Hazardous Materials; Packages Intended for Transport by Aircraft, 27273-27284 [2010-11384]
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Federal Register / Vol. 75, No. 93 / Friday, May 14, 2010 / Proposed Rules
9. In the NPRM, we propose to amend
the amateur service rules to eliminate
the requirement that an amateur station
transmitting a SS emission must
automatically use APC to reduce the
transmitter power when the station
transmits with a power greater than one
watt and to reduce from one hundred
watts to a peak of ten watts the
transmitter power output that an
amateur station may transmit when the
station is transmitting a SS emission.1
Because ‘‘small entities,’’ as defined in
the RFA, are not persons eligible for
licensing in the amateur service, this
proposed rule does not apply to ‘‘small
entities.’’ Rather, it applies exclusively
to individuals who are the control
operators of amateur radio stations.
Therefore, we certify that the proposals
in this NPRM, if adopted, will not have
a significant economic impact on a
substantial number of small entities.
III. Ordering Clauses
10. The Commission’s Consumer and
Governmental Affairs Bureau, Reference
Information Center, shall send a copy of
this Notice of Proposed Rulemaking,
including the Initial Regulatory
Flexibility Certification, to the Chief
Counsel for Advocacy of the Small
Business Administration.
List of Subjects in 47 CFR Part 97
Radio.
Federal Communications Commission
Marlene H. Dortch,
Secretary.
Proposed Rules
For the reasons discussed in the
preamble, the Federal Communications
Commission proposes to amend 47 CFR
part 97 as follows:
PART 97—AMATEUR RADIO SERVICE
1. The authority citation for part 97
continues to read as follows:
Authority: 48 Stat. 1066, 1082, as
amended; 47 U.S.C. 154, 303. Interpret or
apply 48 Stat. 1064–1068, 1081–1105, as
amended; 47 U.S.C. 151–155, 301–609,
unless otherwise noted.
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§ 97.313
[Amended]
2. Section 97.311 is amended by
removing paragraph (d).
3. Section 97.313 is amended by
adding paragraph (j) to read as follows:
§ 97.313
Transmitter power standards.
*
*
*
*
*
(j) No station may transmit with a
transmitter output exceeding 10 W PEP
1 See
47 CFR 97.311(d).
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when the station is transmitting a SS
emission type.
[FR Doc. 2010–11386 Filed 5–13–10; 8:45 am]
BILLING CODE 6712–01–P
DEPARTMENT OF TRANSPORTATION
Pipeline and Hazardous Materials
Safety Administration
49 CFR Parts 171 and 173
[Docket No. PHMSA–07–29364 (HM–231A)]
RIN 2137–AE32
Hazardous Materials; Packages
Intended for Transport by Aircraft
AGENCY: Pipeline and Hazardous
Materials Safety Administration
(PHMSA), DOT.
ACTION: Notice of proposed rulemaking
(NPRM).
SUMMARY: PHMSA proposes to amend
requirements in the Hazardous
Materials Regulations to enhance the
integrity of inner packagings or
receptacles of combination packagings
containing liquid hazardous material by
ensuring they remain intact when
subjected to the reduced pressure and
other forces encountered in air
transportation. In order to substantially
decrease the likelihood of a hazardous
materials release, the proposed
amendments: prescribe specific test
protocols and standards for determining
whether an inner packaging or
receptacle is capable of meeting the
pressure differential requirements
specified in the regulations and,
consistent with the 2011–2012 edition
of the International Civil Aviation
Organization Technical Instructions for
the Safe Transport of Dangerous Goods
by Aircraft (ICAO Technical
Instructions), require the closures on all
inner packagings containing liquids
within a combination packaging to be
secured by a secondary means or, under
certain circumstances, permit the use of
a liner.
DATES: Comments must be received by
July 13, 2010.
ADDRESSES: You may submit comments
identified by the docket number
PHMSA–07–29364 (HM–231A) by any
of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov. Follow the
online instructions for submitting
comments.
• Fax: 1–202–493–2251.
• Mail: Docket Operations, U.S.
Department of Transportation, West
Building, Ground Floor, Room W12–
140, Routing Symbol M–30, 1200 New
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Jersey Avenue, SE., Washington, DC
20590.
• Hand Delivery: To Docket
Operations, Room W12–140 on the
ground floor of the West Building, 1200
New Jersey Avenue, SE., Washington,
DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal
Holidays.
Instructions: All submissions must
include the agency name and docket
number for this notice at the beginning
of the comment. Note that all comments
received will be posted without change
to the docket management system,
including any personal information
provided.
Docket: For access to the dockets to
read background documents or
comments received, go to https://
www.regulations.gov or DOT’s Docket
Operations Office (see ADDRESSES).
Privacy Act: Anyone is able to search
the electronic form of any written
communications and comments
received into any of our dockets by the
name of the individual submitting the
document (or signing the document, if
submitted on behalf of an association,
business, labor union, etc.). You may
review DOT’s complete Privacy Act
Statement in the Federal Register
published on April 11, 2000 (Volume
65, Number 70; Pages 19477–78).
FOR FURTHER INFORMATION CONTACT:
Michael G. Stevens, Office of Hazardous
Materials Standards, Pipeline and
Hazardous Materials Safety
Administration, U.S. Department of
Transportation, 1200 New Jersey
Avenue, SE., Washington, DC 20590–
0001, telephone (202) 366–8553, or
Janet McLaughlin, Office of Security
and Hazardous Materials, Federal
Aviation Administration, U.S.
Department of Transportation, 490
L’Enfant Plaza, SW., Room 2200,
Washington, DC 20024, telephone (202)
385–4897.
SUPPLEMENTARY INFORMATION:
Contents
I. Background
II. Problem
III. ANPRM
A. Studies and Data
B. Pressure Differential Testing
C. Alternatives to Testing
D. Packaging Components
IV. Summary of Proposals in This NPRM
A. Incorporation of Revised ICAO TI
Packaging Provisions
B. Enhanced Pressure Differential
Capability Standard
C. Combined Enhanced Pressure
Differential Capability Standard and
Incorporation of Revised ICAO TI
Packaging Provisions
D. Vibration Testing
V. Regulatory Analyses and Notices
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A. Statutory/Legal Authority for This
Rulemaking
B. Executive Order 12866 and DOT
Regulatory Policies and Procedures
C. Executive Order 13132
D. Executive Order 13175
E. Regulatory Flexibility Act, Executive
Order 13272, and DOT Regulatory
Policies and Procedures
F. Unfunded Mandates Reform Act
G. Paperwork Reduction Act
H. Regulatory Identifier Number (RIN)
I. Environmental Assessment
J. Privacy Act
I. Background
The Hazardous Materials Regulations
(HMR; 49 CFR parts 171–180) authorize
a variety of packaging types for the
transportation of hazardous materials in
commerce. Combination packagings are
the most common type of packaging
used for the transportation of both
liquid and solid hazardous materials by
aircraft. A combination packaging
consists of one or more inner packagings
or one or more articles secured in a nonbulk outer packaging.1
Requirements for combination
packagings used to transport hazardous
materials are set forth in parts 173 and
178 of the HMR. Certain classes and
quantities of hazardous materials may
be transported in ‘‘non-UN standard’’
combination packagings, which are
subject only to the general requirements
in subpart B of part 173, including the
following:
—The packaging must be designed,
constructed, filled, and closed so that
it will not release its contents under
conditions normally incident to
transportation. § 173.24(b)(1).
—The effectiveness of the package must
be maintained to withstand minimum
and maximum temperatures, changes
in humidity and pressure, and shocks,
loadings and vibrations normally
encountered during transportation.
§ 173.24(b)(2).
— Each non-bulk packaging must be
capable of withstanding, without
rupture or leakage, the vibration test
procedure specified in § 178.608 of
this subchapter, which sets forth a
specific test method to measure the
vibration capability of a non-bulk
packaging. § 173.24a(a)(5).
A packaging authorized for
transportation by aircraft must also be
designed and constructed to prevent
leakage that may be caused by changes
in altitude and temperature.
§ 173.27(c)(1). Inner packagings of
combination packagings for which
1 As a receptacle for a liquid or solid, a non-bulk
outer packaging is one that has a maximum capacity
of 450 liters (119 gallons) and, for solid contents,
a maximum net mass of 400 kg (882 pounds).
§ 171.8.
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retention of liquid is a basic function
must be capable of withstanding the
greater of: (1) An internal pressure that
produces a gauge pressure of not less
than 75 kPa for liquids in Packing
Group III of Class 3 or Division 6.1 and
95 kPa for other liquids; or (2) a
pressure related to the vapor pressure of
the liquid to be transported as
determined by specified formulae.
§ 173.27(c). A number of voluntary
industry consensus standards have been
developed, some of which include test
methods intended to evaluate the effects
of pressure differential on packagings at
the various altitudes experienced in the
air transport environment. These
standards-setting organizations have
also conducted measurement studies
and testing to identify the transportation
forces a package encounters and
developed integrity standards and
industry best-practices to ensure the
pressure differential capability standard
is met. This process assists all parties to
design and manufacture packaging with
quality standards that could be used to
verify conformance with capability
requirements. However, these voluntary
industry standards are not included or
referenced in the HMR, and the HMR do
not provide specific guidance to
shippers or packaging manufacturers as
to how to comply with the pressure
differential standards.
Subparts L and M of part 178 contain
UN performance standards for non-bulk
packagings adopted in PHMSA’s ‘‘HM–
181’’ final rules in 1990 and 1991. 55 FR
52401 (December 21, 1990); 56 FR
66124 (December 20, 1991). These
performance standards criteria replaced
the former detailed construction
specifications and provide packaging
design flexibility that is not possible
with detailed design specifications. The
performance criteria require design
qualification testing and periodic
retesting to verify whether a design type
meets the performance standards. For
combination packagings, drop and
stacking testing are required, and the
packaging must be ‘‘capable’’ of passing
a vibration test. §§ 178.603, 178.606,
178.608. The packaging (including the
inner packagings) must be closed for
testing, and tests must be carried out on
the completed package that is prepared
for testing, in the same manner as if
prepared for transportation. § 178.602.
In the HM–181 advance notice of
proposed rulemaking (47 FR 16268
(April 15, 1982)) and the notice of
proposed rulemaking (52 FR 16482
(May 5, 1987)), we proposed to require
the hydrostatic pressure test in
§ 178.605 to be performed on all inner
packagings of UN standard combination
packaging designs intended for
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transportation by aircraft. The pressure
test would have addressed pressure
differentials encountered during air
transportation. This amendment was not
adopted in the final rule. 55 FR 52402
(December 21, 1990). Instead, consistent
with the ICAO Technical Instructions
and the HMR in effect at the time, we
elected to continue the requirement for
all packagings containing liquids offered
or intended for transportation aboard
aircraft to be capable of withstanding
without leakage a specified pressure
differential. § 173.27(c).
Since that time, ICAO has added a
note to Part 4; 1.1.6 of the Technical
Instructions stating that the capability of
a packaging to meet the pressure
differential performance standard
should be determined by testing, with
the appropriate test method selected
based on packaging type. However,
ICAO has not adopted specific test
methods in the Technical Instructions.
Because the HMR do not specify test
methods for verifying that a packaging
meets the pressure differential
requirement, some shippers and
packaging manufacturers have used
historical data (i.e., lack of incidents)
and other methods (e.g. computer
modeling, analogies, or engineering
studies) to demonstrate that their
packagings satisfy the pressure
differential capability requirement.
Shippers and packaging manufacturers
have differing views on how the
requirements are to be verified, and use
various test methods to demonstrate
compliance. This leads to a non-uniform
approach, and it is difficult for PHMSA
and FAA to verify whether a package
meets the pressure differential
requirement because no test report,
documentation, or other proof of
compliance is required by the HMR.
Additionally, it does not provide an
effective method of oversight to
determine whether regulatory
requirements are meeting actual forces
encountered in transportation. If there is
no control, the evaluation of quality and
failure analysis is not possible. Even the
most conscientious and safety-focused
shippers have difficulty understanding
how to comply with the requirements in
§ 173.27. Other shippers and packaging
manufacturers may be taking advantage
of the absence of specific requirements
for verifying compliance.
The absence of specific test methods
in the HMR leads to inconsistencies in
package integrity and results in varying
levels of compliance among shippers.
References to the pressure differential
requirements in § 173.27(c) are found
throughout the regulations for
packagings and packages offered for air
transportation and transported by
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aircraft without methods specified to
verify compliance with this critical
safety requirement. This results in wide
disparities in packaging quality and the
potential for sub-standard packages to
be introduced into the air transport
environment, increasing the probability
of releases of hazardous materials
aboard aircraft. In addition, some
shippers or manufacturers may not
realize that inner packagings of non-UN
standard combination packagings are
required to meet the pressure
differential capability requirements of
the HMR and the ICAO Technical
Instructions. This includes packagings
authorized under the limited quantity,
consumer commodity, and Category B
Biological Substance exceptions. A
significant percentage of aircraft
incidents involving liquid hazardous
materials appear to result from failures
of these packagings. We strongly believe
the introduction of specific test methods
and amendments that clarify the
requirements for packagings offered for
transportation by aircraft will enhance
safety by reducing risk and level the
playing field for shippers,
manufacturers and air carriers alike.
II. Problem
When a package reaches high
altitudes during transport, it
experiences low pressure on its exterior.
This results in a pressure differential
between the interior and exterior of the
package since the pressure inside
remains at the higher ground-level
pressure. Higher altitudes create lower
external pressures and, therefore, larger
pressure differentials. This condition is
especially problematic for combination
packagings containing liquids. When an
inner packaging, such as a glass bottle
or plastic receptacle, is initially filled
and sealed, the cap must be tightened to
a certain torque to obtain sealing forces
sufficient to contain the liquids in the
packaging. This will require certain
forces to be placed upon the bottle and
cap threads as well as the sealing
surface of the cap or cap liner to ensure
the packaging remains sealed. Once at
altitude, due to the internal pressure of
the liquid acting upon the closure
combined with the reduced external air
pressure, the forces acting on the
threads and the forces acting on the
sealing surfaces will not be the same as
when the packaging was initially closed.
Under normal conditions encountered
in air transport (26 kPa reduction in
pressure at 8000 ft), the pressure
differentials are not overly severe.
However, if the compartment is
depressurized at altitude or if the
compartment is not pressurized at all,
such as on certain ‘‘feeder’’ aircraft, the
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pressure differential may be severe
enough to cause package failure and
release of the hazardous materials in the
aircraft. High-altitude stresses are
encountered when cargo and feeder
aircraft transport packages in nonpressurized or partially-pressurized
cargo holds.
