Control of Communicable Diseases; Importation of Human Remains, 64808-64819 [2019-24943]
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Federal Register / Vol. 84, No. 227 / Monday, November 25, 2019 / Proposed Rules
effective on January 23, 2017.6 EPA has
made, and will continue to make, these
materials generally available through
www.regulations.gov and at the EPA
Region 4 office (please contact the
person identified in the FOR FURTHER
INFORMATION CONTACT section of this
preamble for more information).
IV. Proposed Action
EPA is proposing to approve the
aforementioned changes to the
Chattanooga portion of the Tennessee
SIP because the changes are consistent
with section 110 of the CAA. The SIP
revision adds, clarifies, and updates
Rule 6 consistent with applicable
requirements.
V. Statutory and Executive Order
Reviews
Under the CAA, the Administrator is
required to approve a SIP submission
that complies with the provisions of the
Act and applicable Federal regulations.
See 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions,
EPA’s role is to approve state choices,
provided that they meet the criteria of
the CAA. This action merely proposes to
approve state law as meeting Federal
requirements and does not impose
additional requirements beyond those
imposed by state law. For that reason,
this proposed action:
• Is not a significant regulatory action
subject to review by the Office of
Management and Budget under
Executive Orders 12866 (58 FR 51735,
October 4, 1993) and 13563 (76 FR 3821,
January 21, 2011);
• Is not an Executive Order 13771 (82
FR 9339, February 2, 2017) regulatory
action because SIP approvals are
exempted under Executive Order 12866;
• Does not impose an information
collection burden under the provisions
of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.);
• Is certified as not having a
significant economic impact on a
substantial number of small entities
under the Regulatory Flexibility Act (5
U.S.C. 601 et seq.);
• Does not contain any unfunded
mandate or significantly or uniquely
affect small governments, as described
in the Unfunded Mandates Reform Act
of 1995 (Pub. L. 104–4);
• Does not have Federalism
implications as specified in Executive
Order 13132 (64 FR 43255, August 10,
1999);
• Is not an economically significant
regulatory action based on health or
6 EPA’s approval also includes regulations/
ordinances submitted for the other ten jurisdictions
within the Bureau. See footnote 2 and 4, supra.
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safety risks subject to Executive Order
13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action
subject to Executive Order 13211 (66 FR
28355, May 22, 2001);
• Is not subject to requirements of
Section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) because
application of those requirements would
be inconsistent with the CAA; and
• Does not provide EPA with the
discretionary authority to address, as
appropriate, disproportionate human
health or environmental effects, using
practicable and legally permissible
methods, under Executive Order 12898
(59 FR 7629, February 16, 1994).
The SIP is not approved to apply on
any Indian reservation land or in any
other area where EPA or an Indian tribe
has demonstrated that a tribe has
jurisdiction. In those areas of Indian
country, the rule does not have tribal
implications as specified by Executive
Order 13175 (65 FR 67249, November 9,
2000), nor will it impose substantial
direct costs on tribal governments or
preempt tribal law.
List of Subjects in 40 CFR Part 52
Environmental protection, Air
pollution control, Incorporation by
reference, Lead, Nitrogen dioxide,
Ozone, Particulate matter, Sulfur oxides,
Volatile organic compounds.
Authority: 42 U.S.C. 7401 et seq.
Dated: November 13, 2019.
Mary S. Walker,
Regional Administrator, Region 4.
[FR Doc. 2019–25287 Filed 11–22–19; 8:45 am]
BILLING CODE 6560–50–P
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
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of proposed rulemaking
(NPRM).
AGENCY:
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
SUMMARY:
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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: https://
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 https://
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
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
dgmqpolicyoffice@cdc.gov.
SUPPLEMENTARY INFORMATION: The
NPRM is organized as follows:
FOR FURTHER INFORMATION CONTACT:
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
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Federal Register / Vol. 84, No. 227 / Monday, November 25, 2019 / Proposed Rules
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.
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
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 redesignated 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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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
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.
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
2 https://www.cdc.gov/importation/humanremains.html.
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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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
4 https://www.washingtonpost.com/news/
morning-mix/wp/2016/03/26/the-husband-andwife-duo-who-allegedly-dismembered-diseasedbodies-and-sold-them-for-profit/.
5 https://www.reuters.com/investigates/specialreport/usa-bodies-brokers/.
6 See also data in economic analysis below.
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package or the remains were found to be
leaking.
HHS/CDC has two regulatory
provisions that control the safe
importation of human remains into the
United States:
• Under § 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 § 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 § 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
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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’’
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is currently defined under § 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, punctureresistant body bag (i.e., two sealed body
bags, one inside the other),
• A casket with an interior lining
certified by the manufacturer to be leakproof 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 § 71.55) and human body parts
primarily imported for other reasons,
which may fall under § 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 § 71.55 that
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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 § 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 § 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 § 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
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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 § 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 § 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 § 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
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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 § 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.
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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.
HHS/CDC has two regulatory
provisions that control the safe
importation of human remains into the
United States:
• Under § 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 § 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 §§ 71.54 and 71.55 are
applicable to imported human remains,
CBPU.S. Customs and Border Protection
agents often hold bodies and body parts
7 https://www.washingtonpost.com/news/
morning-mix/wp/2016/03/26/the-husband-andwife-duo-who-allegedly-dismembered-diseasedbodies-and-sold-them-for-profit/.
