[Federal Register Volume 63, Number 170 (Wednesday, September 2, 1998)]
[Proposed Rules]
[Pages 46844-46859]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-23665]
[[Page 46843]]
_______________________________________________________________________
Part IV
Department of Transportation
_______________________________________________________________________
Research and Special Programs Administration
_______________________________________________________________________
49 CFR Part 171, et al.
Hazardous Materials: Revision to Standards for Infectious Substances
and Genetically Modified Micro-organisms; Proposed Rule
Federal Register / Vol. 63, No. 170 / Wednesday, September 2, 1998 /
Proposed Rules
[[Page 46844]]
DEPARTMENT OF TRANSPORTATION
Research and Special Programs Administration
49 CFR Parts 171, 172, 173, 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: Advance notice of proposed rulemaking (ANPRM); notice of public
meeting.
-----------------------------------------------------------------------
SUMMARY: RSPA is considering revising the requirements for infectious
substances, including regulated medical waste (RMW) to: adopt defining
criteria, hazard communication and packaging requirements for Division
6.2 materials consistent with international standards; revise broad
exceptions for diagnostic specimens and biological products; provide
additional packagings for RMW; and make other changes to improve and
clarify regulatory requirements and exceptions. These proposals are
intended to ensure an acceptable level of safety in the transport of
infectious substances, facilitate international transportation and make
it easier to understand and comply with the regulations.
In order to enhance the opportunity to provide comments to RSPA
concerning this notice, the public is invited to provide written or E-
mail comments during the comment period and to participate in an
electronic public meeting on the Internet on September 14, 15 and 16,
1998.
DATES: Comment date: Comments must be submitted on or before December
1, 1998.
Electronic public meeting date: The electronic public meeting will
commence on September 14, 1998, at 9:00 a.m. and end on September 16,
1998 at 12 noon (Eastern Daylight Time).
ADDRESSES: Information on the electronic meeting, including the
Internet address, is available under SUPPLEMENTARY INFORMATION. Written
comments: Address written 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 the docket number
(Docket Number RSPA-98-3971). Persons wishing to receive confirmation
of receipt of their comments should include a self-addressed, stamped
postcard. Comments may also be submitted by E-mail to
rules@rspa.dot.gov''.
Dockets Management System is located on the Plaza Level of the
Nassif Building at the Department of Transportation at the above
address. Public dockets may be reviewed there between the hours of
10:00 a.m. and 5:00 p.m., Monday through Friday, except Federal
holidays. In addition, the public may also review comments by accessing
the docket management system through the DOT home page (http://
dms.dot.gov). An electronic copy of the document may be downloaded
using a modem and suitable communications software from the Government
Printing Office Electronic Bulletin Board Service at (202) 512-1661.
FOR FURTHER INFORMATION CONTACT: Eileen Mack, Office of Hazardous
Materials Standards, (202) 366-8553, Research and Special Programs
Administration, U.S. Department of Transportation, 400 Seventh Street,
SW, Washington, DC 20590-0001.
SUPPLEMENTARY INFORMATION: Electronic public meeting: The electronic
public meeting will be held at the conferences and public meetings
section of RSPA's hazmat home page. The Universal Resource Locator
(URL) address is ``http://hazmat.dot.gov/forum''. The electronic
meeting will enable anyone with Internet access to participate in a
near real-time electronic discussion of the rulemaking. This type of
meeting may also increase the breadth of domestic and international
participation in the commenting process. The message board will be
posted on RSPA's hazmat web site and will be hot-linked to this advance
notice of proposed rulemaking. A transcript of the electronic public
meeting will be placed in the docket. The topics are as follows:
List of Topics
I. Background
II. Proposed Revisions
A. World Health Organization Risk Groups/International
Recommendations and Regulations
B. Diagnostic Specimens
C. Biological Products
D. Genetically Modified Organisms and Micro-organisms
E. Hazard Communication
F. Regulated Medical Waste
G. Materials of Trade Exception
H. Discussion of Petition for Rulemaking
I. Segregation from Foodstuffs
I. Background
On September 20, 1995, RSPA published a final rule (60 FR 48780) to
revise the requirements for Division 6.2 materials (infectious
substances). The rule clarified the scope of regulation for infectious
substances, provided relief for certain shipments of regulated medical
waste (RMW) that conform to other Federal agency regulations, allowed
certain quantities of RMW to be transported by aircraft, and made other
changes to clarify the regulatory provisions applicable to infectious
substances. The final rule was intended to address critical, yet non-
controversial, issues. RSPA stated in the final rule that other, more
complex issues would be considered in a future rulemaking. This ANPRM
seeks comment on RSPA's discussion of certain issues and solicits
information to address the agency's concerns for safety in
transportation of infectious substances and genetically modified micro-
organisms and organisms.
II. Revisions Under Consideration
A. World Health Organization (WHO) Risk Groups/International
Recommendations and Regulations
In this ANPRM, RSPA is 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, RSPA is considering
adopting risk groups and defining criteria developed by the World
Health Organization (WHO) for Division 6.2 materials. These risk groups
are described in the following table:
[[Page 46845]]
Risk Group Table
------------------------------------------------------------------------
Risk to Risk to the
Risk Group Pathogen individuals community
------------------------------------------------------------------------
4.......... Usually causes serious HIGH............ HIGH.
human or animal
disease and can be
readily transmitted
from one individual to
another, directly or
indirectly, and for
which effective
treatment and
preventative measures
are not usually
available.
3.......... Usually causes serious HIGH............ LOW.
human or animal
disease but does not
ordinarily spread from
one infected
individual to another
and for which
effective treatment
and preventative
measures are available.
2.......... 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,
effective treatment
and preventive
measures are available
and only a limited
risk of spreading
infection exists.
1.......... Micro-organisms that NONE OR VERY LOW NONE OR VERY
are unlikely to cause LOW.
human or animal
disease.
------------------------------------------------------------------------
Because the hazards posed by infectious substances vary greatly
depending on the pathogenicity of the organism, mode and relative ease
of transmission, and other factors, RSPA believes that classifying
these materials based on the level of risk and applying requirements
commensurate with the risk will ensure an adequate level of safety
without imposing an undue burden on the regulated community. RSPA does
not intend to provide a list of infectious substances that correlates
with each risk group. Instead, RSPA would defer to the Department of
Health and Human Services' Centers for Disease Control and Prevention
(CDC), Office of Public Health, for guidance in determining the risk
group of a specific material. RSPA seeks comments on whetheradoption of
this risk-based classification criteria will improve safety in the
transportation of infectious substances.
B. Diagnostic Specimens
Currently, in Sec. 173.134 of the Hazardous Materials Regulations
(HMR; 49 CFR Parts 171-180), RSPA defers to the CDC regulations in 42
CFR Part 72 for packaging, hazard communication, and handling in the
transportation of diagnostic specimens. Based upon reports of
undisclosed and improperly prepared shipments of diagnostic specimens,
RSPA believes that many shipments of diagnostic specimens are not
properly identified and lack adequate hazard communication. RSPA also
is concerned that, in some instances, packagings for diagnostic
specimens lack sufficient integrity to survive normal handling in
transportation. RSPA's Hazardous Materials Information System (HMIS)
database contains a number of reports on packages of these materials
that were damaged in transportation, causing costly delays and posing
risks to cargo handlers, flight crews, emergency responders, and others
who may have been exposed to infectious substances.
At the same time, RSPA recognizes that thousands of shipments of
diagnostic specimens are transported by highway without incident to and
from clinics, households and laboratories by private or contract
carriers. To ensure that diagnostic specimens are regulated consistent
with the degree of risk posed by the material, RSPA is considering
differentiating between a diagnostic specimen known or suspected to
contain an infectious substance and a diagnostic specimen that is
offered for transportation and transported for routine screening where
there is a lower probability that a risk group 2 or 3 pathogen is
present.
RSPA is considering requirements that would treat diagnostic
specimens that are known or suspected to contain a Risk Group 2, 3 or 4
pathogen as an infectious substance. For diagnostic specimens
transported for routine screening (i.e., materials with a low
probability of containing a Risk Group 2 or 3 pathogen), RSPA is
considering whether to apply reduced packaging and hazard communication
requirements. Proposed Sec. 173.196(c) specifies quantity limits for
inner receptacles and for outer packagings, and requires that a
packaging meet performance tests for non-bulk packagings in Subpart M
of part 178 of the HMR except that the height for the drop test must be
at least 1.2 meters (3.9 feet).
C. Biological Products
Under current provisions, biological products are excepted from the
HMR provided they meet the Food and Drug Administration (FDA) and U.S.
