[Federal Register Volume 60, Number 182 (Wednesday, September 20, 1995)]
[Rules and Regulations]
[Pages 48780-48787]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-23243]
[[Page 48779]]
_______________________________________________________________________
Part III
Department of Transportation
_______________________________________________________________________
Research and Special Programs Administration
_______________________________________________________________________
49 CFR Part 171 et al.
Infectious Substances; Final Rule
Federal Register / Vol. 60, No. 182 / Wednesday, September 20, 1995,
/ Rules and Regulations
[[Page 48780]]
DEPARTMENT OF TRANSPORTATION
Research and Special Programs Administration
49 CFR Parts 171, 172, 173, and 178
[Docket No. HM-181G; Amdt. Nos. 171-138, 172-146, 173-247, 178-111]
RIN 2137-AC36
Infectious Substances
AGENCY: Research and Special Programs Administration (RSPA), DOT.
ACTION: Final rule.
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SUMMARY: RSPA published a notice of proposed rulemaking (NPRM) in
December 1994 that proposed to revise the regulations pertaining to
infectious substances, including regulated medical waste (RMW). In this
final rule, RSPA is revising requirements for Division 6.2 materials
(infectious substances). This rule clarifies the scope of regulation
for infectious substances, provides relief for certain shipments of RMW
that conform to other Federal agency regulations, allows certain
quantities of RMW to be transported by aircraft, and makes other
changes to clarify regulatory provisions applicable to infectious
substances. This rulemaking action is necessary to ensure that the
regulations for infectious substances and regulated medical waste are
cost effective and provide an adequate level of safety in
transportation.
DATES: Effective date. The effective date of these amendments is
October 1, 1995.
Compliance date. Voluntary compliance with the regulations, as
amended herein, is authorized immediately. The mandatory compliance
date for these regulations is January 1, 1996.
FOR FURTHER INFORMATION CONTACT: Jennifer Antonielli, Office of
Hazardous Materials Standards, (202) 366-8553, Research and Special
Programs Administration, U.S. Department of Transportation, 400 Seventh
Street, SW., Washington, DC 20590-0001.
SUPPLEMENTARY INFORMATION:
I. Background
In a final rule published on September 22, 1994 (59 FR 48762), RSPA
revised 49 CFR 171.14(b) to delay the compliance date for requirements
applicable to RMW and materials infectious only to animals from October
1, 1994, to October 1, 1995. RSPA also delayed the compliance date for
requirements for infectious substances, other than RMW and animal-only
pathogens, from October 1, 1994, to January 1, 1995.
On December 21, 1994, RSPA published a notice of proposed
rulemaking and announced a public meeting under Docket HM-181G (59 FR
65860). In the notice, RSPA proposed to revise the requirements for
infectious substances, including regulated medical waste, which were
adopted in final rules under Docket HM-181 in December 1990 and 1991.
Some of the proposals contained in the NPRM were substantive, such as
the proposal to add an exception from specific packaging and labeling
requirements for RMW if it is prepared in accordance with the
regulations of the Occupational Safety and Health Administration
(OSHA). However, the majority of the changes proposed in the notice
were minor and primarily intended to ease compliance by clarifying the
requirements. Also in the NPRM, RSPA outlined issues for possible
future rulemaking action. The public meeting, which gave interested
persons an opportunity to orally present their comments on the notice,
was held on January 17, 1994, in Washington, DC.
This rule was developed, with the concerns of the health care
industry and medical waste companies in mind, in coordination with
other Federal agencies (e.g., OSHA, Centers for Disease Control and
Prevention (CDC), Food and Drug Administration (FDA), and Environmental
Protection Agency (EPA)) to minimize differences between the Hazardous
Materials Regulations (HMR) and other Federal agency regulations to
ease compliance and eliminate gaps and inadequacies in regulatory
coverage to assure that safety is maintained in transportation. RSPA
will continue to be aware of significant steps being taken by other
Federal agencies to remain cognizant of potential impacts regarding
infectious substances and regulated medical waste prior to their
entering, and in, transportation.
In March 1995, the President directed Federal agencies to review
all agency regulations to eliminate or revise those that are outdated
or in need of reform. RSPA issued a notice on April 4, 1995, under
Docket HM-222 (60 FR 17049), that announced its review of the HMR and
related programs and solicited comments on possible candidates for
elimination or revision to provide clarity or relief from undue
requirements. The provisions contained in this final rule contribute to
meeting the goals of the President's Regulatory Reinvention Initiative.
II. Summary of Comments and Regulatory Changes
RSPA received 41 written comments on the notice of proposed
rulemaking and 4 oral statements at the public meeting. The comments
were submitted by hospitals, pharmaceutical companies, trade
associations, packaging manufacturers, academic institutions,
transporters of medical waste, and private individuals. Commenters
generally supported RSPA's efforts to amend the regulations to
regulating those materials that likely pose a threat in transportation
to ensure the safe transportation of infectious substances and RMW. The
commenters also were pleased that RSPA coordinated with other Federal
agencies in the development of these regulations. Several commenters
stated that, although the proposed amendments narrowed the scope of and
clarified the infectious substance and RMW provisions, they need more
refinement. The commenters predominantly addressed the following
topics: (1) The definition of ``regulated medical waste''; (2)
exclusion of discarded cultures and stocks from the definition of RMW;
(3) a packaging and labeling exception for RMW; (4) a laundry
exception; (5) the definitions of ``biological product'' and
``diagnostic specimen'' and retention of exceptions for these
materials; and (6) aligning the infectious substance provisions with
the international standards. A detailed discussion of the comments and
RSPA's response to them is provided in the following summary.
A. Definition of RMW
RSPA received numerous comments concerning the proposed revision of
the definition of ``regulated medical waste'' (RMW). The majority of
commenters favored RSPA's proposal to limit the definition of RMW to
materials containing an infectious substance. Commenters stated that
RSPA defined RMW rationally, and that this definition would
significantly reduce the amount of medical waste required to be
specially handled without jeopardizing transportation safety. Also,
commenters stated that the proposed definition, which allows shippers
to segregate their waste, is more cost-effective than treating all
waste as RMW. One commenter stated, ``Adoption of a criteria-based
definition, as opposed to a list-based definition, also eliminates the
categories of waste (e.g., unused sharps) that are not hazardous.''
