[Federal Register Volume 59, Number 244 (Wednesday, December 21, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-31174]


[[Page Unknown]]

[Federal Register: December 21, 1994]


_______________________________________________________________________

Part III





Department of Transportation





_______________________________________________________________________



Research and Special Programs Administration



_______________________________________________________________________



49 CFR Part 171, et al.




Infectious Substances; Proposed Rule
DEPARTMENT OF TRANSPORTATION

Research and Special Programs Administration

49 CFR Parts 171, 172, 173, and 178

[Docket No. HM-181G; Notice Number 94-11]
RIN 2137-AC36

 
Infectious Substances

AGENCY: Research and Special Programs Administration (RSPA), DOT.

ACTION: Notice of proposed rulemaking and notice of public meeting.

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SUMMARY: RSPA is proposing to revise the regulations pertaining to 
infectious substances, including regulated medical waste (RMW), based 
on petitions for reconsideration and comments received following 
issuance of a final rule in December 1991, comments received in 
response to an advance notice of proposed rulemaking issued in March 
1993, and agency initiative. RSPA is proposing to clarify that RMW is a 
subcategory of infectious substances; allow RMW to be offered for 
transportation and transported if it conforms to certain requirements 
of the Occupational Safety and Health Administration; add provisions 
for transporting RMW by aircraft; and make other changes to clarify the 
regulatory provisions applicable to infectious substances. The proposed 
changes are intended to ensure the safe transportation of infectious 
substances, provide relief from certain requirements of the hazardous 
materials regulations in those instances where other Federal agency 
regulations achieve an acceptable level of safety for transportation of 
RMW, and clarify provisions which were adopted in the December 1991 
final rule.
    RSPA also is announcing a public meeting to solicit comments on the 
proposals contained in this document.

DATES: Comments. Comments must be submitted on or before March 21, 
1995.
    Public Meeting. A public meeting will be held from 9:30 a.m. to 5 
p.m. on January 17, 1995, in Washington, DC.

ADDRESSES: Comments: Address comments to the Dockets Unit (DHM-30), 
Hazardous Materials Safety, Room 8421, RSPA, U.S. Department of 
Transportation, 400 Seventh St., SW., Washington, DC 20590-0001. 
Comments should identify the docket number (HM-181G) and Notice number 
(94-11) and be submitted, when possible, in five copies. Persons 
wishing to receive confirmation of receipt of their comments should 
include a self-addressed stamped postcard. The Dockets Unit is located 
in room 8421 of the Nassif Building, 400 Seventh Street SW., 
Washington, DC 20590-0001. Office hours are 8:30 a.m. to 5 p.m., Monday 
through Friday, except on public holidays when the office is closed.
    Public Meeting: The public meeting will be held at the Federal 
Aviation Administration Auditorium, 3rd Floor, Building FOB 10A, 
Washington, DC. Any person wishing to present an oral statement at the 
public meeting should notify Jennifer Antonielli, by telephone or in 
writing, by January 12, 1995. Each request must identify the speaker; 
organization represented, if any; daytime telephone number; and 
anticipated length of presentation, not to exceed 10 minutes. It is 
requested that written text of the oral presentation be presented to 
the presiding officer prior to the oral presentation. The meeting may 
conclude before 5:00 p.m. if all persons wishing to speak have been 
heard.

FOR FURTHER INFORMATION CONTACT: Eileen Martin or Jennifer Antonielli, 
Office of Hazardous Materials Standards, (202) 366-4488, Research and 
Special Programs Administration, U.S. Department of Transportation, 400 
Seventh Street, SW., Washington, DC 20590-0001.

SUPPLEMENTARY INFORMATION:

Table of Contents:

I. Background
II. Final Rule Extending Compliance Dates
III. Response to Petitions for Reconsideration
IV. General Summary of the ANPRM
V. Proposed Rule
VI. Scope of Future Work
VII. Regulatory Analyses and Notices

I. Background

History of Department of Transportation Regulation of Etiologic Agents/
Infectious Substances

A. Regulation Prior to 1991
    The Hazardous Materials Regulations Board (Board; a predecessor to 
the RSPA) adopted a final rule under Docket HM-142 on September 30, 
1972 (37 FR 20554), that added ``etiologic agents'' to the list of 
hazardous materials regulated by the Secretary. The final rule at 49 
CFR 173.386(a)(1) defined an etiologic agent as

a viable microorganism, or its toxin, which causes or may cause 
human disease, and is limited to those agents listed in 42 CFR 
72.25(c) of the regulations of the Department of Health, Education, 
and Welfare.

(The Department of Health, Education, and Welfare (HEW) is now the 
Department of Health and Human Services (DHHS)). The final rule at 49 
CFR 173.387 also specified packaging requirements for etiologic agents, 
and excepted, at 49 CFR 173.386(d), from DOT regulation ``diagnostic 
specimens'' and ``biological products,'' which were subject to 
regulation by HEW. The final rule was adopted after notice and 
opportunity to comment (36 FR 25163, December 29, 1971).
    On November 29, 1972, after receiving two petitions for 
reconsideration and several comments, the Board proposed in the Federal 
Register (37 FR 25243) to except from DOT regulation cultures of 
etiologic agents of less than 50 milliliters (1.666 fluid ounces) in 
one package. The petitions stated that such an exception was necessary 
to allow physicians in rural areas to transport cultures to 
laboratories on passenger-carrying aircraft, rather than by slower 
surface transportation which, in turn, promotes health safety. The 
petitions added that cultures of etiologic agents may perish if in 
transportation too long. The Board adopted the proposal as final on 
March 29, 1973 (38 FR 8161). One commenter objected to excepting such 
quantities of etiologic agents from all regulation. The Board noted, 
however, that quantities of etiologic agents excepted from DOT 
regulation would still be subject to HEW labeling and packaging 
regulations under 42 CFR 72.25(c). The March 29, 1973 rule also adopted 
incident notification requirements for etiologic agents, as proposed on 
July 22, 1972 (37 FR 14728).
B. The 1988 notice of proposed rulemaking (NPRM) under Docket HM-142A
    On November 10, 1988, RSPA proposed (Docket HM-142A, 53 FR 45525) 
to revise the definition of ``etiologic agent,'' remove the 50 
milliliter (ml) exception, and align the per package quantity limits of 
etiologic agents aboard aircraft with the International Civil Aviation 
Organization Technical Instructions for the Safe Transport of Dangerous 
Goods by Air (ICAO Technical Instructions). RSPA proposed broadening 
the definition of ``etiologic agent'' to include, in addition to 
etiologic agents listed by DHHS (Centers for Disease Control and 
Prevention (CDC)) in 42 CFR 72.3, any agent that poses a similar degree 
of hazard, such as the human immunodeficiency virus (HIV). RSPA noted 
that the proposed definition was not as broad as the definition for 
infectious substances (Division 6.2) contained in the United Nations 
Recommendations on the Transport of Dangerous Goods (UN 
Recommendations) and international regulations based on the UN 
Recommendations, such as the ICAO Technical Instructions. CDC has not 
updated the list in 42 CFR 72.3 since July 1, 1980 (45 FR 48627). On 
March 2, 1990 (55 FR 7678), CDC proposed to delete the list from its 
regulations and adopt criteria to define ``etiologic agent,'' but a 
final rule has not been published.
C. January 3, 1991 final rule under Docket HM-142A
    On January 3, 1991, RSPA published a final rule in the Federal 
Register (56 FR 197) under Docket HM-142A. The final rule (1) adopted a 
revised definition of ``etiologic agent,'' (2) removed the 50 ml 
exception, and (3) clarified quantity limitations for etiologic agents 
transported aboard aircraft. ``Etiologic agent'' was defined to mean