Department of Agriculture (USDA) regulations for the transfer of
biological products specified in 9 CFR parts 102, 103, and 104 and 21
CFR parts 312 and 600-680. In this ANPRM, RSPA is considering whether
to revise Sec. 173.134(b) to except only licensed biological products.
A licensed biological product is defined in this ANPRM as a material
approved by FDA for human use as a drug in the diagnosis, cure,
mitigation, treatment, or prevention of disease and that is derived
from biological sources, e.g., blood plasma and/or platelets and
products obtained from these materials. In the case of biological
products known to contain infectious substances, RSPA proposes that
they be treated as infectious substances. RSPA is interested in
receiving information on whether the risks associated with the
transportation of licensed biological products warrant the granting of
these exceptions and whether there are any risks that have been
overlooked. RSPA is also interested in information concerning whether
it is appropriate for RSPA to continue to defer to FDA and USDA
regulations regarding these materials.
In addition to the above, RSPA is considering whether to add a new
special provision in Sec. 172.102 (consistent with ICAO Technical
Instruction Special Provision A81) to except blood and blood products
from existing quantity limits by aircraft when the materials are
packaged in accordance with proposed Sec. 173.196, packaged in primary
receptacles that do not exceed 500 ml (17 ounces), and contained in
outer packagings not exceeding 4 L (1 gallon).
D. Genetically Modified Organisms and Micro-organisms
The UN Recommendations and the ICAO Technical Instructions treat
any genetically modified material that meets the definition of Division
6.2 as an infectious substance. In addition, those international
standards classify a genetically modified material that does not meet
the definition of a Division 6.2 material, but is capable of altering
animals, plants, or microbiological substances in a way not normally
the result of natural reproduction, in hazard class 9 material. The UN
Recommendations also contain a
[[Page 46846]]
provision that excludes from regulation genetically modified micro-
organisms that are authorized and licensed for use by the government of
the country of origin, transit, and destination.
RSPA is considering whether to align the HMR with the international
provisions for genetically modified organisms and micro-organisms. RSPA
invites commenters to address whether RSPA should proceed with
developing regulations for genetically modified micro-organisms or
whether provisions for the safe transport of these substances are
adequately addressed in other agencies' regulations. Are the conditions
specified in proposed Sec. 173.140 that provide exceptions from the HMR
for genetically modified micro-organisms and organisms justifiable in
terms of safety and are they easily understood, or are there
alternative safety controls that may be more appropriate?
E. Hazard Communication
RSPA is considering several options with respect to the marking or
placarding of bulk packagings and transport vehicles containing
infectious substances, including regulated medical waste (RMW), and is
interested in receiving comments on those options. RSPA is considering
requiring the display of an INFECTIOUS SUBSTANCE placard for any
quantity of an infectious substance known or reasonably expected to
contain a Risk Group 4 pathogen. RSPA seeks comment on whether a
requirement to display placards on bulk packagings, freight containers,
unit load devices, transport vehicles, or rail cars for shipments of
infectious substances known or reasonably expected to contain a Risk
Group 4 pathogen, regardless of the quantity of material, is necessary.
RSPA is considering amending Sec. 172.504(e), Table 1, column 1, to
include 6.2 infectious substances known or reasonably expected to
contain a Risk Group 4 pathogen, and to add the appropriate references
to an INFECTIOUS SUBSTANCE placard in columns 2 and 3 of the Table.
Additionally, a new ``INFECTIOUS SUBSTANCE'' placard would be proposed,
as shown below:
BILLING CODE 4910-60-P
[GRAPHIC] [TIFF OMITTED] TP02SE98.002
BILLING CODE 4910-60-C
RSPA is also considering whether placards should be required to be
displayed for bulk packagings, freight containers, unit load devices,
transport vehicles or rail cars that contain other infectious
substances, including RMW. If placarding is considered necessary, Table
2 of Sec. 172.504 would be revised to
[[Page 46847]]
require display of placards for these materials. Consistent with
exceptions in Sec. 172.504(c), transport vehicles or freight containers
that contain less than 454 kg (1,001 pounds) aggregate gross weight of
infectious substances would not be required to be placarded.
Alternatively, RSPA is considering a requirement to mark bulk
packagings, freight containers, transport vehicles or rail cars with a
display similar to that required for units that have been fumigated.
For example, a rectangular display with the words ``REGULATED MEDICAL
WASTE'' could be prominently displayed so that it can be readily seen
by any person attempting to enter the interior of the bulk packaging,
freight container, transport vehicle, or rail car. This marking is
being considered for domestic transportation of infectious substances,
other than those known or reasonably expected to contain a Risk Group 4
pathogen (see discussion above).
RSPA requests comments on the following questions:
1. Should placarding be required for an infectious substance known
or reasonably expected to contain a Risk Group 4 pathogen regardless of
the quantity of material in the bulk packaging, freight container,
transport vehicle or rail car?
2. For RMW, should placarding be required for a bulk packaging,
freight container, transport vehicle or rail car which contains RMW?
Alternatively, should an optional marking, such as ``REGULATED MEDICAL
WASTE,'' be authorized in lieu of placards?
3. Should other infectious substances shipments (e.g., those known
or reasonably expected to contain a Risk Group 2 or 3 pathogen) be
required to display an INFECTIOUS SUBSTANCE placard? Should an optional
marking, such as the term ``BIOHAZARD'' appearing in a rectangular
display alongside the BIOHAZARD trefoil symbol, be authorized in lieu
of placards?
4. Are placarding and marking proposals for infectious substances,
as considered in this ANPRM, necessary and effective for communicating
the infectious substance hazard to emergency responders?
5. Will transportation safety be significantly improved if
placarding or identification number marking is required?
6. What costs would be incurred by shippers and carriers of
infectious substances, including RMW, in fulfilling the proposed
placarding requirements or the alternate marking requirements? Are
there less costly alternatives to communicate the hazards of infectious
substances, including RMW?
7. If placards are required, how many drivers would need to obtain
a commercial drivers license (CDL) or a hazardous material (HM)
endorsement to the CDL? What would be the associated impacts, including
costs?
8. With respect to labels, RSPA is also considering revising the
telephone number on its INFECTIOUS SUBSTANCE label to reflect the CDC's
new toll free telephone number for reporting incidents involving
infectious substances. Even though both CDC telephone numbers are
currently in operation, should a transition period be provided to allow
for use of existing inventories of currently required labels? If so,
how long?
F. Regulated Medical Waste
RSPA is considering authorizing non-specification bulk packagings
meeting conditions set forth in proposed Sec. 173.197(b) for RMW.
Currently, bulk packagings are only authorized under the terms of 18
exemptions. This proposal would incorporate the provisions of some of
these exemptions into the HMR to allow the use of non-specification
bulk packagings for RMW under specific conditions, thereby eliminating
the need for exemptions. These bulk packagings would require inner
packagings that are securely closed and leak-resistant to be placed
inside fiberglass or plastic containers, bins, or carts. With certain
exceptions, these packagings have demonstrated through the exemption
process that they provide an acceptable level of safety in
transportation.
RSPA is considering, also, whether to revise the quantity
limitations in columns (9A) and (9B) of Sec. 172.101 for RMW to read
``No Limit'' to reflect the language in the ICAO Technical Instructions
for maximum net quantity permitted per non-bulk package. RSPA notes
that the ICAO Technical Instructions in Packing Instruction 622
restrict infectious substances, such as RMW, to non-bulk packagings
only. Consistent with ICAO Technical Instructions, RSPA is considering
whether to limit RMW in bulk packagings to non-air modes (railcar,
motor vehicle, vessel) only.
1. Should the HMR be revised to authorize caster carts as reusable
outer packagings for RMW packaged in plastic film bags, as currently
authorized by 12 exemptions? If so, what specifications and size
limitations are appropriate for caster carts?
2. Should the HMR be revised to authorize roll-off bins as reusable
outer packagings for RMW packaged in plastic film bags, as currently
authorized by 7 exemptions? If so, what specifications and size
limitations are appropriate for roll-off bins?
3. If caster carts or roll-off bins are authorized for transporting
RMW in plastic film bags, should film bags be required to be single or
multiple ply with a total film thickness of 3 mils, a volume not more
than 46 gallons, and a weight not more than 22 pounds, or are there
more appropriate specifications?
4. If authorized for reuse to transport RMW, should roll-off bins
and caster carts be decontaminated with a disinfectant solution after
each use?
5. Should hospitals or clinics that use roll-off bins to transport
RMW be required to register as shippers of bulk hazardous materials?