Some commenters raised concerns that the proposed definition of RMW
is impractical and does not account for the fact that RMW is rarely
``known to contain'' an infectious substance. Commenters claimed that,
in order to confirm the presence of an infectious substance, medical
waste would have to undergo cost-prohibitive testing.
[[Page 48781]]
Commenters stated that shippers are forced to make a ``best guess'' as
to whether a medical waste is subject to the HMR, increasing the
potential for undeclared shipments of RMW. In addition, commenters
argued that not all personnel who are responsible for identifying and
packaging the wastes possess the knowledge required to make an accurate
assessment. A commenter claimed that if RMW is not clearly defined and
if guidance is not provided, the volume of waste treated as RMW will
increase and potentially infectious waste will go undeclared in the
solid waste stream. One commenter stated that the definition ``fails to
provide the appropriate guidance to the health care worker responsible
for segregating the regulated medical waste stream and is virtually
impossible to enforce.'' Some commenters recommended that RSPA adopt
``Universal Precautions,'' a method of infection control introduced by
CDC which considers all blood and certain body fluids, whether or not
known to be infectious, are treated as if known to be potentially
infectious. The commenters added that universal precautions are widely
used in the health care industry and, if adopted, would be consistent
with current practices. Some commenters requested that RSPA add
language to the definition of RMW to include those materials that
``may'' or ``are suspected to'' contain an infectious substance to
eliminate some of the guesswork. While some commenters asked RSPA to
expand the definition of RMW, other commenters stated that RSPA's
definition should be narrowed further. One commenter asserted that the
proposed definition is ``inaccurate and inconsistent with science'' and
claimed that essentially all material, including human skin, harbor a
population of microorganisms capable of causing infection in a
susceptible host. The commenter stated, ``[T]he mere presence of an
infectious substance does not result in risk of infection.'' The
commenter claimed that other factors have to be present for infection
to occur such as, the presence of an infectious agent in the
environment, a susceptible host, a portal of entry into the host, and a
sufficient dose of organisms. Some commenters requested that RSPA limit
the definition of RMW to ``waste * * * which contains an infectious
substance and has been causally linked scientifically to human disease
acquisition.'' Another commenter added, ``RSPA's definition, if applied
literally, would result in classifying as regulated medical waste
virtually all of the waste that is generated in the health care
environment.''
RSPA has considered the commenters' suggestions. With regard to
universal precautions, RSPA acknowledges that they are widely used in
the workplace as recommended in CDC guidelines and required under OSHA
regulations contained in 29 CFR 1910.1030. In addition, RSPA agrees
that broadening the scope of RMW to include all waste containing blood
or certain body fluids may ease RMW identification when the exact
constituents of a waste stream are not known. However, RSPA believes
that this concept might result in overregulation if adopted for the
purposes of transportation. At this time, RSPA has no evidence to
support the conclusion that the benefits associated with implementing
universal precautions in transportation outweigh the compliance costs
and regulatory burdens imposed. Therefore, RSPA is not adopting
universal precautions in this rule. RSPA agrees with commenters that
the principles of disease transmission (i.e., presence of an infectious
agent in the environment, susceptible host, portal of entry, sufficient
virulence, and sufficient dose of organisms to cause infection) would
support limiting the definition to those wastes that in fact pose a
hazard in transportation. However, RSPA believes that this definition
would be difficult and, in some cases, impossible to implement since
certain factors, such as the dose of organisms sufficient to cause
infection, are not known by most shippers. Therefore, RSPA is not
adopting the principles of disease transmission for general
applicability. RSPA does not agree with the commenters who requested
that the definition of RMW be revised to mean ``waste * * * which
contains an infectious substance and has been causally linked
scientifically to human disease acquisition.'' While the commenters'
suggestion supports a definition based on scientific considerations,
RSPA believes that the definition is not practical for all shippers. To
determine whether a particular waste has been linked to disease
acquisition requires knowledge of any incidents that have occurred
involving that waste. This information is not available to most
shippers. Therefore, RSPA is not revising the definition as requested.
However, for shippers that possess this information for a given waste
stream, RSPA believes that the information may be used to determine
whether the waste requires special handling as RMW.
In the proposed rule, RSPA attempted to correct an existing
oversight in the HMR with regard to hazard precedence in a case
involving a material that meets the definitions of both Division 6.2
and Class 7. The oversight is found in Sec. 173.2a(c), which prescribes
that a Division 6.2 material that meets the definition of another
hazard class or division is required to be classed as Division 6.2.
RSPA did not intend for Division 6.2 to take precedence over Class 7,
other than for limited quantities of Class 7. To correct the oversight,
RSPA proposed to exclude waste materials meeting the definition of
Class 7 from the definition of RMW but failed to exclude Class 7
materials from the definition of an infectious substance. As proposed,
Class 7 materials, including wastes, containing an infectious substance
would be excepted from the RMW requirements but subject to all
applicable requirements for infectious substances. In this final rule,
RSPA is not adopting the wording ``other than Class 7 (Radioactive)
materials'' in the proposed definition of regulated medical waste. RSPA
is amending Sec. 173.2a(c)(3) to exclude Class 7 (radioactive)
materials, other than limited quantities, which also meet the
definition of Division 6.2 from being classed as Division 6.2. This
will alleviate the need to make changes in Sec. 173.134 for the
definitions of ``regulated medical waste'' and ``infectious
substances.''