A seemingly ‘‘minor’’ incident can
quickly escalate and result in
irreversible, possibly catastrophic,
consequences. For example, a closure
failure of an inner container could cause
an outer package to fail, resulting in
fumes, smoke or flammable liquid
acting as a catalyst to a more serious
incident. The interaction of events
occurring on aircraft, such as electrical
fires, static electricity or other materials
interacting with the leaking material,
could result in a catastrophic event. The
successful testing of inner packaging
designs may lower the likelihood of
such an event. Taking a systems-safety
approach that includes multiple safety
processes and redundancies can prevent
a minor incident from becoming
potentially much worse.
PHMSA, FAA and, more recently,
several international competent
authorities all agree that the testing of
design samples or prototypes of inner
packagings or receptacles for pressure
differential capability is key to
preventing package failure in air
transport. Testing also forms the basis of
current performance standards in both
the HMR and international regulations.
Additionally, incident data and
compliance verification testing of
combination packagings intended for air
transport and readily available in the
marketplace indicate that an
unacceptable number of packagings are
not able to withstand pressure
differential conditions normally
incident to air transportation. Again, the
packagings of particular concern are
packagings that must be ‘‘capable’’ of
meeting pressure differential
requirements, but are not required to be
certified as meeting a specific
performance test method to verify
compliance with pressure differential
performance standards. Incident data
continue to show that packagings are
leaking aboard aircraft; this likely is in
part attributable to the fact that the HMR
do not specifically provide test methods
for determining that packagings meet
the minimum pressure differential
performance necessary to withstand
conditions of air transport. It cannot be
overemphasized that any incident, such
as a package failure, involving
hazardous materials in air
transportation is unacceptable.
Four recent studies simulated the
impact of high-altitude on package
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integrity. These conditions result in
extreme changes in pressure when
compared to packages being transported
at or close to sea level. These four
studies were discussed in detail in the
ANPRM published under this docket
[73 FR 38361; July 7, 2008] and are
available for review at https://
www.regulations.gov.
In the first study, FAA analyzed
incident data from the DOT Hazardous
Materials Information System (HMIS)
for the years 1998 and 1999 and focused
on properly declared hazardous material
shipments. The study concluded that of
1,583 air incidents reported to PHMSA,
a failure of inner packagings in
combination packaging designs
contributed to 333 spills or leaks. In the
second study, United Parcel Service
(UPS) presented its findings to the
American Society of Testing and
Materials (ASTM) outlining the
conditions that packages experience in
the air transport environment. In 2002,
the FAA initiated a study with Michigan
State University (MSU) to replicate
actual air and pre- and post-truck
transportation conditions to determine
which conditions contribute to package
failures. In this third study on
conditions experienced in air
transportation, FAA examined the
effects of vibration alone, altitude alone,
and a combination of vibration and
altitude on the performance of UN
standard hazardous material
combination packages containing
liquids. In 2003, PHMSA also initiated
a study with MSU to compare the HMR
requirements and the testing used in the
FAA/MSU study to provide for a more
thorough evaluation of the performance
of liquid hazardous materials in
combination packagings when subjected
to the conditions of air transport. This
fourth round of testing was conducted
on a smaller number of packaging
designs; however, a much greater
number of packagings of each design
were tested in the study.
During the first half of 2007, PHMSA
conducted a comprehensive assessment
of hazardous materials transportation
incidents occurring in air transportation
from 1997 through 2006. This study and
its corresponding data may be accessed
in the public docket for this rulemaking.
The study concluded that there has been
no appreciable reduction in package
failures over the past 10 years. It is
estimated that 191,429 tons of liquid
hazardous materials contained in
approximately 16.9 million combination
packages are transported by aircraft
annually. Of that total, the analysis
concluded that approximately 483
combination packagings containing
liquids fail in air transportation each
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year with an average of two incidents
reported as ‘‘serious.’’ 2 However, any
incident, such as a package failure,
involving hazardous materials in air
transportation is unacceptable.
The 2007 study concluded that of the
approximately 483 air incidents
reported each year, at least 44 percent
involved the failure of inner packaging
closures within a combination outer
packaging as the primary cause. Such
failures could have been the result of
pressure differential (packages closed at
sea level subjected to lower pressure on
planes), stress relaxation of the closure
(closures that appear tight but loosen
during transportation), improper
closures, vibration, or some other cause.
The analysis also suggested that most
incidents involved combination
packagings containing flammable
liquids (e.g., paint and paint related
material) of varying degrees of hazard.
Some additional statistical data from the
2007 incident review include:
• Over 40% of failures of
combination packages containing
liquids in air transportation involve
closures and/or inner receptacles.
• Flammable liquids are the most
common liquid hazardous materials
released from failed packages in air
transportation. If such materials found
an ignition source, it could result in a
fire or explosion.
• In incident years 2005–2006, 18 of
953 incidents involving combination
packagings containing liquids, or 2%,
occurred on passenger-carrying aircraft.
Although low when compared to
incidents occurring on cargo-carrying
aircraft, this percentage of package
failures continues to be a troubling
statistic.
• Combination packages containing
liquids that fail in air transportation
release an average 2 liters (0.5 gallons)
of liquid hazardous materials.
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III. ANPRM
On July 7, 2008, PHMSA published an
advance notice of rulemaking (ANPRM;
73 FR 38361) seeking to identify costeffective solutions to reduce incident
rates and the potential severity of
incident consequences without placing
2 The HMR define a ‘‘serious incident’’ as one that
involves one or more of the following: (1) A fatality
or major injury caused by the release of a hazardous
material; (2) the evacuation of 25 or more persons
as a result of release of a hazardous material or
exposure to fire; (3) a release or exposure to fire
which results in the closure of a major
transportation artery; (4) the alteration of an aircraft
flight plan or operation; (5) the release of
radioactive materials from Type B packaging; (6) the
release of over 45 liters (11.9 gallons) or 40
kilograms (88.2 pounds) of a severe marine
pollutant; or (7) the release of a bulk quantity (over
450 liters (119 gallons) or 400 kilograms (882
pounds)) of a hazardous material. § 171.15.
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unnecessary burdens on the regulated
community. We solicited comments on
how to accomplish these goals,
including measures to: (1) Enhance the
effectiveness of performance testing for
packagings used to transport hazardous
materials on aircraft; (2) more clearly
indicate the responsibilities of shippers
that offer packages for air transport in
the HMR; and (3) authorize alternatives
for enhancing package integrity. We
asked a series of questions related to the
packaging of liquid hazardous materials
in combination packagings that are
offered for transportation and
transported by aircraft. A total of 13
persons submitted comments in
response to the ANPRM; the list of
commenters includes:
AHS Association of Hazmat Shippers, Inc.
Ecolab Ecolab, Inc.
ALPA Air Line Pilots Association,
International
COSTHA The Council on Safe Transportation
of Hazardous Articles, Inc.
IOPP Institute of Packaging Professionals
CPC Chemical Packaging Committee
FedEx Federal Express
ISTA International Safe Transit Association
ASTM ASTM International
ICC ICC The Compliance Center, Inc.
MSU Michigan State University School of
Packaging
Viking Viking Packing Specialist
DGAC Dangerous Goods Advisory Council
Commenters generally agree that
regulatory changes are necessary to
address safety issues related to the
transportation of hazardous materials in
non-UN standard packagings on board
aircraft. However, commenters had
varying views on the scope of the safety
problem or specific regulatory
amendments necessary to eliminate or
reduce problems should they exist.
Some commenters also questioned the
validity of studies conducted and
analysis of the underlying data used that
motivated PHMSA to initiate
rulemaking action. These comments are
summarized below.
A. Studies and Data
As indicated previously, recent
studies have simulated the impact of
high altitudes on packaging integrity.
These studies suggest that the current
testing requirements (or lack thereof)
under the HMR may not adequately
address the conditions encountered
during air transportation. Moreover, a
review of incident data conducted by
FAA and PHMSA supports the
conclusion that some combination
packaging designs used to transport
hazardous materials by aircraft may not
meet the capability standards mandated
under the HMR. Indeed, the testing
conducted suggests that the capability
standards themselves may not be
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sufficiently rigorous to ensure that
packagings maintain their integrity
under conditions normally incident to
air transportation. Study data, incidents,
and several years of feedback from
industry indicate that, without specific
standards and protocols, a consistent
approach to compliance cannot be
achieved. This can lead to a potentially
unsafe condition.
Some commenters cited concerns over
how two of the studies were conducted
or suggested that the problems
discussed in the ANPRM may not be as
serious as presented. For example,
Ecolab identifies what it contends are at
least three discrepancies in the two air
packaging integrity studies conducted
by MSU in 2002 and 2003 on behalf of
PHMSA and FAA. Ecolab contends that
these discrepancies, identified by CPC
and published in a 2006 Hazmat
Packager and Shipper article, occurred
because some of the tests utilized for the
studies were not conducted in
accordance with the HMR or
corresponding international standards.
One study allegedly used an improper
closure design that differed from the
originally tested design. CPC asserted
that the improper closure design used in
the study raised the number of
packaging failures from 14 to 42, an
increase of 75%. In its comments,
Ecolab contends that a successfully
tested package will not leak when
closed properly and subjected to normal
conditions of air transport. As a result
of conclusions drawn from these initial
studies and to address challenges made
to the assumptions used in their
methodology, further studies were
budgeted and carried out. PHMSA and
FAA acknowledge that some of the
studies utilized packagings that did not
conform in all respects with HMR
requirements. The characteristics of the
packagings tested were fully disclosed
in the study reports. We do not agree
that the minor differences in the
closures used affects the conclusions of
the studies. We note that the studies
were not used to determine compliance
with HMR requirements, but rather to
measure the capability of commercially
available packaging designs to
withstand the unique conditions
encountered in air transportation.
Although most commenters support
the actual testing of inner packaging
designs for pressure differential
capabilities, several commenters doubt
that incidents are occurring in air
transport as a result of the lack of actual
testing. AHS notes that incident reports
submitted to PHMSA in accordance
with reporting requirements in § 171.16
of the HMR do not indicate whether an
inner packaging failed because it had
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not been tested or because it was not
capable of withstanding forces
encountered in transportation. We note
that it is highly unlikely that a carrier
or other entity without intimate
knowledge of a packaging’s design or
overall integrity would be able to report,
as a root cause, that an incident that
occurred in air transportation resulted
from a lack of actual testing or the
packaging’s inability to withstand the
forces inherent to transportation by
aircraft. However, by carefully analyzing
available incident data and conducting
controlled laboratory studies of
commercially available packaging
designs, we can conclude that the actual
testing for pressure differential
capability was either conducted
incorrectly or not conducted at all.
COSTHA contends that PHMSA
should not be alarmed if leakage from
an inner packaging is contained within
its outer packaging and suggests that
seepage from a closure over time should
be evaluated differently than a complete
failure where the entire contents of an
inner packaging are released within an
outer packaging. We disagree. A
successfully tested and properly filled
and closed inner packaging design
should not leak under normal
conditions encountered in air
transportation. Additionally, an inferior
inner packaging design or component
would be identified through the pass/
fail criteria when originally tested.
Because the primary receptacle within a
combination packaging system is the
most important component of that
system in air transport, it should not fail
except under extreme or highly
abnormal conditions.
Regarding the distribution hazards
experienced in today’s air transport
environment, Ecolab asserts that
shipments have always been subjected
to multiple flight segments and any
consequences resulting from that
environment. Ecolab is correct;
however, although shipments have
routinely utilized multiple flight
segments in the past, the proliferation of
sort systems and feeder aircraft systems
has changed the environment shipments
normally encountered during transit.
Today, air carriers use multiple
mechanical handling systems to sort
packages, and the number of
distribution points has grown with the
natural expansion of commerce.
In its comments, Ecolab states that
better enforcement of existing
regulations related to packaging
integrity is key to reducing the number
of incidents in air transportation. We
agree. Once verifiable and repeatable
testing standards are adopted in the
HMR, shippers, packaging test labs, and
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government regulators can all measure
packaging integrity using the same
process, procedures, and protocols.
Consistency is the most efficient and
effective way to measure success or
failure. Ecolab also notes that, according
to PHMSA’s HMIS incident database,
human error is cited as an accident
cause six times more frequently than
packaging failure. An example of human
error could be the deliberate or
inadvertent consequences resulting from
failure to follow a packaging
manufacturer’s customer notification or
closure instructions. An example of
packaging failure would be differences
in manufacturing tolerances that result
in leakage (failure) from an otherwise
properly closed inner packaging design.
Again, this supports the multi-layered
safety system concept.
B. Pressure Differential Testing
In the ANPRM, we noted that because
specific test methods are not included
in the HMR or the ICAO Technical
Instructions, there are inconsistencies in
package integrity and varying levels of
compliance among shippers. For
example, because the pressure
differential and vibration capability
standards for combination packagings
are not required to be verified by test
protocols, some shippers (self-certifiers)
or manufacturers have used historical
shipping data, computer modeling,
analogies to tested packagings,
engineering studies, or similar methods
to determine that their packagings meet
pressure differential and vibration
capability standards.
Shippers, carriers, packaging
manufacturers, and testing facilities
generally agree that the current
capability requirements for air
packagings are difficult to comply with
and suggest that specific test methods
designed to demonstrate that packagings
will withstand conditions encountered
during air transportation should be
specified in the HMR. Ecolab states that
the current regulatory language in the
HMR regarding the pressure differential
capability of inner packagings should be
replaced with recognized industry
standards for testing and no additional
testing should be proposed. ALPA
recommends that the HMR incorporate
the language contained in the ICAO
Technical Instructions clarifying test
methods and responsible parties. For
example, the ICAO Technical
Instructions suggest test methods
appropriate for certain types of inner
packagings and liquid hazardous
materials in order to promote
compliance with the prescribed
performance standard. ALPA contends
the lack of standardized, easily
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understandable testing protocol
contributes to incidents in air
transportation. Ecolab and Viking both
agree that, to properly determine the
capability of a packaging design, it must
first be tested. ISTA asserts that the
simultaneous combination of low
pressure and vibration exerted on a
package is the only way to accurately
replicate conditions encountered by a
package in air transportation.
The HMR and ICAO Technical
Instructions both require that a shipper
consider the pressure differential
capability for an inner packaging
intended to contain a mixture or
solution based on its vapor pressure.
