Hazardous Materials: Revision to Standards for Infectious
Substances and Genetically Modified Micro-Organisms
[Federal Register: January 22, 2001 (Volume 66, Number 14)]
[Proposed Rules]
[Page 6941-6962]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22ja01-55]
[[Page 6941]]
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Part VI
Department of Transportation
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Research and Special Programs Administration
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49 CFR Parts 171, 172, 173, 177 and 178
Hazardous Materials: Revision to Standards for Infectious Substances
and Genetically Modified Micro-Organisms; Proposed Rule
[[Page 6942]]
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DEPARTMENT OF TRANSPORTATION
Research and Special Programs Administration
49 CFR Parts 171, 172, 173, 177, and 178
[Docket No. RSPA-98-3971 (HM-226)]
RIN 2137-AD13
Hazardous Materials: Revision to Standards for Infectious
Substances and Genetically Modified Micro-Organisms
AGENCY: Research and Special Programs Administration (RSPA), DOT.
ACTION: Notice of proposed rulemaking.
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SUMMARY: RSPA is proposing to revise transportation requirements for
infectious substances, including regulated medical waste, by adopting
defining criteria and packaging requirements for infectious substances
and genetically modified micro-organisms that are consistent with
international standards; revising the current broad exceptions for
diagnostic specimens and biological products; and authorizing bulk
packaging options for regulated medical waste consistent with
requirements in international standards and DOT exemptions. These
proposals are intended to assure an acceptable level of safety for the
transportation of infectious substances and to facilitate domestic and
international transportation.
DATES: Comments. Submit comments by April 23, 2001. To the extent
possible, we will consider comments received after this date in making
our decision on a final rule.
ADDRESSES: Submit comments to the Dockets Management System, U.S.
Department of Transportation, Room PL-401, 400 Seventh Street, SW.,
Washington, DC 20590-0001. Comments should identify Docket Number RSPA-
98-3971 (HM-226) and be submitted in two copies. If you wish to receive
confirmation of receipt of your written comments, include a self-
addressed, stamped postcard. You may also submit comments by e-mail by
accessing the Dockets Management System web site at ``http://
dms.dot.gov/'' and following the instructions for submitting a document
electronically.
The Dockets Management System is located on the Plaza level of the
Nassif Building at the Department of Transportation at the above
address. You can review public dockets there between the hours of 9
a.m. and 5 p.m., Monday through Friday, except federal holidays. You
can also review comments on-line at the DOT Dockets Management System
web site at
``http://dms.dot.gov/.''
FOR FURTHER INFORMATION CONTACT: Eileen Edmonson or Susan Gorsky (202)
366-8553, Office of Hazardous Materials Standards, Research and Special
Programs Administration.
SUPPLEMENTARY INFORMATION:
List of Topics
I. Background
II. Need for New Regulations
III. Summary of Proposals in NPRM
A. Classification Criteria for Infectious Substances
B. Packaging Requirements for Infectious Substances
C. Exceptions for Domestic Shipments of Infectious Substances
D. Diagnostic Specimens
E. Biological Products
F. Genetically Modified Micro-Organisms
G. Regulated Medical Waste
H. Used Health Care Products
I. Hazard Communication
J. Petition for Rulemaking
IV. Section-by-Section Review
V. Regulations of Other Agencies
A. Centers for Disease Control and Prevention
B. Occupational Safety and Health Administration
C. Food and Drug Administration
D. U.S. Department of Agriculture
E. Actions to Assure Regulatory Consistency
VI. Regulatory Analyses and Notices
A. Executive Order 12866 and DOT Regulatory Policies and
Procedures
B. Executive Order 13132
C. Executive Order 13084
D. Regulatory Flexibility Act
E. Paperwork Reduction Act
F. Regulation Identifier Number (RIN)
G. Unfunded Mandates Reform Act
H. Environmental Assessment
I. Background
On September 2, 1998, the Research and Special Programs
Administration (RSPA, we) published an advance notice of proposed
rulemaking (ANPRM) on revisions to the current requirements in the
Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable
to the transportation of infectious substances, Division 6.2, including
regulated medical waste (63 FR 46844). We asked a variety of questions
concerning classification criteria, hazard communication, and packaging
requirements for infectious substances consistent with international
standards; revisions to the current exceptions in the HMR for
diagnostic specimens and biological products; and additional packaging
requirements for regulated medical waste (RMW).
In addition, we conducted an electronic public meeting on the
Internet from September 14-16, 1998, to facilitate public comment on
the issues discussed in the ANPRM. For the Internet meeting, we posted
the questions listed in the ANPRM and additional questions to encourage
commenters to provide specific quantitative information relative to the
transportation of infectious substances.
We received 89 comments in response to the ANPRM and the Internet
meeting. Several commenters submitted more than one response. Most
comments came from industry associations, colleges and universities,
laboratories, and medical waste transporters. Comments were also
submitted by state veterinary laboratories, state departments of
agriculture, health insurance companies, a blood supplier, equipment
suppliers, private citizens, a fire department, a union, and the U.S.
Department of Agriculture.
II. Need for New Regulations
Many commenters question the need for increased regulation of
infectious substances. They cite their experience with transporting
these materials to support their view that there is little or no safety
risk associated with such transportation and, thus, no justification
for the changes proposed in the ANPRM. Commenters further assert that
the proposed packaging and hazard communication requirements will
impose significant transportation costs that are not justified by the
safety risks involved with shipping infectious substances.
We do not agree that there is little risk associated with the
transportation of infectious substances. RSPA's Hazardous Materials
Information System (HMIS) includes reports of carriers discovering
leaking, unlabeled packages containing blood and other potentially
infectious material and of packages containing infectious materials
being damaged in handling and releasing their contents. The Centers for
Disease Control receives about 400 reports each year from carriers who
detect leakage or other damage to packages of infectious substances.
Releases of infectious substances in transportation present the
possibility of exposure for transportation workers and the general
public and can result in costly shipping delays and clean-up efforts.
Further, as a result of a provision in the accident reporting
requirements in the HMR and the wording of the INFECTIOUS SUBSTANCE
label, many releases of infectious substances are reported to CDC
rather than to RSPA. Although the HMR require incident information
reported to CDC also to be
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reported to RSPA in a written incident report, carriers do not
routinely do so. This has resulted in under-reporting of these
incidents in RSPA's HMIS data base.
Over the last several years, individuals and companies commenting
on infectious substances rulemakings or on their own initiative have
reported information concerning infectious substance releases. These
reports include blood pouring from roll-offs and freight containers
transporting regulated medical waste (RMW), the disposal of HIV-
contaminated blood in municipal waste cans, overturned vehicles that
have released diagnostic specimens on highways, ruptured packages
containing diagnostic specimens being transported by aircraft, releases
of treatment-resistant diseases from inadequate packaging, and used
sharps that puncture inner packagings.
Because of these reports and our own findings, we believe that the
current regulatory requirements applicable to transportation of
Division 6.2 materials should be strengthened. Accordingly, in this
NPRM, we are proposing the following changes to the HMR:
Adoption of new classification criteria for infectious
substances based on defining criteria developed by the World Health
Organization and consistent with standards contained in the United
Nations Recommendations on the Transport of Dangerous Goods and the
International Civil Aviation Organization's Technical Instructions for
the Safe Transport of Dangerous Goods by Air.
Revision of current packaging requirements for Division
6.2 materials for consistency with international performance standards.
Elimination of the current exception from requirements in
the HMR for diagnostic specimens to impose certain packaging and hazard
communication requirements. Diagnostic specimens transported in
dedicated motor vehicles by private or contract carriers would continue
to be excepted from most requirements in the HMR.
Modification of the current exception from requirements in
the HMR for biological products, limiting the exception to biological
products licensed for use under current regulations of the Food and
Drug Administration or U.S. Department of Agriculture.
New transportation requirements for the transportation of
genetically modified micro-organisms consistent with international
requirements.
New bulk packaging options for the transportation of RMW,
based on current exemption provisions.
New hazard communication requirements for shipments of
Division 6.2 materials.
III. Summary of Proposals in NPRM
A. Classification Criteria for Infectious Substances
In the ANPRM, we indicated that we are considering revising the
classification criteria for infectious substances consistent with the
United Nations Recommendations on the Transport of Dangerous Goods (UN
Recommendations) and the International Civil Aviation Organization's
Technical Instructions for the Safe Transport of Dangerous Goods by Air
(ICAO Technical Instructions). In particular, we said we are
considering adopting the risk groups and defining criteria developed by
the World Health Organization (WHO) for Division 6.2 materials.
Commenters who support international harmonization of the
classification criteria for infectious substances note that the
proposal in the ANPRM would facilitate shipment of infectious
substances in international commerce and by aircraft. Commenters
opposed to the proposal are concerned about the possible
misinterpretation and misapplication of the WHO risk group criteria.
These commenters believe that the WHO risk group definitions are poorly
worded and subject to broad interpretation and, as a result, assigning
materials to risk group categories may be difficult or impossible.
As we stated in the ANPRM, the hazards posed by Division 6.2
materials vary greatly depending on the pathogenicity of the organism,
the mode and relative ease of transmission, and other factors (63 FR
46845). It should be noted that determining if a material is infectious
has always included subjective analysis in the absence of actual
testing. Classifying these materials based on the level of risk and
applying transportation requirements commensurate with that risk should
ensure an adequate level of safety without imposing an undue burden on
the regulated community. International harmonization of transportation
standards also facilitates foreign trade and helps U.S. companies
compete in the global economy. Most passenger and cargo air carriers
currently require shipments of Division 6.2 materials to conform to the
international standards.
Thus, in this NPRM, we are proposing to define Division 6.2
materials using the WHO risk group criteria. The proposal would require
Division 6.2 materials to be assigned to risk groups based on the
degree to which they cause injury through disease, with Risk Group 1
presenting the lowest risk and Risk Group 4 presenting the highest
risk. Assignment to a risk group would be based on the known medical
history of the patient or animal, endemic local conditions, symptoms of
the patient or animal, or professional judgement concerning the
individual circumstances of the patient or animal. Division 6.2
materials assigned to Risk Group 1 would be excepted from requirements
in the HMR.
Commenters to the ANPRM are concerned that updated lists indicating
risk group assignments for specific pathogens are difficult to obtain.
We are aware of several organizations that maintain such lists. The
American Biological Safety Association (ABSA) lists bacteria, fungi,
viruses, and parasites according to their assigned risk groups. These
lists can be found on-line at the ABSA web site (http://www.absa.org/).
In addition, the ABSA web site includes links to risk group listings
from Canada (in Health Canada's Laboratory Biosafety Guidelines at
http://www.hc-sc.gc.ca/hpb/lcdc/biosafty/docs/index.html) and to
Belguim's Biosafety Server (http://biosafety.ihe.be/), which includes
information on European regulation of infectious substances. The ABSA
web site also includes information on the regulation of infectious
substances in Australia, Brazil, Japan, and New Zealand at http://
biosafety.ihe.be/Menu/BiosWorld.html. We plan to work with WHO and CDC
to assure that updated guidance for determining the risk groups for
specific materials is easily available.
B. Packaging Requirements for Infectious Substances
The HMR currently require an infectious substance to be packaged in
a triple packaging that includes a water-tight primary receptacle, a
water-tight secondary packaging, and an outer packaging. The primary
receptacle or secondary packaging must be capable of withstanding,
without leakage, an internal pressure that produces a pressure
differential of not less than 95kPa (0.95 bar, 14 psi) and temperatures
in the range of -40 deg.C to +55 deg.C (-40 deg.F to +131 deg.F).
The triple packaging must be capable of passing the performance tests
specified in Sec. 178.609.
In this NPRM, we propose to incorporate several changes to the
packaging requirements and performance tests to make them
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consistent with the UN Recommendations and ICAO Technical Instructions.
For example, we propose to require manufacturers to mark packagings
represented as conforming to the specifications for infectious
substances packagings in the HMR consistent with UN marking
requirements. In addition, we propose to require manufacturers to
retain packaging design qualification records and to retest packagings
every 24 months. Further, we propose to replace the current requirement
for a water immersion test with a water-spray test that simulates
exposure to rainfall, as required by the ICAO Technical Instructions.
Similarly, we propose to incorporate the selective testing provisions
in the UN Recommendations and ICAO Technical Instructions to allow
variations in the primary receptacles within the secondary packaging
without further testing of the completed package if an equivalent level
of performance is maintained.
C. Exceptions for Domestic Shipments of Infectious Substances
In the September 1998 ANPRM, we noted that we are considering
several exceptions from HMR requirements for domestic shipments of
infectious substances by motor carrier. For example, the HMR include
exceptions from most requirements of the HMR for hazardous materials
transported as materials of trade. Materials of trade include hazardous
materials carried by private motor carriers engaged in a principal
business other than transportation, such as lawn care, plumbing,
welding, and door-to-door sale of consumer goods. The materials of
trade exception limits the maximum gross weight of materials of trade
that may be carried on a motor vehicle and includes minimum packaging
and hazard communication requirements.
In the ANPRM, we invited comments on expanding the materials of
trade exception to permit certain biological products, diagnostic
specimens, and RMW to be transported by private carriage as materials
of trade. Commenters opposed to a materials of trade exception for
infectious substances assert that such an exception would not provide
an adequate level of safety for transporting infectious materials.
Commenters who support a materials of trade exception note that it
would reduce potential transportation costs, particularly if we remove
the current exceptions in the HMR for diagnostic specimens and
biological products.
In this NPRM, we are proposing to expand the materials of trade
exceptions currently permitted under Sec. 173.6 of the HMR to include
certain biological products, diagnostic specimens, and RMW, including
cultures and stocks. As proposed, this exception does not apply to
materials known to contain or suspected of containing infectious
substances in Risk Group 4.