8 https://www.reuters.com/investigates/specialreport/usa-bodies-brokers/.
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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
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Sfmt 4702
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 leakproof 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 § 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 lessrestrictive 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
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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.
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
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.
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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 noncremated 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 unembalmed human remains.
A more restrictive documentation
requirement would be to require that all
importations of human remains (i.e.,
embalmed remains as well as unembalmed 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
10 Refer
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Frm 00026
Fmt 4702
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64813
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-
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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
$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.
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-BaltimoreArlington, DC-MD-VA-WV-PA are
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
for non-wage
benefits and
overhead
Hourly
wage rate 12
Agency
Cost components
Total
DOS ..................
CDC ..................
CBP ...................
80 hours split between GS–14, step 5 and GS–15, step 5 levels ..............
80 hours split between GS–14, step 5 and GS–15, step 5 levels ..............
80 hours split between GS–14, step 5 and GS–15, step 5 levels ..............
67.72
63.99
67.72
2
2
2
$10,834
10,238
10,834
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.
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.
11 U.S. Office of Personnel and Management.
https://www.opm.gov/policy-data-oversight/payleave/salaries-wages/2018/general-schedule/.
Accessed on March 27, 2019.
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.
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.
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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.
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
inspections
per year
Number
of staff
Type of CDC staff
Number of
hours spent
per inspection
Average
hourly wage
rate 16
Overhead
multi-plier
Annual cost
GS–12 (step 5) ..................................
GS–13 (step 5) ..................................
GS–14 (step 5) ..................................
0.33
0.33
0.33
0.5
0.5
0.5
20
20
20
$41.85
49.76
58.80
1
1
1
$276
328
388
Total ............................................
........................
........................
..............................
........................
........................
993
Travel cost .........................................
Airfare 17 ........
$367
$158
$525
........................
1,518
Hotel, food, lodging 18
Total (personnel + travel) .................................................................................................................................
The total projected costs over a 10year 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.
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
over 10-year
horizon
Annualized cost
over 10-year
horizon
CDC .............................................................................................................................................................
CBP ..............................................................................................................................................................
DoS ..............................................................................................................................................................
Importers of human remains for other purposes .........................................................................................
$18,408
10,518
10,518
7,532
$2,158
1,233
1,233
883
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 5year 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
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.
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.
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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.
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 WashingtonBaltimore-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.
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
for non-wage
benefits and
overhead
Hourly wage
rate 21
Agency
Cost components
Total
CDC ..................
$59.24
2
$71,092
CBP ...................
600 hours split between GS–13, step 5; GS–14, step 5; and GS–15, step
5 levels.
300 hours at the GS–5, GS–9, GS–11, GS–12, and GS–15, step 5 level
41.02
2
24,614
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.
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.
19 U.S. Office of Personnel and Management.
https://www.opm.gov/policy-data-oversight/payleave/salaries-wages/2018/general-schedule/.
Accessed on March 27, 2019.
20 U.S. Office of Personnel and Management.
https://www.opm.gov/policy-data-oversight/payleave/salaries-wages/2018/general-schedule/.
Accessed on March 27, 2019.
21 U.S. Office of Personnel and Management.
https://www.opm.gov/policy-data-oversight/payleave/salaries-wages/2018/general-schedule/.
Accessed on March 27, 2019.
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Federal Register / Vol. 84, No. 227 / Monday, November 25, 2019 / Proposed Rules
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.
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
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-ofdogs-entering-the-united-states-from-egypt.
VerDate Sep<11>2014
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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 notfor-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
PO 00000
Frm 00030
Fmt 4702
Sfmt 4702
64817
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/nonsubstantive 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 nonsubstantive/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).
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Federal Register / Vol. 84, No. 227 / Monday, November 25, 2019 / Proposed Rules
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 noninfectious. 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
Type of
respondent
Regulatory provision or form name
Importers ...........
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).
Importer ............
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.
Ω2) 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
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16:48 Nov 22, 2019
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Number of
respondents
1
150
3,850
1
5/60
321
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
Fmt 4702
Sfmt 4702
Total burden
hours
1
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.
Frm 00031
Average
burden per
response
(in hours)
150
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.
PO 00000
Number of
responses per
respondent
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
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
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U.S.C. 216, 243); secs. 361–369, PHS Act, as
amended (42 U.S.C. 264–272).
2. Amend § 71.50(b) by adding, in
alphabetical order, the definitions
‘‘Death certificate’’, ‘‘Human remains’’,
‘‘Importer’’, and ‘‘Leak-proof container’’
to read as follows:
■
§ 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
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16:48 Nov 22, 2019
Jkt 250001
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, punctureresistant 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 leakproof and puncture-resistant; or
(iii) A sealed metal body-transfer case.
*
*
*
*
*
■ 3. Revise § 71.55 to read as follows:
§ 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 § 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 § 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
PO 00000
Frm 00032
Fmt 4702
Sfmt 9990
64819
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
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]]>Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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).
-----------------------------------------------------------------------
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: https://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 https://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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\2\ https://www.cdc.gov/importation/human-remains.html.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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/.
---------------------------------------------------------------------------
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.
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\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.
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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.
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\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.
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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.
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\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.
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[[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.
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\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.
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\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.
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\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.
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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.
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\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.
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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.
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\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.
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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