a viable microorganism, or its toxin, which is listed in 42 CFR 72.3 
of the regulations of the [CDC] or which causes or may cause severe, 
disabling or fatal human disease.

The definition adopted differed from the proposed definition in 
response to commenters who suggested that the language of the 
definition be modified to better reflect agents that may pose an 
unreasonable risk to health and safety during transportation. 
Accordingly, the wording was revised to include other agents that cause 
or may cause severe, disabling or fatal human diseases in humans in 
addition to the agents listed in 42 CFR 72.3 of the CDC regulations. In 
response to comments, RSPA indicated in the preamble that it believed 
most medical waste is composed of material that does not contain 
etiologic agents, either because it does not contain any infectious 
material or because the infectious material does not meet the 
regulatory definition of etiologic agent. RSPA also stated that, in 
many cases, if medical waste is known or suspected to contain an 
etiologic agent, it is treated on-site to destroy the agent by using a 
method such as incineration, autoclaving, or treatment with 
disinfectants. However, RSPA clearly stated that ``* * * if an 
infectious waste that contains an etiologic agent is offered for 
transportation, it must conform with the requirements in the Hazardous 
Materials Regulations (HMR; 49 CFR parts 171-180) for etiologic 
agents'' (56 FR 198). As stated earlier, the final rule also removed 
the 50 ml exception, as proposed in 1988. The January 3 preamble 
responded to numerous comments received on the 50 ml proposal and 
comprehensively discussed the reasons for this action.
    The January 3 preamble also discussed the relationship of Docket 
HM-142A to Docket HM-181. Docket HM-181, entitled ``Performance-
Oriented Packaging Standards; Miscellaneous Amendments,'' 
comprehensively revised the HMR by eliminating 350 pages of regulation 
and harmonizing HMR requirements for classification, hazard 
communication and packaging with standards in the UN Recommendations. 
In the preamble discussion, RSPA stated that HM-181 had proposed to 
replace the term ``etiologic agent'' with ``infectious substance'' for 
consistency with international regulations. However, RSPA noted that 
the scope of changes proposed under HM-181 was so extensive that RSPA 
was unsure when that proposal would be adopted as final. As a result, 
RSPA proceeded with a separate rulemaking under Docket HM-142A (an 
abbreviated version of the infectious substance provisions in HM-181) 
to ensure that the risks posed by etiologic agents were adequately 
regulated under the HMR. RSPA intended the provisions under HM-142A to 
serve as a transition until the provisions of HM-181 became effective. 
Both final rules were published at approximately the same time. 
However, the initial effective date for HM-142A was February 19, 1991, 
and the effective date for HM-181 was October 1, 1991. Although HM-142A 
was to become effective before HM-181, RSPA encouraged shippers to 
implement the HM-181 provisions as soon as practicable.
D. Performance-oriented packaging standards--HM-181
    In 1987, RSPA proposed to align the classification, packaging, and 
hazard communications provisions in the HMR with the UN Recommendations 
and the ICAO Technical Instructions. The May 5, 1987 NPRM (Docket HM-
181, 52 FR 16482) proposed to replace the term ``etiologic agent'' with 
the term ``infectious substance'' and adopt the INFECTIOUS SUBSTANCE 
label (52 FR 16700). RSPA proposed to include ``infectious substance'' 
in UN classification Class 6, Division 6.2. ``Infectious substance'' 
was proposed to mean

a viable microorganism, or its toxin, which causes or may cause 
human disease, and is limited to those agents listed in 42 CFR 72.3 
of the regulations of the [CDC]. The terms ``infectious substance'' 
and ``etiologic agent'' are synonymous.

(52 FR 16700).
    On December 21, 1990, RSPA issued a final rule under Docket HM-181 
(55 FR 52402) which comprehensively revised the HMR with respect to 
hazard communication, classification, and packaging requirements. 
``Infectious substance'' was defined in 49 CFR 173.134(a)(1) to mean

a viable microorganism, or its toxin, which causes or may cause 
disease in humans or animals, and includes those agents listed in 42 
CFR 72.3 of the regulations of the [CDC] or any other agent that has 
the potential to cause severe, disabling or fatal disease. The terms 
``infectious substance'' and ``etiologic agent'' are synonymous.