The proposed exception specifies that the material must be
contained in combination packagings consisting of one or more inner
packagings inside an outer packaging. The capacity of each inner
packaging may not exceed 0.5 kg (1.1 pound) or 0.5 L (17 ounces), and
the capacity of the outer packaging may not exceed 4 kg (8.8 pounds) or
4 L (1 gallon). The proposed exception also permits combination
packagings consisting of a single inner packaging with a capacity that
does not exceed 16 kg (35.2 pounds) or 16 L (4.2 gallons) contained
inside a single outer packaging. For RMW in combination packagings,
each inner packaging may not exceed 4 kg (8.8 pounds) or 4 L (1 gallon)
and the outer packaging may not exceed 16 kg (35.2 pounds) or 16 L (4.2
gallons). Under this proposal, infectious substances transported as
materials of trade are subject to the general packaging, hazard
communication, and motor vehicle operator notification requirements
currently specified in Sec. 173.6. The proposed materials of trade
exception would apply to entities such as home health care providers
and diagnostic laboratories that transport smaller amounts of
infectious substances. We believe that the increased knowledge of the
personnel handling these materials, most of whom are trained in the
requirements of the Occupational Safety and Health Administration's
(OSHA) Universal Precaution regulations for handling potentially
contaminated material, will substantially reduce the risks associated
with their transportation. In addition, the exception imposes minimum
packaging requirements, at minimal cost, for materials currently
excepted from the HMR.
D. Diagnostic Specimens
In the ANPRM, we proposed removing the existing broad exception
from the HMR for diagnostic specimens and creating a regulatory system
based on the WHO risk group definitions that requires diagnostic
specimens to be packaged, described, and transported in a manner
consistent with their level of risk. We proposed retaining the broad
exception from the HMR for diagnostic specimens assigned to Risk Group
1 only. Further, we proposed exceptions to distinguish between a
diagnostic specimen known or suspected to contain an infectious
substance and one sent for routine testing.
The majority of comments we received in response to the ANPRM
address the proposed regulations for diagnostic specimens. Most
commenters oppose increased regulation for diagnostic specimens,
suggesting that the proposed regulations are not justified by the
safety record and will be difficult and costly to implement. Commenters
further state that the proposed regulations could result in shipment
delays, making early detection and treatment of disease difficult.
Commenters note that shippers of diagnostic specimens may have little
or no knowledge of what pathogens a given specimen may contain, making
application of the WHO risk groups to such materials difficult, at
best. Finally, commenters state that the proposed regulations could
significantly increase health care costs.
Commenters who support regulation of diagnostic specimens note that
releases of these materials do occur in transportation. These
commenters generally support removal of the current exception from the
HMR for diagnostic specimens to ensure packaging quality and to protect
transportation workers and the general public from the risk of exposure
to potentially infectious materials.
We agree with commenters that diagnostic specimens should be
subject to regulation under the HMR. Our HMIS data base includes
reports of packages containing these materials that were damaged in
transportation, resulting in delays and possible risk to cargo
handlers, flight crews, emergency responders, and the general public.
However, we also agree with commenters that the regulatory requirements
proposed in the ANRPM could increase transportation costs for shipment
of these materials.
Accordingly, in this NPRM, we are proposing regulations applicable
to the transportation of diagnostic specimens that are consistent with
proposed amendments to the UN Recommendations. We propose a new entry
in the Hazardous Materials Table--``Diagnostic Specimen.'' There is no
UN number, hazard warning label, or packing group assignment.
Under this proposal, diagnostic specimens meeting the definition of
a Risk Group 4 material are classed and transported as Division 6.2
materials, UN 2814 or UN 2900. All other diagnostic specimens must be
packaged in primary receptacles packed inside secondary packaging to
preclude breakage, punctures, or leakage, and, for liquids, with
sufficient absorbent
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material to absorb the entire contents of the primary receptacle. The
secondary packaging must be secured in outer packagings with suitable
cushioning material. For liquids transported by aircraft, either the
primary receptacle or the secondary packaging must be capable of
withstanding an internal pressure producing a pressure differential of
at least 95kPa (0.95 bar, 14 psi). The completed package must be
capable of passing a drop test from a height of at least 1.2 meters
(3.9 feet). The package must be marked with the words ``Diagnostic
Specimens.'' Diagnostic specimens shipped in conformance with these
proposed provisions are excepted from other requirements in the HMR,
except that diagnostic specimens transported on board aircraft are
subject to the incident reporting requirements in Secs. 171.15 and
171.16. Under this proposal, offerors and transporters of diagnostic
specimens must be informed of the diagnostic specimen packaging
requirements.
In addition to the materials of trade exception discussed above, we
are also proposing a complete exception from the HMR for diagnostic
specimens transported by private or contract motor carriers. Based on
comments received in response to the ANPRM, it is our understanding
that most diagnostic specimens are shipped from collection sites (e.g.,
physicians' offices, nursing homes, clinics, etc.) to testing
laboratories by private or contract couriers in dedicated vehicles. The
couriers are familiar with the materials they transport and trained in
the application of the OSHA Universal Precautions for handling
materials that may contain infectious substances. Our proposal would
require couriers to be informed about the materials they are
transporting. This proposed exception will enable the transportation of
diagnostic specimens quickly, efficiently, and safely to testing
laboratories.
It should be noted that waste diagnostic specimens--that is,
diagnostic specimens that meet the proposed definition for RMW in this
NPRM--could not be transported under the exceptions proposed in this
NPRM for the transportation of diagnostic specimens. Waste diagnostic
specimens would lose their identity as diagnostic specimens for
purposes of the HMR and would have to be transported in accordance with
the HMR requirements applicable to RMW.
Taken together, we believe that these proposals for the
transportation of diagnostic specimens are cost-effective, practical,
and easy to understand and implement. Most important, these proposals
will assure an adequate level of safety.
E. Biological Products
Commenters to the ANPRM generally support its proposals concerning
transportation of biological products. Under current provisions,
biological products are excepted from the HMR provided they meet Food
and Drug Administration (FDA) or U.S. Department of Agriculture (USDA)
regulations governing the transfer of biological products. In this
NPRM, we propose to limit this exception to biological products that
meet the definition of a Risk Group 1 material or are licensed for use
under current FDA or USDA regulations. We propose to require unlicensed
biological products meeting the definition of a Risk Group 2, 3, or 4
infectious substance to be classed as infectious substances, Division
6.2, and packaged in specification packagings authorized for the
transportation of infectious substances.
In addition, we are proposing to add a special provision in
Sec. 172.102, consistent with ICAO Technical Instruction Special
Provision A81, to except blood and blood products from current quantity
limits for shipments by air when the materials are packaged in primary
receptacles that do not exceed 500 ml (17 ounces) and contained in
outer packagings not exceeding 4 L (1 gallon).
We also propose to except from all HMR requirements blood collected
for blood transfusions, blood collected for the preparation of blood
products, blood products intended for transplant, and tissues and
organs intended for transplant.
It should be noted that waste biological products--that is,
biological products that meet the proposed definition for RMW in this
NPRM--may not be transported under the exceptions proposed in this NPRM
for the transportation of biological products. Waste biological
products lose their identity as biological products for purposes of the
HMR and, if they contain infectious substances, must be transported in
accordance with the HMR requirements applicable to RMW.
F. Genetically Modified Micro-Organisms
The UN Recommendations and the ICAO Technical Instructions treat
any genetically modified micro-organism that meets the definition of a
Division 6.2 material as an infectious substance. In addition, these
international standards class a genetically modified micro-organism
that does not meet the definition of a Division 6.2 material, but is
capable of altering plants, animals, or microbiological substances in a
way not normally the result of natural reproduction, as a Class 9
material. The UN Recommendations also contain a provision that excludes
from regulation genetically modified micro-organisms that are
authorized and licensed for use by the government of origin, transit,
and destination.
In the ANPRM, we invited comment on whether the HMR should
incorporate the international transportation standards for genetically
modified micro-organisms. Commenters who addressed this issue are
concerned that the proposed regulations could interfere with food and
animal production. We appreciate their concerns, but we believe that
the potential for environmental and property damage as a result of the
release of genetically modified micro-organisms in transportation
justifies their regulation as Class 9 materials.
Accordingly, in this NPRM, we propose to add ``Genetically modified
micro-organism'' to the Hazardous Materials Table as a Class 9
material. Under this proposal, these materials must be packaged in
conformance with the requirements for packaging infectious substances,
except that the packagings need not be marked or tested in accordance
with Part 178 requirements.
The NPRM proposes two exceptions applicable to the transportation
of genetically modified micro-organisms. First, we propose to except
genetically modified micro-organisms from all requirements in the HMR
if a federal government agency authorizes their final distribution and
use. Second, we propose to except genetically modified micro-organisms
from HMR requirements when transported in a non-passenger-carrying
transport vehicle operated by a private or contract motor carrier. The
materials must be packaged to conform to the provisions described
above, and the package must be marked with the proper shipping name
``Genetically modified micro-organism.'' Further, our proposal requires
couriers to be informed about the materials they are transporting.
G. Regulated Medical Waste
Commenters generally support the proposals outlined in the ANPRM to
permit transportation of RMW in non-specification bulk packagings.
Currently, bulk packagings for the transportation of RMW are only
authorized under the terms of 29 exemptions. For the most part, these
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packagings have demonstrated that they provide an acceptable level of
safety in transportation.
To ensure consistency with international regulations and to provide
the broadest selection of authorized bulk packagings, we are also
proposing to allow the use of ``Large Packagings,'' which are
intermediate bulk packagings containing one or more inner packagings
consistent with the requirements of the UN Recommendations. A
definition for these packagings was proposed in an NPRM issued under
Docket HM-215D, published October 23, 2000 (65 FR 63294) and in the
International Maritime Dangerous Goods Code and ICAO's Technical
Instructions. As proposed under HM-215D, a Large Packaging consists of
an outer packaging containing articles or inner packagings and designed
for mechanical handling. A Large Packaging has a capacity greater than
400 kg (882 lbs.) or 450 liters (119 gallons), but does not exceed 3
cubic meters in volume.
Accordingly, in this NPRM we propose to authorize Large Packagings
and certain non-specification bulk containers for use as outer
packagings for the transportation of RMW. Plastic film bags meeting
performance and test requirements for impact and tear resistance are
authorized as inner packagings for solid RMW. Inner packagings for
liquid RMW must be rigid, leak resistant, puncture resistant, break
resistant, impervious to moisture, and sealed to prevent leakage.
In addition to the above, we propose to revise the quantity
limitations applicable to shipments of RMW on aircraft. Currently, such
shipments are forbidden. We propose to revise the quantity limitations
for non-bulk shipments of RMW on board aircraft to read ``No limit''
for consistency with the ICAO Technical Instructions applicable to
quantity limitations for RMW on airplanes. We propose to continue to
prohibit bulk shipments of RMW on board aircraft.
H. Used Health Care Products
One commenter suggests that the HMR include an exception for used
health care products. The commenter states that used health care
products potentially contaminated with infectious substances, such as
wound care and sanitary products, surgical equipment, diagnostic and
blood testing products, and contraceptives used by consumers, medical
professionals, and pharmaceutical providers are routinely returned to
manufacturers. Used health care products may be returned for assessment
of clinical trials, new product development, customer complaints,
product investigations for government compliance, service and repair,
and competitor trade-ins.
The infectious status of many of these returned used health care
products may not be known. An individual consumer may be unaware that
he has an infectious disease or may be reluctant to reveal this
information, or a patient may be infectious, but not symptomatic. In
addition, patient confidentiality requirements prohibit health care
providers from communicating a patient's infectious status to others.
Further, in the case of potentially contaminated used health care
products, it is the inanimate product that is being shipped, not the
infectious agent. While used health care products may be contaminated
with human blood or other body fluids or tissues, these substances
usually are dried on the health care product. Special conditions
necessary to promote or sustain biological integrity are not available
prior to or during shipment. If infectious agents are present on used
health care products, they are, in the words of the commenter,
``unwanted hitchhikers'' and are subject to hostile conditions that may
inactivate pathogens over time or, at least, do not support their
amplification.
The commenter suggests that neither the HMR nor international
standards clearly address the shipment of potentially contaminated used
health care products. We agree. Thus, in this NPRM we are proposing to
except used health care products being returned to the manufacturer
from the requirements of the HMR provided the products are shipped in a
triple packaging that conforms to certain manufacturing and marking
requirements. Under this proposal, the primary and secondary containers
must be marked with the OSHA BIOHAZARD symbol and must be constructed
of metal or plastic in a manner that assures that they remain intact
during transportation. Under this NPRM, offerors and transporters of
used health care products potentially contaminated with an infectious
substance must be informed about the used health care product packaging
requirements.
I. Hazard Communication
In the ANPRM, we stated that we are considering several options
with respect to the marking or placarding of bulk packagings and
transport vehicles containing infectious substances, including RMW.
Some commenters support a requirement for Division 6.2 placards on each
vehicle or bulk packaging that contains any quantity of a Risk Group 4
infectious substance because of the extreme risks to emergency
responders and the general public associated with the possible release
of such material. These commenters also generally support a requirement
for placards on all bulk shipments of infectious substances. Commenters
who oppose placarding for shipments of infectious substances suggest
that such a requirement is unnecessary, noting that there are
significant differences in the potential harm that could result from a
transportation incident involving infectious substances as compared to
one involving flammable, toxic, or explosive materials.
