|
| |
[Federal Register: August 14, 2002 (Volume 67, Number 157)]
[Rules and Regulations]
[Page 53117-53144]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14au02-30]
[[Page 53117]]
-----------------------------------------------------------------------
Part III
Department of Transportation
-----------------------------------------------------------------------
Research and Special Programs Administration
-----------------------------------------------------------------------
49 CFR Part 171 et. al.
Hazardous Materials: Revision to Standards for Infectious Substances;
Final Rule
[[Page 53118]]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
Research and Special Programs Administration
49 CFR Parts 171, 172, 173, 177, and 178
[Docket No. RSPA-98-3971 (HM-226)]
RIN 2137-AD13
Hazardous Materials: Revision to Standards for Infectious
Substances
AGENCY: Research and Special Programs Administration (RSPA), DOT.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: RSPA is revising transportation requirements for infectious
substances, including regulated medical waste, to: adopt defining
criteria and packaging requirements consistent with international
standards; revise the current broad exceptions for diagnostic specimens
and biological products; and authorize bulk packaging options for
regulated medical waste consistent with requirements in international
standards and DOT exemptions. These revisions will assure an acceptable
level of safety for the transportation of infectious substances, and
facilitate domestic and international transportation.
DATES: Effective Date: This final rule is effective October 1, 2002.
Voluntary Compliance Date: Voluntary compliance is authorized 30
days following publication of this final rule.
Incorporation by Reference Date: The incorporation by reference of
publications listed in this final rule has been approved by the
Director of the Federal Register as of October 1, 2002.
FOR FURTHER INFORMATION CONTACT: Susan Gorsky (202) 366-8553, Office of
Hazardous Materials Standards, Research and Special Programs
Administration.
SUPPLEMENTARY INFORMATION:
List of Topics
I. Background
II. Comment Summary
A. Pending Revisions to the UN Recommendations
B. Infectious Substance Definition
C. Packaging Requirements for Infectious Substances
D. Exceptions for Domestic Shipments of Infectious Substances
E. Diagnostic Specimens
F. Biological Products
G. Genetically Modified Micro-Organisms
H. Regulated Medical Waste
I. Used Health-Care Products
J. Hazard Communication
K. Training
L. Contaminated Food and Food Products
III. Section-by-Section Review
IV. Coordination with Other Federal Agencies
V. Security Issues
VI. Regulatory Analyses and Notices
A. Executive Order 12866 and DOT Regulatory Policies and
Procedures
B. Executive Order 13132
C. Executive Order 13175
D. Regulatory Flexibility Act
E. Paperwork Reduction Act
F. Regulation Identifier Number (RIN)
G. Unfunded Mandates Reform Act
H. Environmental Assessment
I. Background
On January 22, 2001, the Research and Special Programs
Administration (RSPA, we) published a notice of proposed rulemaking
(NPRM; 66 FR 6941) to revise the current requirements in the Hazardous
Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to the
transportation of infectious substances, including regulated medical
waste. The NPRM also proposed new requirements applicable to the
transportation of genetically modified micro-organisms. The NPRM
proposed the following changes to the HMR:
Adoption of new classification criteria for infectious
substances based on defining criteria developed by the World Health
Organization (WHO) and consistent with standards contained in the
United Nations Recommendations on the Transport of Dangerous Goods (UN
Recommendations) and the International Civil Aviation Organization's
Technical Instructions for the Safe Transport of Dangerous Goods by Air
(ICAO Technical Instructions).
Revision of current packaging requirements for Division
6.2 materials for consistency with international performance standards.
Elimination of the current exception from requirements in
the HMR for diagnostic specimens. We proposed certain packaging and
hazard communication requirements. Diagnostic specimens transported in
dedicated motor vehicles by private or contract carriers would continue
to be excepted from most requirements in the HMR.
Modification of the current exception from requirements in
the HMR for biological products, limiting the exception to biological
products licensed for use under current Food and Drug Administration
(FDA) or U.S. Department of Agriculture (USDA) regulations.
New transportation requirements for the transportation of
genetically modified micro-organisms consistent with the UN
Recommendations.
New bulk packaging options for the transportation of
regulated medical waste (RMW), based on current exemption provisions.
New hazard communication requirements for shipments of
Division 6.2 materials.
II. Comment Summary
We received 46 comments on the NPRM from industry associations,
laboratories, medical waste transporters, state departments of
transportation and public health, a blood bank, and private citizens.
Most were supportive of our effort to harmonize the HMR requirements
applicable to the transportation of infectious substances with
international requirements, and of proposals to enhance the safe
transportation of diagnostic specimens and biological products. Based
on comments received and our discussions with other Federal agencies
responsible for regulating infectious substances and genetically
modified micro-organisms, this final rule incorporates the following
changes to the HMR:
New classification criteria for infectious substances
based on defining criteria developed by WHO and consistent with
standards contained in the UN Recommendations and the ICAO Technical
Instructions.
Revised packaging requirements for Division 6.2 materials
consistent with international performance standards.
Revised materials of trade exceptions to include certain
diagnostic specimens, biological products, and RMW. This final rule
includes more specific packaging requirements for such materials of
trade than were proposed in the NPRM.
New packaging and hazard communication requirements for
shipments of diagnostic specimens consistent with international
requirements. Diagnostic specimens transported in dedicated motor
vehicles by private or contract carriers are excepted from most
requirements of the HMR. This final rule also clarifies that diagnostic
specimens that contain a Risk Group 1 pathogen, do not contain a
pathogen, or in which the pathogen is neutralized or inactive, are not
subject to HMR requirements.
Modification of the current exception from requirements in
the HMR for biological products. This final rule revises the proposal
in the NPRM to specify that the exception is limited to biological
products, including experimental products, subject to Federal approval,
permit, or licensing requirements, such as those required by FDA or
USDA.
[[Page 53119]]
New bulk packaging options for the transportation of RMW,
based on current exemption provisions. The packaging options proposed
in the NPRM are modified in this final rule to reflect commenters'
concerns about specifications for the packagings.
New hazard communication requirements for bulk shipments
of RMW to assist emergency responders to identify such shipments.
In discussions during development of this final rule, several
federal agencies involved in the regulation of genetically modified
organisms (i.e., the Environmental Protection Agency (EPA) and the
Department of Agriculture (USDA)) commented that the process of
genetically modifying an organism does not a priori make that organism
a hazard. Rather, the product of the modification must be evaluated for
potential risk. As several federal agencies currently regulate
genetically modified organisms, the proposals in the NPRM concerning
genetically modified organisms are not adopted in this final rule.
Comments we received in response to the NPRM are discussed in
detail below.
A. Pending Revisions to the UN Recommendations
Most commenters support our proposal to harmonize the HMR
requirements for infectious substances with the international
standards. Two commenters note the United Nations may be developing a
complete revision to its current recommendations for the transportation
of infectious substances. According to these commenters, the UN may
change the WHO risk group system as applied to transportation and may
``radically'' simplify current transportation requirements. These
commenters advise us to postpone revising the HMR until the United
Nations completes its work.
The commenters are correct. The UN Committee of Experts on the
Transport of Dangerous Goods is considering revisions to the
requirements in the UN Recommendations applicable to the transport of
infectious substances and genetically modified micro-organisms.
However, it is not certain whether any amendment will be adopted during
the 2001-2002 biennium. Indeed, as yet the UN Committee of Experts has
not received a formal proposal. Given this uncertainty, we do not agree
with delaying action to harmonize the HMR requirements for infectious
substances with current international standards. If the UN Committee of
Experts adopts revisions to the UN Recommendations for transporting
infectious substances, we will consider such revisions in a future
rulemaking.
One commenter notes the proposal as it relates to diagnostic
specimens is not consistent with current requirements for transporting
diagnostic specimens in the ICAO Technical Instructions. This is true;
as we noted in the January 2001 NPRM, the proposal for shipping
diagnostic specimens is consistent with a proposal for the UN
Recommendations, since adopted. Since publication of the NPRM, the ICAO
Dangerous Goods Panel has also adopted these amendments. As a result,
the 2003-2004 edition of the ICAO Technical Instructions will be
consistent with the UN Recommendations and this final rule.
B. Infectious Substance Definition
In the NPRM, consistent with current requirements in the UN
Recommendations, we proposed to define infectious substances, or
Division 6.2 materials, to mean materials known to contain or suspected
to contain a pathogen with the potential to cause disease upon
exposure. We further proposed to require Division 6.2 materials to be
assigned to risk groups using defining criteria developed by WHO. WHO
defines four risk groups for infectious substances based on
pathogenicity, mode and ease of transmission, degree of risk to
individuals and communities, and reversibility of the disease through
known and effective preventative agents and treatment. Risk Group 1
includes micro-organisms unlikely to cause human or animal disease. In
the NPRM, we proposed that Risk Group 1 materials not be subject to
regulation under the HMR.
Several commenters oppose using the WHO risk group criteria for
infectious substances regulated under the HMR. They note that the WHO
system was intended for assessing and addressing risks to researchers
and health care workers in laboratory environments, not for
transportation. We do not agree. While it is true the WHO risk groups
were not originally intended for transportation environments, they do
provide a relatively simple way to delineate and differentiate risks
associated with specific pathogens. As such, the WHO risk groups are a
useful tool for assessing the degree to which specific pathogens should
be regulated in transportation, based on the potential risk to
transportation workers and the general public. Other risk systems (for
example, the biosafety level guidelines in the Centers for Disease
Control and Prevention/National Institutes of Health (CDC/NIH)
publication Biosafety in Microbiological and Biomedical Laboratories)
were also developed for use in laboratories rather than in
transportation. These systems can be more difficult to apply for
transportation purposes than the WHO risk groups.
Some commenters opposed to the use of the WHO risk groups recommend
we create an advisory group to assign risk group classifications for
infectious substances in transportation. We do not believe this is a
practical or feasible approach because of the length of time that would
be involved in establishing the advisory group and awaiting the results
of its deliberations. Other commenters opposed to use of the WHO risk
groups suggest we adopt government or industry consensus standards for
risk group assignments, such as those developed by NIH. The NIH and WHO
lists are very similar; NIH has published specific names of micro-
organisms assigned to each risk group in a table. Although not
complete, the NIH list is a useful reference source for identifying the
appropriate risk group for a given pathogen. (The NIH guidelines can be
found at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html).
