Performance-Oriented Packaging Standards; Final Transitional Provisions; Revisions and Response to Petitions for Reconsideration

DEPARTMENT OF TRANSPORTATION

Research and Special Programs Administration

49 CFR Parts 172, 173, and 178

[Docket No. HM-181H; Amdt. Nos. 172-150, 173-255, 178-117]

RIN 2137-AC80

Performance-Oriented Packaging Standards; Final Transitional

Provisions; Revisions and Response to Petitions for Reconsideration

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

ACTION: Final rule; editorial revisions and response to petitions for

reconsideration.

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SUMMARY: On September 26, 1996, RSPA published a final rule which

amended the Hazardous Materials Regulations to incorporate a number of

changes based on rulemaking petitions from industry, RSPA initiatives

and comments received at public meetings, to the classification of

certain hazardous materials which are poisonous by inhalation and to

provisions for the manufacture, use, and reuse of hazardous materials

packagings. The intended effect of the September 26, 1996 rule is to

improve safety, reduce compliance costs to offerors and transporters of

hazardous materials, make the regulations easier to use and correct

errors. This final rule corrects errors in the September 26, 1996 final

rule and responds to petitions for reconsideration. This final rule

also publishes two letters denying petitions for reconsideration of a

provision in the September 26, 1996 final rule.

DATES: The amendments in this final rule are effective March 26, 1997.

FOR FURTHER INFORMATION CONTACT: Joan McIntyre, telephone (202) 366-

8553, Office of Hazardous Materials Standards, Research and Special

Programs Administration, Washington DC, 20590-0001.

SUPPLEMENTARY INFORMATION:

I. Background

On December 21, 1990, RSPA published a final rule [Docket HM-181;

55 FR 52402], which comprehensively revised the HMR with respect to

hazard communication, classification, and

[[Page 14335]]

packaging requirements based on the United Nations (UN) Recommendations

on the Transport of Dangerous Goods (UN Recommendations). A document

responding to petitions for reconsideration and containing editorial

and substantive revisions to the final rule was published on December

20, 1991 [56 FR 66124]. On October 1, 1992, under Dockets HM-181 and

HM-189, RSPA issued editorial and technical corrections to the

regulations published in 1991. On September 24, 1993, RSPA issued a

final rule under Docket HM-181F [58 FR 50224] which made changes to the

HMR based on agency initiative and petitions for rulemaking received

since the December 20, 1991 response to petitions for reconsideration.

That final rule primarily revised requirements with a mandatory

compliance date of October 1, 1993, as provided in the transitional

provisions in Sec. 171.14(b)(4).

RSPA published a notice of proposed rulemaking (NPRM) on June 26,

1996, under Docket HM-181H [61 FR 33216] to address most remaining

issues associated with the implementation of Docket HM-181 provisions

and certain other issues arising from a final rule issued December 29,

1994, under Docket HM-215A [59 FR 67390]. These issues were raised

through petitions for rulemaking and agency initiative.

In the September 26, 1996 final rule, RSPA adopted changes to

numerous requirements with a compliance date of October 1, 1996. These

changes amended provisions concerning hazard classification, the

maintenance and use of performance packaging, intermediate bulk

containers (IBC), portable tanks, and regulated medical waste.

Following publication of the final rule, RSPA received several

petitions for reconsideration, as well as other correspondence

identifying errors or requesting clarification. This document

incorporates editorial and technical revisions RSPA has determined are

necessary to correct or clarify the final rule.

Because the amendments adopted herein clarify and correct certain

provisions of the September 26, 1996 final rule, and impose no new

regulatory burden on any person, notice and public procedure are

unnecessary. For these same reasons, these amendments are being made

effective without the usual 30-day delay following publication.

II. Summary of Regulatory Changes Made by Section

Listed below is a section-by-section summary of the changes.

Part 172

Section 172.101. Newly added paragraph (c)(10)(iii) is revised for

consistency with newly revised paragraph (c)(12)(iii).

Section 172.101; the Hazardous Materials Table (HMT). In the Docket

HM-181H NPRM, a packaging exception was proposed for ``Magnesium powder

or Magnesium alloys, powder'' in Packing Groups II and III. However,

the final rule did not indicate this exception was limited to Packing

Groups II and III and it could be inferred that a packaging exception

is authorized for Magnesium powder in Packing Group I. This final rule

clarifies that no packaging exception is authorized for this material

in PG I by revising Column (8A) of the HMT to read ``None''.

