[Federal Register Volume 84, Number 227 (Monday, November 25, 2019)]
[Proposed Rules]
[Pages 64808-64819]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24943]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 71
[CDC Docket No. CDC-2019-0063]
RIN 0920-AA72
Control of Communicable Diseases; Importation of Human Remains
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice of proposed rulemaking (NPRM).
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SUMMARY: The Centers for Disease Control and Prevention (CDC) in the
Department of Health and Human Services (HHS) proposes to amend two
provisions within its foreign quarantine regulations to provide
additional clarity and safeguards to address the risk to public health
from the importation of human remains into the United States.
DATES: Written or electronic comments on the NPRM must be received by
January 24, 2020.
Paperwork Reduction Act Public Comments: Submit written or
electronic comments by January 24, 2020. Please see the Paperwork
Reduction Act section for instructions on how to submit comments.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2019-
0063 or RIN 0920-AA72 by either of the following methods:
Federal eRulemaking Portal: 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 H16-4,
Atlanta, GA 30329, ATTN: Human Remains NPRM.
Instructions: All submissions received must include the agency name
and docket number or Regulation Identifier Number (RIN) for this
rulemaking. All relevant comments received will be posted without
change to http://www.regulations.gov, including any personal
information provided.
Comments will also be available for public inspection from Monday
through Friday, except for legal holidays, from 9 a.m. to 5 p.m.,
Eastern Daylight Time, at 1600 Clifton Road NE, Atlanta, Georgia 30329.
Please call ahead to 404-498-1600 and ask for a representative from the
Division of Global Migration and Quarantine (DGMQ) to schedule your
visit.
FOR FURTHER INFORMATION CONTACT: For information regarding this NPRM:
Ashley C. Altenburger, J.D., Division of Global Migration and
Quarantine, Centers for Disease Control and Prevention, 1600 Clifton
Road NE, MS-H16-4, Atlanta, GA 30329. For information regarding CDC
operations related to this NPRM: ATTN: Kendra Stauffer, D.V.M.,
Division of Global Migration and Quarantine, Centers for Disease
Control and Prevention, 1600 Clifton Road NE, MS-V-18-2, Atlanta, GA
30329. Either may also be reached by telephone 404-498-1600 or email
[email protected].
SUPPLEMENTARY INFORMATION: The NPRM is organized as follows:
I. Public Participation
II. Background and Legal Authority
III. Rationale for Notice of Proposed Rulemaking
IV. Summary of Notice of Proposed Rulemaking
A. 71.50 Scope and Definitions
B. 71.55 Importation of Human Remains
V. Required Regulatory Analyses
[[Page 64809]]
A. Executive Orders 12866 and 13563
B. Executive Order 13771
C. The Regulatory Flexibility Act
D. Paperwork Reduction Act of 1995
E. National Environmental Policy Act (NEPA)
F. E.O. 12988: Civil Justice Reform
G. E.O. 13132: Federalism
H. Plain Language Act of 2010
I. Public Participation
Interested persons or organizations are invited to participate in
this rulemaking by submitting written views, recommendations, and data
on all aspects of the proposed rule. Comments received should reference
a specific portion of the rule, and inclusion of any 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 consider confidential or inappropriate
for public disclosure. HHS/CDC will carefully consider and address all
comments submitted and may revise the content of the rule as
appropriate at the final rulemaking stage. HHS/CDC will publish a final
rule after the comment period that reflects any content changes made as
a result of comments received.
II. Background and Legal Authority
The primary legal authorities supporting this rulemaking are
sections 361 and 362 of the Public Health Service Act (42 U.S.C. 264
and 265). Section 361 authorizes the Secretary \1\ of HHS to make and
enforce such 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 or from one state or possession into any other state or
possession.
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\1\ 42 U.S.C. 264 and 265 by their terms grant authority to the
U.S. Surgeon General. The Reorganization Plan No. 3 of 1966
abolished the Office of the Surgeon General and transferred the
Surgeon General's functions to the Secretary of Health, Education,
and Welfare (now Secretary of HHS). 31 FR 8855, 80 Stat. 1610 (Jun.
25, 1966). The Secretary of Health, Education, and Welfare was re-
designated the Secretary of Health and Human Services by section
509(b) of Public Law 96-88, 93 Stat. 695 (codified at 20 U.S.C.
3508(b)). Although the Office of the Surgeon General was re-
established in 1987, the Secretary of HHS has retained the
Secretary's authorities under 42 U.S.C. 264 and 265.
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Section 361(a) (42 U.S.C. 264(a) does not limit the types of
communicable diseases for which regulations may be enacted, but applies
to all communicable diseases that may impact human health. Section
361(a) also authorizes the Secretary to promulgate and enforce a
variety of public health regulations to prevent the spread of
communicable diseases including regulations relating to: Inspection,
fumigation, disinfection, sanitation, pest extermination, destruction
of animals or articles found to be sources of dangerous infection to
human beings, and other measures.
CDC regulations currently define ``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. See 42 CFR 70.1 and 71.1. HHS/CDC is not
proposing any changes to this definition but has included this
information for background only.
Under 42 CFR 71.55, CDC's Division of Global Migration and
Quarantine (CDC/DGMQ) regulates human remains that are imported into
the United States primarily for burial, entombment, or cremation
(hereinafter ``final resting''). CDC/DGMQ is also authorized under 42
CFR 71.32(b) to take public health measures, including detention, at
ports of entry whenever there is ``reason to believe that any arriving
carrier or article or thing onboard a carrier is or may be infected or
contaminated with a communicable disease.'' Under the authority of 42
CFR 71.32(b) and 42 CFR 71.55, CDC has issued guidance regarding the
importation of human remains.\2\
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\2\ https://www.cdc.gov/importation/human-remains.html.
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Under the authority of 42 CFR 71.54, CDC's Division of Select
Agents and Toxins (CDC/DSAT) issues permits for imported infectious
biological agents, infectious substances, and vectors (which includes
human remains and body parts) that are known to or reasonably suspected
of containing an infectious biological agent.
Section 362 (42 U.S.C. 265) authorizes the HHS Secretary \3\ to
issue regulations authorizing the suspension of entries and imports
into the United States based on the presence of a communicable disease
in a foreign country or place.
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\3\ The functions of the President under sections 362 and 364(a)
of the Public Health Service Act (42 U.S.C. 265 and 267(a)) have
been assigned to the HHS Secretary. See Exec. Order 13295 (Apr. 4,
2003), as amended by Exec. Order 13375 (Apr. 1, 2005) and Exec.
Order 13674 (July 31, 2014).
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Regulations at 42 CFR 71.63 authorize the CDC Director to suspend
entries and imports into the United States of animals, articles, or
things from designated foreign countries or places whenever the
Director determines that such an action is necessary to protect public
health. Such an action must be based on a finding that there exists in
a foreign country or place a communicable disease that would threaten
U.S. public health and that the entry or import of that animal,
article, or thing from that country or place increases the risk that
the communicable disease may be introduced, transmitted, or spread into
the United States. Under such circumstances, the Director will
designate the foreign countries or places and the period of time or
conditions under which the introduction of imports into the United
States will be suspended.
HHS/CDC recognizes that other Federal agencies may have equities in
the importation or transportation of human remains or other infectious
substances. These other Federal agencies include the U.S. Department of
Defense (DOD), which oversees the repatriation of remains of U.S.
service personnel; the U.S. Department of State (DOS), which assists in
the repatriation of remains of U.S. citizens who die overseas; the
Department of Transportation, which oversees transportation safety,
including the transportation of hazardous materials; and the Department
of Homeland Security (DHS), Transportation Security Administration
(TSA) which oversees a variety of activities relating to transportation
security. Nothing in this NPRM is intended to alter or conflict with
statutory provisions, regulations, orders, or directives of these
agencies.