We agree with commenters that communication of a Risk Group 4
hazard to transportation workers and emergency response personnel is
important. However, we are concerned that placarding transport vehicles
containing Risk Group 4 infectious substances could compromise the
security of the shipments. Further, shipments of Risk Group 4
infectious substances are strictly controlled by CDC regulation. Thus,
we are not proposing a placarding requirement in this NPRM.
However, we believe bulk packagings and transport vehicles
containing RMW should be marked to communicate to emergency response
personnel the nature of the material being transported. We are aware
that a number of states and local governments have promulgated marking
regulations applicable to the transportation of RMW. Many of these
state and local regulations include a requirement for vehicles
containing shipments of RMW to be identified with a marking similar to
the BIOHAZARD symbol prescribed by OSHA regulations for containers of
potentially infectious material. State, local, and tribal governments
should be aware that the preemption provisions of Federal hazardous
materials transportation law (federal hazmat law; 49 U.S.C. 5101 et
seq.) generally preclude non-federal governments from imposing
requirements applicable to hazardous materials transportation if such
requirements are not consistent with the HMR. 49 U.S.C. 5125. Thus, in
the absence of a waiver of preemption by the Secretary, where state or
local requirements conflict with or are inconsistent with the HMR
requirements, the HMR control.
Federal hazmat law codifies the ``dual compliance'' and
``obstacle'' criteria for preemption of non-federal regulations. As set
forth in 49 U.S.C. 5125(a), these criteria provide that, in the absence
of a waiver of preemption by the Secretary
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under 49 U.S.C. 5125(e) or unless it is authorized by another federal
law, a requirement of a state, political subdivision of a state, or
Indian tribe is explicitly preempted if:
(1) complying with a requirement of the state, political
subdivision or Indian tribe and a requirement of Federal hazardous
materials transportation law or a regulation issued under the law is
not possible; or
(2) the requirement of the state, political subdivision, or Indian
tribe, as applied or enforced, is an obstacle to accomplishing and
carrying out Federal hazardous materials transportation law or a
regulation prescribed under the law.
Federal hazmat law also includes additional preemption provisions
on certain ``covered subject'' areas. The covered subject areas are:
(a) The designation, description, and classification of hazardous
material.
(b) The packing, repacking, handling, labeling, marking, and
placarding of hazardous material.
(c) The preparation, execution, and use of shipping documents
related to hazardous material and requirements related to the number,
contents, and placement of those documents.
(d) The written notification, recording, and reporting of the
unintentional release in transportation of hazardous material.
(e) The design, manufacturing, fabrication, marking, maintenance,
reconditioning, repairing, or testing of a package or container
represented, marked, certified, or sold as qualified for use in
transporting hazardous material. 49 U.S.C. 5125(b).
Marking is a covered subject for purposes of preemption. Thus,
unless authorized by another federal law or a waiver of preemption from
the Secretary of Transportation, a non-federal marking requirement is
preempted when it is not ``substantively the same'' as federal hazmat
law or a regulation issued under it. 49 U.S.C. 5125(b)(1).
In the interest of uniformity, we believe it is essential that
state, local, and tribal marking requirements be consistent from
jurisdiction to jurisdiction. Thus, in this NPRM, we propose to require
bulk packagings containing RMW to be marked with the appropriate UN
identification number. We are also proposing to require bulk packagings
of RMW to be identified with a BIOHAZARD marking that conforms to OSHA
specifications for the BIOHAZARD marking in 29 CFR 1910.1030(g)(1)(i).
In this NPRM, we are also proposing to revise the INFECTIOUS
SUBSTANCE label to reflect the new toll-free number to report
infectious substances incidents to the CDC. That toll-free number is 1-
800-232-0124.
J. Petitions for Rulemaking
The ANPRM requested comments on a petition for rulemaking (P-1350)
submitted by the Medical Waste Institute (MWI) requesting relief for
transportation of waste cultures and stocks that meet the definition
for Division 6.2 materials. Specifically, MWI requests that we revise
the HMR to allow contract and private motor carriers to transport
discarded cultures and stocks of infectious substances in non-
specification packagings if the carriers use dedicated vehicles.
Currently, under Sec. 173.134(b)(3), the HMR allow this type of
transportation for RMW that does not contain a culture or stock of an
infectious substance.
In support of its petition, MWI states that the current packagings
required in the HMR for discarded cultures and stocks are not justified
because they are expensive and lack a safety record that proves their
actual public health and safety benefits. With its petition, MWI
includes HMIS and state incident data on infectious substances for the
period 1989 through March 1997.
Experience under exemption DOT-E 11588 has demonstrated that
Packing Group II packagings transported by a private or contract
carrier in dedicated vehicles provide an acceptable level of protection
for waste cultures and stocks of infectious substances. Private and
contract carriers that transport these materials have an increased
level of knowledge about these materials. Moreover, the use of
dedicated vehicles limits public exposure and assures that packages are
handled by experienced personnel. We also have found that the general
packaging requirements in Secs. 173.24 and 173.24a, coupled with OSHA's
packaging requirements in 29 CFR 1910.1030 for bloodborne pathogens,
are adequate for less virulent types of infectious substances.
Therefore, in this NPRM, we are proposing to revise Sec. 173.134(b) to
permit transportation of waste cultures and stocks of Risk Group 2 or 3
infectious substances in non-specification packagings when transported
by private or contract carriers in dedicated vehicles.
IV. Section-by-Section Review
Part 171
Section 171.7
We propose to revise the table of material incorporated by
reference to add two new references to test methods developed by the
American Society for Testing and Materials. These tests would be
required for plastic inner packagings used to transport RMW inside
Large Packagings and non-specification bulk packagings.
Section 171.8
We propose to add definitions for ``biological product,''
``cultures and stocks,'' ``diagnostic specimen,'' ``genetically
modified micro-organism,'' ``risk group,'' ``sharps,'' and ``toxin.''
These definitions would refer readers to the definitions in Part 173 of
the HMR.
Section 171.14
We propose to allow a two-year transition period for Division 6.2
labels revised as proposed in this NPRM.
Section 171.15
We propose to remove the term ``etiologic agents'' from paragraphs
(a)(3) and (b) and replace it with ``infectious substances.'' In
addition, in paragraph (b) we propose to add wording to emphasize that
a written report of an incident involving infectious substances must be
submitted to RSPA.
Part 172
Section 172.101
For the entry ``Regulated medical waste,'' we propose to remove the
letter ``D'' in column (1). In column (7), we propose to remove the
reference to Special Provision A14 and to revise columns (9A) and (9B)
to replace ``Forbidden'' with ``No Limit'' for quantity limitations on
board aircraft. These proposed changes harmonize requirements in the
HMR with those in the ICAO Technical Instructions and facilitate the
transportation of RMW in non-bulk packagings by aircraft. In addition,
column 8C is revised to replace ``none'' with 197, to indicate that
bulk packagings authorized for the transportation of RMW can be found
in Sec. 173.197 of the HMR. Finally, we propose to revise Special
Provision A13 to prohibit the transportation of bulk packagings of RMW
by aircraft.
For the entries ``Infectious substances, affecting animals only''
and ``Infectious substances, affecting humans,'' we propose to add new
special provisions in column (7). Special Provision A81 provides relief
from quantity limits for the transport of blood or blood products that
contain infectious substances when in primary receptacles not exceeding
500 ml (17 ounces) and in outer packagings not exceeding 4L (1 gallon)
and packaged in accordance with Sec. 173.196. Special Provision A82
provides relief from UN standard packaging for transporting body parts,
whole organs, and whole bodies.
[[Page 6948]]
We propose to add a new entry, ``Genetically modified micro-
organism,'' to the Table as a Class 9 material consistent with entries
in the UN Recommendations, ICAO Technical Instructions, and
International Maritime Dangerous Goods Code.
In addition, we propose to add a new entry, ``Diagnostic
specimen'', to the Table as a Division 6.2 material. There is no UN
number, hazard warning label, or packing group assignment.
We also propose to add two new entries for ``Toxins, liquid,
extracted from living sources, n.o.s., UN 3172'' and ``Toxins, solid,
extracted from living sources, n.o.s., UN 3172.'' For both entries, a
``G'' in column (1) indicates that the shipping description on shipping
papers must include the technical names for the materials. Both entries
indicate that the materials are Division 6.1 materials, UN 3172, PG I,
II, or III. We propose to add Special Provision 141 to state that
toxins that contain infectious substances or are contained in
infectious substances must be classed as Division 6.2 materials and
assigned to UN 2814 or UN 2900, as appropriate.
Section 172.102
We propose to revise this section by removing Special Provision
A14, revising Special Provision A13, and adding Special Provisions 141,
A81, and A82, as detailed above.
Section 172.323
We propose to add this section to require bulk packagings
containing RMW to be marked with a BIOHAZARD marking conforming to OSHA
regulations at 29 CFR 1910.1030.
Section 172.432
We propose to revise the INFECTIOUS SUBSTANCE label to incorporate
the new toll-free telephone number (1-800-232-0124) for reporting
incidents to the CDC.
Part 173
Section 173.6
We propose to add a materials of trade exception for diagnostic
specimens, biological products, and RMW, other than Risk Group 4
materials. The proposed exception includes packaging requirements and
quantity limitations.
Section 173.28
We propose to require Division 6.2 packagings to be decontaminated
prior to reuse.
Section 173.134
In paragraph (a), we propose to revise the definitions and
classification criteria for ``infectious substance,'' ``biological
product,'' ``diagnostic specimen,'' and ``regulated medical waste'' and
to add definitions for ``cultures and stocks,'' ``risk group,''
``sharps,'' and ``toxin.''
We propose to revise the definition of ``infectious substance'' for
consistency with international standards and to require materials
meeting the definition of an infectious substance to be assigned to
risk groups based on the degree to which they cause injury through
disease. Infectious substances assigned to Risk Group 1 are not subject
to regulation under the HMR.
We propose to revise the definition of ``biological product'' to
require biological products known to contain or suspected to contain a
pathogen in Risk Groups 2, 3, or 4 to be classed as Division 6.2
materials, unless otherwise excepted.
We propose to define ``cultures and stocks'' to mean a material
that is prepared and maintained for growth and storage and that
contains a Risk Group 2, 3, or 4 infectious substance.
We propose to revise the definition of ``diagnostic specimen'' to
require a diagnostic specimen known to contain or suspected to contain
a Risk Group 4 pathogen to be classed as a Division 6.2 material. This
determination is based on the known medical history and condition of
the patient or animal, endemic local conditions, symptoms of the source
patient or animal, or professional judgement concerning the individual
circumstances of the patient or animal.
We propose to revise the definition for ``regulated medical waste''
to indicate that regulated medical waste is a waste or reusable
material that contains or is suspected to contain a Risk Group 2 or 3
infectious substance. As proposed in this NPRM, regulated medical waste
containing a Risk Group 4 infectious substance must be classed and
transported as a Division 6.2 material, UN 2900 or UN 2814.
We propose to define ``risk group'' to mean a ranking of a micro-
organism's ability to cause injury through disease. Risk group
assignment criteria include the pathogenicity of the organism, the mode
and relative ease of transmission, the degree of risk to both an
individual and a community, and the reversibility of the disease
through the availability of effective preventive agents and treatments.
We propose to define ``sharps'' to mean any object that may be
contaminated with an infectious substance that is also able to cut or
penetrate the skin or packaging material. The term includes needles,
scalpels, broken glass, culture slides, culture dishes, broken
capillary tubes, broken rigid plastic, and exposed ends of dental
wires.
We propose to define ``toxin'' to mean a Division 6.1 material
secreted from a plant, animal, or bacterial source. The proposed
definition notes that toxins that contain an infectious substance or
are contained in an infectious substance must be classed as Division
6.2 materials.
In paragraph (b), we propose to list exceptions from the HMR
requirements applicable to Division 6.2 materials. Proposed exceptions
include:
1. Biological products licensed/approved for public dissemination
by FDA or USDA;
2. Blood collected for transfusions or the preparation of blood
products, and blood products, tissues, and organs intended for
transplant;
3. Diagnostic specimens or biological products transported by
private or contract motor carriers in dedicated motor vehicles;
4. Material treated so that it no longer contains an infectious
substance;
5. Sanitary waste and sewage;
6. Sewage sludge and compost;
7. Animal waste generated in animal husbandry or food production;
8. Corpses and anatomical parts intended for interment, cremation,
or research; and
9. Forensic material transported on behalf of the federal
government or a state, local government, or tribal government agency.
We also propose to modify the exception for medical waste generated
from households to indicate that such medical waste must be transported
in accordance with applicable state, local, or tribal government
requirements.
In addition, we propose to revise the exception for laundry or
medical equipment conforming to OSHA regulations in 29 CFR 1910.1030 to
clarify that this exception applies to medical equipment intended for
reuse and equipment used for testing. The revised definition further
clarifies that the exception does not apply to medical equipment
transported for disposal.
In paragraph (c), we propose to modify the exception for RMW
transported by contract or private carriers to include waste cultures
and stocks that contain Risk Group 2 or 3 infectious substances.
Finally, we propose to add paragraph (d) to clarify that if an item
listed in paragraphs (b) or (c) of this section meets the definition of
another hazard class or if it is a hazardous substance, hazardous
waste, or marine pollutant, it must be offered for transportation and
[[Page 6949]]
transported in accordance with applicable requirements of the HMR.
Section 173.140
We propose to add new paragraphs (c) and (d) to provide defining
criteria and exceptions for genetically modified micro-organisms that
do not meet the definition of a Division 6.2 material, but that have
the potential to alter animals, plants, or the environment. These
materials are assigned to the Class 9 hazard class. Genetically
modified micro-organisms that meet the criteria for a Division 6.2
material must be classed as infectious substances. We propose to except
genetically modified micro-organisms from HMR requirements if a federal
government agency authorizes their final distribution and use. We also
propose to except genetically modified micro-organisms from HMR
requirements when transported in a non-passenger-carrying transport
vehicle operated by a private or contract motor carrier.