Many commenters agree that
determining the vapor pressure of a
mixture or solution is problematic,
costly, and does not materially
contribute to reducing the likelihood of
packaging failure. Ecolab believes that a
95 kPa differential capability is a
realistic and attainable indication of
inner packaging integrity and that the 75
kPa capability for some hazard classes
and packing groups should be
eliminated for clarity and increased
safety. In addition, Ecolab states that
PHMSA should codify any testing
protocol adopted in Subpart M of Part
178. Because the proposed amendments
in this notice apply to non-UN standard
packagings as well as UN standard
packagings, and the Part 178
requirements apply to UN standard
packagings only, it is appropriate that
the amendments proposed in this notice
be codified in § 173.27. We appreciate
and understand commenter frustration
with regard to calculating the vapor
pressure of a mixture or solution to
determine the appropriate packaging
capable of withstanding the prescribed
pressure differential. In this NPRM, we
are proposing an alternative method that
can be used to calculate the appropriate
packaging required for a mixture or
solution without testing to determine
vapor pressure.
C. Alternatives to Testing
The HMR and ICAO Technical
Instructions both allow a liquid
hazardous material to be contained in
an inner packaging that does not itself
meet the pressure differential
performance standard, provided that the
inner packaging is packed within a
supplementary packaging that does
meet the pressure requirements. In their
comments, AHS and ICC ask PHMSA to
retain in the HMR the option for a
shipper to use supplementary packaging
that meets the pressure differential
requirements. PHMSA agrees with
commenters on this issue and is not
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proposing to amend the HMR to do
otherwise.
The HMR currently permit the use of
variations in inner packagings of a
tested combination package, without
further testing of the package, provided
an equivalent level of performance is
maintained under conditions prescribed
in § 178.601. ICC states that a packaging
designed to successfully withstand the
§ 178.601(g)(2) Variation 2 test protocols
should not be required to contain inner
packagings capable of meeting the
pressure differential and vibration
capabilities of the HMR. We disagree. A
primary inner packaging or receptacle of
known or questionable inferiority is
unacceptable in air transportation
regardless of whether the outer
packaging is of a higher integrity. No
other commenters opposed actual
testing of inner packagings of
combination packagings intended to
contain liquids for transportation by
aircraft.
ICAO recently adopted revised
packaging instructions for incorporation
in the ICAO Technical Instructions that
will become effective January 1, 2011.
The new packing instructions require a
secondary means of closure for all
liquids in combination packagings. This
requirement may be satisfied by using a
liner or other form of containment when
the secondary means of closure cannot
be applied. Inner packagings containing
liquids of Packing Group I must be
placed in rigid leakproof receptacles
with absorbent material before placing
them in outer packagings of a
combination package. None of the
comments submitted to the ANPRM
oppose this requirement; those who did
comment on this requirement support
its adoption in the HMR.
D. Packaging Components
Many commenters state that pressure
differential and vibration capability
standards should apply to both
specification and non-specification
packaging designs. Ecolab asserts that a
properly tested and closed inner
packaging design offers no risk in air
transport. In evaluating the inherent
risks assumed in air transportation and
the potential for high consequence
events should an incident occur, ALPA
supports multiple layers of redundancy
to include actual testing of inner
packaging designs and the use of liners,
absorbent material, and secondary
means of closure. Commenters agree
that the interaction between an inner
packaging containing a liquid and its
closure are critical in air transport.
COSTHA believes that if any component
of a tested design is changed, and it is
not an exact replacement, quality review
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and testing is required. Viking believes
that a successfully tested inner
packaging is only one (albeit a major
one) part of a closure system that also
uses a protective liner and is properly
oriented when stored or transported.
PHMSA and FAA both agree that the
verification of packaging integrity
through testing and the additional
redundant amendments proposed in
this notice will ensure consistency in
the quality of packagings used for the air
transport of liquid hazardous materials
and mitigate or eliminate the
consequences of an incident or accident
should one occur.
IV. Summary of Proposals in This
NPRM
Because aircraft accidents caused by
leaking or breached hazardous materials
packages can have significant or
catastrophic consequences, the air
transportation of hazardous materials
requires clear standards, exceptional
diligence, and attention to detail. To
address the regulatory deficiencies
previously described in detail, we are
proposing amendments to the HMR to
strengthen the integrity of packages
intended for transport by aircraft.
Most commenters support adoption of
the ICAO Technical Instructions
requirement for a secondary means of
closure and utilization of a liner if such
secondary means of closure is infeasible
or impracticable. Further, most
commenters agree that the most
effective means to ensure that
combination packagings are capable of
meeting specified performance
standards is actual testing. We agree.
Therefore, in this NPRM we are
proposing to adopt the new ICAO
Technical Instructions requirements for
combination packagings and test
protocols that may be used to
demonstrate that such packagings
conform to applicable performance
standards. If adopted, these
amendments will add clarity to the
processes required in determining
whether a packaging design is capable
of meeting the forces encountered in air
transportation. We are confident that
these enhancements to current
regulatory requirements will result in a
higher level of safety in air
transportation by reducing the
likelihood of combination package
failures in air transportation.
The following is a summary of the
proposals in this NPRM.
A. Incorporation of Revised ICAO
Technical Instructions Packaging
Provisions
Currently under the HMR, stoppers,
corks, or other such friction-type
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closures must be held securely, tightly,
and effectively in place by positive
means. See § 173.27(d). However, a
screw-type closure on any packaging
must only be secured to prevent the
closure from loosening due to ‘‘vibration
or substantial change in temperature.’’
We have stated in letters of clarification
that a secured closure should
incorporate a secondary means of
maintaining a seal, such as a shrinkwrap band or heat sealed liner. (We
have included three of those letters (02–
0302 dtd. January 23, 2003; 04–0011
dtd. May 12, 2004; 07–0174 dtd. March
17, 2008) in the docket for information
and guidance.) Additionally, laboratory
studies conducted on behalf of PHMSA
and FAA concluded that a simple
application of tape on a screw-type
closure prevented ‘‘back-off’’ under even
extreme conditions. We also note for the
purposes of this notice that:
• Liners typically must be manually
inserted into a packaging before filling.
Because most packaging systems can be
automated or are already automated
with some form of secondary closure
being applied, costs and regulatory
burden to shippers should be minimal.
• Most Packing Group I liquids
already require a leakproof liner in the
HMR and ICAO Technical Instructions.
• A liner or secondary means of
positive closure should not affect an
existing UN standard packaging design
as in most cases it will not be
considered a new design.
• Requiring a secondary positive
means of closure combined with
required verification of pressure
differential capability adds a layered
systems-approach to air transportation
safety.
Packaging failures in air
transportation often are the result of
closures that have loosened in
transportation. Such leaks are
potentially dangerous in all modes of
transportation, but have the potential for
catastrophic results in air
transportation. Therefore, we are
proposing to revise § 173.27(d) to clearly
state that all friction and screw type
closures must be secured by a secondary
means of positive closure. We believe
that adoption of this requirement
provides a necessary added level of
protection to prevent packages from
leaking in air transportation. For liquids
assigned to Packing Groups II or III, a
leakproof liner may be used to satisfy
the secondary closure requirement
where it cannot be applied or it is
impracticable to apply. For liquids of
Packing Group I, we are proposing to
revise § 173.27(e) to require secondary
means of closure, absorbent material,
and a rigid, leakproof liner or
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intermediate packaging. Also, for clarity
we are proposing to remove the
reference to Division 5.2 materials from
the § 173.27(e) introductory text.
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B. Enhanced Pressure Differential
Capability Standard
Currently, the HMR require all
packagings containing liquid hazardous
materials intended for transportation by
aircraft to be capable of withstanding,
without leakage, an internal gauge
pressure of at least 75 kPa for liquids in
Packing Group III of Class 3 or Division
6.1 or 95 kPa for all other liquids, or a
pressure related to the vapor pressure of
the liquid to be conveyed, whichever is
greater. See § 173.27(c). This
requirement also applies to liquids
excepted from specification packaging,
such as limited quantities and consumer
commodities. Liquids contained in
inner receptacles that do not meet the
minimum pressure requirements in
§ 173.27(c) may be placed into
receptacles that do meet the pressure
requirements to ensure that the
completed packaging—inner receptacles
plus outer packaging—will withstand
pressures typically encountered in air
transportation. Single and composite
packagings, or any packaging subject to
hydrostatic pressure testing under
§ 178.605, must have a marked test
pressure of not less than 250 kPa for
liquids in Packing Group I, 80 kPa for
liquids in Packing Group III of Class 3
or Division 6.1, and 100 kPa for other
liquids.
As discussed in detail earlier in this
preamble and in the ANPRM, testing
conducted on behalf of FAA and
PHMSA indicates that many
combination packagings fail when
subjected to conditions intended to
simulate the pressures encountered in
the air transportation environment. One
possible conclusion is that these
packagings might not be capable of
meeting the pressure differential
capability standards. Without testing
there is no assurance that these
packagings are capable of meeting the
prescribed standards. For air
transportation, such deficiencies in
packaging integrity are unacceptable.
In this notice, we are proposing that
conformance with the pressure
differential requirements for rigid
packagings may be demonstrated by
testing performed in accordance with
ASTM D6653, ‘‘Standard Test Methods
for Determining the Effects of High
Altitude on Packaging Systems by
Vacuum Method’’ or ASTM D4991,
‘‘Standard Test Method for Leakage
Testing of Empty Rigid Containers by
Vacuum’’.
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For flexible packaging, we are
proposing that conformance with the
pressure requirements may be
demonstrated by pressure differential
testing performed in accordance with
ASTM F 1140, ‘‘Standard Test Methods
for Internal Pressurization Failure
Resistance of Unrestrained Packages for
Medical Applications’’, ASTM D 3078,
‘‘Standard Test Method for
Determination of Leaks in Flexible
Packaging by Bubble Emission’’ or a
generic test method outlined in a
proposed new Appendix E to Part 173.
Additional test methods that may be
used to confirm pressure differential
capability are the hydrostatic pressure
test in § 178.605 and the International
Safe Transit Association’s ‘‘ISTA 3A,
Packaged-Products for Parcel Delivery
System Shipment 70 kg (150 lb) or Less.’’
However, the ISTA 3A test method is
considered more costly and complex
due to the high cost of equipment and
specialized operators needed to conduct
it.
We have recently had the privilege of
working with the German Federal
Institute for Materials Research and
Testing (BAM) on the problematic issue
of calculating vapor pressures for
liquids at the transportation reference
temperatures (50–55 °C) as well as for
mixtures and solutions. The proposed
table in Appendix E of this notice
provides guidance on determining these
values based on the relationship
between boiling points and vapor
pressures. It allows the shipper or
product manufacturer to estimate the
required capability (test pressure) of
their packaging based on the individual
constituent in a mixture or solution
with either the lowest boiling point or
the highest vapor pressure at 50 °C. We
invite comments on this potentially very
positive initiative.
C. Combined Enhanced Pressure
Differential Capability Standard and
Incorporation of Revised ICAO
Technical Instructions Packaging
Provisions
Laboratory studies have shown that
testing inner packagings or receptacles
of commercially available combination
packaging designs intended or marketed
as authorized for transportation by
aircraft achieves an approximate
effectiveness rating of 95 percent, with
the current compliance rate among
shippers unknown. The current
compliance rate for the use of liners or
secondary means of positive closure by
shippers is estimated to be at least 70 to
90 percent, with an effectiveness rate of
95 to 100 percent. Consequently, we
have decided to propose in this notice
a combination of both regulatory
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alternatives to achieve our objective of
a cost-effective systems approach to
safety that provides redundancy where
necessary and promotes compliance by
issuing regulations that are clear and
easier to understand.
D. Vibration Testing
Section 173.27(c) of the HMR
prescribes a pressure differential
capability standard for inner packagings
of combination packagings intended for
air transport. In addition, in accordance
with § 178.608, combination packagings
must be capable of passing a prescribed
vibration test. As discussed in detail
elsewhere in this preamble, in order to
substantially decrease the likelihood of
a hazardous materials release in air
transport, we are proposing to prescribe
specific test protocols and standards for
determining whether an inner package
or receptacle is capable of meeting the
pressure differential requirements
specified in the regulations. However,
we are not proposing to revise the
current vibration capability standard.
Testing to ascertain conformance with a
pressure differential capability standard
is significantly more cost effective than
testing to ascertain conformance with a
vibration capability standard. Vibration
testing generally requires more
expensive equipment and specially
trained operators. Moreover, laboratory
studies have concluded that the
application of a secondary means of
closure to a packaging capable of
withstanding the pressure differentials
encountered in air transport
substantially reduces the overall failure
rate of packages.
It is our understanding that a number
of shippers and packaging vendors
currently use random vibration tests,
such as those in the ISTA 3A or ASTM
D 4169 standards, in combination with
pressure differential testing for
packagings intended for air transport.
While the HMR prescribe a specific
vibration test protocol, it appears that
the recognized random vibration test
methods, combined with pressure
differential testing, achieve the intent of
the test protocols in the HMR—that is,
to ensure that the packaging will
withstand environmental conditions
normally encountered in air
transportation. In our opinion, the use
of sequential or combined pressure
differential and vibration testing in
accordance with ISTA, ASTM, or other
test protocols would exceed the current
capability standards for pressure
differential and vibration for packages
intended for air transportation. We
would consider that inner containers
demonstrating conformance to these
standards would not be required to
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undergo further testing for pressure or
vibration capability standards when
placed in an outer packaging for
packages intended for air transportation.
As discussed in greater detail in Section
III of this notice, for certain types of
packagings, the HMR provide for
separate testing of packaging
components so that if one component
conforms to the applicable performance
standard, the secondary components
need not meet those standards.
V. Rulemaking Analysis and Notices
A. Statutory/Legal Authority for This
Rulemaking
This NPRM is published under
authority of Federal hazardous materials
transportation law (Federal hazmat law;
49 U.S.C. 5101 et seq.). Section 5103(b)
of Federal hazmat law authorizes the
Secretary of Transportation to prescribe
regulations for the safe transportation,
including security, of hazardous
materials in intrastate, interstate, and
foreign commerce.
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B. Executive Order 12866 and DOT
Regulatory Policies and Procedures
This proposed rule is a significant
regulatory action under section 3(f)
Executive Order 12866 and, therefore,
was reviewed by the Office of
Management and Budget (OMB). The
proposed rule is a significant rule under
the Regulatory Policies and Procedures
order issued by the U.S. Department of
Transportation (44 FR 11034). We have
completed a regulatory evaluation and
placed it in the docket for this
rulemaking.
In this rulemaking, we considered
three regulatory alternatives: (1) Require
a secondary means of closure on inner
packagings or a liner in all combination
packaging designs containing liquids;
(2) require testing to determine whether
an inner packaging intended to contain
liquids is capable of withstanding the
reduced pressures of air transport; or (3)
require a combination of both regulatory
alternatives. We are proposing the
combination alternative, number 3.
