Interstate Shipment of Etiologic Agents, 92-96 [E6-21723]
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Federal Register / Vol. 72, No. 1 / Wednesday, January 3, 2007 / Proposed Rules
TABLE 7 TO SUBPART PPPPP OF PART 63.—APPLICABILITY OF GENERAL PROVISIONS TO SUBPART PPPPP
Citation
Subject
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§ 63.1(c)(6) ....................................
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BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
42 CFR Part 72
RIN 0920–AA03
Interstate Shipment of Etiologic
Agents
Centers for Disease Control and
Prevention (CDC), HHS.
ACTION: Notice for proposed rulemaking.
AGENCY:
SUMMARY: HHS proposes to remove Part
72 of Title 42, Code of Federal
Regulations, which governs the
interstate shipment of etiologic agents,
because the U.S. Department of
Transportation (DOT) already has in
effect a more comprehensive set of
regulations applicable to the transport
in commerce of infectious substances.
DOT harmonizes its transport
requirements with international
standards adopted by the United
Nations (UN) Committee of Experts on
the Transport of Dangerous Goods for
the classification, packaging, and
transport of infectious substances.
Rescinding the rule will eliminate
duplication of the more current DOT
regulations that cover intrastate and
international, as well as interstate,
transport. HHS replaced those sections
of Part 72 that deal with select
biological agents and toxins with a new
set of regulations found in Part 73 of
Title 42. HHS anticipates that removal
of Part 72 will alleviate confusion and
reduce the regulatory burden with no
adverse impact on public health and
safety.
Written comments must be
received on or before March 5, 2007.
Written comments on the proposed
information collection requirements
should also be submitted on or before
March 5, 2007. Comments received after
March 5, 2007 will be considered to the
extent practicable.
ADDRESSES: You may submit written
comments to the following address: U.S.
Department of Health and Human
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Services, Centers for Disease Control
and Prevention, National Center for
Infectious Diseases/OD, ATTN:
Interstate Shipment of Etiologic Agents
Comments, 1600 Clifton Road, NE (C12),
Atlanta, GA 30333. Comments will be
available for public inspection Monday
through Friday, except for legal
holidays, from 9 a.m. until 5 p.m. at
1600 Clifton Road, NE, Atlanta, GA.
Please call Ruenell Massey at 404–639
–945 to schedule your visit. Comments
also may be viewed at https://
www.cdc.gov/ncidod/agentshipment/
index.htm. You may submit written
comments by fax to 404–639–3039,
Attention: Dr. Janet Nicholson, or
electronically via the Internet at https://
www.regulations.gov. To download an
electronic version of the rule, you may
access https://www.regulations.gov. You
must include the agency name (Centers
for Disease Control and Prevention) and
Regulatory Information Number (RIN)
on all submissions for this rulemaking.
FOR FURTHER INFORMATION CONTACT: Dr.
Janet K. Nicholson, National Center for
Infectious Diseases/OD, Centers for
Disease Control and Prevention, U.S.
Department of Health and Human
Services, 1600 Clifton Rd., NE (MS–
C12), Atlanta GA 30333; telephone:
404–639–3945; e-mail jkn1@cdc.gov.
SUPPLEMENTARY INFORMATION: Part 72 of
Title 42 of the Code of Federal
Regulations provides minimal
requirements for packaging and
shipping materials, including diagnostic
specimens and biological products,
reasonably believed to contain an
etiologic agent. It provides more
detailed requirements, including
labeling, for materials containing certain
etiologic agents, with a list of the
biological agents and toxins provided.
For agents on the list, the rule requires
reporting to HHS/CDC damaged
packages and packages not received.
The rule also requires sending certain
agents on the list by registered mail or
an equivalent system.
The rule, as currently promulgated, is
out-of-date, and duplicates more current
regulations of DOT. Further, the
regulation is inconsistent with the
procedures of other transport governing
bodies, such as the International Civil
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Aviation Organization (ICAO) and the
International Air Transport Association
(IATA), for air, and the U.S. Postal
Service for ground.
Section 72.6, a major portion of 42
CFR 72 that dealt with select agents,
was superseded by the issuance of an
Interim Final Rule for 42 CFR 73 on
December 13, 2002 (67 FR 76886). Part
73 implements provisions of the Public
Health Security and Bioterrorism
Preparedness and Response Act of 2002.
The continued existence of the
remaining provisions of the out-of-date
HHS/CDC regulation is confusing to the
packaging and transport communities.
The provisions serve no useful purpose
that merits their retention. HHS/CDC
will remain available for consultation
on and response to public-health issues
and emergencies, in accordance with its
normal duties in the interest of public
health and safety.
Transition From HHS to DOT
Regulations
DOT has the primary statutory
authority to regulate the safe and secure
transportation of all hazardous
materials, including infectious
materials, shipped in intrastate,
interstate, and foreign commerce. The
etiologic agents covered by 42 CFR 72
are considered to be hazardous
materials, and, in practice, the DOT
regulations, 49 CFR 171–178, have
superseded since DOT began including
more specific regulations on infectious
substances. The earlier versions of the
DOT regulations on etiologic agents
were based on and virtually identical to
the HHS regulations. These regulations
have been modified over time, as
necessary, to continue to provide
protection for persons who handle
shipments with as few impediments as
possible to quick shipment. In 1990,
DOT authorized the term ‘‘infectious
substance’’ as synonymous with
‘‘etiologic agent.’’ In 1991, DOT
expanded the definition of ‘‘etiologic
agent’’ to include agents listed in 42
CFR 72, plus others that cause or could
cause severe, disabling or fatal human
disease, thereby including agents such
as human immunodeficiency virus that
were not on the HHS list. DOT also
issued expanded packaging
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requirements at that same time. In 1994
and 1995, DOT worked with other
Federal agencies (including HHS/CDC,
the HHS/Food and Drug
Administration, the Occupational Safety
and Health Administration, and the
Environmental Protection Agency) to
minimize differences between the DOT
regulations and other Federal
regulations on regulated medical waste,
and to ease compliance and eliminate
gaps to assure safety.
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UN Recommendations and Model
Regulations
The UN publishes Recommendations
on the Transport of Dangerous Goods
and Model Regulations on a biennial
basis. The recommendations are
developed by the Committee of Experts
on the Transport of Dangerous Goods of
the UN Economic and Social Council.
Model Regulations were first adopted in
December 1996, for the 10th Revised
Edition. The purpose of the Model
Regulations is to present a basic scheme
of provisions that will allow uniform
development of national and
international regulations that govern the
various modes of transport, thereby
facilitating worldwide harmonization.
In 1997, the World Health
Organization (WHO) published
‘‘Guidelines for the Safe Transport of
Infectious Substances and Diagnostic
Specimens,’’ prepared by the Directors
of WHO Collaborating Centers for
Biosafety and other advisers to provide
practical guidance to facilitate
compliance with international
standards.
HHS/CDC has a WHO Collaborating
Center for Biosafety and Training, and
has provided consultation to the WHO
Secretariat and to the Committee of
Experts on infectious-substance issues
and the development of the UN
Recommendations and Model
Regulations.
DOT has also worked with the
Committee of Experts, and over time has
harmonized the DOT regulations with
the UN Model Regulations.
