Interstate Shipment of Etiologic Agents, 3874-3879 [E8-1050]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• Centers for Disease Control and Prevention

[Federal Register Volume 73, Number 15 (Wednesday, January 23, 2008)]
[Rules and Regulations]
[Pages 3874-3879]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-1050]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 
jkn1@cdc.gov.

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]
BILLING CODE 4163-18-P