RSPA had planned to issue a final rule under Docket HM-142A (etiologic 
agents) before issuing the final rule under Docket HM-181. However, the 
final rule under HM-181 was issued on December 21, 1990, and the final 
rule under HM-142A was not issued until January 3, 1991. As explained 
in the preamble to the January 3, 1991 rule, the comments on HM-142A 
were considered in the decisionmaking process for HM-181, and reflected 
in the December 21, 1990 rule. For example, not only did the December 
1990 definition of ``infectious substance'' adopt the broader 
definition of etiologic agent proposed in 1988, it also reflected 
RSPA's consideration of comments suggesting that the language be 
modified to better define agents that may pose an unreasonable risk to 
health and safety during transportation.
    A document incorporating editorial and substantive revisions to the 
December 1990 final rule was published on December 20, 1991 [56 FR 
66124]. (These final rules are referred to jointly herein as Docket HM-
181.) The revisions contained in the December 1991 rule were primarily 
in response to petitions for reconsideration received on the December 
1990 final rule. The December 1991 rule also made editorial and 
technical corrections to the December 21, 1990 final rule, and to the 
January 3, 1991 final rule.
E. Petition for reconsideration on the January 3, 1991 rule
    A petition for reconsideration filed by the National Solid Wastes 
Management Association (NSWMA) recommended that RSPA revise the 
definition of infectious substances (etiologic agents) to exclude solid 
waste or medical waste as defined in 40 CFR 259.10 of the Environmental 
Protection Agency (EPA) regulations. To allow adequate time to evaluate 
the petition, RSPA delayed the effective date of the January 3 rule to 
September 30, 1991 (February 22, 1991, 56 FR 7312). In a meeting to 
obtain clarification of the petition, NSWMA urged RSPA to reestablish 
the 50 ml exception for infectious substances. The NSWMA stated that 
RSPA's regulation was inconsistent with the approach taken by EPA, and 
would increase the costs of transporting medical waste for the 
regulated community. The NSWMA stated that, contrary to RSPA's preamble 
discussion that most medical waste did not contain etiologic agents or 
was treated on-site to destroy the agent before being transported for 
disposal, substantial quantities of untreated medical waste are 
transported off-site. This information was the first indication RSPA 
had received from any commenter that removal of the 50 ml exception 
would affect a larger segment of the industry than had previously been 
indicated.
    On September 18, 1991 (56 FR 47158), RSPA incorporated HM-142A into 
HM-181 and, in partial response to NSWMA's request, extended the 50 ml 
exception from October 1, 1991, to October 1, 1992. (The September 1991 
rule also required that packages exceeding the 50 ml exception comply 
on October 1, 1991, with the revised hazard communication (shipping 
paper, marking, and labeling) and classification requirements in Docket 
HM-181). RSPA anticipated that this extension would provide enough time 
to fully respond to NSWMA's comments in the final correction document 
to HM-181 that was being prepared. However, NSWMA submitted a September 
26, 1991 letter asking that RSPA clarify that the January 3, 1991 and 
September 18, 1991 final rules ``apply to only isolated cultures or 
stocks such as clinical laboratory specimens and not to 'medical waste' 
as defined in 40 CFR 259.30(a) and 'mixtures' as defined in 40 CFR 
259.31.'' In essence, NSWMA was requesting clarification that the HMR 
did not apply to medical waste containing any amount of an infectious 
substance. In order to allow RSPA additional time to carefully review 
NSWMA's substantive concerns, RSPA again extended the compliance date 
for all new requirements for infectious substances until October 1, 
1992 (October 1, 1991, 56 FR 49830).
F. December 20, 1991 final rule
    In the December 20, 1991 final rule responding to petitions for 
reconsideration in Docket HM-181, RSPA agreed with NSWMA that medical 
waste containing an infectious substance should be treated differently 
than other infectious substances. RSPA had no basis, however, to except 
from regulation medical waste containing an infectious substance, and 
stated ``* * * since the majority of these wastes are untreated and, 
thus, may potentially contain infectious substances, RSPA strongly 
believes that the public and transport personnel be protected from the 
hazards of these materials during transportation'' (56 FR 66142). 
Accordingly, RSPA revised the regulations (49 CFR 173.197 (1991)) to 
specify ``* * * less rigorous requirements for infectious substances 
that are `regulated medical wastes''' (56 FR 66131). RSPA observed that 
EPA's regulations on medical waste in 40 CFR Part 259 had applied in 
only five States and had expired on June 22, 1991, with the end of a 2-
year demonstration program that EPA had established under the Medical 
Waste Tracking Act of 1988 (MWTA; Pub.L. 100-582). To provide less 
rigorous requirements for medical waste containing infectious 
substances, RSPA turned to the expired EPA regulations as a model that 
could be adapted, with some modifications, to the HMR. RSPA wanted to 
take advantage of the technical expertise and knowledge of the medical 
waste industry that EPA had developed during its demonstration project 
under the MWTA. Accordingly, RSPA adopted a definition of ``regulated 
medical waste'' (to distinguish between all medical waste and medical 
waste containing an infectious substance) and specified packaging 
requirements for regulated medical waste (RMW) that were consistent 
with those contained in the expired EPA regulations.
    RSPA thus identified a subcategory of Division 6.2 (infectious 
substances) materials, i.e., RMW, which is an infectious substance that 
is contained in or constitutes medical waste, and provided packaging 
requirements for RMW that were less rigorous than those for other 
infectious substances.
    Under the December 1991 rule, if an infectious substance is offered 
for transportation or transported, the infectious substance must be 
labeled, packaged, and offered for transportation in accordance with 
the HMR, unless it meets one of the exceptions from regulation. The 
1991 rule provided that if the infectious substance was a medical 
waste, or was contained in medical waste, then a shipper could use the 
less rigorous packaging requirements that were provided for RMW.
    If RSPA had not provided this measure of regulatory relief in 
response to petitions, all infectious substances, regardless of how 
they are generated, would be classified and described as Division 6.2 
materials, and would be subject to the full extent of regulation 
provided in the HMR.
G. Petitions for reconsideration and comments received in response to 
the December 20, 1991 rule
    Following issuance of the December 1991 rule, RSPA received 
additional petitions for reconsideration and a number of requests for 
clarification and additional comments concerning the provisions for 
infectious substances and regulated medical waste. The petitioners 
requested a stay in the effectiveness of the final rule and the 
reopening of the rulemaking for additional public input.
    Petitions were submitted by the American Hospital Association 
(AHA), the Association for Practitioners in Infection Control, Inc. 
(APIC), and the Conference on Safe Transportation of Hazardous 
Articles, Inc. (COSTHA). The petitioners asserted that RSPA violated 
the Administrative Procedure Act (5 U.S.C. 553; ``APA'') by adopting 
new requirements for medical waste in the December 20, 1991 rule 
without providing an opportunity for comment; did not adequately assess 
the risks associated with RMW in transportation and the costs and 
benefits of regulation; and did not coordinate with other Federal 
agencies to prevent imposition of conflicting regulations.
    Petitioners also contended that the RMW requirements in the HMR 
conflict with information contained in the report entitled ``The Public 
Health Implications on Medical Waste: A Report to Congress,'' prepared 
in 1990 by the Agency for Toxic Substances and Disease Registry (ATSDR) 
on the Medical Waste Tracking Act. The ATSDR Report contains a 
compilation of information obtained from several State health and 
environmental departments on the amount and types of medical waste 
generated and health and environmental implications of medical waste in 
the United States. The report concludes that infection outside the 
health care setting is not likely, and public health is not likely to 
be adversely affected by medical waste in transportation.
    COSTHA also asserted that RSPA changed the definition of infectious 
substances to include substances ``infectious to animals only'' without 
providing an opportunity to comment.
H. Advance notice of proposed rulemaking
    On March 3, 1993, RSPA issued an advance notice of proposed 
rulemaking (ANPRM) and announced a public meeting under Docket HM-181G 
(58 FR 12207) concerning the issues raised by petitioners and 
commenters and the need for additional regulatory changes pertaining to 
infectious substances. In order to provide time to evaluate the 
comments received in response to the ANPRM, RSPA also extended the 
compliance date (58 FR 12182) for provisions applicable to infectious 
substances from April 1, 1993, to January 1, 1994. The ANPRM addressed 
a number of complex issues pertaining to scope of regulation, 
consistency with regulations of other agencies, the need for revised 
standards for non-bulk and bulk packagings, and defining criteria for 
infectious substances and RMW. Following issuance of the ANPRM, RSPA 
continued its efforts to gain information on other Federal agencies' 
regulatory requirements, and hosted and participated in a number of 
interagency meetings on these issues. On December 20, 1993 (58 FR 
66302), RSPA again extended the compliance date for provisions 
applicable to infectious substances from January 1, 1994, to October 1, 
1994 to provide additional time for resolving the issues of concern.