In October 2001, the WHO convened
a meeting, which included infectiousdisease and biosafety experts, to
consider guidance needed for the safe
transport of infectious substances, and
to identify the infectious substances that
need to be subject to transport
regulation. The meeting developed a
consensus document, and presented it
to the UN Committee of Experts.
Subsequent deliberations resulted in
development and publication of the
13th Revised Edition of the UN Model
Regulations for Transport of Infectious
Substances, published in 2004.
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These model regulations
recommended a new classification
scheme of categories A and B, based on
risk during transport, instead of
primarily in the laboratory. The WHO
and the Committee of Experts assessed
the risk of infection by pathogens in the
transport setting and, with review by
HHS/CDC and other public-health
experts and scientists, refined the list of
Category A agents of concern. Category
A includes ‘‘an infectious substance
which is transported in a form that,
when exposure to it occurs, is capable
of causing permanent disability, lifethreatening or fatal disease to humans or
animals.’’ Category B includes ‘‘an
infectious substance which does not
meet the criteria for inclusion in
Category A.’’ Packaging requirements
were clarified and simplified for each
category.
The ‘‘Infectious Substances’’ portion
of the 14th Revised Edition of the UN
Model Regulations, adopted in
December 2004 and published in 2005,
is very similar to the 13th Edition. The
new edition adds a definition for
‘‘patient specimens’’; adds ‘‘cultures
only’’ to several microorganisms on the
infectious-substances list for Category
A; clarifies shipping names and
labeling; and clarifies exemptions from
regulations.
In September 2005, the WHO
Secretariat published ‘‘Guidance on
Regulations for the Transport of
Infectious Agents’’ (WHO/CDS/CSR/
LYO/2005.22) which combined into one
document the component parts of the
13th and 14th Revised Editions.
Harmonization of DOT Regulations
With UN/WHO Publications
The DOT Notice of Proposed
Rulemaking (NPRM), published on
January 22, 2001 (66 FR 6941), for
public comment, and the final rule,
published on August 14, 2002 (67 FR
53118), which became effective on
October 1, 2002, revised definitions and
adopted packaging requirements
consistent with international standards.
The DOT final rule incorporated new
classification criteria (WHO Risk Groups
1–4 at that time) for infectious
substances, diagnostic specimens,
biological products, genetically
modified organisms and
microorganisms, and medical wastes—
consistent with the 12th Revision of the
UN Model Regulations of 2001. Among
other changes, the final rule revised
packaging requirements for toxic and
infectious substances consistent with
the international performance
standards. HHS/CDC and other relevant
Federal agencies reviewed the DOT
proposals before final publication.
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The DOT Notice of Proposed
Rulemaking (NPRM), published on May
19, 2005 (70 FR 29170), further
harmonized the DOT regulations with
the 13th and 14th Revised Editions of
UN Model Regulations. DOT developed
a final rule after consideration of
comments received from the public,
including the affected commercial,
research, public-health, medical, and
transport communities, and after
discussion with other relevant Federal
regulating authorities. The final rule
was published on June 2, 2006 (71 FR
32244) and became effective on October
1, 2006.
The DOT final rule is almost entirely
consistent with the UN Model
Regulations. One non-substantive
difference is that the final rule retains
the definition of ‘‘biological products’’
that is more consistent with the
definition used by HHS/FDA and other
Federal agencies.
Specimens With Low Likelihood of
Pathogens
Another difference relates to the
exemption from regulation of human
and animal specimens for which there
is minimal likelihood that pathogens are
present. The UN Model Regulations
recommend exemption if the specimen
is transported in a package (three
components) that will prevent any
leakage; is of adequate strength for its
capacity, mass, and intended use; and is
marked as an exempt specimen. The
DOT regulations do not specify any
packaging requirement for these
specimens with minimal likelihood that
pathogens are present.
The requirement for triple packaging
for these specimens, however, is
included in the requirements issued by
other transport-governing organizations.
The U.S. Postal Service Domestic Mail
Manual (DMM) requires special
packaging (not subject to performance
requirements as for infectious
substances) for liquid diagnostic
specimens that would not meet the
current definitions for a Category A or
B infectious substance. The packaging is
consistent with the packaging
recommended in the UN Model
Regulations, except that for specimens
that do not exceed 50 ml. the second
leak-proof container may serve as the
shipping container if it has enough
strength to withstand ordinary postal
processing. It is likely these
requirements will be revised in time to
be entirely consistent with the UN
Model Regulations. The ICAO Technical
Instructions (ICAO TI) govern virtually
all shipments transported
internationally by air, and the majority
of U.S. domestic air shipments.
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Addendum No. 2 to ICAO TI (Doc.
9284), issued June 30, 2005, includes
almost verbatim the language from the
UN Model Regulations regarding
exempt specimens, except that the UN
made recommendations for packaging
and the ICAO TI requires the packaging
specifications. IATA does the same in
Addendum III, posted July 5, 2005, to
the 46th Edition of IATA Dangerous
Goods Regulations. Inclusion of the
triple-packaging provision by these
organizations covers virtually all
shipment in commerce of routine
patient specimens and biological
products for which there is little
likelihood of containing an infectious
substance.
Section by Section—Comments on
Removal
HHS provides a section-by-section
rationale for removing the remaining
portions of 42 CFR 72.
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Section 72.1 Definitions
Current definitions consistent with
UN/WHO recommendations are
provided in the DOT rule that applies to
intra-state and international as well as
interstate transport.
Section 72.2 Transportation of
Diagnostic Specimens, Biological
Products, and Other Materials;
Minimum Packaging Requirements
Section 72.2 provided that diagnostic
specimens and biologic products which
the shipper ‘‘reasonably believes may
contain an etiologic agent’’ must be
‘‘packaged to withstand leakage of
contents, shocks, pressure changes, and
other conditions incident to ordinary
handling in transportation.’’ The DOT
detailed packaging requirements for
Categories A and B have superseded this
very general requirement. The term
‘‘infectious substance’’ has replaced
‘‘etiologic agent’’ in the UN Model
Regulations, and in the DOT and other
applicable regulations. Those
regulations define ‘‘infectious
substance’’ as a ‘‘material known or
reasonably expected to contain a
pathogen.’’
The DOT regulations define
pathogens into two categories. Category
A is an ‘‘infectious substance in a form
that is capable of causing permanent
disability or life-threatening or fatal
disease in otherwise healthy humans or
animals when exposure to it occurs.’’
Category B is an infectious substance
that does not meet the criteria for
Category A. The DOT final rule exempts
a ‘‘material that has a low probability of
containing an infectious substance, or
where the concentration of the
infectious substance is at a level
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naturally occurring in the environment
so it cannot cause disease when
exposure to it occurs.’’ As stated above,
leak-proof packaging of adequate
strength is required for these materials
by the U.S. Postal Service, ICAO, and
IATA. The DOT final rule provides for
classification and shipping as Category
A or B a biological product ‘‘known or
reasonably expected’’ to contain a
pathogen that meets the criteria for
either category, thereby covering the
same substances as covered by the
original intent of section 72.2.