Based on the merits of comments received and RSPA's own initiative,
RSPA is revising the definition of ``regulated medical waste'' as
proposed. RMW is defined as ``a waste or reusable material, other than
a culture or stock of an infectious substance, which contains an
infectious substance and is generated in: (1) The diagnosis, treatment
or immunization of human beings or animals; (2) research pertaining to
the diagnosis, treatment or immunization of human beings or animals; or
(3) the production or testing of biological products.'' RSPA
understands that it is not always feasible for shippers to verify the
presence of an infectious substance in a waste stream. The wording
``contains an infectious substance'' does not imply that the shipper is
required to verify the presence of an infectious substance by testing
or other means. Shippers may use information that is available to them
(e.g., source of material, patient's medical history, preliminary test
data) to make the most accurate determination possible as to whether or
not a waste meets the definition of RMW under the HMR. If the shipper
does not possess any
[[Page 48782]]
information concerning a waste stream, the shipper may employ universal
precautions, which considers waste containing human blood and certain
human body fluids as infectious. However, as previously stated, it is
not RSPA's intent to require the use of universal precautions. RSPA
strongly encourages the use of segregation and separation practices at
the point of generation. It is our understanding that many entities
currently implement such practices, which help to minimize shipping
costs and ensure that only those wastes that pose a hazard are
regulated.
In the NPRM, RSPA proposed to except certain categories of waste
from the definition of RMW. Included was an exception for waste
generated in animal husbandry or food production. RSPA received a
comment requesting clarification of whether waste generated in animal
research activities also would be excluded from the definition of RMW.
The answer is no. Waste, generated in research activities, that
contains an infectious substance and is offered for transportation or
transported in commerce is regulated as RMW. The definition of RMW, as
adopted in this final rule, includes waste that is generated in the
diagnosis, treatment or immunization of human beings or animals or
research pertaining thereto. RSPA is excluding waste generated in
animal husbandry or food production because regulation of these
activities under the HMR could impose burdens on agricultural and farm
operations disproportionate to benefits likely to be achieved.
Regulation of waste that is generated in animal research activities and
contains an infectious substance is fully within the scope of the HMR.
RSPA clarified in the notice that the exceptions applicable to
biological products and diagnostic specimens do not apply to materials
which have become wastes. One commenter recommended that RSPA limit the
definition of RMW to include only those discarded (waste) biological
products and diagnostic specimens that have been confirmed to contain
an infectious substance by a screening test required or recommended by
the Food and Drug Administration. RSPA understands that not all
biological products or diagnostic specimens are tested before shipment
for treatment or disposal. Therefore, RSPA is not adopting a
requirement to limit the application of the definition of RMW as
requested by the commenter. If the discarded biological product or
diagnostic specimen contains an infectious substance and has not been
treated to eliminate the hazard, it must be shipped as RMW.
Another commenter requested that RSPA clarify that it is the
responsibility of the shipper, and not the carrier, to properly class a
material. The commenter stated that the waste generator is in the best
position to determine whether the waste is a regulated medical waste,
an infectious substance, or not regulated. In accordance with
Sec. 173.22, a person who offers a hazardous material for
transportation in commerce is responsible for properly classing the
material in accordance with the hazard class definitions of 49 CFR Part
173. Because this requirement already appears in the HMR, RSPA is not
adding an additional requirement. Also, RSPA notes that some carriers
assume responsibilities of the waste generator through contractual
arrangement.
B. Discarded Cultures and Stocks
Several commenters agreed with RSPA's proposal to exclude waste
cultures and stocks from the definition of RMW and subject them to
requirements applicable to non-waste cultures and stocks of infectious
substances. Commenters stated that cultures and stocks contain a high
concentration of microorganisms that have the potential to cause
disease in humans or animals and require special handling. In addition,
the commenters claimed that cultures and stocks typically are treated
on-site by autoclave or other treatment method. Therefore, commenters
affirmed that RSPA would not be imposing an unreasonable burden on
shippers by requiring the infectious substance requirements for
untreated cultures and stocks. However, other commenters believed that
discarded cultures and stocks should be considered as RMW. According to
one commenter, most laboratories and hospitals sterilize cultures and
stocks before transporting them off-site; therefore, the packaging for
RMW should be adequate for the hazards posed by these materials.
Another commenter asserted that waste cultures and stocks should not be
treated differently from RMW but did not substantiate its claim.
In the notice, RSPA clarified that if a material has been
sterilized or treated to eliminate its hazard as an infectious
substance, it is not subject to the HMR, provided it does not meet the
definition of any other hazard class. Therefore, cultures and stocks
that have been autoclaved, incinerated, or treated by other effective
means are not subject to the HMR, provided they do not meet the
definition of any other hazard class. In view of the comments, RSPA is
excluding untreated cultures and stocks intended for disposal from the
definition of RMW. These materials are included under the definition of
infectious substances.
C. RMW Packaging and Labeling Exception
In the notice, RSPA proposed to except RMW from the specific
packaging requirements of Sec. 173.197 and labeling requirements of
Subpart E of Part 172 if packaged in rigid non-bulk packagings
conforming to the general packaging requirements of Secs. 173.24 and
173.24a and OSHA packaging and marking requirements in 29 CFR
1910.1030. RSPA proposed to limit the exception to RMW that is offered
for transportation or transported by private or contract carrier. The
majority of the commenters addressing this subject supported the
proposed exception. Some commenters indicated that the exception will
allow generators of RMW to maintain their current practices. One
commenter recommended that RSPA limit the application of the RMW
exception to contract carriers registered with the Federal Highway
Administration (FHWA) and vehicles operated by drivers holding a
Commercial Drivers License (CDL). If the exception is not modified, the
commenter stated that the exception ``would be abused by any number of
carriers who may not be familiar or in compliance with DOT Motor
Carrier Safety Regulations or familiar with industry standards and
practices.''
RSPA disagrees with this commenter. Familiarity with the Federal
Motor Carrier Safety Regulations (FMCSR; 49 CFR Parts 300-399) and
possession of a CDL would not necessarily enhance a carrier's or
driver's specialized knowledge of medical waste requirements. In
addition, the FMCSR and CDL requirements are only applicable to highway
motor carriers and drivers. Because the HMR relate to all modes of
transportation, the commenter's suggestion to limit the applicability
of the exception to RMW transported by contract carriers registered
under the FMCSR and drivers with CDLs is not adopted.
