[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
[[Page
6943]]
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
[[Page
6944]]
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
[[Page
6945]]
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
[[Page
6946]]
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
[[Page
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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
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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