Further, the HHS rule covered the
substances only in transport from one
State to another or from one State
through another State and back to the
State of origin. The DOT regulations
cover transport within State, and in
international commerce, as well as from
State-to-State.
Section 72.3 Transportation of
Materials Containing Certain Etiologic
Agents; Minimum Packaging
Requirements
This section provided a list of specific
agents that cannot be shipped in
interstate traffic, unless packaged,
labeled, and shipped in accordance with
the requirements specified in the
section. Neither the list of agents, nor
the packaging, labeling, and shipping
requirements, have been kept up-todate, and have now become outmoded
because of the extensive process
undertaken biennially by the UN
Committee of Experts on the Transport
of Dangerous Goods and the
harmonization of the DOT regulations
with the resultant UN Model
Regulations and the WHO ‘‘Guidance on
the Transport of Infectious Substances.’’
The HHS/CDC WHO Collaborating
Center for Biosafety has been a partner
in that effort.
The list included in the June 2, 2006,
DOT final rule differs from the list in
the UN Model Regulations in the 14th
Revision in only two instances. The
DOT list does not include hepatitis B
virus (cultures only), and it includes
‘‘and other lyssaviruses’’ as part of the
rabies listing. All microorganisms on the
DOT list are to be packaged and shipped
as Category A infectious substances.
A comprehensive discussion of the
new method of categorizing substances
as Category A or B for purposes of
transportation can be found in the
previously referenced DOT final rule
entitled ‘‘Hazardous Materials:
Infectious Substances; Harmonization
with the United Nations
Recommendations; Final Rule’’ (71 FR
32244, June 2, 2006). HHS/CDC
encourages all persons who are
interested in commenting on the
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rescission of 42 CFR 72 to read the DOT
final rule for a more comprehensive
understanding of the new method of
categorization, and to review the
substances in Category A.
In brief, the UN Committee of Experts
on the Transport of Dangerous Goods,
with input of HHS/CDC, the WHO
Secretariat, and others, developed a
classification scheme more suited for
the risks inherent in transport as
opposed to risks in the laboratory. The
previous system of four risk groups,
with ‘‘4’’ as highest risk, was developed
primarily to protect workers in the
laboratory environment. The new
Category A includes an infectious
substance transported in a form that is
capable of causing permanent disability
or life-threatening or fatal disease to
otherwise healthy humans or animals
when exposure to it occurs. It includes
substances previously categorized in
Risk Group 4 and some in Risk Groups
2 and 3. Category B includes infectious
substances (diagnostic or clinical
specimens) that do not meet the criteria
for Category A. The DOT final rule
provides a list (not all-inclusive) of
Category A agents.
HHS encourages the public to review
the current packaging requirements
provided in the DOT final rule cited
above, as well as the DOT final rule
entitled ‘‘Revisions to Standards for
Infectious Substances’’ published in the
Federal Register (67 FR 53118), August
14, 2002. The requirements are
consistent with the requirements
adopted by the UN, and have been
refined over time to be more specific
than the older HHS requirements, with
some liquid-volume changes from those
specified in 72.2(a)(b). Another example
of refinement is that the DOT
regulations require the outer packaging
to release carbon dioxide gas when dry
ice (72.2(c)) is used, while maintaining
structural integrity of the package.
72.3(d) describes a label that is
required on the outer shipping container
for etiologic agents transported in
interstate traffic. The UN Model
Regulations have also described a label
that can be recognized for transport of
these agents anywhere in the world.
With harmonization of the DOT
regulations with the international
regulations, the label required in this
section of the HHS regulation is
duplicative, and no longer necessary.
72.3(e) required reporting of damaged
packages to HHS. The label mentioned
above included the statement: ‘‘In case
of damage or leakage, notify Director
CDC,’’ and a telephone number was
provided. Reporting over the years has
been sporadic, and has served little
direct purpose. The attention to the
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importance of preventing leakage and
preventing exposure has resulted in the
benefit that most carriers have cleanup
procedures in place, and most reports
are made after the persons involved
have followed the company procedures
for cleanup. Having procedures in place,
such as the U.S. Postal Service has, is
preferable to relying on a call to HHS to
obtain directions. Moreover, the DOT
regulations (at 49 CFR 171.15 and
171.16) require carriers to report
transportation incidents that involve
infectious substances. Immediate
reporting by telephone is required for
incidents where fire, breakage, spillage,
or suspected contamination occurs that
involves the shipment of infectious
substances (see 49 CFR 171.15(a)(3)). In
addition, a written report is required for
any unintentional release of hazardous
materials from a packaging during
transportation (see 49 CFR 171.16(a)).
Additional reporting of incidents to
HHS is redundant and unnecessary. The
DOT regulations permit a carrier to
provide telephoned incident reports to
HHS instead of DOT. For consistency,
DOT will amend this provision of its
regulations after rescission of Part 72.
DOT regulations require packages that
contain infectious substances to be
labeled to indicate the infectious hazard
(see 49 CFR 172.434 for a depiction of
the required label). The label currently
includes this statement: ‘‘In case of
damage or leakage immediately notify
public health authority. In USA, notify
Director—CDC; Atlanta, GA; 1–800–
232–0124.’’ DOT will consider revising
the INFECTIOUS SUBSTANCE label
after rescission of Part 72.
The WHO ‘‘Guidance on Regulations
for the Transport of Infectious
Substances,’’ September 2005, provides
specific recommended procedures for
spill cleanup. This Guidance is
available to the agencies that govern
land and air shipment. The
recommended procedures reflect those
contained in the WHO Laboratory
Biosafety Manual, Third Edition, 2004.
As discussed below, the DOT
regulations provide criteria for incident
reporting. The HHS regulation required
reporting of ‘‘damaged packages’’
without additional criteria for reporting.
Nothing will be lost by withdrawing this
requirement for immediate and routine
reporting of damaged packages.
Although routine reporting to HHS
will not be required by regulation after
removal of Part 72, HHS will remain
available for consultation on and
response to public-health issues and
emergencies, in accordance with its
normal duties in the interest of public
health and safety. As part of this
support, HHS will maintain the current
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reporting telephone number on a 7 day/
24 hour basis in order to assist DOT
with the management of suspected
exposures.
HHS/CDC and the HHS/National
Institutes of Health are currently
revising the manual, Biosafety in
Microbiological and Biomedical
Laboratories. The section of the 5th
Edition that is related to transport of
agents is expected to contain general
guidelines for the cleanup of infectious
substances. This section will be useful
to organizations responsible for
transporting packages; having clean-up
procedures in place is the most
important element of response to a
damaged package.
72.3(f) Registered mail or an
equivalent system. This section lists
several agents that are required to be
shipped by registered mail or an
equivalent system, with required
notification of receipt. All but one of
these agents (Histoplasma capsulatum)
is included on the list of select agents
and toxins covered by 42 CFR 73. 42
CFR 73 establishes more strict
requirements for transfer of these agents.
The sender and recipient must have a
certificate of registration for the agent. A
form is submitted to HHS for approval
of the transfer. Packaging and shipping
must comply with all applicable
requirements (Category A for these
agents), including those of DOT. The
recipient must notify the sender and
HHS of receipt within 2 business days,
or of non-receipt within 48 hours after
expected time of receipt. The
requirement for registered mail for these
agents is no longer applicable.