III. Rationale for Notice of Proposed Rulemaking
HHS/CDC's role is to ensure that human remains imported into the
United States do not contain a communicable disease or an infectious
biological agent that could threaten public health. In recent years,
HHS/CDC has received an increased number of notifications regarding the
importation of body parts that are improperly packaged (e.g., contained
in garbage bags or coolers susceptible of leaking fluid) or that lack
proper documentation (e.g., importers stating only that the remains are
to be used for ``training.'').4 5 6 In some cases, importers
have misrepresented the contents of the
[[Page 64810]]
package or the remains were found to be leaking.
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\4\ https://www.washingtonpost.com/news/morning-mix/wp/2016/03/26/the-husband-and-wife-duo-who-allegedly-dismembered-diseased-bodies-and-sold-them-for-profit/.
\5\ https://www.reuters.com/investigates/special-report/usa-bodies-brokers/.
\6\ See also data in economic analysis below.
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HHS/CDC has two regulatory provisions that control the safe
importation of human remains into the United States:
Under Sec. 71.54, CDC requires an import permit for the
importation of a whole body or body part that is known to contain or
reasonably suspected of containing an infectious biological agent.
Under current Sec. 71.55, CDC requires that imported
human remains be cremated, or properly embalmed and placed in a
hermetically sealed casket, or accompanied by a permit issued by the
CDC Director if the cause of death was a quarantinable communicable
disease.
Because both Sec. 71.54 and 71.55 are applicable to imported human
remains, U.S. Customs and Border Protection (CBP) agents often hold
bodies and body parts for several days at the port of entry until a
determination is made as to which regulatory provision should apply. In
the past, while CDC has published guidance to its website, it now
believes that further rulemaking is needed to address these concerns.
Therefore, HHS/CDC is now proposing to formally amend its regulations
to codify current policy, to clarify roles and responsibilities, and to
better inform importers what requirements may apply, including when a
permit may be needed. These changes are not intended to affect the
operations of other Federal partners who have equities in either the
importation of human remains or the regulation of such imports.
IV. Summary of Notice of Proposed Rulemaking
A. 71.50 Scope and Definitions
Through this NPRM, HHS/CDC is proposing to include four new
definitions under 42 CFR 71.50, Scope and definitions, which is
applicable to importations under part 71 subpart F: ``death
certificate,'' ``human remains,'' ``importer,'' and ``leak-proof
container.'' We welcome public comment on all proposed definitions.
HHS/CDC proposes to define death certificate, for purposes of this
regulation, to mean an official government document that certifies that
a death has occurred and provides identifying information about the
deceased, including (at a minimum) name, age, and sex. The document
must also certify the time, place, and cause of death (if known). If
the official government document is not written in English, then it
must be accompanied by an English language translation of the official
government document, the authenticity of which has been attested to by
a person licensed to perform acts in legal affairs in the country where
the death occurred. In lieu of a death certificate, a copy of the
Consular Mortuary Certificate and the Affidavit of Foreign Funeral
Director and Transit Permit, shall together constitute acceptable
identification of human remains.
By clearly enumerating these data elements, HHS/CDC will be better
able to verify a body being imported for final resting matches the
description on the death certificate. Further, by proposing to require
that the document either be written in English or accompanied by a
translation, this definition will facilitate importation into the U.S.
CDC will work with DOS to the ensure that the Consular Mortuary
Certificate continues to identify whether the individual died of a
communicable disease so that a public health risk assessment can be
conducted before importation.
HHS/CDC proposes to define human remains, for purposes of this
regulation, to mean a deceased human body or any portion of a deceased
human body, except:
Clean, dry bones or bone fragments; human hair; teeth;
fingernails or toenails; or
A deceased human body and portions thereof that have
already been fully cremated prior to import; or
Human cells, tissues or cellular or tissue-based products
(HCT/Ps) intended for implantation, transplantation, infusion, or
transfer into a human recipient.
This proposed definition excludes clean, dry bones or bone
fragments, human hair, teeth, fingernails or toenails and fully
cremated bodies or portions thereof because these items do not contain
body fluids and therefore are not considered to pose a threat to public
health. By narrowing this definition, HHS/CDC is also able to convey
which portions of the dead body it intends to regulate. For purposes of
this regulation, the proposed definition also excludes HCT/Ps intended
for implantation, transplantation, infusion, or transfer into a human
recipient because these items are regulated by a separate HHS agency
(the Food and Drug Administration).
HHS/CDC proposes to define importer, for purposes this regulation,
as any person importing or attempting to import an item regulated under
the subpart.
This proposed definition will be applicable to all provisions under
subpart F of 42 CFR part 71. ``Person'' is currently defined under
Sec. 71.50 as any individual or partnership, firm, company,
corporation, association, organization, or similar legal entity,
including those that are not-for-profit. No changes will be made to the
definition of ``Person.''
HHS/CDC is proposing to replace the current requirement that
remains be contained within a ``hermetically sealed casket'' with a
requirement and definition of leak-proof container, defined for the
purposes of this regulation, as a container that is puncture-resistant
and sealed in a manner so as to contain all contents and prevent
leakage of fluids during handling, storage, transport, or shipping,
such as:
A double-layered plastic, puncture-resistant body bag
(i.e., two sealed body bags, one inside the other),
A casket with an interior lining certified by the
manufacturer to be leak-proof and puncture-resistant, or
A sealed metal body-transfer case.
This will ensure that importers are aware that coolers, garbage
bags, and similar non-leak-proof containers are not acceptable because
these items do not prevent the leakage of fluids used to transport
human remains.
B. 71.55 Importation of Human Remains
To best reflect current practice, HHS/CDC proposes to rename
current 42 CFR 71.55 ``Dead Bodies'' to ``Importation of Human
Remains'' to clarify that our authority extends to portions of the
human body, and not only to ``dead bodies'' as a whole, as well as to
highlight the difference in documentation needed between human remains
imported for final resting (under Sec. 71.55) and human body parts
primarily imported for other reasons, which may fall under Sec. 71.54
``Import regulations for infectious biological agents, infectious
substances, and vectors.''
Under proposed 42 CFR 71.55(a), all human remains intended for
import into the United States and those transiting through the United
States en route to a foreign destination must be contained in a leak-
proof container that is packaged and shipped in accordance with all
applicable legal requirements. This requirement will ensure that
individuals handling the packages of human remains are not exposed to
body fluids that may contain an infectious biological agent or
embalming material, regardless of whether the remains are intended for
importation or are in transit through the United States. HHS/CDC also
proposes to eliminate specific requirements under current Sec. 71.55
that
[[Page 64811]]
human remains of a person who died of a quarantinable communicable
disease be ``embalmed'' and placed into a ``hermetically sealed
casket'' because this no longer reflects current best practices and
unnecessarily increases the burden on importers.
Proposed Sec. 71.55(b) informs the public that imports of human
remains known to contain or reasonably suspected of containing an
infectious biological agent must abide by 42 CFR 71.54 to ensure that
all measures are taken to protect U.S. public health. This includes
remains known to contain or reasonably suspected of containing an
infectious biological agent that have not or cannot be rendered
noninfectious.
Under proposed Sec. 71.55(c)(1)(i), to ensure that human remains
imported for final resting enter only for the intended purpose, we have
included a proposed requirement that such remains be consigned
``directly'' to a licensed mortuary, cemetery, or crematory. Section
71.55(c)(1)(ii), requires that these remains (unless embalmed) must
also be accompanied by a death certificate or, if the death certificate
is incomplete or missing, an importer certification statement
confirming that the human remains are not known to contain or stating
why the human remains are not reasonably suspected of containing an
infectious biological agent. Such documentation ensures that the human
remains do not pose a threat to public health because the decedent
succumbed to a communicable disease, including a quarantinable
communicable disease.