II. Final Rule Extending Compliance Dates

    In a final rule published on September 22, 1994 (59 FR 48762), RSPA 
revised 49 CFR 171.14(b) to once again delay compliance dates. For 
regulatory requirements for RMW and for materials infectious only to 
animals, the compliance date was extended from October 1, 1994, to 
October 1, 1995. This time period should be adequate for RSPA to 
evaluate comments received in response to this Notice, and make any 
necessary changes to the HMR based on the merits of those comments.
    For other infectious substances, e.g., for cultures and stocks of 
substances infectious to humans, the compliance date was extended from 
October 1, 1994, to January 1, 1995. The provisions for these materials 
generally were not at issue in comments or petitions to the December 
1991 final rule. The principal effects of the January 1, 1995 
compliance date will be a nomenclature change from the old ``etiologic 
agent'' hazard class to the new Division 6.2 (infectious substances) 
classification, broadening the definition of infectious substances to 
cover substances, such as the human immunodeficiency virus (HIV) and 
Lyme disease, which are not listed in the CDC regulations (42 CFR 
72.3). The removal of the 50 ml exception and expansion of the 
definition of infectious substances originally were to have occurred on 
February 19, 1991 (Docket HM-142A; January 3, 1991; 56 FR 197). RSPA 
believes it is necessary to implement these requirements as quickly as 
possible to ensure public safety and end confusion as to the status of 
materials that were not regulated prior to 1990. The interested reader 
is directed to the final rule for further information concerning the 
extension of compliance dates.

III. Response to Petitions for Reconsideration

    With respect to the issue of providing notice and comment, the 
December 20, 1991 final rule was issued to correct obvious errors and 
respond to over 250 petitions for reconsideration of the final rule 
published on December 21, 1990. The rulemaking proceeding under HM-181 
spanned over 10 years, provided numerous opportunities for public 
comment (with over 2,500 comments received), and complied fully with 
the requirements of the APA. Similarly, the final rule issued under HM-
142A was preceded by an NPRM and opportunity to comment.
    The specific criteria and provisions for medical waste were 
contained in the December 20, 1991 final rule to provide relief from 
the more burdensome infectious substances packaging requirements 
adopted in the December 21, 1990 final rule. Relief was provided in 
response to petitions for reconsideration stating that packaging 
prescribed in Sec. 173.196 would be both cost-prohibitive and 
impractical for medical waste and that, rather than being treated on-
site, significant quantities of medical waste containing infectious 
substances were routinely transported off-site for treatment or 
disposal. The relief granted for medical waste was well within the 
scope of the NPRM and the final rule.
    Infectious substances, including medical waste containing 
infectious substances, are regulated under the HMR and have been since 
1973. For various reasons, many generators and transporters of medical 
waste may not have been fully aware of these requirements. The change 
in the definition of an etiologic agent/infectious substance under 
Dockets HM-142A and HM-181, coupled with the elimination of the 50 ml 
exception, increased both the awareness of this issue and the 
likelihood that more medical waste would be subject to the HMR. 
Moreover, the petitions appeared to be based on a misconception that 
RSPA intended to regulate all medical waste, rather than only that 
medical waste containing an infectious substance. To the extent that 
there existed any confusion regarding the scope of RSPA's regulation of 
medical waste, the notice published today sets forth a proposed 
definition of RMW that clearly limits RMW to a waste containing an 
infectious substance. Accordingly, in this notice, RSPA is giving those 
persons who may have been unaware of, or confused by, the previous 
requirements an opportunity to comment on the proposals.
    With regard to analysis of risk and economic impact, in the 
regulatory evaluation for HM-181, RSPA performed a macroscopic analysis 
of costs and benefits generically addressing all hazardous materials, 
their packagings, and impacts of changes to classification and hazard 
communication. The HMR address tens of thousands of hazardous materials 
and over 100 different types of packagings. Under HM-181, it was not 
feasible or necessary to specifically analyze each hazardous material 
or category of materials or each type of packaging and determine that 
the benefits of change to classification, hazard communication or 
packaging for each would outweigh associated costs. The benefits of the 
system put in place under HM-181, involving the assessment of levels of 
hazard for materials and assignment of packagings based on levels of 
hazard, were demonstrated to greatly exceed the costs of the system. 
RSPA did not receive any comments in response to the notices in Dockets 
HM-181 or HM-142A on any economic impacts the rule would have on the 
medical waste industry. Therefore, RSPA disagrees with the petitioners 
who claimed that RSPA did not adequately assess costs and benefits 
attributable to changes to regulatory requirements, particularly with 
regard to medical waste. For this notice, RSPA has prepared a 
regulatory evaluation and is providing an opportunity to comment on the 
proposals.
    With respect to other Federal regulation of infectious substances, 
RSPA has participated in a number of interagency meetings to exchange 
information on the Federal regulations and identify any duplication, 
conflict, gaps, or discrepancies. As discussed in greater detail under 
Section VI of this notice, RSPA intends to continue to cooperate with 
other Federal agencies to harmonize requirements on infectious 
substances. With respect to State regulation, RSPA is aware that many 
States have regulations on the transportation of medical waste, 
although the States vary in the extent and scope of their regulation. 
As discussed in Section VII.B. below, Federal law preempts State 
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 include the 
designation, description, classification, packaging, handling, marking, 
and labeling of hazardous material.
    With respect to the ATSDR Report, that report addressed all medical 
waste generated in the United States. RSPA is concerned only with 
regulating medical waste that contains an infectious substance, and is 
proposing to regulate only that medical waste.
    With respect to COSTHA's petition concerning substances infectious 
only to animals, in the November 1987 NPRM under Docket HM-181, RSPA 
had proposed a shipping description for ``Infectious substances, 
affecting animals only'', applicable only to international 
transportation (i.e., identified with an ``I'' in Column 1 of the 
Hazardous Materials Table in Sec. 172.101). In the December 1990 final 
rule, RSPA removed the ``I'', making the description applicable to both 
domestic and international transportation, and revised the definition 
for infectious substances to include those affecting animals only. This 
action was taken to harmonize with the UN Recommendations to the 
maximum extent practicable. In response to COSTHA's petition, RSPA is 
providing notice and opportunity to comment on the proposal in this 
NPRM.

