[Federal Register Volume 63, Number 170 (Wednesday, September 2, 1998)]
[Proposed Rules]
[Pages 46844-46859]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-23665]



[[Page 46843]]

_______________________________________________________________________

Part IV





Department of Transportation





_______________________________________________________________________



Research and Special Programs Administration



_______________________________________________________________________



49 CFR Part 171, et al.



Hazardous Materials: Revision to Standards for Infectious Substances 
and Genetically Modified Micro-organisms; Proposed Rule

  Federal Register / Vol. 63, No. 170 / Wednesday, September 2, 1998 / 
Proposed Rules  

[[Page 46844]]



DEPARTMENT OF TRANSPORTATION

Research and Special Programs Administration

49 CFR Parts 171, 172, 173, and 178

[Docket No. RSPA 98-3971 (HM-226)]
RIN 2137-AD13


Hazardous Materials: Revision to Standards for Infectious 
Substances and Genetically Modified Micro-organisms

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

ACTION: Advance notice of proposed rulemaking (ANPRM); notice of public 
meeting.

-----------------------------------------------------------------------

SUMMARY: RSPA is considering revising the requirements for infectious 
substances, including regulated medical waste (RMW) to: adopt defining 
criteria, hazard communication and packaging requirements for Division 
6.2 materials consistent with international standards; revise broad 
exceptions for diagnostic specimens and biological products; provide 
additional packagings for RMW; and make other changes to improve and 
clarify regulatory requirements and exceptions. These proposals are 
intended to ensure an acceptable level of safety in the transport of 
infectious substances, facilitate international transportation and make 
it easier to understand and comply with the regulations.
    In order to enhance the opportunity to provide comments to RSPA 
concerning this notice, the public is invited to provide written or E-
mail comments during the comment period and to participate in an 
electronic public meeting on the Internet on September 14, 15 and 16, 
1998.

DATES: Comment date: Comments must be submitted on or before December 
1, 1998.
    Electronic public meeting date: The electronic public meeting will 
commence on September 14, 1998, at 9:00 a.m. and end on September 16, 
1998 at 12 noon (Eastern Daylight Time).

ADDRESSES: Information on the electronic meeting, including the 
Internet address, is available under SUPPLEMENTARY INFORMATION. Written 
comments: Address written comments to the Dockets Management System, 
U.S. Department of Transportation, Room PL-401, 400 Seventh Street, SW, 
Washington, DC 20590-0001. Comments should identify the docket number 
(Docket Number RSPA-98-3971). Persons wishing to receive confirmation 
of receipt of their comments should include a self-addressed, stamped 
postcard. Comments may also be submitted by E-mail to 
``[email protected]''.
    Dockets Management System is located on the Plaza Level of the 
Nassif Building at the Department of Transportation at the above 
address. Public dockets may be reviewed there between the hours of 
10:00 a.m. and 5:00 p.m., Monday through Friday, except Federal 
holidays. In addition, the public may also review comments by accessing 
the docket management system through the DOT home page (http://
dms.dot.gov). An electronic copy of the document may be downloaded 
using a modem and suitable communications software from the Government 
Printing Office Electronic Bulletin Board Service at (202) 512-1661.

FOR FURTHER INFORMATION CONTACT: Eileen Mack, Office of Hazardous 
Materials Standards, (202) 366-8553, Research and Special Programs 
Administration, U.S. Department of Transportation, 400 Seventh Street, 
SW, Washington, DC 20590-0001.

SUPPLEMENTARY INFORMATION: Electronic public meeting: The electronic 
public meeting will be held at the conferences and public meetings 
section of RSPA's hazmat home page. The Universal Resource Locator 
(URL) address is ``http://hazmat.dot.gov/forum''. The electronic 
meeting will enable anyone with Internet access to participate in a 
near real-time electronic discussion of the rulemaking. This type of 
meeting may also increase the breadth of domestic and international 
participation in the commenting process. The message board will be 
posted on RSPA's hazmat web site and will be hot-linked to this advance 
notice of proposed rulemaking. A transcript of the electronic public 
meeting will be placed in the docket. The topics are as follows:

List of Topics

I. Background
II. Proposed Revisions
    A. World Health Organization Risk Groups/International 
Recommendations and Regulations
    B. Diagnostic Specimens
    C. Biological Products
    D. Genetically Modified Organisms and Micro-organisms
    E. Hazard Communication
    F. Regulated Medical Waste
    G. Materials of Trade Exception
    H. Discussion of Petition for Rulemaking
    I. Segregation from Foodstuffs

I. Background

    On September 20, 1995, RSPA published a final rule (60 FR 48780) to 
revise the requirements for Division 6.2 materials (infectious 
substances). The rule clarified the scope of regulation for infectious 
substances, provided relief for certain shipments of regulated medical 
waste (RMW) that conform to other Federal agency regulations, allowed 
certain quantities of RMW to be transported by aircraft, and made other 
changes to clarify the regulatory provisions applicable to infectious 
substances. The final rule was intended to address critical, yet non-
controversial, issues. RSPA stated in the final rule that other, more 
complex issues would be considered in a future rulemaking. This ANPRM 
seeks comment on RSPA's discussion of certain issues and solicits 
information to address the agency's concerns for safety in 
transportation of infectious substances and genetically modified micro-
organisms and organisms.

II. Revisions Under Consideration

A. World Health Organization (WHO) Risk Groups/International 
Recommendations and Regulations

    In this ANPRM, RSPA is considering revising the classification 
criteria for infectious substances consistent with the United Nations 
Recommendations on the Transport of Dangerous Goods (UN 
Recommendations) and the International Civil Aviation Organization's 
Technical Instructions for the Safe Transport of Dangerous Goods by Air 
(ICAO Technical Instructions). In particular, RSPA is considering 
adopting risk groups and defining criteria developed by the World 
Health Organization (WHO) for Division 6.2 materials. These risk groups 
are described in the following table:

[[Page 46845]]



                            Risk Group Table                            
------------------------------------------------------------------------
                                           Risk to         Risk to the  
Risk  Group          Pathogen            individuals        community   
------------------------------------------------------------------------
4..........  Usually causes serious   HIGH............  HIGH.           
              human or animal                                           
              disease and can be                                        
              readily transmitted                                       
              from one individual to                                    
              another, directly or                                      
              indirectly, and for                                       
              which effective                                           
              treatment and                                             
              preventative measures                                     
              are not usually                                           
              available.                                                
3..........  Usually causes serious   HIGH............  LOW.            
              human or animal                                           
              disease but does not                                      
              ordinarily spread from                                    
              one infected                                              
              individual to another                                     
              and for which                                             
              effective treatment                                       
              and preventative                                          
              measures are available.                                   
2..........  Can cause human or       MODERATE........  LOW.            
              animal disease but is                                     
              unlikely to be a                                          
              serious hazard and,                                       
              while capable of                                          
              causing serious                                           
              infection on exposure,                                    
              effective treatment                                       
              and preventive                                            
              measures are available                                    
              and only a limited                                        
              risk of spreading                                         
              infection exists.                                         
1..........  Micro-organisms that     NONE OR VERY LOW  NONE OR VERY    
              are unlikely to cause                      LOW.           
              human or animal                                           
              disease.                                                  
------------------------------------------------------------------------

    Because the hazards posed by infectious substances vary greatly 
depending on the pathogenicity of the organism, mode and relative ease 
of transmission, and other factors, RSPA believes that classifying 
these materials based on the level of risk and applying requirements 
commensurate with the risk will ensure an adequate level of safety 
without imposing an undue burden on the regulated community. RSPA does 
not intend to provide a list of infectious substances that correlates 
with each risk group. Instead, RSPA would defer to the Department of 
Health and Human Services' Centers for Disease Control and Prevention 
(CDC), Office of Public Health, for guidance in determining the risk 
group of a specific material. RSPA seeks comments on whetheradoption of 
this risk-based classification criteria will improve safety in the 
transportation of infectious substances.

B. Diagnostic Specimens

    Currently, in Sec. 173.134 of the Hazardous Materials Regulations 
(HMR; 49 CFR Parts 171-180), RSPA defers to the CDC regulations in 42 
CFR Part 72 for packaging, hazard communication, and handling in the 
transportation of diagnostic specimens. Based upon reports of 
undisclosed and improperly prepared shipments of diagnostic specimens, 
RSPA believes that many shipments of diagnostic specimens are not 
properly identified and lack adequate hazard communication. RSPA also 
is concerned that, in some instances, packagings for diagnostic 
specimens lack sufficient integrity to survive normal handling in 
transportation. RSPA's Hazardous Materials Information System (HMIS) 
database contains a number of reports on packages of these materials 
that were damaged in transportation, causing costly delays and posing 
risks to cargo handlers, flight crews, emergency responders, and others 
who may have been exposed to infectious substances.
    At the same time, RSPA recognizes that thousands of shipments of 
diagnostic specimens are transported by highway without incident to and 
from clinics, households and laboratories by private or contract 
carriers. To ensure that diagnostic specimens are regulated consistent 
with the degree of risk posed by the material, RSPA is considering 
differentiating between a diagnostic specimen known or suspected to 
contain an infectious substance and a diagnostic specimen that is 
offered for transportation and transported for routine screening where 
there is a lower probability that a risk group 2 or 3 pathogen is 
present.
    RSPA is considering requirements that would treat diagnostic 
specimens that are known or suspected to contain a Risk Group 2, 3 or 4 
pathogen as an infectious substance. For diagnostic specimens 
transported for routine screening (i.e., materials with a low 
probability of containing a Risk Group 2 or 3 pathogen), RSPA is 
considering whether to apply reduced packaging and hazard communication 
requirements. Proposed Sec. 173.196(c) specifies quantity limits for 
inner receptacles and for outer packagings, and requires that a 
packaging meet performance tests for non-bulk packagings in Subpart M 
of part 178 of the HMR except that the height for the drop test must be 
at least 1.2 meters (3.9 feet).