Costs for the combination alternative
range from $2.2M to $5.7M while net
benefits range from $41.6M to $67.9M.
at a 7% discount rate over a 10-year
period. Benefit-cost ratios for the
combination alternative range from 7.3:1
to 31.5:1. We invite commenters to
address the potential costs of the
enhanced packaging requirements in
this notice, including the number of
inner and outer packaging designs that
would be affected.
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C. Executive Order 13132
This notice has been analyzed in
accordance with the principles and
criteria contained in Executive Order
13132 (‘‘Federalism’’). This notice
preempts State, local and Indian tribe
requirements but does not propose any
regulation with 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))
preempting State, local and Indian tribe
requirements on the following subjects:
(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 notice addresses covered subject
item (5) described above and preempts
State, local, and Indian tribe
requirements not meeting the
‘‘substantively the same’’ standard.
Federal hazardous materials
transportation law provides at 49 U.S.C.
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 notice and not later than
two years after the date of issuance. The
effective date of Federal preemption of
this notice will be 90 days from
publication in the Federal Register.
D. Executive Order 13175
This notice has been analyzed in
accordance with the principles and
criteria contained in Executive Order
13175 (‘‘Consultation and Coordination
with Indian Tribal Governments’’).
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Because this proposed rule does not
have tribal implications and does not
impose direct compliance costs, the
funding and consultation requirements
of Executive Order 13175 do not apply.
E. Regulatory Flexibility Act, Executive
Order 13272, and DOT Procedures and
Policies
The Regulatory Flexibility Act (5
U.S.C. 601–611) requires each agency to
analyze proposed regulations and assess
their impact on small businesses and
other small entities to determine
whether the proposed rule is expected
to have a significant impact on a
substantial number of small entities. A
regulatory evaluation for this NPRM,
which includes a detailed small
business impact analysis, is in the
public docket for this rulemaking. Based
on the analysis in the public docket, I
certify that while this notice will impact
a significant number of small entities, it
will not have a significant economic
impact on a substantial number of small
entities.
This notice has been developed in
accordance with Executive Order 13272
(‘‘Proper Consideration of Small Entities
in Agency Rulemaking’’) and DOT’s
procedures and policies to promote
compliance with the Regulatory
Flexibility Act to ensure potential
impacts of draft rules on small entities
are properly considered.
F. Unfunded Mandates Reform Act of
1995
This notice does not impose
unfunded mandates under the
Unfunded Mandates Reform Act of
1995. It will not result in costs of $141.3
million or more, in the aggregate, to any
of the following: State, local, or Native
American tribal governments, or the
private sector.
G. Paperwork Reduction Act
PHMSA currently has an approved
information collection under Office of
Management and Budget (OMB) Control
Number 2137–0572, ‘‘Testing
Requirements for Non-Bulk Packaging,’’
with an expiration date of March 31,
2010. This NPRM may result in an
increase in the annual burden and costs
of this information collection due to
proposed changes to require packaging
manufacturers to conduct testing to
confirm that a combination packaging
intended for the air transportation of
liquid hazardous materials is capable of
withstanding the pressures encountered
on board aircraft and to maintain a
documented record of the test results.
Under the Paperwork Reduction Act
of 1995, no person is required to
respond to an information collection
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unless it has been approved by OMB
and displays a valid OMB control
number. Section 1320.8(d), title 5, Code
of Federal Regulations requires that
PHMSA provide interested members of
the public and affected agencies an
opportunity to comment on information
and recordkeeping requests.
This notice identifies a revised
information collection request that
PHMSA will submit to OMB for
approval based on the requirements in
this proposed rule. PHMSA has
developed burden estimates to reflect
changes in this proposed rule, and
estimates the information collection and
recordkeeping burden as proposed in
this rule to be as follows:
OMB Control No.: 2137–0572.
Annual Number of Respondents:
1,496.
Annual Number of Responses: 29,712.
Annual Burden Hours: 54,525.
Annual Burden Costs: $1,557,779.25.
PHMSA specifically requests
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 this
information collection should be
directed to Deborah Boothe or T. Glenn
Foster, Office of Hazardous Materials
Standards (PHH–11), Pipeline and
Hazardous Materials Safety
Administration, 1200 New Jersey
Avenue, SE., Washington, DC 20590–
0001, Telephone (202) 366–8553.
Address written comments to the
Dockets Unit as identified in the
ADDRESSES section of this rulemaking.
We must receive comments regarding
information collection burdens prior to
the close of the comment period
identified in the DATES section of this
rulemaking. In addition, you may
submit comments specifically related to
the information collection burden to the
PHMSA Desk Officer, Office of
Management and Budget, at fax number
202–395–6974. If these proposed
requirements are adopted in a final rule,
PHMSA will submit the revised
information collection and
recordkeeping requirements to OMB for
approval.
H. Environmental Assessment
The National Environmental Policy
Act (NEPA), §§ 4321–4375, requires
Federal Agencies to analyze regulatory
actions to determine whether the action
will have a significant impact on the
human environment. The Council on
Environmental Quality (CEQ)
regulations order Federal Agencies to
conduct an environmental review
considering (1) the need for the action,
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(2) alternatives to the action, (3)
environmental impacts of the action and
alternatives, and (4) the agencies and
persons consulted during the
consideration process. 40 CFR
1508.9(b).
Purpose and Need. As discussed
elsewhere in this preamble, PHMSA
proposes to amend requirements in the
Hazardous Materials Regulations to
enhance the integrity of inner
packagings or receptacles of
combination packagings containing
liquid hazardous material by ensuring
they remain intact when subjected to
the reduced pressure and other forces
encountered in air transportation. In
order to substantially decrease the
likelihood of an unintentional
hazardous materials release to the
environment, the proposed amendments
in this notice prescribe specific test
protocols and standards for determining
whether an inner packaging or
receptacle is capable of meeting the
pressure differential requirements
specified in the regulations and aligns
the HMR with international air
transportation standards.
Alternatives. PHMSA considered four
possible alternatives to strengthen
packaging requirements for air
shipments of liquid hazardous
materials:
Alternative 1: Do nothing. Under this
alternative, the current regulatory
scheme applicable to air shipment of
hazardous liquids would continue in
place. We rejected this alternative
because newly identified safety risks
would not be addressed.
Alternative 2: Require that friction
and screw type closures of inner
packagings intended to contain liquids
as part of a combination packaging to be
secured by a secondary means of
closure. Under this alternative, we
would adopt the packaging amendments
included in the 2011–2012 edition of
the ICAO Technical Instructions.
Specifically, we would require friction
and screw type closures of inner
packagings intended to contain liquids
as part of a combination packaging to be
secured by a secondary means of
closure. For liquids assigned to Packing
Groups II or III, a leakproof liner could
be used to satisfy the secondary closure
requirement where it could not be
applied or would be impracticable to
apply. For liquids of Packing Group I, a
secondary means of closure, absorbent
material and a leakproof liner would be
required. We rejected Alternative 2.
While it would address many of the
safety issues associated with the
transportation of liquid hazardous
materials, Alternative 2 alone does not
represent a comprehensive systems-
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27281
oriented regulatory solution and would
not address problems associated with
the current pressure differential
capability standard.
Alternative 3: Require enhanced
pressure differential capability
requirements on all inner packagings
intended to contain liquids as part of a
combination packaging. Currently, the
HMR require that all packages
transported by air and for which
retention of liquids is a basic function
must be capable of withstanding,
without leakage, a certain pressure
differential, which is usually 95
kilopascals (kPa) (§ 173.27[c]). This
integrity standard applies to both
specification and non-specification
packaging. Under this alternative, we
would require packaging manufacturers
to conduct testing to confirm that a
combination packaging intended for the
air transportation of liquid hazardous
materials is capable of withstanding the
pressures encountered on board aircraft
and to maintain a documented record of
the test results. We rejected this
alternative. While it would address
many of the safety issues associated
with the transportation of liquid
hazardous materials, Alternative 3 alone
does not represent a comprehensive
systems-oriented regulatory solution.
Moreover, it does not address critical
international harmonization issues.
Alternative 4: Adopt the provisions in
both Alternatives 2 and 3. Under this
alternative, PHMSA would adopt the
new and revised regulatory provisions
summarized in the discussion of
Alternatives 2 and 3 above. This is the
selected alternative. The proposed
testing requirements will enhance safety
by ensuring that all liquid hazardous
materials shipments are contained in
packages capable of withstanding
normal conditions encountered in air
transport and packaged to reduce the
possibility of damage that could lead to
an incident. It also harmonizes domestic
packaging requirements with
international standards, thereby
reducing confusion, promoting safety,
and facilitating efficient transportation.
Analysis of Environmental Impacts.
Hazardous materials are substances that
may pose a threat to public safety or the
environment during transportation
because of their physical, chemical, or
nuclear properties. The hazardous
material regulatory system is a risk
management system that is preventionoriented and focused on identifying a
safety hazard and reducing the
probability and quantity of a hazardous
material release. Releases of hazardous
materials can result in explosions or
fires, while radioactive, toxic,
infectious, or corrosive hazardous
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materials can have short- or long-term
exposure effects on humans or the
environment.
The potential for environmental
damage or contamination exists when
packages of hazardous materials are
involved in accidents or en route
incidents resulting from cargo shifts,
valve failures, package failures, loading,
unloading, collisions, or handling
problems. The release of hazardous
materials can cause the loss of
ecological resources and the
contamination of air, aquatic
environments, and soil. Contamination
of soil can lead to the contamination of
ground water. For the most part, the
adverse environmental impacts
associated with releases of most
hazardous materials are short-term
impacts that can be reduced or
eliminated through prompt clean-up/
decontamination of the accident scene.
We have reviewed the risks associated
with transporting combination packages
containing liquid hazardous materials
by aircraft and by surface transportation
to and from aircraft. The amount of
liquid hazardous material contained in
air-eligible combination packages to
which this notice of proposed
rulemaking applies is minimal and
ranges anywhere from 0.5L to 220L.
However, hazardous materials that pose
the highest risk to humans and the
environment are packaged in much
smaller quantities when transported by
aircraft thereby minimizing any
consequences to both should a package
fail and release its contents. For these
reasons, we conclude there will be little
or no impact to the environment if the
provisions proposed in this NPRM are
adopted.
Consultation and Public Comment.
We invite commenters to address
potential environmental impacts
associated with the proposals in this
NPRM.
I. Privacy Act
Anyone is able to search the
electronic form for all comments
received into any of our dockets by the
name of the individual submitting the
comments (or signing the comment, if
submitted on behalf of an association,
business, labor union, etc.). You may
review DOT’s complete Privacy Act
Statement in the Federal Register
published on April 11, 2000 (Volume
65, Number 70; Pages 19477–78) or you
may visit ‘‘https://dms.dot.gov’’.
J. 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 number contained in the
heading of this document can be used
to cross-reference this action with the
Unified Agenda.
List of Subjects
49 CFR Part 171
Exports, Hazardous materials
transportation, Hazardous waste,
Imports, Incorporation by reference,
Reporting and recordkeeping
requirements.
49 CFR Part 173
Hazardous materials transportation,
Packaging and containers, Radioactive
materials, Reporting and recordkeeping
requirements, Uranium.
In consideration of the foregoing, 49
CFR chapter I is proposed to be
amended as follows:
PART 171—GENERAL INFORMATION,
REGULATIONS, AND DEFINITIONS
1. The authority citation for part 171
continues to read as follows:
Authority: 49 U.S.C. 5101–5128; 44701; 49
CFR 1.45 and 1.53; Pub. L. 101–410 section
4 (28 U.S.C. 2461 note); Pub. L. 104–134
section 31001.
2. In § 171.7, in paragraph (b) table,
the following changes are made:
a. Under the source ‘‘American
Society for Testing and Materials,’’ the
organization’s telephone number and
website address are added and the
material entries ‘‘ASTM D 3078,
Standard Test Method for Determination
of Leaks in Flexible Packaging by
Bubble Emission,’’ ‘‘ASTM D 4991,
Standard Test Method for Leakage
Testing of Empty Rigid Containers by
Vacuum,’’ ‘‘ASTM D 6653, Standard Test
Methods for Determining the Effects of
High Altitude on Packaging Systems by
Vacuum Method’’ and ‘‘ASTM F 1140,
Standard Test Methods for Internal
Pressurization Failure Resistance of
Unrestrained Packages for Medical
Applications’’ are added in appropriate
numerical order;
b. The new source entry ‘‘International
Safe Transit Association, 1400 Abbott
Road, Suite 160, East Lansing, MI
48823–1900. (517) 333–3437. https://
www.ista.org.’’ is added and, the
material entry ‘‘ISTA 3A, PackagedProducts for Parcel Delivery System
Shipment 70 kg (150 lb) or Less’’ is
added to the ‘‘Source and name of
material’’ column and the reference
entry ‘‘Part 173, appendix E’’ is added to
the corresponding ‘‘49 CFR reference’’
column.
The additions read as follows:
§ 171.7
Reference material.
*
*
*
*
*
(b) List of informational materials not
requiring incorporation by reference. * *
*
emcdonald on DSK2BSOYB1PROD with PROPOSALS
Source and name of material
49 CFR reference
*
*
*
*
*
*
American Society for Testing and Materials, 100 Bar Harbor Drive, West Conshohocken, PA 19428. Noncurrent ASTM
Standards are available from: Engineering Societies Library, 354 East 47th Street, New York, NY 10017. Telephone:
(610) 832–9585. Web site: https://www.astm.org.
ASTM D 3078 ‘‘Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission’’ ...............
ASTM D 4991 Standard Test Method for Leakage Testing of Empty Rigid Containers by Vacuum ..................................
ASTM D 6653 Standard Test Methods for Determining the Effects of High Altitude on Packaging Systems by Vacuum
Method.
*
*
*
*
*
*
ASTM F 1140 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages for
Medical Applications.
*
*
*
*
*
*
International Safe Transit Association, 1400 Abbott Road Suite 160, East Lansing, MI 48823–1900. Telephone: (517)
333–3437. Web site: https://www.ista.org.
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Part 173, appendix E.
Part 173, appendix E.
Part 173, appendix E.
*
Part 173, appendix E.
*
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Source and name of material
49 CFR reference
ISTA 3A, Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less ..............................................
*
*
*
PART 173—SHIPPERS—GENERAL
REQUIREMENTS FOR SHIPMENTS
AND PACKAGINGS
3. The authority citation for part 173
continues to read as follows:
Authority: 49 U.S.C. 5101–5128, 44701; 49
CFR 1.45, 1.53.
4. In § 173.27, paragraphs (a), (c)(2),
(d) and (e) are revised to read as follows:
emcdonald on DSK2BSOYB1PROD with PROPOSALS
§ 173.27 General requirements for
transportation by aircraft.
(a) The requirements of this section
are in addition to requirements
prescribed elsewhere under this part
and apply to packages offered or
intended for transportation aboard
aircraft.
