[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.
-----------------------------------------------------------------------
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