Another commenter asserted that the exception allowing OSHA
packaging and marking does not sufficiently communicate the nature and
risk of the package to the carrier. The commenter requested that RSPA
require packages containing RMW to display the name, address, and
telephone number of the generator and the date of generation. The
commenter stated that in the event of a needle stick injury, OSHA
requires the employer/carrier to ascertain the route of exposure.
According to the
[[Page 48783]]
commenter, some carriers pick up RMW from several generators on a given
route and it is impossible to determine the route of exposure if the
source of the package is unknown.
In the NPRM, RSPA proposed to except RMW from specific packaging
and labeling requirements, but not from marking or other hazard
communication requirements. Section 172.301(d) requires that non-bulk
packages of hazardous material be marked with the name and address of
the consignee or consignor, unless the package is transported by
highway and is not being transferred from one carrier to another; or is
part of a carload, truckload, or freight container load, and the entire
contents of the rail car, truck or freight container are shipped from
one consignor to one consignee. In cases which the name and address of
the consignor or consignee are not required on package markings, a
carrier may, by contractual arrangement, have the waste generator mark
its name and address on packages or use other means to keep track of
where packages originate. RSPA does not believe there is a need for a
regulatory requirement for the consignor's name and address to appear
on a package in all instances. Therefore, the commenter's
recommendation is not adopted.
In this final rule, RSPA is authorizing non-bulk, non-specification
packagings for RMW under the conditions specified in the NPRM. RSPA
intends to monitor incident reports for these shipments to ensure that
the packaging and handling requirements achieve an acceptable level of
safety. If they do not, RSPA will propose adjustments in future
rulemaking action.
D. Exception for Laundry and Medical Equipment
To relieve the burden of compliance with both the HMR and OSHA
regulations, RSPA proposed to except from the HMR contaminated laundry
and medical equipment that conforms to OSHA regulations at 29 CFR
1910.1030. Of the few commenters addressing this issue, most supported
RSPA's proposed exception. However, one commenter contended that
laundry should not be regulated differently than RMW. The commenter
reported that although OSHA requires sharps to be separated from other
RMW, in reality, sharps are occasionally left in laundry which poses a
hazard to personnel handling the laundry. The commenter stated, ``it is
appropriate to include laundry in a RMW category because laundry, while
not itself a waste, does contain RMW.''
RSPA agrees with the commenter that laundry and disposable garments
share similar characteristics. However, laundry and disposable
materials are handled differently from the point of generation to
decontamination or disposal. Typically, laundry is segregated from
waste materials at the point of generation and specially handled and
reprocessed by employees dealing exclusively with laundry. Conversely,
disposable garments and the like are combined with other non-sharp
wastes at the point of generation and managed as medical waste,
regulated or non-regulated. RSPA believes that the OSHA requirements
applicable to laundry and medical equipment provide an adequate level
of safety in transportation and it is unreasonable and impractical to
require RMW packaging and hazard communication for laundry and medical
equipment that are intended for reuse. OSHA prescribes that
contaminated laundry shall be placed and transported in bags or
containers labeled or color-coded in accordance with 29 CFR
1910.1030(g)(1)(i) of the OSHA regulations or, if utilizing universal
precautions, alternative labeling is permitted if it is recognizable to
all employees as requiring compliance with universal precautions. In
addition, OSHA requires contaminated laundry that is wet and presents a
reasonable likelihood of soak-through of or leakage from the bag or
container to be placed in bags or containers which prevent soak-through
and/or leakage of fluids to the exterior. See 29 CFR
1910.1030(d)(4)(iv). OSHA prescribes that medical equipment, including
equipment used for diagnosis, research, or treatment, shall be
decontaminated, to the maximum extent practicable, before
transportation. If decontamination is impractical, the equipment should
be labeled with the ``BIOHAZARD'' label. See 29 CFR
1910.1030(d)(2)(xiv). In this final rule, RSPA is adopting the
exception for laundry and medical equipment as proposed in the NPRM.
E. Biological Products and Diagnostic Specimens
In an attempt to clarify the scope of the HMR, RSPA proposed to
amend the definitions of ``biological product'' and ``diagnostic
specimen'' to include only those materials that contain an infectious
substance. However, commenters' responses suggest that the proposal may
have added confusion. Some commenters contended that it was illogical
for RSPA to amend the definitions of biological products and diagnostic
specimens to limit them to materials that contain an infectious
substance, but continue to except them from the HMR. Commenters
asserted that defining a ``diagnostic specimen'' as ``a material that
contains an infectious substance being shipped for purposes of
diagnosis'' is contradictory. One commenter argued that the primary
reason a diagnostic specimen is shipped is to determine, through
testing, whether or not it contains an infectious substance. Another
commenter requested that RSPA keep its previous definitions of
diagnostic specimen and biological product because they are consistent
with other Federal regulations. RSPA agrees with the commenters and is
not amending the definitions of ``biological product'' and ``diagnostic
specimen'' as proposed in the notice.
Several commenters also opposed retaining the exceptions for
biological products and diagnostic specimens, asserting that
insufficient protection will be afforded to transport workers and the
public if biological products and diagnostic specimens, especially
those that are known to contain an infectious substance, are excepted
from regulation. One commenter stated that these exceptions effectively
eliminate Division 6.2 materials from the HMR.
RSPA agrees with commenters that some level of regulation may be
needed for biological products and diagnostic specimens under the HMR
to ensure safety, but RSPA is not imposing any requirements for these
materials in this rule. Under the current requirements, a biological
product or diagnostic specimen that contains an infectious substance is
excepted from the HMR, unless the biological product or diagnostic
specimen is being discarded, in which case it would be regulated as
RMW. RSPA anticipates proposing to delete the exceptions for biological
products and diagnostic specimens and impose appropriate requirements
for these materials, if justified after evaluation of associated
benefits and costs, in future rulemaking action.