HHS/CDC is aware that certain Federal partners, such as DOD and
DOS, may require that human remains of military or civilian personnel
continue on to a place of final resting outside of the United States
after the remains are transported into the United States. Such a
transport will not be deemed an ``import'' under this provision and
therefore will not be subject to the requirement that remains be
consigned ``directly'' to a licensed mortuary, cemetery, or crematory,
because the remains are ``transiting'' through the United States en
route to final destination. Under this proposal, HHS/CDC will not
prevent human remains from transiting through a U.S. port of entry en
route to another country, provided that the remains are properly
packaged in a leak-proof container and in compliance with applicable
transportation requirements.
Under proposed Sec. 71.55(c)(2)(i), if human remains are imported
for medical examination or autopsy, the remains must be consigned
directly to an entity authorized to perform such functions under the
laws of the applicable jurisdiction prior to subsequent burial,
entombment, or cremation. By ``authorized,'' HHS/CDC includes
government entities that typically perform medical examinations or
autopsies such as state or local coroners' offices, as well as private
entities operating in compliance with the laws of the relevant
jurisdiction. Upon completion of the medical examination or autopsy,
the human remains must be immediately delivered to a licensed mortuary,
cemetery, or crematory that will be responsible for final resting.
Section 71.55(c)(2)(ii), requires that these remains (unless embalmed)
be accompanied by a death certificate or, if the death certificate is
incomplete or missing, an importer certification statement confirming
that the human remains are not known to contain or stating why the
human remains are not reasonably suspected of containing an infectious
biological agent. Such documentation ensures that the human remains
being imported do not pose a threat to public health because the
decedent succumbed to a communicable disease, including a quarantinable
communicable disease.
Both Sec. 71.55(c)(1) and (2) include the clause ``unless
embalmed'' because embalmed remains are considered to have been
rendered noninfectious and therefore would not require a death
certificate to ensure that the individual did not die of a communicable
disease. HHS/CDC understands that certain countries do not state cause
of death on a death certificate due to privacy concerns. For this
reason, also under proposed Sec. 71.55(c)(1) and (2), if the death
certificate is incomplete or if cause of death is not listed, the human
remains must be accompanied by an importer certification statement
confirming that the human remains are not known to contain or
reasonably suspected of containing an infectious biological agent.
CDC will also deem a consular mortuary certificate that references
whether the person died of a communicable disease, accompanied by an
affidavit or sworn declaration by the local funeral director and
transit permit, together as sufficient documentation in lieu of a death
certificate. CDC welcomes public comment on whether other valid
documents should be accepted in lieu of a death certificate.
Proposed Sec. 71.55(c)(3) requires that, unless embalmed, all
``human remains'' (as that term is defined) imported into the United
States for purposes other than final resting or autopsy be accompanied
by an importer certification statement confirming that the human
remains are not known to contain or stating why the human remains are
not reasonably suspected of containing an infectious biological agent.
This proposed language addresses the other uses for human remains such
as medical training or anatomical display.
HHS/CDC understands that certain partner agencies, such as the FAA
Civil Aerospace Medical Institute (CAMI), may import human remains in
order to help accident investigators determine the cause and
contributing factors of an aircraft accident. Performing toxicology and
other medical tests on human remains, as well as reviewing medical
records, toxicological testing results, and autopsy reports, can help
accident investigators determine, for example, if an airman's medical
impairment or incapacitation contributed to the cause of an aircraft
accident. HHS/CDC does not consider importations of human remains for
these purposes to constitute ``human remains imported for medical
examination or autopsy'' because the purpose is not to determine
individual cause of death, but rather to aid in accident investigation.
In addition, other organizations may import cadavers or partial human
remains for product or safety testing or other scientific purposes.
Human remains imported for these purposes would fall under the
``imported for any other purpose'' under (c)(3) and would require,
unless embalmed, an importer certification statement confirming that
the human remains are not known to contain or stating why the human
remains are not reasonably suspected of containing an infectious
biological agent.
Finally, under proposed Sec. 71.55(d), the CDC Director may
suspend the entry or importation of human remains under 42 CFR 71.63 if
the Director determines that such an action is necessary to protect the
public health. Such an action may occur when (i) the import is coming
from a foreign country designated by the CDC Director as a place where
a communicable disease exists that could threaten U.S. public health
and (ii) the import increases the risk of introducing or spreading the
communicable disease into the United States. In the past, this
provision has only been invoked to temporarily suspend wildlife
reservoirs of zoonotic disease and HHS/CDC does not anticipate that
this provision will be invoked frequently absent a public health
emergency where such measures would be needed to protect U.S. public
health. HHS/CDC welcomes public comment on this proposed emergency
measure.
[[Page 64812]]
VI. Required Regulatory Analyses
A. Executive Orders 12866 and 13563
Executive Orders 12866 ``Improving Regulation and Regulatory
Review,'' and 13563, ``Regulatory Planning and Review,'' direct
agencies to assess the 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, reducing costs, harmonizing rules,
and promoting flexibility.
Statement of Need
As discussed in more detail above, HHS/CDC proposes to amend two
provisions within its foreign quarantine regulations (specifically, 42
CFR 71.50 and 71.55) to provide additional clarity and safeguards to
address the risk to public health from the importation of human remains
into the United States. In recent years, HHS/CDC has received an
increased number of notifications regarding the importation of body
parts that are improperly packaged (e.g., contained in garbage bags or
coolers susceptible of leaking fluid) or that lack proper documentation
(e.g., importers stating only that the remains are to be used for
``training.'').7 8 In some cases, importers have
misrepresented the contents of the package or the remains were found to
be leaking.
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\7\ https://www.washingtonpost.com/news/morning-mix/wp/2016/03/26/the-husband-and-wife-duo-who-allegedly-dismembered-diseased-bodies-and-sold-them-for-profit/.
\8\ https://www.reuters.com/investigates/special-report/usa-bodies-brokers/.
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HHS/CDC has two regulatory provisions that control the safe
importation of human remains into the United States:
Under Sec. 71.54, CDC requires an import permit for the
importation of a whole body or body part that is known to contain or
reasonably suspected of containing an infectious biological agent.
Under current Sec. 71.55, CDC requires that imported
human remains be cremated, or properly embalmed and placed in a
hermetically sealed casket, or accompanied by a permit issued by the
CDC Director if the cause of death was a quarantinable communicable
disease.
Because both Sec. Sec. 71.54 and 71.55 are applicable to imported
human remains, CBPU.S. Customs and Border Protection agents often hold
bodies and body parts for several days at the port of entry until a
determination is made as to which regulatory provision should apply. In
the past, while CDC has published guidance to its website, it now
believes that further rulemaking is needed to address these concerns.
Therefore, HHS/CDC is now proposing to formally amend its regulations
to codify current policy, to clarify roles and responsibilities, and to
better inform importers what requirements may apply, including when a
permit may be needed. These changes are not intended to affect the
operations of other Federal partners who have equities in either the
importation of human remains or the regulation of such imports.
The proposed regulatory changes described in the preamble and
reported below are a codification of current requirements authorized
under existing 42 CFR 71.32(b), 71.54, 71.55, and 71.63, and described
in guidance. Since this NPRM does not change the regulatory baseline,
HHS/CDC expects minimal economic impacts on importers of human remains,
Department of Homeland Security/Customs and Border Protection/
Transportation Security Administration (DHS/CBP, DHS/TSA,), HHS/CDC,
Department of State (DOS), airline or other industries that facilitate
the importation of human remains, or state and local public health
departments (Ph.D.s).
