
HHS/CDC estimates the time to prepare and submit such a request is four 
hours. We received no comments regarding this process.

B. Executive Order 12988, Civil Justice Reform and Executive Order 
13132, Federalism

    This rule has been reviewed under Executive Order 12988, Civil 
Justice Reform, and Executive Order 13132, Federalism. This rule: (1) 
Preempts all State and local laws and regulations that are in conflict 
with this rule; (2) has no retroactive effect; and (3) does not require 
administrative proceedings before parties may file suit in court 
challenging this rule.

C. Plain Language in Government Writing

    Pursuant to Presidential Memorandum of June 1, 1998 Plain Language 
in Government Writing (63 FR 31885), Executive Departments and Agencies 
are directed to use plain language in all proposed and final rules. 
HHS/CDC believes it has used plain language in drafting of this final 
rule. We received no comments from the public to the proposed rule in 
this regard.

List of Subjects in 42 CFR Part 71

    Airports, Animals, Communicable diseases, Harbors, Imports, 
Pesticides and pests, Public health, Quarantine, Reporting and 
recordkeeping requirements.

    Dated: January 28, 2013.
Kathleen Sebelius,
Secretary, Department of Health and Human Services.

    For the reasons stated in the preamble, the Centers for Disease 
Control and Prevention, U.S. Department of Health and Human Services, 
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. Revise Sec.  71.54 to read as follows:


Sec.  71.54  Import regulations for infectious biological agents, 
infectious substances, and vectors.

    (a) The following definitions apply to this section:
    Animal. Any member of the animal kingdom except a human including 
an animal product (e.g., a mount, rug, or other display item composed 
of the hide, hair, skull, teeth, bones, or claws).
    Diagnostic specimen. Specimens of human and animal matter 
(including tissue, blood, body discharges, fluids, excretions or 
similar material), or environmental samples.
    Genomic material. Deoxyribonucleic acid (DNA) or Ribonucleic acid 
(RNA) comprising the genome or organism's hereditary information, that 
may be single-stranded or double-stranded, and in a linear, circular, 
or segmented configuration and may be positive sense (same polarity as 
mRNA), negative sense, or ambisense (mixture of the two).
    Infectious biological agent. A microorganism (including, but not 
limited to, bacteria (including rickettsiae), viruses, fungi, or 
protozoa) or prion, whether naturally occurring, bioengineered, or 
artificial, or a component of such microorganism or prion that is 
capable of causing communicable disease in a human.
    Infectious substance. Any material that is known or reasonably 
expected to contain an infectious biological agent.
    Select agents and toxins. Biological agents and toxins that could 
pose a severe threat to public health and safety as listed in 42 CFR 
73.3 and 73.4.
    Vector. Any animals (vertebrate or invertebrate) including 
arthropods or any noninfectious self-replicating system (e.g., plasmids 
or other molecular vector) or animal products (e.g., a mount, rug, or 
other display item composed of the hide, hair, skull, teeth, bones, or 
claws of an animal) that are known to transfer or are capable of 
transferring an infectious biological agent to a human.
    (b) Unless excluded pursuant to paragraph (f) of this section, a 
person may not import into the United States any infectious biological 
agent, infectious substance, or vector unless:
    (1) It is accompanied by a permit issued by the Centers for Disease 
Control and Prevention (CDC). The possession of a permit issued by the 
CDC does not satisfy permitting requirements placed on materials by the 
U.S. Department of Agriculture that may pose hazards to agriculture or 
agricultural production in addition to hazards to human health.
    (2) The importer is in compliance with all of the permit 
requirements and conditions that are outlined in the permit issued by 
the CDC.
    (3) The importer has implemented biosafety measures commensurate 
with the hazard posed by the infectious biological agent, infectious 
substance, and/or vector to be imported, and the level of risk given 
its intended use.
    (4) The importer takes measures to help ensure that the shipper 
complies with all applicable legal requirements concerning the 
packaging, labeling, and shipment of infectious substances.
    (c) If noted as a condition of the issued permit, subsequent 
transfers of any infectious biological agent, infectious substance or 
vector within the United States will require an additional permit 
issued by the CDC.
    (d) A permit is valid only for:
    (1) The time period and/or term indicated on the permit, and
    (2) Only for so long as the permit conditions continue to be met.

[[Page 7679]]

    (e) A permit can be denied, revoked or suspended if:
    (1) The biosafety measures of the permit holder are not 
commensurate with the hazard posed by the infectious biological agent, 
infectious substance, or vector, and the level of risk given its 
intended use; or,
    (2) The permit holder fails to comply with all conditions, 
restrictions, and precautions specified in the permit.
    (f) A permit issued under this part is not required for an item if:
    (1) It is a biological agent listed in 42 CFR Part 73 as a select 
agent and its importation has been authorized in accordance with 42 CFR 
73.16 or 9 CFR 121.16.
    (2) With the exception of bat or nonhuman primate specimens, it is 
a diagnostic specimen not known by the importer to contain, or 
suspected by the importer of containing, an infectious biological agent 
and is accompanied by an importer certification statement confirming 
that the material is not known to contain or suspected of containing an 
infectious biological agent, or has been rendered noninfectious.
    (3) With the exception of live bats or bat or nonhuman primate 
products, it is an animal or animal product being imported for 
educational, exhibition, or scientific purposes and is accompanied by 
documentation confirming that the animal or animal product is not known 
to contain (or suspected of containing) an infectious biological agent 
or has been rendered noninfectious.
    (4) It consists only of nucleic acids that cannot produce 
infectious forms of any infectious biological agent and the specimen is 
accompanied by an importer certification statement confirming that the 
material is not known to contain or suspected of containing an 
infectious biological agent.
    (5) It is a product that is cleared, approved, licensed, or 
otherwise authorized under any of the following laws:
    (i) The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
seq.), or
    (ii) Section 351 of the Public Health Service Act pertaining to 
biological products (42 U.S.C. 262), or
    (iii) The Virus-Serum-Toxin Act (21 U.S.C. 151-159).
    (6) It is an animal or animal product listed in 42 CFR Part 71 and 
its importation has been authorized in accordance with 42 CFR 71.52, 
71.53, or 71.56.
    (g) To apply for a permit, an individual must:
    (1) Submit a signed, completed CDC Form 0.753 (Application for 
Permit to Import Biological Agents or Vectors of Human Disease into the 
United States) to the HHS/CDC Import Permit Program.
    (2) Have in place biosafety measures that are commensurate with the 
hazard posed by the infectious biological agent, infectious substance, 
and/or vector to be imported, and the level of risk given its intended 
use.
    (h) Issuance of a permit may be contingent upon an inspection of 
the importer's facility by the CDC to evaluate whether the importer's 
biosafety measures (e.g., physical structure and features of the 
facility, and operational and procedural safeguards) are commensurate 
with the hazard posed by the infectious biological agent, infectious 
substance, and/or vector, and the level of risk given its intended use.
    (i) Denial, suspension, or revocation of a permit under this 
section may be appealed to the CDC Director. The appeal must be in 
writing, state the factual basis for the appeal, and be submitted to 
the CDC Director within 30 calendar days of the denial, suspension, or 
revocation of the permit. HHS/CDC will issue a written response to the 
appeal, which shall constitute final agency action.

[FR Doc. 2013-02391 Filed 2-1-13; 8:45 am]
BILLING CODE 4163-18-P