6. Should there be a time limit on the period a bin may hold RMW at
the generator's site, to prevent the waste from decomposing and
possibly releasing high concentrations of infectious vapors should a
film bag be torn?
7. Should roll-off bins be allowed only if they are mechanically
unloaded, without the inner packaging being handled manually?
G. Materials of Trade Exception
Under Docket HM-200, Hazardous Materials in Intrastate Commerce (62
FR 1216, as amended at 62 FR 49566 and 62 FR 51560), RSPA adopted
exceptions from most of the requirements of the HMR for hazardous
materials when transported as materials of trade. Materials of trade
include certain hazardous materials carried by a private motor carrier
engaged in a principal business other than transportation, such as lawn
care, plumbing, welding, door-to-door sale of consumer goods, and farm
operations. Specific limitations (such as maximum gross weight of
materials of trade that may be carried on a motor vehicle) and safety
provisions (such as packaging and hazard communication) contained in
current Sec. 173.6 achieve an acceptable level of safety at a minimal
cost to the carrier.
In this ANPRM, RSPA is inviting comments on whether to amend
Sec. 173.6 to permit certain biological products, diagnostic specimens
and RMW in Division 6.2, to be transported by private carraige as
materials of trade. Entities, such as home health care and diagnostic
laboratories, that transport smaller amounts of infectious substances
in direct support of a principal business other than transportation
would be included.
RSPA requests comments on whether an acceptable level of safety
would be
[[Page 46848]]
achieved, also, through a materials of trade exception for infectious
substances. What, if any, hazard communication should be required for
carriage of such materials? If so, what should the communication be?
Section 173.6 specifies quantity limits for the packaging and the
motor vehicle, and minimal hazard communication, for materials
transported by a private motor carrier engaged in a principal business
other than the transportation of hazardous materials. RSPA invites
comments on the costs and benefits associated with this proposal and
whether special recognition should be given to private carriage by
highway, including the transportation of risk group 4 pathogens.
H. Discussion of Petition for Rulemaking
On August 28, 1997, The Medical Waste Institute (MWI) submitted a
petition for rulemaking (P-1350) requesting relief for the
transportation of waste cultures and stocks that meet the definition
for infectious substances. This petition and its enclosures have been
entered as part of the public docket for this rulemaking and can be
obtained by contacting the Department of Transportation Dockets
Management System using the information provided in the address section
at the beginning of this rule.
Specifically, MWI requested that RSPA 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. The petitioners requested that this
relief be authorized for Biosafety Level 1, 2, and 3 materials, as
defined in Health and Human Services publication No. 93-8395. These
biosafety levels are based on the same WHO risk groups as referenced in
Sec. 173.134(a) of the accompanying regulatory text. Currently, the HMR
allows this type of transportation for RMW that does not contain a
waste culture or stock of an infectious substance. The HMR require a
waste culture or stock to be transported in a packaging meeting the
performance criteria in Sec. 178.609. Section 178.609 specifies
requirements for a triple packaging that survives several rigorous
performance tests, including a 9 m (30-foot) drop test and a 1 m (3-
foot) puncture test. By comparison, Sec. 173.197 currently requires
that the packaging for RMW that does not contain a waste culture or
stock of an infectious substance meet performance criteria of a UN
specification packaging at the Packing Group II performance level
contained in 49 CFR Part 178, Subpart M, except Sec. 178.609. In
addition, when packaging authorized in Sec. 173.134 is used, RSPA
currently requires that the material be transported in a dedicated
vehicle by a private or contract carrier and conform to Biosafety
Levels 1, 2, or 3.
MWI included with its petition for rulemaking DOT and State
incident data on infectious substances from 1989 through March 1997.
The petitioner stated that the information shows a relatively low
number of hazardous materials incidents in the U.S. involving a release
of RMW transported by highway. MWI further said that:
The CDC reports hospital waste disposal practices have not
resulted in epidemiologic evidence of disease in communities;
Emergency responders take the same precautions with
infectious substance releases as they do with RMW releases;
Packing group II packagings are not justified for
discarded cultures and stocks;
Discarded cultures and stocks from non-health care
settings pose the same level of risk as those from health care
settings; and
The HMR's general packaging requirements coupled with
OSHA's bloodborne packaging standards have a proven safety record.
From these points, the MWI concluded that the current packagings
required in the HMR for discarded cultures and stocks are not justified
because they are onerous and expensive and lack a safety record that
proves their actual public health and safety benefit. The MWI also
enclosed an EPA press release announcing its medical waste incinerator
program, and language that MWI suggests justifies discarded cultures
and stocks to be defined as RMW when transported by private or contract
motor carriers.
As a result of a provision in Sec. 171.15(b) and the wording of the
INFECTIOUS SUBSTANCE label in Sec. 172.432, many releases of infectious
substances are reported directly to CDC but not to RSPA. Section
171.15(b) allows carriers that report infectious substance (etiologic
agent) incidents the option of reporting the event to the CDC or DOT.
Although Sec. 171.15(c) requires incident information reported to CDC
to be reported to RSPA in the form of a written report, often this
information is not provided to RSPA. This has resulted in an under-
reporting of these events in RSPA's HMIS incident database. Further,
pre-1996 HMR exceptions for packagings containing 50 ml (1.7 ounces) or
less of an infectious substance (known then as an etiologic agent) were
often misapplied and used to ship larger amounts of an infectious
substance.
The Sec. 171.15(b) exception, when properly applied, relieved
carriers from immediate telephonic notification requirements of the
HMR. It was intended to avoid duplication with CDC regulations because
these materials were subject to CDC requirements in 42 CFR Part 72.
Because a number of incidents involving infectious substances were not
reported to DOT, RSPA is considering revising Sec. 171.15 to clarify
that any incident involving the release of an infectious substance be
reported to RSPA, in addition to the CDC, in the form of an incident
report.
Over the last few years, individuals and companies commenting on
infectious substance rulemakings, or on their own initiative, reported
to RSPA information concerning infectious substance releases. They have
reported witnessing blood pouring from rolloffs and freight containers
transporting RMW, the disposal of AIDS-contaminated blood in municipal
waste cans, overturned vehicles that have released diagnostic specimens
on the highways, leaking non-bulk packagings of RMW, ruptured packages
containing diagnostic specimens being transported by aircraft, releases
of treatment-resistant diseases from insufficient packaging, and used
sharps that punctured inner packagings. As a result of information
received from these sources, and through RSPA's own initiative and
incident reporting system, RSPA is now considering whether to take a
more conservative approach, on the side of safety, to the
transportation of waste cultures and stocks.
Several commenters, responding to earlier NPRMs issued on this
subject under Docket HM-181G, stated that a high concentration of
micro-organisms exist in cultures and stocks of infectious substances.
These micro-organisms have the potential to cause disease and,
therefore, require special handling. CDC supported special handling of
these materials in a October 24, 1996 final rule (61 FR 55190) and in
response to RSPA's rulemaking actions on infectious substances issued
under Docket HM-181G. In meetings and conversations with RSPA, CDC
recommended more rigorous packagings for cultures and stocks of
infectious substances. Therefore, RSPA did not base its current
regulations for these materials solely on incident reports. In
addition, RSPA recommends, through guidance provided in the 1996 North
American Emergency Response Guidebook, that emergency responders treat
infectious substances and RMW
[[Page 46849]]
the same since both are Division 6.2 materials.
RSPA finds, through experience gained under exemption DOT-E 11588,
that Packing Group II packagings transported by a private or contract
carrier in a dedicated vehicle 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 from working with these materials.
Moreover, use of dedicated vehicles limits exposure of these packagings
to other packagings and assures that shipments are handled by
experienced personnel. RSPA also finds that the general packaging
requirements in Secs. 173.24 and 173.24a coupled with OSHA's packaging
requirements for bloodborne pathogens contained in 29 CFR 1910.1030 are
adequate for less virulent infectious substances. RSPA seeks specific
comments on the MWI petition for rulemaking.
I. Segregation from Foodstuffs
RSPA currently requires segregation of poisons from foodstuffs. Is
there sufficient justification to support imposing similar restrictions
on all or certain packages containing infectious substances?
III. Section-by-Section Review
This discussion is included to provide the reader with additional
information to more fully explain potential approaches. RSPA seeks
comments on these potential approaches and may publish an NPRM to
further refine these approaches or to propose alternatives to these
approaches based on comments we receive.
Section 171.14
Paragraph (f) would be added to establish a two-year transition
period for the use of infectious substance labels that do not include
the CDC's new toll-free telephone number for reporting infectious
substance incidents.