HHS/CDC regulations are necessary to correct the market failure in
which human remains are improperly packaged (e.g., contained in garbage
bags or coolers susceptible of leaking fluid) or that lack proper
documentation that could pose additional risk to individuals in the
event of an accidental exposure. These changes should reduce risks of
exposure for other non-importer stakeholders (e.g., carrier or vessel
staff, other travelers, TSA or CBP staff who inspect cargo) to
communicable diseases. The container requirement limits exposures to
leaking fluids. The documentation requirements ensure that human
remains that pose a public health risk are accompanied with the proper
permit documentation under existing 42 CFR 71.54 or are consigned
``directly'' to a licensed mortuary, cemetery, or crematory. If human
remains are consigned directly to a licensed mortuary, cemetery, or
crematory, the human remains will be handled by professionals with
experience handling human remains. Otherwise, the documentation and
container requirements would limit others' exposure to human remains or
may provide additional information (via the documentation requirements)
on potential public health risks in the event of an exposure.
The requirements specified under proposed 42 CFR 71.55(a) conform
with existing CDC guidance that human remains should be transported in
a leak-proof container that is packaged and shipped in accordance with
all applicable legal requirements. For human remains for which the
cause of death was a quarantinable communicable disease, HHS/CDC
requirements will change from the more restrictive hermetically sealed
casket to the less restrictive leakproof container. These requirements
are also consistent with requirements imposed by the four largest U.S.
carriers in 2019 for transport of human remains (i.e., Delta, American,
United, and Southwest Airlines). In practice, HHS/CDC is unaware of any
imported human remains of individuals who died of a quarantinable
disease in the previous 15 years. HHS/CDC proposes to eliminate
specific requirements under current Sec. 71.55 that human remains of a
person who died of a quarantinable communicable disease be ``embalmed''
and placed into a ``hermetically sealed casket'' because this no longer
reflects current best practices and would unnecessarily increase the
burden on importers.
The requirements under proposed 42 CFR 71.55(b) simply refer to
existing permit requirements described in 42 CFR 71.54 for all imported
human remains known to contain or reasonably suspected of containing an
infectious biological agent. There is no change to 42 CFR 71.54, simply
clarification of when 42 CFR 71.54 should apply to transport of human
remains. The requirements under proposed 42 CFR 71.55(c) clarify the
documentation requirements for un-embalmed human remains imports that
do not need permits according to existing 42 CFR 71.54. These
documentation requirements are consistent with existing practices in
the Department of State's Foreign Affairs Manual and consistent with
other agencies' requirements for transporting human remains to
facilitate U.S. Customs Clearance.
HHS/CDC qualitatively considered alternatives to codifying current
practice. HHS/CDC considered a less-restrictive requirement than
transport of human remains in a leakproof container. Qualitatively,
HHS/CDC does not believe this regulatory action would significantly
change the current status quo. As noted, the current requirements of
the four largest U.S. carriers to ship human remains are already
consistent with the HHS/CDC's leakproof container requirement. If HHS/
CDC chose not to
[[Page 64813]]
regulate the type of container, airlines may choose to maintain their
existing requirement for transporting human remains internationally in
leakproof containers to avoid exposures to their employees, which may
also be regulated, after entry through ports of entry, under the U.S.
Department of Labor's Occupational Safety and Health Administration's
requirements (refer to 29 CFR 1910.1030). In addition, importers (other
than colleges, hospitals, or laboratories) of human remains for
purposes other than burial, entombment, or cremation may already be
subject to U.S. Department of Transportation packaging requirements
delineated in 49 CFR 173.199. These requirements are more restrictive
than HHS/CDC's leakproof container requirement.
Another alternative would be to require a more restrictive
requirement, such as a hermetically sealed casket, to import all un-
embalmed human remains. Qualitatively, the cost of this alternative
would be much more expensive than the status quo guidance and HHS/CDC
does not believe the marginal improvement to public health would
justify the substantially increased cost of requiring hermetically
sealed caskets to import all un-embalmed human remains.
HHS/CDC documentation requirements are consistent with existing
international agreements and instruments governing the international
transportation of human remains as noted in the DOS Foreign Affairs
Manual, 7 FAM 252(b).\9\ The documentation requirements listed in
proposed 42 CFR 71.55(c) only apply to human remains that are not
embalmed. Since the majority of human remains imported for burial,
entombment, or cremation are embalmed, most importations would not be
affected by this codification of current practice.
---------------------------------------------------------------------------
\9\ The international agreements and instruments listed in 7 FAM
252(b) are (1) Council of Europe, Agreement on The Transfer Of
Corpses, Signed at Strasbourg, October 26th, 1973; (2) Pan American
World Health Organization, XVII Pan American Sanitary Conference,
XVIII Regional Committee Meeting, Resolution XXIX, adopted in
Washington, October 7th, 1966, International Transportation Of Human
Remains; and (3) International Arrangements Concerning the
Conveyance of Corpses, Signed at Berlin, February 10, 1937.
---------------------------------------------------------------------------
A less restrictive alternative would be to also omit the
documentation requirements for un-embalmed human remains. However, as
noted in 7 FAM 258, DOS states that the consular mortuary certificate
is designed to facilitate U.S. Customs Clearance. In addition, DOS
requests a certificate of death, an affidavit by the local funeral
director, and a transit permit as required by local laws to support
exporting human remains. It should be noted that the documentation
requested by DOS to support the transportation of cremated human
remains (which are exempt from HHS/CDC requirements) are similar to the
requested documentation for non-cremated human remains.\10\ In general,
HHS/CDC would expect that death certificates or the Affidavit of
Foreign Funeral Director and Transit Permit would be created in the
event of an overseas death and would be available for most human
remains imported for burial, entombment, or cremation. However, it may
not be necessary to provide either a (translated) death certificate or
to translate the Affidavit of Foreign Funeral Director or Transit
Permit. Thus, the primary cost may be for translation services for
these documents if human remains are imported from a non-English-
speaking country. Since the importation of most human remains are
already facilitated by DOS consular offices, translated documentation
may already be provided to U.S. consular offices in most cases. Without
the documentation required in this NPRM, it would not be possible for
HHS/CDC to confirm that individuals did not die from a quarantinable
communicable disease or otherwise pose a public health risk to
individual exposed to their un-embalmed remains. In the past, HHS/CDC
has not routinely had issues obtaining these documents for imported,
un-embalmed human remains for burial, entombment, or cremation in the
past, but would welcome public comment on the cost of producing such
documentation. Qualitatively, HHS/CDC believes that the costs
associated with increased risk of exposure to un-embalmed human remains
infected with communicable diseases justify the expense for the
documentation requirements codified in proposed 42 CFR 71.55(c) for un-
embalmed human remains.
---------------------------------------------------------------------------
\10\ Refer to 7 FAM 256.
---------------------------------------------------------------------------
A more restrictive documentation requirement would be to require
that all importations of human remains (i.e., embalmed remains as well
as un-embalmed remains) comply with this documentation requirement.
However, HHS/CDC does not believe that the public health risks posed by
embalmed human remains (e.g. exposure to embalming fluids) shipped in
leakproof containers necessitate additional documentation requirements
for public health purposes.
HHS/CDC also considered an alternative in which different
requirements would apply to different countries. However, since most
human remains that are imported to the United States were U.S.
citizens, permanent residents, or their relatives, HHS/CDC does not
generally believe the risk of exposure to communicable diseases is
likely to vary depending based on the country from which human remains
are imported. HHS/CDC does address the potential need to apply
different requirements to different countries in proposed 42 CFR
71.55(d). The CDC Director may suspend the entry or importation of
human remains under 42 CFR 71.63 if the Director determines that such
an action is necessary to protect the public health. Such an action may
occur when (i) the import is coming from a foreign country designated
by the CDC Director as a place where a communicable disease exists that
could threaten U.S. public health and (ii) the import increases the
risk of introducing or spreading the communicable disease into the
United States. In the past, this provision has only been invoked to
temporarily suspend wildlife reservoirs of zoonotic disease and HHS/CDC
does not anticipate that this provision will be invoked frequently
absent a public health emergency where such measures would be needed to
protect U.S. public health.