C. Biological Products

    Under current provisions, biological products are excepted from the 
HMR provided they meet the Food and Drug Administration (FDA) and U.S. 
Department of Agriculture (USDA) regulations for the transfer of 
biological products specified in 9 CFR parts 102, 103, and 104 and 21 
CFR parts 312 and 600-680. In this ANPRM, RSPA is considering whether 
to revise Sec. 173.134(b) to except only licensed biological products. 
A licensed biological product is defined in this ANPRM as a material 
approved by FDA for human use as a drug in the diagnosis, cure, 
mitigation, treatment, or prevention of disease and that is derived 
from biological sources, e.g., blood plasma and/or platelets and 
products obtained from these materials. In the case of biological 
products known to contain infectious substances, RSPA proposes that 
they be treated as infectious substances. RSPA is interested in 
receiving information on whether the risks associated with the 
transportation of licensed biological products warrant the granting of 
these exceptions and whether there are any risks that have been 
overlooked. RSPA is also interested in information concerning whether 
it is appropriate for RSPA to continue to defer to FDA and USDA 
regulations regarding these materials.
    In addition to the above, RSPA is considering whether to add a new 
special provision in Sec. 172.102 (consistent with ICAO Technical 
Instruction Special Provision A81) to except blood and blood products 
from existing quantity limits by aircraft when the materials are 
packaged in accordance with proposed Sec. 173.196, packaged in primary 
receptacles that do not exceed 500 ml (17 ounces), and contained in 
outer packagings not exceeding 4 L (1 gallon).

D. Genetically Modified Organisms and Micro-organisms

    The UN Recommendations and the ICAO Technical Instructions treat 
any genetically modified material that meets the definition of Division 
6.2 as an infectious substance. In addition, those international 
standards classify a genetically modified material that does not meet 
the definition of a Division 6.2 material, but is capable of altering 
animals, plants, or microbiological substances in a way not normally 
the result of natural reproduction, in hazard class 9 material. The UN 
Recommendations also contain a

[[Page 46846]]

provision that excludes from regulation genetically modified micro-
organisms that are authorized and licensed for use by the government of 
the country of origin, transit, and destination.
    RSPA is considering whether to align the HMR with the international 
provisions for genetically modified organisms and micro-organisms. RSPA 
invites commenters to address whether RSPA should proceed with 
developing regulations for genetically modified micro-organisms or 
whether provisions for the safe transport of these substances are 
adequately addressed in other agencies' regulations. Are the conditions 
specified in proposed Sec. 173.140 that provide exceptions from the HMR 
for genetically modified micro-organisms and organisms justifiable in 
terms of safety and are they easily understood, or are there 
alternative safety controls that may be more appropriate?

E. Hazard Communication

    RSPA is considering several options with respect to the marking or 
placarding of bulk packagings and transport vehicles containing 
infectious substances, including regulated medical waste (RMW), and is 
interested in receiving comments on those options. RSPA is considering 
requiring the display of an INFECTIOUS SUBSTANCE placard for any 
quantity of an infectious substance known or reasonably expected to 
contain a Risk Group 4 pathogen. RSPA seeks comment on whether a 
requirement to display placards on bulk packagings, freight containers, 
unit load devices, transport vehicles, or rail cars for shipments of 
infectious substances known or reasonably expected to contain a Risk 
Group 4 pathogen, regardless of the quantity of material, is necessary. 
RSPA is considering amending Sec. 172.504(e), Table 1, column 1, to 
include 6.2 infectious substances known or reasonably expected to 
contain a Risk Group 4 pathogen, and to add the appropriate references 
to an INFECTIOUS SUBSTANCE placard in columns 2 and 3 of the Table. 
Additionally, a new ``INFECTIOUS SUBSTANCE'' placard would be proposed, 
as shown below:

BILLING CODE 4910-60-P

[GRAPHIC] [TIFF OMITTED] TP02SE98.002


BILLING CODE 4910-60-C

    RSPA is also considering whether placards should be required to be 
displayed for bulk packagings, freight containers, unit load devices, 
transport vehicles or rail cars that contain other infectious 
substances, including RMW. If placarding is considered necessary, Table 
2 of Sec. 172.504 would be revised to

[[Page 46847]]

require display of placards for these materials. Consistent with 
exceptions in Sec. 172.504(c), transport vehicles or freight containers 
that contain less than 454 kg (1,001 pounds) aggregate gross weight of 
infectious substances would not be required to be placarded. 
Alternatively, RSPA is considering a requirement to mark bulk 
packagings, freight containers, transport vehicles or rail cars with a 
display similar to that required for units that have been fumigated. 
For example, a rectangular display with the words ``REGULATED MEDICAL 
WASTE'' could be prominently displayed so that it can be readily seen 
by any person attempting to enter the interior of the bulk packaging, 
freight container, transport vehicle, or rail car. This marking is 
being considered for domestic transportation of infectious substances, 
other than those known or reasonably expected to contain a Risk Group 4 
pathogen (see discussion above).
    RSPA requests comments on the following questions:
    1. Should placarding be required for an infectious substance known 
or reasonably expected to contain a Risk Group 4 pathogen regardless of 
the quantity of material in the bulk packaging, freight container, 
transport vehicle or rail car?
    2. For RMW, should placarding be required for a bulk packaging, 
freight container, transport vehicle or rail car which contains RMW? 
Alternatively, should an optional marking, such as ``REGULATED MEDICAL 
WASTE,'' be authorized in lieu of placards?
    3. Should other infectious substances shipments (e.g., those known 
or reasonably expected to contain a Risk Group 2 or 3 pathogen) be 
required to display an INFECTIOUS SUBSTANCE placard? Should an optional 
marking, such as the term ``BIOHAZARD'' appearing in a rectangular 
display alongside the BIOHAZARD trefoil symbol, be authorized in lieu 
of placards?
    4. Are placarding and marking proposals for infectious substances, 
as considered in this ANPRM, necessary and effective for communicating 
the infectious substance hazard to emergency responders?
    5. Will transportation safety be significantly improved if 
placarding or identification number marking is required?
    6. What costs would be incurred by shippers and carriers of 
infectious substances, including RMW, in fulfilling the proposed 
placarding requirements or the alternate marking requirements? Are 
there less costly alternatives to communicate the hazards of infectious 
substances, including RMW?
    7. If placards are required, how many drivers would need to obtain 
a commercial drivers license (CDL) or a hazardous material (HM) 
endorsement to the CDL? What would be the associated impacts, including 
costs?
    8. With respect to labels, RSPA is also considering revising the 
telephone number on its INFECTIOUS SUBSTANCE label to reflect the CDC's 
new toll free telephone number for reporting incidents involving 
infectious substances. Even though both CDC telephone numbers are 
currently in operation, should a transition period be provided to allow 
for use of existing inventories of currently required labels? If so, 
how long?

F. Regulated Medical Waste

    RSPA is considering authorizing non-specification bulk packagings 
meeting conditions set forth in proposed Sec. 173.197(b) for RMW. 
Currently, bulk packagings are only authorized under the terms of 18 
exemptions. This proposal would incorporate the provisions of some of 
these exemptions into the HMR to allow the use of non-specification 
bulk packagings for RMW under specific conditions, thereby eliminating 
the need for exemptions. These bulk packagings would require inner 
packagings that are securely closed and leak-resistant to be placed 
inside fiberglass or plastic containers, bins, or carts. With certain 
exceptions, these packagings have demonstrated through the exemption 
process that they provide an acceptable level of safety in 
transportation.
    RSPA is considering, also, whether to revise the quantity 
limitations in columns (9A) and (9B) of Sec. 172.101 for RMW to read 
``No Limit'' to reflect the language in the ICAO Technical Instructions 
for maximum net quantity permitted per non-bulk package. RSPA notes 
that the ICAO Technical Instructions in Packing Instruction 622 
restrict infectious substances, such as RMW, to non-bulk packagings 
only. Consistent with ICAO Technical Instructions, RSPA is considering 
whether to limit RMW in bulk packagings to non-air modes (railcar, 
motor vehicle, vessel) only.
    1. Should the HMR be revised to authorize caster carts as reusable 
outer packagings for RMW packaged in plastic film bags, as currently 
authorized by 12 exemptions? If so, what specifications and size 
limitations are appropriate for caster carts?
    2. Should the HMR be revised to authorize roll-off bins as reusable 
outer packagings for RMW packaged in plastic film bags, as currently 
authorized by 7 exemptions? If so, what specifications and size 
limitations are appropriate for roll-off bins?
    3. If caster carts or roll-off bins are authorized for transporting 
RMW in plastic film bags, should film bags be required to be single or 
multiple ply with a total film thickness of 3 mils, a volume not more 
than 46 gallons, and a weight not more than 22 pounds, or are there 
more appropriate specifications?
    4. If authorized for reuse to transport RMW, should roll-off bins 
and caster carts be decontaminated with a disinfectant solution after 
each use?
    5. Should hospitals or clinics that use roll-off bins to transport 
RMW be required to register as shippers of bulk hazardous materials?
    6. Should there be a time limit on the period a bin may hold RMW at 
the generator's site, to prevent the waste from decomposing and 
possibly releasing high concentrations of infectious vapors should a 
film bag be torn?
    7. Should roll-off bins be allowed only if they are mechanically 
unloaded, without the inner packaging being handled manually?