F. Extension of Compliance Date
In the notice, RSPA proposed to extend the compliance date for the
requirements applicable to RMW and infectious substances affecting
animals only, from October 1, 1995, to January 1, 1996. Some commenters
supported having additional time to come into compliance with the
requirements for RMW and infectious substances affecting animals only.
The commenters stated that an extension will also allow RSPA time to
issue its final rule and provide regulated industry sufficient time to
comply with the new changes. However, other commenters expressed
concern in regard to RSPA's proposal to
[[Page 48784]]
extend the compliance date from October 1, 1995, to January 1, 1996.
These commenters suggested that the compliance date be delayed for an
indefinite period of time until the final rule has been issued and RSPA
has resolved all of the issues.
RSPA disagrees with these latter comments and believes there is a
need to put these requirements in place as quickly as practicable, to
help eliminate ongoing confusion over what regulatory requirements
apply. Also, RSPA believes that implementation on January 1, 1996 is a
reasonable extension of time. Therefore, the proposal is adopted.
Because these amendments extend the compliance date from October 1,
1995, to January 1, 1996, they are effective without the customary 30-
day delay following publication. This will allow the changes to appear
in the next revision of 49 CFR.
G. Air Transportation
RSPA received several comments concerning the proposal to add
Special Provisions ``A13'' and ``A14'' to allow certain quantities of
regulated medical waste aboard aircraft. Most of the commenters
supported removal of the prohibition to transport RMW by air. Some
commenters questioned RSPA's rationale for the quantities selected in
the proposed rule. One commenter expressed concern about allowing 12
liters of RMW by air without prescribing higher integrity packaging
requirements. Some commenters stated that RMW should not be restricted
to any quantity limits since the International Civil Aviation
Organization (ICAO) Technical Instructions do not impose quantity
limits for RMW.
RSPA selected the proposed quantity limits in the NPRM based on
comments received on the March 3, 1993 advance notice of proposed
rulemaking and for consistency with quantity limits under U.S. Postal
Service regulations. Therefore, RSPA is adding these special
provisions, as proposed, to facilitate air transportation of RMW.
H. Animal Pathogens
In the NPRM, RSPA requested comments concerning HMR regulation of
infectious substances affecting animals only. RSPA received limited
comments on this issue. One commenter stated that RSPA does not have
the authority to regulate infectious substances affecting animals only
and that the likelihood of an incident involving an animal exposed to
an infectious substance as a result of a release in transportation is
small.
RSPA agrees with the commenter that the probability of an incident
occurring involving animals exposed to animal pathogens during
transportation might be low. However, the potential exists and RSPA is
aware of at least one such incident. Under the Federal hazardous
material transportation law, RSPA is required to promulgate regulations
for the transport of materials that may pose an unreasonable risk to
health, safety and property. Protection of animals is encompassed
within this jurisdiction. In addition, RSPA has determined that the
costs incurred by regulation of these materials is minimal compared to
the benefits acquired. In regard to other applicable Federal
regulations, RSPA has examined the Department of Agriculture's
regulations concerning animal pathogens contained in 9 CFR parts 1-199
and determined that they do not adequately address transportation
concerns with regard to communication of hazard, provision of emergency
response information, and packaging. Therefore, RSPA is regulating
infectious substances affecting animals only, as proposed.
I. Other Issues
Two commenters asked RSPA to clarify its preemption authority in
the preamble. The commenters suggested that States may impose
requirements on the transportation of medical waste that go beyond
those imposed by this rule. In particular, the commenters noted, States
may define infectious substances and medical waste more broadly, to
include categories of materials not regulated under the HMR. One
commenter stated: ``a decision by RSPA not to regulate (e.g., a
decision to exclude certain materials from the definition of regulated
medical waste), should carry as much preemptive effect as a decision to
regulate.''
As provided in Subpart C to Part 107, any law, regulation, order,
ruling, provision or other requirement of a State, political
subdivision, or Indian tribe that concerns a ``covered subject,'' as
defined at Sec. 107.202(a), and that is not substantively the same as
any provision of the Federal hazmat law or any regulation issued
thereunder, is preempted. Covered subjects include classification of,
and specification of packaging and hazard communication requirements
for the transportation of, hazardous materials. Non-Federal
requirements pertaining to the transportation of infectious substances
that concern a covered subject accordingly are subject to preemption
under this standard.
The HMR do not, however, preempt non-Federal requirements imposed
on the transportation of materials that are not hazardous materials as
defined in the HMR. One exception to this general principle, however,
would be where a non-Federal law or regulation requires a method of
hazard communication for non-hazardous materials sufficiently similar
to that prescribed by the HMR for a hazardous material that the
regulation is ``tantamount to the creation of an additional class of
hazardous materials with its own marking requirements.'' 59 FR 6186,
6192 (Feb. 9, 1994) (preemption determination PD-6). Short of this type
of circumstance (de facto classification of materials as hazardous
materials), however, State, local and tribal regulation of materials
that are not hazardous materials is not subject to preemption by the
Federal hazmat law. RSPA has proposed to extend application of the HMR
to all intrastate transportation in a notice of proposed rulemaking
published on July 9, 1993, under Docket HM-200 (58 FR 36920). Further
action under that docket is pending.
RSPA received comments requesting that RSPA require treated medical
waste to be physically altered until it is unrecognizable so that it
can be readily identified as non-regulated. Although this practice may
be required under certain State medical waste regulatory programs, RSPA
is not adopting it at this time because it is beyond the scope of this
rule.
In the NPRM, RSPA invited comments on possible adoption of a
vehicle placarding requirement for Division 6.2 materials based on a
petition for reconsideration (P-1080). Due to inadequate information,
RSPA did not propose to adopt such a requirement in the NPRM but stated
that it is under consideration for future rulemaking. Several
commenters urged RSPA to clarify that RMW is not and will not be
subject to placarding requirements. The commenters asserted that
bloodmobiles carrying bulk blood intended for disposal would be subject
to CDL and drug and alcohol regulations if placarding is required. RSPA
is not adopting a placarding requirement, as requested by the
petitioner, or vehicle marking requirement for Division 6.2 materials
in this rule. However, RSPA is aware that several States have differing
marking requirements for medical wastes. It may be appropriate, for
purposes of national uniformity and minimum communication, to propose
in future rulemaking a special marking, other than a placard, to
identify the presence of these materials in a vehicle.