The rest of the economic evaluation below focuses on estimation of
the potential costs and benefits of the requirements included in this
NPRM relative to the current status quo.
Economic Impact
DOS works with U.S. residents to process the required documentation
for importing human remains into the United States for burial,
entombment, or cremation. Their requirements are reported in the
current version of the Foreign Affairs Manual (FAM). In 7 FAM
252(a)(3), DOS notes that CDC's authority is not limited to
quarantinable communicable diseases but extends to the importation of
remains of persons who died of other communicable diseases.
Specifically, 7 FAM 252(a)(3) states that ``In general, U.S. public
health requirements will be satisfied if the remains are shipped in a
leak-proof container and accompanied by the death certificate or the
consular mortuary certificate, which must state that the deceased did
not die from a quarantinable communicable disease. A leak-proof
container is one that is puncture-resistant and sealed in a manner to
contain all contents and prevent leakage of fluids during handling,
storage, transport, or shipping. While additional restrictions are not
generally employed, CDC reserves the right to do so on a case-by-
[[Page 64814]]
case basis when necessary to prevent the spread of disease.''
This description is consistent with the codification of
requirements of human remains for the purposes of burial, entombment,
or cremation under proposed 42 CFR 71.55 as summarized above. Because
this is a codification of current practice, the economic impact on
importers of human remains and DOS are expected to be minimal. To
estimate the cost to DOS to update the FAM to include references to
proposed 42 CFR 71.55, the cost was estimated by assuming that 1 GS-14,
step 5 employee and one GS-15, step 5 employee each spend 40 hours
(i.e., 80 hours in total) for any updates to cite the language in
proposed 42 CFR 71.55. The hourly wage rates for these two employees
based in Washington-Baltimore-Arlington, DC-MD-VA-WV-PA are $62.23 (GS-
14) and $73.20 (GS-15).\11\ To account for the non-wage benefits, we
multiplied the wage cost by two to result in a total cost estimate of
$10,834. The costs for CBP and CDC are expected to be similar (Table
1), because this change is a codification of current practice. Thus,
the expected one-time costs associated with codification for all three
agencies can be estimated at $31,906.
---------------------------------------------------------------------------
\11\ U.S. Office of Personnel and Management. https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/2018/general-schedule/. Accessed on March 27, 2019.
Table 1--Summary of the One-Time Costs in 2018 USD To Update Official Documents for Department of State (DOS),
Centers for Disease Control and Prevention (CDC), and Customs and Border Protection (CBP) Costs From the
Codification in Proposed 42 CFR 71.55 of the Requirements Authorized Under Existing 42 CFR 71.32(b), 71.54, and
71.63
----------------------------------------------------------------------------------------------------------------
Multiplier
Hourly wage for non-wage
Agency Cost components rate \12\ benefits and Total
overhead
----------------------------------------------------------------------------------------------------------------
DOS............................... 80 hours split between GS- 67.72 2 $10,834
14, step 5 and GS-15, step
5 levels.
CDC............................... 80 hours split between GS- 63.99 2 10,238
14, step 5 and GS-15, step
5 levels.
CBP............................... 80 hours split between GS- 67.72 2 10,834
14, step 5 and GS-15, step
5 levels.
-----------------------------------------------------------------------------
Total......................... ............................ .............. .............. $31,906
----------------------------------------------------------------------------------------------------------------
Individuals importing human remains for purposes other than burial,
entombment, or cremation, may be less familiar with CDC requirements
authorized under existing 42 CFR 71.32(b) and 71.54. As a result,
importers of human remains for other purposes may not be aware of the
requirement that human remains must arrive in an appropriate, leak-
proof shipping container as specified under proposed 42 CFR 71.55(a).
In addition, they may not be aware that, unless human remains are
embalmed and therefore rendered noninfectious, they must be accompanied
by a death certificate listing cause of death or that if the death
certificate is incomplete or if cause of death is not listed, the human
remains must be accompanied by an importer certification statement
either confirming that the human remains are not known to contain or
stating why the human remains are not reasonably suspected of
containing an infectious biological agent as specified under proposed
42 CFR 71.55(c). In addition, importers would need to apply for a
permit under existing 42 CFR 71.54 if they are unable to demonstrate
that human remains are not reasonably suspected of containing an
infectious biological agent. Upon publication of a final rule, CDC will
update its website to ensure that importers have access to the most up-
to-date information regarding packaging and documentation requirements
for human remains.
---------------------------------------------------------------------------
\12\ U.S. Office of Personnel and Management. https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/2018/general-schedule/. Accessed on March 27, 2019.
---------------------------------------------------------------------------
The codification of existing requirements should not result in an
additional regulatory burden and should help reduce the costs by
reducing confusion regarding the requirements for importing human
remains for purposes other than burial, entombment or cremation.
However, as an upper bound cost estimate, we assumed that one
additional importer would apply for a permit to import human remains
for other purposes every other year after the final rule goes into
effect. When importers first apply for a permit, the greatest expense
is associated with the need for DSAT to perform an inspection of the
importers' facilities and to document their findings. This process also
requires time for importers to support the inspection and respond to
questions from DSAT subject matter experts. HHS/CDC estimated the
amount of time per inspection to include about 20 hours of staff time
split between the GS-12, GS-13, and GS-14 pay levels. To estimate
costs, HHS/CDC assumed the staff would be compensated at step 5 as
summarized in Table 2. In addition to hourly wages, non-wage benefits
and overhead costs were estimated by multiplying the wage cost by two.
The average round trip airfare for flights from Atlanta was estimated
at $367 using data from the Bureau of Transportation Statistics.\13\
The average Federal per diem for lodging, meals, and incidental
expenses was estimated at $158 per day for one day.\14\ Assuming that
inspections occur on average (0.5 times per year, the annual cost would
be estimated at $1,518 per year.
---------------------------------------------------------------------------
\13\ Bureau of Transportation Statistics. Average Domestic
Airfares (Atlanta, 2018 Q4). https://transtats.bts.gov/AIRFARES/.
Accessed on June 19, 2019.
\14\ FederalPay.org. 2018 Federal Per Diem Rates. (Average of 50
states). https://www.federalpay.org/perdiem/2018. Accessed on June
19, 2019.
---------------------------------------------------------------------------
[[Page 64815]]
In addition to CDC costs, importers would have to spend time to
support the inspection and respond to CDC questions. HHS/CDC would
welcome public comment on the costs to importers to support such
inspections. HHS/CDC assumed the amount of time required would be
equivalent to CDC staff time (i.e., about 20 hours) and that the
individual working on the inspection would be compensated at a rate
equivalent to the national average wage rate reported for individuals
working as Sales Representatives, Wholesale and Manufacturing,
Technical and Scientific Products as reported in the Bureau of Labor
Statistics' May 2018 National Occupational Employment and Wage
Estimates (Occupation code= 41-4011).\15\ Their 2018 reported hourly
wage rate was $44.15. Assuming 0.5 inspections per year and a
multiplier of 2 to cover non-wage benefits and overhead, the annual
cost for importers was estimated at $883 per year. In total, the annual
cost for increased inspections for CDC ($1,518) and importers ($883)
was estimated at $2,401. This should represent an upper bound estimate
as HHS/CDC does not anticipate a large increase in inspections as a
result of this NPRM.
---------------------------------------------------------------------------
\15\ Bureau of Labor Statistics, May 2018 National Occupational
Employment and Wage Estimates (Occupation code= 41-4011). https://www.bls.gov/oes/current/oes_nat.htm. Accessed on June 19, 2019.