G. Materials of Trade Exception

    Under Docket HM-200, Hazardous Materials in Intrastate Commerce (62 
FR 1216, as amended at 62 FR 49566 and 62 FR 51560), RSPA adopted 
exceptions from most of the requirements of the HMR for hazardous 
materials when transported as materials of trade. Materials of trade 
include certain hazardous materials carried by a private motor carrier 
engaged in a principal business other than transportation, such as lawn 
care, plumbing, welding, door-to-door sale of consumer goods, and farm 
operations. Specific limitations (such as maximum gross weight of 
materials of trade that may be carried on a motor vehicle) and safety 
provisions (such as packaging and hazard communication) contained in 
current Sec. 173.6 achieve an acceptable level of safety at a minimal 
cost to the carrier.
    In this ANPRM, RSPA is inviting comments on whether to amend 
Sec. 173.6 to permit certain biological products, diagnostic specimens 
and RMW in Division 6.2, to be transported by private carraige as 
materials of trade. Entities, such as home health care and diagnostic 
laboratories, that transport smaller amounts of infectious substances 
in direct support of a principal business other than transportation 
would be included.
    RSPA requests comments on whether an acceptable level of safety 
would be

[[Page 46848]]

achieved, also, through a materials of trade exception for infectious 
substances. What, if any, hazard communication should be required for 
carriage of such materials? If so, what should the communication be?
    Section 173.6 specifies quantity limits for the packaging and the 
motor vehicle, and minimal hazard communication, for materials 
transported by a private motor carrier engaged in a principal business 
other than the transportation of hazardous materials. RSPA invites 
comments on the costs and benefits associated with this proposal and 
whether special recognition should be given to private carriage by 
highway, including the transportation of risk group 4 pathogens.

H. Discussion of Petition for Rulemaking

    On August 28, 1997, The Medical Waste Institute (MWI) submitted a 
petition for rulemaking (P-1350) requesting relief for the 
transportation of waste cultures and stocks that meet the definition 
for infectious substances. This petition and its enclosures have been 
entered as part of the public docket for this rulemaking and can be 
obtained by contacting the Department of Transportation Dockets 
Management System using the information provided in the address section 
at the beginning of this rule.
    Specifically, MWI requested that RSPA revise the HMR to allow 
contract and private motor carriers to transport discarded cultures and 
stocks of infectious substances in non-specification packagings if the 
carriers use dedicated vehicles. The petitioners requested that this 
relief be authorized for Biosafety Level 1, 2, and 3 materials, as 
defined in Health and Human Services publication No. 93-8395. These 
biosafety levels are based on the same WHO risk groups as referenced in 
Sec. 173.134(a) of the accompanying regulatory text. Currently, the HMR 
allows this type of transportation for RMW that does not contain a 
waste culture or stock of an infectious substance. The HMR require a 
waste culture or stock to be transported in a packaging meeting the 
performance criteria in Sec. 178.609. Section 178.609 specifies 
requirements for a triple packaging that survives several rigorous 
performance tests, including a 9 m (30-foot) drop test and a 1 m (3-
foot) puncture test. By comparison, Sec. 173.197 currently requires 
that the packaging for RMW that does not contain a waste culture or 
stock of an infectious substance meet performance criteria of a UN 
specification packaging at the Packing Group II performance level 
contained in 49 CFR Part 178, Subpart M, except Sec. 178.609. In 
addition, when packaging authorized in Sec. 173.134 is used, RSPA 
currently requires that the material be transported in a dedicated 
vehicle by a private or contract carrier and conform to Biosafety 
Levels 1, 2, or 3.
    MWI included with its petition for rulemaking DOT and State 
incident data on infectious substances from 1989 through March 1997. 
The petitioner stated that the information shows a relatively low 
number of hazardous materials incidents in the U.S. involving a release 
of RMW transported by highway. MWI further said that:
     The CDC reports hospital waste disposal practices have not 
resulted in epidemiologic evidence of disease in communities;
     Emergency responders take the same precautions with 
infectious substance releases as they do with RMW releases;
     Packing group II packagings are not justified for 
discarded cultures and stocks;
     Discarded cultures and stocks from non-health care 
settings pose the same level of risk as those from health care 
settings; and
     The HMR's general packaging requirements coupled with 
OSHA's bloodborne packaging standards have a proven safety record.
    From these points, the MWI concluded that the current packagings 
required in the HMR for discarded cultures and stocks are not justified 
because they are onerous and expensive and lack a safety record that 
proves their actual public health and safety benefit. The MWI also 
enclosed an EPA press release announcing its medical waste incinerator 
program, and language that MWI suggests justifies discarded cultures 
and stocks to be defined as RMW when transported by private or contract 
motor carriers.
    As a result of a provision in Sec. 171.15(b) and the wording of the 
INFECTIOUS SUBSTANCE label in Sec. 172.432, many releases of infectious 
substances are reported directly to CDC but not to RSPA. Section 
171.15(b) allows carriers that report infectious substance (etiologic 
agent) incidents the option of reporting the event to the CDC or DOT. 
Although Sec. 171.15(c) requires incident information reported to CDC 
to be reported to RSPA in the form of a written report, often this 
information is not provided to RSPA. This has resulted in an under-
reporting of these events in RSPA's HMIS incident database. Further, 
pre-1996 HMR exceptions for packagings containing 50 ml (1.7 ounces) or 
less of an infectious substance (known then as an etiologic agent) were 
often misapplied and used to ship larger amounts of an infectious 
substance.
    The Sec. 171.15(b) exception, when properly applied, relieved 
carriers from immediate telephonic notification requirements of the 
HMR. It was intended to avoid duplication with CDC regulations because 
these materials were subject to CDC requirements in 42 CFR Part 72. 
Because a number of incidents involving infectious substances were not 
reported to DOT, RSPA is considering revising Sec. 171.15 to clarify 
that any incident involving the release of an infectious substance be 
reported to RSPA, in addition to the CDC, in the form of an incident 
report.
    Over the last few years, individuals and companies commenting on 
infectious substance rulemakings, or on their own initiative, reported 
to RSPA information concerning infectious substance releases. They have 
reported witnessing blood pouring from rolloffs and freight containers 
transporting RMW, the disposal of AIDS-contaminated blood in municipal 
waste cans, overturned vehicles that have released diagnostic specimens 
on the highways, leaking non-bulk packagings of RMW, ruptured packages 
containing diagnostic specimens being transported by aircraft, releases 
of treatment-resistant diseases from insufficient packaging, and used 
sharps that punctured inner packagings. As a result of information 
received from these sources, and through RSPA's own initiative and 
incident reporting system, RSPA is now considering whether to take a 
more conservative approach, on the side of safety, to the 
transportation of waste cultures and stocks.
    Several commenters, responding to earlier NPRMs issued on this 
subject under Docket HM-181G, stated that a high concentration of 
micro-organisms exist in cultures and stocks of infectious substances. 
These micro-organisms have the potential to cause disease and, 
therefore, require special handling. CDC supported special handling of 
these materials in a October 24, 1996 final rule (61 FR 55190) and in 
response to RSPA's rulemaking actions on infectious substances issued 
under Docket HM-181G. In meetings and conversations with RSPA, CDC 
recommended more rigorous packagings for cultures and stocks of 
infectious substances. Therefore, RSPA did not base its current 
regulations for these materials solely on incident reports. In 
addition, RSPA recommends, through guidance provided in the 1996 North 
American Emergency Response Guidebook, that emergency responders treat 
infectious substances and RMW

[[Page 46849]]

the same since both are Division 6.2 materials.
    RSPA finds, through experience gained under exemption DOT-E 11588, 
that Packing Group II packagings transported by a private or contract 
carrier in a dedicated vehicle provide an acceptable level of 
protection for waste cultures and stocks of infectious substances. 
Private and contract carriers that transport these materials have an 
increased level of knowledge from working with these materials. 
Moreover, use of dedicated vehicles limits exposure of these packagings 
to other packagings and assures that shipments are handled by 
experienced personnel. RSPA also finds that the general packaging 
requirements in Secs. 173.24 and 173.24a coupled with OSHA's packaging 
requirements for bloodborne pathogens contained in 29 CFR 1910.1030 are 
adequate for less virulent infectious substances. RSPA seeks specific 
comments on the MWI petition for rulemaking.

I. Segregation from Foodstuffs

    RSPA currently requires segregation of poisons from foodstuffs. Is 
there sufficient justification to support imposing similar restrictions 
on all or certain packages containing infectious substances?

III. Section-by-Section Review

    This discussion is included to provide the reader with additional 
information to more fully explain potential approaches. RSPA seeks 
comments on these potential approaches and may publish an NPRM to 
further refine these approaches or to propose alternatives to these 
approaches based on comments we receive.

Section 171.14

    Paragraph (f) would be added to establish a two-year transition 
period for the use of infectious substance labels that do not include 
the CDC's new toll-free telephone number for reporting infectious 
substance incidents.

Section 171.15

    In paragraphs (a) (3) and (b), the term ``etiologic agents'' would 
be revised to read ``infectious substances.'' In paragraph (b), 
information would be added to clarify that a written report, DOT Form F 
5800.1, is required for all infectious substance incidents, including 
those reported to the CDC.

Section 172.101

    For the entry, ``Regulated medical waste'', the letter ``D'' in 
column (1) would be removed, in column (7) the reference to Special 
Provision A14 would be removed, and columns (9A) and (9B) would be 
amended to indicate ``No limit'' as opposed to ``Forbidden'' for 
quantity limitations. These changes would harmonize requirements in the 
HMR with those in the ICAO Technical Instructions and facilitate the 
transport of RMW in non-bulk packagings by aircraft. It should be noted 
that, although ``No limit'' would be specified for per-package quantity 
limits in the Hazardous Materials Table (the Table), Special Provision 
A13 would be revised to prohibit the use of bulk packagings aboard 
aircraft. Further, quantity limits may apply with regard to the types 
of packagings authorized for RMW in Part 173 and to air transportation 
under Sec. 175.75. RSPA requests comments concerning the need, if any, 
for further limitations or relaxations on the quantities of RMW 
authorized for transportation by aircraft.
    For the entries ``Infectious substances, affecting animals only'' 
and ``Infectious substances, affecting humans'' new special provisions 
would be added in Column (7). One, A81, would provide relief from 
quantity limits for the transport of blood or blood products known to 
contain or suspected of containing infectious substances when in 
primary receptacles not exceeding 500 ml (17 ounces) and in outer 
packagings not exceeding 4 L (1 gallon) and packaged in accordance with 
Sec. 173.196. The second, A82, would provide relief from UN standard 
packaging for transporting body parts, whole organs, and whole bodies.
    A new entry, ``Genetically modified micro-organisms'' would be 
added to the Table as a Class 9 (miscellaneous) material consistent 
with the entry in the UN Recommendations, the ICAO Technical 
Instructions and the IMDG Code.
    Another new entry, ``Diagnostic Specimen'', would be added to the 
Table as a Division 6.2 material. However, this proper shipping name 
would be authorized only for diagnostic specimens excepted under 
proposed Sec. 173.196(c). There would be no identification number, 
hazard warning label, or packing group assignment.
    In order to eliminate any confusion and costs that could result 
from the use of several proper shipping names for the same material, 
the other proper shipping names for infectious waste that are 
authorized in the UN Recommendation and the ICAO Technical 
Instructions, ``Biomedical waste, n.o.s.'', ``Clinical waste, 
unspecified, n.o.s.'', and ``Medical waste, n.o.s.'', would not be 
added to Sec. 172.101. RSPA believes the proper shipping name 
``Regulated medical waste'' more accurately describes the material and 
is the preferable shipping name. Also, it is RSPA's understanding that 
the other names were added to satisfy requests from specific countries 
that were already using these shipping names. International shipments 
using these names would be authorized for transport to their final 
destinations under the import-export provisions in Secs. 171.11, 
171.12, and 171.12a.