There are other risk group listings that also provide useful guidance
for assigning a specific pathogen to a risk group, including a list
developed by the American Biological Safety Association (available on
line at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.absa.org/riskgroups/index.htm) and the list of
agents in the CDC/NIH publication Biosafety in Microbiological and
Biomedical Laboratories (available on line at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.cdc.gov/od/ohs/biosfty/biosfty.htm). We do not agree the HMR should incorporate
one or more of these lists by reference into the HMR. However, in this
final rule we are including these lists in the table of informational
materials in Sec. 171.7(b).
Instead of the WHO risk groups, one commenter suggests we utilize
the existing Packing Group system in the HMR to address differing risks
associated with the transportation of specific infectious substances.
Thus, the commenter suggests Packing Group I would contain virulent
pathogens that have a high risk of airborne infection, readily
penetrate unbroken skin, are extremely persistent in the environment,
and for which effective preventative or treatment measures are not
readily available. Packing Group II would contain pathogens with a
significantly lower risk of airborne infection, the primary exposure
risk of which is entry through broken skin or contact with mucous
membranes, and for which effective preventative or
[[Page 53120]]
treatment measures are readily available. Packing Group III would
contain pathogens classed as WHO Risk Group 2 materials.
We do not agree the existing Packing Group system provides a viable
alternative to the WHO risk groups. As set forth in the NPRM, the WHO
risk groups are used to identify pathogens not subject to regulation
(Risk Group 1) or to identify certain pathogens (Risk Group 2 and 3)
that may be shipped under certain exceptions, such as materials of
trade. Unless an exception is authorized, all Risk Group 2, 3, and 4
infectious substances must be transported in specification triple
packagings authorized under the HMR. In addition, they must be marked
and labeled in accordance with applicable requirements, and accompanied
by appropriate shipping and emergency response documentation. The
packing group system suggested by the commenter would require shippers
to distinguish between Risk Group 2 and 3 infectious substances when
making packaging decisions, and would be more difficult, confusing, and
burdensome to implement than the system proposed in the NPRM.
The NPRM proposed to assign infectious substances to risk groups
based on the known medical history of the patient or animal, endemic
local conditions, symptoms of the patient or animal, or professional
judgement concerning the individual circumstances of the patient or
animal. One commenter suggests this provision could endanger patient
confidentiality and violate medical privacy regulations. We disagree.
The proposal does not require health care professionals to disclose
medical histories or patient symptoms. Rather, the proposal suggests
these factors should be considered as the health care professional
assigns an infectious substance to a risk group for purposes of
transportation. Disclosure of the factors contributing to this
determination or the name of the patient is not required. Further, the
requirement for inclusion of an itemized list of contents within a
package containing Division 6.2 materials requires a shipper only to
identify the material. There is no requirement to include a patient
name on the itemized list.
One commenter suggests we modify the list of factors used to
determine risk group assignments to include the type of test ordered on
the specimen. We do not believe it is necessary to specify this
information as a factor in making risk group determinations. Shippers
should make risk group assignments based, in part, on professional
judgement concerning the individual circumstances of the patient or
animal. Such professional judgement should include the types of tests
ordered or other factors.
One commenter recommends we regulate infectious substances meeting
the defining criteria for a Risk Group 1 material for transportation
purposes We disagree. By definition, Risk Group 1 infectious substances
are micro-organisms unlikely to cause human or animal disease. Risk
Group 1 infectious substances in transportation pose little or no risk
to transportation workers or to the general public. Risk Group 1
infectious substances are not subject to regulation under international
transportation requirements because the risk posed by such materials is
very low. There is no compelling safety rationale for regulating such
materials under the HMR.
A number of commenters suggest specific revisions to the proposed
definition of infectious substances. For example, several recommend
including prions in the definition. Prions are not micro-organisms, but
are proteinaceous infectious particles consisting of an abnormal
isoform of a normal cellular protein. Prions are implicated as a cause
for neuro-degenerative diseases such as kuru and Creutzfeldt-Jacob
disease in humans, and bovine spongiform encephalopathy and scrapie in
animals. We agree with commenters that a strict reading of the proposed
definition in the NPRM would appear to exclude prions; therefore, we
have modified the definition to specifically include them. We further
revised the definition for clarity and to remove superfluous or
inaccurate terminology.
One commenter suggests limiting regulation of infectious substances
in transportation to those capable of infecting ``immunocompetent
humans and animals.'' For purposes of the HMR, ``immunocompetent''
would mean the human or animal possesses an effective body immune
mechanism with no reduced immunity to infection by any known cause. We
disagree. The WHO risk group system assigns infectious substances to
risk groups based on their ability to infect immunocompetent humans and
animals. Thus, it is not necessary to make this explicit in the HMR.
Accordingly, in this final rule we are defining Division 6.2
materials using the WHO risk group criteria. Division 6.2 materials
must be assigned to risk groups based on the degree to which they cause
injury through disease, with Risk Group 1 presenting the lowest risk
and Risk Group 4 presenting the highest risk. Assignments to risk
groups are based on the known medical history of the patient or animal,
endemic local conditions, symptoms of the patient or animal, or
professional judgement concerning the individual circumstances of the
patient or animal. Division 6.2 materials assigned to Risk Group 1 are
excepted from all HMR requirements, unless they meet the definition of
another hazard class.
C. Packaging Requirements for Infectious Substances
In the NPRM, we proposed to incorporate several changes to the
infectious substances regulations applicable to packaging requirements
and performance tests. The changes were intended to make the HMR
requirements consistent with the UN Recommendations and ICAO Technical
Instructions For example, we proposed to require manufacturers to meet
UN marking requirements for packagings represented as conforming to the
specifications for infectious substances packagings in the HMR. In
addition, we proposed to require manufacturers to retain packaging
design qualification records and to retest packagings every 24 months.
Further, we proposed to replace the current requirement for a water
immersion test with a water-spray test to simulate exposure to
rainfall, as required by the ICAO Technical Instructions. Similarly, we
proposed to incorporate the selective testing provisions in the UN
Recommendations and ICAO Technical Instructions. These provisions allow
variations in the primary receptacles within the secondary packaging,
without further testing of the completed package, if an equivalent
level of performance is maintained. Commenters endorse these proposals.
We are adopting them in this final rule without change.
One commenter suggests a more stringent packaging requirement for
infectious substances. The commenter recommends we replace the current
triple packaging requirement (water-tight primary receptacle, water-
tight secondary packaging, and outer packaging) with a quintuple
packaging. In the quintuple packaging, the primary receptacle is
enclosed in a sealed plastic bag with absorbent material inside a
watertight primary container inside a watertight secondary container
inside a tertiary container or overpack. We disagree. The accident
record demonstrates a triple packaging meeting the performance standard
established in the HMR is sufficient to contain the material under
normal conditions of transportation.
[[Page 53121]]
D. Exceptions for Domestic Shipments of Infectious Substances
In the NPRM, we proposed to expand the materials of trade (MOTS)
exceptions currently permitted under Sec. 173.6 of the HMR. The
proposal expanded the MOTS exception to include certain biological
products, diagnostic specimens, and RMW, including cultures and stocks.
MOTS include hazardous materials carried by private motor carriers
engaged in a principal business other than transportation, such as lawn
care, plumbing, welding, and door-to-door sale of consumer goods. The
MOTS exception limits the maximum gross weight of MOTS that may be
carried on a motor vehicle and includes minimum packaging and hazard
communication requirements. As proposed in the NPRM, the MOTS exception
for infectious substances specified combination packagings, with
limitations on capacity.
A number of commenters address the proposed MOTS exception for
infectious substances. Several commenters oppose the exception,
suggesting it is too broad and does not provide adequate packaging or
hazard communication. Other commenters support the exception, but
recommend we incorporate minimal acceptable standards for packaging.
These commenters note that most items shipped under the MOTS exception
must be shipped in their original packaging or the equivalent. However,
biological products, diagnostic specimens, and RMW are packaged for the
first time when they are collected at the site from which they will be
shipped. Thus, these commenters suggest the inner packaging should be
puncture- and leak-resistant and there should be sufficient absorbent
material for the contents of the inner packaging.
We agree with commenters that the MOTS exception for Division 6.2
materials should include general packaging standards. Therefore, in
this final rule, we are adding performance requirements for combination
packagings authorized under the MOTS exception for transportation of
Division 6.2 materials. The inner packaging of the combination
packaging must be leak tight for liquids, and the outer packaging must
contain absorbent material sufficient to absorb the entire contents of
the inner packagings. For sharps, which are objects that can pierce
certain types of packaging, the inner packaging of the combination
packaging must be constructed of a rigid, puncture-resistant material.
For all Division 6.2 materials, the outer packaging must be a strong,
tight packaging that is securely sealed. Note that Division 6.2
materials shipped in conformance with the MOTS exception are subject to
all applicable requirements in Sec. 173.6. This includes requirements
to mark packages with a common name or proper shipping name, and to
inform the motor vehicle operator of the presence of a hazardous
material and the requirements of Sec. 173.6.
A commenter asks us to clarify the MOTS exception for RMW, with
respect to home health care providers. Specifically, this commenter
believes the NPRM was confusing in its treatment of waste generated
from households. The commenter states the NPRM proposed the MOTS
exception in Sec. 173.6 as appropriate for home health care providers.
At the same time, the NPRM provided a complete exception in
Sec. 173.134 from HMR requirements for medical waste generated from
households and transported in accordance with applicable state or local
requirements. The exception for medical waste generated from households
applies to waste collected by local sanitation workers along with
trash, garbage, and other non-medical household waste. The MOTS
exception applies to RMW generated through home treatment of medical
conditions by professional health care providers. These health care
providers remove such waste and transport it elsewhere for disposal.
One commenter recommends the HMR include an exception from all
transportation regulatory requirements, except for minimal packaging
standards, for Risk Group 2 materials transported by highway. The
commenter did not provide a reason for this recommendation. We
disagree. Risk Group 2 infectious substances can pose risks to
transportation workers and the general public. We believe they should
be regulated in the same manner as Risk Group 3 infectious substances.
One commenter suggests the final rule should include an exception
for environmental microbiological samples collected in the field to
evaluate occupational and residential exposure risks. An example is a
piece of moldy wallboard. The organisms in such samples are
predominantly from the environment rather than humans, and therefore
pose a limited risk of infection to the individual or the community. We
agree and so modified the list of materials excepted from the HMR to
include environmental microbiological samples being transported for
analysis and/or testing. Note, however, that a material or object known
or suspected to be contaminated with an infectious substance must be
transported in accordance with all applicable HMR requirements.