Conclusion

    By initiating rulemaking, including issuance of the ANPRM and this 
NPRM, RSPA has granted the petitioners' requests to provide notice and 
an opportunity to comment on provisions concerning RMW and infectious 
substances that are infectious to animals only. RSPA agrees with the 
petitioners and commenters that the HMR should be carefully tailored to 
the hazards posed by these materials, so that they can be safely 
transported without imposing unreasonable requirements on industry. To 
the maximum extent practicable, RSPA is proposing to accommodate RMW 
prepared in accordance with other Federal regulations, as discussed in 
Section V of this notice. Furthermore, RSPA is proposing to amend and 
clarify certain provisions that are frequently misconstrued.

IV. General Summary of the ANPRM

    The ANPRM was issued to invite interested persons to participate in 
the rulemaking process by submitting views and information on issues 
concerning Division 6.2 materials. RSPA asked 29 questions in the 
ANPRM. The questions addressed areas in the HMR that were identified as 
problem areas in comments and petitions received following issuance of 
the December 1991 final rule. RSPA requested information on a number of 
complex issues including the burdens of compliance with the HMR and 
other Federal regulations, the need for revised packaging standards, 
the need to expand or narrow the definitions for infectious substances 
and RMW, and the costs incurred to manage these materials in 
transportation. RSPA requested commenters to provide as much 
quantitative information as was available concerning costs and benefits 
attributable to their recommendations.
    RSPA received approximately 54 written comments in response to the 
ANPRM and 13 oral comments at the public meeting. Comments were 
submitted by a variety of organizations, including associations 
representing hospitals, blood centers and laboratories, disposal 
service companies, Federal and State agencies, packaging manufacturers, 
and private individuals. In responding to the ANPRM, some commenters 
submitted views on issues not specifically addressed in the ANPRM.
    The commenters provided widely divergent views on the extent to 
which the regulations should be revised or amended. Some commenters 
believed that RSPA should adopt a ``universal precautions'' approach, 
as utilized by the Occupational Safety and Health Administration (OSHA) 
of the Department of Labor in regulations applicable to bloodborne 
pathogens (29 CFR 1910.1030); that is, all materials that are 
potentially infectious are treated as if known to be infectious. Others 
suggested that RSPA should withdraw from regulation of infectious 
substances and RMW, asserting that other agencies' regulations provide 
an adequate level of safety in transportation. Several commenters 
claimed that the regulation of RMW was best left to the EPA, even 
though EPA regulation of RMW ended in 1991.
    Several commenters provided information on the overall quantities 
and costs of disposal for medical waste. However, there was not much 
useful information as to what portion of that waste stream was subject 
to RSPA requirements, either before or after the HM-181 final rules, 
incremental costs or savings resulting from the December 1991 final 
rule, or even what portion of the disposal costs were the result of 
regulatory requirements. Commenters estimated varying disposal costs 
from $0.10 to $2.00 per pound.