In the preamble of the notice, RSPA stated that this rulemaking
action was limited to amendments that could be accomplished in the
short term and that
[[Page 48785]]
more substantive issues would be addressed in future rulemaking. Some
commenters contended that dividing the problematic issues into two or
more rulemakings would be confusing. These commenters urged RSPA to
make all necessary adjustments to the regulations in one rule.
RSPA believes that certain changes to the requirements for RMW
adopted under Docket HM-181 on December 20, 1991, are necessary, before
they become mandatory, to eliminate confusion and facilitate
transportation of RMW. However, in order to make the necessary changes
to the RMW requirements and publish the rule before October 1, 1995,
RSPA had to limit the amendments in this rule to minor, short-term
adjustments.
RSPA received comments requesting that bulk packaging standards for
RMW be incorporated into the HMR. Currently, their use is authorized
under the provisions of a number of exemptions. RSPA stated in the
preamble of the notice that it anticipates proposing to convert the
provisions of some or all of these exemptions into regulations of
general applicability. RSPA intends to address bulk packagings for RMW
in a future rulemaking.
Several commenters encouraged RSPA to align the classification,
hazard communication, and packaging requirements for Division 6.2
materials in the HMR with the most recent edition of the UN
Recommendations and ICAO Technical Instructions. Specifically, some
commenters recommended that RSPA require infectious substances
packagings to be UN marked and certified for consistency with
international standards.
RSPA believes that uniform standards, applicable to both domestic
and international transportation, are essential to ensuring the safe
and efficient movement of infectious substances. To this end, RSPA
continues to work with other Federal agencies and the United Nations
Subcommittee of Experts on the Transport of Dangerous Goods to improve
standards for classification, hazard communication, packaging and
operational control of infectious substances. The HMR generally are
consistent with the United Nations Recommendations on the Transport of
Dangerous Goods (UN Recommendations), although there are differences.
RSPA anticipates proposing changes to the HMR in future rulemaking
concerning defining criteria, particularly the adoption of risk groups
and regulation of genetically-modified organisms and microorganisms,
biological products and diagnostic specimens, and new shipping
descriptions and marking requirements for non-bulk packagings based on
the UN Recommendations. Both through rulemaking action and in working
with other Federal agencies, RSPA anticipates advocating standards
based on UN Recommendations.
RSPA intends to continue its review of the HMR and the regulations
of other Federal agencies and to work with these agencies to identify
and eliminate inconsistencies, overlaps, gaps and inadequacies in
regulatory coverage. Moreover, as new information becomes available,
RSPA may propose to make adjustments to the requirements for Division
6.2 materials in future rulemaking as necessary.
III. Section-by-Section
Part 171
Section 171.14. RSPA is amending Sec. 171.14(b)(7) to change the
compliance date from October 1, 1995, to January 1, 1996, to give
industry additional time to comply with the changes adopted in this
final rule.
Part 172
Section 172.101. RSPA is amending Column (8A) of the Hazardous
Materials Table for the entries, ``Infectious substances, affecting
humans'', ``Infectious substances, affecting animals'' and ``Regulated
medical waste'', to reflect the correct section references. RSPA is
revising the identification number in Column 4 for ``Regulated medical
waste'' from ``NA9275'' to ``UN3291.'' RSPA also is adding two special
provisions, ``A13'' and ``A14,'' in Column 7 for ``Regulated medical
waste.''
Section 172.102. RSPA is adding Special Provisions ``A13'' and
``A14'' to permit transportation of RMW by aircraft as proposed.
Special Provision A13 allows the transportation of sharps aboard
passenger and cargo-carrying aircraft in quantities not exceeding 16
kilograms (35 pounds) per package and maximum liquid content of 50
milliliters (1.7 ounces) for each inner packaging. Special Provision
A14 permits the transportation of RMW by aircraft in quantities of not
more than 16 kilograms (35 pounds) for solid waste and 12 liters (3
gallons) for liquid waste, when means of transportation other than air
are impracticable or unavailable. These provisions are necessary to
facilitate transportation of RMW in rural areas and ensure that
shippers of used sharps do not encounter unnecessary delays or
frustration of shipments.
Part 173
Section 173.2a. RSPA is amending Sec. 173.2a(c)(3) to provide that
Division 6.2 materials do not include those meeting the criteria for
Class 7 (radioactive) materials, other than limited quantities. RSPA
did not intend for Division 6.2 to take precedence over Class 7
materials.
Section 173.134. RSPA is revising Sec. 173.134 for clarity and to
provide relief from overly restrictive requirements for certain
shipments of RMW. RSPA is not amending the definitions of ``biological
product'' and ``diagnostic specimen'' as proposed. RSPA believes, based
on commenters' observations, that clarifying RSPA's intent in the
preamble is likely to be more effective than revising the definitions.
Based on comments received, RSPA is relocating the definition of
``regulated medical waste'' and its exceptions from Appendix G of Part
173 to Sec. 173.134 to ease compliance with the HMR. In addition, RSPA
is relocating the exceptions for biological products and diagnostic
specimens from Sec. 173.196 to Sec. 173.134. RSPA is adding an
exception for material that once contained an infectious substance but
has been treated to eliminate the hazard. In addition, RSPA is
clarifying that the following materials are not considered RMW: (1) EPA
hazardous wastes; (2) waste derived from households; (3) corpses,
remains, and anatomical parts intended for ceremonial interment or
cremation, and (4) animal waste generated in animal husbandry or food
production.
Based on commenters' requests and RSPA initiative, RSPA is revising
the definition of RMW by adopting a criteria-based definition as
opposed to a list-based definition, that is, removing the categories in
Appendix G and replacing them with a general definition. Regulated
medical waste is defined as a waste or reusable material, other than a
culture or stock of an infectious substance, that contains an
infectious substance and is generated in the diagnosis, treatment or
immunization of human beings or animals, research pertaining thereto,
or the production or testing of biological products.
