[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]]

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Part III





Department of Transportation





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Research and Special Programs Administration



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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