Section 172.102

    Special Provision A13 would be revised to prohibit the use of bulk 
packagings for RMW aboard aircraft, thus imposing a maximum gross mass 
of 400 kg or 450 L per package. Special Provision A14 would be removed.
    Two new Special Provisions, A81 and A82, that are consistent with 
A81 in the ICAO Technical Instructions, would be added, as discussed 
earlier in this section-by-section review under Sec. 172.101.

Section 172.432

    The current telephone number, ``404-633-5313'', printed on the 
INFECTIOUS SUBSTANCE label for reporting infectious substance incidents 
would be changed at the request of CDC to reflect its new toll free 
phone number for this purpose, to ``800-232-0124''. A two-year 
transition period would be provided in Sec. 171.14 to allow shippers to 
exhaust their label inventories.

Section 173.6

    Paragraph (a)(4) would be redesignated as paragraph (a)(5) and a 
new paragraph (a)(4) would be added to permit certain biological 
products, diagnostic specimens and RMW in Division 6.2 to be 
transported by entities, such as home health care providers and 
diagnostic laboratories, that transport smaller amounts of infectious 
substances in direct support of a principal business other than the 
transportation of hazardous materials.

Section 173.134

    The criteria for Division 6.2 materials specified in Sec. 173.134 
would be revised based on the UN Recommendations and the 1999-2000 
edition of the ICAO Technical Instructions. This section would also be 
revised to incorporate certain domestic exceptions for transportation 
by highway. The current definition for infectious substances would be 
revised to remove the term ``viable microorganism'' and clarify the 
term ``pathogens.'' The defining criteria would exclude toxins, include 
the WHO risk groups, and except from Division 6.2 infectious substances 
that are unlikely to cause disease, i.e., risk group

[[Page 46850]]

1 pathogens. The definitions for the terms ``diagnostic specimen'' and 
``biological product'' would be amended to include the WHO risk groups 
and be compatible with the ICAO Technical Instructions. Paragraph (b) 
would be amended to except licensed biological products from regulation 
under the HMR and, under certain conditions, except diagnostic 
specimens and biological products where a low probability exists that 
they contain a WHO risk group 2 or 3 pathogen.
    RSPA is considering requiring that animals which contain or are 
contaminated with genetically modified micro-organisms or organisms 
(Sec. 173.140(d)(4)) that meet the criteria of an infectious substance 
(Sec. 173.134(c)(5)) be transported under terms and conditions approved 
by RSPA's Associate Administrator for Hazardous Materials Safety, 
consistent with standards specified in the UN Recommendations and ICAO 
Technical Instructions.

Section 173.140

    New paragraphs (c) and (d) would be added to provide defining 
criteria and exceptions for a genetically modified micro-organism that 
does not meet the definition of a Division 6.2 material but has the 
potential to alter animals, plants, or the environment. These materials 
would be assigned to the Class 9 hazard class. A genetically modified 
micro-organism that meets the criteria for a Division 6.2 material 
would be classed and described as an infectious substance. A 
genetically modified micro-organism would be required to be packaged in 
accordance with Sec. 173.196, except that the packagings need not be 
marked in accordance with Sec. 178.503 or tested in accordance with 
Sec. 178.609. In addition, the quantity in the primary receptacles 
would be limited to a maximum of 100 ml (3.4 ounces) or 100 g (4 
ounces) for consistency with the ICAO Technical Instructions. A Class 9 
genetically modified micro-organism and organism packages would not be 
assigned a packing group and would be excepted from all requirements in 
the HMR if authorized for final distribution and use by a U.S. 
Government agency.

Section 173.196

    Existing paragraph (a) would be revised and redesignated as 
paragraph (b). New paragraph (a) would clarify that Sec. 173.196 
prescribes non-bulk packagings for infectious substances. Existing 
paragraphs (b), (c), (d), and (e) would be incorporated in new 
paragraph (b). New paragraph (b) would include an exception from 
requirements for an absorbent material for solid infectious substances, 
and other revisions to provide consistency with the ICAO Technical 
Instructions. These revisions would include package and overpack 
marking requirements and requirements to ensure the containment 
integrity of the packagings during air transport, including 
circumstances where the refrigerant is dissipated or lost. The existing 
text in paragraph (h) of this section excepting biological products and 
diagnostic specimens from regulation under the HMR would be deleted. 
New exceptions for diagnostic specimens and biological products would 
be relocated to Sec. 173.134. A new paragraph (c) would be added to 
remove from regulation diagnostic specimens with a low probability of 
containing a risk group 2 or 3 pathogen when a limited amount of the 
material is placed in a non-specification packaging. A new paragraph 
(d) would be added to prescribe non-specification packaging provisions 
for body parts and certain diagnostic infectious substances. Former 
paragraph (g) would be renamed paragraph (e).

Section 173.197

    RSPA is considering revising the RMW packaging requirements to 
allow five types of packagings: (1) infectious substances packaging in 
accordance with Sec. 173.196; (2) RMW packaging in accordance with 
current Sec. 173.197; (3) packagings that conform to 29 CFR 1910.1030; 
(4) non-specification bulk packagings currently authorized under 
exemptions; and (5) intermediate bulk containers (IBCs).
    In addition, the provisions for RMW packaging meeting the criteria 
in Sec. 173.197 would be revised to permit liquid materials to be 
placed in a packaging suitable for solids when the liquid can be fully 
absorbed by the absorbent material in the packaging, the packaging is 
capable of retaining liquids, and the packaging conforms to the OSHA 
bloodborne pathogen packaging standards in 29 CFR 1910.1030.
    Existing paragraph (b) would be removed because the anniversary 
date for this provision is no longer applicable.
    Several commenters to earlier rulemakings on RMW were unaware that 
the HMR allow the use of non-bulk, single packagings for RMW. This 
proposal would clarify that the packaging requirements in Sec. 173.197 
allow the shipper to use single or combination UN specification 
packagings if the performance standards are met.

Section 178.503

    In Sec. 178.503, a new paragraph (f) would be added to incorporate 
package markings consistent with those in the ICAO Technical 
Instructions and UN Recommendations for infectious substances.

Section 178.601

    A sentence would be added to paragraph (c)(1) of this section to 
include the tests for infectious substance packaging in the definition 
for design qualification testing. As a result of this change, 
manufacturers of infectious substance packagings would be required to 
retain design qualification records, as required in Sec. 178.601(l).

Section 178.609

    Several amendments may be incorporated in this section to harmonize 
it with the UN Recommendations and the ICAO Technical Instructions. The 
section heading may be revised to remove the wording ``(etiologic 
agents)''. Paragraph (c) would be revised to permit the use of expanded 
plastics for inner packagings and require the packaging tests to be 
determined by the most fragile inner packaging. Paragraphs (d)(1)(i), 
(d)(1)(iii), (d)(1)(iv) would be revised for editorial purposes. 
Paragraph (e) would be revised to replace the current water immersion 
test with a water spray test that simulates exposure to rainfall 
consistent with the ICAO Technical Instructions. The last sentences in 
paragraphs (h)(1) and (h)(2) would be revised to clarify the 
requirements for conducting the penetration test. Specifically, the 
text would be revised to clearly indicate that penetration of the 
primary receptacle is not acceptable. Paragraph (i) would be revised to 
clarify that infectious substances are required to be marked in 
accordance with Sec. 178.503 and redesignated as a new paragraph (l). 
New paragraphs (i), (j) and (k) would be added to incorporate the 
selective testing provisions in the UN Recommendations and ICAO 
Technical Instructions. These provisions allow variations in the 
primary receptacles within the secondary packaging without further 
testing of the completed packaging if an equivalent level of 
performance is maintained.

IV. Regulatory Analyses and Notices

A. Executive Order 12866 and DOT Regulatory Policies and Procedures

    This ANPRM is not a significant regulatory action under section 
3(f) of Executive Order 12866, and was not

[[Page 46851]]

reviewed by the Office of Management and Budget. It is not a 
significant regulatory action under the regulatory policies and 
procedures of the Department of Transportation (44 FR 11034, March 1, 
1979).
    Any future NPRM on infectious substances may contain proposals that 
have substantial effects on hospitals (SIC 8062), nursing and personal 
care facilities (SIC 8059), medical and dental laboratories (SIC 807), 
home health care services (SIC 8082), offices and clinics of doctors of 
medicine (SIC 8011) and dentists (SIC 8021), and research, development 
and testing services (SIC 8731). The primary economic impact of a 
proposed rule along the lines of this ANPRM would be on persons who 
offer for transportation or transport diagnostic specimens and 
biological products, subclassifications of infectious substances that 
are currently excepted from all requirements of the HMR. At this time, 
RSPA has neither sufficient data in the form of reported incidents 
concerning fire, breakage, spillage, or suspected contamination 
involving shipments of diagnostic specimens and biological products 
with which it may assess actual risks in transportation. Also, RSPA 
does not have a thorough understanding of current distribution systems 
by which it may estimate costs that would result from a decision to 
apply requirements of the HMR to various modes of transportation and 
types of carriage (i.e., common, contract and private). A primary 
purpose of this ANPRM is for RSPA to gather additional information that 
will assist the agency in measuring the anticipated benefits to 
society, through increased safety in the transportation of these 
hazardous materials, against anticipated costs to society resulting 
from new rules and regulations. RSPA requests comments on costs and 
benefits that may result from any future rulemaking.

