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

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