The same commenter also expresses a concern about the effect of the
proposals in the NPRM on samples shipped to laboratories to evaluate
their proficiency in analyzing and identifying pathogens and other
materials. The commenter is concerned the NPRM would require such
samples to be identified in shipping documentation or on labels. In
fact, this is not the case. The HMR requires the technical name of an
infectious substances to be shown in parentheses as part of the basic
shipping description on shipping papers and package markings. However,
the definition of ``technical name'' in Sec. 171.8 of the HMR permits
use of a generic description in place of the technical name for
proficiency testing. Thus, an infectious substance sample sent to a
laboratory for proficiency testing may show a generic microbiological
description, such as bacteria, myobacteria, fungus, or viral sample, as
part of the shipping description. Packaging, marking, and labeling the
proficiency testing sample as an infectious substance and using a
generic technical name should not compromise proficiency testing
programs.
E. Diagnostic Specimens
In the NPRM, we proposed regulations applicable to the
transportation of diagnostic specimens consistent with the UN
Recommendations. Diagnostic specimens are human or animal material
being transported for diagnostic or investigational purposes. We
proposed a new entry in the Hazardous Materials Table--``Diagnostic
Specimen.'' We did not propose a UN number, warning label, or packing
group assignment.
As proposed in the NPRM, diagnostic specimens meeting the
definition of a Risk Group 4 material would be classed and required to
be transported as Division 6.2 materials, UN 2814 or UN 2900. All other
diagnostic specimens would be packaged in non-specification packagings
meeting minimum performance criteria. Under the proposal, packages
containing diagnostic specimens would be required to be marked
``Diagnostic Specimens.'' Diagnostic specimens shipped in accordance
with these provisions would be excepted from all other HMR
requirements, except for incident reporting for diagnostic specimens
transported by aircraft.
[[Page 53122]]
Several commenters oppose the NPRM proposal for diagnostic
specimens. These commenters suggest that requirements for the shipment
of diagnostic specimens should be applied based on whether a specimen
could reasonably be suspected of being infectious. According to these
commenters, any shipments other than routine screening samples or
samples transported to investigate non-communicable diseases or
conditions should be fully regulated as Division 6.2 materials. As we
noted in the NPRM (66 FR 6944), we issued an ANPRM under this docket
(63 FR 46844; September 2, 1998) proposing a regulatory regime for
diagnostic specimens similar to this commenter's suggestion. Commenters
to the ANPRM almost unanimously opposed this approach, stating it would
be difficult and costly to implement. Commenters to the ANPRM also
stated such a requirement could result in shipment delays. This would
make early detection and treatment of disease difficult, and could
significantly increase health care costs. We agreed. The NPRM proposal
specifies a more practical, cost-effective, and easy-to-understand
regulatory system for diagnostic specimens, consistent with
requirements established in the UN Recommendations.
A number of commenters suggest the table entry for diagnostic
specimens is ambiguous and may cause confusion. The table entry
indicates that diagnostic specimens are regulated as hazardous
materials. However, the specific provisions proposed for transportation
of diagnostic specimens except such shipments from most requirements
applicable to hazardous materials. Several commenters recommend we
remove the entry from the table, to clarify that diagnostic specimens
are not regulated as hazardous materials.
We disagree. In fact, the NPRM proposed a table entry for
diagnostic specimens precisely to indicate diagnostic specimens would
be regulated as hazardous materials under the HMR. There are a number
of materials listed in the table as hazardous materials that are
excepted from most HMR requirements, as we proposed to do for
diagnostic specimens. For example, lithium batteries are regulated for
transportation purposes as a hazardous material and are listed in the
table, but are excepted from many requirements of the HMR when shipped
in accordance with the provisions in Sec. 173.185.
One commenter notes that diagnostic specimens are usually shipped
with a transport media. The transport media preserves the specimen,
prevents overgrowth, and facilitates isolation and analysis. This
transport media may inactivate or disable any pathogens contained in
the specimen. The commenter states that the NPRM overlooks this aspect
of diagnostic specimens shipments, exaggerating the risk associated
with transportation. Other commenters agree and suggest the final rule
should clarify that if no pathogen is present in the diagnostic
specimen or if the pathogen is neutralized, then the specimen is not
regulated under the HMR. We agree. In this final rule, we added
diagnostic specimens in which no pathogen is present or the pathogen is
neutralized to the list of materials not subject to regulation as
infectious substances under the HMR. Note, however, that a transport
media used in the shipment of infectious substances may itself be a
hazardous material--i.e., it meets the definition of one of the defined
hazard classes based on flammability, corrosivity, toxicity, or other
hazard characteristic. If so, the shipment must be transported in
accordance with HMR requirements for the specific hazard class. Note,
also, that a diagnostic specimen shipped in a packaging with a
neutralizing agent designed to function only if the inside packaging
containing the diagnostic specimen ruptures or breaks, must be shipped
in accordance with the requirements applicable to diagnostic specimens
in Sec. 173.199.
Several commenters suggest the regulations should take into account
the physical nature of a diagnostic specimen when prescribing packaging
requirements. For example, commenters state certain diagnostic samples,
such as dried blood spots, fecal smears, and skin punches, do not
present the same risks in transportation as liquid or semi-solid
diagnostic samples. Similarly, commenters state urine and oral tissues
are incapable of transmitting disease in the same manner as blood.
These commenters recommend modification of the regulations to
distinguish between diagnostic specimens that pose a threat of
infection to transport workers and the general public, and those that
do not. We disagree. Solid-form diagnostic specimens potentially
containing infectious substances do present a risk of infection, as do
urine and oral tissues. Although this risk may be less than for blood,
we believe the minimal packaging standards for the transportation of
diagnostic specimens should apply consistently to all materials meeting
the definition of a diagnostic specimen in this final rule. Moreover,
the packaging standards established in this final rule do distinguish
between solid- and liquid-form diagnostic specimens. For example, the
capacity limits for liquid diagnostic specimens are less. Further,
liquid diagnostic specimen packagings transported by aircraft must be
capable of withstanding, without leakage, an internal pressure
producing a pressure differential of not less than 95 kPa.
Several commenters address the specific packaging requirements
proposed for the transportation of diagnostic specimens. The NPRM
proposed to require diagnostic specimens to be packaged in primary
receptacles packed inside secondary packaging, secured in an outer
packaging with suitable cushioning material. One commenter states there
is no need to secure the secondary packaging inside the outer
packaging, because the specimen is twice contained in leak-proof,
watertight packaging with absorbent material in between. This commenter
asserts the proposal adds to overall packaging costs with no
transportation safety benefit. We disagree. The requirement to secure
secondary packaging inside the outer packaging helps assure the
integrity of the entire packaging, by preventing damage to the
secondary packaging resulting from handling during transportation.
Moreover, the requirement is consistent with international standards.
Further, secondary packaging can be secured inside an outer packaging
in several ways that do not necessarily involve tying or fastening the
secondary packaging to the outer packaging. For example, if the
secondary packaging fits snugly within the outer packaging, the
secondary packaging would be considered to be secured within the outer
packaging.
In addition, several commenters state the proposed capacity limits
on packages of diagnostic specimens should be more flexible to
accommodate dry ice for preservation of specimens. The NPRM proposed an
outer packaging capacity limit of 4L (1 gallon) for liquid diagnostic
specimens, and 4 kg (8.8 pounds) for solid diagnostic specimens. These
capacity limits apply to the diagnostic specimen only; packagings may
be larger to accommodate dry ice used for preservation of specimens.
Note, however, that shipments using dry ice are subject to applicable
requirements in Sec. 173.217.
Another commenter suggests the packaging requirements for
diagnostic specimens should be more stringent than in the NPRM. This
commenter recommends a quintuple packaging, consisting of a primary
receptacle
[[Page 53123]]
enclosed in a sealed plastic bag contained in a primary container,
inside a secondary container, inside a tertiary container. We disagree.
The packaging for diagnostic specimens proposed in the NPRM is
consistent with packaging requirements in the UN Recommendations.
Further, the packaging suggested by the commenter would add
significantly to the cost of shipping diagnostic specimens.
One commenter addresses the ``diagnostic specimen'' marking
requirement proposed in the NPRM. This commenter states the proposed
marking requirement is redundant and provides no transportation
benefit. We disagree. Under the proposal in the NPRM, packages
containing diagnostic specimens must be marked ``Diagnostic Specimen.''
No other marking or labeling is required, nor are shipping papers
required; thus, it is difficult to see how the proposed marking could
be ``redundant.'' The marking is intended to communicate a potential
hazard to transportation workers. Diagnostic specimens shipped in
accordance with the provisions in the NPRM could contain infectious
material, and the marking indicates transportation workers should take
appropriate precautions if the package is damaged or leaking.
Another commenter suggests we adopt and modify the ``Excepted
Quantities Label'' authorized by International Air Transport
Association (IATA) standards, to indicate a shipment contains a
diagnostic specimen. We believe the marking requirement in this final
rule accomplishes the same goal without the additional regulatory
burden that would result from a new labeling requirement. However, this
final rule does not prohibit shippers from voluntarily applying the
``Excepted Quantities Label'' to such packages in addition to the
``Diagnostic Specimen'' marking.
In addition to the MOTS exception previously discussed, the NPRM
also proposed a complete exception from the HMR for diagnostic
specimens transported by private or contract motor carriers. One
commenter opposes this exception, out of concern that inadequate
packaging would expose untrained emergency response personnel to
potentially infectious materials. However, most commenters generally
are supportive of this proposal, agreeing the packaging and procedures
used for courier shipments of diagnostic specimens are sufficient to
assure the safety of such shipments in transportation. Further,
couriers are familiar with the materials they transport, and are
trained in the application of the Occupational Safety and Health
Administration (OSHA) standards for Universal Precautions for handling
materials potentially containing infectious substances. Therefore, this
exception is adopted as proposed in this final rule.
The NPRM proposed to except diagnostic specimens prepared in
accordance with proposed Sec. 173.199 from training requirements in
Subpart H of Part 172 of the HMR. In lieu of training, the NPRM
proposed to require offerors and transporters of diagnostic specimens
to be informed of the diagnostic specimen packaging requirements.
Commenters did not specifically address this aspect of the proposed
requirements for diagnostic specimens in the NPRM. One commenter asked
us to clarify the meaning of ``must be informed'' as used in proposed
Sec. 173.199.