Section 72.4 Notice of Delivery; Failure
to Receive
This section required notification of
the Director of HHS of non-delivery
within five days of expected delivery of
the agents listed in 72.3(f). As stated
above, 42 CFR 73 provides more strict
notification requirements for these
agents. Notification is required of nondelivery within 48 hours of expected
delivery time; also submission of a form
confirming receipt is required within
two business days of receipt of a select
agent or toxin.
The amendment published on March
18, 2005 (70 FR 13316), which
conformed this section to the new 42
CFR 73, is no longer necessary, and is
removed.
Section 72.5 Requirements; Variations
This section allowed the Director of
HHS to approve variations in
requirements if protection remains
equivalent. No variations have been
approved that DOT has not also
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approved. Removal of the rule
eliminates the basis of necessity for the
Director of HHS to have such authority.
Section 72.6 Additional Requirements
for Facilities Transferring or Receiving
Select Agents
This entire section, 72.6(a)–(j), was
replaced or amended by publication by
HHS in the Federal Register of 42 CFR
73, ‘‘Possession, Use, and Transfer of
Select Agents and Toxins,’’ as Interim
Final Rules on December 13, 2002 (67
FR 76886), and November 3, 2003 (68
FR 62245), and as a Final Rule on March
18, 2005 (70 CFR 13294), with an
effective date of April 18, 2005.
These rulemakings also replaced the
list of agents at ‘‘Appendix A to Part
72—Select Agents,’’ as well as the
‘‘Exemptions’’ section following the
Appendix.
The amendments published on March
18, 2005 (70 FR 13316), which
conformed section 72.6(h) and
Appendix A to 42 CFR 73, are no longer
needed, and would be removed by this
notice of proposed rulemaking.
Section 72.7. Penalties
Penalties were specified for violations
of this part, with stronger penalties for
violations related to select agents.
Similar penalties for violations of
provisions of part 73 related to select
agents have been specified by revision
to 42 CFR Part 1003—Civil Money
Penalties, Assessments and Exclusions.
The DOT regulations provide for
penalty for non-compliance, as do ICAO
and other entities with instructions or
regulations regarding transport of
infectious substances.
Authority
The HHS regulation of the interstate
transfer of etiologic agents is based on
the general authority found in Section
264 of Title 42, United States Code,
Regulations to Control Communicable
Diseases, in Part G, Quarantine and
Inspection.
Regulatory Analyses
Rescinding Part 72 reduces the
regulatory burden on affected entities.
The DOT Hazardous Materials
Transportation regulations and the HHS
Select Agent regulations already apply,
and shippers are following them. DOT
and HHS have completed the required
analyses for rules that supersede the
rule being removed, and which are
already in effect. Eliminating this
Federal regulation will be beneficial to
the regulated community by alleviating
confusion and duplication.
HHS does not anticipate the proposed
removal to have any impact on other
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Federal programs involved in transport
of materials that are reasonably believed
to contain infectious substances, such as
the HHS/CDC Import Permit Program;
the HHS/CDC Clinical Laboratories
Improvement Program; the HHS/CDC
Select Agent Program; and various
research programs of HHS/NIH and
HHS/FDA and other Agencies. Agencies
will need to review and update
references in their guidance and
regulating documents.
Paperwork Reduction Act
This notice of proposed rulemaking
does not impose any new informationcollection requirements, and does not
invoke any issues that make it subject to
the Paperwork Reduction Act.
The only impact of removal of 42 CFR
72 is to reduce burden. It eliminates
specification for a second label to be
attached to the outer shipping container.
This label is no longer needed since it
duplicates the label recommended by
the UN Model Regulations, and adopted
by DOT and other organizations (such as
ICAO, IATA, and the U.S. Postal
Service) that govern shipments of
infectious substances.
Impact of paperwork previously
involved with sections that dealt with
notice of delivery or failure to receive
(72.4) is insignificant because HHS has
rarely received such paperwork.
Executive Order 12866 and Regulatory
Flexibility Act
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Executive Order 12866
Executive Order 12866 directs
agencies to assess all costs and benefits
of available regulatory alternatives and,
when regulation is necessary, to select
regulatory approaches that maximize
net benefits (including potential
economic, environmental, public health
and safety, and other advantages;
distributive impacts; and equity). The
Executive Order classifies a ‘‘significant
regulatory action,’’ requiring review by
the Office of Management and Budget
unless OMB waives such review, as any
regulatory action that is likely to result
in a rule that may: (1) Have an annual
effect on the economy of $100 million
or more or adversely affect in a material
way the economy, a sector of the
economy, productivity, competition,
jobs, the environment, public health or
safety, or State, local, or tribal
governments or communities; (2) Create
a serious inconsistency or interfere with
an action taken or planned by another
agency; (3) Materially alter the
budgetary impact of entitlements,
grants, user fees, or loan programs or the
rights and obligations of recipients
thereof; or (4) Raise novel legal or policy
VerDate Aug<31>2005
19:33 Dec 29, 2006
Jkt 211001
issues arising out of legal mandates, the
President’s priorities, or the principles
set forth in the Executive Order.
The economic, interagency,
budgetary, legal, and policy
implications of this proposed rule have
been examined, and the regulatory
action has been deemed to be ‘‘not a
significant regulatory action’’ under the
Executive Order because removal of this
regulation is not likely to result in a rule
that may raise novel legal or policy
issues arising out of legal mandates, the
President’s priorities, or the principles
set forth in the Executive Order.
PART 72—[REMOVED AND
RESERVED]
Dated: July 21, 2006.
Julie Louise Gerberding,
Director, Centers for Disease Control and
Prevention.
Dated: August 21, 2006.
Michael O. Leavitt,
Secretary.
Editorial Note: This document was
received at the Office of the Federal Register
on December 15, 2006.
[FR Doc. E6–21723 Filed 12–29–06; 8:45 am]
Regulatory Flexibility Act
BILLING CODE 4163–18–P
HHS does not anticipate that this
notice of proposed rule making will
have any economic impact on small
businesses and other small entities.
DEPARTMENT OF COMMERCE
Unfunded Mandates
National Oceanic and Atmospheric
Administration
This notice of proposed rulemaking
imposes no mandates, and will not
result in any expenditure burden, on
State, local, or tribal governments.
50 CFR Part 635
Executive Order 12988
Atlantic Highly Migratory Species
(HMS); U.S. Atlantic Swordfish Fishery
Management Measures
This notice of proposed rulemaking
includes no provisions that would lead
to burden on the court system.
Executive Order 13132
This notice of proposed rulemaking
does not propose any regulation that
would preempt State, local and Indian
tribe requirements, or that would have
any substantial direct effects on the
States, relationship between the
national government and the States, or
the distribution of power and
responsibilities among the various
levels of government.
Environmental Assessment
This notice of proposed rule making
is not a major regulatory action, and will
not result in any impact on the
environment; transport of infectious
substances across State lines is
comprehensively covered by existing
regulations of other Agencies.
List of Subjects in 42 CFR Part 72
Biologics, Hazardous materials
transportation, Packaging and
containers, Penalties, Transportation.