*
*
*
*
*
(c) * * *
(2) Any packaging design not already
subject to § 178.605, for which the
retention of liquid is a basic function
(e.g., the inner packagings of a
combination packaging), must be
capable of withstanding without leakage
the greater of—
(i) An internal pressure that produces
a gauge pressure of not less 75 kPa (11
psig) for liquids in Packing Group III of
Class 3 or Division 6.1; or 95 kPa (14
psig) for other liquids in accordance
with an appropriate test method that
produces the required pressure
differential between the inside and
outside of an applicable packaging; or
(ii) A pressure related to the vapor
pressure of the liquid to be conveyed,
determined by one of the following:
(A) The total gauge pressure measured
in the receptacle (i.e., the vapor pressure
of the material and the partial pressure
of air or other inert gases, less 100 kPa
(15 psia)) at 55 °C (131 °F), multiplied
by a safety factor of 1.5; determined on
the basis of a filling temperature of 15
°C (59 °F) and a degree of filling such
that the receptacle is not completely full
at a temperature of 55 °C (131 °F) or
less;
(B) 1.75 times the vapor pressure at 50
°C (122 °F) less 100 kPa (15 psia); or
(C) 1.5 times the vapor pressure at 55
°C (131 °F) less 100 kPa (15 psia).
(iii) The capability of a packaging to
withstand an internal pressure without
leakage that produces the specified
pressure differential must be
determined by successfully testing
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*
*
design samples or prototypes. The
appropriate test method and test
duration selected must be based on
packaging type (e.g., material of
construction) in accordance with
paragraph (a) of Appendix E to this part.
Examples of acceptable test methods to
determine pressure differential
capability are identified in Appendix E
to this part. For a liquid hazardous
material where the vapor pressure is
unknown, the initial boiling point may
be used to determine minimum
packaging requirements as specified in
the Appendix E Table of this part. For
one or more liquid hazardous materials
contained in a mixture or solution, the
individual constituent with the highest
vapor pressure at 50 °C or the lowest
initial boiling point (at sea level) may be
used to determine minimum packaging
requirements for the entire mixture or
solution as specified in this section.
(iv) Testing must be verifiable and
appropriately documented. Supporting
documentation must be made available
for inspection by a representative of the
Department upon request and for at
least 90 days once the package is offered
for transportation.
*
*
*
*
*
(d) Closures. The body and closure of
any packaging must be constructed so as
to be able to adequately resist the effects
of temperature and vibration occurring
in conditions normally incident to air
transportation. Inner packaging or
receptacle closures must be held
securely, tightly and effectively in place
by secondary means. Examples of such
methods include: Adhesive tape,
friction sleeves, welding or soldering,
positive locking wires, locking rings,
induction heat seals, and child-resistant
closures. The closure device must be so
designed that it is unlikely that it can be
incorrectly or incompletely closed. For
other than liquids of Packing Group I,
when a secondary means of closure
cannot be applied or is impracticable to
apply to an inner packaging containing
liquids, this requirement may be
satisfied by securely closing the inner
packaging and placing it in a leakproof
liner before placing the inner packaging
in its outer packaging. A liquid of
Packing Group I with a secondary
means of closure applied must be
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*
Part 173, appendix E.
*
packaged and closed in accordance with
paragraph (e)(1) of this section.
(e) Absorbent materials. Except as
otherwise provided in this subchapter,
liquid hazardous materials of Classes 3,
4, or 8, or Divisions 5.1 or 6.1 that are
packaged and offered for transport in
glass, earthenware, plastic, or metal
inner packagings must be packaged
using absorbent material as follows:
(1) Packing Group I liquids on
passenger-carrying and cargo-carrying
aircraft must be contained in an inner
packaging with a secondary means of
closure applied that is further packaged
in a rigid leakproof liner or rigid
intermediate packaging containing
sufficient absorbent material to absorb
the entire contents of the inner
packaging before being placed in its
outer package.
(2) Absorbent material must not react
dangerously with the liquid (see
§§ 173.24 and 173.24a.).
*
*
*
*
*
5. In part 173, appendix E is added to
read as follows:
Appendix E to Part 173—Test
Procedures for Packagings Intended to
Meet Pressure Differential
Requirements for Air Transport
(a) Test method. Testing for pressure
differential capability may be conducted
using internal hydraulic or pneumatic
pressure (gauge) or external vacuum
methods. External vacuum tests are not
acceptable if the specified pressure
differential is not achieved or maintained.
The external vacuum test is also not normally
suitable for: Flexible packagings; packagings
filled and closed under an absolute
atmospheric pressure lower than 95 kPa or an
altitude greater than 1,500 feet; and
packagings intended for the transport of high
vapor pressure liquids (i.e., vapor pressures
greater than 111 kPa @ 50 °C or 130 kPa @
55 °C). Metal packagings and composite
packagings other than plastic (e.g., glass,
porcelain, or stoneware), including their
closures, must be subjected to the test
pressure for at least 5 minutes. Plastic
packagings, including their closures, must be
subjected to the test pressure for at least 30
minutes. The minimum test pressure is one
that produces an internal pressure (gauge) of
not less 75 kPa (11 psig) for liquids in
Packing Group III of Class 3 or Division 6.1;
or 95 kPa (14 psig) for other liquids in
accordance with an appropriate test method
that produces the required pressure
differential between the inside and outside of
an applicable packaging. The following
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standards are examples of acceptable
methods that may be used to determine
pressure differential capabilities of a
packaging design:
(i) For non-flexible (i.e., ‘‘rigid’’) inner
packagings:
(A) ASTM D 4991, ‘‘Standard Test Method
for Leakage Testing of Empty Rigid
Containers by Vacuum.’’
(B) ASTM D 6653, ‘‘Standard Test Methods
for Determining the Effects of High Altitude
on Packaging Systems by Vacuum Method.’’
(C) International Safe Transit Association,
‘‘ISTA 3A, Packaged-Products for Parcel
Delivery System Shipment 70 kg (150 lb) or
Less.’’
(ii) For flexible inner packagings:
(A) ASTM D 3078, ‘‘Standard Test Method
for Determination of Leaks in Flexible
Packaging by Bubble Emission.’’
(B) ASTM F 1140, ‘‘Standard Test Methods
for Internal Pressurization Failure Resistance
of Unrestrained Packages for Medical
Applications.’’
(iii) The hydrostatic pressure test under
§ 178.605 of this subchapter.
(iv) Generic flexible test method. This test
procedure is used to evaluate a flexible bag
or pouch to determine pressure differential
capabilities. The test specimens and the
number of samples must be chosen at
random, to permit an adequate determination
of representative performance. When
conducting the pressure differential test to
meet the requirements for air transport, a
minimum of three (3) representative
specimens of each flexible inner packaging
must be tested. Testing must be conducted on
the flexible packaging (primary receptacle or
secondary packaging) to establish pressure
differential capabilities. Test specimens must
be prepared and tested at ambient laboratory
conditions.
(A) To begin the procedure, lay flexible
container on flat surface and, at one of the
bottom corners, cut an access hole
approximately 1⁄4″ long across the corner.
Insert a 4″ × 1⁄4;″ plastic guide tube into the
cut corner of the bag. Leave a minimum of
2″ of tubing extending from the corner of the
bag. This tube is used as a guide to insert the
copper tube. Seal the bag according to the
manufacturer’s instructions while
maintaining the 2″ extension on the outside
of the bag. Position the bag to guide the
copper tube into the bag where the plastic
tube is extending out of the flexible bag. To
seal the cut end of the bag, use sponge rubber
to protect the bag from the clamps. Clamp the
flat area of the copper tube with quick
(Initial) Boiling Point in °C .................................................
≥ 48 °C
≥ 45 °C
≥ 40 °C
Vapor Pressure @ 50 °C in kPa ...........................................
≤ 111 °C
≤ 125 °C
≤ 150 °C
Required Minimum Test Pressure in kPa ..........................
95 kPa 1
120 kPa
165 kPa
NOTE 1: 75 kPa (minimum) for liquids in Packing Group III of Class 3 or Division 6.1.
clamps. Place the bag on a flat surface and
rest for 30 minutes.
(B) After 30 minutes, slowly pressurize the
sample to 2–3 psi. Hold for one minute.
Continue to increase the pressure until a
pressure of 95 kPa (14 psig) is reached. Once
the desired pressure is reached, conduct the
test and monitor for 30 minutes. Upon
completion of the test, submerge the bag in
water, or other appropriate means, to check
for leakage. Disconnect the pressure hoses
from each of the fittings and inspect each
specimen carefully and note any leakage that
may have occurred or damage to the
specimen. Document results of test on test
report for packaging design.
(b) Table. For a liquid where the boiling
point, initial boiling point or vapor pressure
is known, the following table prescribes the
corresponding minimum test pressure for
packagings subject to pressure differential
requirements in § 173.27(c). For a mixture or
solution, the individual constituent with the
highest vapor pressure at 50 °C or the
individual constituent with the lowest initial
boiling point may be used to determine the
minimum test pressure its packaging must be
capable of withstanding for the mixture or
solution as a whole.
≥ 35 °C
≤ 175 °C
210 kPa
≥ 30 °C
≤ 205 °C
260 kPa
Issued in Washington, DC, on May 7, 2010
under authority delegated in 49 CFR part
106.
Magdy El-Sibaie,
Associate Administrator for Hazardous
Materials Safety.
[FR Doc. 2010–11384 Filed 5–13–10; 8:45 am]
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BILLING CODE 4910–60–P
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≥ 25 °C
≤ 240 °C
320 kPa
≥ 20 °C
≤ 300 °C
425 kPa
Agencies
[Federal Register Volume 75, Number 93 (Friday, May 14, 2010)]
[Proposed Rules]
[Pages 27273-27284]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-11384]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
Pipeline and Hazardous Materials Safety Administration
49 CFR Parts 171 and 173
[Docket No. PHMSA-07-29364 (HM-231A)]
RIN 2137-AE32
Hazardous Materials; Packages Intended for Transport by Aircraft
AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.
ACTION: Notice of proposed rulemaking (NPRM).
-----------------------------------------------------------------------
SUMMARY: PHMSA proposes to amend requirements in the Hazardous
Materials Regulations to enhance the integrity of inner packagings or
receptacles of combination packagings containing liquid hazardous
material by ensuring they remain intact when subjected to the reduced
pressure and other forces encountered in air transportation. In order
to substantially decrease the likelihood of a hazardous materials
release, the proposed amendments: prescribe specific test protocols and
standards for determining whether an inner packaging or receptacle is
capable of meeting the pressure differential requirements specified in
the regulations and, consistent with the 2011-2012 edition of the
International Civil Aviation Organization Technical Instructions for
the Safe Transport of Dangerous Goods by Aircraft (ICAO Technical
Instructions), require the closures on all inner packagings containing
liquids within a combination packaging to be secured by a secondary
means or, under certain circumstances, permit the use of a liner.
DATES: Comments must be received by July 13, 2010.
ADDRESSES: You may submit comments identified by the docket number
PHMSA-07-29364 (HM-231A) by any of the following methods:
Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the online instructions for submitting
comments.
Fax: 1-202-493-2251.
Mail: Docket Operations, U.S. Department of
Transportation, West Building, Ground Floor, Room W12-140, Routing
Symbol M-30, 1200 New Jersey Avenue, SE., Washington, DC 20590.
Hand Delivery: To Docket Operations, Room W12-140 on the
ground floor of the West Building, 1200 New Jersey Avenue, SE.,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
Instructions: All submissions must include the agency name and
docket number for this notice at the beginning of the comment. Note
that all comments received will be posted without change to the docket
management system, including any personal information provided.
Docket: For access to the dockets to read background documents or
comments received, go to https://www.regulations.gov or DOT's Docket
Operations Office (see ADDRESSES).
Privacy Act: Anyone is able to search the electronic form of any
written communications and comments received into any of our dockets by
the name of the individual submitting the document (or signing the
document, if submitted on behalf of an association, business, labor
union, etc.). You may review DOT's complete Privacy Act Statement in
the Federal Register published on April 11, 2000 (Volume 65, Number 70;
Pages 19477-78).
FOR FURTHER INFORMATION CONTACT: Michael G. Stevens, Office of
Hazardous Materials Standards, Pipeline and Hazardous Materials Safety
Administration, U.S. Department of Transportation, 1200 New Jersey
Avenue, SE., Washington, DC 20590-0001, telephone (202) 366-8553, or
Janet McLaughlin, Office of Security and Hazardous Materials, Federal
Aviation Administration, U.S. Department of Transportation, 490
L'Enfant Plaza, SW., Room 2200, Washington, DC 20024, telephone (202)
385-4897.
SUPPLEMENTARY INFORMATION:
Contents
I. Background
II. Problem
III. ANPRM
A. Studies and Data
B. Pressure Differential Testing
C. Alternatives to Testing
D. Packaging Components
IV. Summary of Proposals in This NPRM
A. Incorporation of Revised ICAO TI Packaging Provisions
B. Enhanced Pressure Differential Capability Standard
C. Combined Enhanced Pressure Differential Capability Standard
and Incorporation of Revised ICAO TI Packaging Provisions
D. Vibration Testing
V. Regulatory Analyses and Notices
[[Page 27274]]
A. Statutory/Legal Authority for This Rulemaking
B. Executive Order 12866 and DOT Regulatory Policies and
Procedures
C. Executive Order 13132
D. Executive Order 13175
E. Regulatory Flexibility Act, Executive Order 13272, and DOT
Regulatory Policies and Procedures
F. Unfunded Mandates Reform Act
G. Paperwork Reduction Act
H. Regulatory Identifier Number (RIN)
I. Environmental Assessment
J. Privacy Act
I. Background
The Hazardous Materials Regulations (HMR; 49 CFR parts 171-180)
authorize a variety of packaging types for the transportation of
hazardous materials in commerce. Combination packagings are the most
common type of packaging used for the transportation of both liquid and
solid hazardous materials by aircraft. A combination packaging consists
of one or more inner packagings or one or more articles secured in a
non-bulk outer packaging.\1\
---------------------------------------------------------------------------
\1\ As a receptacle for a liquid or solid, a non-bulk outer
packaging is one that has a maximum capacity of 450 liters (119
gallons) and, for solid contents, a maximum net mass of 400 kg (882
pounds). Sec. 171.8.
---------------------------------------------------------------------------
Requirements for combination packagings used to transport hazardous
materials are set forth in parts 173 and 178 of the HMR. Certain
classes and quantities of hazardous materials may be transported in
``non-UN standard'' combination packagings, which are subject only to
the general requirements in subpart B of part 173, including the
following:
--The packaging must be designed, constructed, filled, and closed so
that it will not release its contents under conditions normally
incident to transportation. Sec. 173.24(b)(1).