As used in new Sec. 173.199 of this final rule, ``must be
informed'' means persons who offer or transport diagnostic specimens
for transportation in accordance with Sec. 173.199 must know about and
be able to apply the requirements of Sec. 173.199 to specific
shipments. There are no record-keeping or certification requirements
associated with this provision, which distinguishes this requirement as
a less formal type of training requirement than would otherwise be
required by subpart H of part 172. In this final rule, we modified the
NPRM proposal to indicate persons who ship or transport diagnostic
specimens must know about the provisions in Sec. 173.199.
The NPRM proposed to subject diagnostic specimens transported by
aircraft to incident reporting requirements. Several commenters oppose
this proposal. They suggest an incident-reporting requirement may cause
air carriers to refuse shipments of diagnostic specimens, which could
lead to serious delays in the testing process and adversely affect the
provision of quality health care to patients. We disagree that the
incident reporting requirement should be removed from this final rule.
Commenters' suggestion that air carriers may refuse shipments as a
result of this requirement is speculative; no air carriers indicated
they would refuse shipments as a result of this provision. Further, we
believe the benefits of incident reporting will be significant. Since
diagnostic specimens are currently excepted from all regulatory
requirements in the HMR, we currently have only anecdotal information
concerning incidents involving diagnostic specimens. Information
provided through incident reports will allow us to more fully evaluate
the risks posed by these materials in transportation and to assess the
efficacy of the packaging requirements imposed by this final rule.
One commenter suggests air carriers may not be able to identify a
leak as coming from a package containing a diagnostic specimen. Since
the package must be marked with the words ``Diagnostic Specimen,'' we
do not believe such identification will be difficult.
Two commenters suggest the proposed requirements for transporting
diagnostic specimens will be ``prohibitively expensive'' for the
industry. However, these commenters do not provide supporting evidence
for this assertion. We disagree. The provisions for air shipment of
diagnostic specimens are consistent with the UN Recommendations and
will be consistent with the 2003-2004 Edition of the ICAO Technical
Instructions, which most air carriers follow for both domestic and
international transportation. Further, the final rule includes several
exceptions for ground transportation of diagnostic specimens, thus
minimizing new costs for health care providers.
Accordingly, this final rule adopts the provisions applicable to
the transportation of diagnostic specimens proposed in the NPRM.
Diagnostic specimens meeting the definition of a Risk Group 4 material
must be classed and transported as Division 6.2 materials, UN 2814 or
UN 2900. Diagnostic specimens known or suspected to contain a Risk
Group 2 or 3 infectious substance must be packaged in primary
receptacles packed inside secondary packaging to preclude breakage,
punctures, or leakage. For liquids, there must be sufficient absorbent
material to absorb the entire contents of the primary receptacle. The
secondary packaging must be secured in outer packagings with suitable
cushioning material. For liquids transported by aircraft, either the
primary receptacle or the secondary packaging must be capable of
withstanding an internal pressure producing a pressure differential of
at least 95kPa (0.95 bar, 14 psi). The completed package must be
capable of passing a drop test from a height of at least 1.2 meters
(3.9 feet). The package must be marked with the words ``Diagnostic
Specimen.'' Diagnostic specimens shipped in conformance with these
provisions are excepted from all other requirements in the HMR, with
one exception. Diagnostic specimens transported on board aircraft are
subject to the incident reporting requirements in Secs. 171.15 and
171.16. Under this
[[Page 53124]]
final rule, offerors and transporters of diagnostic specimens must know
about the diagnostic specimen packaging requirements. A commenter asked
if diagnostic specimens shipped in conformance with these provisions
would be subject to HMR requirements for notification-of-pilot-in-
command. The answer is no.
We note that waste diagnostic specimens--diagnostic specimens
meeting the definition for RMW in this final rule--may not be
transported under the exceptions established in this final rule for the
transportation of diagnostic specimens. Waste diagnostic specimens lose
their identity as diagnostic specimens for purposes of the HMR, and
must be transported in accordance with the HMR requirements applicable
to RMW.
F. Biological Products
Commenters to the NPRM generally support its proposals concerning
transportation of biological products. Currently, biological products
are excepted from the HMR provided they meet FDA or USDA regulations
governing the transfer of biological products. In the January 2001
NPRM, we proposed to limit this exception to biological products
meeting the definition of a Risk Group 1 material or licensed for use
under current FDA or USDA regulations. We proposed to require
unlicenced biological products meeting the definition of a Risk Group
2, 3, or 4 infectious substance to be classed as infectious substances,
Division 6.2, and packaged in specification packagings authorized for
the transportation of infectious substances.
In addition, we proposed to add a special provision in Sec. 172.102
relating to the transportation of blood and blood products. For
consistency with ICAO Technical Instruction Special Provision A81, this
special provision would except blood and blood products from current
quantity limits for shipments by air when the materials are packaged in
primary receptacles not exceeding 500 mL (17 ounces) and contained in
outer packagings not exceeding 4 L (1 gallon).
We also proposed to except from all HMR requirements the following:
blood collected for blood transfusions; blood collected for the
preparation of blood products; blood products intended for transplant;
and tissues and organs intended for transplant.
A number of commenters note that veterinary biological products are
regulated by USDA, regardless of their licensing status. Such
veterinary biological products are subject to comprehensive regulation
(9 CFR Parts 101 through 124). For example, veterinary biological
products in pre-license status are regulated by USDA under 9 CFR 103.3
and are shipped only after USDA review and approval. The USDA
requirements are designed to assure that the biological materials are
not contaminated during shipment and pose no threat to agriculture or
livestock. Similarly, under the Virus-Serum-Toxic Act of 1913 (21
U.S.C. 151 et seq.), imported veterinary biological products are
subject to permit rather than licensing requirements. USDA regulations
assure that imported veterinary biological products meet the same high
standards for distribution and sale in the United States as
domestically produced biological products. Based on USDA's
comprehensive regulatory scheme, commenters recommend that imported
veterinary biological products subject to USDA permitting procedures be
excepted from HMR requirements. We agree biological products subject to
USDA regulation should be excepted from HMR requirements, and have
modified the list of exceptions in this final rule accordingly.
A commenter recommends we expand the exception from regulation for
biological products subject to Federal approval and licensing
requirements, to include products manufactured by facilities licensed
by or registered with a Federal agency. We disagree. The current
exception is product-specific because Federal requirements for approval
and licensing of biological products assure their safety. Products
manufactured by licensed or registered facilities may or may not be
subject to Federal approval processes and so may or may not have a
record demonstrating their safety.
One commenter disagrees with the proposed exception in the NPRM for
blood collected for transfusions. The commenter states all human blood
should be treated as infectious material. If not, transport workers
would be subject to less stringent protective requirements than
laboratory and hospital workers. We disagree. Blood collection
facilities are subject to the OSHA regulations for handling potentially
infectious blood and blood products (29 1910.1030). The OSHA
regulations include requirements for handling, packaging, and shipping
blood. Because blood collection facilities are subject to OSHA
regulations, we believe an exception from the HMR for blood collected
for transfusion is justified.
One commenter suggests the exception for blood collected for
transfusion and blood products should be expanded to include blood and
plasma transported for testing as part of the donor process. We agree
that blood sent for testing as part of the donor process should be
excepted from regulation under the HMR. Therefore, we modified the
proposal in the NPRM to except from the HMR blood sent for testing as
part of the donor process, unless the person collecting the blood has
reason to believe the sample contains an infectious substance. In such
instances, the blood sent for testing must be packaged and shipped as a
diagnostic specimen. Note also that blood and blood products
transported for testing as part of the donor process is subject to OSHA
requirements for handling and shipping.
Several commenters suggest the proposed exception from HMR
requirements for blood collected for transfusion and blood products,
organs, and tissues intended for transplant, should be expanded to
include plasma derivatives. Plasma derivatives are derived from the
same units of pre-screened blood used for transfusion. However, plasma
derivatives are not ``transfused.'' They are ``infused.'' These
commenters request clarifying the final rule to specify plasma
derivatives are covered by the same exception as blood collected for
transfusion. Plasma derivatives are covered under the exception for
biological products in Sec. 173.34(b) of this final rule. Therefore, no
additional clarifying language is necessary.
A number of commenters note the proposed addition of Special
Provision A81 does not reflect the most recent amendments to the UN
Recommendations and the ICAO Technical Instructions. Effective June 20,
2001, the UN Recommendations and ICAO Technical Instructions include a
Special Provision to except from aircraft quantity limits, body fluids
packed in primary receptacles not exceeding 1,000 mL in outer
packagings not exceeding 4 L. In this final rule, we revised Special
Provision A81 for consistency with the most recent editions of the UN
Recommendations and ICAO Technical Instructions. Thus, under this final
rule, Special Provision A81 applies to shipments of any body fluid
(e.g., blood, plasma, urine, semen, saliva, spinal fluid, amniotic
fluid, and the like).
One commenter recommends we expand the exception from HMR
requirements for blood collected for transfusions or blood products, to
include waste generated from the collection and testing of blood and
blood products. We disagree. Waste is not packaged and transported with
the same care as blood and blood products intended for transfusion,
even under the
[[Page 53125]]
exception granted in this final rule. Further, waste generated from the
collection of blood may include sharps and similar objects.
We note that all waste biological products--biological products
meeting the definition for RMW in this final rule--may not be
transported under the exceptions in this final rule for the
transportation of biological products. Waste biological products lose
their identity as biological products for purposes of the HMR and, if
they contain infectious substances, must be transported in accordance
with the HMR requirements applicable to RMW.
G. Genetically Modified Micro-Organisms
In the NPRM, we proposed adding ``Genetically modified micro-
organism'' to the Hazardous Materials Table as a Class 9 material. We
proposed to require these materials to be packaged in conformance with
the requirements for packaging infectious substances, except that the
packagings need not be marked or tested in accordance with part 178
requirements.
The NPRM also proposed two exceptions applicable to the
transportation of genetically modified micro-organisms. First, we
proposed to except genetically modified micro-organisms from all
requirements in the HMR if a Federal government agency authorizes their
final distribution and use. Second, we proposed to except genetically
modified micro-organisms from HMR requirements when transported in a
non-passenger-carrying transport vehicle operated by a private or
contract motor carrier.