Section 173.196
We propose to revise this section for clarity and consistency with
the UN Recommendations and ICAO Technical Instructions. These revisions
include packaging and overpack marking requirements to ensure the
integrity of the packagings during air transport, including
circumstances where the refrigerant is dissipated or lost. A new
paragraph (d) is added to prescribe non-specification packaging
provisions for body parts.
Section 173.197
We propose to revise this section to authorize certain bulk
packagings for the transportation of RMW. Paragraph (a) proposes
general requirements for both non-bulk and bulk packagings. Proposed
paragraph (b) requires non-bulk packagings to conform to the
requirements of part 178 at the Packing Group II performance level.
Proposed paragraphs (c) and (d) authorize Large Packagings and non-
specification bulk containers for the transportation of RMW. These
proposed packaging provisions are based on the terms of 29 current
exemptions and our own initiative. Proposed paragraph (c) sets forth
conditions governing the use of Large Packagings. Proposed paragraph
(d) sets forth the conditions governing the use of non-specification
wheeled carts and bulk outer packagings. Proposed paragraph (e)
specifies the inner packagings authorized for use with bulk outer
packagings.
Section 173.199
We propose to add a new Sec. 173.199 to address packaging
requirements for diagnostic specimens and used health care products.
Diagnostic specimens meeting the definition of a Risk Group 4 material
must be classed and transported as infectious substances, UN 2814 or UN
2900. Generally, we propose to permit all other diagnostic specimens to
be shipped in triple packagings that are capable of passing a 1.2 meter
(3.9 feet) drop test.
We propose to require liquid diagnostic specimens to be packaged in
leakproof primary receptacles with a volumetric capacity of not more
than 500 ml (17 ounces). For shipments by aircraft, the primary
receptacle or secondary packaging must be able to withstand without
leakage an internal pressure producing a pressure differential of not
less than 95 kPa (0.95 bar, 14 psi). The secondary packaging must be
leakproof and impervious to moisture. The volumetric capacity of the
outer packaging may not exceed 4 L (1 gallon).
We propose to require solid diagnostic specimens to be packaged in
a siftproof primary receptacle with a capacity of not more than 500 g
(1.1 pounds). The secondary packaging must be leakproof. The capacity
of the outer packaging may not exceed 4 kg (8.8 pounds).
We propose to permit shipment of used health care products being
returned to the manufacturer in triple packagings, in which the primary
and secondary containers must be constructed of plastic or metal and
must be marked with the OSHA BIOHAZARD symbol. A used health care
product that can cut or penetrate skin or packaging material must be
transported in a puncture-resistant primary container.
Under this proposal, diagnostic specimens and used health care
products shipped in accordance with these provisions are not subject to
any other requirements in the HMR, except for minimal training
requirements and, for diagnostic specimens, incident reporting for
shipments offered for transportation or transported by aircraft.
Section 173.200
We propose to add a new Sec. 173.200 to address packaging
requirements for genetically modified micro-organisms. We propose to
require genetically modified micro-organisms to be packaged in
conformance with Sec. 173.196, except that the packagings need not be
marked in accordance with Sec. 178.503 nor tested in accordance with
Sec. 178.609. Alternatively, we propose to permit genetically modified
micro-organisms to be transported in packagings that meet the
specifications in Secs. 173.203 or 173.213 at the Packing Group III
performance level.
Part 177
Section 177.834
We propose to revise paragraphs (a) and (g) to indicate that
packages containing Division 6.2 materials must be properly secured in
a transport vehicle.
Section 177.843
We propose to add a new paragraph (d) to require a transport
vehicle to be decontaminated prior to reuse if a Division 6.2 material
is released from its packaging inside the vehicle.
Part 178
Section 178.503
We propose to add a new paragraph (f) to incorporate package
markings for infectious substances packagings consistent with those in
the ICAO Technical Instructions and the UN Recommendations.
Section 178.601
We propose to add a sentence to paragraph (c)(1) of this section to
include the tests for infectious substance packaging in the definition
of design qualification testing. As a result of this proposed change,
manufacturers of infectious substances packagings are required to
retain design qualification records in accordance with
Sec. 178.601(c)(l). In addition, we propose to add a sentence to
paragraph (c)(2) to indicate that, for infectious substances
packagings, periodic retesting is the performance of tests specified in
Sec. 178.609 at the frequency specified in Sec. 178.601(e). Finally, we
propose to add a sentence to paragraph (e) to require packagings used
to transport infectious substances to pass periodic retests.
Section 178.609
We propose to revise the section heading to remove the wording
``(etiologic agents).'' We propose to revise paragraph (c) to permit
the use of expanded plastics for inner packagings and require the
packaging tests to be determined by the most fragile inner packaging.
Paragraphs (d)(1)(i), (d)(1)(iii), and (d)(1)(iv) are revised for
clarity. We propose to revise paragraph (e) to replace the current
water immersion test with a water spray test that simulates exposure to
rainfall consistent with the ICAO Technical Instructions. Paragraphs
(h)(1) and (h)(2) are revised to clearly indicate that,
[[Page 6950]]
during the penetration test, penetration of the primary receptacle is
not acceptable. Current paragraph (i) is deleted. We propose to add new
paragraph (i) to incorporate the selective testing provisions in the UN
Recommendations and ICAO Technical Instructions. These provisions allow
variations in the primary receptacles within the secondary packaging
without further testing of the completed packaging if an equivalent
level of performance is maintained.
V. Regulations of Other Agencies
In addition to RSPA, several federal agencies have responsibility
for regulating infectious substances and genetically modified micro-
organisms.
A. Centers for Disease Control and Prevention
The Department of Health and Human Services is authorized to
promulgate regulations to prevent the introduction, transmission, and
spread of communicable diseases in the United States. CDC has been
delegated authority to regulate the interstate shipment of infectious
substances. The current CDC regulations are codified at 42 CFR Part 72.
The regulations provide requirements for minimum packaging and labeling
for diagnostic specimens and biological products, and include a list of
select agents for which special labeling and tracking is required.
On October 28, 1999, CDC published an NPRM, proposing to clarify
and expand existing requirements for proper packaging and handling of
infectious substances (64 FR 58022). The NPRM includes proposals to
ensure that all biological materials known or suspected to contain an
infectious substance are packaged to minimize the potential for leakage
during transit. The proposed regulations are intended to harmonize CDC
regulations with those of other federal agencies and with international
standards.
B. Occupational Safety and Health Administration
The Department of Labor's Occupational Safety and Health
Administration (OSHA) is authorized to assure safe and healthy
workplaces by the Occupational Safety and Health Act of 1970 (OSH Act).
OSHA regulations governing occupational exposure to bloodborne
pathogens in human blood and body fluids, unfixed tissues, organs, cell
cultures, and other fluids from humans or animals are codified at 29
CFR Part 1910.1030. The regulations require persons who handle
bloodborne pathogens to utilize Universal Precautions as a means of
infection control. The Universal Precautions require human blood and
body fluids to be treated as if known to be infectious. Among other
requirements, the regulations require specimens of blood or other
potentially infectious materials to be placed in containers that
prevent leakage during collection, handling, processing, storage, or
transport. The regulations also require containers of potentially
infectious material to be labeled with a BIOHAZARD label.
C. Food and Drug Administration
The Food and Drug Administration (FDA) regulates, licenses, and
approves biological and related products to ensure their purity,
potency, safety, and efficacy. FDA regulates vaccines, blood
derivatives, allergenic extracts, blood components, whole blood,
tissues, monoclonal antibodies, biotech derived products, somatic cell
and gene therapies, in vitro diagnostics, and medical devices. FDA's
regulations are codified at 21 CFR Parts 1-1299.
D. U.S. Department of Agriculture
The U.S. Department of Agriculture's (USDA) Center for Veterinary
Biologics assures that pure, safe, potent, and effective veterinary
biological products are available for the diagnosis, prevention, and
treatment of animal diseases. The program assures that biological
products are free of disease-producing agents, develops appropriate
standards and procedures for product release, issues licenses and
permits, monitors and inspects products and facilities, and controls
field tests and the release of veterinary biological products. USDA
regulations for veterinary biological products are codified at 9 CFR
parts 101-124.
Several USDA agencies regulate and monitor the use of biotechnology
for agriculture. The Animal and Plant Health Inspection Service
regulates the movement, importation, and field testing of Genetically
Engineered Organisms (GEOs) through permitting and notification
procedures. The Food Safety Inspection Service has responsibility for
the safe use of engineered domestic livestock, poultry, and products
derived from them. The Agricultural Research Service conducts in-house
research on GEOs. The Cooperative State Research, Education, and
Extension Service administers the biotechnology risk assessment program
as well as research programs in gene mapping, sequencing and
biotechnology applications. USDA regulations applicable to GEOs are at
7 CFR part 340.
E. Actions to Assure Regulatory Consistency
A number of commenters to the ANPRM urged us to work with other
federal agencies to assure that regulations applicable to the
transportation of infectious substances are compatible. We agree that
persons who offer for transportation or transport infectious substances
or genetically modified micro-organisms should not be forced to comply
with several sets of inconsistent or conflicting regulations imposed by
different federal regulatory agencies. We met with CDC to discuss its
1999 NPRM and potential areas of conflict with the HMR and
international standards. In addition, we provided CDC, USDA, FDA, and
OSHA with copies of our NPRM in advance of publication in the Federal
Register for their information and comment, and asked specifically for
potential areas of conflict between their regulations and the proposals
in this NPRM. None of these agencies identified any potentially
conflicting regulatory requirements in their informal responses to our
request. We encourage commenters to address this issue as well.
VI. Regulatory Analyses and Notices
A. Executive Order 12866 and DOT Regulatory Policies and Procedures
This proposed rule is not a significant regulatory action under
Executive Order 12866 and, therefore, was not reviewed by the Office of
Management and Budget. This proposed rule is not a significant
regulatory action under the Regulatory Policies and Procedures of the
Department of Transportation (44 FR 11034). A preliminary regulatory
evaluation that considers various regulatory alternatives is available
for review in the public docket.
The costs of these proposed regulations identified in the
regulatory evaluation are attributed to the regulation of shipments of
diagnostic specimens that include a Risk Group 2, 3 or 4 pathogen. Our
tentative estimate of costs is slightly more than $2 million per year.
Because of a lack of reliable information concerning deaths,
injuries, property damage, and other costs attributable to incidents
involving the release of an infectious substance, we are unable to
quantify potential savings that may result from these proposed rules,
if adopted as final. Affected parties and other concerned persons are
requested to provide comments on costs and/or potential benefits.
Benefits resulting from implementation of the NPRM proposals
include the following:
[[Page 6951]]
1. International harmonization: Harmonization of requirements in
the HMR with standards specified in the UN Recommendations, ICAO
Technical Instructions, IMDG Code, and TDG will remove current
inconsistencies among the regulations, thereby facilitating efficient
transportation of infectious substances across national borders. More
importantly, harmonized regulations reduce the potential for
misunderstanding and confusion and, thus, enhance safety.
2. Conversion of exemptions to regulations of general
applicability: Conversion of 29 exemptions applicable to the bulk
transportation of RMW to regulations of general applicability will
result in a slight cost savings to the 29 exemptions holders and 65
parties-to-the-exemption holders. In addition, the industry will be
able to take advantage of the added flexibility provided by the
increased number of packaging options for transporting RMW.
3. Modification of current exceptions for diagnostic specimens and
biological products: We believe that potentially infectious diagnostic
specimens and biological products should not be transported without
regard to packaging and with no communication of hazard to those who
may come into contact with them. The HMIS data base and anecdotal
information indicate that packages of these currently excepted
materials are sometimes damaged during transportation, resulting in
delays and possible risk to cargo handlers, flight crews, emergency
responders, and the general public. The proposed requirements in the
NPRM for more stringent packaging for these materials combined with the
proposed exceptions for transportation of these materials as materials
of trade or by private or contract carriers in dedicated vehicles will
assure swift and efficient transportation while reducing the risks to
transportation workers and the general public. Enhancements to
packaging would also reduce the risk of exposure for laboratory workers
opening and handling packages at the point of receipt. The minimal
level of regulation proposed for these materials would enhance overall
safety while imposing insignificant costs on the regulated industry.
4. New requirements for genetically modified micro-organisms: We
believe that genetically modified micro-organisms that have not been
approved for distribution should not be transported without regard to
packaging and communication of hazard. Thus, we are proposing new
packaging and hazard communication requirements for these currently
unregulated materials. The proposal to incorporate into the HMR
international standards applicable to genetically modified micro-
organisms will enhance transportation safety and reduce potential
adverse environmental impacts while imposing minimal requirements on
the regulated industry.
Although we cannot assign definitive dollar amounts to these
potential benefits, we believe that, taken together, the proposals are
the least costly alternatives available for ensuring an acceptable
level of transportation safety and that the potential benefits to
society more than offset the potential costs associated with this
proposed rule.
B. Executive Order 13132
This proposed rule has been analyzed in accordance with the
principles and criteria contained in Executive Order 13132
(``Federalism''). This proposed rule would preempt state, local, and
Indian tribe requirements but does not propose any regulation that has
substantial direct effects on the states, the relationship between the
national government and the states, or the distribution of power and
responsibilities among the various levels of government. Therefore, the
consultation and funding requirements of Executive Order 13132 do not
apply.