Table 2--Estimated Annual CDC Cost in 2018 USD for Inspections of the Facilities for an Importer of Human Remains for Purposes Other Than Final Resting
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Number of hours Average
Type of CDC staff Number of inspections spent per hourly wage Overhead Annual cost
staff per year inspection rate \16\ multi-plier
--------------------------------------------------------------------------------------------------------------------------------------------------------
GS-12 (step 5)....................................... 0.33 0.5 20 $41.85 1 $276
GS-13 (step 5)....................................... 0.33 0.5 20 49.76 1 328
GS-14 (step 5)....................................... 0.33 0.5 20 58.80 1 388
--------------------------------------------------------------------------------------------------
Total............................................ .............. .............. ................. .............. .............. 993
--------------------------------------------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------------------------------------------
Travel cost............................ Airfare \17\................ $367 Hotel, food, lodging \18\ $158 $525
----------------------------------------------------------------------------------------------------------------
Total (personnel + travel).......................................................................................... .............. 1,518
--------------------------------------------------------------------------------------------------------------------------------------------------------
The total projected costs over a 10-year time horizon for each
government agency and for importers can be estimated using a 3%
discount rate. Table 3 summarizes the present value and annualized
value of costs over the full 10-year period. In total, the estimated
cost is $46,977 over 10 years or an annualized value of $5,507 per
year.
---------------------------------------------------------------------------
\16\ U.S. Office of Personnel and Management. https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/2018/general-schedule/. Atlanta-Athens-Clarke county-Sandy Springs, GA-AL
Accessed on June 19, 2019.
\17\ Bureau of Transportation Statistics. Average Domestic
Airfares (Atlanta, 2018 Q4). https://transtats.bts.gov/AIRFARES/.
Accessed on June 19, 2019.
\18\ FederalPay.org 2018 Federal Per Diem Rates. (Average of 50
states). https://www.federalpay.org/perdiem/2018. Accessed on June
19, 2019.
Table 3--Present Value and Annualized Value of Costs in 2018 USD Over 10
Years Using a 3% Discount Rate for Government Agencies and for Importers
of Human Remains for Purposes Other Than Final Resting
------------------------------------------------------------------------
Net present cost Annualized cost
over 10-year over 10-year
horizon horizon
------------------------------------------------------------------------
CDC............................... $18,408 $2,158
CBP............................... 10,518 1,233
DoS............................... 10,518 1,233
Importers of human remains for 7,532 883
other purposes...................
-------------------------------------
Total......................... 46,977 5,507
------------------------------------------------------------------------
In the past, imported human remains for reasons other than burial,
entombment or cremation have arrived in inappropriate (i.e., not leak-
proof) containers or without sufficient documentation to determine
whether such remains may contain or be reasonably suspected of
containing an infectious biological agent. This has led to confusion at
the port of entry and detention of the human remains pending an
investigation. CDC reviewed available importation records and
identified six human remains shipments that required repackaging over
the 5-year period from 2014 to 2018. Of the six shipments, four
occurred between November 2017 and the end of 2018. These
investigations require significant effort to resolve. CDC involvement
usually includes scientific, legal, policy, and leadership staff from
CDC/DGMQ and CDC/DSAT. In each of these cases, CDC determined that a
permit issued according to existing 42 CFR 71.54 would be required when
human remains are reasonably suspected of containing an infectious
biological agent if they are without adequate shipping containers or
proper documentation, unless they are cremated, embalmed, or otherwise
rendered noninfectious per the proposed definition of ``human
remains.''
Although the amount of time per investigation event varies, on
average, each importation investigation was estimated to require
approximately 600 hours of CDC staff time split between
[[Page 64816]]
the GS-13, GS-14, and GS-15 levels. The time spent included conference
calls with the importer and CBP, legal review, permit issuance under 42
CFR 71.54, if applicable, among other activities (Table 4). The 2018
reported hourly wage rates for GS-13, GS-14, and GS-15 employees at
step 5 are $49.76, $58.80, and $69.17 per hour respectively in the
Atlanta, GA area.\19\ If this amount of time is split evenly across
each level, the estimated cost per investigation would be $35,546. This
amount can then be multiplied by 2 to account for non-wage benefits and
overhead to estimate a total cost of $71,092 per investigation.
---------------------------------------------------------------------------
\19\ U.S. Office of Personnel and Management. https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/2018/general-schedule/. Accessed on March 27, 2019.
---------------------------------------------------------------------------
In addition to CDC costs, CBP also incurs costs to deal with each
investigation including time spent communicating with CDC. The amount
of time spent by CBP is also significant and conservatively estimated
at 50% of the time spent by CDC staff. The estimated hourly wage rate
for CBP officers was estimated by assuming that the workload would be
split evenly across employees at the GS-5, GS-9, GS-11, and GS-12
levels with support from GS-15 managers providing additional
coordination with CDC senior staff. Thus, compensation was split evenly
across grades and each grade was assumed to be compensated at the step
5 level using the Washington-Baltimore-Arlington hourly pay scale (on
average, $41.02 per hour).\20\ This would result in a wage cost of
$12,306. After multiplying wages by 2 to account for non-wage benefits
and overtime, the estimated CBP cost would be $24,614. Adding the CBP
and CDC costs, the total cost per investigation event would be $71,092
+ $24,614 = $95,706.
---------------------------------------------------------------------------
\20\ U.S. Office of Personnel and Management. https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/2018/general-schedule/. Accessed on March 27, 2019.
Table 4--Benefits (Averted Costs) per Event in 2018 USD in Which Human Remains Without Adequate Documentation or
Shipping Containers Are Imported for Purposes Other Than Burial, Entombment, or Cremation and Are Held at the
Port of Entry Pending an Investigation
----------------------------------------------------------------------------------------------------------------
Multiplier
Hourly wage for non-wage
Agency Cost components rate \21\ benefits and Total
overhead
----------------------------------------------------------------------------------------------------------------
CDC............................... 600 hours split between GS- $59.24 2 $71,092
13, step 5; GS-14, step 5;
and GS-15, step 5 levels.
CBP............................... 300 hours at the GS-5, GS-9, 41.02 2 24,614
GS-11, GS-12, and GS-15,
step 5 level.
-----------------------------------------------------------------------------
Total......................... ............................ .............. .............. 95,706
----------------------------------------------------------------------------------------------------------------
In addition to costs to CDC and CBP, importers of human remains for
purposes other than final resting might not use leak-proof containers
or fail to provide import permits or importer certification
statement(s). When this occurs, importers spend a considerable amount
of time communicating with CDC and CBP about missing documentation,
searching for missing documentation after those human remains arrive at
ports of entry, or repackaging shipments at the importer's expense.
This codification of requirements authorized under 42 CFR 71.32(b), 42
CFR 71.54, and 42 CFR 71.55 pertaining to the importation of human
remains should reduce confusion. Besides the time spent on searching
for documentation and the cost of repackaging, the human remains may
begin to decompose during the investigation process, which would affect
the value of imports that may otherwise be used for purposes other than
final resting. HHS/CDC does not have any way to estimate time for
repackaging costs or decomposition costs, but would welcome public
comment on these costs. By reducing confusion, some of these costs may
be averted when the proposed 42 CFR 71.55 goes into effect. On the
other hand, codification of these requirements may increase the costs
of human remains for purposes other than burial, entombment, or
cremation if such importations are currently occurring without CBP or
CDC oversight.
---------------------------------------------------------------------------
\21\ U.S. Office of Personnel and Management. https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/2018/general-schedule/. Accessed on March 27, 2019.
---------------------------------------------------------------------------
The one-time costs of updating communications materials and the
costs for an additional 0.5 importers per year to undergo an inspection
to verify their ability to safely import human remains for purposes
other than final resting was estimated to cost $46,977 over 10 years
(annualized cost: $5,507). These costs can be compared to the benefits
(averted costs per investigation after human remains are held at the
port of entry because they arrived in a container that was not leak-
proof or with improper documentation ($95,706). During calendar years
2014-2018, there were seven time-intensive investigations for an
average 1.4 investigations per year. Among these events, one shipment
of human remains was re-exported. The remaining six shipments all
required repackaging and were held by CBP for between 2 days and 22
days (average hold: 11.3 days). Of the seven total investigations, six
involved human remains imported for purposes other than final resting.
