[Federal Register Volume 76, Number 199 (Friday, October 14, 2011)]
[Proposed Rules]
[Pages 63891-63896]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-26656]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 71
[Docket No. CDC-2011-0007]
RIN 0920-AA37
Foreign Quarantine; Etiological Agents, Hosts, and Vectors
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice of proposed rulemaking.
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SUMMARY: The Centers for Disease Control and Prevention (CDC) within
the U.S. Department of Health and Human Services (HHS) is issuing this
Notice of Proposed Rulemaking (NPRM) to revise the regulations that
cover the importation of etiological agents and the hosts and vectors
of human disease. The changes are proposed to improve CDC's ability to
prevent the introduction, transmission, or spread of communicable
diseases into the United States.
DATES: To be assured consideration, comments must be received on or
before December 13, 2011. Comments received after the close of the
comment period will be considered to the fullest extent possible.
ADDRESSES: You may submit comments, identified by Regulatory
Information Number (RIN) 0920-AA37 in the heading of this document, by
any of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
E-mail: [email protected]. Please include the RIN number
in the subject line of the message.
Fax: 404-718-2093.
Mail: Division of Select Agents and Toxins, Centers for
Disease Control and Prevention, ATTN: Importation Regulations, 1600
Clifton Road, NE., MS A-46, Atlanta, Georgia 30333.
Hand Delivery/Courier: Division of Select Agents and
Toxins, Centers for Disease Control and Prevention, ATTN: Importation
Regulations, 1600 Clifton Road, NE., MS A-46, Atlanta, Georgia 30333.
Instructions: All submissions received must include the agency name
and RIN for this rulemaking. All relevant comments received will be
posted without change to http://www.regulations.gov, including any
personal information provided.
Docket: For access to the docket to read background documents or
comments received or to download an electronic version of the NPRM, go
to http://www.regulations.gov. Comments will be available for public
inspection Monday through Friday, except for legal holidays, from 9
a.m. until 5 p.m. at 1600 Clifton Road, NE., Atlanta, GA 30333. Please
call ahead to 1-866-694-4867 and ask for a representative in the
Division of Select Agents and Toxins to schedule your visit. Our
general policy for comments and other submissions from members of the
public is to make these submissions available for public viewing on the
Internet as they are received and without change.
FOR FURTHER INFORMATION CONTACT: Robbin Weyant, PhD, 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 to this notice of proposed
rulemaking is organized as follows:
I. Background
A. HHS/CDC Authority
II. Proposed Changes to 42 CFR 71.54
A. Section Heading & Definitions
B. Biosafety and Inspection Provisions
[[Page 63892]]
C. Permit Exemptions
D. Transportation
E. Appeals Process
III. Required Regulatory Analyses and Executive Order 12866, and the
Regulatory Flexibility Act
IV. 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
A. HHS/CDC Authority
This NPRM is proposed 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 of these materials.
II. Proposed Changes to 42 CFR 71.54
This document proposes to revise the regulations that cover the
importation of etiological agents and the hosts and vectors of human
disease (42 CFR 71.54) as described below. We will consider comments
that are received within 60 days of publication of this notice in the
Federal Register.
A. Section Heading and Definitions
The heading for 42 CFR 71.54 would be changed from ``Etiological
agents, hosts, and vectors.'' to ``Import Regulations for Infectious
Biological Agents, Infectious Material, and Vectors'' to clarify
proposed changes discussed below. Under the proposed changes, only the
following infectious biological agents, materials, and vectors would
require a permit issued by the CDC Director prior to entry into the
United States, or subsequently being transferred within the United
States:
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 material. Any material which is known or suspected to
contain a biological agent infectious to humans.
Vector. Any animals (vertebrate or invertebrate) including
arthropods or any noninfectious self-replicating system known to
transfer or capable of transferring an infectious biological agent to a
human (e.g., a mosquito).
We also propose to remove the term ``host'' because we believe
``host'' means the same as the current proposed definition for
``vector.'' However, CDC is interested in comments concerning the
removal of the term ``host'' from the proposed language. CDC is also
interested in comments concerning the scope of the definition for
``vector'' and whether it should be limited in some manner to exclude
animals intended to be exhibited in zoos or mounted animals or hides
intended for museum displays while remaining broad enough to include
mosquitoes that carry the malaria parasite Plasmodium between humans.