The Federal hazardous materials transportation law, 49 U.S.C. 5101-
5127, contains an express preemption provision (49 U.S.C. 5125(b)) that
preempts state, local, and Indian tribe requirements on certain covered
subjects. Covered subjects are:
(1) The designation, description, and classification of hazardous
materials;
(2) The packing, repacking, handling, labeling, marking, and
placarding of hazardous materials;
(3) The preparation, execution, and use of shipping documents
related to hazardous materials and requirements related to the number,
contents, and placement of those documents;
(4) The written notification, recording, and reporting of the
unintentional release in transportation of hazardous material; or
(5) The design, manufacture, fabrication, marking, maintenance,
recondition, repair, or testing of a packaging or container
represented, marked, certified, or sold as qualified for use in
transporting hazardous material.
This proposed rule addresses covered subject items 1-5 above and
would preempt state, local, and Indian tribe requirements not meeting
the ``substantively the same'' standard. This proposed rule is
necessary to assure an acceptable level of safety for the
transportation of infectious substances and facilitate international
transportation of these materials.
Federal hazardous materials transportation law provides at section
5125(b)(2) that, if DOT issues a regulation concerning any of the
covered subjects, DOT must determine and publish in the Federal
Register the effective date of federal preemption. The effective date
may not be earlier than the 90th day following the date of issuance of
the final rule and not later than two years after the date of issuance.
We propose that the effective date of federal preemption be one year
from publication of a final rule in the Federal Register.
C. Executive Order 13084
This proposed rule has been analyzed in accordance with the
principles and criteria contained in Executive Order 13084
(``Consultation and Coordination with Indian Tribal Governments'').
Because this proposed rule does not significantly or uniquely affect
the communities of the Indian tribal governments and does not impose
substantial direct compliance costs, the funding and consultation
requirements of Executive Order 13084 do not apply.
D. Regulatory Flexibility Act
The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) requires an
agency to review regulations to assess their impact on small entities
unless the agency determines that a rule is not expected to have a
significant impact on a substantial number of small entities. Based on
the assessment in the preliminary regulatory evaluation, I hereby
certify that while the proposed rule would apply to a substantial
number of small entities, there would not be a significant economic
impact on those small businesses. This certification is based upon a
consideration that the identified costs are randomly distributed to the
more than 441,000 establishments (offices and clinics of doctors of
medicine, dentists, doctors of osteopathy, chiropractors, optometrists,
podiatrists, and health practitioners; nursing and personal care
facilities; hospitals; and medical and dental laboratories) that
comprise Standard Industrial Classification (SIC) Major Group 80
(Health Services). The slightly more than $2 million in annual costs
attributed to this proposed rule is a mere fraction of the $300 billion
in receipts reported by the health services industry. We believe none
of those costs will be disproportionately borne by any of the
identified groups of small businesses. If your business or organization
is a small entity and if adoption of some or all of the proposed
[[Page 6952]]
provisions could have a significant economic impact on your operations,
please submit a comment to explain how and to what extent your business
or organization could be affected.
E. Paperwork Reduction Act
RSPA has current information collection approvals under OMB No.
2137-0039, Hazardous Materials Incident Reports, which expires March
31, 2002, with 33,811 burden hours and $811,221.66 annual costs; and
OMB No. 2137-0557, Approvals for Hazardous Materials, which expires
August 31, 2003, with 180,302 burden hours and $413,737.40 annual
costs. We believe that this proposed rule may result in an increase in
annual burden hours and costs. If these proposals are finalized, the
current approvals would be required to be revised and resubmitted to
OMB for extension and re-approval.
Section 1320.8(d), Title 5, Code of Federal Regulations requires
RSPA to provide interested members of the public and affected agencies
an opportunity to comment on information collection and recordkeeping
requests. This notice identifies information collections that we may
submit to OMB for extension and re-approval based on the requirements
in this proposed rule. We have revised burden estimates, where
appropriate, to reflect current reporting levels or adjustments based
on changes in this proposed rule since the information collection was
last approved. We estimate that the total information collection and
recordkeeping burden as proposed in this rule would be revised as
follows:
OMB No.: 2137-0039.
Total Annual Responses: 22,900.
Total Annual Burden Hours: 34,441.
Total Annual Burden Cost: $825,621.66.
OMB No.: 2137-0557.
Number of Respondents: 3,523.
Total Annual Responses: 3,875.
Total Annual Burden Hours: 18,405.
Total Annual Burden Cost: $415,237.40.
We specifically request comments on the information collection and
recordkeeping burdens associated with developing, implementing, and
maintaining these requirements for approval under this proposed rule.
Requests for a copy of the information collection should be
directed to Deborah Boothe, Office of Hazardous Materials Standards
(DHM-10), Research and Special Programs Administration, Room 8102, 400
Seventh Street, SW., Washington, DC 20590-0001, Telephone (202) 366-
8553.
Written comments should be addressed to the Dockets Unit as
identified in the ADDRESSES section of this rulemaking. Comments should
be received prior to the close of the comment period identified in the
DATES section of this rulemaking. Under the Paperwork Reduction Act of
1995, no person is required to respond to an information collection
unless it displays a valid OMB control number. If these proposed
requirements are adopted in a final rule, RSPA will submit the revised
information collection and recordkeeping requirements to the Office of
Management and Budget for approval.
F. Regulation Identifier Number (RIN)
A regulation identifier number (RIN) is assigned to each regulatory
action listed in the Unified Agenda of Federal Regulations. The
Regulatory Information Service Center publishes the Unified Agenda in
April and October of each year. The RIN contained in the heading of
this document can be used to cross-reference this action with the
Unified Agenda.
G. Unfunded Mandates Reform Act
This NPRM imposes no mandates and thus does not impose unfunded
mandates under the Unfunded Mandates Reform Act of 1995.
H. Environmental Assessment
We find that there are no significant environmental impacts
associated with this proposed rule. An environmental assessment has
been placed in the public docket for this rulemaking.
List of Subjects
49 CFR Part 171
Exports, Hazardous materials transportation, Hazardous waste,
Imports, Reporting and recordkeeping requirements.
49 CFR Part 172
Education, Hazardous materials transportation, Hazardous waste,
Labeling, Markings, Packaging and containers, Reporting and
recordkeeping requirements.
49 CFR Part 173
Hazardous materials transportation, Packaging and containers,
Radioactive materials, Reporting and recordkeeping requirements.
49 CFR Part 177
Hazardous materials transportation, Motor carriers, Radioactive
materials, Reporting and recordkeeping requirements.
49 CFR Part 178
Hazardous materials transportation, Motor vehicle safety, Packaging
and containers, Reporting and recordkeeping requirements.
In consideration of the foregoing, we propose to amend 49 CFR parts
171, 172, 173, 177, and 178 as follows:
PART 171--GENERAL INFORMATION, REGULATIONS, AND DEFINITIONS
1. The authority citation for part 171 would continue to read as
follows:
Authority: 49 U.S.C. 5101-5127; 49 CFR part 1.
2. In Sec. 171.7, in the table in paragraph (a)(3), two new entries
would be added in alphanumeric sequence under the American Society for
Testing and Materials, to read as follows:
Sec. 171.7 Reference material.
(a) * * *
(3) Table of material incorporated by reference. * * *
------------------------------------------------------------------------
49 CFR
Source and name of material reference
------------------------------------------------------------------------
* * * * * * *
American Society for Testing and Materials
* * * * * * *
ASTM D 1709-97 Standard Test Methods for Impact 173.197
Resistance of Plastic Film by the Free-Falling Dart
Method, 1997 Edition..................................
* * * * * * *
ASTM D 1922-94A Standard Test Method for Propagation 173.197
Tear Resistance of Plastic Film and Thin Sheeting by
Pendulum Method, 1994 edition.........................
* * * * * * *
------------------------------------------------------------------------
[[Page 6953]]
* * * * *
3. Section 171.8 would be amended by adding the following
definitions in alphabetical order to read as follows:
Sec. 171.8 Definition and abbreviations.
* * * * *
Biological product. See Sec. 173.134 of this subchapter.
* * * * *
Cultures and stocks. See Sec. 173.134 of this subchapter.
* * * * *
Diagnostic specimen. See Sec. 173.134 of this subchapter.
* * * * *
Genetically modified micro-organism. See Sec. 173.140 of this
subchapter.
* * * * *
Risk group. See Sec. 173.134 of this subchapter.
* * * * *
Sharps. See Sec. 173.134 of this subchapter.
* * * * *
Toxin. See Sec. 173.134 of this subchapter.
* * * * *
4. Section 171.14 would be amended by adding paragraph (f) to read
as follows:
Sec. 171.14 Transitional provisions for implementing certain
requirements.
* * * * *
(f) Division 6.2 labels that conform to specifications in
Sec. 172.432 of this subchapter in effect on October 1, 2000, may be
used until [two years from the effective date of final rule].
Sec. 171.15 [Amended]
5. In Sec. 171.15, the following changes would be made:
a. Paragraph (a)(3) would be amended by removing the term
``(etiologic agents)''.
b. Paragraph (b) introductory text would be amended by removing the
term ``etiologic agents'' and in its place adding the term ``infectious
substances''.
c. Paragraph (b) introductory text would be amended by adding the
wording ``; however, a written report is still required as stated in
paragraph (c) of this section'' immediately after the number ``202-267-
2675''.
PART 172--HAZARDOUS MATERIALS TABLE, SPECIAL PROVISIONS, HAZARDOUS
MATERIALS COMMUNICATIONS, EMERGENCY RESPONSE INFORMATION, AND
TRAINING REQUIREMENTS
6. The authority citation for part 172 would continue to read as
follows:
Authority: 49 U.S.C. 5101-5127; 49 CFR 1.53.
7. In Sec. 172.101, the following proper shipping names would be
added, in alphabetical order, or revised in the Hazardous Materials
Table to read as follows:
Sec. 172.101 Purpose and use of hazardous materials table.
* * * * *
Sec. 172.101.--Hazardous Materials Table
--------------------------------------------------------------------------------------------------------------------------------------------------------
(8) Packaging (Sec. 173.* (9) Quantity (10) Vessel
Hazardous * *) limitations stowage
materials Hazard ---------------------------------------------------------------------
Symbols descriptions class or Identification PG Label Special Cargo
and proper division Numbers codes provisions Non- Passenger air-
shipping names Exceptions bulk Bulk aircraft/ craft Location Other
rail only
(1) (2)............ (3) (4) (5) (6) (7) (8A) (8B) (8C) (9A) (9B) (10A) (10B)
--------------------------------------------------------------------------------------------------------------------------------------------------------
[ADD]
Diagnostic 6.2 ........ A82 134 199 None 4L or 4kg 4L or A 40
specimen. 4kg
* * * * * * *
Genetically 9 UN3245 ........ 9 .......... 140 200 None No Limit No Limit A 40
modified micro-
organisms.
* * * * * * *
G Toxins, liquid, 6.1 UN3172 I 6.1 141 201 243 1 L 30 L B 40
extracted from II 202 243 5 L 60 L B 40
living sources III 153 203 241 60 L 220 L A 40
n.o.s.
G Toxins, solid, 6.1 UN3172 I 6.1 141 211 243 5 kg 50 kg B
extracted from II 212 243 25 kg 100kg B
living sources III 153 213 241 100 kg 200kg A
n.o.s.
* * * * * * *
[REVISE]
G Infectious 6.2 UN2900 6.2 A81, A82 134 196 None 50 ml or 4L or B 40
substances, 50 g 4kg
affecting
animals only.
G Infectious 6.2 UN2814 6.2 A81, A82 134 196 None 50 ml or 4L or B 40
substances, 50 g 4kg
affecting
humans.
* * * * * * *
Regulated 6.2 UN3291 II 6.2 A13 134, 197 197 197 No Limit No Limit A 40
medical waste.
* * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 6954]]
* * * * *
8. In Sec. 172.102, in paragraph (c)(1), Special provision 141
would be added, and in paragraph (c)(2), Special Provision A13 would be
revised, Special provision A14 would be removed, and Special Provisions
A81 and A82 would be added in alphanumeric order to read as follows:
Sec. 172.102 Special provisions.
* * * * *
(c) * * *
(1) * * *
Code/Special Provisions
* * * * *
141 A toxin from a plant, animal or bacterial source that
contains an infectious substance, or a toxin that is contained in an
infectious substance, must be classed as Division 6.2 and assigned
to UN 2814 or UN 2900, as appropriate.
(2) * * *
Code/Special Provisions
* * * * *
A13 Bulk packagings are not authorized for transportation by
aircraft.
* * * * *
A81 The quantity limits in columns (9A) and (9B) do not apply
to blood or blood products known to contain or suspected of
containing an infectious substance when transported in primary
receptacles not exceeding 500 ml (17 ounces) and in outer packagings
not exceeding 4 L (1 gallon) and packaged in accordance with
Sec. 173.196 of this subchapter. A82 The quantity limits in columns
(9A) and (9B) do not apply to human or animal body parts, whole
organs or whole bodies known to contain or suspected of containing
an infectious substance.
* * * * *
9. A new Sec. 172.323 would be added to read as follows:
Sec. 172.323 Infectious substances.
(a) In addition to any identification number required by this
subpart, a bulk packaging containing a regulated medical waste, as
defined in Sec. 173.134(a)(5) of this subchapter, must be marked with a
BIOHAZARD marking that conforms to 29 CFR 1910.1030(g)(1)(i)--
(1) On two opposing sides or two ends other than the bottom if the
packaging has a capacity of less than 3,785 L (1,000 gallons). The
BIOHAZARD marking must measure at least 273 mm (10.8 inches) on each
side and must be visible from the direction it faces.