A number of commenters address the proposals for genetically
modified micro-organisms. Of major concern to the commenters is that
the proposed requirements are not risk-based, but instead assume
genetically modified micro-organisms pose a threat during
transportation merely because of the fact that they are genetically
modified. One commenter asserts the proposed Class 9 definition for
genetically modified micro-organisms is scientifically meaningless,
burdensome, and likely to impede essential research and development
involving these materials. Other commenters are concerned that, as
defined in the NPRM, genetically modified micro-organisms could include
products enhanced through biotechnology. They fear that the requirement
to transport genetically modified micro-organisms as Class 9 materials
could be interpreted to apply to bulk shipments of biotechnology-
enhanced agricultural commodities or products. Most commenters
recommend we regulate genetically modified micro-organisms only when
they also meet the definition of an infectious substance.
We agree the NPRM proposals applicable to genetically modified
micro-organisms may be unnecessarily broad, confusing, and difficult to
apply and interpret. Further, there are a host of other stringent
Federal requirements applicable to research, licensing, permitting,
movement, and use of genetically modified micro-organisms. These
regulatory systems were initially described in the policy statement
referred to as ``The Coordinated Framework'' (51 FR 23302, June 26,
1986). For more specific details, please see the appropriate agency
websites--for example, the EPA Biopesticides and Pollution Prevention
Division at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.epa.gov/pesticides/biopesticides/; the EPA
Office of Pollution Prevention and Toxics at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.epa.gov/opptintr/biotech/index.html; the Animal and Plant Health Inspection
Service at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.aphis.usda.gov; and the FDA Center for Food
Safety and Applied Nutrition at http:// vm.cfsan.fda.gov/list.html.
Because a number of Federal regulatory agencies have rigorous
programs in place to regulate the safety and distribution of
genetically modified micro-organisms, and because the United States is
engaged in ongoing international negotiations concerning global
regulation of these materials, the proposals in the NPRM applicable to
genetically modified micro-organisms are not adopted in this final
rule. Note, however, that genetically modified micro-organisms meeting
the definition of a Division 6.2 material are subject to regulation
under the HMR.
H. Regulated Medical Waste
Commenters generally support the proposals in the NPRM to permit
transportation of RMW in certain non-specification bulk packagings.
However, commenters suggest several modifications to the proposals in
the NPRM.
The NPRM defines ``regulated medical waste'' to mean waste or
reusable material containing or suspected of containing an infectious
substance in Risk Groups 2 or 3. RMW is generated in the diagnosis,
treatment, or immunization of human beings or animals; research on the
diagnosis, treatment, or immunization of human beings or animals; or
the production or testing of biological products. RMW containing an
infectious substance in Risk Group 4 must be classed as Division 6.2,
described as an infectious substance, and assigned to UN 2814 or UN
2900, as appropriate. One commenter states the RMW definition is
impossible to implement because generators of RMW will not know the
specific materials contained in the waste. We disagree. Generators of
RMW know the nature of the waste because of the materials they handle
during the course of their operations. Further, Risk Group 4 materials
are very closely regulated by the CDC, so a generator of RMW should
know whether the waste contains a Risk Group 4 material.
One commenter recommends we require RMW containing Risk Group 1
infectious material to meet ``minor'' regulatory requirements. We
disagree. As stated above, Risk Group 1 infectious substances are
unlikely to cause human or animal disease, and so pose little or no
risk to transportation workers or to the general public. There is no
compelling safety rationale for regulating RMW containing only Risk
Group 1 infectious material.
The NPRM proposed to authorize certain non-specification bulk
containers for use as outer packagings for the transportation of RMW.
Two commenters oppose this proposal out of concern that it represents a
relaxation of current requirements for authorized RMW packagings to
meet Packing Group II performance standards. We disagree. This final
rule retains the Packing Group II performance requirements for non-bulk
packagings. For bulk packagings, which are currently authorized under
the terms of 29 exemptions, this final rule permits RMW to be
transported in certain non-specification packagings with proven safety
records gained through exemptions experience. These packagings have a
demonstrated safety record. In addition, this final rule establishes
performance standards for the authorized bulk packagings, including a
requirement for certain packagings to be capable of passing a drop test
at the Packing Group II performance level.
One commenter suggests the proposal would permit regulated medical
waste to be transported in large, open-top, roll-off bulk containers.
This is not the case. The non-specification bulk packagings authorized
for the transportation of RMW must be closed with a lid or closure, to
prevent intrusion of water into the packaging or release of contents
from the packaging.
Several commenters suggest the provisions applicable to authorized
bulk packagings are needlessly detailed. For example, commenters
question the necessity of the proposed requirement for a wheeled cart
(Cart) to be mounted on a minimum of four wheels and to have a gasketed
lid. We agree. In this
[[Page 53126]]
final rule, we modified the bulk packaging provisions to provide for
more flexibility in their design.
Other commenters suggest we should permit more flexibility for
inner packagings inside bulk outer packagings. For example, one
commenter notes that the 10-gallon limit on the size of sharps
containers used as inner packagings, could preclude shipment of such
items as specialized single-use drills, skin staple guns, and heart/
lung machine and cell saver canisters, as RMW. We agree and modified
this final rule accordingly. For sharps containers, this final rule
requires a container with a capacity greater than 20 gallons to be
capable of passing the performance tests in Sec. 178.601 of the HMR at
the Packing Group II performance level. A sharps container with a
capacity of 20 gallons or less must be puncture resistant, but need not
be capable of passing the Part 178 performance tests.
Commenters do not address our proposal to allow RMW to be
transported in ``Large Packagings,'' which are intermediate bulk
packagings containing one or more inner packagings consistent with the
requirements of the UN Recommendations. We adopted a definition for
these packagings in a final rule issued under Docket HM-215D, published
June 21, 2001 (66 FR 33316). The International Maritime Dangerous Goods
Code also incorporates this definition. As defined under HM-215D, a
Large Packaging consists of an outer packaging containing articles or
inner packagings and designed for mechanical handling. A Large
Packaging has a capacity greater than 400 kg (882 lbs) or 450 liters
(119 gallons), but does not exceed 3 cubic meters (7,000 liters, 793
gallons, or 106 cubic feet) in volume. The proposals in the NPRM
concerning Large Packagings are adopted without change in this final
rule.
One commenter raises concerns about the ``certification'' process
for RMW packagings. The commenter suggests the ``certification''
standards are vague and assume manufacturing uniformity, which may or
may not be present, according to the commenter. The commenter asserts
``only the most sophisticated parties, that is, the larger
transporters, have had containers certified'' and this limits
generators' flexibility in selecting the most appropriate, cost-
effective packaging for transporting RMW. We disagree. Currently, the
packaging standards in Sec. 173.197 specify that non-bulk packagings
for RMW must conform to the requirements of Part 178 at the Packing
Group II performance level. This means each packaging must be marked to
certify the packaging conforms to all applicable requirements. The
packaging design and manufacturing requirements apply to any
manufacturer of a specification packaging, not just ``the most
sophisticated parties.'' Further, bulk packagings for transportation of
RMW are currently authorized only under the terms of exemptions. The
proposals in the NPRM in fact increase flexibility, and thus reduce
costs for offerors and transporters of RMW by providing a range of bulk
packaging options. These options include non-specification packaging
options, not currently authorized under the HMR. We are adopting the
NPRM proposals in this final rule.
The NPRM proposed to require inner packagings authorized for Large
Packagings, Carts, and bulk outer packagings (BOP) to be marked or
tagged with the name and location of the offeror. The proposal included
an exception from these marking requirements when the entire contents
of the Large Packaging, Cart, or BOP originate at a single facility and
are delivered to a single location. One commenter opposes this
exception. The commenter describes two incidents involving RMW found
along public highways, presumably fallen from a transport vehicle. The
bags within which the RMW was contained were not marked with the name
and location of either the offeror or the consignee, and so could not
be traced. The commenter suggests a lack of identification on inner
packagings may exacerbate problems related to illegal dumping of RMW or
poor package handling. We disagree. This exception is consistent with
the current exception from marking for all hazardous materials
shipments transported by highway without transfer from one motor
carrier to another. This exception is also consistent with the current
marking exception for shipments where the entire contents of a
transport vehicle or freight container are shipped from one consignor
to one consignee.
In response to a petition for rulemaking, the NPRM proposed to
revise the HMR to permit transportation of Risk Group 2 or 3 waste
cultures or stocks in non-specification packagings when transported by
common or contract carriers in dedicated vehicles. Commenters did not
specifically address this proposal. It is adopted as proposed in this
final rule.
One commenter opposes the proposal in the NPRM to revise the
quantity limitations applicable to shipments of RMW on aircraft.
Currently, such shipments are forbidden. We proposed to revise the
quantity limitations for non-bulk shipments of RMW on board aircraft to
read ``No limit'' for consistency with the ICAO Technical Instructions
applicable to quantity limitations for RMW on airplanes. We proposed to
continue to prohibit bulk shipments of RMW on board aircraft. The
commenter suggests RMW shipments are not time critical, and thus do not
need to be transported by air, except in the rare instances already
authorized by Special Provision A14. (Special Provision A14 permits air
shipments of small quantities of RMW when other means of transportation
are impracticable or unavailable.) We disagree. The proposals for
transporting RMW on board aircraft are adopted in this final rule for
consistency with the UN Recommendations and ICAO Technical
Instructions. When properly packaged, non-bulk shipments of RMW may be
safely transported by air.
One commenter notes many RMW generators depend on the entity
transporting the RMW for many services related to the management of the
waste. The commenter suggests the proposals applicable to RMW in the
NPRM would require both generators and carriers to perform the same
functions, greatly increasing the costs of compliance for generators.
We disagree. A health care facility may contract with a waste hauler to
perform all offeror functions associated with the transportation of its
RMW. In this case, the waste hauler becomes the offeror of the RMW and
is responsible for classifying the RMW, selecting appropriate
packagings, assuring packagings are not overfilled, securing the
closures on packagings, marking and labeling the packagings as
appropriate, and generating shipping papers in accordance with the HMR.
Workers in the health care facility who perform no offeror functions
affecting the transportation safety of the shipment, but merely deposit
medical waste in containers provided by the waste hauler, are not
subject to HMR requirements. However, workers at a health care facility
who perform offeror functions are subject to applicable requirements of
the HMR. If a health care facility and a waste hauler split the
performance of offeror functions, both the facility and the waste
hauler are subject to the HMR as offerors.