V. Proposed Rule

    After considering the comments and petitions for reconsideration 
that were filed, and following an examination of the issues surrounding 
the transportation of infectious substances and RMW, RSPA is limiting 
the proposals in this notice to those issues concerning infectious 
substances and RMW that must be addressed in the short term to ensure 
safe transportation of these materials without unduly impacting the 
regulated industry. RSPA intends to address other pertinent issues, 
such as harmonizing the HMR with international regulations, adopting 
bulk packaging provisions for RMW, and evaluating the adequacy of 
existing Federal regulations for biological products and diagnostic 
specimens, in future rulemaking action. Although these issues are 
important, they are complex and may result in additional requirements 
or substantial changes to the HMR. Thus, it is not appropriate to 
include them in this notice, except to discuss them in terms of future 
action. The ``long-term'' issues are discussed further in Section VI of 
this notice.
    In this NPRM, RSPA is proposing to amend the provisions of the HMR 
applicable to Division 6.2 materials to enhance the effectiveness of 
the HMR and minimize costs incurred by industry. Interested persons are 
invited to comment on these proposals. A public meeting will be held on 
January 17, 1995, at which oral comments are invited.
A. Definitions
    Several commenters requested confirmation of their understanding 
that the provisions for RMW do not apply to sterilized medical wastes 
or wastes that do not contain an infectious substance. This 
understanding is correct. As stated in the preamble to the January 3, 
1991 final rule, if a medical waste has been treated so as to eliminate 
its hazard as an infectious substance, then it is not subject to the 
HMR. No additional processing of the waste for aesthetics, such as that 
formerly required by the EPA under the MWTA, is required. To clarify 
this point, RSPA is proposing to revise Sec. 173.134 by adding 
exceptions for any material that contained an infectious substance but 
has been treated to eliminate the hazard. In addition, consistent with 
EPA-provided exceptions under the MWTA regulations and based on RSPA's 
own initiative, RSPA is proposing to clarify that the following 
materials are not considered RMW: (1) EPA hazardous wastes; (2) 
household waste; (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's initiative, RSPA is 
proposing to simplify the definition of RMW by adopting a criteria-
based definition, rather than a list-based definition. The definition 
in Appendix G to part 173 did not specify that a category of waste, 
such as ``unused sharps,'' was only regulated if the waste contained an 
infectious substance. RSPA never intended to regulate medical waste 
that does not contain an infectious substance. Therefore, RSPA is 
proposing to revise the definition of RMW to remove the Appendix G 
categories and replace them with a generic definition. RMW would be 
defined as a waste or reusable material, other than a Class 7 
(radioactive) material or a culture or stock of an infectious 
substance, which 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.
    Another issue of concern to RSPA was whether waste cultures and 
stocks should be treated as RMW or as infectious substances for the 
purposes of packaging and hazard communication for transportation. 
Several commenters recommended that waste cultures and stocks should be 
treated as infectious substances rather than as RMW. One commenter 
stated that the hazards posed by these materials are the same 
regardless of ``whether the untreated cultures and stocks are to 
undergo further manipulation or are destined for disposal.'' Another 
commenter stated that cultures and stocks demand very careful packaging 
and handling. The commenter added that packagings required for most RMW 
are not adequate for untreated cultures and stocks. Some commenters 
stated that cultures and stocks should be handled as RMW because 
optimal conditions for growth are no longer present in the waste stream 
and most of these materials are sterilized before transportation. In 
the case of the generators that cannot sterilize on-site, the Texas 
Water Commission asserted that the quantity of these materials in the 
waste stream is probably insufficient to make the waste significantly 
more infectious than other forms of RMW.
    RSPA agrees with those commenters who suggested that discarded 
cultures and stocks, because of their concentration, pose a greater 
degree of risk than other medical waste and should be treated as 
infectious substances rather than RMW. Therefore, RSPA is proposing to 
exclude untreated waste cultures and stocks from the definition of RMW 
and subject them to the more rigorous packaging provisions applicable 
to infectious substances other than RMW. RSPA does not believe that 
this proposal will impose additional burdens on industry because, based 
on comments, these materials are largely treated on-site prior to 
disposal.
    RSPA received comments stating that contaminated laundry and other 
recyclable/reusable materials, such as used surgical instruments that 
are cleaned and sterilized off-site, should be handled in accordance 
with OSHA regulations. The OSHA regulations in 29 CFR 1910.1030 provide 
that contaminated laundry shall be placed and transported in bags or 
containers labeled or color-coded in accordance with paragraph 
(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. One commenter stated that 
since these waste materials are not considered hazardous wastes under 
EPA regulations, they should not be RMW under DOT regulations. The 
American Type Culture Collection suggested that laundry and surgical 
instruments should only be regulated in transportation if they are 
known to be infectious. To relieve the burden of dual compliance with 
the HMR and OSHA regulations, RSPA is proposing to except contaminated 
laundry and other reusable materials from the HMR if they are handled 
in accordance with the OSHA requirements in 29 CFR 1910.1030.
    In the ANPRM, RSPA reopened the issue of regulating infectious 
substances affecting animals only. Several commenters objected to 
regulating substances ``infectious to animals only.'' Commenters 
suggested that RSPA include only those substances infectious to humans 
and those infectious to humans and animals (zoonotic), but not those 
infectious to animals only. Some commenters stated that the regulations 
of the Animal and Plant Health Inspection Service (APHIS) of the United 
States Department of Agriculture adequately covers substances 
infectious to animals. One commenter suggested that if RSPA defers to 
other regulations for these materials, the HMR should cross-reference 
those Federal regulations.
    Under the Federal hazardous material transportation law, RSPA must 
regulate the transportation of materials that may pose an unreasonable 
risk to health and safety or property. Animal pathogens may pose an 
unreasonable risk to animals. Furthermore, RSPA has examined the APHIS 
regulations contained in 9 CFR parts 1-199 and determined that they do 
not address transportation concerns with regard to communication of 
hazard, provision of emergency response information, and adequacy of 
packaging. Therefore, in this notice, RSPA is proposing to regulate 
Division 6.2 materials affecting animals only. Although the 
requirements that were scheduled to go into effect on October 1, 1994, 
included ``animals'' in the definition of ``infectious substance,'' 
RSPA has delayed the compliance date for these materials until October 
1, 1995. See Section II for more information concerning the extension 
of compliance dates. RSPA is requesting more comments on this issue.
    RSPA received several requests to clarify that the terms 
``biological product'' and ``diagnostic specimen'' do not include 
materials that do not contain infectious substances. As previously 
stated, RSPA does not intend to regulate materials that do not pose a 
hazard in transportation. Therefore, for clarity, RSPA is proposing to 
revise the definitions of ``biological product'' and ``diagnostic 
specimen'' to include only those materials that contain an infectious 
substance. RSPA also would clarify that the terms ``biological 
product,'' ``diagnostic specimen,'' and ``regulated medical waste'' are 
all subcategories of Division 6.2 materials.
B. RMW Exception
    RSPA received several comments on the ANPRM claiming that the 
regulations imposed by RSPA overlap, and sometimes conflict with, 
regulations/guidelines established by other agencies, which 
unnecessarily increases costs and confusion. One commenter suggested 
that inconsistencies should be eliminated between Federal and State 
regulations governing RMW. Another commenter stated that overlapping 
regulations clearly increase non-compliance; however, the associated 
costs are difficult to assess. One commenter asserted that current 
Federal regulations do not appear to be financially burdensome but do 
complicate compliance. One commenter claimed that overlapping Federal 
regulations are not so much burdensome or costly, as that they are 
largely ignored. Another commenter stated that varying medical waste 
regulations increase the volume of waste that must be specially 
handled. Many commenters requested consolidation of the regulations.
    More specifically, commenters stated that the appearance of 
multiple labels on a package of infectious substances causes 
unnecessary confusion to transport workers and emergency responders. 
One commenter claimed that multiple labels contribute to the 
mismanagement of medical waste by transport workers and emergency 
response personnel. Several commenters recommended that one label is 
sufficient to communicate the hazard. One commenter suggested that the 
CDC ``BIOMEDICAL MATERIAL'' label and the OSHA ``BIOHAZARD'' marking 
should be allowed only on stationary materials and equipment. Some 
commenters recommended that RSPA adopt the UN Recommendations label for 
infectious substances because it is internationally recognized. One 
commenter stated that appropriate worker training would eliminate much 
of the confusion experienced by transport workers and emergency 
response personnel.
    RSPA recognizes that overlapping Federal regulations for infectious 
substances and RMW cause confusion and result in frustrated shipments. 
Therefore, RSPA is proposing to provide an exception from the HMR 
labeling and packaging requirements for RMW, transported by private and 
contract carriers, that is packaged in a packaging that complies with 
OSHA requirements, is rigid, conforms to the general packaging 
requirements of 49 CFR 173.24 and 173.24a, and is marked with the OSHA 
``BIOHAZARD'' marking. This exception would be limited to transport by 
private or contract carrier because these carriers generally transport 
RMW exclusively and have the demonstrated ability to implement 
appropriate handling procedures which offset potentially lesser 
packaging integrity. RMW that is offered for transportation and 
transported by common carrier would be subject to the packaging 
requirements of Sec. 173.197. RSPA invites comments on this matter.
    Other than this exception for RMW, RSPA is not proposing in this 
NPRM to accept other agencies' labels or markings in place of the label 
or marking requirements for infectious substances packagings. The 
``INFECTIOUS SUBSTANCE'' label is internationally recognized, is 
required under the ICAO Technical Instructions for transport by 
aircraft, and is consistent in size and appearance with DOT's other 
hazard warning labels. Unlike OSHA's ``BIOHAZARD'' marking, the DOT 
label conveys the class number of the material, emergency information 
in the event of a spill or incident, and has minimum size requirements 
to ensure its visibility.
C. Miscellaneous
    RSPA is proposing to relocate the exceptions for biological 
products and diagnostic specimens in Sec. 173.196 and the definition 
and exceptions for RMW in Appendix G to part 173 to Sec. 173.134 to 
ease compliance. Also, in response to a question concerning use of the 
term ``diagnostic specimen'' versus ``clinical specimen,'' many 
commenters recommended that RSPA continue using ``diagnostic specimen'' 
instead of ``clinical specimen'' because the term ``diagnostic 
specimen'' is commonly used in industry. RSPA agrees and would retain 
the terminology. RSPA is proposing to amend the terminology used in the 
incident reporting requirements in Sec. 171.15 from ``etiologic 
agents'' to ``infectious substances (etiologic agents)''.
    RSPA has received several requests for clarification as to whether 
infectious substance packagings that successfully pass the tests in 
Sec. 178.609 must be certified and marked. According to Sec. 173.196, 
packagings for infectious substances are required to be capable of 
passing the tests in Sec. 178.609. These packagings are not required to 
be marked and certified. RSPA is proposing to add a provision in 
Sec. 178.609 that clarifies that packagings conforming to this section 
are not subject to the marking requirements of Sec. 173.503. However, 
the eighth revised edition of the UN Recommendations prescribes 
packaging certification marking requirements for infectious substances 
packagings. Therefore, RSPA may propose similar requirements in the 
interest of international harmonization, in future rulemaking action. 
(See Section VI of this notice.)
    RSPA would clarify in Sec. 173.134 that Division 6.2 materials 
other than RMW are not assigned a packing group. RMW would be assigned 
to a Packing Group II performance level.
D. Air Transportation
    In response to a question in the ANPRM, RSPA received comments 
concerning shipments of RMW by modes other than highway. Commenters 
stated that RMW is transported predominantly by highway; however, other 
modes of transportation also are used. Some commenters reported that 
used sharps are transported by air through the U.S. Postal Service 
(USPS) ``mail-in'' sharps program. RSPA received a petition requesting 
an amendment to the HMR to permit the transportation of similar 
quantities and packages of RMW by aircraft other than in mail. RSPA 
also received comments from a number of health care facilities located 
in rural areas, e.g., Alaska, requesting that the regulations 
facilitate transportation of medical wastes by aircraft. The commenters 
stated that health clinics in remote areas are only accessible by air 
or water. Commenters reported that it is not practical for the air 
carriers to provide cargo-only flights.
    RSPA is proposing to add two special provisions that would permit 
the transportation of RMW by aircraft. A new Special Provision ``A13'' 
would be added to allow the transportation of sharps aboard passenger 
and cargo-carrying aircraft in quantities of not more than 16 kilograms 
(35 pounds) per package and maximum liquid content of 50 milliliters 
for each inner packaging. This provision is consistent with USPS 
regulations for the mailability of used sharps under 39 CFR Part 111 
and would serve to eliminate confusion as to whether sharps mailers are 
acceptable for air transportation. RSPA also is proposing to add 
Special Provision ``A14'' to allow shipments of RMW to be transported 
by aircraft in quantities not exceeding 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. Even 
though these provisions would not have any effect on the movement of 
RMW until adopted, proposal of these provisions is intended to clarify 
that sharps and RMW from Alaska and other remote areas are permitted 
aboard aircraft. See Section VI of this preamble for possible future 
rulemaking concerning quantity limitations aboard aircraft.
    RSPA also is proposing to revise the I.D. number for RMW from a 
domestic-only recognized I.D. number (NA 9275) to an internationally 
recognized I.D. number (UN 3291). This proposed amendment is consistent 
with the UN Recommendations and the ICAO Technical Instructions.
E. Proposed Extension of Compliance Date
    RSPA intended to issue this notice of proposed rulemaking 
simultaneously with the final rule which was published on September 22, 
1994 (see Section II of this notice). Due to a delay in publication of 
this notice, RSPA is proposing to extend the compliance date once again 
for requirements applicable to regulated medical waste and infectious 
substances affecting only animals from October 1, 1995, to January 1, 
1996. This is intended to allow sufficient time for the public to 
comment on the proposals contained in this notice, for RSPA to evaluate 
the comments received, and, based on the merits of the comments, 
publish a final rule. RSPA invites comments on the need for this 
proposed extension.