Section 171.15
In paragraphs (a) (3) and (b), the term ``etiologic agents'' would
be revised to read ``infectious substances.'' In paragraph (b),
information would be added to clarify that a written report, DOT Form F
5800.1, is required for all infectious substance incidents, including
those reported to the CDC.
Section 172.101
For the entry, ``Regulated medical waste'', the letter ``D'' in
column (1) would be removed, in column (7) the reference to Special
Provision A14 would be removed, and columns (9A) and (9B) would be
amended to indicate ``No limit'' as opposed to ``Forbidden'' for
quantity limitations. These changes would harmonize requirements in the
HMR with those in the ICAO Technical Instructions and facilitate the
transport of RMW in non-bulk packagings by aircraft. It should be noted
that, although ``No limit'' would be specified for per-package quantity
limits in the Hazardous Materials Table (the Table), Special Provision
A13 would be revised to prohibit the use of bulk packagings aboard
aircraft. Further, quantity limits may apply with regard to the types
of packagings authorized for RMW in Part 173 and to air transportation
under Sec. 175.75. RSPA requests comments concerning the need, if any,
for further limitations or relaxations on the quantities of RMW
authorized for transportation by aircraft.
For the entries ``Infectious substances, affecting animals only''
and ``Infectious substances, affecting humans'' new special provisions
would be added in Column (7). One, A81, would provide relief from
quantity limits for the transport of blood or blood products known to
contain or suspected of containing infectious substances when 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. The second, A82, would provide relief from UN standard
packaging for transporting body parts, whole organs, and whole bodies.
A new entry, ``Genetically modified micro-organisms'' would be
added to the Table as a Class 9 (miscellaneous) material consistent
with the entry in the UN Recommendations, the ICAO Technical
Instructions and the IMDG Code.
Another new entry, ``Diagnostic Specimen'', would be added to the
Table as a Division 6.2 material. However, this proper shipping name
would be authorized only for diagnostic specimens excepted under
proposed Sec. 173.196(c). There would be no identification number,
hazard warning label, or packing group assignment.
In order to eliminate any confusion and costs that could result
from the use of several proper shipping names for the same material,
the other proper shipping names for infectious waste that are
authorized in the UN Recommendation and the ICAO Technical
Instructions, ``Biomedical waste, n.o.s.'', ``Clinical waste,
unspecified, n.o.s.'', and ``Medical waste, n.o.s.'', would not be
added to Sec. 172.101. RSPA believes the proper shipping name
``Regulated medical waste'' more accurately describes the material and
is the preferable shipping name. Also, it is RSPA's understanding that
the other names were added to satisfy requests from specific countries
that were already using these shipping names. International shipments
using these names would be authorized for transport to their final
destinations under the import-export provisions in Secs. 171.11,
171.12, and 171.12a.
Section 172.102
Special Provision A13 would be revised to prohibit the use of bulk
packagings for RMW aboard aircraft, thus imposing a maximum gross mass
of 400 kg or 450 L per package. Special Provision A14 would be removed.
Two new Special Provisions, A81 and A82, that are consistent with
A81 in the ICAO Technical Instructions, would be added, as discussed
earlier in this section-by-section review under Sec. 172.101.
Section 172.432
The current telephone number, ``404-633-5313'', printed on the
INFECTIOUS SUBSTANCE label for reporting infectious substance incidents
would be changed at the request of CDC to reflect its new toll free
phone number for this purpose, to ``800-232-0124''. A two-year
transition period would be provided in Sec. 171.14 to allow shippers to
exhaust their label inventories.
Section 173.6
Paragraph (a)(4) would be redesignated as paragraph (a)(5) and a
new paragraph (a)(4) would be added to permit certain biological
products, diagnostic specimens and RMW in Division 6.2 to be
transported by entities, such as home health care providers and
diagnostic laboratories, that transport smaller amounts of infectious
substances in direct support of a principal business other than the
transportation of hazardous materials.
Section 173.134
The criteria for Division 6.2 materials specified in Sec. 173.134
would be revised based on the UN Recommendations and the 1999-2000
edition of the ICAO Technical Instructions. This section would also be
revised to incorporate certain domestic exceptions for transportation
by highway. The current definition for infectious substances would be
revised to remove the term ``viable microorganism'' and clarify the
term ``pathogens.'' The defining criteria would exclude toxins, include
the WHO risk groups, and except from Division 6.2 infectious substances
that are unlikely to cause disease, i.e., risk group
[[Page 46850]]
1 pathogens. The definitions for the terms ``diagnostic specimen'' and
``biological product'' would be amended to include the WHO risk groups
and be compatible with the ICAO Technical Instructions. Paragraph (b)
would be amended to except licensed biological products from regulation
under the HMR and, under certain conditions, except diagnostic
specimens and biological products where a low probability exists that
they contain a WHO risk group 2 or 3 pathogen.
RSPA is considering requiring that animals which contain or are
contaminated with genetically modified micro-organisms or organisms
(Sec. 173.140(d)(4)) that meet the criteria of an infectious substance
(Sec. 173.134(c)(5)) be transported under terms and conditions approved
by RSPA's Associate Administrator for Hazardous Materials Safety,
consistent with standards specified in the UN Recommendations and ICAO
Technical Instructions.
Section 173.140
New paragraphs (c) and (d) would be added to provide defining
criteria and exceptions for a genetically modified micro-organism that
does not meet the definition of a Division 6.2 material but has the
potential to alter animals, plants, or the environment. These materials
would be assigned to the Class 9 hazard class. A genetically modified
micro-organism that meets the criteria for a Division 6.2 material
would be classed and described as an infectious substance. A
genetically modified micro-organism would be required to be packaged in
accordance with Sec. 173.196, except that the packagings need not be
marked in accordance with Sec. 178.503 or tested in accordance with
Sec. 178.609. In addition, the quantity in the primary receptacles
would be limited to a maximum of 100 ml (3.4 ounces) or 100 g (4
ounces) for consistency with the ICAO Technical Instructions. A Class 9
genetically modified micro-organism and organism packages would not be
assigned a packing group and would be excepted from all requirements in
the HMR if authorized for final distribution and use by a U.S.
Government agency.
Section 173.196
Existing paragraph (a) would be revised and redesignated as
paragraph (b). New paragraph (a) would clarify that Sec. 173.196
prescribes non-bulk packagings for infectious substances. Existing
paragraphs (b), (c), (d), and (e) would be incorporated in new
paragraph (b). New paragraph (b) would include an exception from
requirements for an absorbent material for solid infectious substances,
and other revisions to provide consistency with the ICAO Technical
Instructions. These revisions would include package and overpack
marking requirements and requirements to ensure the containment
integrity of the packagings during air transport, including
circumstances where the refrigerant is dissipated or lost. The existing
text in paragraph (h) of this section excepting biological products and
diagnostic specimens from regulation under the HMR would be deleted.
New exceptions for diagnostic specimens and biological products would
be relocated to Sec. 173.134. A new paragraph (c) would be added to
remove from regulation diagnostic specimens with a low probability of
containing a risk group 2 or 3 pathogen when a limited amount of the
material is placed in a non-specification packaging. A new paragraph
(d) would be added to prescribe non-specification packaging provisions
for body parts and certain diagnostic infectious substances. Former
paragraph (g) would be renamed paragraph (e).
Section 173.197
RSPA is considering revising the RMW packaging requirements to
allow five types of packagings: (1) infectious substances packaging in
accordance with Sec. 173.196; (2) RMW packaging in accordance with
current Sec. 173.197; (3) packagings that conform to 29 CFR 1910.1030;
(4) non-specification bulk packagings currently authorized under
exemptions; and (5) intermediate bulk containers (IBCs).
In addition, the provisions for RMW packaging meeting the criteria
in Sec. 173.197 would be revised to permit liquid materials to be
placed in a packaging suitable for solids when the liquid can be fully
absorbed by the absorbent material in the packaging, the packaging is
capable of retaining liquids, and the packaging conforms to the OSHA
bloodborne pathogen packaging standards in 29 CFR 1910.1030.
Existing paragraph (b) would be removed because the anniversary
date for this provision is no longer applicable.
Several commenters to earlier rulemakings on RMW were unaware that
the HMR allow the use of non-bulk, single packagings for RMW. This
proposal would clarify that the packaging requirements in Sec. 173.197
allow the shipper to use single or combination UN specification
packagings if the performance standards are met.
Section 178.503
In Sec. 178.503, a new paragraph (f) would be added to incorporate
package markings consistent with those in the ICAO Technical
Instructions and UN Recommendations for infectious substances.
Section 178.601
A sentence would be added to paragraph (c)(1) of this section to
include the tests for infectious substance packaging in the definition
for design qualification testing. As a result of this change,
manufacturers of infectious substance packagings would be required to
retain design qualification records, as required in Sec. 178.601(l).