In the NPRM, we noted in the preamble that waste diagnostic
specimens and waste biological products--diagnostic specimens and
biological products meeting the definition for RMW--could not be
transported under the exceptions proposed in the NPRM for these
[[Page 53127]]
materials. One commenter opposes this distinction, stating that
excepted products should continue to be excepted from HMR requirements
when their status changes to waste. The commenter states regulating a
material differently at various stages places an undue and unrealistic
burden on medical staff in the field. We disagree. By definition, RMW
is a waste or reusable material containing or suspected of containing a
Risk Group 2 or 3 infectious substance. If a diagnostic specimen is
found not to contain a pathogen, then it is not subject to regulation
as RMW. Similarly, if an excepted biological product is not
contaminated during use or handling with an infectious material, then
it is not subject to regulation as RMW. Laboratory workers, health care
providers, and medical staff should have no problem identifying those
diagnostic specimens or biological products meeting the RMW definition,
and transporting them with other RMW generated by the facility.
I. Used Health Care Products
In the NPRM we proposed to except from the HMR used health care
products returned to the manufacturer, provided the products are
shipped in a triple packaging conforming to certain manufacturing and
marking requirements. The proposal required the primary and secondary
containers to be marked with the OSHA BIOHAZARD symbol. In addition, we
proposed to require the secondary container to be a watertight metal or
plastic packaging designed and constructed in a manner to assure the
used health care product and primary container remain intact during
transportation. The NPRM proposed to require offerors and transporters
of used health care products potentially contaminated with an
infectious substance to be informed about the used health care product
packaging requirements.
Several commenters address this proposal. Most suggest that the
proposal is too broad. Further, commenters suggest that, for purposes
of the HMR, the definition of used health care products should be
limited to used products contaminated with potentially infectious body
fluids or materials. Transportation requirements should apply only to
products where the infectious hazards cannot be removed or mitigated
prior to transportation. We agree and modified this final rule
accordingly.
Commenters also suggest the packaging requirements for shipment of
used health care products should be risk-based performance standards
rather than triple-pack specification standards, as proposed in the
NPRM. We agree. Therefore, in this final rule we are revising the
packaging requirements proposed in the NPRM to provide more flexibility
for shippers.
Note that the person offering a used health care product for
transportation under the HMR, not the original manufacturer of the
product, is responsible for assuring compliance with the transportation
requirements.
J. Hazard Communication
In the NPRM, we proposed to require bulk packagings containing RMW
to be marked with the appropriate UN identification number and with a
BIOHAZARD marking. The BIOHAZARD marking would have to conform to OSHA
specifications for the BIOHAZARD marking in 29 CFR 1910.1030(g)(1)(i)
to communicate to emergency response personnel the nature of the
material being transported. We proposed to require the size of the
BIOHAZARD marking to measure at least 273 mm (10.8 inches) on each
side. Two commenters note many states require a 152.4 mm (6 inches)
size marking, and ask us to consider changing our proposed size
requirement. We agree and modified this final rule accordingly. In
addition, the final rule includes a graphic representation of the
BIOHAZARD symbol.
One commenter requests we allow a transition period for the new
BIOHAZARD marking for bulk shipments of RMW, and for the marking
requirements on inner packagings authorized for use inside bulk
packagings authorized for the transportation of RMW. We agree. In this
final rule we are specifying the effective date for both marking
requirements as one year after the effective date of this final rule.
One commenter suggests all unique marking requirements for
infectious substances, including regulated medical wastes, should be
consolidated into one section in subpart D of part 172, rather than
located in sections authorizing exceptions from certain requirements or
in packaging authorization sections. We disagree. Placing some marking
requirements with authorized exceptions or with packaging authorization
requirements helps shippers easily identify all requirements with which
they must comply when preparing packages for transportation.
Several commenters note certain packages of infectious substances
may be subject to labeling requirements under both the HMR and the OSHA
BIOHAZARD labeling requirements in 29 CFR 1910.1030. These commenters
suggest we adopt a single labeling requirement, or we work
cooperatively with OSHA to clarify that the OSHA BIOHAZARD label should
not be used for transportation. While we agree with commenters that a
dual labeling requirement for certain packages of infectious substances
may be confusing, we determined that the OSHA BIOHAZARD label is not
prohibited under Sec. 172.401 of the HMR. We do permit use of the
BIOHAZARD label in place of the INFECTIOUS SUBSTANCE label under
certain conditions. However, substituting the BIOHAZARD label for the
INFECTIOUS SUBSTANCE label in all cases is not feasible. The INFECTIOUS
SUBSTANCE label is consistent with labels authorized by the UN
Recommendations and the ICAO Technical Instructions for international
shipments of infectious substances. We do work with OSHA to minimize
regulatory duplications and inconsistencies and will continue to do so.
State, local, and tribal governments should be aware the Federal
hazardous materials transportation law (Federal hazmat law; 49 U.S.C.
5101 et seq.) contains an express preemption provision preempting
state, local, and Indian tribe requirements on certain covered subjects
(49 U.S.C. 5125(b)). The covered subject areas are:
(a) The designation, description, and classification of hazardous
material.
(b) The packing, repacking, handling, labeling, marking, and
placarding of hazardous material.
(c) The preparation, execution, and use of shipping documents
related to hazardous material and requirements related to the number,
contents, and placement of those documents.
(d) The written notification, recording, and reporting of the
unintentional release in transportation of hazardous material.
(e) The design, manufacturing, fabrication, marking, maintenance,
reconditioning, repairing, or testing of a package or container
represented, marked, certified, or sold as qualified for use in
transporting hazardous material.
The marking of a hazardous material for purposes of transportation
in commerce is a covered subject for purposes of preemption. Thus,
unless authorized by another Federal law or a waiver of preemption from
the Secretary of Transportation, a non-Federal marking requirement
applicable to transportation in commerce is preempted when it is not
``substantively the same'' as Federal hazmat law or a regulation issued
under it. 49 U.S.C.
[[Page 53128]]
5125(b)(1). After August 14, 2003, non-Federal marking requirements
applicable to hazardous materials transportation not substantively the
same as the marking requirements for RMW included in this final rule
are preempted, unless authorized by another Federal law or a waiver of
preemption.
K. Training
Several commenters addressed training requirements associated with
the regulation of infectious substances under the HMR. Currently,
Subpart H of Part 172 requires a hazmat employer to assure each of its
hazmat employees is trained, including general awareness/
familiarization training, function-specific training, and safety
training. A hazmat employee may not perform any function regulated
under the HMR unless he or she is trained. One commenter states this
level of training is infeasible and unnecessary for health care
professionals, and suggests training should be more abbreviated and
targeted to specific functions. This commenter further suggests we
consider increasing the packaging integrity for shipments of infectious
substances, in lieu of applying the hazmat employee training
requirements to health care professionals.
We disagree that application of the training requirements to health
care professionals is ``infeasible'' and ``unnecessary.'' Training is
essential to successful compliance with the HMR. Most health care
professionals are already familiar with and trained in requirements
that can be used to satisfy some training obligations under the HMR,
such as the OSHA Universal Precautions procedures. Further, increased
packaging integrity cannot be a substitute for training. Health care
professionals need training to properly use any packaging authorized
for the transportation of infectious substances, or the regulatory
requirements would be meaningless. Moreover, for shipments conforming
to requirements for materials of trade or diagnostic specimens in this
final rule, the associated training requirements are minimal. They do
not include the certification and record keeping provisions in subpart
H of part 172.
Another commenter recommends we specify the level of training
required for health care professionals, and other offerors and
transporters of infectious substances. We disagree. Flexibility is
built into the HMR training requirements, allowing hazmat employers to
determine the method of training and the level to which each employee
must be trained. This flexibility helps to minimize the training burden
on both hazmat employers and hazmat employees. This commenter also
recommends we delay enforcement of the new requirements in this final
rule to allow an appropriate period for retraining. Again, we disagree.
This final rule is effective October 2, 2002; this should provide ample
time to assure hazmat employees are trained in the new requirements.
L. Contaminated Food and Food Products
One commenter states that the definition of ``infectious
substance'' in Sec. 173.134, as proposed, could be read to require food
and food ingredients tainted with salmonella to be shipped in
accordance with requirements for transportation of infectious
substances. Salmonella is listed in 42 CFR 72.3 as an infectious
substance. This commenter notes salmonella-tainted food does not pose a
significant, acute threat to transport workers or to the general public
since it must normally be ingested to cause disease. This commenter
suggests the final rule incorporate an exception from regulation for
food and food ingredients tainted with salmonella or other bacteria. We
agree. Indeed, there is no significant threat to life or property from
the transportation of food, food ingredients, or food products
contaminated with bacteria or other types of pathogens, particularly
when such food is being transported as a result of a recall by the
original processor. We modified the list of exceptions from HMR
requirements in the final rule accordingly.
III. Section-by-Section Review
Part 171
Section 171.7
We are revising the table of material incorporated by reference to
add two new references to test methods developed by the American
Society for Testing and Materials. These tests are required for plastic
inner packagings used to transport RMW inside Large Packagings and non-
specification bulk packagings. We are also revising the table of
informational material not requiring incorporation by reference. This
revision will add three resources for shippers to use to assign a risk
group to a specific infectious substance.
Section 171.8
We are adding definitions for ``biological product,'' ``cultures
and stocks,'' ``diagnostic specimen,'' ``risk group,'' ``sharps,'' and
``toxin.'' These definitions refer readers to the definitions in
Sec. 173.134 of the HMR.
Section 171.14
We are allowing a two-year transition period for the revised
Division 6.2 labels adopted in this final rule.
Section 171.15
We are removing the term ``etiologic agents'' from paragraphs
(a)(3) and (b) and replacing it with ``infectious substances.'' In
addition, in paragraph (b) we are adding wording to emphasize that a
written report of an incident involving infectious substances must be
submitted to RSPA.
Part 172
Section 172.101
For the entry ``Regulated medical waste,'' we are removing the
letter ``D'' in column (1). In column (7), we are removing the
reference to Special Provision A14 and revising columns (9A) and (9B)
to replace ``Forbidden'' with ``No Limit'' for quantity limitations on
board aircraft. These changes harmonize requirements in the HMR with
those in the ICAO Technical Instructions, and facilitate the
transportation of RMW in non-bulk packagings by aircraft. In addition,
column 8C is revised to replace ``none'' with ``197'', to indicate bulk
packagings authorized for the transportation of RMW can be found in
Sec. 173.197 of the HMR. Finally, we are revising Special Provision A13
to prohibit the transportation of bulk packagings of RMW by aircraft.