(2) On each end and each side if the packaging has a capacity of
3,785 L (1,000 gallons) or more. The BIOHAZARD marking must measure at
least 273 mm (10.8 inches) on each side and must be visible from the
direction it faces.
(b) For a bulk packaging contained in or on a transport vehicle or
freight container, if the BIOHAZARD marking on the bulk packaging is
not visible, the transport vehicle or freight container must be marked
as required by paragraph (a) of this section on each side and each end.
10. In Sec. 172.432, the illustration in paragraph (a) would be
revised to read as follows:
Sec. 172.432 INFECTIOUS SUBSTANCE label.
(a) * * *
* * * * *
BILLING CODE 4910-60-P
[[Page 6955]]
[GRAPHIC] [TIFF OMITTED] TP22JA01.166
* * * * *
PART 173--SHIPPERS--GENERAL REQUIREMENTS FOR SHIPMENTS AND
PACKAGINGS
11. The authority citation for part 173 would continue to read as
follows:
Authority: 49 U.S.C. 5101-5127, 44701; 49 CFR 1.45, 1.53.
12. In Sec. 173.6, paragraph (a)(1) introductory text would be
revised, paragraph (a)(4) would be redesignated as paragraph (a)(5),
and a new paragraph (a)(4) would be added to read as follows:
Sec. 173.6 Materials of trade exceptions.
* * * * *
(a) * * *
(1) A Class 3, 8, 9, Division 4.1, 5.1, 5.2, 6.1, 6.2, or ORM-D
material contained in a packaging having a gross mass or capacity not
over--
* * * * *
(4)(i) A Division 6.2 material, other than a Risk Group 4 material,
that is a diagnostic specimen, biological product or regulated medical
waste. The material must be contained in a combination packaging
consisting of--
(A) One or more inner packagings where the gross mass or capacity
of each inner packaging does not exceed 0.5 kg (1.1 pound), or 0.5 L
(17 ounces), and an outer packaging having a gross mass or capacity not
exceeding 4 kg (8.8 pounds) or 4 L (1 gallon); or
(B) A single inner packaging with a gross mass or capacity not
exceeding 16 kg (35.2 pounds) or 16 L (4.2 gallons) in a single outer
packaging.
(ii) Regulated medical waste may be packaged in a combination
packaging consisting of inner packagings having a gross mass or
capacity not exceeding 4 kg (8.8 pounds) or 4 L (1 gallon), and an
outer packaging having a gross mass or capacity not exceeding 16 kg
(35.2 pounds) or 16 L (4.2 gallons). Packagings intended to contain
sharps must be resistant to puncture and leak resistant.
* * * * *
13. Section 173.28 would be amended by adding paragraph (f) to read
as follows:
Sec. 173.28 Reuse, reconditioning and remanufacture of packagings.
* * * * *
(f) A Division 6.2 packaging that is to be reused must be
decontaminated prior to reuse by any means that is effective for
neutralizing the infectious substance the packaging previously
contained. A secondary packaging or outer packaging that conforms to
the requirements of Sec. 173.196 or Sec. 173.199 need not be
decontaminated prior to reuse if no leakage from the primary receptacle
has occurred.
14. Section 173.134 would be revised to read as follows:
[[Page 6956]]
Sec. 173.134 Class 6, Division 6.2--Definitions and exceptions.
(a) Definitions and classification criteria. For the purpose of
this subchapter, the following definitions and classification criteria
apply:
(1) Division 6.2 (infectious substance) means a material known to
contain or suspected of containing a pathogen that has the potential to
cause disease when exposure to it occurs. Pathogens are micro-organisms
(including bacteria, viruses, rickettsia, parasites, and fungi) or
recombinant micro-organisms (hybrid or mutant) that cause infectious
disease in humans or animals. A Division 6.2 material must be assigned
to a risk group in accordance with this paragraph (a). Assignment to UN
2814 or UN 2900 is based on known medical condition and history of the
source patient or animal, endemic local conditions, symptoms of the
source patient or animal, or professional judgement concerning
individual circumstances of the source patient or animal.
(2) Biological product means:
(i) A Division 6.2 material that is derived from a living organism
that includes, but is not limited to, materials manufactured and
distributed in accordance with one of the following provisions:
(A) 9 CFR part 102 (Licenses for Biological Products);
(B) 9 CFR part 103 (Experimental Products, Distribution, and
Evaluation of Biological Products Prior to Licensing);
(C) 9 CFR part 104 (Permits for Biological Products);
(D) 21 CFR part 312 (Investigational New Drug Application); or
(E) 21 CFR parts 600 to 680 (Biologics).
(ii) A biological product is used for prevention, treatment, or
diagnosis of disease in humans or animals, or for developmental,
experimental, or investigational purposes related to these uses. This
term includes a finished product such as a vaccine or an unfinished
product intended for further processing into a finished product;
however, it does not include a diagnostic specimen. Biological products
known to contain or suspected of containing a pathogen in Risk Group 2,
3, or 4 must be classed as Division 6.2 and described under UN 2814 or
UN 2900, as appropriate, unless otherwise excepted.
(3) Cultures and stocks means a material that is prepared and
maintained for growth and storage and that contains a Risk Group 2, 3
or 4 infectious substance.
(4) Diagnostic specimen means any human or animal material,
including excreta, secreta, blood and its components, tissue, and
tissue fluids being transported for diagnostic or investigational
purposes, but excluding live infected humans or animals. A diagnostic
specimen is not assigned a UN identification number unless the source
patient or animal has or may have a serious human or animal disease
from a Risk Group 4 micro-organism, in which case it must be assigned
to UN 2814 or UN 2900, as appropriate. Assignment to UN 2814 or UN 2900
is based on known medical condition and history of the patient or
animal, endemic local conditions, symptoms of the source patient or
animal, or professional judgement concerning individual circumstances
of the source patient or animal.
(5) Regulated medical waste means a waste or reusable material that
contains or is suspected of containing an infectious substance in Risk
Group 2 or 3 and is generated in the diagnosis, treatment, or
immunization of human beings or animals; research on the diagnosis,
treatment or immunization of human beings or animals; or the production
or testing of biological products. Regulated medical waste containing
an infectious substance in Risk Group 4 must be classed as Division 6.2
and described under UN 2814 or UN 2900, as appropriate.
(6) Risk group means a ranking of a micro-organism's ability to
cause injury through disease. A risk group is defined by criteria
developed by the World Health Organization (WHO) based on the
pathogenicity of the organism, the mode and relative ease of
transmission, the degree of risk to both an individual and a community,
and the reversibility of the disease through the availability of known
and effective preventative agents and treatment. There is no
relationship between a risk group and a packing group. The criteria for
each risk group according to the level of risk are as follows:
Risk Group Table
----------------------------------------------------------------------------------------------------------------
Risk group Pathogen Risk to individuals Risk to the community
----------------------------------------------------------------------------------------------------------------
4.................. A pathogen that usually causes serious HIGH HIGH
human or animal disease and that can
be readily transmitted from one
individual to another, directly or
indirectly, and for which effective
treatments and preventive measures are
not usually available.
3.................. A pathogen that usually causes serious HIGH LOW
human or animal disease but does not
ordinarily spread from one infected
individual to another, and for which
effective treatments and preventive
measures are available.
2.................. A pathogen that can cause human or MODERATE LOW
animal disease but is unlikely to be a
serious hazard, and, while capable of
causing serious infection on exposure,
for which there are effective
treatments and preventive measures
available and the risk of spread of
infection is limited.
1.................. A micro-organism that is unlikely to NONE OR VERY LOW NONE OR VERY LOW
cause human or animal disease. A
material containing only such micro-
organisms is not subject to the
requirements of this subchapter.
----------------------------------------------------------------------------------------------------------------
(7) Sharps means any object that may be contaminated with a
pathogen that is also capable of cutting or penetrating skin or a
packaging material. The term includes needles, scalpels, broken glass,
culture slides, culture dishes, broken capillary tubes, broken rigid
plastic, and exposed ends of dental wires.
(8) Toxin means a Division 6.1 material secreted from a plant,
animal, or bacterial source. A toxin that contains an infectious
substance or a toxin that is contained in an infectious substance must
be classed as Division 6.2 and described under UN 2814 or UN 2900, as
appropriate.
(b) Exceptions. The following are not subject to the requirements
of this subchapter as Division 6.2 materials:
(1) Biological products that are known to contain or suspected of
containing a pathogen in Risk Group 1, or that do not contain a
pathogen.
(2) Biological products that have successfully completed all
applicable
[[Page 6957]]
federal approval or licensing requirements, such as those required by
the Food and Drug Administration of the Department of Health and Human
Services or the U.S. Department of Agriculture.
(3) Blood that has been collected for the purpose of blood
transfusion or for the preparation of blood products, and blood
products, tissues, or organs intended for use in transplant operations.
(4) A diagnostic specimen or biological product when transported by
a private or contract carrier in a motor vehicle used exclusively to
transport diagnostic specimens or biological products. Medical or
clinical equipment and laboratory products may be transported aboard
the same vehicle provided they are properly packaged and secured
against exposure/contamination to the diagnostic specimen. If a
diagnostic specimen or biological product meets the definition of
regulated medical waste in paragraph (a)(5) of this section, it must be
offered for transportation and transported in conformance with the
appropriate requirements for regulated medical waste.
(5) Laundry or medical equipment that conforms to the regulations
of the Occupational Safety and Health Administration of the Department
of Labor in 29 CFR 1910.1030. This exception includes medical equipment
that is intended for use, cleaning, or refurbishment, such as reusable
surgical equipment, or equipment used for testing where the components
within which the equipment is contained essentially function as
packaging. This exception does not apply to medical equipment that is
being transported for disposal.
(6) A material, including waste, that previously contained an
infectious substance that has been treated by steam sterilization,
chemical disinfection, or other appropriate method, so that it no
longer meets the definition of an infectious substance.
(7) A living person.
(8) Any waste or recyclable material, other than regulated medical
waste, including--
(i) Garbage and trash derived from hotels, motels, and households,
including but not limited to single and multiple residences;
(ii) Sanitary waste or sewage;
(iii) Sewage sludge or compost;
(iv) Animal waste generated in animal husbandry or food production;
or
(v) Medical waste generated from households and transported in
accordance with applicable state, local, or tribal requirements.
(9) Corpses, remains, and anatomical parts that are intended for
interment, cremation, or medical research at a college, hospital, or
laboratory.
(10) Forensic material that is transported on behalf of a U.S.
Government, state, local or Indian tribal government agency. The
material must be shipped in a packaging conforming to the provisions of
Sec. 173.24.
(c) Exceptions for regulated medical waste. The following
provisions apply to the transportation of regulated medical waste:
(1) A regulated medical waste that is transported by a private or
contract carrier is excepted from--
(i) The requirement for an ``INFECTIOUS SUBSTANCE'' label if the
outer packaging is marked with a ``BIOHAZARD'' marking in accordance
with 29 CFR 1910.1030; and
(ii) For other than a waste culture or stock of an infectious
substance, the specific packaging requirements of this section if
packaged in a rigid non-bulk packaging conforming to the general
packaging requirements of Secs. 173.24 and 173.24a and packaging
requirements specified in 29 CFR 1910.1030.
(2) A waste culture or stock of a Risk Group 2 or 3 infectious
substance may be offered for transportation and transported as a
regulated medical waste when it is packaged in a rigid non-bulk
packaging conforming to the general packaging requirements of
Secs. 173.24 and 173.24a and packaging requirements specified in 29 CFR
1910.1030 and transported by a private or contract carrier using a
vehicle dedicated to the transportation of regulated medical waste.
(d) If an item listed in paragraph (b) or (c) of this section meets
the definition of another hazard class or if it is a hazardous
substance, hazardous waste, or marine pollutant, it must be offered for
transportation and transported in accordance with applicable
requirements of this subchapter.
15. Section 173.140 would be amended by removing ``; or'' at the
end of paragraph (a) and adding a period in its place and by adding
paragraphs (c) and (d) to read as follows:
Sec. 173.140 Class 9-Definitions.
* * * * *
(c) Genetically modified micro-organism. A genetically modified
micro-organism is a micro-organism that has been purposely altered
through genetic engineering in a way that does not occur naturally.
(1) A Class 9 genetically modified micro-organism does not meet the
definition of a Division 6.2 material, but has the potential to alter
animals, plants or microbiological substances in a way not normally the
result of natural reproduction.
(2) A genetically modified micro-organism that also meets the
definition for a Division 6.2 material must be classed as a Division
6.2 material.
(3) A live animal that contains, or is contaminated with, a
genetically modified micro-organism, including a genetically modified
micro-organism that also meets the definition of a Division 6.2
material, must be transported under terms and conditions approved by
the Associate Administrator for Hazardous Materials Safety.
(4) A genetically modified micro-organism known or suspected to be
dangerous to the environment may not be transported by air unless
approved by the Associate Administrator for Hazardous Materials Safety.
(d) Exceptions for genetically modified micro-organisms. (1) A
genetically modified micro-organism that is authorized by a U.S.
Government agency for final distribution and use is not subject to
requirements of this subchapter.
(2) A genetically modified micro-organism is excepted from all
other requirements of this subchapter when transported in a non-
passenger carrying transport vehicle operated by a private or contract
motor carrier. The material must be packaged in accordance with the
provisions in Sec. 173.203 or Sec. 173.213 at the Packing Group III
performance level, and marked with the proper shipping name
``Genetically modified micro-organism''. Each person who offers or
transports a genetically modified micro-organism under the provisions
of this paragraph (d) must be informed of the requirements of this
paragraph (d).
16. Section 173.196 would be revised to read as follows:
Sec. 173.196 Infectious substances.