B. Executive Order 12612

    This notice has been analyzed in accordance with the principles and 
criteria contained in Executive Order 12612 (``Federalism''). Federal 
hazardous materials transportation law, 49 U.S.C. 5701-5127, contains 
an express preemption provision (49 U.S.C. 5125(b)) that preempts 
State, local, and Indian tribe requirements on certain covered 
subjects. Covered subjects are:
    (i) the designation, description, and classification of hazardous 
material;
    (ii) the packing, repacking, handling, labeling, marking, and 
placarding of hazardous material;
    (iii) the preparation, execution, and use of shipping documents 
related to hazardous material and requirements related to the number, 
contents, and placement of those documents;
    (iv) the written notification, recording, and reporting of the 
unintentional release in transportation of hazardous material; or
    (v) the design, manufacturing, fabricating, marking, maintenance, 
reconditioning, repairing, or testing of a packaging or container 
represented, marked, certified, or sold as qualified for use in 
transporting hazardous material.
    This advance notice of proposed rulemaking addresses covered 
subjects under items i-v above and, if adopted, would preempt State, 
local, or Indian tribe requirements not meeting the ``substantively the 
same'' standard. Federal hazardous materials transportation law 
provides at Sec. 5125(b)(2) that if RSPA issues a regulation concerning 
any of the covered subjects RSPA must determine and publish in the 
Federal Register the effective date of Federal preemption. The 
effective date may not be earlier than the 90th day following the date 
of issuance of the final rule and not later than two years after the 
date of issuance. Thus, RSPA lacks discretion in this area, and 
preparation of a federalism assessment is not warranted.

C. Executive Order 13084

    This notice has not yet been analyzed in accordance with the 
principles and criteria contained in Executive Order 13084 
(``Consultation and Coordination with Indian Tribal Governments''). 
Because revised rules and regulations evolving from this ANPRM are not 
expected to significantly or uniquely affect the communities of Indian 
tribal governments, the funding and consultation requirements of this 
Executive Order would not apply. Nevertheless, this ANPRM specifically 
requests comments from affected persons, including Indian tribal 
governments, as to its potential impact.

D. Regulatory Flexibility Act

    Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), RSPA 
must consider whether a potential notice of proposed rulemaking would 
have a significant economic impact on a substantial number of small 
entities. Unless alternative definitions have been established by the 
agency in consultation with the Small Business Administration, the 
definition of ``small business'' has the same meaning as under the 
Small Business Act. Because RSPA has established no special definition, 
the agency employs thresholds published under criteria in 13 CFR 
121.101, e.g., $5 million for facilities falling within major group 80 
(health services) and 500 employees for commercial physical and 
biological research (SIC 8731).
    Because it has not yet proposed any new requirements, RSPA cannot 
yet determine potential effects upon small entities. Accordingly, an 
Initial Regulatory Flexibility Assessment discussing the impact of this 
potential rulemaking on small entities has not been prepared. However, 
RSPA has determined that an NPRM that closely follows considerations in 
this ANPRM may have potential impacts on small businesses, and State 
and local governments. The agency expects that comments received on 
this ANPRM will assist it in determining the number of potentially 
affected small entities and in weighing the impact of various 
regulatory alternatives for the purpose of drafting revised rules and 
regulations.

E. Paperwork Reduction Act

    Under the Paperwork Reduction Act of 1995, no person is required to 
respond to a collection of information unless it displays a valid OMB 
control number. This ANPRM does not propose any new information 
collection burdens.

F. 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 contained in the heading of 
this document can be used to cross-reference this action with the 
Unified Agenda.

G. Unfunded Mandates Reform Act

    This ANPRM imposes no mandates and thus does not impose unfunded 
mandates under the Unfunded Mandates Reform Act of 1995.

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, Labels, 
Markings, Packaging and containers, Reporting and record keeping 
requirements.

49 CFR Part 173

    Hazardous materials transportation, Packaging and containers.

[[Page 46852]]

49 CFR Part 178

    Hazardous materials transportation, Packaging and containers.

    In consideration of the foregoing, 49 CFR parts 171, 172, 173, and 
178 may be proposed to be amended as follows:

PART 171--GENERAL INFORMATION, REGULATIONS, AND DEFINITIONS

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

    Authority: 49 U.S.C. 5101-5127; 49 CFR part 1.

    1a. Section 171.14 would be amended by adding paragraph (f) to read 
as follows:


Sec. 171.14  Transitional provisions for implementing requirements 
based on the UN Recommendations.

* * * * *
    (f) Until [TWO YEARS FROM THE EFFECTIVE DATE OF FINAL RULE], labels 
which conform to specifications in subpart E of part 172 contained in 
the 49 CFR, parts 100 to 185, edition revised as of October 1, 1998, 
for a Division 6.2 material may be used in place of the Division 6.2 
labels currently specified in subpart E of Part 172 of this subchapter.


Sec. 171.15  [Amended]

    2. In Sec. 171.15, the following changes would be made:
    a. Paragraph (a)(3) would be amended by removing the term 
``(etiologic agents)''.
    b. Paragraph (b) would be amended by removing the term ``etiologic 
agents'' and in its place adding the term ``infectious substances''.
    c. Paragraph (b) would be amended by adding the wording ``; 
however, a written report is still required as stated in paragraph (c) 
of this section'' immediately after the number ``202-267-2675''.

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

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

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

    3. In Sec. 172,101, the following proper shipping names would be 
added to or revised in the Hazardous Materials Table: following proper 
shipping names would be added to or revised in the Hazardous Materials 
Table:


Sec. 172.101  Hazardous Materials Table

* * * * *

[[Page 46853]]



                                                                                                                                                                                                
                                                                                                                                                                                                
                  Hazardous                                                                            (8)  Packaging  (Sec.  173.***)     (9) Quantity limitations       (10) Vessel stowage   
                  materials        Hazard                                                          ---------------------------------------------------------------------------------------------
   Symbols       descriptions     class or   Identification      PG      Label codes     Special                                            Passenger       Cargo                               
                  and proper      Division       Numbers                               provisions   Exceptions    Nonbulk       Bulk        aircraft/     aircraft      Location        Other   
                shipping names                                                                                                                rail          only                                
(1)            (2)............        (3)    (4)...........         (5)        (6)    (7).........        (8A)        (8B)  (8C)........  (9A)........  (9B)........  (10A).......  (10B)       
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
               [ADD]                                                                                                                                                                            
               Diagnostic               6.2  ..............  ..........  ...........  A82.........         134         196  None........  4L or 4kg...  4L or 4kg...                            
                specimen.                                                                                                                                                                       
                                                                                                                                                                                                
                                                                                        * * * * * * * * *                                                                                       
               Genetically              9    UN3245........  ..........          9    ............         140         140  None........  No Limit....  No Limit....  B...........              
                modified micro-                                                                                                                                                                 
                organisms.                                                                                                                                                                      
                                                                                                                                                                                                
                                                                                        * * * * * * * * *                                                                                       
               [REVISE]                                                                                                                                                                         
               Infectious               6.2  UN2900........  ..........          6.2  A81, A82....         134         196  None........  50 ml or 50   4L or 4kg...  B...........              
                substances,                                                                                                                g.                                                   
                affecting                                                                                                                                                                       
                animals, only.                                                                                                                                                                  
               Infectious               6.2  UN2814........  ..........          6.2  A81, A82....         134         196  None........  50 ml or 50   4L or 4kg...  B...........              
                substances,                                                                                                                g.                                                   
                affecting                                                                                                                                                                       
                humans.                                                                                                                                                                         
                                                                                                                                                                                                
                                                                                        * * * * * * * * *                                                                                       
               Regulated                6.2  UN3291........  ..........          6.2  A13.........         134         197  197.........  No Limit....  No Limit....  E...........              
                medical waste.                                                                                                                                                                  
                                                                                                                                                                                                
                                                                                        * * * * * * * * *                                                                                       
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 46854]]

* * * * *
    4. In Sec. 172.102, in paragraph (c)(2), Special provision A14 
would be removed, Special Provision A13 would be revised, and Special 
Provisions A81 and A82 would be added in alphanumeric order to read as 
follows:


Sec. 172.102  Special provisions.

* * * * *
    (c) * * *
    (2) * * *
A13  Bulk packagings are not authorized for transportation by 
aircraft.
* * * * *
A81  The quantity limits in column (9A) do not apply to blood or 
blood products known to contain or suspected of containing 
infectious substances when transported in primary receptacles not 
exceeding 500 ml (17 ounces) and in outer packagings not exceeding 4 
L (1 gallon) and packaged in accordance with Sec. 173.196.
A82  The quantity limits in columns (9A) and (9B) do not apply to 
body parts, whole organs or whole bodies known to contain or 
suspected of containing infectious substances; these materials must 
be packaged in accordance with Sec. 173.134 of this subchapter or, 
alternatively, in a strong outer packaging in accordance with 
173.196(c)(3) with leakproof inner receptacles or liners so as not 
to present a hazard to persons or animals during transport.
* * * * *
    5. Section 172.432, the illustration in paragraph (a) and paragraph 
(b) would be revised to read as follows:


Sec. 172.432  INFECTIOUS SUBSTANCE label.

    (a) * * *

BILLING CODE 4910-60-P
[GRAPHIC] [TIFF OMITTED] TP02SE98.003


BILLING CODE 4910-60-c

[[Page 46855]]

    (b) In addition to complying with Sec. 172.407, the background on 
the INFECTIOUS SUBSTANCE label must be white.