For the entries ``Infectious substances, affecting animals only''
and ``Infectious substances, affecting humans,'' we are adding new
special provisions in column (7). Special Provision A81 provides relief
from quantity limits for the transport of body fluids containing
infectious substances, when in primary receptacles not exceeding 1,000
mL (34 ounces) and in outer packagings not exceeding 4L (1 gallon) and
packaged in accordance with Sec. 173.196. Special Provision A82
provides relief from UN standard packaging for transporting body parts,
whole organs, and whole bodies.
In addition, we are adding a new entry, ``Diagnostic specimen'', to
the Table as a Division 6.2 material. There is no UN number, hazard
warning label, or packing group assignment.
We are also adding two new entries for ``Toxins, extracted from
living sources, liquid, n.o.s., UN 3172'' and ``Toxins, extracted from
living sources, solid, n.o.s., UN 3172.'' For both entries, a ``G'' in
column (1) indicates that the
[[Page 53129]]
shipping description on shipping papers must include the technical
names for the materials. Both entries indicate the materials are
Division 6.1 materials, UN 3172, PG I, II, or III. We are adding
Special Provision 141 to state that toxins containing infectious
substances or contained in infectious substances must be classed as
Division 6.2 materials and assigned to UN 2814 or UN 2900, as
appropriate.
Section 172.102
We are revising this section by removing Special Provision A14,
revising Special Provision A13, and adding Special Provisions 141, A81,
and A82, as above detailed.
Section 172.323
We are adding this section to require bulk packagings containing
RMW to be marked with a BIOHAZARD marking conforming to OSHA
regulations at 29 CFR 1910.1030. In response to comments, this final
rule requires the size of the marking to be at least 152.4 mm (6
inches) on each side. In this final rule, we are adding new paragraph
(c) to require the BIOHAZARD marking to be displayed on a background of
contrasting color. In addition, this final rule includes a graphic
representation of the BIOHAZARD symbol.
Section 172.432
We are revising the INFECTIOUS SUBSTANCE label to incorporate the
new toll-free telephone number (1-800-232-0124) for reporting incidents
to the CDC.
Section 172.502
We are revising paragraph (b) to indicate the restrictions on
placarding in paragraph (a) of this section do not apply to the display
of a BIOHAZARD marking on a white square-on-point background.
Part 173
Section 173.6
We are adding a MOTS exception for diagnostic specimens, biological
products, and RMW, other than Risk Group 4 materials. The exception
includes packaging requirements and quantity limitations. As suggested
by commenters, this section incorporates minimum performance packaging
standards for MOTS that are diagnostic specimens, biological products,
or RMW.
Section 173.28
We are adding a requirement for Division 6.2 packagings to be
disinfected prior to reuse. As suggested by a commenter, this
requirement is modified from the NPRM proposal to substitute the term
``disinfect'' for ``decontaminate.''
Section 173.134
In paragraph (a), we are revising the definitions and
classification criteria for ``infectious substance,'' ``biological
product,'' ``diagnostic specimen,'' and ``regulated medical waste;''
and adding definitions for ``cultures and stocks,'' ``risk group,''
``sharps,'' ``toxin,'' and ``used health care product.''
We are revising the definition of ``infectious substance'' for
consistency with international standards, and to require materials
meeting the definition of an infectious substance to be assigned to
risk groups based on the degree to which they cause injury through
disease. Infectious substances assigned to Risk Group 1 are not subject
to regulation under the HMR. In response to comments, we revised the
definition proposed in the NPRM for clarity and specificity.
We are revising the definition of ``biological product'' to require
biological products known to contain or suspected to contain a pathogen
in Risk Groups 2, 3, or 4, to be classed as Division 6.2 materials,
unless otherwise excepted.
We are defining ``cultures and stocks'' to mean a material prepared
and maintained for growth and storage, and containing a Risk Group 2,
3, or 4 infectious substance.
We are revising the definition of ``diagnostic specimen'' to
require a diagnostic specimen known to contain or suspected to contain
a Risk Group 4 pathogen to be classed as a Division 6.2 material and
described by the proper shipping name ``Infectious Substance''. This
determination is based on the known medical history and condition of
the patient or animal, endemic local conditions, symptoms of the source
patient or animal, or professional judgement concerning the individual
circumstances of the patient or animal.
We are revising the definition for ``regulated medical waste'' to
indicate regulated medical waste is a waste or reusable material
containing or suspected to contain a Risk Group 2 or 3 infectious
substance. Regulated medical waste containing a Risk Group 4 infectious
substance must be classed and transported as a Division 6.2 material,
UN 2900 or UN 2814.
We are adding a definition for ``risk group'' to mean a ranking of
a micro-organism's ability to cause injury through disease. For
consistency with terminology used by other entities that use risk group
definitions, in this final rule the definition is modified to
substitute ``the severity of the disease caused by the organism'' for
``the pathogenicity of the organism'' as proposed in the NPRM. Thus,
risk group assignment criteria include: the severity of the disease
caused by the organism; the mode and relative ease of transmission; the
degree of risk to both an individual and a community; and the
reversibility of the disease through the availability of effective
preventive agents and treatments.
We are defining ``sharps'' to mean any object that may be
contaminated with an infectious substance, and is able to cut or
penetrate the skin or packaging material. The term includes needles,
syringes, scalpels, broken glass, culture slides, culture dishes,
broken capillary tubes, broken rigid plastic, and exposed ends of
dental wires. In response to comments, we have the definition proposed
in the NPRM to include uncontaminated objects that may become
contaminated during handling and transportation.
We are defining ``toxin'' to mean a Division 6.1 material obtained
from a plant, animal, or bacterial source. The definition notes toxins
containing an infectious substance or contained in an infectious
substance, must be classed as Division 6.2 materials.
In paragraph (b), we are listing exceptions from the HMR
requirements applicable to Division 6.2 materials. These exceptions
include:
1. Biological products subject to Federal approval, permit, or
licensing requirements.
2. Blood collected for transfusions or the preparation of blood
products; and blood products, tissues, and organs intended for
transplant.
3. Diagnostic specimens or biological products transported by
private or contract motor carriers in dedicated motor vehicles.
4. Material treated so that it no longer contains an infectious
substance, including diagnostic specimens that do not contain a
pathogen or in which the pathogen is inactivated or neutralized.
5. Sanitary waste and sewage.
6. Sewage sludge and compost.
7. Animal waste generated in animal husbandry or food production.
8. Corpses and anatomical parts intended for interment, cremation,
or research.
9. Environmental microbiological samples collected to evaluate
occupational and residential exposure risks.
10. Agricultural and food products.
In the NPRM, we proposed an exception from most HMR requirements
for forensic material transported on behalf of the Federal government
or a
[[Page 53130]]
state, local government, or tribal government agency, provided the
material was shipped in a packaging conforming to the provisions of
Sec. 173.24. After the NPRM was published, we discussed this exception
with officials from the Federal Bureau of Investigation (FBI). We were
particularly concerned with shipments of forensic material associated
with bio-terrorism incidents. Based on our discussions with the FBI,
this final rule modifies the exception proposed in the NPRM. This final
rule requires forensic material known or suspected to contain a Risk
Group 4 infectious substance or an infectious substance listed as a
select agent in 42 CFR part 72 to be transported in packaging capable
of meeting the HMR performance test standards for infectious substance
packaging. In addition, the secondary packaging must be marked with a
BIOHAZARD symbol conforming to specifications in 29 CFR
1910.1030(g)(1)(i). An itemized list of contents must be enclosed
between the secondary packaging and the outer packaging.
We are also modifying the exception for medical waste generated
from households, to indicate such medical waste must be transported in
accordance with applicable state, local, or tribal government
requirements.
In addition, we are revising the exception for laundry or medical
equipment conforming to OSHA regulations in 29 CFR 1910.1030. This
final rule clarifies that this exception applies to medical equipment
intended for reuse and equipment used for testing. The revised
definition further clarifies that the exception does not apply to
medical equipment transported for disposal.
In this final rule, we modified the exception for blood and blood
products to add human cell, tissues, and cellular and tissue-based
products regulated under authority of the Public Health Service Act
and/or the Food, Drug, and Cosmetic Act.
In paragraph (c), we are modifying the exception for RMW
transported by contract or private carriers, to include waste cultures
and stocks containing Risk Group 2 or 3 infectious substances.
Finally, we are adding paragraph (d) to clarify that if an item
listed in paragraphs (b) or (c) of this section meets the definition of
another hazard class, it must be offered for transportation and
transported in accordance with applicable requirements of the HMR.
Similarly, if an item listed in paragraphs (b) or (c) of this section
is a hazardous substance, hazardous waste, or marine pollutant, it must
be offered for transportation and transported in accordance with
applicable requirements of the HMR.
Section 173.196
We are revising this section for clarity and consistency with the
UN Recommendations and ICAO Technical Instructions. These revisions
include packaging requirements to ensure the integrity of the
packagings during air transport, including circumstances where the
refrigerant is dissipated or lost. We are adding new paragraph (d) to
prescribe non-specification packaging provisions for body parts.
Section 173.197
We are revising this section to authorize certain bulk packagings
for the transportation of RMW. Paragraph (a) includes general
requirements for non-bulk and bulk packagings. Paragraph (b) requires
non-bulk packagings to conform to the requirements of part 178 at the
Packing Group II performance level. Paragraphs (c) and (d) authorize
Large Packagings and non-specification bulk containers for the
transportation of RMW. Paragraph (c) sets forth conditions governing
the use of Large Packagings. Paragraph (d) sets forth the conditions
governing the use of non-specification carts and bulk outer packagings.
Paragraph (e) specifies the inner packagings authorized for use with
bulk outer packagings.
Section 173.199
We are adding Sec. 173.199 to address packaging requirements for
diagnostic specimens and used health care products. Diagnostic
specimens meeting the definition of a Risk Group 4 material must be
classed and transported as infectious substances, UN 2814 or UN 2900,
as appropriate. Generally, all other diagnostic specimens may be
shipped in triple packagings capable of passing a 1.2 meter (3.9 feet)
drop test.
Liquid diagnostic specimens must be packaged in leakproof primary
receptacles with a volumetric capacity of not more than 500 mL (17
ounces). For shipments by aircraft, the primary receptacle or secondary
packaging must be able to withstand, without leakage, an internal
pressure producing a pressure differential of not less than 95 kPa
(0.95 bar, 14 psi). The secondary packaging must be leakproof. The
volumetric capacity of the outer packaging may not exceed 4 L (1
gallon).