(a) Division 6.2 packaging. A Division 6.2 packaging must meet the
test standards of Sec. 178.609 of this subchapter and must be marked in
conformance with Sec. 178.503(f) of this subchapter. Division 6.2
packaging is a triple packaging that consists of the following
components:
(1) A watertight primary receptacle.
(2) A watertight secondary packaging. If multiple primary
receptacles are placed in a single secondary packaging, they must be
wrapped individually to prevent contact between them.
(3) An outer packaging of adequate strength for its capacity, mass
and intended use. The outer packaging must
[[Page 6958]]
measure at least 100 mm (3.9 inches) at its smallest overall external
dimension.
(4) For a liquid infectious substance, an absorbent material placed
between the primary receptacle and the secondary packaging. The
absorbent material must be sufficient to absorb the entire contents of
all primary receptacles.
(5) An itemized list of contents enclosed between the secondary
packaging and the outer packaging.
(6) The primary receptacle or secondary packaging used for
infectious substances must be capable of withstanding, without leakage,
an internal pressure that produces a pressure differential of not less
than 95 kPa (0.95 bar, 14 psi) and temperatures in the range of -40
deg.C to +55 deg.C (-40 deg.F to +131 deg.F).
(b) Additional requirements for packaging infectious substances.
Infectious substances must be packaged according to the following
requirements depending on the physical state and other characteristics
of the material:
(1) Infectious lyophilized substances. Primary receptacles must be
flame-sealed glass ampules or rubber-stopped glass vials fitted with
metal seals.
(2) Liquid or solid infectious substances--(i) Infectious
substances shipped at ambient temperatures or higher. Authorized
primary receptacles are those of glass, metal, or plastic. Positive
means of ensuring a leakproof seal, such as heat seal, skirted stopper,
or metal crimp seal, must be provided. If screw caps are used, they
must be secured by positive means, such as with adhesive tape.
(ii) Infectious substances shipped refrigerated or frozen (ice,
pre-frozen packs, dry ice). Ice or dry ice must be placed outside the
secondary packagings or in an overpack with one or more complete
packages marked in accordance with Sec. 178.503 of this subchapter.
Interior supports must be provided to secure the secondary packagings
in the original position after the ice or dry ice has dissipated. If
ice is used, the outside packaging must be leakproof. If dry ice is
used, the outside packaging must permit the release of carbon dioxide
gas and otherwise meet the provisions in Sec. 173.217. The primary
receptacle and the secondary packaging must maintain their integrity at
the temperature of the refrigerant used as well as the temperatures and
pressures of air transport to which they could be subjected if
refrigeration were lost.
(iii) Infectious substances shipped in liquid nitrogen. Primary
receptacles capable of withstanding very low temperatures must be used.
Secondary packaging must withstand very low temperatures and in most
cases will need to be fitted over individual primary receptacles. The
primary receptacle and the secondary packaging must maintain their
integrity at the temperature of the liquid nitrogen as well as the
temperatures and pressures of air transport to which they could be
subjected if refrigeration were to be lost. Refrigerated liquid
nitrogen packagings must be metal vacuum insulated vessels or flasks
(also called ``dry shippers'') vented to the atmosphere to prevent any
increase in pressure within the packaging. The use of safety relief
valves, check valves, frangible discs, or similar devices in the vent
lines is prohibited. Fill and discharge openings must be protected
against the entry of foreign materials that might cause an increase in
the internal pressure. The package orientation markings specified in
Sec. 172.312(b) of this subchapter must be marked on the packaging. The
packaging must be designed to prevent the release of any refrigerated
liquid nitrogen irrespective of the packaging orientation.
(c) Live animals may not be used to transport infectious substances
unless such substances cannot be sent by any other means. An animal
that contains or is contaminated with an infectious substance must be
transported under terms and conditions approved by the Associate
Administrator for Hazardous Materials Safety.
(d) Body parts, organs or whole bodies meeting the definition of
Division 6.2 material must be packaged as follows:
(1) In Division 6.2 packaging, as specified in paragraphs (a) and
(b) of this section; or
(2) In packaging that meets the requirements of Sec. 173.197(a).
17. Section 173.197 would be revised to read as follows:
Sec. 173.197 Regulated medical waste.
(a) General provisions. Non-bulk and bulk packagings used for the
transportation of regulated medical waste must be rigid containers that
meet the provisions of subpart B of this part. The packaging must be
puncture-resistant for sharps and sharps with residual fluid as
demonstrated by conducting the performance tests in part 178, subpart
M, of this subchapter on packagings containing materials representative
of the sharps and fluids (such as sterile sharps) that are intended to
be transported in the packagings.
(b) Non-bulk packagings. Except as otherwise provided in this
subchapter, non-bulk packagings for regulated medical waste must
conform to the requirements of part 178 of this subchapter at the
Packing Group II performance level.
(c) Large packagings. Large Packagings constructed, tested, and
marked in accordance with the requirements of the UN Recommendations
and conforming to other requirements of this paragraph (c) may be used
for the transportation of regulated medical waste, provided that the
inner packagings conform to the requirements of paragraph (e) of this
section. Each Large Packaging must be capable of meeting the vibration
test specified in Sec. 178.819 of this subchapter. Each Large Packaging
is subject to the periodic design requalification requirements for
intermediate bulk containers in Sec. 178.801(e) of this subchapter and
to the proof of compliance requirements of Sec. 178.801(j) and record
retention requirements of Sec. 178.801(l) of this subchapter. Inner
packagings used for liquids must be rigid.
(1) Authorized packagings. The following Large Packagings are
authorized for the transportation of liquid or solid regulated medical
waste:
(i) Metal: 50A, 50B, or 50N.
(ii) Rigid plastic: 50H.
(2) Additional requirements. Each Large Packaging used to transport
liquid regulated medical waste must contain absorbent material in
sufficient quantity and appropriate location to absorb the entire
amount of liquid present in the event of an unintentional release of
contents. Each Large Packaging intended for the transportation of
sharps containers must be puncture resistant and capable of retaining
liquids and must meet the performance tests specified for intermediate
bulk containers intended for the transportation of liquids in subpart O
of part 178 of this subchapter.
(d) Non-specification bulk packaging. A wheeled cart (CART) or bulk
outer packaging (BOP) is authorized as an outer packaging for the
transportation of regulated medical waste in accordance with the
provisions of this paragraph (d).
(1) General requirements. The following requirements apply to the
transportation of regulated medical waste in CARTs or BOPs:
(i) Each CART or BOP must have non-bulk inner packagings that
conform to paragraph (e) of this section.
(ii) Each CART or BOP must have interior surfaces that are smooth,
non-porous, and free of cracks, crevices, and other defects that could
damage inner packagings or impede decontamination operations.
(iii) Except as otherwise provided in this paragraph (d), each CART
or BOP
[[Page 6959]]
must be used exclusively for the transportation of regulated medical
waste. Prior to reuse, each CART or BOP must be decontaminated by any
means that is effective for neutralizing the infectious substance the
packaging previously contained.
(iv) Untreated cultures and stocks of infectious substances that
contain Risk Group 4 materials may not be transported in a CART or BOP.
(v) Division 6.1 toxic waste or Class 7 radioactive waste, with the
exception of materials that are chemotherapeutic waste, may not be
transported in a CART or BOP.
(vi) Division 6.1 or Class 7 chemotherapeutic waste; untreated
stocks and cultures of infectious substances that contain Risk Group 2
or 3 pathogenic organisms; unabsorbed liquids; and sharps containers
may be transported in a CART or BOP only if packaged in rigid non-bulk
packagings that conform to paragraph (a) of this section.
(2) Wheeled cart (CART). A CART is authorized as an outer packaging
for the transportation of regulated medical waste if it conforms to the
following requirements:
(i) Each CART must consist of a solid, one-piece body, mounted on a
minimum of four (4) fixed wheels, with a nominal volume that does not
exceed 1,655 liters (437 gallons).
(ii) Each CART must be constructed of metal, rigid plastic, or
fiberglass with a hinged and gasketed lid that, when closed, prevents
leakage during transport.
(iii) Each CART must be capable of meeting the requirements of
Sec. 178.603 (drop test), as specified for solids at the Packing Group
II performance level.
(iv) Inner packagings must be placed into a CART and restrained in
such a manner as to minimize the risk of breakage.
(3) Bulk outer packaging (BOP). A BOP is authorized as an outer
packaging for regulated medical waste if it conforms to the following
requirements:
(i) Each BOP must be constructed of metal or fiberglass and have a
capacity of at least 3.5 cubic meters (123.6 cubic feet) and not more
than 45 cubic meters (1,590 cubic feet).
(ii) Each BOP must have bottom and side joints of fully welded or
seamless construction and a rigid, weatherproof top that prevents the
intrusion of water (e.g., rain or snow).
(iii) Each opening in a BOP must be fitted with a closure that
prevents the intrusion of water or the release of any liquid during all
loading, unloading, and transportation operations.
(iv) In the upright position, each BOP must be leakproof and able
to contain a liquid quantity of at least 300 liters (79.2 gallons) with
closures open.
(v) Inner packagings must be placed in a BOP in such a manner as to
minimize the risk of breakage. Rigid inner packagings may not be placed
in the same BOP with plastic film bag inner packagings unless separated
from each other by rigid barriers or dividers that prevent damage to
the packagings caused by load shifting during normal conditions of
transportation.
(vi) Division 6.1 or Class 7 chemotherapeutic waste, untreated
cultures and stocks of infectious substances that contain Risk Group 2
or 3 pathogenic organisms, unabsorbed liquids, and sharps may be
transported in a BOP only if separated and secured as provided by
paragraph (d)(3)(v) of this section.
(e) Inner packagings authorized for Large Packagings, CARTs, and
BOPs. Inner packagings must be durably marked or tagged with the name
and location (city and state) of the offeror, except when the entire
contents of the Large Packaging, CART, or BOP originates at a single
location and is delivered to a single location.
(1) Solids. A plastic film bag is authorized as an inner packaging
for solid regulated medical waste transported in a CART, Large
Packaging, or BOP. Waste material containing absorbed liquid may be
packaged as a solid in a plastic film bag if the bag contains
sufficient absorbent material to absorb and retain all liquid during
transportation.
(i) The film bag may not exceed a volume of 175 L (46 gallons). The
film bag must be marked and certified by its manufacturer as having
passed the tests prescribed for tear resistance in ASTM D 1709-97,
Standard Test Methods for Impact Resistance of Plastic Film by the
Free-Falling Dart Method, 1997 Edition, and for impact resistance in
ASTM D 1922-94A, Standard Test Method for Propagation Tear Resistance
of Plastic Film and Thin Sheeting by Pendulum Method, 1994 edition. The
film bag must meet an impact resistance of 165 grams and a tearing
resistance of 480 grams in both the parallel and perpendicular planes
with respect to the length of the bag.
(ii) The plastic film bag must be closed with a minimum of
entrapped air to prevent leakage in transportation. The bag must be
capable of being held in an inverted position with the closed end at
the bottom for a period of 5 minutes without leakage.
(iii) When used as an inner packaging for CARTs or BOPs, a plastic
film bag may not weigh more than 10 kg (22 lbs.) when filled.
(2) Liquids. Liquid regulated medical waste that is transported in
a Large Packaging, CART, or BOP must be packaged in a rigid inner
packaging that conforms to the requirements of paragraph (a) of this
section. Liquid materials are not authorized for transportation in
inner packagings larger than 19 L (5 gallons).
(3) Sharps. Sharps that are transported in a Large Packaging, CART,
or BOP must be packaged in a puncture-resistant inner packaging (sharps
container). Each inner packaging may not exceed 38 L (10 gallons) in
volume.
18. A new Sec. 173.199 would be added to read as follows:
Sec. 173.199 Diagnostic specimens and used health care products.
(a) Diagnostic specimens. Diagnostic specimens are excepted from
other requirements of this subchapter when offered for transportation
or transported in accordance with this section. Diagnostic specimens
offered for transportation or transported by aircraft under the
provisions of this section are subject to the incident reporting
requirements in Secs. 171.15 and 171.16 of this subchapter. A
diagnostic specimen that meets the definition of a hazard class other
than Division 6.2 must be offered for transportation or transported in
accordance with applicable requirements of this subchapter.
(1) Diagnostic specimens must be packaged in a triple packaging,
consisting of a primary receptacle, a secondary packaging, and an outer
packaging.
(2) Primary receptacles must be packed in secondary packaging in
such a way that, under normal conditions of transport, they cannot
break, be punctured, or leak their contents into the secondary
packaging.
(3) Secondary packagings must be secured in outer packagings with
suitable cushioning material such that any leakage of the contents will
not impair the protective properties of the cushioning material or the
outer packaging.
(4) The completed package must be capable of successfully passing
the drop test in Sec. 178.603 of this subchapter at a drop height of at
least 1.2 meters (3.9 feet). Each package must be clearly and durably
marked with the words ``Diagnostic Specimen.''
(b) Liquid diagnostic specimens. Liquid diagnostic specimens must
be packaged in conformance with the following provisions:
[[Page 6960]]
(1) The primary receptacle must be leakproof with a volumetric
capacity of not more than 500 ml (16.9 ounces).
(2) Absorbent material must be placed between the primary
receptacle and secondary packaging. If several fragile primary
receptacles are placed in a single secondary packaging, they must be
individually wrapped or separated so as to prevent contact between
them. The absorbent material must be of sufficient quantity to absorb
the entire contents of the primary receptacles.
(3) The secondary packaging must be leakproof.
(4) For shipments by aircraft, the primary receptacle or the
secondary packaging must be capable of withstanding without leakage an
internal pressure producing a pressure differential of not less than 95
kPa (0.95 bar, 14 psi).