PART 173--SHIPPERS--GENERAL REQUIREMENTS FOR SHIPMENTS AND 
PACKAGINGS

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

    Authority: 49 U.S.C. 51015127, 44701; 49 CFR 1.45, 1.53.

    6. In Sec. 173.6, paragraph (a)(1) introductory text would be 
amended by adding the term ``6.2'' immediately following the term 
``6.1'', paragraph (a)(4) would be redesignated as paragraph (a)(5) and 
a new paragraph (a)(4) would be added to read as follows:


Sec. 173.6  Materials of trade exceptions.

* * * * *
    (a) * * *
    (4) A Division 6.2 material, other than a risk group 4 or a culture 
or stock, that is a diagnostic specimen, biological product or 
regulated medical waste contained in a combination packaging consisting 
of inner packagings having a gross mass or capacity not over 0.5 kg (1 
pound), or 0.5 L (1 pint), and an outer packaging having a gross mass 
or capacity not exceeding 4 kg (8.8 pounds) or 4 L (1 gallon).
* * * * *
    7. Section 173.134 would be revised to read as follows:


Sec. 173.134  Class 6, Division 6.2--Definitions and exceptions.

    (a) Definitions. For the purposes of this subchapter, the following 
terms pertain to Division 6.2 (infectious substances) materials:
    (1) Division 6.2 material means a material containing an infectious 
substance subject to the requirements of this subchapter, including, 
but not limited to, a biological product, a diagnostic specimen, 
cultures and stocks of an infectious substance, and regulated medical 
waste.
    (2) Infectious substance means a material known to contain, or 
reasonably expected to contain, pathogens. Pathogens are micro-
organisms (including bacteria, viruses, rickettsia, parasites, and 
fungi) or recombinant micro-organisms (hybrid or mutant) that are known 
or reasonably expected to cause infectious disease in humans or 
animals. An infectious substance is assigned to a risk group based on 
its level of risk and is subject to the provisions of this subchapter 
as a Division 6.2 material if it has the potential to spread disease 
when exposure to it occurs.
    (3) Biological product means a material derived from a living 
organism that is manufactured and distributed 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). A biological 
product is used for prevention, treatment, or diagnosis of disease in 
humans or animals, or for developmental, experimental, or 
investigational purposes related to these uses. This term includes, but 
is not limited to, a finished or unfinished product such as a vaccine; 
however, it does not include a diagnostic specimen.
    (4) Cultures and stocks means material that contains a risk group 
2, 3 or 4 pathogen for purpose of growth or storage.
    (5) Diagnostic specimen means any human or animal material 
including, but not limited to, excreta, secreta, blood, blood and its 
components, tissue, and tissue fluids, being transported for diagnostic 
or investigational purposes, but excluding live humans or animals. 
Exceptions are provided in paragraph (c)(4) of this section for Risk 
Group 2, 3, and 4 materials transported by private or contract motor 
carrier.
    (6) Regulated medical waste means a waste or reusable material that 
contains or is suspected of containing an infectious substance in other 
than risk group 4 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.
    (7) Risk group means a ranking based on level of risk using 
criteria developed by the World Health Organization (WHO). A risk group 
is characterized by the pathogenicity of the organism, the mode and 
relative ease of transmission, the degree of risk to both an individual 
and a community, and the reversibility of the disease through the 
availability of known and effective preventative agents and treatment. 
The criteria for each risk group according to the level of risk are as 
follows:
    (i) Risk group 4 means a pathogen that usually causes serious human 
or animal disease and that can be readily transmitted from one 
individual to another, directly or indirectly, and for which effective 
treatment and preventative measures are not usually available (i.e., 
high individual and community risk).
    (ii) Risk group 3 means a pathogen that usually causes serious 
human or animal disease but does not ordinarily spread from one 
infected individual to another, and for which effective treatment and 
preventative measures are available (i.e., high individual risk and low 
community risk).
    (iii) Risk group 2 means a pathogen that can cause human or animal 
disease but is unlikely to be a serious hazard, and, while capable of 
causing serious infection on exposure, for which there are effective 
treatment and preventive measures available and the risk of spread of 
infection is limited (i.e., moderate individual risk and low community 
risk).
    (iv) Risk group 1 means a micro-organism that is unlikely to cause 
human or animal disease (i.e., no, or very low, individual or community 
risk). A material containing only such micro-organisms is not subject 
to the requirements of this subchapter.
    (8) Sharps means any object that can penetrate the skin, including, 
but not limited to, needles, scalpels, broken glass, broken capillary 
tubes, and exposed ends of dental wires that may be contaminated with a 
pathogen.
    (b) Exceptions for biological products. (1) A biological product 
which is known or reasonably expected to contain a pathogen in risk 
groups 2, 3, or 4 must be classified in Division 6.2 under UN 2814 or 
UN 2900, as appropriate, unless otherwise excepted.
    (2) A biological product that has successfully completed all 
screening and confirmatory tests required by the Food and Drug 
Administration of the Department of Health and Human Services or the 
Department of Agriculture, as appropriate, to identify pathogens is not 
considered an infectious substance and is not subject to the 
requirements of this subchapter.
    (c) Exceptions for diagnostic specimens. (1) A diagnostic specimen 
that is known or reasonably expected to contain a pathogen in risk 
group 2 or 3 (medium to high probability) or for which there is any 
probability that it contains a pathogen of risk group 4 must be 
classified in Division 6.2 under UN 2814 or UN 2900, as appropriate, 
unless otherwise excepted. A specimen transported for the purpose of 
initial or confirmatory testing for the presence of a pathogen falls 
within this group.
    (2) A diagnostic specimen for which a relatively low probability 
exists that a pathogen of risk groups 2 or 3 is present may be 
transported under the exceptions provided in Sec. 173.196(c).

[[Page 46856]]

    (3) A diagnostic specimen that is known or reasonably expected to 
contain a pathogen in risk group 1 only or is known not to contain a 
pathogen is not considered an infectious substance and is not subject 
to the requirements of this subchapter.
    (4) A diagnostic specimen which meets the provisions of paragraph 
(c)(1) or (c)(2) of this section is excepted from all other 
requirements of this subchapter when transported by a private or 
contract motor carrier not engaged in the transportation of passengers 
and the material is packaged and marked with the proper shipping name 
``Diagnostic Specimen'' in accordance with the provisions for 
diagnostic specimens in Sec. 173.196(c) of this subchapter.
    (5) Animals which contain or are contaminated with an infectious 
substance must be transported under the terms and conditions approved 
by the Associate Administrator for Hazardous Materials Safety.
    (d) Other exceptions. (1) The following are not subject to the 
requirements of this subchapter as a Division 6.2 material:
    (i) A living person;
    (ii) Laundry or medical equipment that conforms to the regulations 
of the Occupational Safety and Health Administration of the Department 
of Labor in 29 CFR 1910.1030;
    (iii) A material, including waste, that previously contained an 
infectious substance that has been treated by steam sterilization, 
chemical disinfection, or other appropriate method, so that it no 
longer meets the definition of an infectious substance;
    (iv) Any waste or recyclable material, other than regulated medical 
waste, including--
    (A) Garbage and trash derived from hotels, motels, and households, 
including but not limited to single and multiple residences;
    (B) Sanitary waste or sewage;
    (C) Sewage sludge or compost; and
    (D) Animal waste generated in animal husbandry or food production;
    (E) Medical waste generated from households; or
    (F) Corpses, remains, and anatomical parts that are intended for 
interment or cremation;
    (v) Forensic material that is transported on behalf of, a Federal, 
State, local or Indian tribal government agency provided they are 
shipped in a packaging conforming to the provisions of Sec. 173.24 of 
this subchapter. A package being shipped and transported under this 
provision must be marked ``Diagnostic Specimen''.
    (2) [Reserved]
    9. In Sec. 173.140, paragraphs (c) and (d) would be added to read 
as follows:


Sec. 173.140  Class 9--Definitions.

* * * * *
    (c) Any material that is a genetically modified micro-organism or 
organism.
    (1) This includes micro-organisms and organisms in which:
    (i) Genetic material has been purposely altered through genetic 
engineering in a way that does not occur naturally; and
    (ii) The material does not meet the definition of an infectious 
substance, but has the potential to alter animals, plants or 
microbiological substances in a way not normally the result of natural 
reproduction.
    (2) A genetically modified micro-organism or organism that meets 
the definition of an infectious substance in Sec. 173.134 is subject to 
the requirements for a Division 6.2 material.
    (d) Exceptions. (1) A genetically modified micro-organism or 
organism that is authorized for final distribution and use by a U.S. 
Government agency is not subject to requirements of this subchapter.
    (2) Genetically modified micro-organisms or organisms that meet the 
definition of a Class 9 material are not assigned a packing group.
    (3) Packaging requirements for genetically modified micro-organisms 
and organisms are specified in Sec. 173.196(c).
    (4) A genetically modified micro-organism or organism is excepted 
from all other requirements of this subchapter when transported by a 
private or contract motor carrier not engaged in the transportation of 
passengers, and the material is packaged and marked with the proper 
shipping name ``Genetically modified micro-organism,'' in accordance 
with the provisions in Sec. 173.196(c)(4).
    (5) Animals which contain or are contaminated with a genetically 
modified micro-organism must be transported under the terms and 
conditions approved by the Associate Administrator for Hazardous 
Materials Safety.
    10. Section 173.196 would be revised to read as follows:


Sec. 173.196  Infectious substances.