Solid diagnostic specimens must be packaged in a siftproof primary
receptacle with a capacity of not more than 500 g (1.1 pounds). The
secondary packaging must be leakproof. The capacity of the outer
packaging may not exceed 4 kg (8.8 pounds).
Shipments of used health care products contaminated with an
infectious substance and being returned to the manufacturer, must be
transported in triple packagings and must be marked with the OSHA
BIOHAZARD symbol. A used health care product that can cut or penetrate
skin or packaging material must be transported in a puncture-resistant
primary container. In response to comments, we revised this section to
provide more packaging flexibility.
Diagnostic specimens and used health care products shipped in
accordance with these provisions are not subject to most other
requirements in the HMR. However, these shipments are subject to
minimal training requirements. Further, diagnostic specimens are
subject to incident reporting for shipments offered for transportation
or transported by aircraft.
Part 177
Section 177.834
We are revising paragraphs (a) and (g) to indicate packages
containing Division 6.2 materials must be properly secured in a
transport vehicle.
Section 177.843
We are adding paragraph (d) to require a transport vehicle to be
disinfected prior to reuse if a Division 6.2 material is released from
its packaging inside the vehicle. As suggested by a commenter, we
modified this requirement to substitute the term ``disinfect'' for
``decontaminate.''
Part 178
Section 178.503
We are adding paragraph (f) to incorporate markings for infectious
substances packagings consistent with those in the ICAO Technical
Instructions and the UN Recommendations.
Section 178.601
We are adding a sentence to paragraph (c)(1) of this section to
include the tests for infectious substance packaging in the definition
of design qualification testing. As a result, manufacturers of
infectious substances packagings are required to retain design
qualification records in accordance with Sec. 178.601(c)(l). In
addition, we are adding a sentence to paragraph (c)(2) to indicate, for
infectious substances packagings, periodic retesting is the performance
of tests specified in Sec. 178.609 at the frequency specified in
Sec. 178.601(e). Finally, we are adding a
[[Page 53131]]
sentence to paragraph (e) to require packagings used for transporting
infectious substances to pass periodic retests.
Section 178.609
We are revising the section heading to remove the wording
``(etiologic agents).'' We are revising paragraph (c) to permit the use
of expanded plastics for inner packagings and require the packaging
tests to be determined by the most fragile inner packaging. Paragraphs
(d)(1)(i), (d)(1)(iii), and (d)(1)(iv) are revised for clarity. We are
revising paragraph (e) to replace the current water immersion test with
a water spray test to simulate exposure to rainfall consistent with the
ICAO Technical Instructions. We are revising paragraphs (h)(1) and
(h)(2) to clearly indicate that, during the penetration test,
penetration of the primary receptacle is not acceptable. We are
deleting current paragraph (i). We are adding new paragraph (i) to
incorporate the selective testing provisions in the UN Recommendations
and ICAO Technical Instructions. These provisions allow variations in
the primary receptacles within the secondary packaging without further
testing of the completed packaging, if an equivalent level of
performance is maintained.
IV. Coordination with Other Federal Agencies
In addition to RSPA, several Federal agencies have responsibility
for regulating infectious substances. We provided CDC, USDA, FDA, EPA,
and OSHA with copies of this final rule in advance of publication in
the Federal Register for their information and comment. We asked them
specifically to identify potential areas of conflict between their
regulations and the provisions of this final rule. None of these
agencies identified any potentially conflicting regulatory
requirements.
V. Security Issues
As a result of the terrorist attacks of September 11, 2001, and
subsequent threats related to biological materials, we are reviewing
the HMR to determine if additional requirements are necessary to assure
the security of hazardous materials in transportation. Certain
infectious substances, including Bacillus anthracis (anthrax) and other
materials listed as select agents by the CDC (42 CFR part 72), are
materials that may pose a potential security risk. We initiated a
project to address security issues related to infectious substances and
other hazardous materials to determine if rulemaking action is
necessary.
VI. Regulatory Analyses and Notices
A. Executive Order 12866 and DOT Regulatory Policies and Procedures
This final rule is considered a significant regulatory action under
Executive Order 12866, and the Regulatory Policies and Procedures of
the Department of Transportation (44 FR 11034). A regulatory evaluation
is available for review in the public docket.
The costs identified in the regulatory evaluation are minimal. They
are primarily attributed to the regulation of shipments of diagnostic
specimens containing a Risk Group 2, 3 or 4 pathogen and of new
specification packaging requirements for infectious substances. Our
estimate of costs is for a one-time initial cost of $33,332, and a
subsequent annual cost of $28,351.
Because of a lack of reliable information concerning deaths,
injuries, property damage, and other costs attributable to incidents
involving the release of an infectious substance, we are unable to
quantify potential savings that may result from this final rule.
Reported incidents to RSPA between 1990 and the present resulted in 2
minor injuries and $3,281 in property damage. However, we believe that
incidents are significantly under-reported.
Benefits resulting from implementation of this final rule include
the following:
1. International harmonization. Harmonization of requirements in
the HMR with standards specified in the UN Recommendations, ICAO
Technical Instructions, and IMDG Code will remove current
inconsistencies among the regulations. This action will facilitate
efficient transportation of infectious substances across national
borders. More importantly, harmonized regulations reduce the potential
for misunderstanding and confusion, enhancing safety.
2. Conversion of exemptions to regulations of general
applicability. Conversion of 29 exemptions applicable to the bulk
transportation of RMW to regulations of general applicability, will
result in a slight cost savings to the 29 exemptions holders and 65
parties-to-the-exemption holders. In addition, the entire industry will
be able to take advantage of the added flexibility provided by the
increased number of packaging options for transporting RMW.
3. Modification of current exceptions for diagnostic specimens and
biological products. We believe potentially infectious diagnostic
specimens and biological products should be transported in authorized
packaging. Further, such shipments should include communication of
hazard to those who may come into contact with them. The HMIS data base
and anecdotal information indicate packages of these currently excepted
materials are sometimes damaged during transportation. This damage can
result in delays and possible risk to cargo handlers, flight crews,
emergency responders, and the general public. The requirements in this
final rule for more stringent packaging for these materials, combined
with the exceptions for transportation of these materials as MOTS or by
private or contract carriers in dedicated vehicles will assure swift
and efficient transportation. This final rule will also reduce the
risks to transportation workers and the general public. Enhancements to
packaging also reduce the risk of exposure for laboratory workers
opening and handling packages at the point of receipt. The minimal
level of regulation proposed for these materials enhances overall
safety while imposing insignificant costs on the regulated industry.
Although we cannot assign definitive dollar amounts to these
potential benefits, we believe the final rule adopts the least costly
alternatives available for ensuring an acceptable level of
transportation safety, and the potential benefits to society exceed the
potential costs associated with this final rule.
B. Executive Order 13132
This final rule has been analyzed in accordance with the principles
and criteria contained in Executive Order 13132 (``Federalism''). This
final rule 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 that preempts state,
local, and Indian tribe requirements on certain covered subjects (49
U.S.C. 5125(b)). Covered subjects are:
(1) The designation, description, and classification of hazardous
materials;
(2) The packing, repacking, handling, labeling, marking, and
placarding of hazardous materials;
(3) The preparation, execution, and use of shipping documents
related to hazardous materials and requirements
[[Page 53132]]
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 final rule addresses covered subject items 1-5 above and
preempts state, local, and Indian tribe requirements not meeting the
``substantively the same'' standard. This final rule is necessary to
assure an acceptable level of safety for the transportation of
infectious substances and facilitate international transportation of
these materials.
Federal hazardous materials transportation law provides at
Sec. 5125(b)(2) that, if we issue a regulation concerning any of the
covered subjects, we must determine and publish in the Federal Register
the effective date of Federal preemption. The effective date may not be
earlier than the 90th day following the date of issuance of the final
rule and not later than two years after the date of issuance. The
effective date of Federal preemption is one year from publication of
this final rule in the Federal Register.
C. Executive Order 13175
This final rule has been analyzed in accordance with the principles
and criteria contained in Executive Order 13175 (``Consultation and
Coordination with Indian Tribal Governments''). This final rule does
not have tribal implications, does not impose substantial direct
compliance costs, and is not required by statute. Consequently, the
funding and consultation requirements of Executive Order 13175 do not
apply.
D. Regulatory Flexibility Act
The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) requires an
agency to review regulations to assess their impact on small entities
unless the agency determines a rule is not expected to have a
significant impact on a substantial number of small entities. Based on
the assessment in the regulatory evaluation, I hereby certify that
while this final rule applies to a substantial number of small
entities, there will not be a significant economic impact on those
small entities. This certification is based upon a consideration that
the identified costs are randomly distributed to the more than 441,000
establishments (offices and clinics of doctors of medicine, dentists,
doctors of osteopathy, chiropractors, optometrists, podiatrists, and
health practitioners; nursing and personal care facilities; hospitals;
and medical and dental laboratories) that comprise Standard Industrial
Classification (SIC) Major Group 80 (Health Services). The annual costs
attributed to this final rule are minimal, especially when compared to
the $300 billion in receipts reported by the health services industry.
We believe none of those costs will be disproportionately borne by any
of the identified groups of small businesses.
E. Paperwork Reduction Act
RSPA has current information collection approvals under OMB No.
2137-0039, Hazardous Materials Incident Reports, which expires May 31,
2004, with 34,441 burden hours and $825,621.66 annual costs; and OMB
No. 2137-0557, Approvals for Hazardous Materials, which expires May 31,
2004, with 18,405 burden hours and $415,237.40 annual costs. This final
rule will result in small increases in annual burden hours and costs.
Section 1320.8(d), Title 5, Code of Federal Regulations requires
RSPA to provide interested members of the public and affected agencies
an opportunity to comment on information collection and record keeping
requests. The NPRM identified and requested comment on revised
information collections submitted to OMB for approval. We estimated the
total information collection and record keeping burden as proposed in
the NPRM would be revised as follows:
OMB No. 2137-0039:
Number of Respondents: 1,536.
Total Annual Responses: 22,900.
Total Annual Burden Hours: 34,441.
Total Annual Burden Cost: $825,621.66.
OMB No. 2137-0557:
Number of Respondents: 3,523.
Total Annual Responses: 3,875.
Total Annual Burden Hours: 18,405.
Total Annual Burden Cost: $415,237.40.
We received no comments on these revised information collections.
Under the Paperwork Reduction Act of 1995, no person is required to
respond to an inf |