(5) The outer packaging may not exceed 4 L (1 gallon) capacity.
(c) Solid diagnostic specimens. Solid diagnostic specimens must be
packaged in a triple packaging, consisting of a primary receptacle,
secondary packaging, and outer packaging, that conforms to the
following provisions:
(1) The primary receptacle must be siftproof with a capacity of not
more than 500 g (1.1 pounds).
(2) If several fragile primary receptacles are placed in a single
secondary packaging, they must be individually wrapped or separated so
as to prevent contact between them.
(3) The secondary packaging must be siftproof.
(4) The outer packaging may not exceed 4 kg (8.8 pounds) capacity.
(d) Used health care products. Used health care products are
medical, diagnostic, or research devices and equipment, and personal
care products used by consumers, medical professionals, or
pharmaceutical providers that may be contaminated with an infectious
substance but do not meet the definition of a diagnostic specimen,
biological product, or regulated medical waste. Used health care
products being returned to the manufacturer are excepted from the
requirements of this subchapter when offered for transportation or
transported in accordance with this section. For purposes of this
section, a health care product is used when it has been removed from
its original inner packaging. Used health care products contaminated
with or suspected of contamination with a Risk Group 4 infectious
substance may not be transported under the provisions of this section.
(1) Each used health care product must be drained of free liquid to
the extent practicable and placed in a watertight metal or plastic
primary container. The primary container must be designed and
constructed in such a manner as to assure that it remains intact under
conditions normally incident to transportation. Each primary container
used to transport a used health care product that is capable of cutting
or penetrating skin or packaging material must be capable of retaining
the product without puncture of the packaging under normal conditions
of transport. Each primary container must be marked with a BIOHAZARD
marking that conforms to 29 CFR 1910.1030(g)(1)(i).
(2) Each primary container must be placed inside a watertight metal
or plastic secondary container. The secondary container must be
designed and constructed in such a manner as to assure that it remains
intact under conditions normally incident to transportation. The
secondary container must be marked with a BIOHAZARD marking that
conforms to 29 CFR 1910.1030(g)(1)(i).
(3) The secondary container must be placed inside an outer
packaging with sufficient cushioning material to prevent movement
between the secondary container and the outer packaging. An itemized
list of the contents of the primary container and information
concerning possible contamination with a Division 6.2 material,
including its possible location on the product, must be placed between
the secondary container and the outside packaging.
(e) Training. Each person who offers or transports a diagnostic
specimen or used health care product under the provisions of this
section must be informed of the requirements of this section.
19. A new Sec. 173.200 would be added to read as follows:
Sec. 173.200 Genetically modified micro-organisms.
A genetically modified micro-organism must be packaged as follows:
(a) In accordance with the provisions in Sec. 173.203 or
Sec. 173.213 for liquids or solids, respectively, at the Packing Group
III performance level; or
(b) In accordance with the provisions of Sec. 173.196(a), except
that the completed package is not subject to the test requirements in
Sec. 178.609 of this subchapter.
PART 177--CARRIAGE BY PUBLIC HIGHWAY
20. The authority citation for part 177 would continue to read as
follows:
Authority: 49 U.S.C. 5101-5127; 49 CFR 1.53.
21. In Sec. 177.834, paragraphs (a) and (g) would be revised to
read as follows:
Sec. 177.834 General requirements.
(a) Packages secured in a vehicle. Any tank, barrel, drum,
cylinder, or other packaging not permanently attached to a motor
vehicle that contains any Class 2 (gases), Class 3 (flammable liquid),
Division 6.1 (poisonous), Division 6.2 (infectious substance), Class 7
(radioactive), or Class 8 (corrosive) material must be secured against
movement within the vehicle on which it is being transported, under
conditions normally incident to transportation.
* * * * *
(g) Prevent relative motion between containers. Containers of Class
1 (explosive), Class 2 (gases), Class 3 (flammable liquid), Class 4
(flammable solid), Class 5 (oxidizing), Division 6.1 (poisonous),
Division 6.2 (infectious substance), or Class 8 (corrosive) materials
must be so braced as to prevent motion thereof relative to the vehicle
while in transit. Containers having valves or other fittings must be so
loaded that there will be the minimum likelihood of damage thereto
during transportation.
* * * * *
22. In Sec. 177.843, new paragraph (d) would be added to read as
follows:
Sec. 177.843 Contamination of vehicles.
* * * * *
(d) Each transport vehicle used to transport Division 6.2 materials
must be decontaminated prior to reuse if a Division 6.2 material is
released from its packaging during transportation. Decontamination may
be by any means that is effective for neutralizing the material
released.
PART 178--SPECIFICATIONS FOR PACKAGINGS
23. The authority citation for part 178 would continue to read as
follows:
Authority: 49 U.S.C. 5101-5127; 49 CFR 1.53.
24. In Sec. 178.503, paragraph (f) would be added to read as
follows:
Sec. 178.503 Marking of packagings.
* * * * *
(f) A manufacturer must mark every UN specification package that is
represented as manufactured to meet the requirements of Sec. 178.609
for packaging of infectious substances with the marks specified in this
section. The markings must be durable, legible, and must be readily
visible, as specified in Sec. 178.3(a). An infectious substance
packaging that
[[Page 6961]]
successfully passes the tests conforming to the UN standard must be
marked as follows:
(1) The United Nations symbol as illustrated in paragraph (e) of
this section.
(2) The code designating the type of packaging and material of
construction according to the identification codes for packagings
specified in Sec. 178.502.
(3) The text ``CLASS 6.2''.
(4) The last two digits of the year of manufacture of the
packaging.
(5) The country authorizing the allocation of the mark. The letters
``USA'' indicate that the packaging is manufactured and marked in the
United States in compliance with the provisions of this subchapter.
(6) The name and address or symbol of the manufacturer or the
approval agency certifying compliance with subparts L and M of this
part. Symbols, if used, must be registered with the Associate
Administrator for Hazardous Materials Safety.
(7) For packagings meeting the requirements of Sec. 178.609(i)(3),
the letter ``U'' must be inserted immediately following the marking
designating the type of packaging and material required in paragraph
(f)(2) of this section.
25. In Sec. 178.601, paragraphs (c)(1), (c)(2), and (e) would be
revised to read as follows:
Sec. 178.601 General requirements.
* * * * *
(c) * * *
(1) Design qualification testing is the performance of the tests
prescribed in Sec. 178.603, Sec. 178.604, Sec. 178.605, Sec. 178.606,
Sec. 178.607, Sec. 178.608, or Sec. 178.609, as applicable, for each
new or different packaging, at the start of production of that
packaging.
(2) Periodic retesting is the performance of the drop,
leakproofness, hydrostatic pressure, and stacking tests, as applicable,
as prescribed in Sec. 178.603, Sec. 178.604, Sec. 178.605, or
Sec. 178.606, respectively, at the frequency specified in paragraph (e)
of this section. For infectious substances packagings that are required
to meet the requirements of Sec. 178.609, periodic retesting is the
performance of the tests specified in Sec. 178.609 at the frequency
specified in paragraph (e) of this section.
* * * * *
(e) Periodic retesting. The packaging manufacturer must achieve
successful test results for the periodic retesting at intervals
established by the manufacturer of sufficient frequency to ensure that
each packaging produced by the manufacturer is capable of passing the
design qualification tests. Changes in retest frequency are subject to
the approval of the Associate Administrator for Hazardous Materials
Safety. For single or composite packagings, the periodic retests must
be conducted at least once every 12 months. For combination packagings,
the periodic retests must be conducted at least once every 24 months.
For infectious substances packagings, the periodic retests must be
conducted at least once every 24 months.
* * * * *
26. In Sec. 178.609, the section heading, paragraph (c) preceding
the table, the introductory text of paragraph (d)(1), paragraphs
(d)(1)(i), (d)(1)(iii), (d)(1)(iv), (e), (h)(1), (h)(2), and (i) would
be revised to read as follows:
Sec. 178.609 Test requirements for packagings for infectious
substances.
* * * * *
(c) Packagings prepared as for transport must be subjected to the
tests in Table I of this paragraph (c), which, for test purposes,
categorize packagings according to their material characteristics. For
outer packagings, the headings in Table I relate to fiberboard or
similar materials whose performance may be rapidly affected by
moisture; plastics, which may embrittle at low temperature; and other
materials, such as metal, for which performance is not significantly
affected by moisture or temperature. Where a primary receptacle and a
secondary packaging of an inner packaging are made of different
materials, the material of the primary receptacle determines the
appropriate test. In instances where a primary receptacle is made of
more than one material, the material most likely to be damaged
determines the appropriate test.
* * * * *
(d) * * *
(1) Where the samples are in the shape of a box, five must be
dropped in sequence:
(i) Flat on the base;
(ii) * * *
(iii) Flat on the longest side;
(iv) Flat on the shortest side; and * * * * *
(e) The samples must be subjected to a water spray that simulates
exposure to rainfall of approximately 50 mm (2 inches) per hour for at
least one hour. They must then be subjected to the test described in
paragraph (d) of this section.
* * * * *
(h) * * *
(1) Samples must be placed on a level, hard surface. A cylindrical
steel rod with a mass of at least 7 kg (15 pounds), a diameter not
exceeding 38 mm (1.5 inches), and, at the impact end edges, a radius
not exceeding 6 mm (0.2 inches), must be dropped in a vertical free
fall from a height of 1 m (3 feet), measured from the impact end of the
sample's impact surface. One sample must be placed on its base. A
second sample must be placed in an orientation perpendicular to that
used for the first. In each instance, the steel rod must be aimed to
impact the primary receptacle(s). There must be no leakage from the
primary receptacle(s) following each impact.
(2) Samples must be dropped onto the end of a cylindrical steel
rod. The rod must be set vertically in a level, hard surface. It must
have a diameter of 38 mm (1.5 inches) and a radius not exceeding 6 mm
(0.2 inches) at the edges of the upper end. The rod must protrude from
the surface a distance at least equal to that between the primary
receptacle(s) and the outer surface of the outer packaging with a
minimum of 200 mm (7.9 inches). One sample must be dropped in a
vertical free fall from a height of 1 m (3 feet), measured from the top
of the steel rod. A second sample must be dropped from the same height
in an orientation perpendicular to that used for the first. In each
instance, the packaging must be oriented so that the steel rod will
impact the primary receptacle(s). There must be no leakage from the
primary receptacle(s) following each impact.
(i) Variations. The following variations in the primary receptacles
placed within the secondary packaging are allowed without additional
testing of the completed package. An equivalent level of performance
must be maintained.
(1) Variation 1. Primary receptacles of equivalent or smaller size
as compared to the tested primary receptacles may be used provided they
meet all of the following conditions:
(i) The primary receptacles are of similar design to the tested
primary receptacle (e.g., shape: round, rectangular, etc.).
(ii) The material of construction of the primary receptacle (glass,
plastics, metal, etc.) offers resistance to impact and a stacking force
equal to or greater than that of the originally tested primary
receptacle.
(iii) The primary receptacles have the same or smaller openings and
the closure is of similar design (e.g., screw cap, friction lid, etc.).
(iv) Sufficient additional cushioning material is used to fill void
spaces and to prevent significant movement of the primary receptacles.
[[Page 6962]]
(v) Primary receptacles are oriented within the intermediate
packaging in the same manner as in the tested package.
(2) Variation 2. A lesser number of the tested primary receptacles,
or of the alternative types of primary receptacles identified in
paragraph (i)(1) of this section, may be used provided sufficient
cushioning is added to fill the void space(s) and to prevent
significant movement of the primary receptacles.
(3) Variation 3. Primary receptacles of any type may be placed
within a secondary packaging and shipped without testing in the outer
packaging provided all of the following conditions are met:
(i) The secondary and outer packaging combination must be
successfully tested in accordance with paragraphs (a) through (h) of
this section with fragile (e.g., glass) inner receptacles.
(ii) The total combined gross weight of inner receptacles may not
exceed one-half the gross weight of inner receptacles used for the drop
test in paragraph (d) of this section.
(iii) The thickness of cushioning material between inner
receptacles and between inner receptacles and the outside of the
secondary packaging may not be reduced below the corresponding
thicknesses in the originally tested packaging. If a single inner
receptacle was used in the original test, the thickness of cushioning
between the inner receptacles must be no less than the thickness of
cushioning between the outside of the secondary packaging and the inner
receptacle in the original test. When either fewer or smaller inner
receptacles are used (as compared to the inner receptacles used in the
drop test), sufficient additional cushioning material must be used to
fill the void.
(iv) The outer packaging must pass the stacking test in
Sec. 178.606 while empty. The total weight of identical packages must
be based on the combined mass of inner receptacles used in the drop
test in paragraph (d) of this section.
(v) For inner receptacles containing liquids, an adequate quantity
of absorbent material must be present to absorb the entire liquid
contents of the inner receptacles.
(vi) If the outer packaging is intended to contain inner
receptacles for liquids and is not leakproof, or is intended to contain
inner receptacles for solids and is not sift proof, a means of
containing any liquid or solid contents in the event of leakage must be
provided. This can be a leakproof liner, plastic bag, or other equally
effective means of containment.
(vii) In addition, the marking required in Sec. 178.503(f) of this
subchapter must be followed by the letter ``U''.
Issued in Washington, D.C., on December 27, 2000, under
authority delegated in 49 CFR part 106.
Robert A. McGuire,
Associate Administrator for Hazardous Materials Safety, Research and
Special Programs Administration.
[FR Doc. 01-92 Filed 1-19-01; 8:45 am]
BILLING CODE 4910-60-P
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