Section 178.609
Several amendments may be incorporated in this section to harmonize
it with the UN Recommendations and the ICAO Technical Instructions. The
section heading may be revised to remove the wording ``(etiologic
agents)''. Paragraph (c) would be revised 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), (d)(1)(iv) would be revised for editorial purposes.
Paragraph (e) would be revised to replace the current water immersion
test with a water spray test that simulates exposure to rainfall
consistent with the ICAO Technical Instructions. The last sentences in
paragraphs (h)(1) and (h)(2) would be revised to clarify the
requirements for conducting the penetration test. Specifically, the
text would be revised to clearly indicate that penetration of the
primary receptacle is not acceptable. Paragraph (i) would be revised to
clarify that infectious substances are required to be marked in
accordance with Sec. 178.503 and redesignated as a new paragraph (l).
New paragraphs (i), (j) and (k) would be added 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.
IV. Regulatory Analyses and Notices
A. Executive Order 12866 and DOT Regulatory Policies and Procedures
This ANPRM is not a significant regulatory action under section
3(f) of Executive Order 12866, and was not
[[Page 46851]]
reviewed by the Office of Management and Budget. It is not a
significant regulatory action under the regulatory policies and
procedures of the Department of Transportation (44 FR 11034, March 1,
1979).
Any future NPRM on infectious substances may contain proposals that
have substantial effects on hospitals (SIC 8062), nursing and personal
care facilities (SIC 8059), medical and dental laboratories (SIC 807),
home health care services (SIC 8082), offices and clinics of doctors of
medicine (SIC 8011) and dentists (SIC 8021), and research, development
and testing services (SIC 8731). The primary economic impact of a
proposed rule along the lines of this ANPRM would be on persons who
offer for transportation or transport diagnostic specimens and
biological products, subclassifications of infectious substances that
are currently excepted from all requirements of the HMR. At this time,
RSPA has neither sufficient data in the form of reported incidents
concerning fire, breakage, spillage, or suspected contamination
involving shipments of diagnostic specimens and biological products
with which it may assess actual risks in transportation. Also, RSPA
does not have a thorough understanding of current distribution systems
by which it may estimate costs that would result from a decision to
apply requirements of the HMR to various modes of transportation and
types of carriage (i.e., common, contract and private). A primary
purpose of this ANPRM is for RSPA to gather additional information that
will assist the agency in measuring the anticipated benefits to
society, through increased safety in the transportation of these
hazardous materials, against anticipated costs to society resulting
from new rules and regulations. RSPA requests comments on costs and
benefits that may result from any future rulemaking.
B. Executive Order 12612
This notice has been analyzed in accordance with the principles and
criteria contained in Executive Order 12612 (``Federalism''). Federal
hazardous materials transportation law, 49 U.S.C. 5701-5127, 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:
(i) the designation, description, and classification of hazardous
material;
(ii) the packing, repacking, handling, labeling, marking, and
placarding of hazardous material;
(iii) the preparation, execution, and use of shipping documents
related to hazardous material and requirements related to the number,
contents, and placement of those documents;
(iv) the written notification, recording, and reporting of the
unintentional release in transportation of hazardous material; or
(v) the design, manufacturing, fabricating, marking, maintenance,
reconditioning, repairing, or testing of a packaging or container
represented, marked, certified, or sold as qualified for use in
transporting hazardous material.
This advance notice of proposed rulemaking addresses covered
subjects under items i-v above and, if adopted, would preempt State,
local, or Indian tribe requirements not meeting the ``substantively the
same'' standard. Federal hazardous materials transportation law
provides at Sec. 5125(b)(2) that if RSPA issues a regulation concerning
any of the covered subjects RSPA 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. Thus, RSPA lacks discretion in this area, and
preparation of a federalism assessment is not warranted.
C. Executive Order 13084
This notice has not yet been analyzed in accordance with the
principles and criteria contained in Executive Order 13084
(``Consultation and Coordination with Indian Tribal Governments'').
Because revised rules and regulations evolving from this ANPRM are not
expected to significantly or uniquely affect the communities of Indian
tribal governments, the funding and consultation requirements of this
Executive Order would not apply. Nevertheless, this ANPRM specifically
requests comments from affected persons, including Indian tribal
governments, as to its potential impact.
D. Regulatory Flexibility Act
Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), RSPA
must consider whether a potential notice of proposed rulemaking would
have a significant economic impact on a substantial number of small
entities. Unless alternative definitions have been established by the
agency in consultation with the Small Business Administration, the
definition of ``small business'' has the same meaning as under the
Small Business Act. Because RSPA has established no special definition,
the agency employs thresholds published under criteria in 13 CFR
121.101, e.g., $5 million for facilities falling within major group 80
(health services) and 500 employees for commercial physical and
biological research (SIC 8731).
Because it has not yet proposed any new requirements, RSPA cannot
yet determine potential effects upon small entities. Accordingly, an
Initial Regulatory Flexibility Assessment discussing the impact of this
potential rulemaking on small entities has not been prepared. However,
RSPA has determined that an NPRM that closely follows considerations in
this ANPRM may have potential impacts on small businesses, and State
and local governments. The agency expects that comments received on
this ANPRM will assist it in determining the number of potentially
affected small entities and in weighing the impact of various
regulatory alternatives for the purpose of drafting revised rules and
regulations.
E. Paperwork Reduction Act
Under the Paperwork Reduction Act of 1995, no person is required to
respond to a collection of information unless it displays a valid OMB
control number. This ANPRM does not propose any new information
collection burdens.
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 ANPRM imposes no mandates and thus does not impose unfunded
mandates under the Unfunded Mandates Reform Act of 1995.
List of Subjects
49 CFR Part 171
Exports, Hazardous materials transportation, Hazardous waste,
Imports, Incorporation by reference, Reporting and recordkeeping
requirements.
49 CFR Part 172
Hazardous materials transportation, Hazardous waste, Labels,
Markings, Packaging and containers, Reporting and record keeping
requirements.
49 CFR Part 173
Hazardous materials transportation, Packaging and containers.
[[Page 46852]]
49 CFR Part 178
Hazardous materials transportation, Packaging and containers.
In consideration of the foregoing, 49 CFR parts 171, 172, 173, and
178 may be proposed to be amended as follows:
PART 171--GENERAL INFORMATION, REGULATIONS, AND DEFINITIONS
1. The authority citiation for part 171 would continue to read as
follows:
Authority: 49 U.S.C. 5101-5127; 49 CFR part 1.
1a. Section 171.14 would be amended by adding paragraph (f) to read
as follows:
Sec. 171.14 Transitional provisions for implementing requirements
based on the UN Recommendations.
* * * * *
(f) Until [TWO YEARS FROM THE EFFECTIVE DATE OF FINAL RULE], labels
which conform to specifications in subpart E of part 172 contained in
the 49 CFR, parts 100 to 185, edition revised as of October 1, 1998,
for a Division 6.2 material may be used in place of the Division 6.2
labels currently specified in subpart E of Part 172 of this subchapter.
Sec. 171.15 [Amended]
2. 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) would be amended by removing the term ``etiologic
agents'' and in its place adding the term ``infectious substances''.
c. Paragraph (b) 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
3. The authority citation for part 172 would continue to read as
follows:
Authority: 49 U.S.C. 5101-5127; 49 CFR 1.53.
3. In Sec. 172,101, the following proper shipping names would be
added to or revised in the Hazardous Materials Table: following proper
shipping names would be added to or revised in the Hazardous Materials
Table:
Sec. 172.101 Hazardous Materials Table
* * * * *
[[Page 46853]]
Hazardous (8) Packaging (Sec. 173.***) (9) Quantity limitations (10) Vessel stowage
materials Hazard ---------------------------------------------------------------------------------------------
Symbols descriptions class or Identification PG Label codes Special Passenger Cargo
and proper Division Numbers provisions Exceptions Nonbulk Bulk aircraft/ aircraft Location Other
shipping names rail only
(1) (2)............ (3) (4)........... (5) (6) (7)......... (8A) (8B) (8C)........ (9A)........ (9B)........ (10A)....... (10B)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
[ADD]
Diagnostic 6.2 .............. .......... ........... A82......... 134 196 None........ 4L or 4kg... 4L or 4kg...
specimen.
* * * * * * * * *
Genetically 9 UN3245........ .......... 9 ............ 140 140 None........ No Limit.... No Limit.... B...........
modified micro-
organisms.