--The effectiveness of the package must be maintained to withstand
minimum and maximum temperatures, changes in humidity and pressure, and
shocks, loadings and vibrations normally encountered during
transportation. Sec. 173.24(b)(2).
-- Each non-bulk packaging must be capable of withstanding, without
rupture or leakage, the vibration test procedure specified in Sec.
178.608 of this subchapter, which sets forth a specific test method to
measure the vibration capability of a non-bulk packaging. Sec.
173.24a(a)(5).
A packaging authorized for transportation by aircraft must also be
designed and constructed to prevent leakage that may be caused by
changes in altitude and temperature. Sec. 173.27(c)(1). Inner
packagings of combination packagings for which retention of liquid is a
basic function must be capable of withstanding the greater of: (1) An
internal pressure that produces a gauge pressure of not less than 75
kPa for liquids in Packing Group III of Class 3 or Division 6.1 and 95
kPa for other liquids; or (2) a pressure related to the vapor pressure
of the liquid to be transported as determined by specified formulae.
Sec. 173.27(c). A number of voluntary industry consensus standards
have been developed, some of which include test methods intended to
evaluate the effects of pressure differential on packagings at the
various altitudes experienced in the air transport environment. These
standards-setting organizations have also conducted measurement studies
and testing to identify the transportation forces a package encounters
and developed integrity standards and industry best-practices to ensure
the pressure differential capability standard is met. This process
assists all parties to design and manufacture packaging with quality
standards that could be used to verify conformance with capability
requirements. However, these voluntary industry standards are not
included or referenced in the HMR, and the HMR do not provide specific
guidance to shippers or packaging manufacturers as to how to comply
with the pressure differential standards.
Subparts L and M of part 178 contain UN performance standards for
non-bulk packagings adopted in PHMSA's ``HM-181'' final rules in 1990
and 1991. 55 FR 52401 (December 21, 1990); 56 FR 66124 (December 20,
1991). These performance standards criteria replaced the former
detailed construction specifications and provide packaging design
flexibility that is not possible with detailed design specifications.
The performance criteria require design qualification testing and
periodic retesting to verify whether a design type meets the
performance standards. For combination packagings, drop and stacking
testing are required, and the packaging must be ``capable'' of passing
a vibration test. Sec. Sec. 178.603, 178.606, 178.608. The packaging
(including the inner packagings) must be closed for testing, and tests
must be carried out on the completed package that is prepared for
testing, in the same manner as if prepared for transportation. Sec.
178.602.
In the HM-181 advance notice of proposed rulemaking (47 FR 16268
(April 15, 1982)) and the notice of proposed rulemaking (52 FR 16482
(May 5, 1987)), we proposed to require the hydrostatic pressure test in
Sec. 178.605 to be performed on all inner packagings of UN standard
combination packaging designs intended for transportation by aircraft.
The pressure test would have addressed pressure differentials
encountered during air transportation. This amendment was not adopted
in the final rule. 55 FR 52402 (December 21, 1990). Instead, consistent
with the ICAO Technical Instructions and the HMR in effect at the time,
we elected to continue the requirement for all packagings containing
liquids offered or intended for transportation aboard aircraft to be
capable of withstanding without leakage a specified pressure
differential. Sec. 173.27(c).
Since that time, ICAO has added a note to Part 4; 1.1.6 of the
Technical Instructions stating that the capability of a packaging to
meet the pressure differential performance standard should be
determined by testing, with the appropriate test method selected based
on packaging type. However, ICAO has not adopted specific test methods
in the Technical Instructions.
Because the HMR do not specify test methods for verifying that a
packaging meets the pressure differential requirement, some shippers
and packaging manufacturers have used historical data (i.e., lack of
incidents) and other methods (e.g. computer modeling, analogies, or
engineering studies) to demonstrate that their packagings satisfy the
pressure differential capability requirement. Shippers and packaging
manufacturers have differing views on how the requirements are to be
verified, and use various test methods to demonstrate compliance. This
leads to a non-uniform approach, and it is difficult for PHMSA and FAA
to verify whether a package meets the pressure differential requirement
because no test report, documentation, or other proof of compliance is
required by the HMR. Additionally, it does not provide an effective
method of oversight to determine whether regulatory requirements are
meeting actual forces encountered in transportation. If there is no
control, the evaluation of quality and failure analysis is not
possible. Even the most conscientious and safety-focused shippers have
difficulty understanding how to comply with the requirements in Sec.
173.27. Other shippers and packaging manufacturers may be taking
advantage of the absence of specific requirements for verifying
compliance.
The absence of specific test methods in the HMR leads to
inconsistencies in package integrity and results in varying levels of
compliance among shippers. References to the pressure differential
requirements in Sec. 173.27(c) are found throughout the regulations
for packagings and packages offered for air transportation and
transported by
[[Page 27275]]
aircraft without methods specified to verify compliance with this
critical safety requirement. This results in wide disparities in
packaging quality and the potential for sub-standard packages to be
introduced into the air transport environment, increasing the
probability of releases of hazardous materials aboard aircraft. In
addition, some shippers or manufacturers may not realize that inner
packagings of non-UN standard combination packagings are required to
meet the pressure differential capability requirements of the HMR and
the ICAO Technical Instructions. This includes packagings authorized
under the limited quantity, consumer commodity, and Category B
Biological Substance exceptions. A significant percentage of aircraft
incidents involving liquid hazardous materials appear to result from
failures of these packagings. We strongly believe the introduction of
specific test methods and amendments that clarify the requirements for
packagings offered for transportation by aircraft will enhance safety
by reducing risk and level the playing field for shippers,
manufacturers and air carriers alike.
II. Problem
When a package reaches high altitudes during transport, it
experiences low pressure on its exterior. This results in a pressure
differential between the interior and exterior of the package since the
pressure inside remains at the higher ground-level pressure. Higher
altitudes create lower external pressures and, therefore, larger
pressure differentials. This condition is especially problematic for
combination packagings containing liquids. When an inner packaging,
such as a glass bottle or plastic receptacle, is initially filled and
sealed, the cap must be tightened to a certain torque to obtain sealing
forces sufficient to contain the liquids in the packaging. This will
require certain forces to be placed upon the bottle and cap threads as
well as the sealing surface of the cap or cap liner to ensure the
packaging remains sealed. Once at altitude, due to the internal
pressure of the liquid acting upon the closure combined with the
reduced external air pressure, the forces acting on the threads and the
forces acting on the sealing surfaces will not be the same as when the
packaging was initially closed. Under normal conditions encountered in
air transport (26 kPa reduction in pressure at 8000 ft), the pressure
differentials are not overly severe. However, if the compartment is
depressurized at altitude or if the compartment is not pressurized at
all, such as on certain ``feeder'' aircraft, the pressure differential
may be severe enough to cause package failure and release of the
hazardous materials in the aircraft. High-altitude stresses are
encountered when cargo and feeder aircraft transport packages in non-
pressurized or partially-pressurized cargo holds.
A seemingly ``minor'' incident can quickly escalate and result in
irreversible, possibly catastrophic, consequences. For example, a
closure failure of an inner container could cause an outer package to
fail, resulting in fumes, smoke or flammable liquid acting as a
catalyst to a more serious incident. The interaction of events
occurring on aircraft, such as electrical fires, static electricity or
other materials interacting with the leaking material, could result in
a catastrophic event. The successful testing of inner packaging designs
may lower the likelihood of such an event. Taking a systems-safety
approach that includes multiple safety processes and redundancies can
prevent a minor incident from becoming potentially much worse.
PHMSA, FAA and, more recently, several international competent
authorities all agree that the testing of design samples or prototypes
of inner packagings or receptacles for pressure differential capability
is key to preventing package failure in air transport. Testing also
forms the basis of current performance standards in both the HMR and
international regulations. Additionally, incident data and compliance
verification testing of combination packagings intended for air
transport and readily available in the marketplace indicate that an
unacceptable number of packagings are not able to withstand pressure
differential conditions normally incident to air transportation. Again,
the packagings of particular concern are packagings that must be
``capable'' of meeting pressure differential requirements, but are not
required to be certified as meeting a specific performance test method
to verify compliance with pressure differential performance standards.
Incident data continue to show that packagings are leaking aboard
aircraft; this likely is in part attributable to the fact that the HMR
do not specifically provide test methods for determining that
packagings meet the minimum pressure differential performance necessary
to withstand conditions of air transport. It cannot be overemphasized
that any incident, such as a package failure, involving hazardous
materials in air transportation is unacceptable.
Four recent studies simulated the impact of high-altitude on
package integrity. These conditions result in extreme changes in
pressure when compared to packages being transported at or close to sea
level. These four studies were discussed in detail in the ANPRM
published under this docket [73 FR 38361; July 7, 2008] and are
available for review at https://www.regulations.gov.
In the first study, FAA analyzed incident data from the DOT
Hazardous Materials Information System (HMIS) for the years 1998 and
1999 and focused on properly declared hazardous material shipments. The
study concluded that of 1,583 air incidents reported to PHMSA, a
failure of inner packagings in combination packaging designs
contributed to 333 spills or leaks. In the second study, United Parcel
Service (UPS) presented its findings to the American Society of Testing
and Materials (ASTM) outlining the conditions that packages experience
in the air transport environment. In 2002, the FAA initiated a study
with Michigan State University (MSU) to replicate actual air and pre-
and post-truck transportation conditions to determine which conditions
contribute to package failures. In this third study on conditions
experienced in air transportation, FAA examined the effects of
vibration alone, altitude alone, and a combination of vibration and
altitude on the performance of UN standard hazardous material
combination packages containing liquids. In 2003, PHMSA also initiated
a study with MSU to compare the HMR requirements and the testing used
in the FAA/MSU study to provide for a more thorough evaluation of the
performance of liquid hazardous materials in combination packagings
when subjected to the conditions of air transport. This fourth round of
testing was conducted on a smaller number of packaging designs;
however, a much greater number of packagings of each design were tested
in the study.
During the first half of 2007, PHMSA conducted a comprehensive
assessment of hazardous materials transportation incidents occurring in
air transportation from 1997 through 2006. This study and its
corresponding data may be accessed in the public docket for this
rulemaking. The study concluded that there has been no appreciable
reduction in package failures over the past 10 years. It is estimated
that 191,429 tons of liquid hazardous materials contained in
approximately 16.9 million combination packages are transported by
aircraft annually. Of that total, the analysis concluded that
approximately 483 combination packagings containing liquids fail in air
transportation each
[[Page 27276]]
year with an average of two incidents reported as ``serious.'' \2\
However, any incident, such as a package failure, involving hazardous
materials in air transportation is unacceptable.
---------------------------------------------------------------------------
\2\ The HMR define a ``serious incident'' as one that involves
one or more of the following: (1) A fatality or major injury caused
by the release of a hazardous material; (2) the evacuation of 25 or
more persons as a result of release of a hazardous material or
exposure to fire; (3) a release or exposure to fire which results in
the closure of a major transportation artery; (4) the alteration of
an aircraft flight plan or operation; (5) the release of radioactive
materials from Type B packaging; (6) the release of over 45 liters
(11.9 gallons) or 40 kilograms (88.2 pounds) of a severe marine
pollutant; or (7) the release of a bulk quantity (over 450 liters
(119 gallons) or 400 kilograms (882 pounds)) of a hazardous
material. Sec. 171.15.
---------------------------------------------------------------------------
The 2007 study concluded that of the approximately 483 air
incidents reported each year, at least 44 percent involved the failure
of inner packaging closures within a combination outer packaging as the
primary cause. Such failures could have been the result of pressure
differential (packages closed at sea level subjected to lower pressure
on planes), stress relaxation of the closure (closures that appear
tight but loosen during transportation), improper closures, vibration,
or some other cause. The analysis also suggested that most incidents
involved combination packagings containing flammable liquids (e.g.,
paint and paint related material) of varying degrees of hazard. Some
additional statistical data from the 2007 incident review include:
Over 40% of failures of combination packages containing
liquids in air transportation involve closures and/or inner
receptacles.
Flammable liquids are the most common liquid hazardous
materials released from failed packages in air transportation. If such
materials found an ignition source, it could result in a fire or
explosion.
In incident years 2005-2006, 18 of 953 incidents involving
combination packagings containing liquids, or 2%, occurred on
passenger-carrying aircraft. Although low when compared to incidents
occurring on cargo-carrying aircraft, this percentage of package
failures continues to be a troubling statistic.
Combination packages containing liquids that fail in air
transportation release an average 2 liters (0.5 gallons) of liquid
hazardous materials.
III. ANPRM
On July 7, 2008, PHMSA published an advance notice of rulemaking
(ANPRM; 73 FR 38361) seeking to identify cost-effective solutions to
reduce incident rates and the potential severity of incident
consequences without placing unnecessary burdens on the regulated
community. We solicited comments on how to accomplish these goals,
including measures to: (1) Enhance the effectiveness of performance
testing for packagings used to transport hazardous materials on
aircraft; (2) more clearly indicate the responsibilities of shippers
that offer packages for air transport in the HMR; and (3) authorize
alternatives for enhancing package integrity. We asked a series of
questions related to the packaging of liquid hazardous materials in
combination packagings that are offered for transportation and
transported by aircraft. A total of 13 persons submitted comments in
response to the ANPRM; the list of commenters includes:
AHS Association of Hazmat Shippers, Inc.
Ecolab Ecolab, Inc.
ALPA Air Line Pilots Association, International
COSTHA The Council on Safe Transportation of Hazardous Articles,
Inc.
IOPP Institute of Packaging Professionals
CPC Chemical Packaging Committee
FedEx Federal Express
ISTA International Safe Transit Association
ASTM ASTM International
ICC ICC The Compliance Center, Inc.
MSU Michigan State University School of Packaging
Viking Viking Packing Specialist
DGAC Dangerous Goods Advisory Council
Commenters generally agree that regulatory changes are necessary to
address safety issues related to the transportation of hazardous
materials in non-UN standard packagings on board aircraft. However,
commenters had varying views on the scope of the safety problem or
specific regulatory amendments necessary to eliminate or reduce
problems should they exist. Some commenters also questioned the
validity of studies conducted and analysis of the underlying data used
that motivated PHMSA to initiate rulemaking action. These comments are
summarized below.
A. Studies and Data
As indicated previously, recent studies have simulated the impact
of high altitudes on packaging integrity. These studies suggest that
the current testing requirements (or lack thereof) under the HMR may
not adequately address the conditions encountered during air
transportation. Moreover, a review of incident data conducted by FAA
and PHMSA supports the conclusion that some combination packaging
designs used to transport hazardous materials by aircraft may not meet
the capability standards mandated under the HMR. Indeed, the testing
conducted suggests that the capability standards themselves may not be
sufficiently rigorous to ensure that packagings maintain their
integrity under conditions normally incident to air transportation.