For the reasons set forth in the
preamble under the authority of 42
U.S.C. 264, 271; 31 U.S.C. 9701; 18
U.S.C. 3559, 3571, and 42 U.S.C. 262
note, the Department of Health and
Human Services proposes to amend title
42 (Public Health) of the Code of
Federal Regulations by removing part 72
(Interstate Shipment of Etiologic
Agents).
PO 00000
Frm 00047
Fmt 4702
Sfmt 4702
[I.D. 110206A]
RIN 0648–AU86
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Notification of public hearings.
AGENCY:
SUMMARY: NMFS published a proposed
rule on November 28, 2006, to amend
regulations governing the U.S. Atlantic
swordfish fishery that would provide a
reasonable opportunity for U.S. vessels
to more fully harvest the domestic U.S.
North Atlantic swordfish quota. This
notice announces the dates, locations,
and times of seven public hearings to
obtain public comment on the proposed
rule. Comments received at these
hearings will assist NMFS in selecting
management measures to more fully
utilize the International Commission on
the Conservation of Atlantic Tunas
(ICCAT)-recommended U.S. North
Atlantic swordfish quota in recognition
of the improved stock status of North
Atlantic swordfish. These public
hearings will be combined with scoping
meetings on potential shark
management measures that require an
amendment to the Consolidated Atlantic
Highly Migratory Species Fishery
Management Plan (HMS FMP). Notice of
the shark scoping meetings is published
today in a separate Federal Register
document.
DATES: Public hearings will be held in
January 2007. For specific dates and
times, see SUPPLEMENTARY INFORMATION.
E:\FR\FM\03JAP1.SGM
03JAP1
Agencies
[Federal Register Volume 72, Number 1 (Wednesday, January 3, 2007)]
[Proposed Rules]
[Pages 92-96]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-21723]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 72
RIN 0920-AA03
Interstate Shipment of Etiologic Agents
AGENCY: Centers for Disease Control and Prevention (CDC), HHS.
ACTION: Notice for proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: HHS proposes to remove Part 72 of Title 42, Code of Federal
Regulations, which governs the interstate shipment of etiologic agents,
because the U.S. Department of Transportation (DOT) already has in
effect a more comprehensive set of regulations applicable to the
transport in commerce of infectious substances. DOT harmonizes its
transport requirements with international standards adopted by the
United Nations (UN) Committee of Experts on the Transport of Dangerous
Goods for the classification, packaging, and transport of infectious
substances. Rescinding the rule will eliminate duplication of the more
current DOT regulations that cover intrastate and international, as
well as interstate, transport. HHS replaced those sections of Part 72
that deal with select biological agents and toxins with a new set of
regulations found in Part 73 of Title 42. HHS anticipates that removal
of Part 72 will alleviate confusion and reduce the regulatory burden
with no adverse impact on public health and safety.
DATES: Written comments must be received on or before March 5, 2007.
Written comments on the proposed information collection requirements
should also be submitted on or before March 5, 2007. Comments received
after March 5, 2007 will be considered to the extent practicable.
ADDRESSES: You may submit written comments to the following address:
U.S. Department of Health and Human Services, Centers for Disease
Control and Prevention, National Center for Infectious Diseases/OD,
ATTN: Interstate Shipment of Etiologic Agents Comments, 1600 Clifton
Road, NE (C12), Atlanta, GA 30333. Comments will be available for
public inspection Monday through Friday, except for legal holidays,
from 9 a.m. until 5 p.m. at 1600 Clifton Road, NE, Atlanta, GA. Please
call Ruenell Massey at 404-639 -945 to schedule your visit. Comments
also may be viewed at https://www.cdc.gov/ncidod/agentshipment/
index.htm. You may submit written comments by fax to 404-639-3039,
Attention: Dr. Janet Nicholson, or electronically via the Internet at
https://www.regulations.gov. To download an electronic version of the
rule, you may access https://www.regulations.gov. You must include the
agency name (Centers for Disease Control and Prevention) and Regulatory
Information Number (RIN) on all submissions for this rulemaking.
FOR FURTHER INFORMATION CONTACT: Dr. Janet K. Nicholson, National
Center for Infectious Diseases/OD, Centers for Disease Control and
Prevention, U.S. Department of Health and Human Services, 1600 Clifton
Rd., NE (MS-C12), Atlanta GA 30333; telephone: 404-639-3945; e-mail
jkn1@cdc.gov.
SUPPLEMENTARY INFORMATION: Part 72 of Title 42 of the Code of Federal
Regulations provides minimal requirements for packaging and shipping
materials, including diagnostic specimens and biological products,
reasonably believed to contain an etiologic agent. It provides more
detailed requirements, including labeling, for materials containing
certain etiologic agents, with a list of the biological agents and
toxins provided. For agents on the list, the rule requires reporting to
HHS/CDC damaged packages and packages not received. The rule also
requires sending certain agents on the list by registered mail or an
equivalent system.
The rule, as currently promulgated, is out-of-date, and duplicates
more current regulations of DOT. Further, the regulation is
inconsistent with the procedures of other transport governing bodies,
such as the International Civil Aviation Organization (ICAO) and the
International Air Transport Association (IATA), for air, and the U.S.
Postal Service for ground.
Section 72.6, a major portion of 42 CFR 72 that dealt with select
agents, was superseded by the issuance of an Interim Final Rule for 42
CFR 73 on December 13, 2002 (67 FR 76886). Part 73 implements
provisions of the Public Health Security and Bioterrorism Preparedness
and Response Act of 2002.
The continued existence of the remaining provisions of the out-of-
date HHS/CDC regulation is confusing to the packaging and transport
communities. The provisions serve no useful purpose that merits their
retention. HHS/CDC will remain available for consultation on and
response to public-health issues and emergencies, in accordance with
its normal duties in the interest of public health and safety.
Transition From HHS to DOT Regulations
DOT has the primary statutory authority to regulate the safe and
secure transportation of all hazardous materials, including infectious
materials, shipped in intrastate, interstate, and foreign commerce. The
etiologic agents covered by 42 CFR 72 are considered to be hazardous
materials, and, in practice, the DOT regulations, 49 CFR 171-178, have
superseded since DOT began including more specific regulations on
infectious substances. The earlier versions of the DOT regulations on
etiologic agents were based on and virtually identical to the HHS
regulations. These regulations have been modified over time, as
necessary, to continue to provide protection for persons who handle
shipments with as few impediments as possible to quick shipment. In
1990, DOT authorized the term ``infectious substance'' as synonymous
with ``etiologic agent.'' In 1991, DOT expanded the definition of
``etiologic agent'' to include agents listed in 42 CFR 72, plus others
that cause or could cause severe, disabling or fatal human disease,
thereby including agents such as human immunodeficiency virus that were
not on the HHS list. DOT also issued expanded packaging
[[Page 93]]
requirements at that same time. In 1994 and 1995, DOT worked with other
Federal agencies (including HHS/CDC, the HHS/Food and Drug
Administration, the Occupational Safety and Health Administration, and
the Environmental Protection Agency) to minimize differences between
the DOT regulations and other Federal regulations on regulated medical
waste, and to ease compliance and eliminate gaps to assure safety.