* * * * * * * * *
[REVISE]
Infectious 6.2 UN2900........ .......... 6.2 A81, A82.... 134 196 None........ 50 ml or 50 4L or 4kg... B...........
substances, g.
affecting
animals, only.
Infectious 6.2 UN2814........ .......... 6.2 A81, A82.... 134 196 None........ 50 ml or 50 4L or 4kg... B...........
substances, g.
affecting
humans.
* * * * * * * * *
Regulated 6.2 UN3291........ .......... 6.2 A13......... 134 197 197......... No Limit.... No Limit.... E...........
medical waste.
* * * * * * * * *
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 46854]]
* * * * *
4. In Sec. 172.102, in paragraph (c)(2), Special provision A14
would be removed, Special Provision A13 would be revised, and Special
Provisions A81 and A82 would be added in alphanumeric order to read as
follows:
Sec. 172.102 Special provisions.
* * * * *
(c) * * *
(2) * * *
A13 Bulk packagings are not authorized for transportation by
aircraft.
* * * * *
A81 The quantity limits in column (9A) do not apply to blood or
blood products known to contain or suspected of containing
infectious substances 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.
A82 The quantity limits in columns (9A) and (9B) do not apply to
body parts, whole organs or whole bodies known to contain or
suspected of containing infectious substances; these materials must
be packaged in accordance with Sec. 173.134 of this subchapter or,
alternatively, in a strong outer packaging in accordance with
173.196(c)(3) with leakproof inner receptacles or liners so as not
to present a hazard to persons or animals during transport.
* * * * *
5. Section 172.432, the illustration in paragraph (a) and paragraph
(b) would be revised to read as follows:
Sec. 172.432 INFECTIOUS SUBSTANCE label.
(a) * * *
BILLING CODE 4910-60-P
[GRAPHIC] [TIFF OMITTED] TP02SE98.003
BILLING CODE 4910-60-c
[[Page 46855]]
(b) In addition to complying with Sec. 172.407, the background on
the INFECTIOUS SUBSTANCE label must be white.
PART 173--SHIPPERS--GENERAL REQUIREMENTS FOR SHIPMENTS AND
PACKAGINGS
5. The authority citation for part 173 would continue to read as
follows:
Authority: 49 U.S.C. 51015127, 44701; 49 CFR 1.45, 1.53.
6. In Sec. 173.6, paragraph (a)(1) introductory text would be
amended by adding the term ``6.2'' immediately following the term
``6.1'', 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) * * *
(4) A Division 6.2 material, other than a risk group 4 or a culture
or stock, that is a diagnostic specimen, biological product or
regulated medical waste contained in a combination packaging consisting
of inner packagings having a gross mass or capacity not over 0.5 kg (1
pound), or 0.5 L (1 pint), and an outer packaging having a gross mass
or capacity not exceeding 4 kg (8.8 pounds) or 4 L (1 gallon).
* * * * *
7. Section 173.134 would be revised to read as follows:
Sec. 173.134 Class 6, Division 6.2--Definitions and exceptions.
(a) Definitions. For the purposes of this subchapter, the following
terms pertain to Division 6.2 (infectious substances) materials:
(1) Division 6.2 material means a material containing an infectious
substance subject to the requirements of this subchapter, including,
but not limited to, a biological product, a diagnostic specimen,
cultures and stocks of an infectious substance, and regulated medical
waste.
(2) Infectious substance means a material known to contain, or
reasonably expected to contain, pathogens. Pathogens are micro-
organisms (including bacteria, viruses, rickettsia, parasites, and
fungi) or recombinant micro-organisms (hybrid or mutant) that are known
or reasonably expected to cause infectious disease in humans or
animals. An infectious substance is assigned to a risk group based on
its level of risk and is subject to the provisions of this subchapter
as a Division 6.2 material if it has the potential to spread disease
when exposure to it occurs.
(3) Biological product means a material derived from a living
organism that is manufactured and distributed in accordance with the
provisions of 9 CFR part 102 (Licenses for Biological Products), 9 CFR
part 103 (Experimental Products, Distribution, and Evaluation of
Biological Products Prior to Licensing), 9 CFR part 104 (Permits for
Biological Products), 21 CFR part 312 (Investigational New Drug
Application), or 21 CFR parts 600 to 680 (Biologics). 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, but
is not limited to, a finished or unfinished product such as a vaccine;
however, it does not include a diagnostic specimen.
(4) Cultures and stocks means material that contains a risk group
2, 3 or 4 pathogen for purpose of growth or storage.
(5) Diagnostic specimen means any human or animal material
including, but not limited to, excreta, secreta, blood, blood and its
components, tissue, and tissue fluids, being transported for diagnostic
or investigational purposes, but excluding live humans or animals.
Exceptions are provided in paragraph (c)(4) of this section for Risk
Group 2, 3, and 4 materials transported by private or contract motor
carrier.
(6) Regulated medical waste means a waste or reusable material that
contains or is suspected of containing an infectious substance in other
than risk group 4 and is generated in--
(i) The diagnosis, treatment or immunization of human beings or
animals;
(ii) Research pertaining to the diagnosis, treatment or
immunization of human beings or animals; or
(iii) The production or testing of biological products.
(7) Risk group means a ranking based on level of risk using
criteria developed by the World Health Organization (WHO). A risk group
is characterized by 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.
The criteria for each risk group according to the level of risk are as
follows:
(i) Risk group 4 means a pathogen that usually causes serious human
or animal disease and that can be readily transmitted from one
individual to another, directly or indirectly, and for which effective
treatment and preventative measures are not usually available (i.e.,
high individual and community risk).
(ii) Risk group 3 means a pathogen that usually causes serious
human or animal disease but does not ordinarily spread from one
infected individual to another, and for which effective treatment and
preventative measures are available (i.e., high individual risk and low
community risk).
(iii) Risk group 2 means a pathogen that can cause human or animal
disease but is unlikely to be a serious hazard, and, while capable of
causing serious infection on exposure, for which there are effective
treatment and preventive measures available and the risk of spread of
infection is limited (i.e., moderate individual risk and low community
risk).
(iv) Risk group 1 means a micro-organism that is unlikely to cause
human or animal disease (i.e., no, or very low, individual or community
risk). A material containing only such micro-organisms is not subject
to the requirements of this subchapter.
(8) Sharps means any object that can penetrate the skin, including,
but not limited to, needles, scalpels, broken glass, broken capillary
tubes, and exposed ends of dental wires that may be contaminated with a
pathogen.
(b) Exceptions for biological products. (1) A biological product
which is known or reasonably expected to contain a pathogen in risk
groups 2, 3, or 4 must be classified in Division 6.2 under UN 2814 or
UN 2900, as appropriate, unless otherwise excepted.
(2) A biological product that has successfully completed all
screening and confirmatory tests required by the Food and Drug
Administration of the Department of Health and Human Services or the
Department of Agriculture, as appropriate, to identify pathogens is not
considered an infectious substance and is not subject to the
requirements of this subchapter.
(c) Exceptions for diagnostic specimens. (1) A diagnostic specimen
that is known or reasonably expected to contain a pathogen in risk
group 2 or 3 (medium to high probability) or for which there is any
probability that it contains a pathogen of risk group 4 must be
classified in Division 6.2 under UN 2814 or UN 2900, as appropriate,
unless otherwise excepted. A specimen transported for the purpose of
initial or confirmatory testing for the presence of a pathogen falls
within this group.
(2) A diagnostic specimen for which a relatively low probability
exists that a pathogen of risk groups 2 or 3 is present may be
transported under the exceptions provided in Sec. 173.196(c).
[[Page 46856]]
(3) A diagnostic specimen that is known or reasonably expected to
contain a pathogen in risk group 1 only or is known not to contain a
pathogen is not considered an infectious substance and is not subject
to the requirements of this subchapter.
(4) A diagnostic specimen which meets the provisions of paragraph
(c)(1) or (c)(2) of this section is excepted from all other
requirements of this subchapter when transported by a private or
contract motor carrier not engaged in the transportation of passengers
and the material is packaged and marked with the proper shipping name
``Diagnostic Specimen'' in accordance with the provisions for
diagnostic specimens in Sec. 173.196(c) of this subchapter.
(5) Animals which contain or are contaminated with an infectious
substance must be transported under the terms and conditions approved
by the Associate Administrator for Hazardous Materials Safety.
