[Federal Register Volume 73, Number 15 (Wednesday, January 23, 2008)]
[Rules and Regulations]
[Pages 3874-3879]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-1050]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR PART 72
RIN 0920-AA19
Interstate Shipment of Etiologic Agents
AGENCY: Centers for Disease Control and Prevention (CDC), HHS.
ACTION: Final rule.
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SUMMARY: HHS is removing 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 eliminates 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. Removal of Part 72 alleviates
confusion and reduces the regulatory burden with no anticipated adverse
impact on public health and safety.
DATES: Effective Date: This final rule is effective 30 days after
publication in the Federal Register.
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-D10), Atlanta, GA 30333; telephone: 404-639-2100; e-mail
[email protected].
SUPPLEMENTARY INFORMATION: On January 3, 2007, HHS published a notice
of proposed rulemaking (NPRM) to remove Part 72 of Title 42 of the Code
of Federal Regulations. The comment period for the proposed rule closed
on March 5, 2007. HHS received no comments on the proposed rule.
With minor modification for clarification, this supplementary
information is the same as was in the NPRM.
Part 72 (being removed by this final rule) 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.
42 CFR 72, 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
transporting select agents, was superseded by the
[[Page 3875]]
issuance of an Interim Final Rule for 42 CFR part 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 for
transporting select agents.
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 part 72 are considered to be
hazardous materials, and, in practice, the DOT regulations, 49 CFR 171-
180, have superseded 42 CFR part 72 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
part 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 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.
United Nations Recommendations and Model Regulations
The United Nations (UN) publishes its Recommendations on the
Transport of Dangerous Goods and Model Regulations, here described as
the ``UN Model Regulations'' or ``model regulations,'' on a biennial
basis. The model regulations are developed by the Committee of Experts
on the Transport of Dangerous Goods of the UN Economic and Social
Council. Although regulations for transporting infectious substances
have existed in all of the editions of the UN Model Regulations, those
for infectious medical waste were first adopted in December 1996, in
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 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 revised requirements for transporting of infectious
substances in the 13th Revised Edition of the UN Model Regulations in
2004.
These model regulations recommended a new classification scheme of
categories A and B, based on risk during transport, instead of risk
that occurs 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. This list
is not exhaustive. 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 of the UN Model Regulations.
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
[[Page 3876]]
the 13th and 14th Revised Editions of the 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
The DOT final rule also exempts from regulation 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. For example, the U.S. Postal Service Domestic Mail
Manual (DMM) requires special packaging (not subject to performance
requirements it prescribes for infectious substances) for liquid
diagnostic specimens that would not meet the current definitions for a
Category A or B infectious substance. This 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. The ICAO Technical Instructions (ICAO TI)
govern virtually all shipments transported internationally by air, and
the majority of U.S. domestic air shipments. Addendum No. 2 to ICAO TI
(Doc. 9284), issued on 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 on 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 in commerce.
Section 72.2 Transportation of Diagnostic Specimens, Biological
Products, and Other Materials; Minimum Packaging Requirements
Section 72.2 provides 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 detailed DOT 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 classifying and shipping as a Category A or B a
biological product ``known or reasonably expected'' to contain a
pathogen that meets the criteria for either category, thereby covering,
when transported in commerce, those same substances 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 in commerce
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 outdated 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 was a partner in that effort.
The indicative list included in the preamble of the June 2, 2006,
DOT final rule differs from the list in the UN Model Regulations in the
14th Revised Edition 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, and other infectious substances that meet the criteria for
Category A, 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 interested persons to read the DOT final rule for a more
comprehensive understanding of the new method of categorizing and
defining a Category A material, and to
[[Page 3877]]
review the substances it lists in its preamble that meet the Category A
definition. The DOT included this list as a guide (not all-inclusive)
of infectious substances the WHO and HHS determined are examples of
Category A agents.
In brief, the UN Committee of Experts on the Transport of Dangerous
Goods, with the 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 the 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.
HHS also encourages the public to review the current packaging
requirements provided in the 2006 DOT final rule cited above, as well
as those published in the DOT's 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) and (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 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; including those
covered under 49 CFR 171.15 (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, we will ask the DOT to consider
amending 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.'' We will also ask the DOT to 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, vessel, and air shipments. 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 requires 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 the effective date of this final rule to remove Part
72, HHS will remain available for consultation on and in 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 revised the
manual ``Biosafety in Microbiological and Biomedical Laboratories'' in
2007. Although Annex B of this 5th Edition is concerned with
decontamination and disinfection primarily in the laboratory
environment, it could 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. The WHO publishes a
``Laboratory Biosafety Manual'' that includes a simpler list of
procedures for spill clean-up in the section on transport of infectious
substances.
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 part 73. 42 CFR part 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 for
Category A agents, including those of the 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. As a result of
these requirements, 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 select agents or
toxins listed in 72.3(f). As stated above, 42 CFR part 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
[[Page 3878]]
conformed this section to the new 42 CFR part 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 part 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 are removed by this final rule.
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. The HHS considers the intrastate,
interstate, and international regulations of the DOT and UN Model
Regulations for transporting infectious substances to include the
majority of the HHS's etiologic agents covered under its authority.
Regulatory Analysis
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 is beneficial to the
regulated community by alleviating confusion and duplication.
HHS does not anticipate the removal to have any impact on other
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 to reflect
changes brought about by this final rule.
Paperwork Reduction Act
This final rule 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 part 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.
Consequently, the removal of 42 CFR part 72 will eliminate the need
for the duplicative labeling requirements and the collection of data
associated with the notice of delivery or failure to receive packages.
However, the removal of 42 CFR 72 does not eliminate the provisions set
forth in Subpart F (Importations) of the Foreign Quarantine Regulations
(42 CFR part 71), which contains provisions for importation of
etiologic agents, hosts, and vectors (See 42 CFR 71.54). Specifically,
this provision requires persons that import or distribute after
importation these materials to obtain a permit issued by the CDC (OMB
Control Number 0920-0199).
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 final rule have been examined, and the regulatory
action has been deemed to be `` a significant regulatory action'' under
the Executive Order because removal of this regulation will eliminate
confusing and potentially contradictory regulatory requirements which
should benefit the regulated community.
Regulatory Flexibility Act
The HHS Secretary hereby certifies that the final rule will not
have a significant economic impact on a substantial number of small
entities.
Executive Order 12988
This action has been determined not significant for purposes of
Executive Order 12866, and therefore, has not been reviewed by the
Office of Management and Budget.
Executive Order 13132
This final rule does not include any regulation that preempts
State, local and Indian tribe requirements, or that has any substantial
direct effects on the States, relationship between the
[[Page 3879]]
national government and the States, or the distribution of power and
responsibilities among the various levels of government.
List of Subjects in 42 CFR Part 72
Biologics, Hazardous materials transportation, Packaging and
containers, Penalties, Transportation.
0
For the reasons set forth in the preamble and 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 amends 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: August 15, 2007.
Julie Louise Gerberding,
Director, Centers for Disease Control and Prevention.
Dated: October 11, 2007.
Michael O. Leavitt,
Secretary.
[FR Doc. E8-1050 Filed 1-22-08; 8:45 am]
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