Also in Sec. 173.134, RSPA is adding an exception for RMW that is
packaged in a rigid, non-bulk packaging that meets the general
packaging requirements of Secs. 173.24 and 173.24a, meets packaging and
marking requirements in 29 CFR 1910.1030, and is offered for
transportation or transported by private or contract carrier.
[[Page 48786]]
In paragraph (c) of this section, RSPA is clarifying that Division
6.2 materials other than RMW are not assigned a packing group. RMW is
assigned to a Packing Group II performance level.
Part 178
Section 178.609. RSPA is adding a new paragraph (i) to clarify that
packagings for infectious substances conforming to this section are not
required to be marked and certified in accordance with Sec. 178.503.
IV. Regulatory Analyses and Notices
A. Executive Order 12866 and DOT Regulatory Policies and Procedures
This final rule is considered a significant regulatory action under
section 3(f) of Executive Order 12866 and, therefore, was reviewed by
the Office of Management and Budget. This rule is significant under the
Regulatory Policies and Procedures of the Department of Transportation
(44 FR 11034), because of substantial public interest. A regulatory
evaluation is available for review in the docket.
B. Executive Order 12612
This final rule has been analyzed in accordance with the principles
and criteria contained in Executive Order 12612 (``Federalism'').
Federal law expressly preempts State, local, and Indian tribe
requirements applicable to the transportation of hazardous material
that cover certain subjects and are not substantively the same as the
Federal requirements. 49 U.S.C. 5125(b)(1). These subjects 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
pertaining to hazardous material and requirements respecting the
number, content, and placement of those documents;
(D) the written notification, recording, and reporting of the
unintentional release in transportation of hazardous material; or
(E) the design, manufacturing, fabrication, marking, maintenance,
reconditioning, repairing, or testing of a package or container which
is represented, marked, certified, or sold as qualified for use in the
transportation of hazardous material.
This final rule concerns the classification, packaging, labeling,
and handling of hazardous material, among other covered subjects.
This rule preempts any State, local, or Indian tribe requirements
concerning these subjects unless the non-Federal requirements are
``substantively the same'' (see 49 CFR 107.202(d)) as the Federal
requirements.
Federal law (49 U.S.C. 5125(b)(2)) provides that if DOT issues a
regulation concerning any of the covered subjects after November 16,
1990, DOT must determine and publish in the Federal Register the
effective date of Federal preemption. That 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 for the requirements in this final
rule that concern covered subjects is January 1, 1996.
C. Regulatory Flexibility Act
This final rule revises requirements for infectious substances and
regulated medical waste contained in the HMR by narrowing the scope of
these provisions. The changes in this rule provide relief to shippers,
carriers of infectious substances and regulated medical waste, and some
packaging manufacturers. Although the changes will affect many small
entities, such as medical clinics, we expect the economic impact on
each of them to be minimal. Therefore, I certify that this rule will
not have a significant economic impact on a substantial number of small
entities.
D. Paperwork Reduction Act
There are no new information collection requirements in this final
rule.
E. Regulation Identifier Number (RIN)
A regulation identifier number (RIN) is assigned to each regulatory
action listed in the Unified Agenda of Federal Regulations. The
Regulatory Information Service Center publishes the Unified Agenda in
April and October of each year. The RIN numbers contained in the
heading of this document can be used to cross-reference this action
with the Unified Agenda.
List of Subjects
49 CFR Part 171
Exports, Hazardous materials transportation, Hazardous waste,
Imports, Incorporation by reference, Reporting and recordkeeping
requirements.
49 CFR Part 172
Hazardous materials transportation, Hazardous waste, Labeling,
Marking, Packaging and containers, Reporting and recordkeeping
requirements.
49 CFR Part 173
Hazardous materials transportation, Packaging and containers,
Radioactive materials, Reporting and recordkeeping requirements,
Uranium.
49 CFR Part 178
Hazardous materials transportation, Motor vehicle safety, Packaging
and containers, Reporting and recordkeeping requirements.
In consideration of the foregoing, 49 CFR parts 171, 172, 173, and
178 are amended as follows:
PART 171--GENERAL INFORMATION, REGULATIONS, AND DEFINITIONS
1. The authority citation for part 171 continues to read as
follows:
Authority: 49 U.S.C. 5101-5127; 49 CFR 1.53.
2. In Sec. 171.8, the following definition is added in appropriate
alphabetical order to read as follows:
Sec. 171.8 Definitions and abbreviations.
* * * * *
Regulated medical waste. See Sec. 173.134 of this subchapter.
* * * * *
Sec. 171.14 [Amended]
3. In Sec. 171.14, as revised at 59 FR 67406, effective October 1,
1995, in paragraph (a)(1)(ii), in the heading, the wording ``October 1,
1995'' is revised to read ``January 1, 1996'' and, in the regulatory
text, the wording ``October 1, 1995'' is revised to read ``January 1,
1996''.
Sec. 171.15 [Amended]
4. In Sec. 171.15, the wording ``etiologic agents'' in paragraphs
(a)(3) and (b) introductory text is revised to read ``infectious
substances (etiologic agents)''.
PART 172--HAZARDOUS MATERIALS TABLE, SPECIAL PROVISIONS, HAZARDOUS
MATERIALS COMMUNICATIONS, EMERGENCY RESPONSE INFORMATION, AND
TRAINING REQUIREMENTS
5. The authority citation for part 172 continues to read as
follows:
Authority: 49 U.S.C. 5101-5127; 49 CFR 1.53.
Sec. 172.101 [Amended]
6. In Sec. 172.101, in the Hazardous Materials Table, as revised at
59 FR 67409, effective October 1, 1995, the following changes are made:
a. For the entry, ``Infectious substances, affecting animals
only'', in Column (8A), ``196'' is removed and replaced with ``134''.