Study data, incidents, and several years of feedback from industry
indicate that, without specific standards and protocols, a consistent
approach to compliance cannot be achieved. This can lead to a
potentially unsafe condition.
Some commenters cited concerns over how two of the studies were
conducted or suggested that the problems discussed in the ANPRM may not
be as serious as presented. For example, Ecolab identifies what it
contends are at least three discrepancies in the two air packaging
integrity studies conducted by MSU in 2002 and 2003 on behalf of PHMSA
and FAA. Ecolab contends that these discrepancies, identified by CPC
and published in a 2006 Hazmat Packager and Shipper article, occurred
because some of the tests utilized for the studies were not conducted
in accordance with the HMR or corresponding international standards.
One study allegedly used an improper closure design that differed from
the originally tested design. CPC asserted that the improper closure
design used in the study raised the number of packaging failures from
14 to 42, an increase of 75%. In its comments, Ecolab contends that a
successfully tested package will not leak when closed properly and
subjected to normal conditions of air transport. As a result of
conclusions drawn from these initial studies and to address challenges
made to the assumptions used in their methodology, further studies were
budgeted and carried out. PHMSA and FAA acknowledge that some of the
studies utilized packagings that did not conform in all respects with
HMR requirements. The characteristics of the packagings tested were
fully disclosed in the study reports. We do not agree that the minor
differences in the closures used affects the conclusions of the
studies. We note that the studies were not used to determine compliance
with HMR requirements, but rather to measure the capability of
commercially available packaging designs to withstand the unique
conditions encountered in air transportation.
Although most commenters support the actual testing of inner
packaging designs for pressure differential capabilities, several
commenters doubt that incidents are occurring in air transport as a
result of the lack of actual testing. AHS notes that incident reports
submitted to PHMSA in accordance with reporting requirements in Sec.
171.16 of the HMR do not indicate whether an inner packaging failed
because it had
[[Page 27277]]
not been tested or because it was not capable of withstanding forces
encountered in transportation. We note that it is highly unlikely that
a carrier or other entity without intimate knowledge of a packaging's
design or overall integrity would be able to report, as a root cause,
that an incident that occurred in air transportation resulted from a
lack of actual testing or the packaging's inability to withstand the
forces inherent to transportation by aircraft. However, by carefully
analyzing available incident data and conducting controlled laboratory
studies of commercially available packaging designs, we can conclude
that the actual testing for pressure differential capability was either
conducted incorrectly or not conducted at all.
COSTHA contends that PHMSA should not be alarmed if leakage from an
inner packaging is contained within its outer packaging and suggests
that seepage from a closure over time should be evaluated differently
than a complete failure where the entire contents of an inner packaging
are released within an outer packaging. We disagree. A successfully
tested and properly filled and closed inner packaging design should not
leak under normal conditions encountered in air transportation.
Additionally, an inferior inner packaging design or component would be
identified through the pass/fail criteria when originally tested.
Because the primary receptacle within a combination packaging system is
the most important component of that system in air transport, it should
not fail except under extreme or highly abnormal conditions.
Regarding the distribution hazards experienced in today's air
transport environment, Ecolab asserts that shipments have always been
subjected to multiple flight segments and any consequences resulting
from that environment. Ecolab is correct; however, although shipments
have routinely utilized multiple flight segments in the past, the
proliferation of sort systems and feeder aircraft systems has changed
the environment shipments normally encountered during transit. Today,
air carriers use multiple mechanical handling systems to sort packages,
and the number of distribution points has grown with the natural
expansion of commerce.
In its comments, Ecolab states that better enforcement of existing
regulations related to packaging integrity is key to reducing the
number of incidents in air transportation. We agree. Once verifiable
and repeatable testing standards are adopted in the HMR, shippers,
packaging test labs, and government regulators can all measure
packaging integrity using the same process, procedures, and protocols.
Consistency is the most efficient and effective way to measure success
or failure. Ecolab also notes that, according to PHMSA's HMIS incident
database, human error is cited as an accident cause six times more
frequently than packaging failure. An example of human error could be
the deliberate or inadvertent consequences resulting from failure to
follow a packaging manufacturer's customer notification or closure
instructions. An example of packaging failure would be differences in
manufacturing tolerances that result in leakage (failure) from an
otherwise properly closed inner packaging design. Again, this supports
the multi-layered safety system concept.
B. Pressure Differential Testing
In the ANPRM, we noted that because specific test methods are not
included in the HMR or the ICAO Technical Instructions, there are
inconsistencies in package integrity and varying levels of compliance
among shippers. For example, because the pressure differential and
vibration capability standards for combination packagings are not
required to be verified by test protocols, some shippers (self-
certifiers) or manufacturers have used historical shipping data,
computer modeling, analogies to tested packagings, engineering studies,
or similar methods to determine that their packagings meet pressure
differential and vibration capability standards.
Shippers, carriers, packaging manufacturers, and testing facilities
generally agree that the current capability requirements for air
packagings are difficult to comply with and suggest that specific test
methods designed to demonstrate that packagings will withstand
conditions encountered during air transportation should be specified in
the HMR. Ecolab states that the current regulatory language in the HMR
regarding the pressure differential capability of inner packagings
should be replaced with recognized industry standards for testing and
no additional testing should be proposed. ALPA recommends that the HMR
incorporate the language contained in the ICAO Technical Instructions
clarifying test methods and responsible parties. For example, the ICAO
Technical Instructions suggest test methods appropriate for certain
types of inner packagings and liquid hazardous materials in order to
promote compliance with the prescribed performance standard. ALPA
contends the lack of standardized, easily understandable testing
protocol contributes to incidents in air transportation. Ecolab and
Viking both agree that, to properly determine the capability of a
packaging design, it must first be tested. ISTA asserts that the
simultaneous combination of low pressure and vibration exerted on a
package is the only way to accurately replicate conditions encountered
by a package in air transportation.
The HMR and ICAO Technical Instructions both require that a shipper
consider the pressure differential capability for an inner packaging
intended to contain a mixture or solution based on its vapor pressure.
Many commenters agree that determining the vapor pressure of a mixture
or solution is problematic, costly, and does not materially contribute
to reducing the likelihood of packaging failure. Ecolab believes that a
95 kPa differential capability is a realistic and attainable indication
of inner packaging integrity and that the 75 kPa capability for some
hazard classes and packing groups should be eliminated for clarity and
increased safety. In addition, Ecolab states that PHMSA should codify
any testing protocol adopted in Subpart M of Part 178. Because the
proposed amendments in this notice apply to non-UN standard packagings
as well as UN standard packagings, and the Part 178 requirements apply
to UN standard packagings only, it is appropriate that the amendments
proposed in this notice be codified in Sec. 173.27. We appreciate and
understand commenter frustration with regard to calculating the vapor
pressure of a mixture or solution to determine the appropriate
packaging capable of withstanding the prescribed pressure differential.
In this NPRM, we are proposing an alternative method that can be used
to calculate the appropriate packaging required for a mixture or
solution without testing to determine vapor pressure.
C. Alternatives to Testing
The HMR and ICAO Technical Instructions both allow a liquid
hazardous material to be contained in an inner packaging that does not
itself meet the pressure differential performance standard, provided
that the inner packaging is packed within a supplementary packaging
that does meet the pressure requirements. In their comments, AHS and
ICC ask PHMSA to retain in the HMR the option for a shipper to use
supplementary packaging that meets the pressure differential
requirements. PHMSA agrees with commenters on this issue and is not
[[Page 27278]]
proposing to amend the HMR to do otherwise.
The HMR currently permit the use of variations in inner packagings
of a tested combination package, without further testing of the
package, provided an equivalent level of performance is maintained
under conditions prescribed in Sec. 178.601. ICC states that a
packaging designed to successfully withstand the Sec. 178.601(g)(2)
Variation 2 test protocols should not be required to contain inner
packagings capable of meeting the pressure differential and vibration
capabilities of the HMR. We disagree. A primary inner packaging or
receptacle of known or questionable inferiority is unacceptable in air
transportation regardless of whether the outer packaging is of a higher
integrity. No other commenters opposed actual testing of inner
packagings of combination packagings intended to contain liquids for
transportation by aircraft.
ICAO recently adopted revised packaging instructions for
incorporation in the ICAO Technical Instructions that will become
effective January 1, 2011. The new packing instructions require a
secondary means of closure for all liquids in combination packagings.
This requirement may be satisfied by using a liner or other form of
containment when the secondary means of closure cannot be applied.
Inner packagings containing liquids of Packing Group I must be placed
in rigid leakproof receptacles with absorbent material before placing
them in outer packagings of a combination package. None of the comments
submitted to the ANPRM oppose this requirement; those who did comment
on this requirement support its adoption in the HMR.
D. Packaging Components
Many commenters state that pressure differential and vibration
capability standards should apply to both specification and non-
specification packaging designs. Ecolab asserts that a properly tested
and closed inner packaging design offers no risk in air transport. In
evaluating the inherent risks assumed in air transportation and the
potential for high consequence events should an incident occur, ALPA
supports multiple layers of redundancy to include actual testing of
inner packaging designs and the use of liners, absorbent material, and
secondary means of closure. Commenters agree that the interaction
between an inner packaging containing a liquid and its closure are
critical in air transport. COSTHA believes that if any component of a
tested design is changed, and it is not an exact replacement, quality
review and testing is required. Viking believes that a successfully
tested inner packaging is only one (albeit a major one) part of a
closure system that also uses a protective liner and is properly
oriented when stored or transported. PHMSA and FAA both agree that the
verification of packaging integrity through testing and the additional
redundant amendments proposed in this notice will ensure consistency in
the quality of packagings used for the air transport of liquid
hazardous materials and mitigate or eliminate the consequences of an
incident or accident should one occur.
IV. Summary of Proposals in This NPRM
Because aircraft accidents caused by leaking or breached hazardous
materials packages can have significant or catastrophic consequences,
the air transportation of hazardous materials requires clear standards,
exceptional diligence, and attention to detail. To address the
regulatory deficiencies previously described in detail, we are
proposing amendments to the HMR to strengthen the integrity of packages
intended for transport by aircraft.
Most commenters support adoption of the ICAO Technical Instructions
requirement for a secondary means of closure and utilization of a liner
if such secondary means of closure is infeasible or impracticable.
Further, most commenters agree that the most effective means to ensure
that combination packagings are capable of meeting specified
performance standards is actual testing. We agree. Therefore, in this
NPRM we are proposing to adopt the new ICAO Technical Instructions
requirements for combination packagings and test protocols that may be
used to demonstrate that such packagings conform to applicable
performance standards. If adopted, these amendments will add clarity to
the processes required in determining whether a packaging design is
capable of meeting the forces encountered in air transportation. We are
confident that these enhancements to current regulatory requirements
will result in a higher level of safety in air transportation by
reducing the likelihood of combination package failures in air
transportation.
The following is a summary of the proposals in this NPRM.
A. Incorporation of Revised ICAO Technical Instructions Packaging
Provisions
Currently under the HMR, stoppers, corks, or other such friction-
type closures must be held securely, tightly, and effectively in place
by positive means. See Sec. 173.27(d). However, a screw-type closure
on any packaging must only be secured to prevent the closure from
loosening due to ``vibration or substantial change in temperature.'' We
have stated in letters of clarification that a secured closure should
incorporate a secondary means of maintaining a seal, such as a shrink-
wrap band or heat sealed liner. (We have included three of those
letters (02-0302 dtd. January 23, 2003; 04-0011 dtd. May 12, 2004; 07-
0174 dtd. March 17, 2008) in the docket for information and guidance.)
Additionally, laboratory studies conducted on behalf of PHMSA and FAA
concluded that a simple application of tape on a screw-type closure
prevented ``back-off'' under even extreme conditions. We also note for
the purposes of this notice that:
Liners typically must be manually inserted into a
packaging before filling. Because most packaging systems can be
automated or are already automated with some form of secondary closure
being applied, costs and regulatory burden to shippers should be
minimal.
Most Packing Group I liquids already require a leakproof
liner in the HMR and ICAO Technical Instructions.
A liner or secondary means of positive closure should not
affect an existing UN standard packaging design as in most cases it
will not be considered a new design.
Requiring a secondary positive means of closure combined
with required verification of pressure differential capability adds a
layered systems-approach to air transportation safety.
Packaging failures in air transportation often are the result of
closures that have loosened in transportation. Such leaks are
potentially dangerous in all modes of transportation, but have the
potential for catastrophic results in air transportation. Therefore, we
are proposing to revise Sec. 173.27(d) to clearly state that all
friction and screw type closures must be secured by a secondary means
of positive closure. We believe that adoption of this requirement
provides a necessary added level of protection to prevent packages from
leaking in air transportation. For liquids assigned to Packing Groups
II or III, a leakproof liner may be used to satisfy the secondary
closure requirement where it cannot be applied or it is impracticable
to apply. For liquids of Packing Group I, we are proposing to revise
Sec. 173.27(e) to require secondary means of closure, absorbent
material, and a rigid, leakproof liner or
[[Page 27279]]
intermediate packaging. Also, for clarity we are proposing to remove
the reference to Division 5.2 materials from the Sec. 173.27(e)
introductory text.
B. Enhanced Pressure Differential Capability Standard
Currently, the HMR require all packagings containing liquid
hazardous materials intended for transportation by aircraft to be
capable of withstanding, without leakage, an internal gauge pressure of
at least 75 kPa for liquids in Packing Group III of Class 3 or Division
6.1 or 95 kPa for all other liquids, or a pressure related to the vapor
pressure of the liquid to be conveyed, whichever is greater. See Sec.
173.27(c). This requirement also applies to liquids excepted from
specification packaging, such as limited quantities and consumer
commodities. Liquids contained in inner receptacles that do not meet
the minimum pressure requirements in Sec. 173.27(c) may be placed into
receptacles that do meet the pressure requirements to ensure that the
completed packaging--inner receptacles plus outer packaging--will
withstand pressures typically encountered in air transportation. Single
and composite packagings, or any packaging subject to hydrostatic
pressure testing under Sec. 178.605, must have a marked test pressure
of not less than 250 kPa for liquids in Packing Group I, 80 kPa for
liquids in Packing Group III of Class 3 or Division 6.1, and 100 kPa
for other liquids.
As discussed in detail earlier in this preamble and in the ANPRM,
testing conducted on behalf of FAA and PHMSA indicates that many
combination packagings fail when subjected to conditions intended to
simulate the pressures encountered in the air transportation
environment. One possible conclusion is that these packagings might not
be capable of meeting the pressure differential capability standards.