One of these shipments was re-exported and the other five shipments of
human remains were cremated after being held by CBP. Four of the seven
investigations occurred in 2018, demonstrating an increasing trend in
improperly imported human remains.
A comparison can be made between the estimated costs and potential
benefits (i.e., averted Federal Government costs for an investigation).
This comparison suggests that even if only one held importation
requiring investigation will be averted in the 10 years after the
codification goes into effect, the expected benefits (averted costs)
would exceed expected costs assuming a discount rate of 3% per year. To
the extent that this NPRM would increase the number of inspections by
DSAT, the need to conduct investigations should decrease
proportionately. This is because it is assumed that the need for
investigations results from lack of awareness of importation
requirements for human remains for purposes other than final resting as
authorized under existing 42 CFR 71.32(b), 42 CFR 71.54 and 42 CFR
71.55. However, the inspection process itself should allow importers to
fully understand their import requirements in regard to shipping
containers, documentation, or permits.
[[Page 64817]]
In addition to the reduced costs associated with imported human
remains for purposes other than burial, entombment, or cremation
arriving with inadequate documentation or shipping containers, there
may be additional savings for the small numbers of human remains that
arrive with insufficient documentation for burial, entombment, or
cremation. During calendar years 2014 through 2018, CDC requested
additional documentation from seven importers of human remains for
burial, entombment or cremation (average 1.4 events per year) and 9
importers of human remains for purposes other than final resting (1.8
events per year). In contrast to the time-intensive investigation
events described above, these events were usually resolved quickly
because death certificates listing cause of death or importer
certification statements either confirming that the human remains were
not known to contain or stating why the human remains were not
reasonably suspected of containing an infectious biological agent were
provided relatively quickly. However, delays still incur some
additional time costs that may be averted if the requirements codified
in proposed 42 CFR 71.55 are better understood.
Finally, the proposed language in 42 CFR 71.55(d) that existing 42
CFR 71.63 may apply to imported human remains, if the Director
designates a foreign country and determines that such an action is
necessary to protect the public health, is again codifying an existing
requirement. Since its enactment, CDC has applied 42 CFR 71.63 one
time, on May 10, 2019, to suspend entry of dogs from Egypt after three
dogs with canine rabies virus variant were imported into the United
States within four years.\22\ However, the suspension has not been in
place long enough to do a full economic analysis and a suspension of
imports for dogs may not be analogous to a suspension of imports for
human remains in terms of economic impact.
---------------------------------------------------------------------------
\22\ CDC (May 10, 2019) Notice of Temporary Suspension of Dogs
Entering the United States From Egypt. 84 FR 20628. https://www.federalregister.gov/documents/2019/05/10/2019-09654/notice-of-temporary-suspension-of-dogs-entering-the-united-states-from-egypt.
---------------------------------------------------------------------------
B. Executive Order 13771
Executive Order 13771 ``Reducing Regulation and Controlling
Regulatory Costs,'' requires executive departments and agencies to
eliminate at least two existing regulations for every new significant
regulation that imposes costs. HHS/CDC has determined that this rule
imposes no more than de minimis costs, and therefore not considered a
regulatory action.
C. The Regulatory Flexibility Act
Under the Regulatory Flexibility Act, as amended by the Small
Business Regulatory Enforcement Fairness Act (SBREFA), agencies are
required to analyze regulatory options to minimize significant economic
impact of a rule on small businesses, small governmental units, and
small not-for-profit organizations. HHS/CDC finds that the NPRM is not
expected to change the cost of compliance for small businesses, small
governmental units, or small not-for-profit organizations.
D. Paperwork Reduction Act of 1995
HHS/CDC has determined that this NPRM contains proposed information
collections that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C.
3501-3520). A description of these proposed provisions is given below
with an estimate of the annual reporting and recordkeeping burden.
Included in the estimate is the time for reviewing instructions,
searching existing data sources, gathering and maintaining the data
needed, and completing and reviewing each collection of information.
Comments are invited on the following subjects.
Whether the proposed collection of information is
necessary for the proper performance of the functions of HHS/CDC,
including whether the information will have practical utility.
The accuracy of HHS/CDC's estimate of the burden of the
collection of information.
Ways to enhance the quality, utility, and clarity of the
information to be collected.
Ways to minimize the burden of the collection of
information on respondents, including by using information technology.
HHS/CDC currently has approval to collect certain information
concerning the importation of dead bodies under two OMB Control
Numbers: 0920-0134 Foreign Quarantine Regulations (expiration date 03/
31/2022) and 0920-0199 Application for Permit to Import Biological
Agents and Vectors of Human Disease into the United States and
Application for Permit to Import or Transport Live Bats (42 CFR 71.54)
(expiration date 04/30/2021). This NPRM is proposing updates to one
information collection: 0920-0134. CDC is taking public comment on the
burden to the public outlined in this update.
Written comments should be received within 60 days of the
publication of this NPRM. Please send written comments to Information
Collection Review Office, 1600 Clifton Road NE, Atlanta, GA 30333.
Proposed Projects
(1) Foreign Quarantine Regulations (42 CFR part 71) (OMB Control
No. 0920-0134)--Nonmaterial/non-substantive change--National Center for
Emerging, and Zoonotic Infectious Diseases (NCEZID), Centers for
Disease Control and Prevention (CDC).
Description
Section 361 of the Public Health Service (PHS) Act (42 U.S.C. 264)
authorizes the Secretary of Health and Human Services to make and
enforce regulations necessary to prevent the introduction,
transmission, or spread of communicable diseases from foreign countries
into the United States. Legislation and existing regulations governing
foreign and interstate quarantine activities (42 CFR parts 70 and 71)
authorize CDC quarantine officers and customs personnel to inspect and
undertake necessary control measures in order to protect the public's
health. Other inspection agencies assist quarantine officers in public
health risk assessment and management of persons, animals, and other
importations of public health importance, including human remains.
Human remains may harbor communicable diseases, and if not packaged and
processed according to accepted standards, may represent a risk to
handlers and the receiving community.
Requiring a death certificate that states the cause of death (or a
specified alternative document) and requiring appropriate packaging of
human remains mitigates the introduction and spread of communicable
diseases into the United States with a minimum of recordkeeping and
reporting as well as a minimum of interference with trade and travel.
The death certificate will only be required for those seeking to import
human remains that have not been embalmed or otherwise rendered
noninfectious.
At present, HHS/CDC has approval from OMB to collect
certain information and impose recordkeeping requirements related to
foreign quarantine responsibilities under OMB Control Number 0920-0134
(expiration 05/31/2019). HHS/CDC is proposing a non-substantive/
nonmaterial change to:
42 CFR 71.55 Dead Bodies, 42 CFR 71.32(b)--Death
certificates (No Form).
42 CFR 71.32 Statements or documentation of non-
infectiousness (No Form).
[[Page 64818]]
Description of Respondents
Respondents to this data collection are individuals seeking to
import human remains into the United States.
There is no burden to respondents other than the time taken to
acquire a death certificate for the human remains being imported to the
United States or to produce documentation stating that the human
remains have been embalmed or otherwise rendered non-infectious.
However, death certificates and embalming documentation are routinely
produced by mortuary providers or hospitals after a death. DOS also
provides a consular mortuary certificate that also commonly states the
cause of death for an individual who dies abroad or, if the cause of
death is not known, can reference whether the person died of a
communicable disease. HHS/CDC does not anticipate significant
additional administrative burden in acquiring these documents.