B. Biosafety and Inspection Provisions
The key principle in selecting the appropriate safeguards for the
conduct of the microbiological research is ``risk assessment.'' Risk
assessment is a process used to identify the hazardous characteristics
of a known infectious agent or potentially infectious agent or
material, the activities that can result in exposure to such an agent,
the likelihood that such exposure will cause a laboratory-acquired
infection (LAI), and the probable consequences of such an infection.
The information identified through risk assessment is used to guide the
selection of appropriate microbiological practices, safety equipment,
and facility safeguards (biosafety measures) that, when used properly,
can prevent exposures and dramatically reduce the incidence of LAIs.
Risk assessment is a common first step in an overall risk-management
process.
The safe possession and work with infectious biological agents,
infectious material, and vectors requires that importers have the
appropriate biosafety measures in place for imported material.
Accordingly, CDC proposes that import regulations clearly state that
the applicant have biosafety measures that are commensurate with the
hazard posed by the infectious biological agent, infectious material,
and/or vector to be imported, and the level of risk given its intended
use. These biosafety measures may be entity-wide, laboratory-specific,
or agent-specific. CDC believes importers engaged in microbiological
research and related activities utilizing safe laboratory practices,
safety equipment, and facility safeguards will reduce the incidence of
LAIs and other incidents and will protect the public health and
environment.
In developing the appropriate biosafety measures, importers working
with infectious biological agents, infectious material, and vectors
should use the appropriate microbiological practices, safety equipment,
and facility safeguards that, when used properly, can prevent exposures
and dramatically reduce the incidence of LAIs. An applicant should
consider: (1) The CDC/National Institutes of Health (NIH) publication,
``Biosafety in Microbiological and Biomedical Laboratories'' (BMBL),
including all appendices. Copies may be obtained at the CDC Web site at
http://www.cdc.gov/ and (2) The ``NIH Guidelines for Research Involving
Recombinant DNA Molecules (NIH Guidelines).'' Copies may be obtained
from the NIH Web site at http://oba.od.nih.gov/rdna/nih_guidelines_oba.html.
To implement CDC's inspection authority as provided under 42 U.S.C.
264(a), CDC proposes that prior to CDC issuing a permit, it may inspect
the applicant's facility to evaluate whether the importer's
implementation of its biosafety measures (e.g., physical structure and
features of the facility, and operational and procedural safeguards)
are effective and commensurate with the risk posed by the infectious
biological agent, infectious material, and/or vector, and the level of
risk given its intended use. 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), and (2) that
have not been inspected by CDC's Select Agent Program.
Even though CDC is proposing that the import regulations
specifically state a requirement for appropriate biosafety measures as
a prerequisite for the
[[Page 63893]]
issuance of a permit, we believe, based on our experience with import
permit submissions addressing the capabilities of the receiving
laboratories, that most, if not all, importers of etiological agents
already have written biosafety plans. Based on permit applications
submitted to CDC between March 1, 2011, and July 22, 2011, the total
number of applicants with adequate written biosafety plans was 632 out
of 644 or 98%. Based on the content of those plans, CDC is confident
that each of them would meet the requirement for appropriate biosafety
measures of this NPRM. If an importer's biosafety measures were found
to be inadequate, CDC would offer to work with the entity to address
any biosafety issues prior to denying the permit.