[[Page 48787]]
b. For the entry, ``Infectious substances, affecting humans'', in
Column (8A), ``196'' is removed and replaced with ``134''.
c. For the entry, ``Regulated medical waste'', in Column (4), the
identification number ``NA9275'' is removed and replaced with
``UN3291''; in Column (7), ``A13, A14'' is added; and in Column (8A),
``197'' is removed and replaced with ``134''.
7. In Sec. 172.102, in paragraph (c)(2), Special Provisions A13 and
A14 are added in alphanumeric sequence, to read as follows:
Sec. 172.102 Special provisions.
* * * * *
(c) * * *
(2) * * *
Code/Special Provisions
* * * * *
A13 Non-bulk packagings conforming to Sec. 173.197 of this
subchapter not exceeding 16 kilograms (35 pounds) gross mass
containing only used sharps are permitted for transportation by
aircraft. Maximum liquid content in each inner packaging may not
exceed 50 milliliters (1.7 ounces).
A14 Non-bulk packagings of regulated medical waste conforming
to Sec. 173.197 of this subchapter not exceeding 16 kilograms (35
pounds) gross mass for solid waste or 12 liters (3 gallons) total
volume for liquid waste may be transported by passenger and cargo
aircraft when means of transportation other than air are
impracticable or not available.
* * * * *
PART 173--SHIPPERS--GENERAL REQUIREMENTS FOR SHIPMENTS AND
PACKAGINGS
8. The authority citation for part 173 continues to read as
follows:
Authority: 49 U.S.C. 5101-5127; 49 CFR 1.53.
9. In Sec. 173.2a, paragraph (c)(3) is revised to read as follows:
Sec. 173.2a Classification of a material having more than one hazard.
* * * * *
(c) * * *
(3) A Division 6.2 (infectious substance) material that also meets
the definition of another hazard class or division, other than Class 7,
or that also is a limited quantity Class 7 material, shall be classed
as Division 6.2;
* * * * *
10. Section 173.134 is revised to read as follows:
Sec. 173.134 Class 6, Division 6.2--Definitions, exceptions and
packing group assignments.
(a) Definitions. For the purposes of this subchapter, the
categories of materials that constitute Division 6.2 are defined as
follows:
(1) An infectious substance means a viable microorganism, or its
toxin, that causes or may cause disease in humans or animals, and
includes those agents listed in 42 CFR 72.3 of the regulations of the
Department of Health and Human Services and any other agent that causes
or may cause severe, disabling or fatal disease. The terms infectious
substance and etiologic agent are synonymous.
(2) A diagnostic specimen means any human or animal material
including, but not limited to, excreta, secreta, blood, blood
components, tissue, and tissue fluids, being shipped for purposes of
diagnosis.
(3) A biological product means a material that is prepared and
manufactured in accordance with the provisions of 9 CFR part 102
(Licenses for biological products), 9 CFR part 103 (Experimental
products, distribution, and evaluation of biological products prior to
licensing), 9 CFR part 104 (Permits for biological products), 21 CFR
part 312 (Investigational new drug application), or 21 CFR parts 600 to
680 (Biologics).
(4) A regulated medical waste means a waste or reusable material,
other than a culture or stock of an infectious substance, that contains
an infectious substance and is generated in--
(i) The diagnosis, treatment or immunization of human beings or
animals;
(ii) Research pertaining to the diagnosis, treatment or
immunization of human beings or animals; or
(iii) The production or testing of biological products.
(b) Exceptions. (1) The following are not subject to any
requirements of this subchapter if the items as packaged do not contain
any material otherwise subject to the requirements of this subchapter:
(i) Biological products;
(ii) Diagnostic specimens;
(iii) Laundry or medical equipment that conforms to 29 CFR
1910.1030 of the regulations of the Occupational Safety and Health
Administration of the Department of Labor;
(iv) A material, including waste, that previously contained an
infectious substance and has been treated by steam sterilization,
chemical disinfection, or other appropriate method, so that it no
longer poses the hazard of an infectious substance;
(v) Any waste material, including garbage, trash and sanitary waste
in septic tanks, derived from households, including but not limited to
single and multiple residences, hotels and motels;
(vi) Corpses, remains and anatomical parts that are intended for
ceremonial interment or cremation; and
(vii) Animal waste generated in animal husbandry or food
production.
(2) A hazardous waste is not subject to regulation as a regulated
medical waste.
(3) A regulated medical waste that is transported by a private or
contract carrier is excepted from--
(i) The requirement of an ``INFECTIOUS SUBSTANCE'' label if the
outer packaging is marked with a ``BIOHAZARD'' marking in accordance
with 29 CFR 1910.1030; and
(ii) The specific packaging requirements of Sec. 173.197, if
packaged in a rigid non-bulk packaging conforming to--
(A) The general packaging requirements of Secs. 173.24 and 173.24a;
and
(B) Packaging requirements specified in 29 CFR 1910.1030.
(c) Assignment of packing groups and applicable packaging sections.
(1) Division 6.2 materials, other than regulated medical waste, are not
assigned a packing group. Packaging requirements for these materials
are prescribed in Sec. 173.196.
(2) Except as otherwise provided, regulated medical waste is
assigned to Packing Group II and must be packaged as specified in
Sec. 173.197.
Appendix G [Removed]
11. Appendix G to part 173 is removed.
PART 178--SPECIFICATIONS FOR PACKAGINGS
12. The authority citation for part 178 continues to read as
follows:
Authority: 49 U.S.C. 5101-5127; 49 CFR 1.53.
13. In Sec. 178.609, paragraph (i) is added to read as follows:
Sec. 178.609 Test requirements for packagings for infectious
substances (etiologic agents).
* * * * *
(i) Packagings subject to this section are not subject to
Sec. 178.503 or any other requirements of this subpart, except
Sec. 178.608.
Issued in Washington, DC on September 14, 1995, under authority
delegated in 49 CFR part 1.
D.K. Sharma,
Administrator, Research and Special Programs Administration.
[FR Doc. 95-23243 Filed 9-15-95; 8:45 am]
BILLING CODE 4910-60-P