VI. Scope of Future Work

    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 are generally 
consistent with the United Nations Recommendations on the Transport of 
Dangerous Goods (UN Recommendations), although there are some 
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, and new shipping descriptions and marking requirements 
for non-bulk packagings based on the UN Recommendations.
    The ICAO Technical Instructions prescribe no air quantity limits 
for RMW. RSPA may propose to align its air quantity limits for RMW with 
the ICAO in future rulemaking action.
    Transportation safety for all categories of infectious substances 
(i.e., cultures and stocks, diagnostic specimens, biological products 
containing infectious substances, and RMW) could be enhanced through 
imposition of uniform classification, hazard communication and 
packaging requirements. Both through rulemaking action and in working 
with other Federal agencies, RSPA anticipates advocating standards 
based on UN Recommendations, such as for the internationally-recognized 
``INFECTIOUS SUBSTANCE'' label and for performance-oriented packaging.
    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. Although RSPA is aware of allegations of 
inconsistent regulations, RSPA has not identified any regulatory 
impediment to compliance with the HMR and the regulations of other 
agencies.
    There are obvious overlaps between agency regulations, such as 
differing labeling and packaging requirements of RSPA and the CDC for 
cultures and stocks of infectious substances. CDC has expressed a 
willingness to work with RSPA in resolving these differences through 
changes to one or both agencies' regulations. There also are differing 
labeling and packaging requirements of RSPA and OSHA for medical waste 
as discussed in the proposed rule change elsewhere in this notice. 
Although compliance with two or more differing agencies' regulations 
may be burdensome, RSPA has not identified any situation where 
compliance with one agency's regulations is a barrier to compliance 
with another agency's regulations. However, RSPA agrees with 
commenters' contentions that differing requirements cause confusion and 
increase compliance costs and the likelihood of non-compliance based on 
misunderstanding. RSPA intends to work with other Federal agencies to 
eliminate overlaps, where feasible.
    Of more concern to RSPA than overlapping requirements are gaps or 
inadequacies of regulation which may impact transportation safety. RSPA 
is particularly concerned that diagnostic specimens and biological 
products known or suspected to contain infectious substances may be 
transported with inadequate or no hazard communication (e.g., shipping 
paper descriptions identifying them as hazardous, package markings and 
labels to identify the hazard class and name of the hazardous material, 
emergency response information specifying steps to be taken in the 
event of an incident in transportation) and may be transported in 
packagings which are inadequate for the conditions of transport and the 
risks posed by the materials contained therein.
    RSPA recognizes that the regulations under the Food and Drug 
Administration (FDA) of the Department of Health and Human Services (21 
CFR parts 312 and 600-680) and APHIS of the United States Department of 
Agriculture (9 CFR parts 102-104) are designed to protect the safety, 
potency, and purity of the biological product and are not specifically 
intended to protect transport workers or the public against exposure to 
biological products. RSPA also understands that CDC regulations in 42 
CFR 72.3 govern packaging and labeling for diagnostic specimens that 
are equivalent to the HMR for infectious substances. However, 
regulatory gaps may exist in CDC's regulations because the list of 
agents is outdated. For example, the list does not include HIV or Lyme 
disease.
    Because of the need for expeditious delivery, many biological 
products and diagnostic specimens are transported by aircraft. Although 
not subject to incident reporting requirements of the HMR, RSPA 
understands that packages of these materials often are damaged in 
transit aboard aircraft, causing costly delays and posing risks to 
cargo handlers, emergency responders, others who may be exposed to the 
materials and property. Although many commenters to the ANPRM on this 
issue supported regulation of these materials under the HMR, RSPA is 
not proposing to impose requirements on biological products and 
diagnostic specimens at this time. RSPA would continue to except 
biological products and diagnostic specimens from the HMR. RSPA 
anticipates proposing deletion of exceptions for these materials, if 
justified in terms of benefits versus costs, in future rulemaking 
action. Other exceptions, such as those for hazardous wastes, may be 
reconsidered at a future date if safety concerns warrant.
    RSPA would authorize, by today's proposed rule, non-bulk, non-
specification packagings for RMW under specified conditions. RSPA 
intends to monitor closely incident reports for these shipments to 
ensure that the packaging and handling requirements achieve an 
acceptable level of safety and, if not, will propose adjustments in 
future rulemaking action.
    Several other issues may be considered in future rulemaking action. 
Although no bulk packagings for RMW are specified in the HMR, their use 
is authorized under the provisions of a number of exemptions. RSPA 
anticipates proposing to convert the provisions of some or all of these 
exemptions into regulations of general applicability. RSPA currently 
requires the segregation of poisons from foodstuffs. There may be 
sufficient justification, in terms of safety, to impose similar 
restrictions on all infectious substances or RMW only. RSPA is aware 
that a number of States have differing vehicle marking requirements for 
vehicles containing RMW. Although RSPA has not required a vehicle 
marking to date, there may be a need to propose one. Finally, in the 
interest of minimizing cost impacts on the regulated industry, RSPA did 
not adopt vehicle placarding requirements for Division 6.2 materials. 
For purposes of emergency response and international harmonization, it 
may be beneficial to adopt an ``INFECTIOUS SUBSTANCE'' placard in 
future rulemaking action.