C. Permit Exemptions
Select Agents and Toxins
Currently, in accordance with 9 CFR part 121 and 42 CFR part 73
(Select Agent Regulations), only individuals or entities registered
with the CDC or U.S. Department of Agriculture, Animal and Plant Health
Inspection Service's (APHIS') Select Agent Program can legally import
select agents (i.e., biological agents and toxins that could pose a
severe threat to public health and safety) into the United States. A
select agent may only be imported under the conditions described in 9
CFR 121.16 and 42 CFR 73.16 and must be authorized by APHIS or CDC
prior to importation. Therefore, we are proposing that importation of
select agents in accordance with the Select Agent Regulations be
exempted from the requirement to have an additional import permit under
42 CFR 71.54.
Diagnostic Specimens
As defined by the proposed rule, a diagnostic specimen is any
specimen of human or animal matter (including tissue, blood, body
discharges, fluids, excretions or similar material), or an
environmental sample. CDC's policy regarding diagnostic specimens is
that only diagnostic specimens that are known to contain, or are
suspected of containing, an infectious biological agent require a
permit issued by the CDC Director prior to entry into the United States
or subsequent transfer within the United States. CDC proposes to
clarify this policy in the regulation by adding a provision that a
permit is not required for a diagnostic specimen not known by the
importer to contain, or suspected by the importer of containing, an
infectious biological agent and the specimen is accompanied by an
importer certification statement confirming that the material is not
known or suspected to contain an infectious biological agent. Importers
would not be required to perform confirmatory tests on these specimens,
only certify in writing that they have no reason to believe that the
samples contain an infectious biological agent. Examples of these types
of diagnostic specimens not known by the importer to contain, or
suspected by the importer of containing, an infectious biological agent
may include urine samples submitted for urine drug screens or serum
samples submitted for cholesterol testing.
Genomic Material
Genomic material from infectious biological agents can consist of
Deoxyribonucleic acid (DNA) or Ribonucleic acid (RNA). The nucleic acid
comprising the genome may be single-stranded or double-stranded, and in
a linear, circular or segmented configuration. Single-stranded viral
genomes may be positive sense (same polarity as mRNA), negative sense,
or ambisense (mixture of the two). Viral genomes which consist of
positive sense RNA are infectious when the purified viral RNA is
applied to permissive cells in the absence of any viral proteins. In
some cases, viral genomes which are composed of double-stranded DNA are
also infectious (e.g., genome of Cercopithecine Herpesvirus 1 (Herpes B
virus)). If genomic material being imported does not encode for
infectious and/or replication competent forms of an infectious
biological agent then a permit is not required. For example, a permit
would not be required for RNA obtained from negative stranded RNA
viruses or for genomic DNA isolated from bacteria. As such, CDC
proposes to clarify this policy by adding a provision in the regulation
that a permit is not required for 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. Importers would not be required to perform
confirmatory tests on these specimens, only certify in writing that
they have no reason to believe that the samples can produce infectious
forms of any infectious biological agent.
Regulated Products
CDC proposes to exempt material contained in certain products from
the requirement to obtain a CDC Permit for importation into the United
States or subsequent transfer within the United States. If the material
is contained in a product that is cleared, approved, licensed, or
authorized under the provisions of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 301 et seq.), Section 351 of the Public Health Service
Act pertaining to biological products (42 U.S.C. 262), or the Virus-
Serum-Toxin Act (21 U.S.C. 151-159), CDC has determined that it is
unlikely that material in these products would present a risk of the
introduction, transmission, or spreading of a communicable disease.
This exemption would include all investigational products for which an
Investigational New Drug application (IND) is in place with the U.S.
Food and Drug Administration (FDA). Examples of products that have been
cleared, approved, licensed, or authorized by the FDA include FDA-
licensed live attenuated vaccines and diagnostic test kits authorized
for marketing or investigational use. Examples of products for Section
351 of the Public Health Service Act pertaining to biological products
(42 U.S.C. 262) or the Virus-Serum-Toxin Act (21 U.S.C. 151-159)
include vaccines, antibody products, and blood products.
CDC proposes to clarify this policy by adding a provision in the
regulation that a permit is not required for a product that is cleared,
approved, licensed, or is otherwise authorized under the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 301 et seq), Section 351 of the
Public Health Service Act pertaining to biological products (42 U.S.C.
262), or the Virus-Serum-Toxin Act (21 U.S.C. 151-159).
D. Transportation
During the importation of the infectious biological agents,
infectious material, or vectors, the importer must be in compliance
with all applicable laws concerning the packaging and shipment of
infectious substances, including the following:
Agriculture (9 CFR parts 92, 94, 95 96, 121, 122, and
130),
Occupational Health and Safety Administration (29 CFR
1910.1030),
Transportation (49 CFR parts 171 through 180), and
Postal Service (39 CFR part 111).
As such, CDC proposes to clarify this policy by adding the language
``The importer is in compliance with all applicable laws concerning the
packaging and shipment of infectious substances'' at Sec. 71.54(b)(4).
E. Appeals Process
Since 2003, CDC has denied 2 applications for permits. CDC proposes
to provide applicants with an opportunity for a written appeal in the
[[Page 63894]]
event that the CDC Director denies a request for a permit to import
infectious biological agents, infectious material, 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 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). CDC would then issue a written response,
which would then constitute final agency action. CDC invites comments
on this process.