    (a) When Sec. 172.101 of this subchapter specifies that an 
infectious substance be packaged under this section, only non-bulk 
packagings prescribed in this section may be used.
    (1) An infectious substance must be classified and described under 
UN 2814 or UN 2900 and must be packaged in a Division 6.2 packaging 
meeting requirements of paragraph (b) of this section.
    (2) An infectious substance that is authorized to be described 
under the proper shipping name ``Diagnostic Specimen'' must be packaged 
in accordance with paragraph (b) or (c) of this section. If the 
diagnostic specimen meets the requirements of Sec. 173.134(c)(2) and is 
transported by highway only by a private or contract carrier, it may be 
packaged in conformance with provisions of paragraph (c) of this 
section.
    (3) Body parts, organs or whole bodies must be packaged in a:
    (i) Division 6.2 packaging meeting the requirements of paragraph 
(b) of this section;
    (ii) Diagnostic specimen packaging meeting the requirements of 
paragraph (c) of this section, or
    (iii) Non-specification packaging meeting the requirements of 
paragraph (d) of this section.
    (b) Division 6.2 packaging. A Division 6.2 packaging must conform 
to a UN standard specified in subpart L of part 178 of this subchapter 
and meet the test standards of Sec. 178.609 of this subchapter. The 
packaging must include:
    (1) Inner packagings comprising:
    (i) A watertight primary receptacle;
    (ii) A watertight secondary packaging; and
    (iii) Other than for a solid infectious substance, an absorbent 
material must be placed between the primary receptacle and the 
secondary packaging. If multiple primary receptacles are placed in a 
single secondary packaging, they must be wrapped individually to ensure 
that contact between them is prevented. The absorbent material, such as 
cotton or wool, must be sufficient to absorb the entire contents of all 
primary receptacles.
    (2) An outer packaging of adequate strength for its capacity, mass 
and intended use.
    (3) The smallest overall external dimensions of the outer packaging 
must be at least 100 mm (3.9 inches).
    (4) An itemized list of contents must be enclosed between the 
secondary packaging and the outer packaging.
    (5) Based on their physical and chemical form, infectious 
substances must be packaged according to the following guidelines:
    (i) Lyophilized substances. Primary receptacles must include flame-
sealed glass ampules or rubber-stopped glass vials fitted with metal 
seals.
    (ii) Liquid or solid substances--
    (A) Substances shipped at ambient temperatures or higher. 
Authorized primary receptacles include those of glass, metal or 
plastic. Positive means of ensuring a leakproof seal, such as heat

[[Page 46857]]

seal, skirted stopper or metal crimp seal must be provided. If screw 
caps are used, they must be secured with adhesive tape.
    (B) Substances shipped refrigerated or frozen (ice, pre-frozen 
packs, dry ice). Ice or dry ice must be placed outside the secondary 
packagings. Interior supports must be provided to secure the secondary 
packagings in the original position after the ice or dry ice has 
dissipated. If ice is used, the packaging must be leakproof. If dry ice 
is used, the outer packaging must permit the release of carbon dioxide 
gas and otherwise meet the provisions in Sec. 173.217.
    (C) Substances shipped in liquid nitrogen. Plastic primary 
receptacles capable of withstanding very low temperatures must be used. 
Secondary packaging must withstand very low temperatures and in most 
cases will need to be fitted over individual primary receptacles. For 
transportation of liquid nitrogen aboard aircraft, see Sec. 171.11 of 
this subchapter.
    (6) Whatever the intended temperature of shipment, the primary 
receptacle or secondary packaging used for infectious substances must 
be capable of withstanding, without leakage, an internal pressure which 
produces a pressure differential of not less than 95 kPa (14 psi) and 
temperatures in the range of -40 deg.C to +55 deg.C (-40 deg.F to 
+131 deg.F).
    (c) Diagnostic specimens and genetically modified micro-organisms 
and organisms. (1) A diagnostic specimen that otherwise conforms to 
terms and conditions specified in Sec. 173.134(c)(1) and (c)(4) must be 
packaged as specified in paragraph (b) of this section, except that the 
package need only be capable of meeting test standards of Sec. 178.609 
of this subchapter and at a drop test height of not less than 1.2 m 
(3.9 feet), rather than 9 m (30 feet).
    (2) A diagnostic specimen that otherwise conforms to terms and 
conditions specified in Sec. 173.134(c)(2) and (c)(4) must be packaged 
as follows:
    (i) In a leakproof primary receptacle that does not contain more 
than 500 ml (17 ounces) or 500 mg (1.1 pounds).
    (ii) In an outer packaging that does not contain more than 4 L (1 
gallon) or 4 kg (8.8 pounds).
    (iii) The packing conforms to requirements in Sec. 173.196(b), but 
is not subject to the marking requirements in subpart L of part 178 of 
this subchapter or the performance tests in subpart M of part 178 of 
this subchapter. However, each completed package must be capable of 
successfully passing the drop test specified in Sec. 178.603 of this 
subchapter. The height of the drop test must meet or exceed 1.2 m (3.9 
feet).
    (iv) For a solid diagnostic specimen, the primary receptacle and 
secondary packaging is excepted from requirements pertaining to their 
ability to withstand a pressure differential of not less than 95 kPa.
    (3) Except as provided in paragraph (c)(4) of this section, a 
genetically modified micro-organism or organism must be packaged as 
specified in paragraph (b) of this section, except that the package 
need only be capable of meeting test standards of Sec. 178.609 of this 
subchapter and at a drop test height of not less than 1.2 m (3.9 feet), 
rather than 9 m (30 feet).
    (4) A genetically modified micro-organism or organism that 
otherwise conforms to terms and conditions specified in 
Sec. 173.140(d)(4) must be packaged as follows:
    (i) In a leakproof primary receptacle that does not contain more 
than 500 ml (17 ounces) or 500 mg (1.1 pounds).
    (ii) In an outer packaging that does not contain more than 4 L (1 
gallon) or 4 kg (8.8 pounds).
    (iii) The packaging conforms to requirements in Sec. 173.196(b), 
but is not subject to the marking requirements in subpart L of part 178 
of this subchapter or the performance tests in subpart M of part 178 of 
this subchapter. However, each completed package must be capable of 
successfully passing the drop test specified in Sec. 178.603 of this 
subchapter. The height of the drop test must meet or exceed 1.2 m (3.9 
feet).
    (iv) For a solid genetically modified micro-organism or organism, 
the primary receptacle and secondary packaging is excepted from 
requirements pertaining to their ability to withstand a pressure 
differential of not less than 95 kPa.
    (d) Non-specification packaging requirements. This packaging 
consists of a non-bulk strong outer packaging and a leakproof inner 
packaging, such as a liner or receptacle, that conforms to the 
conditions specified in Secs. 173.24 and 173.24a and the following 
additional requirements:
    (1) When transported by aircraft, the packaging must conform to 
requirements specified in Sec. 173.27;
    (2) When transported with dry ice, the packaging must conform to 
requirements specified in paragraph (b)(5)(ii)(B) of this section; and
    (3) When shipped in liquid nitrogen, the packaging must conform to 
requirements specified in paragraph (b)(5)(ii)(C) of this section.
    (e) The requirements of this section are in addition to the 
requirements of the Department of Health and Human Services contained 
in 42 CFR part 72.
    11. Section 173.197 would be revised to read as follows:


Sec. 173.197  Regulated medical waste.

    (a) Non-bulk packagings. Non-bulk packagings conforming to the 
requirements of part 178 of this subchapter at the Packing Group II 
performance level are authorized for regulated medical waste as 
follows. The packagings must be:
    (1) Rigid;
    (2) Leak-resistant;
    (3) Impervious to moisture;
    (4) Of sufficient strength to prevent tearing or bursting under 
normal conditions of use and handling;
    (5) Sealed to prevent leakage during transport;
    (6) Puncture-resistant for sharps and sharps with residual fluids; 
and
    (7) Break-resistant and tightly lidded or stoppered for fluids in 
quantities greater than 20 cubic centimeters.
    (b) Special bulk packagings. Authorized packagings consist of one 
of the outer bulk packagings with multiple inner packagings, as 
described in this paragraph.
    (1) Outer packagings. (i) Intermediate bulk container (IBC) 
packaging. Intermediate bulk containers are authorized as outer 
packagings subject to the conditions and limitations of this paragraph 
provided they conform to the requirements in subpart O of part 178 of 
this subchapter at the Packing Group II performance level, as follows:
    (A) Liquids or solids. The following are authorized as outer 
packagings with inner packagings that contain liquids or solids:
    (1) Composite: 31HZ1. The letter ``Z'' must be replaced with a 
capital letter which indicates the material of construction of the 
outer packaging (see Sec. 178.702 of this subchapter);
    (2) Metal: 31A, 31B, or 31N; or
    (3) Rigid plastic: 31H1 or 31H2.
    (B) Solids only. The following are authorized as outer packagings 
with inner packagings that contain solids only:
    (1) Composite: 11HZ1 or 12HZ1. The letter ``Z'' must be replaced 
with a capital letter which indicates the material of construction of 
the outer packaging (see Sec. 178.702 of this subchapter);
    (2) Metal: 11A, 11B, 11N, 12A, 12B, or 12N; or (3) Rigid plastic: 
11H1, 11H2, 21H1 or 21H2.
    (C) Additional provisions. An IBC authorized for solids only, may 
be used for small quantities of liquids provided that sufficient 
absorbent material is used to absorb the entire amount of liquid

[[Page 46858]]

present. IBCs intended to carry sharps must be resistant to puncture 
and retain liquids under the performance tests of subpart O of part 
178.
    (ii) Non-specification bulk packaging. A non-specification 
packaging is authorized as an outer packaging subject to the conditions 
and limitations of this paragraph as follows:
    (A) The packaging must be a metal or plastic bulk packaging of 
rigid, seamless construction, with the following features:
    (1) A lid or closure that is closed, sealed and latched during 
transportation; and
    (2) A maximum capacity greater than 450 L (119 gallons) but less 
than 1,000 L (264 gallons) as a receptacle for a liquid or a maximum 
net mass greater than 400 kg (882 pounds) but less than 1,000 kg (2,205 
pounds) as a receptacle for a solid;
    (B) Be capable of meeting the drop test requirements of 
Sec. 178.810 and stacking test requirements of Sec. 178.815, for the 
Packing Group II performance level for solids;
    (C) Have an interior surface that is smooth, non-porous, and free 
of cracks and crevices that could obstruct decontamination operations;
    (D) Be in dedicated service for the transportation of waste 
materials;
    (E) Prior to reuse, be decontaminated; and
    (F) The outer packaging must be maintained in an upright position 
during transportation.
    (G) The package must be legibly marked with package orientation 
markings that conform pictorially to ISO Standard 780 on two opposite 
vertical sides of the package with the arrows pointing in the correct 
upright direction.
    (2) Inner packaging: Inner packagings must conform to the following 
requirements to be authorized for use in special bulk packagings:
    (i) A plastic film inner packaging may not exceed a volume of 175 L 
(46 gallons) and must have a film thickness of at least 0.076 cm (0.003 
inches);
    (ii) Sharps must be packaged in puncture-resistant containers that 
are not greater than 38 L (10 gallons) in volume;
    (iii) Inner packagings for liquids must meet the non-bulk packaging 
standards for Packing Group II for liquids. Liquid materials are not 
authorized for transportation in inner packagings larger than 19 L (5 
gallons); and
    (iv) Inner packagings must be securely closed with a minimum of 
entrapped air and sealed with a positive sealing mechanism to prevent 
leakage.