Without testing there is no assurance that these packagings are capable
of meeting the prescribed standards. For air transportation, such
deficiencies in packaging integrity are unacceptable.
In this notice, we are proposing that conformance with the pressure
differential requirements for rigid packagings may be demonstrated by
testing performed in accordance with ASTM D6653, ``Standard Test
Methods for Determining the Effects of High Altitude on Packaging
Systems by Vacuum Method'' or ASTM D4991, ``Standard Test Method for
Leakage Testing of Empty Rigid Containers by Vacuum''.
For flexible packaging, we are proposing that conformance with the
pressure requirements may be demonstrated by pressure differential
testing performed in accordance with ASTM F 1140, ``Standard Test
Methods for Internal Pressurization Failure Resistance of Unrestrained
Packages for Medical Applications'', ASTM D 3078, ``Standard Test
Method for Determination of Leaks in Flexible Packaging by Bubble
Emission'' or a generic test method outlined in a proposed new Appendix
E to Part 173.
Additional test methods that may be used to confirm pressure
differential capability are the hydrostatic pressure test in Sec.
178.605 and the International Safe Transit Association's ``ISTA 3A,
Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or
Less.'' However, the ISTA 3A test method is considered more costly and
complex due to the high cost of equipment and specialized operators
needed to conduct it.
We have recently had the privilege of working with the German
Federal Institute for Materials Research and Testing (BAM) on the
problematic issue of calculating vapor pressures for liquids at the
transportation reference temperatures (50-55 [deg]C) as well as for
mixtures and solutions. The proposed table in Appendix E of this notice
provides guidance on determining these values based on the relationship
between boiling points and vapor pressures. It allows the shipper or
product manufacturer to estimate the required capability (test
pressure) of their packaging based on the individual constituent in a
mixture or solution with either the lowest boiling point or the highest
vapor pressure at 50 [deg]C. We invite comments on this potentially
very positive initiative.
C. Combined Enhanced Pressure Differential Capability Standard and
Incorporation of Revised ICAO Technical Instructions Packaging
Provisions
Laboratory studies have shown that testing inner packagings or
receptacles of commercially available combination packaging designs
intended or marketed as authorized for transportation by aircraft
achieves an approximate effectiveness rating of 95 percent, with the
current compliance rate among shippers unknown. The current compliance
rate for the use of liners or secondary means of positive closure by
shippers is estimated to be at least 70 to 90 percent, with an
effectiveness rate of 95 to 100 percent. Consequently, we have decided
to propose in this notice a combination of both regulatory alternatives
to achieve our objective of a cost-effective systems approach to safety
that provides redundancy where necessary and promotes compliance by
issuing regulations that are clear and easier to understand.
D. Vibration Testing
Section 173.27(c) of the HMR prescribes a pressure differential
capability standard for inner packagings of combination packagings
intended for air transport. In addition, in accordance with Sec.
178.608, combination packagings must be capable of passing a prescribed
vibration test. As discussed in detail elsewhere in this preamble, in
order to substantially decrease the likelihood of a hazardous materials
release in air transport, we are proposing to prescribe specific test
protocols and standards for determining whether an inner package or
receptacle is capable of meeting the pressure differential requirements
specified in the regulations. However, we are not proposing to revise
the current vibration capability standard. Testing to ascertain
conformance with a pressure differential capability standard is
significantly more cost effective than testing to ascertain conformance
with a vibration capability standard. Vibration testing generally
requires more expensive equipment and specially trained operators.
Moreover, laboratory studies have concluded that the application of a
secondary means of closure to a packaging capable of withstanding the
pressure differentials encountered in air transport substantially
reduces the overall failure rate of packages.
It is our understanding that a number of shippers and packaging
vendors currently use random vibration tests, such as those in the ISTA
3A or ASTM D 4169 standards, in combination with pressure differential
testing for packagings intended for air transport. While the HMR
prescribe a specific vibration test protocol, it appears that the
recognized random vibration test methods, combined with pressure
differential testing, achieve the intent of the test protocols in the
HMR--that is, to ensure that the packaging will withstand environmental
conditions normally encountered in air transportation. In our opinion,
the use of sequential or combined pressure differential and vibration
testing in accordance with ISTA, ASTM, or other test protocols would
exceed the current capability standards for pressure differential and
vibration for packages intended for air transportation. We would
consider that inner containers demonstrating conformance to these
standards would not be required to
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undergo further testing for pressure or vibration capability standards
when placed in an outer packaging for packages intended for air
transportation. As discussed in greater detail in Section III of this
notice, for certain types of packagings, the HMR provide for separate
testing of packaging components so that if one component conforms to
the applicable performance standard, the secondary components need not
meet those standards.
V. Rulemaking Analysis and Notices
A. Statutory/Legal Authority for This Rulemaking
This NPRM is published under authority of Federal hazardous
materials transportation law (Federal hazmat law; 49 U.S.C. 5101 et
seq.). Section 5103(b) of Federal hazmat law authorizes the Secretary
of Transportation to prescribe regulations for the safe transportation,
including security, of hazardous materials in intrastate, interstate,
and foreign commerce.
B. Executive Order 12866 and DOT Regulatory Policies and Procedures
This proposed rule is a significant regulatory action under section
3(f) Executive Order 12866 and, therefore, was reviewed by the Office
of Management and Budget (OMB). The proposed rule is a significant rule
under the Regulatory Policies and Procedures order issued by the U.S.
Department of Transportation (44 FR 11034). We have completed a
regulatory evaluation and placed it in the docket for this rulemaking.
In this rulemaking, we considered three regulatory alternatives:
(1) Require a secondary means of closure on inner packagings or a liner
in all combination packaging designs containing liquids; (2) require
testing to determine whether an inner packaging intended to contain
liquids is capable of withstanding the reduced pressures of air
transport; or (3) require a combination of both regulatory
alternatives. We are proposing the combination alternative, number 3.
Costs for the combination alternative range from $2.2M to $5.7M while
net benefits range from $41.6M to $67.9M. at a 7% discount rate over a
10-year period. Benefit-cost ratios for the combination alternative
range from 7.3:1 to 31.5:1. We invite commenters to address the
potential costs of the enhanced packaging requirements in this notice,
including the number of inner and outer packaging designs that would be
affected.
C. Executive Order 13132
This notice has been analyzed in accordance with the principles and
criteria contained in Executive Order 13132 (``Federalism''). This
notice preempts State, local and Indian tribe requirements but does not
propose any regulation with 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))
preempting State, local and Indian tribe requirements on the following
subjects:
(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 notice addresses covered subject item (5) described above and
preempts State, local, and Indian tribe requirements not meeting the
``substantively the same'' standard.
Federal hazardous materials transportation law provides at 49
U.S.C. 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 notice and not later than two years after the date of issuance. The
effective date of Federal preemption of this notice will be 90 days
from publication in the Federal Register.
D. Executive Order 13175
This notice has been analyzed in accordance with the principles and
criteria contained in Executive Order 13175 (``Consultation and
Coordination with Indian Tribal Governments''). Because this proposed
rule does not have tribal implications and does not impose direct
compliance costs, the funding and consultation requirements of
Executive Order 13175 do not apply.
E. Regulatory Flexibility Act, Executive Order 13272, and DOT
Procedures and Policies
The Regulatory Flexibility Act (5 U.S.C. 601-611) requires each
agency to analyze proposed regulations and assess their impact on small
businesses and other small entities to determine whether the proposed
rule is expected to have a significant impact on a substantial number
of small entities. A regulatory evaluation for this NPRM, which
includes a detailed small business impact analysis, is in the public
docket for this rulemaking. Based on the analysis in the public docket,
I certify that while this notice will impact a significant number of
small entities, it will not have a significant economic impact on a
substantial number of small entities.
This notice has been developed in accordance with Executive Order
13272 (``Proper Consideration of Small Entities in Agency Rulemaking'')
and DOT's procedures and policies to promote compliance with the
Regulatory Flexibility Act to ensure potential impacts of draft rules
on small entities are properly considered.
F. Unfunded Mandates Reform Act of 1995
This notice does not impose unfunded mandates under the Unfunded
Mandates Reform Act of 1995. It will not result in costs of $141.3
million or more, in the aggregate, to any of the following: State,
local, or Native American tribal governments, or the private sector.
G. Paperwork Reduction Act
PHMSA currently has an approved information collection under Office
of Management and Budget (OMB) Control Number 2137-0572, ``Testing
Requirements for Non-Bulk Packaging,'' with an expiration date of March
31, 2010. This NPRM may result in an increase in the annual burden and
costs of this information collection due to proposed changes to require
packaging manufacturers to conduct testing to confirm that a
combination packaging intended for the air transportation of liquid
hazardous materials is capable of withstanding the pressures
encountered on board aircraft and to maintain a documented record of
the test results.
Under the Paperwork Reduction Act of 1995, no person is required to
respond to an information collection
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unless it has been approved by OMB and displays a valid OMB control
number. Section 1320.8(d), title 5, Code of Federal Regulations
requires that PHMSA provide interested members of the public and
affected agencies an opportunity to comment on information and
recordkeeping requests.
This notice identifies a revised information collection request
that PHMSA will submit to OMB for approval based on the requirements in
this proposed rule. PHMSA has developed burden estimates to reflect
changes in this proposed rule, and estimates the information collection
and recordkeeping burden as proposed in this rule to be as follows:
OMB Control No.: 2137-0572.
Annual Number of Respondents: 1,496.
Annual Number of Responses: 29,712.
Annual Burden Hours: 54,525.
Annual Burden Costs: $1,557,779.25.
PHMSA specifically requests 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 this information collection should be
directed to Deborah Boothe or T. Glenn Foster, Office of Hazardous
Materials Standards (PHH-11), Pipeline and Hazardous Materials Safety
Administration, 1200 New Jersey Avenue, SE., Washington, DC 20590-0001,
Telephone (202) 366-8553.
Address written comments to the Dockets Unit as identified in the
ADDRESSES section of this rulemaking. We must receive comments
regarding information collection burdens prior to the close of the
comment period identified in the DATES section of this rulemaking. In
addition, you may submit comments specifically related to the
information collection burden to the PHMSA Desk Officer, Office of
Management and Budget, at fax number 202-395-6974. If these proposed
requirements are adopted in a final rule, PHMSA will submit the revised
information collection and recordkeeping requirements to OMB for
approval.
H. Environmental Assessment
The National Environmental Policy Act (NEPA), Sec. Sec. 4321-4375,
requires Federal Agencies to analyze regulatory actions to determine
whether the action will have a significant impact on the human
environment. The Council on Environmental Quality (CEQ) regulations
order Federal Agencies to conduct an environmental review considering
(1) the need for the action, (2) alternatives to the action, (3)
environmental impacts of the action and alternatives, and (4) the
agencies and persons consulted during the consideration process. 40 CFR
1508.9(b).
Purpose and Need. As discussed elsewhere in this preamble, PHMSA
proposes to amend requirements in the Hazardous Materials Regulations
to enhance the integrity of inner packagings or receptacles of
combination packagings containing liquid hazardous material by ensuring
they remain intact when subjected to the reduced pressure and other
forces encountered in air transportation. In order to substantially
decrease the likelihood of an unintentional hazardous materials release
to the environment, the proposed amendments in this notice prescribe
specific test protocols and standards for determining whether an inner
packaging or receptacle is capable of meeting the pressure differential
requirements specified in the regulations and aligns the HMR with
international air transportation standards.
Alternatives. PHMSA considered four possible alternatives to
strengthen packaging requirements for air shipments of liquid hazardous
materials:
Alternative 1: Do nothing. Under this alternative, the current
regulatory scheme applicable to air shipment of hazardous liquids would
continue in place. We rejected this alternative because newly
identified safety risks would not be addressed.
Alternative 2: Require that friction and screw type closures of
inner packagings intended to contain liquids as part of a combination
packaging to be secured by a secondary means of closure. Under this
alternative, we would adopt the packaging amendments included in the
2011-2012 edition of the ICAO Technical Instructions. Specifically, we
would require friction and screw type closures of inner packagings
intended to contain liquids as part of a combination packaging to be
secured by a secondary means of closure. For liquids assigned to
Packing Groups II or III, a leakproof liner could be used to satisfy
the secondary closure requirement where it could not be applied or
would be impracticable to apply. For liquids of Packing Group I, a
secondary means of closure, absorbent material and a leakproof liner
would be required. We rejected Alternative 2. While it would address
many of the safety issues associated with the transportation of liquid
hazardous materials, Alternative 2 alone does not represent a
comprehensive systems-oriented regulatory solution and would not
address problems associated with the current pressure differential
capability standard.
Alternative 3: Require enhanced pressure differential capability
requirements on all inner packagings intended to contain liquids as
part of a combination packaging. Currently, the HMR require that all
packages transported by air and for which retention of liquids is a
basic function must be capable of withstanding, without leakage, a
certain pressure differential, which is usually 95 kilopascals (kPa)
(Sec. 173.27[c]). This integrity standard applies to both
specification and non-specification packaging. Under this alternative,
we would require packaging manufacturers to conduct testing to confirm
that a combination packaging intended for the air transportation of
liquid hazardous materials is capable of withstanding the pressures
encountered on board aircraft and to maintain a documented record of
the test results. We rejected this alternative. While it would address
many of the safety issues associated with the transportation of liquid
hazardous materials, Alternative 3 alone does not represent a
comprehensive systems-oriented regulatory solution. Moreover, it does
not address critical international harmonization issues.
Alternative 4: Adopt the provisions in both Alternatives 2 and 3.
Under this alternative, PHMSA would adopt the new and revised
regulatory provisions summarized in the discussion of Alternatives 2
and 3 above. This is the selected alternative. The proposed testing
requirements will enhance safety by ensuring that all liquid hazardous
materials shipments are contained in packages capable of withstanding
normal conditions encountered in air transport and packaged to reduce
the possibility of damage that could lead to an incident. It also
harmonizes domestic packaging requirements with international
standards, thereby reducing confusion, promoting safety, and
facilitating efficient transportation.
Analysis of Environmental Impacts. Hazardous materials are
substances that may pose a threat to public safety or the environment
during transportation because of their physical, chemical, or nuclear
properties. The hazardous material regulatory system is a risk
management system that is prevention-oriented and focused on
identifying a safety hazard and reducing the probability and quantity
of a hazardous material release. Releases of hazardous materials can
result in explosions or fires, while radioactive, toxic, infectious, or
corrosive hazardous
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materials can have short- or long-term exposure effects on humans or
the environment.
The potential for environmental damage or contamination exists when
packages of hazardous materia