F. Alternatives Considered
In researching the proposed changes, we reviewed how U.S.
Department of Agriculture/Animal and Plant Health Inspection Service
(USDA/APHIS) regulates the importation plant and animal products and
the Federal Select Agent Program regulates the possession, use, and
transfer of select agents and toxins. We learned that HHS/CDC
identified, through its Select Agent Program inspection program,
specific biosafety measure implementation issues in 81 of the 316 the
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. USDA/APHIS has identified similar biosafety issues.
Thus, in the proposed rule, import regulations clearly state that
the applicant have biosafety measures that are commensurate with the
hazard posed by the infectious biological agent, infectious material,
and/or vector to be imported, and the level of risk given its intended
use. The safe possession and work with infectious biological agents,
infectious material, and vectors requires that importers have the
appropriate biosafety measures in place for imported material. These
biosafety measures may be entity-wide, laboratory-specific, or agent-
specific. HHS/CDC believes importers engaged in microbiological
research and related activities utilizing safe laboratory practices,
safety equipment, and facility safeguards will reduce the incidence of
LAIs and other incidents and will protect the public health and
environment. HHS/CDC also considered a requirement that the applicant
must develop and implement a written biosafety plan that is
commensurate with the hazard posed by the infectious biological agent,
infectious material, and/or vector to be imported, and the level of
risk given its intended use, including what elements of the plan are
essential to prevent exposures and dramatically reduce the incidence of
LAIs and protect the public health and environment. However, we believe
that most, if not all, importers of etiological agents already have
such biosafety plans based on our experience with import permit
submissions addressing Section G (Receiving Laboratory Capabilities) of
the permit application. The total number of applicants estimated to
have biosafety plans from March 2011 to the present is 632 out of 644
or 98%. CDC would be interested in comments concerning the cost and
burden of formalizing a written biosafety plan.
Finally, we also provided exemptions to allow importers to import
certain material that is already approved or authorized by another
agency or material that has been determined not to be an infectious
biological agent. We believe this will reduce burden for clinical/
diagnostic laboratories or small business selling manufactured goods.
III. Required Regulatory Analyses Under Executive Orders 13563 and
12866
Executive Orders 13563 and 12866 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 has been designated a ``significant regulatory
action'' although not economically significant, under section 3(f) of
Executive Order 12866. Accordingly, the rule has been reviewed by the
Office of Management and Budget.
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 proposed requirement to have in place
biosafety measures, our current experience with 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. In fact, based on the review of
applications received since March 2011, we estimated 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 CDC will inspect an import facility, as
noted above, 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 BSL-3, BSL-4, ABSL-3, ABSL-4 or BSL-3 Agriculture laboratory as
described in the BMBL (e.g., Mycobacterium tuberculosis), and (2) that
have not been inspected by CDC's Select Agent Program.
Since 2009, we have refined the 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 we anticipate would require a biosafety
inspection; we first identified those facilities that applied to import
``BSL-3 agents'' for research. From that list, we deleted those
facilities already receiving periodic biosafety from either CDC or
APHIS inspections due to their registration with the Federal Select
Agent Program and concluded that approximately 25 facilities would need
to be inspected per year to verify that they have in place the
appropriate biosafety measures that are commensurate with the risk
posed by the infectious biological agent, infectious material, and/or
vector, and the level of risk given its intended use. We based our
estimate on fact that the remaining facilities would not need to be
inspected based on our current experience with reviewing the
information contained in the import permit applications which address
in detail the capabilities of receiving laboratories (description of
any required personal protective equipment and laboratory equipment
(biosafety cabinets, autoclaves), which if used properly ensures
materials are properly
[[Page 63895]]
handled and contained). We therefore anticipate that this requirement
will impose only a minimal burden on importers. However, we believe
that the addition of this requirement is important to ensure that
current and future importing facilities have and maintain the
appropriate biosafety measures for working safely with imported
infectious agents by inspecting these facilities. HHS/CDC's belief in
the importance of including a requirement that importers are subject to
an inspection to verify the implementation of appropriate biosafety
measures is based on our eight years of experience in the area of
select agent regulatory oversight. While 100% of entities registered
for the possession, use, or transfer of select agents and toxins (42
CFR part 73) had appropriately filled out their application and had an
adequate written biosafety plan, HHS/CDC identified, through its Select
Agent Program inspection program, specific biosafety measure
implementation issues in 81 of the 316 the entities inspected by HHS/
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. USDA/APHIS has a
similar experience with those Select Agent entities for which it has
principle oversight. Thus, we have learned from inspecting entities
registered with the HHS/CDC's Select Agent Program that the ``trust''
approach to accepting information received from paperwork is
ineffective. We found that the information provided in the paperwork
did not always match the biosafety practices that are employed by the
facility. As such, we believe that HHS/CDC's Permitting Program should
adopt a parallel program to verify biosafety measures.