(d) Other exceptions. (1) The following are not subject to the
requirements of this subchapter as a Division 6.2 material:
(i) A living person;
(ii) 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;
(iii) 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;
(iv) Any waste or recyclable material, other than regulated medical
waste, including--
(A) Garbage and trash derived from hotels, motels, and households,
including but not limited to single and multiple residences;
(B) Sanitary waste or sewage;
(C) Sewage sludge or compost; and
(D) Animal waste generated in animal husbandry or food production;
(E) Medical waste generated from households; or
(F) Corpses, remains, and anatomical parts that are intended for
interment or cremation;
(v) Forensic material that is transported on behalf of, a Federal,
State, local or Indian tribal government agency provided they are
shipped in a packaging conforming to the provisions of Sec. 173.24 of
this subchapter. A package being shipped and transported under this
provision must be marked ``Diagnostic Specimen''.
(2) [Reserved]
9. In Sec. 173.140, paragraphs (c) and (d) would be added to read
as follows:
Sec. 173.140 Class 9--Definitions.
* * * * *
(c) Any material that is a genetically modified micro-organism or
organism.
(1) This includes micro-organisms and organisms in which:
(i) Genetic material has been purposely altered through genetic
engineering in a way that does not occur naturally; and
(ii) The material does not meet the definition of an infectious
substance, 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 or organism that meets
the definition of an infectious substance in Sec. 173.134 is subject to
the requirements for a Division 6.2 material.
(d) Exceptions. (1) A genetically modified micro-organism or
organism that is authorized for final distribution and use by a U.S.
Government agency is not subject to requirements of this subchapter.
(2) Genetically modified micro-organisms or organisms that meet the
definition of a Class 9 material are not assigned a packing group.
(3) Packaging requirements for genetically modified micro-organisms
and organisms are specified in Sec. 173.196(c).
(4) A genetically modified micro-organism or organism is excepted
from all other requirements of this subchapter when transported by a
private or contract motor carrier not engaged in the transportation of
passengers, and the material is packaged and marked with the proper
shipping name ``Genetically modified micro-organism,'' in accordance
with the provisions in Sec. 173.196(c)(4).
(5) Animals which contain or are contaminated with a genetically
modified micro-organism must be transported under the terms and
conditions approved by the Associate Administrator for Hazardous
Materials Safety.
10. Section 173.196 would be revised to read as follows:
Sec. 173.196 Infectious substances.
(a) When Sec. 172.101 of this subchapter specifies that an
infectious substance be packaged under this section, only non-bulk
packagings prescribed in this section may be used.
(1) An infectious substance must be classified and described under
UN 2814 or UN 2900 and must be packaged in a Division 6.2 packaging
meeting requirements of paragraph (b) of this section.
(2) An infectious substance that is authorized to be described
under the proper shipping name ``Diagnostic Specimen'' must be packaged
in accordance with paragraph (b) or (c) of this section. If the
diagnostic specimen meets the requirements of Sec. 173.134(c)(2) and is
transported by highway only by a private or contract carrier, it may be
packaged in conformance with provisions of paragraph (c) of this
section.
(3) Body parts, organs or whole bodies must be packaged in a:
(i) Division 6.2 packaging meeting the requirements of paragraph
(b) of this section;
(ii) Diagnostic specimen packaging meeting the requirements of
paragraph (c) of this section, or
(iii) Non-specification packaging meeting the requirements of
paragraph (d) of this section.
(b) Division 6.2 packaging. A Division 6.2 packaging must conform
to a UN standard specified in subpart L of part 178 of this subchapter
and meet the test standards of Sec. 178.609 of this subchapter. The
packaging must include:
(1) Inner packagings comprising:
(i) A watertight primary receptacle;
(ii) A watertight secondary packaging; and
(iii) Other than for a solid infectious substance, an absorbent
material must be placed between the primary receptacle and the
secondary packaging. If multiple primary receptacles are placed in a
single secondary packaging, they must be wrapped individually to ensure
that contact between them is prevented. The absorbent material, such as
cotton or wool, must be sufficient to absorb the entire contents of all
primary receptacles.
(2) An outer packaging of adequate strength for its capacity, mass
and intended use.
(3) The smallest overall external dimensions of the outer packaging
must be at least 100 mm (3.9 inches).
(4) An itemized list of contents must be enclosed between the
secondary packaging and the outer packaging.
(5) Based on their physical and chemical form, infectious
substances must be packaged according to the following guidelines:
(i) Lyophilized substances. Primary receptacles must include flame-
sealed glass ampules or rubber-stopped glass vials fitted with metal
seals.
(ii) Liquid or solid substances--
(A) Substances shipped at ambient temperatures or higher.
Authorized primary receptacles include those of glass, metal or
plastic. Positive means of ensuring a leakproof seal, such as heat
[[Page 46857]]
seal, skirted stopper or metal crimp seal must be provided. If screw
caps are used, they must be secured with adhesive tape.
(B) Substances shipped refrigerated or frozen (ice, pre-frozen
packs, dry ice). Ice or dry ice must be placed outside the secondary
packagings. 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 packaging must be leakproof. If dry ice
is used, the outer packaging must permit the release of carbon dioxide
gas and otherwise meet the provisions in Sec. 173.217.
(C) Substances shipped in liquid nitrogen. Plastic 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. For
transportation of liquid nitrogen aboard aircraft, see Sec. 171.11 of
this subchapter.
(6) Whatever the intended temperature of shipment, the primary
receptacle or secondary packaging used for infectious substances must
be capable of withstanding, without leakage, an internal pressure which
produces a pressure differential of not less than 95 kPa (14 psi) and
temperatures in the range of -40 deg.C to +55 deg.C (-40 deg.F to
+131 deg.F).
(c) Diagnostic specimens and genetically modified micro-organisms
and organisms. (1) A diagnostic specimen that otherwise conforms to
terms and conditions specified in Sec. 173.134(c)(1) and (c)(4) must be
packaged as specified in paragraph (b) of this section, except that the
package need only be capable of meeting test standards of Sec. 178.609
of this subchapter and at a drop test height of not less than 1.2 m
(3.9 feet), rather than 9 m (30 feet).
(2) A diagnostic specimen that otherwise conforms to terms and
conditions specified in Sec. 173.134(c)(2) and (c)(4) must be packaged
as follows:
(i) In a leakproof primary receptacle that does not contain more
than 500 ml (17 ounces) or 500 mg (1.1 pounds).
(ii) In an outer packaging that does not contain more than 4 L (1
gallon) or 4 kg (8.8 pounds).
(iii) The packing conforms to requirements in Sec. 173.196(b), but
is not subject to the marking requirements in subpart L of part 178 of
this subchapter or the performance tests in subpart M of part 178 of
this subchapter. However, each completed package must be capable of
successfully passing the drop test specified in Sec. 178.603 of this
subchapter. The height of the drop test must meet or exceed 1.2 m (3.9
feet).
(iv) For a solid diagnostic specimen, the primary receptacle and
secondary packaging is excepted from requirements pertaining to their
ability to withstand a pressure differential of not less than 95 kPa.
(3) Except as provided in paragraph (c)(4) of this section, a
genetically modified micro-organism or organism must be packaged as
specified in paragraph (b) of this section, except that the package
need only be capable of meeting test standards of Sec. 178.609 of this
subchapter and at a drop test height of not less than 1.2 m (3.9 feet),
rather than 9 m (30 feet).
(4) A genetically modified micro-organism or organism that
otherwise conforms to terms and conditions specified in
Sec. 173.140(d)(4) must be packaged as follows:
(i) In a leakproof primary receptacle that does not contain more
than 500 ml (17 ounces) or 500 mg (1.1 pounds).
(ii) In an outer packaging that does not contain more than 4 L (1
gallon) or 4 kg (8.8 pounds).
(iii) The packaging conforms to requirements in Sec. 173.196(b),
but is not subject to the marking requirements in subpart L of part 178
of this subchapter or the performance tests in subpart M of part 178 of
this subchapter. However, each completed package must be capable of
successfully passing the drop test specified in Sec. 178.603 of this
subchapter. The height of the drop test must meet or exceed 1.2 m (3.9
feet).
(iv) For a solid genetically modified micro-organism or organism,
the primary receptacle and secondary packaging is excepted from
requirements pertaining to their ability to withstand a pressure
differential of not less than 95 kPa.
(d) Non-specification packaging requirements. This packaging
consists of a non-bulk strong outer packaging and a leakproof inner
packaging, such as a liner or receptacle, that conforms to the
conditions specified in Secs. 173.24 and 173.24a and the following
additional requirements:
(1) When transported by aircraft, the packaging must conform to
requirements specified in Sec. 173.27;
(2) When transported with dry ice, the packaging must conform to
requirements specified in paragraph (b)(5)(ii)(B) of this section; and
(3) When shipped in liquid nitrogen, the packaging must conform to
requirements specified in paragraph (b)(5)(ii)(C) of this section.