PART 178--SPECIFICATIONS FOR PACKAGINGS

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

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

    13. In Sec. 178.503, paragraph (f) would be added to read as 
follows:


Sec. 178.503  Marking of packagings.

* * * * *
    (f) A manufacturer must mark every UN specification package that is 
represented as manufactured to meet the requirements of Sec. 178.609 
for packaging of infectious substances with the marks specified in this 
section. The markings must be durable, legible and placed in a location 
and of such a size relative to the packaging as to be readily visible, 
as specified in Sec. 178.3(a). An infectious substance packaging that 
successfully passes the tests conforming to the UN standard must be 
marked as follows:
    (1) The United Nations symbol as illustrated in paragraph (e) of 
this section.
    (2) The code designating the type of packaging and material of 
construction according to the identification codes for packagings 
specified in Sec. 178.502 of this subpart.
    (3) The text ``CLASS 6.2''.
    (4) The last two digits of the year of manufacture of the 
packaging.
    (5) The country authorizing the allocation of the mark. The letters 
``USA'' indicate that the packaging is manufactured and marked in the 
United States in compliance with the provisions of this subchapter.
    (6) The name and address or symbol of the manufacturer or the 
approval agency certifying compliance with subparts L and M of this 
part. Symbols, if used, must be registered with the Associate 
Administrator for Hazardous Materials Safety.
    (7) For packagings meeting the requirements of Sec. 178.609(k), the 
letter ``U'' must be inserted immediately following the marking 
designating the type of packaging and material required in paragraph 
(f)(2) of this section.
    (8) Examples of markings for infectious substance packages include:
    [GRAPHIC] [TIFF OMITTED] TP02SE98.004
    
4G/CLASS 6.2/97/USA/ACME876
[GRAPHIC] [TIFF OMITTED] TP02SE98.005

1A2/CLASS 6.2/97/USA/ACME CORP. 123 ELM ST DALLAS, TX 75230
[GRAPHIC] [TIFF OMITTED] TP02SE98.006

1A2U/CLASS 6.2/97/USA/ACME CORP. 123 ELM ST DALLAS, TX 75230
    14. In Sec. 178.601, paragraph (c)(1) would be revised to read as 
follows:


Sec. 178.601  General requirements.

* * * * *
    (c) * * *
    (1) Design qualification testing is the performance of the tests 
prescribed in Sec. 178.603, 178.604, 178.605, 178.606, 178.607, or 
178.609, as applicable, for each new or different packaging, at the 
start of production of that packaging.
* * * * *
    15. In Sec. 178.609, paragraph (i) would be redesignated as 
paragraph (l), the section heading, paragraph (c) preceding the table, 
the undersignated sentence preceding paragraph (d)(1) introductory 
text, paragraphs (d)(1) introductory text, (d)(1)(i), (d)(1)(iii), 
(d)(1)(iv), (e), (h)(1), (h)(2), and newly designated paragraph (l) 
would be revised, and new paragraphs (i), (j), and (k) would be added 
to read as follows:


Sec. 178.609  Test requirements for packagings for infectious 
substances.

* * * * *
    (c) Packagings prepared for transport must be subjected to the 
tests in Table I of this paragraph, which, for test purposes, 
categorizes packagings according to their material characteristics. For 
outer packagings, the headings in Table I relate to fiberboard or 
similar materials whose performance may be rapidly affected by 
moisture; plastics, which may embrittle at low temperature; and other 
materials such as metal whose performance is not significantly affected 
by moisture or temperature. Where a primary receptacle and a secondary 
packaging of an inner packaging are made of different materials, the 
material of the primary receptacle determines the appropriate test. In 
instances where a primary receptacle is made of more than one material, 
the material most likely to be damaged determines the appropriate test.
* * * * *
    (d) * * *
    The drops must be performed as follows:
    (1) Where the samples are in the shape of a box, five must be 
dropped in sequence:
    (i) Flat on the base;
    (ii) * * *
    (iii) Flat on the longest side;
    (iv) Flat on the shortest side; and
* * * * *

[[Page 46859]]

    (e) The samples must be subjected to a water spray that simulates 
exposure to rainfall of approximately 50 mm per hour for at least one 
hour. They must then be subjected to the test described in paragraph 
(d) of this section.
* * * * *
    (h) * * *
    (1) Samples must be placed on a level hard surface. A cylindrical 
steel rod with a mass of at least 7 kg (15 pounds), a diameter not 
exceeding 38 mm (1.5 inches) and the impact end edges a radius not 
exceeding 6 mm (0.2 inches), must be dropped in a vertical free fall 
from a height of 1 m (3 feet), measured from the impact end of the 
impact surface of the sample. One sample must be placed on its base. A 
second sample must be placed in an orientation perpendicular to that 
used for the first. In each instance the steel rod must be aimed to 
impact the primary receptacle(s). Following each impact, there shall be 
no leakage from the primary receptacle(s).
    (2) Samples must be dropped onto the end of a cylindrical steel 
rod. The rod must be set vertically in a level hard surface. It must 
have a diameter of 38 mm (1.5 inches) and the edges of the upper end a 
radius not exceeding 6 mm (0.2 inches). The rod must protrude from the 
surface a distance at least equal to that between the primary 
receptacle(s) and the outer surface of the outer packaging with a 
minimum of 200 mm (7.9 inches). One sample must be dropped in a 
vertical free fall from a height of 1 m (3 feet), measured from the top 
of the steel rod. A second sample must be dropped from the same height 
in an orientation perpendicular to that used for the first. In each 
instance the packaging should be so orientated that the steel rod must 
be aimed to impact the primary receptacle(s). Following each impact, 
there shall be no leakage from the primary receptacle(s).
    (i) Provided an equivalent level of performance is maintained, the 
following variations in the primary receptacles placed within the 
secondary packaging are allowed without additional testing of the 
completed package:
    (1) Primary receptacles of equivalent or smaller size as compared 
to the tested primary receptacles may be used provided:
    (i) The primary receptacles are of similar design to the tested 
primary receptacle (e.g., shape: round, rectangular, etc.);
    (ii) The material of construction of the primary receptacle (glass, 
plastics, metal, etc.) offers resistance to impact and a stacking force 
equal to or greater than that of the originally tested primary 
receptacle;
    (iii) The primary receptacles have the same or smaller openings and 
the closure is of similar design (e.g., screw cap, friction lid, etc.);
    (iv) Sufficient additional cushioning material is used to fill void 
spaces and to prevent significant movement of the primary receptacles; 
and
    (v) Primary receptacles are oriented within the intermediate 
packaging in the same manner as in the tested package.
    (2) [Reserved]
    (j) A lesser number of the tested primary receptacles, or of the 
alternative types of primary receptacles identified in paragraph (i) of 
this section, may be used provided sufficient cushioning is added to 
fill the void space(s) and to prevent significant movement of the 
primary receptacles.
    (k) Primary receptacles of any type may be placed within a 
secondary packaging and shipped without testing in the outer packaging 
under the following conditions:
    (1) The secondary/outer packaging combination must have been 
successfully tested in accordance with paragraphs (a) through (h) of 
this section with fragile (e.g., glass) inner receptacles;
    (2) The total combined gross weight of inner receptacles must not 
exceed one-half the gross weight of inner receptacles used for the drop 
test in paragraph (d) of this section;
    (3) The thickness of cushioning material between inner receptacles 
and between inner receptacles and the outside of the secondary 
packaging must not be reduced below the corresponding thicknesses in 
the originally tested packaging. If a single inner receptacle was used 
in the original test, the thickness of cushioning between the inner 
receptacles must not be less than the thickness of cushioning between 
the outside of the secondary packaging and the inner receptacle in the 
original test. When either fewer or smaller inner receptacles are used 
(as compared to the inner receptacles used in the drop test), 
sufficient additional cushioning material must be used to fill the 
void;
    (4) The outer packaging must have successfully passed the stacking 
test in Sec. 178.606 of this subchapter while empty. The total weight 
of identical packages must be based on the combined mass of inner 
receptacles used in the drop test in paragraph (d) of this section;
    (5) For inner receptacles containing liquids, an adequate quantity 
of absorbent material must be present to absorb the entire liquid 
contents of the inner receptacles; and
    (6) If the outer packaging is intended to contain inner receptacles 
for liquids and is not leakproof, or is intended to contain inner 
receptacles for solids and is not siftproof, a means of containing any 
liquid or solid contents in the event of leakage must be provided in 
the form of a leak-proof liner, plastic bag or other equally effective 
means of containment.
    (7) In addition, the marking required in Sec. 178.503(f) of this 
subchapter must be followed by the letter ``U''.
    (l) Packagings subject to this section are not subject to any other 
requirements of this subpart, except Sec. 178.608.

    Issued in Washington, DC on August 28, 1998, under authority 
delegated in 49 CFR part 106.
Alan I. Roberts,
Associate Administrator for Hazardous Materials Safety.
[FR Doc. 98-23665 Filed 8-31-98; 10:20 am]
BILLING CODE 4910-60-P