UN Recommendations and Model Regulations
The UN publishes Recommendations on the Transport of Dangerous
Goods and Model Regulations on a biennial basis. The recommendations
are developed by the Committee of Experts on the Transport of Dangerous
Goods of the UN Economic and Social Council. Model Regulations were
first adopted in December 1996, for the 10th Revised Edition. The
purpose of the Model Regulations is to present a basic scheme of
provisions that will allow uniform development of national and
international regulations that govern the various modes of transport,
thereby facilitating worldwide harmonization.
In 1997, the World Health Organization (WHO) published ``Guidelines
for the Safe Transport of Infectious Substances and Diagnostic
Specimens,'' prepared by the Directors of WHO Collaborating Centers for
Biosafety and other advisers to provide practical guidance to
facilitate compliance with international standards.
HHS/CDC has a WHO Collaborating Center for Biosafety and Training,
and has provided consultation to the WHO Secretariat and to the
Committee of Experts on infectious-substance issues and the development
of the UN Recommendations and Model Regulations.
DOT has also worked with the Committee of Experts, and over time
has harmonized the DOT regulations with the UN Model Regulations.
In October 2001, the WHO convened a meeting, which included
infectious-disease and biosafety experts, to consider guidance needed
for the safe transport of infectious substances, and to identify the
infectious substances that need to be subject to transport regulation.
The meeting developed a consensus document, and presented it to the UN
Committee of Experts. Subsequent deliberations resulted in development
and publication of the 13th Revised Edition of the UN Model Regulations
for Transport of Infectious Substances, published in 2004.
These model regulations recommended a new classification scheme of
categories A and B, based on risk during transport, instead of
primarily in the laboratory. The WHO and the Committee of Experts
assessed the risk of infection by pathogens in the transport setting
and, with review by HHS/CDC and other public-health experts and
scientists, refined the list of Category A agents of concern. Category
A includes ``an infectious substance which is transported in a form
that, when exposure to it occurs, is capable of causing permanent
disability, life-threatening or fatal disease to humans or animals.''
Category B includes ``an infectious substance which does not meet the
criteria for inclusion in Category A.'' Packaging requirements were
clarified and simplified for each category.
The ``Infectious Substances'' portion of the 14th Revised Edition
of the UN Model Regulations, adopted in December 2004 and published in
2005, is very similar to the 13th Edition. The new edition adds a
definition for ``patient specimens''; adds ``cultures only'' to several
microorganisms on the infectious-substances list for Category A;
clarifies shipping names and labeling; and clarifies exemptions from
regulations.
In September 2005, the WHO Secretariat published ``Guidance on
Regulations for the Transport of Infectious Agents'' (WHO/CDS/CSR/LYO/
2005.22) which combined into one document the component parts of the
13th and 14th Revised Editions.
Harmonization of DOT Regulations With UN/WHO Publications
The DOT Notice of Proposed Rulemaking (NPRM), published on January
22, 2001 (66 FR 6941), for public comment, and the final rule,
published on August 14, 2002 (67 FR 53118), which became effective on
October 1, 2002, revised definitions and adopted packaging requirements
consistent with international standards. The DOT final rule
incorporated new classification criteria (WHO Risk Groups 1-4 at that
time) for infectious substances, diagnostic specimens, biological
products, genetically modified organisms and microorganisms, and
medical wastes--consistent with the 12th Revision of the UN Model
Regulations of 2001. Among other changes, the final rule revised
packaging requirements for toxic and infectious substances consistent
with the international performance standards. HHS/CDC and other
relevant Federal agencies reviewed the DOT proposals before final
publication.
The DOT Notice of Proposed Rulemaking (NPRM), published on May 19,
2005 (70 FR 29170), further harmonized the DOT regulations with the
13th and 14th Revised Editions of UN Model Regulations. DOT developed a
final rule after consideration of comments received from the public,
including the affected commercial, research, public-health, medical,
and transport communities, and after discussion with other relevant
Federal regulating authorities. The final rule was published on June 2,
2006 (71 FR 32244) and became effective on October 1, 2006.
The DOT final rule is almost entirely consistent with the UN Model
Regulations. One non-substantive difference is that the final rule
retains the definition of ``biological products'' that is more
consistent with the definition used by HHS/FDA and other Federal
agencies.
Specimens With Low Likelihood of Pathogens
Another difference relates to the exemption from regulation of
human and animal specimens for which there is minimal likelihood that
pathogens are present. The UN Model Regulations recommend exemption if
the specimen is transported in a package (three components) that will
prevent any leakage; is of adequate strength for its capacity, mass,
and intended use; and is marked as an exempt specimen. The DOT
regulations do not specify any packaging requirement for these
specimens with minimal likelihood that pathogens are present.
The requirement for triple packaging for these specimens, however,
is included in the requirements issued by other transport-governing
organizations. The U.S. Postal Service Domestic Mail Manual (DMM)
requires special packaging (not subject to performance requirements as
for infectious substances) for liquid diagnostic specimens that would
not meet the current definitions for a Category A or B infectious
substance. The packaging is consistent with the packaging recommended
in the UN Model Regulations, except that for specimens that do not
exceed 50 ml. the second leak-proof container may serve as the shipping
container if it has enough strength to withstand ordinary postal
processing. It is likely these requirements will be revised in time to
be entirely consistent with the UN Model Regulations. The ICAO
Technical Instructions (ICAO TI) govern virtually all shipments
transported internationally by air, and the majority of U.S. domestic
air shipments.
[[Page 94]]
Addendum No. 2 to ICAO TI (Doc. 9284), issued June 30, 2005, includes
almost verbatim the language from the UN Model Regulations regarding
exempt specimens, except that the UN made recommendations for packaging
and the ICAO TI requires the packaging specifications. IATA does the
same in Addendum III, posted July 5, 2005, to the 46th Edition of IATA
Dangerous Goods Regulations. Inclusion of the triple-packaging
provision by these organizations covers virtually all shipment in
commerce of routine patient specimens and biological products for which
there is little likelihood of containing an infectious substance.
Section by Section--Comments on Removal
HHS provides a section-by-section rationale for removing the
remaining portions of 42 CFR 72.
Section 72.1 Definitions
Current definitions consistent with UN/WHO recommendations are
provided in the DOT rule that applies to intra-state and international
as well as interstate transport.
Section 72.2 Transportation of Diagnostic Specimens, Biological
Products, and Other Materials; Minimum Packaging Requirements
Section 72.2 provided that diagnostic specimens and biologic
products which the shipper ``reasonably believes may contain an
etiologic agent'' must be ``packaged to withstand leakage of contents,
shocks, pressure changes, and other conditions incident to ordinary
handling in transportation.'' The DOT detailed packaging requirements
for Categories A and B have superseded this very general requirement.
The term ``infectious substance'' has replaced ``etiologic agent'' in
the UN Model Regulations, and in the DOT and other applicable
regulations. Those regulations define ``infectious substance'' as a
``material known or reasonably expected to contain a pathogen.''
The DOT regulations define pathogens into two categories. Category
A is an ``infectious substance in a form that is capable of causing
permanent disability or life-threatening or fatal disease in otherwise
healthy humans or animals when exposure to it occurs.'' Category B is
an infectious substance that does not meet the criteria for Category A.