Part 173

Section 173.28. The footnote to the minimum thickness table in

paragraph (b)(4) is revised to clarify that drums having a minimum

thickness of 0.82 mm body and 1.09 mm heads which were manufactured and

marked prior to January 1, 1997 may be reused.

Section 173.134. RSPA received two petitions for reconsideration of

a provision to authorize certain discarded cultures and stocks of

infectious substances to be described and packaged as regulated medical

waste rather than infectious substances. On February 11, 1997, RSPA

denied a petition for reconsideration from Browning Ferris Industries

and on February 13, 1997, RSPA denied a petition for reconsideration

from the Medical Waste Institute. This document publishes verbatim the

two letters as follows:

February 11, 1997.

Ms. Mary Ellen Lynch,

Director of Environmental Policy, Browning Ferris Industries, 1350

Connecticut Avenue, NW., Suite 1101, Washington, DC 20036.

Dear Ms. Lynch: This letter responds to Browning Ferris

Industries'' (BFI) October 25, 1996 petition for reconsideration of

the provision in the Research and Special Programs Administration's

(RSPA) final rule (61 FR 50616; September 26, 1996) in Docket HM-

181H that expands the definition of regulated medical waste to

include waste cultures and stocks of infectious substances. RSPA

denies BFI's petition for reconsideration for reasons set forth in

the following paragraphs.

Prior to the HM-181H final rule, 49 CFR 173.134(a)(4) limited

the definition of regulated medical waste to exclude waste cultures

and stocks of infectious substances. The final rule in Docket HM-

181H added a new paragraph (b)(4) to Section 173.134 authorizing

certain waste cultures and stocks (i.e., those in Biosafety Levels

1, 2 and 3, as defined in the Department of Health and Human

Services' (HHS) Publication No. (CDC) 93-8395, Biosafety in

Microbiological and Biomedical Laboratories, 3rd edition, May 1993,

Section II) to be described and packaged as regulated medical waste

rather than infectious substances. This action resulted in those

materials being authorized in non-bulk UN packagings that conform to

Packing Group II performance requirements.

In its October 25, 1996 petition, BFI petitions RSPA to

reconsider revisions to 49 CFR 173.134 in light of regulations

proposed on June 10, 1996 (61 FR 29327), by HHS's Centers for

Disease Control and Prevention (CDC). The CDC issued its final rule,

entitled Additional Requirements for Facilities Transferring or

Receiving Select Agents, on October 24, 1996 (61 FR 55190).

In its petition, BFI made three major assertions, which are

quoted, as follows:

RSPA failed to consider the pending CDC regulations prior to

promulgating a final regulations (sic) for packaging and

transportation of cultures and stocks of infectious substances.

Given the Congressionally mandated regulatory scheme now pending

before CDC, it is neither reasonable nor in the public interest for

RSPA to impose another more burdensome regulatory scheme on the same

materials and for the same purpose of regulating the interstate (as

well as intrastate) transportation of infectious agents--including

discarded cultures and stocks of infectious agents--that could have

adverse consequences for human health and safety.

RSPA should reconsider the final Section 173.134 rule and

promulgate a final rule that is consistent with the final CDC rule

governing shipping and handling requirements for facilities that

transfer and receive select infectious agents that have the

potential to pose a severe threat to public health and safety.

Discarded cultures and stocks of infectious substances other than

those included on the CDC Appendix A list should be regulated as

regulated medical waste pursuant to 49 CFR Part 173.134, including

the packaging regulations of that provision.

With regard to the first assertion, when RSPA published its

final rule on September 26, 1996, the CDC had not yet issued its

final rule. At the time RSPA was developing its final rule, CDC had

issued only a notice of proposed rulemaking (NPRM). RSPA was not in

a position to prejudge the provisions of the CDC final rule. Because

numerous changes could have been made before the rule was finalized,

RSPA did not rely on the NPRM. In fact, CDC solicited comments

regarding those agents to be added or deleted from the proposed list

and in its final rule changed the list of select agents that BFI

asserts RSPA should have considered. In its final rule, CDC added,

revised, and removed numerous entries from its proposed rule.