We also anticipate that there will be no cost to CDC to implement
these recommended changes since we already review documents regarding
biosafety and have a staff of fully trained and experienced biosafety
inspectors. Finally, we believe the projected travel costs to perform
these inspections will be at no additional cost to CDC since we plan to
coordinate these inspections with those we are already conducting under
the Federal Select Agent Inspection Program.
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. As discussed above, CDC does not
anticipate that this NPRM will have a significant economic impact on a
substantial number of small businesses and other small entities. Of the
entities impacted by this rule, CDC estimates that approximately 100
applications received out of 2000 applications are from small
businesses. 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, size standard eligibility 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, annual receipts may not exceed
$2.5 to $21.5 million for services provided or maximum number of
employees may range from 100 to 500 depending on the particular product
being provided. Based on this definition, we did not consider
universities or major pharmaceutical companies as small businesses. CDC
would be interested in comments concerning the cost and burden of this
proposed rule, especially from an importer that might be considered a
small business or entity or from the private sector.
IV. 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
information collection and recordkeeping requirements included in this
proposed rule 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 the proposed rule.
In the past, CDC has denied applications for permits. Thus, in this
rule, CDC proposes to provide applicants with an opportunity for a
written appeal in the event that the CDC Director denies a request for
a permit to import infectious biological agents, infectious material,
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 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). CDC would then issue
a written response, which would then constitute final agency action.
CDC estimates the time to prepare and submit such a request is 4 hours.
CDC invites comments on this process.
B. Executive Order 12988, Civil Justice Reform and Executive Order
13132, Federalism
This proposed 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. CDC
believes it has used plain language in drafting of the proposed rule
and would welcome any comment from the public 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: June 20, 2011.
Kathleen Sebelius,
Secretary.
For the reasons stated in the preamble, the Centers for Disease
Control and Prevention, U.S. Department of Health and Human Services,
proposes to amend 42 CFR part 71, subpart F, as follows:
PART 71--FOREIGN QUARANTINE
1. The authority citation for part 71 continues to read as follows:
Authority: 42 U.S.C. 243, 248, 249, and 264-272.
2. Revise Sec. 71.54 to read as follows:
Sec. 71.54 Import Regulations for Infectious Biological Agents,
Infectious Material, and Vectors.
(a) Definitions:
Animal. Any member of the animal kingdom except a human.
[[Page 63896]]
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 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 material. Any material which is known or suspected to
contain a biological agent infectious to humans.
Select agents and toxins. Biological agents and toxins that could
pose a severe threat to public health and safety listed in 42 CFR 73.3
and 73.4.
Vector. Any animals (vertebrate or invertebrate) including
arthropods or any noninfectious self-replicating system known to
transfer or 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 material or vector unless:
(1) It is accompanied by a permit issued by CDC. The possession of
a permit issued by 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 permit requirements and
conditions.
(3) The importer has implemented biosafety measures commensurate
with the hazard posed by the infectious biological agent, infectious
material, and/or vector to be imported, and the level of risk given its
intended use.
(4) The importer is in compliance with all applicable laws
concerning the packaging and shipment of infectious substances.
(c) If noted as a condition of the issued permit, subsequent
transfers of any infectious biological agent, infectious material 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.
(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 materials, 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 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) It is a diagnostic specimen not known by the importer to
contain, or suspected by the importer of containing, an 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.
(3) 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.
(4) 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).
(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 CDC Import Permit Program.
(2) Have in place biosafety measures that are commensurate with the
hazard posed by the infectious biological agent, infectious material,
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
material, 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. CDC will issue a written response to the
appeal, which shall constitute final agency action.
[FR Doc. 2011-26656 Filed 10-13-11; 8:45 am]
BILLING CODE 4163-18-P