The DOT final rule exempts a ``material that has a low probability of
containing an infectious substance, or where the concentration of the
infectious substance is at a level naturally occurring in the
environment so it cannot cause disease when exposure to it occurs.'' As
stated above, leak-proof packaging of adequate strength is required for
these materials by the U.S. Postal Service, ICAO, and IATA. The DOT
final rule provides for classification and shipping as Category A or B
a biological product ``known or reasonably expected'' to contain a
pathogen that meets the criteria for either category, thereby covering
the same substances as covered by the original intent of section 72.2.
Further, the HHS rule covered the substances only in transport from
one State to another or from one State through another State and back
to the State of origin. The DOT regulations cover transport within
State, and in international commerce, as well as from State-to-State.
Section 72.3 Transportation of Materials Containing Certain Etiologic
Agents; Minimum Packaging Requirements
This section provided a list of specific agents that cannot be
shipped in interstate traffic, unless packaged, labeled, and shipped in
accordance with the requirements specified in the section. Neither the
list of agents, nor the packaging, labeling, and shipping requirements,
have been kept up-to-date, and have now become outmoded because of the
extensive process undertaken biennially by the UN Committee of Experts
on the Transport of Dangerous Goods and the harmonization of the DOT
regulations with the resultant UN Model Regulations and the WHO
``Guidance on the Transport of Infectious Substances.'' The HHS/CDC WHO
Collaborating Center for Biosafety has been a partner in that effort.
The list included in the June 2, 2006, DOT final rule differs from
the list in the UN Model Regulations in the 14th Revision in only two
instances. The DOT list does not include hepatitis B virus (cultures
only), and it includes ``and other lyssaviruses'' as part of the rabies
listing. All microorganisms on the DOT list are to be packaged and
shipped as Category A infectious substances.
A comprehensive discussion of the new method of categorizing
substances as Category A or B for purposes of transportation can be
found in the previously referenced DOT final rule entitled ``Hazardous
Materials: Infectious Substances; Harmonization with the United Nations
Recommendations; Final Rule'' (71 FR 32244, June 2, 2006). HHS/CDC
encourages all persons who are interested in commenting on the
rescission of 42 CFR 72 to read the DOT final rule for a more
comprehensive understanding of the new method of categorization, and to
review the substances in Category A.
In brief, the UN Committee of Experts on the Transport of Dangerous
Goods, with input of HHS/CDC, the WHO Secretariat, and others,
developed a classification scheme more suited for the risks inherent in
transport as opposed to risks in the laboratory. The previous system of
four risk groups, with ``4'' as highest risk, was developed primarily
to protect workers in the laboratory environment. The new Category A
includes an infectious substance transported in a form that is capable
of causing permanent disability or life-threatening or fatal disease to
otherwise healthy humans or animals when exposure to it occurs. It
includes substances previously categorized in Risk Group 4 and some in
Risk Groups 2 and 3. Category B includes infectious substances
(diagnostic or clinical specimens) that do not meet the criteria for
Category A. The DOT final rule provides a list (not all-inclusive) of
Category A agents.
HHS encourages the public to review the current packaging
requirements provided in the DOT final rule cited above, as well as the
DOT final rule entitled ``Revisions to Standards for Infectious
Substances'' published in the Federal Register (67 FR 53118), August
14, 2002. The requirements are consistent with the requirements adopted
by the UN, and have been refined over time to be more specific than the
older HHS requirements, with some liquid-volume changes from those
specified in 72.2(a)(b). Another example of refinement is that the DOT
regulations require the outer packaging to release carbon dioxide gas
when dry ice (72.2(c)) is used, while maintaining structural integrity
of the package.
72.3(d) describes a label that is required on the outer shipping
container for etiologic agents transported in interstate traffic. The
UN Model Regulations have also described a label that can be recognized
for transport of these agents anywhere in the world. With harmonization
of the DOT regulations with the international regulations, the label
required in this section of the HHS regulation is duplicative, and no
longer necessary.
72.3(e) required reporting of damaged packages to HHS. The label
mentioned above included the statement: ``In case of damage or leakage,
notify Director CDC,'' and a telephone number was provided. Reporting
over the years has been sporadic, and has served little direct purpose.
The attention to the
[[Page 95]]
importance of preventing leakage and preventing exposure has resulted
in the benefit that most carriers have cleanup procedures in place, and
most reports are made after the persons involved have followed the
company procedures for cleanup. Having procedures in place, such as the
U.S. Postal Service has, is preferable to relying on a call to HHS to
obtain directions. Moreover, the DOT regulations (at 49 CFR 171.15 and
171.16) require carriers to report transportation incidents that
involve infectious substances. Immediate reporting by telephone is
required for incidents where fire, breakage, spillage, or suspected
contamination occurs that involves the shipment of infectious
substances (see 49 CFR 171.15(a)(3)). In addition, a written report is
required for any unintentional release of hazardous materials from a
packaging during transportation (see 49 CFR 171.16(a)). Additional
reporting of incidents to HHS is redundant and unnecessary. The DOT
regulations permit a carrier to provide telephoned incident reports to
HHS instead of DOT. For consistency, DOT will amend this provision of
its regulations after rescission of Part 72.
DOT regulations require packages that contain infectious substances
to be labeled to indicate the infectious hazard (see 49 CFR 172.434 for
a depiction of the required label). The label currently includes this
statement: ``In case of damage or leakage immediately notify public
health authority. In USA, notify Director--CDC; Atlanta, GA; 1-800-232-
0124.'' DOT will consider revising the INFECTIOUS SUBSTANCE label after
rescission of Part 72.
The WHO ``Guidance on Regulations for the Transport of Infectious
Substances,'' September 2005, provides specific recommended procedures
for spill cleanup. This Guidance is available to the agencies that
govern land and air shipment. The recommended procedures reflect those
contained in the WHO Laboratory Biosafety Manual, Third Edition, 2004.
As discussed below, the DOT regulations provide criteria for incident
reporting. The HHS regulation required reporting of ``damaged
packages'' without additional criteria for reporting. Nothing will be
lost by withdrawing this requirement for immediate and routine
reporting of damaged packages.
Although routine reporting to HHS will not be required by
regulation after removal of Part 72, HHS will remain available for
consultation on and response to public-health issues and emergencies,
in accordance with its normal duties in the interest of public health
and safety. As part of this support, HHS will maintain the current
reporting telephone number on a 7 day/24 hour basis in order to assist
DOT with the management of suspected exposures.
HHS/CDC and the HHS/National Institutes of Health are currently
revising the manual, Biosafety in Microbiological and Biomedical
Laboratories. The section of the 5th Edition that is related to
transport of agents is expected to contain general guidelines for the
cleanup of infectious substances. This section will be useful to
organizations responsible for transporting packages; having clean-up
procedures in place is the most important element of response to a
damaged package.