With data provided by CBP, CDC is updating the estimate of the
number of imports of human remains that will require a death
certificate from 20 to 150, and increasing by 1850 the estimate of the
number of human remains that will require some statement or
documentation of non-infectiousness. CDC believes this is a more
accurate estimate of the volume of imported human remains imported into
the United States, and not an increase in respondent burden. As stated
above, both of these documents are routinely provided by mortuary
services and do not represent an increase in respondent burden
specifically for this proposed rulemaking
Additionally, as this NPRM proposes to clarify the requirements for
importing human remains, HHS/CDC is also proposing to rename the
provision. The associated information collections will clearly
reference the title:
42 CFR 71.55 Importation of Human Remains--Death
Certificate (No Form).
42 CFR 71.32, 71.55 Statements or documentation of non-
infectiousness (No Form).
Table 5 below presents the estimate of annual burden (in hours)
associated with the reporting requirement under this OMB control
number, accounting for the proposed rule changes.
Table 5--Estimated Annual Reporting Burden 0920-0134
----------------------------------------------------------------------------------------------------------------
Average
Regulatory provision Number of Number of burden per Total burden
Type of respondent or form name respondents responses per response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Importers................. 42 CFR 71.55 150 1 1 150
Importation of
Human Remains--
Death Certificate
(No Form).
Importer.................. 42 CFR 71.32, 71.55 3,850 1 5/60 321
Statements or
documentation of
non-infectiousness
(No Form).
----------------------------------------------------------------------------------------------------------------
The estimates are based on experience to date with current
recordkeeping and reporting requirements of 42 CFR 71.55 Dead Bodies--
Death Certificate (No Form) and 42 CFR 71.32 Statements or
documentation of non-infectiousness, are based on discussion with
partners at DOS and DHS.
[lparb]2) Application for Permit to Import Biological Agents and
Vectors of Human Disease into the United States and Application for
Permit to Import or Transport Live Bats (42 CFR 71.54) (OMB Control No.
0920-0199) No Change Requested--Center for Preparedness and Response,
Centers for Disease Control and Prevention.
CDC/DSAT administers OMB Control No. 0920-0199 and does not propose
any changes in information collection. Due to DSAT's experience with
issuing CDC import permits, DSAT does not expect any additional burden
from respondents because respondents understand that any material
including human remains that is reasonably suspected of containing an
infectious biological agent submits an application for CDC import
permit.
On an annual basis, DSAT usually receives approximately 3
applications for importing human remains that are known to contain or
reasonably suspected of containing an infectious biological agent. DSAT
performs inspection of these requests to ensure that the facility has
the appropriate biosafety conditions to receive these materials. DSAT
plans to use current resources for processing any applications received
for importing human remains that are known to contain or reasonably
suspected of containing an infectious biological agent.
E. National Environmental Policy Act (NEPA)
HHS/CDC has determined that the proposed amendments to 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 needed.
F. E.O. 12988: Civil Justice Reform
HHS/CDC has reviewed this rule under Executive Order 12988 on Civil
Justice Reform and determines that this NPRM meets the standard in the
Executive Order.
G. E.O. 13132: Federalism
Under Executive Order 13132, if the rulemaking would limit or
preempt State authorities, then a federalism analysis is required. The
agency must consult with State and local officials to determine whether
the rule would have a substantial direct effect on State or local
Governments, as well as whether it would either preempt State law or
impose a substantial direct cost of compliance on them.
HHS/CDC has determined that this NPRM will not have sufficient
federalism implications to warrant the preparation of a federalism
summary impact statement.
H. Plain Language Act of 2010
Under 63 FR 31883 (June 10, 1998), Executive Departments and
Agencies are required to use plain language in all proposed and final
rules. HHS/CDC has attempted to use plain language in this rulemaking
to make our intentions and rationale clear and requests input from the
public in this regard.
List of Subjects in 42 CFR Part 71
Burial, Communicable diseases, Cremation, Death certificate,
Entombment, Human remains, Importer, Infectious biological agent, Leak-
proof container, Public health, Quarantinable communicable diseases.
For the reasons discussed in the preamble, we propose to amend 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
[[Page 64819]]
U.S.C. 216, 243); secs. 361-369, PHS Act, as amended (42 U.S.C. 264-
272).
0
2. Amend Sec. 71.50(b) by adding, in alphabetical order, the
definitions ``Death certificate'', ``Human remains'', ``Importer'', and
``Leak-proof container'' to read as follows:
Sec. 71.50 Scope and definitions.
* * * * *
(b)* * *
* * * * *
Death certificate means an official government document that
certifies that a death has occurred and provides identifying
information about the deceased, including (at a minimum) name, age, and
sex. The document must also certify the time, place, and cause of death
(if known). If the official government document is not written in
English, then it must be accompanied by an English language translation
of the official government document, the authenticity of which has been
attested to by a person licensed to perform acts in legal affairs in
the country where the death occurred. In lieu of a death certificate, a
copy of the Consular Mortuary Certificate and the Affidavit of Foreign
Funeral Director and Transit Permit, shall together constitute
acceptable identification of human remains.
* * * * *
Human remains means a deceased human body or any portion of a
deceased human body, except:
(i) Clean, dry bones or bone fragments; human hair; teeth;
fingernails or toenails; or
(ii) A deceased human body and portions thereof that have already
been fully cremated prior to import; or
(iii) Human cells, tissues or cellular or tissue-based products
intended for implantation, transplantation, infusion, or transfer into
a human recipient.
Importer means any person importing or attempting to import an item
regulated under this subpart.
* * * * *
Leak-proof container means a container that is puncture-resistant
and sealed in such a manner as to contain all contents and prevent
leakage of fluids during handling, storage, transport, or shipping,
such as
(i) A double-layered plastic, puncture-resistant body bag (i.e.,
two sealed body bags, one inside the other);
(ii) A casket with an interior lining certified by the manufacturer
to be leak-proof and puncture-resistant; or
(iii) A sealed metal body-transfer case.
* * * * *
0
3. Revise Sec. 71.55 to read as follows:
Sec. 71.55 Importation of human remains.
(a) Human remains imported into the United States, or in transit
within the United States and not intended for import, must be fully
contained within a leak-proof container that is packaged and shipped in
accordance with all applicable legal requirements.
(b) The provisions of Sec. 71.54 shall apply to all imported human
remains known to contain or reasonably suspected of containing an
infectious biological agent.
(c) Unless accompanied by a permit issued under Sec. 71.54, human
remains imported into the United States must meet one of the following
requirements:
(1) Human remains imported for burial, entombment, or cremation
must:
(i) Be consigned directly to a licensed mortuary, cemetery, or
crematory for immediate and final preparation prior to burial,
entombment, or cremation; and
(ii) Unless embalmed, be accompanied by a death certificate or, if
the death certificate is incomplete or missing, an importer
certification statement confirming that the human remains are not known
to contain or stating why the human remains are not reasonably
suspected of containing an infectious biological agent.
(2) Human remains imported for medical examination or autopsy must:
(i) Be consigned directly to an entity authorized to perform such
functions under the laws of the applicable jurisdiction prior to
subsequent burial, entombment, or cremation; and
(ii) Unless embalmed, be accompanied by a death certificate or, if
the death certificate is incomplete or missing, an importer
certification statement confirming that the human remains are not known
to contain or stating why the human remains are not reasonably
suspected of containing an infectious biological agent.
(3) Human remains imported for any other purpose, unless embalmed,
must be accompanied by an importer certification statement confirming
that the human remains are not known to contain or stating why the
human remains are not reasonably suspected of containing an infectious
biological agent.
(d) The Director may suspend the importation of human remains under
42 CFR 71.63 if the Director designates the foreign country and
determines that such an action is necessary to protect the public
health.
Dated: October 31, 2019.
Alex M. Azar II,
Secretary, Department Of Health and Human Services.
[FR Doc. 2019-24943 Filed 11-22-19; 8:45 am]
BILLING CODE 4163-18-P