(e) The requirements of this section are in addition to the
requirements of the Department of Health and Human Services contained
in 42 CFR part 72.
11. Section 173.197 would be revised to read as follows:
Sec. 173.197 Regulated medical waste.
(a) Non-bulk packagings. Non-bulk packagings conforming to the
requirements of part 178 of this subchapter at the Packing Group II
performance level are authorized for regulated medical waste as
follows. The packagings must be:
(1) Rigid;
(2) Leak-resistant;
(3) Impervious to moisture;
(4) Of sufficient strength to prevent tearing or bursting under
normal conditions of use and handling;
(5) Sealed to prevent leakage during transport;
(6) Puncture-resistant for sharps and sharps with residual fluids;
and
(7) Break-resistant and tightly lidded or stoppered for fluids in
quantities greater than 20 cubic centimeters.
(b) Special bulk packagings. Authorized packagings consist of one
of the outer bulk packagings with multiple inner packagings, as
described in this paragraph.
(1) Outer packagings. (i) Intermediate bulk container (IBC)
packaging. Intermediate bulk containers are authorized as outer
packagings subject to the conditions and limitations of this paragraph
provided they conform to the requirements in subpart O of part 178 of
this subchapter at the Packing Group II performance level, as follows:
(A) Liquids or solids. The following are authorized as outer
packagings with inner packagings that contain liquids or solids:
(1) Composite: 31HZ1. The letter ``Z'' must be replaced with a
capital letter which indicates the material of construction of the
outer packaging (see Sec. 178.702 of this subchapter);
(2) Metal: 31A, 31B, or 31N; or
(3) Rigid plastic: 31H1 or 31H2.
(B) Solids only. The following are authorized as outer packagings
with inner packagings that contain solids only:
(1) Composite: 11HZ1 or 12HZ1. The letter ``Z'' must be replaced
with a capital letter which indicates the material of construction of
the outer packaging (see Sec. 178.702 of this subchapter);
(2) Metal: 11A, 11B, 11N, 12A, 12B, or 12N; or (3) Rigid plastic:
11H1, 11H2, 21H1 or 21H2.
(C) Additional provisions. An IBC authorized for solids only, may
be used for small quantities of liquids provided that sufficient
absorbent material is used to absorb the entire amount of liquid
[[Page 46858]]
present. IBCs intended to carry sharps must be resistant to puncture
and retain liquids under the performance tests of subpart O of part
178.
(ii) Non-specification bulk packaging. A non-specification
packaging is authorized as an outer packaging subject to the conditions
and limitations of this paragraph as follows:
(A) The packaging must be a metal or plastic bulk packaging of
rigid, seamless construction, with the following features:
(1) A lid or closure that is closed, sealed and latched during
transportation; and
(2) A maximum capacity greater than 450 L (119 gallons) but less
than 1,000 L (264 gallons) as a receptacle for a liquid or a maximum
net mass greater than 400 kg (882 pounds) but less than 1,000 kg (2,205
pounds) as a receptacle for a solid;
(B) Be capable of meeting the drop test requirements of
Sec. 178.810 and stacking test requirements of Sec. 178.815, for the
Packing Group II performance level for solids;
(C) Have an interior surface that is smooth, non-porous, and free
of cracks and crevices that could obstruct decontamination operations;
(D) Be in dedicated service for the transportation of waste
materials;
(E) Prior to reuse, be decontaminated; and
(F) The outer packaging must be maintained in an upright position
during transportation.
(G) The package must be legibly marked with package orientation
markings that conform pictorially to ISO Standard 780 on two opposite
vertical sides of the package with the arrows pointing in the correct
upright direction.
(2) Inner packaging: Inner packagings must conform to the following
requirements to be authorized for use in special bulk packagings:
(i) A plastic film inner packaging may not exceed a volume of 175 L
(46 gallons) and must have a film thickness of at least 0.076 cm (0.003
inches);
(ii) Sharps must be packaged in puncture-resistant containers that
are not greater than 38 L (10 gallons) in volume;
(iii) Inner packagings for liquids must meet the non-bulk packaging
standards for Packing Group II for liquids. Liquid materials are not
authorized for transportation in inner packagings larger than 19 L (5
gallons); and
(iv) Inner packagings must be securely closed with a minimum of
entrapped air and sealed with a positive sealing mechanism to prevent
leakage.
PART 178--SPECIFICATIONS FOR PACKAGINGS
12. The authority citation for part 178 would continue to read as
follows:
Authority: 49 U.S.C. 5101-5127; 49 CFR 1.53.
13. 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 placed in a location
and of such a size relative to the packaging as to be readily visible,
as specified in Sec. 178.3(a). An infectious substance packaging that
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 of this subpart.
(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(k), 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.
(8) Examples of markings for infectious substance packages include:
[GRAPHIC] [TIFF OMITTED] TP02SE98.004
4G/CLASS 6.2/97/USA/ACME876
[GRAPHIC] [TIFF OMITTED] TP02SE98.005
1A2/CLASS 6.2/97/USA/ACME CORP. 123 ELM ST DALLAS, TX 75230
[GRAPHIC] [TIFF OMITTED] TP02SE98.006
1A2U/CLASS 6.2/97/USA/ACME CORP. 123 ELM ST DALLAS, TX 75230
14. In Sec. 178.601, paragraph (c)(1) 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, 178.604, 178.605, 178.606, 178.607, or
178.609, as applicable, for each new or different packaging, at the
start of production of that packaging.
* * * * *
15. In Sec. 178.609, paragraph (i) would be redesignated as
paragraph (l), the section heading, paragraph (c) preceding the table,
the undersignated sentence preceding paragraph (d)(1) introductory
text, paragraphs (d)(1) introductory text, (d)(1)(i), (d)(1)(iii),
(d)(1)(iv), (e), (h)(1), (h)(2), and newly designated paragraph (l)
would be revised, and new paragraphs (i), (j), and (k) would be added
to read as follows:
Sec. 178.609 Test requirements for packagings for infectious
substances.
* * * * *
(c) Packagings prepared for transport must be subjected to the
tests in Table I of this paragraph, which, for test purposes,
categorizes 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 whose 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) * * *
The drops must be performed as follows:
(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
* * * * *
[[Page 46859]]
(e) The samples must be subjected to a water spray that simulates
exposure to rainfall of approximately 50 mm 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 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
impact surface of the sample. 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). Following each impact, there shall be
no leakage from the primary receptacle(s).
(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 the edges of the upper end a
radius not exceeding 6 mm (0.2 inches). 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 should be so orientated that the steel rod must
be aimed to impact the primary receptacle(s). Following each impact,
there shall be no leakage from the primary receptacle(s).
(i) Provided an equivalent level of performance is maintained, the
following variations in the primary receptacles placed within the
secondary packaging are allowed without additional testing of the
completed package:
(1) Primary receptacles of equivalent or smaller size as compared
to the tested primary receptacles may be used provided:
(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;
and
(v) Primary receptacles are oriented within the intermediate
packaging in the same manner as in the tested package.
(2) [Reserved]
(j) A lesser number of the tested primary receptacles, or of the
alternative types of primary receptacles identified in paragraph (i) 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.
(k) Primary receptacles of any type may be placed within a
secondary packaging and shipped without testing in the outer packaging
under the following conditions:
(1) The secondary/outer packaging combination must have been
successfully tested in accordance with paragraphs (a) through (h) of
this section with fragile (e.g., glass) inner receptacles;
(2) The total combined gross weight of inner receptacles must not
exceed one-half the gross weight of inner receptacles used for the drop
test in paragraph (d) of this section;
(3) The thickness of cushioning material between inner receptacles
and between inner receptacles and the outside of the secondary
packaging must 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 not be 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;
(4) The outer packaging must have successfully passed the stacking
test in Sec. 178.606 of this subchapter 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;
(5) For inner receptacles containing liquids, an adequate quantity
of absorbent material must be present to absorb the entire liquid
contents of the inner receptacles; and
(6) 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 siftproof, a means of containing any
liquid or solid contents in the event of leakage must be provided in
the form of a leak-proof liner, plastic bag or other equally effective
means of containment.
(7) In addition, the marking required in Sec. 178.503(f) of this
subchapter must be followed by the letter ``U''.
(l) Packagings subject to this section are not subject to any other
requirements of this subpart, except Sec. 178.608.
Issued in Washington, DC on August 28, 1998, under authority
delegated in 49 CFR part 106.
Alan I. Roberts,
Associate Administrator for Hazardous Materials Safety.
[FR Doc. 98-23665 Filed 8-31-98; 10:20 am]
BILLING CODE 4910-60-P