72.3(f) Registered mail or an equivalent system. This section lists
several agents that are required to be shipped by registered mail or an
equivalent system, with required notification of receipt. All but one
of these agents (Histoplasma capsulatum) is included on the list of
select agents and toxins covered by 42 CFR 73. 42 CFR 73 establishes
more strict requirements for transfer of these agents. The sender and
recipient must have a certificate of registration for the agent. A form
is submitted to HHS for approval of the transfer. Packaging and
shipping must comply with all applicable requirements (Category A for
these agents), including those of DOT. The recipient must notify the
sender and HHS of receipt within 2 business days, or of non-receipt
within 48 hours after expected time of receipt. The requirement for
registered mail for these agents is no longer applicable.
Section 72.4 Notice of Delivery; Failure to Receive
This section required notification of the Director of HHS of non-
delivery within five days of expected delivery of the agents listed in
72.3(f). As stated above, 42 CFR 73 provides more strict notification
requirements for these agents. Notification is required of non-delivery
within 48 hours of expected delivery time; also submission of a form
confirming receipt is required within two business days of receipt of a
select agent or toxin.
The amendment published on March 18, 2005 (70 FR 13316), which
conformed this section to the new 42 CFR 73, is no longer necessary,
and is removed.
Section 72.5 Requirements; Variations
This section allowed the Director of HHS to approve variations in
requirements if protection remains equivalent. No variations have been
approved that DOT has not also approved. Removal of the rule eliminates
the basis of necessity for the Director of HHS to have such authority.
Section 72.6 Additional Requirements for Facilities Transferring or
Receiving Select Agents
This entire section, 72.6(a)-(j), was replaced or amended by
publication by HHS in the Federal Register of 42 CFR 73, ``Possession,
Use, and Transfer of Select Agents and Toxins,'' as Interim Final Rules
on December 13, 2002 (67 FR 76886), and November 3, 2003 (68 FR 62245),
and as a Final Rule on March 18, 2005 (70 CFR 13294), with an effective
date of April 18, 2005.
These rulemakings also replaced the list of agents at ``Appendix A
to Part 72--Select Agents,'' as well as the ``Exemptions'' section
following the Appendix.
The amendments published on March 18, 2005 (70 FR 13316), which
conformed section 72.6(h) and Appendix A to 42 CFR 73, are no longer
needed, and would be removed by this notice of proposed rulemaking.
Section 72.7. Penalties
Penalties were specified for violations of this part, with stronger
penalties for violations related to select agents. Similar penalties
for violations of provisions of part 73 related to select agents have
been specified by revision to 42 CFR Part 1003--Civil Money Penalties,
Assessments and Exclusions. The DOT regulations provide for penalty for
non-compliance, as do ICAO and other entities with instructions or
regulations regarding transport of infectious substances.
Authority
The HHS regulation of the interstate transfer of etiologic agents
is based on the general authority found in Section 264 of Title 42,
United States Code, Regulations to Control Communicable Diseases, in
Part G, Quarantine and Inspection.
Regulatory Analyses
Rescinding Part 72 reduces the regulatory burden on affected
entities. The DOT Hazardous Materials Transportation regulations and
the HHS Select Agent regulations already apply, and shippers are
following them. DOT and HHS have completed the required analyses for
rules that supersede the rule being removed, and which are already in
effect. Eliminating this Federal regulation will be beneficial to the
regulated community by alleviating confusion and duplication.
HHS does not anticipate the proposed removal to have any impact on
other
[[Page 96]]
Federal programs involved in transport of materials that are reasonably
believed to contain infectious substances, such as the HHS/CDC Import
Permit Program; the HHS/CDC Clinical Laboratories Improvement Program;
the HHS/CDC Select Agent Program; and various research programs of HHS/
NIH and HHS/FDA and other Agencies. Agencies will need to review and
update references in their guidance and regulating documents.
Paperwork Reduction Act
This notice of proposed rulemaking does not impose any new
information-collection requirements, and does not invoke any issues
that make it subject to the Paperwork Reduction Act.
The only impact of removal of 42 CFR 72 is to reduce burden. It
eliminates specification for a second label to be attached to the outer
shipping container. This label is no longer needed since it duplicates
the label recommended by the UN Model Regulations, and adopted by DOT
and other organizations (such as ICAO, IATA, and the U.S. Postal
Service) that govern shipments of infectious substances.
Impact of paperwork previously involved with sections that dealt
with notice of delivery or failure to receive (72.4) is insignificant
because HHS has rarely received such paperwork.
Executive Order 12866 and Regulatory Flexibility Act
Executive Order 12866
Executive Order 12866 directs agencies to assess all costs and
benefits of available regulatory alternatives and, when regulation is
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety,
and other advantages; distributive impacts; and equity). The Executive
Order classifies a ``significant regulatory action,'' requiring review
by the Office of Management and Budget unless OMB waives such review,
as any regulatory action that is likely to result in a rule that may:
(1) Have an annual effect on the economy of $100 million or more or
adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or tribal governments or
communities; (2) Create a serious inconsistency or interfere with an
action taken or planned by another agency; (3) Materially alter the
budgetary impact of entitlements, grants, user fees, or loan programs
or the rights and obligations of recipients thereof; or (4) Raise novel
legal or policy issues arising out of legal mandates, the President's
priorities, or the principles set forth in the Executive Order.
The economic, interagency, budgetary, legal, and policy
implications of this proposed rule have been examined, and the
regulatory action has been deemed to be ``not a significant regulatory
action'' under the Executive Order because removal of this regulation
is not likely to result in a rule that may raise novel legal or policy
issues arising out of legal mandates, the President's priorities, or
the principles set forth in the Executive Order.
Regulatory Flexibility Act
HHS does not anticipate that this notice of proposed rule making
will have any economic impact on small businesses and other small
entities.
Unfunded Mandates
This notice of proposed rulemaking imposes no mandates, and will
not result in any expenditure burden, on State, local, or tribal
governments.
Executive Order 12988
This notice of proposed rulemaking includes no provisions that
would lead to burden on the court system.
Executive Order 13132
This notice of proposed rulemaking does not propose any regulation
that would preempt State, local and Indian tribe requirements, or that
would have any substantial direct effects on the States, relationship
between the national government and the States, or the distribution of
power and responsibilities among the various levels of government.
Environmental Assessment
This notice of proposed rule making is not a major regulatory
action, and will not result in any impact on the environment; transport
of infectious substances across State lines is comprehensively covered
by existing regulations of other Agencies.
List of Subjects in 42 CFR Part 72
Biologics, Hazardous materials transportation, Packaging and
containers, Penalties, Transportation.
For the reasons set forth in the preamble under the authority of 42
U.S.C. 264, 271; 31 U.S.C. 9701; 18 U.S.C. 3559, 3571, and 42 U.S.C.
262 note, the Department of Health and Human Services proposes to amend
title 42 (Public Health) of the Code of Federal Regulations by removing
part 72 (Interstate Shipment of Etiologic Agents).
PART 72--[REMOVED AND RESERVED]
Dated: July 21, 2006.
Julie Louise Gerberding,
Director, Centers for Disease Control and Prevention.
Dated: August 21, 2006.
Michael O. Leavitt,
Secretary.
Editorial Note: This document was received at the Office of the
Federal Register on December 15, 2006.
[FR Doc. E6-21723 Filed 12-29-06; 8:45 am]
BILLING CODE 4163-18-P