VII. Regulatory Analyses and Notices

A. Executive Order 12866 and DOT Regulatory Policies and Procedures
    This proposed 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 proposed 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 proposed rule concerns the classification, packaging, 
labeling, and handling of hazardous material, among other covered 
subjects.
    If adopted as final, this rule would preempt 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. RSPA 
requests comments on what the effective date of Federal preemption 
should be for the requirements in this proposed rule that concern 
covered subjects.
C. Regulatory Flexibility Act
    This proposed rule would revise the requirements for infectious 
substances and regulated medical waste contained in the HMR by 
narrowing the scope of these provisions. The proposed changes in this 
rule would provide relief to shippers, carriers of infectious 
substances and regulated medical waste, and some packaging 
manufacturers, some of whom are small entities (e.g., medical clinics, 
governmental jurisdictions, and not-for-profit organizations). 
Therefore, I certify that this proposal will not, if promulgated, have 
a significant economic impact on a substantial number of small 
entities. This certification is subject to modification as a result of 
a review of comments received in response to this proposal.
D. Paperwork Reduction Act
    There are no new information collection requirements in this 
proposed 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 would be amended as follows:

PART 171--GENERAL INFORMATION, REGULATIONS, AND DEFINITIONS

    1. The authority citation for part 171 would continue to read as 
follows:

    Authority: 49 U.S.C. 5101-5127; 49 CFR 1.53.

    2. In Sec. 171.8, the following definition would be added in 
appropriate alphabetical order:


Sec. 171.8  Definitions and abbreviations.

* * * * *
    Regulated medical waste. See Sec. 173.134 of this subchapter.
* * * * *


Sec. 171.15  [Amended]

    3. In Sec. 171.15, the wording ``etiologic agents'' in paragraphs 
(a)(3) and (b) introductory text would be revised to read ``infectious 
substances (etiologic agents)''.

PART 172--HAZARDOUS MATERIALS TABLE, SPECIAL PROVISIONS, HAZARDOUS 
MATERIALS COMMUNICATIONS, EMERGENCY RESPONSE INFORMATION, AND 
TRAINING REQUIREMENTS

    4. The authority citation for part 172 would continue to read as 
follows:

    Authority: 49 U.S.C. 5101-5127; 49 CFR 1.53.


Sec. 172.101  [Amended]

    5. In Sec. 172.101, in the Hazardous Materials Table, the following 
changes would be made:
    a. For the entry, ``Infectious substances, affecting animals 
only'', in Column (8A), ``196'' would be removed and replaced with 
``134''.
    b. For the entry, ``Infectious substances, affecting humans'', in 
Column (8A), ``196'' would be removed and replaced with ``134''.
    c. For the entry, ``Regulated medical waste'', in Column (4), the 
identification number ``NA9275'' would be removed and replaced with 
``UN3291''; in Column (7), ``A13, A14'' would be added; and in Column 
(8A), ``197'' would be removed and replaced with ``134''.
    6. In Sec. 172.102, in paragraph (c)(2), Special Provisions A13 and 
A14 would be 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 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

    7. The authority citation for part 173 would continue to read as 
follows:

    Authority: 49 U.S.C. 5101-5127; 49 CFR 1.53.

    8. Section 173.134 would be 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 comprise Division 6.2 are defined as 
follows:
    (1) An infectious substance means a viable microorganism, or its 
toxin, which 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 being 
shipped for purposes of diagnosis which contains an infectious 
substance including, but not limited to, excreta, secreta, blood, blood 
components, tissue, and tissue fluids.
    (3) A biological product means a material which contains an 
infectious substance and 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 Class 7 (radioactive) material or a culture or stock of an 
infectious substance, which 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 which 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, which previously contained an 
infectious substance, that has been treated by steam sterilization, 
chemical disinfection, or other appropriate methods, so that it no 
longer poses the hazard of an infectious substance;
    (v) Household waste, i.e., any waste material, including garbage, 
trash and sanitary waste in septic tanks, derived from households, 
including 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 for 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/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]

    9. Appendix G to part 173 would be removed.

PART 178--SPECIFICATIONS FOR PACKAGINGS

    10. The authority citation for part 178 would continue to read as 
follows:

    Authority: 49 U.S.C. 5101-5127; 49 CFR 1.53.

    11. In Sec. 178.609, paragraph (i) would be 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 December 14, 1994, under authority 
delegated in 49 CFR part 106, appendix A.
Alan I. Roberts,
Associate Administrator for Hazardous Materials Safety.
[FR Doc. 94-31174 Filed 12-20-94; 8:45 am]
BILLING CODE 4910-60-P