With regard to the second assertion, RSPA has not imposed

``another more burdensome regulatory scheme on the same materials

and for the same purpose of regulating the interstate (as well as

intrastate) transportation of infectious agents''. CDC and RSPA have

jointly regulated infectious substances (or

[[Page 14336]]

``etiologic agents'') under different statutory authority for many

years and have taken steps to ensure consistency between the two

agencies' regulations and avoid unnecessary overlap of requirements.

The final CDC regulations address different issues than the HMR and

focus on additional requirements for facilities that transfer or

receive specified select agents that are capable of causing

substantial harm to human health. In its preamble to its final rule,

CDC states:

Several commenters were concerned about shipping select agents

and about acceptable carriers and carrier responsibilities. Nothing

in this final rule is intended to preempt other applicable

regulations. Select agents included under this final rule are

required to be packaged, labeled and shipped in accordance with all

applicable federal regulations. CDC believes that compliance with

existing federal regulations on packaging, labeling and shipping

select agents, in combination with the transfer requirements of this

final rule, provide sufficient safeguards for safe and secure

transport.

In summary, the RSPA and CDC final rules address different

concerns and do not impose an overlapping scheme on the same

materials for the same purpose. Compliance with both rules is

feasible.

Also pertaining to BFI's second assertion, RSPA has not imposed

``a more burdensome regulatory scheme''. The June 26, 1996 NPRM for

HM-181H proposed only to incorporate provisions of an exemption,

DOT-E 11588, into the regulations. DOT-E 11588 authorized waste

cultures and stocks in Biosafety Levels 1, 2, and 3 (as defined in

HHS Publication No. 93-8395) to be described and packaged as

regulated medical waste rather than infectious substances. The HM-

181 final rule is consistent with the NPRM and represents a

relaxation of the regulatory scheme for these waste materials.

With regard to BFI's third assertion, RSPA believes that BFI's

concern is that select agents could be transported as regulated

medical waste rather than as infectious substances. RSPA agrees with

BFI that it would be inappropriate for these virulent agents to be

transported in the lower integrity packagings which are permitted

for regulated medical waste. The CDC final rule makes it clear (see

preamble discussion on page 55193) that select agents must be

destroyed on-site and may not be transported for disposal (i.e., as

waste) unless they have first been treated and destroyed. Therefore,

it is RSPA's position that a culture or stock of a select agent

cannot become a regulated medical waste under 49 CFR 173.134 because

the CDC regulations for destruction on-site preclude its being

offered for transportation as a waste.

For the above reasons, your petition for reconsideration is

denied. If BFI has additional information which it believes would

warrant further rulemaking action on this issue, we recommend that

it submit a petition for rulemaking under 49 CFR 106.31 outlining

the recommended changes it believes should be made to the HMR, and

including the additional justification.

Sincerely,

Alan I. Roberts,

Associate Administrator for Hazardous Materials Safety.

February 13, 1997.

Richard S. Moskowitz, Esq.,

Medical Waste Institute, 4301 Connecticut Avenue, NW., Suite 300,

Washington, DC 20008.

Dear Mr. Moskowitz: This letter is in response to the Medical

Waste Institute's (the Institute) October 23, 1996 petition for

reconsideration of the provision in the Research and Special

Programs Administration's (RSPA) final rule (61 FR 50616; September

26, 1996) in Docket HM-181H that authorizes discarded cultures and

stocks of infectious substances to be described and packaged as

regulated medical waste. RSPA denies the Institute's petition for

reconsideration of the final rule in Docket HM-181H.

The Institute alleged that RSPA dismissed two requests submitted

by the Institute in its comments to the June 26, 1996 notice of

proposed rulemaking (NPRM). The first request was to allow discarded

cultures and stocks to be packaged in packagings (herein referred to

as ``OSHA-authorized packaging'') conforming to bloodborne pathogen

standards of the Department of Labor's Occupational Safety and

Health Administration (OSHA), which are permitted for other

regulated medical waste under Section 173.134(b)(3)(ii). The

Institute also requested that RSPA allow private carriers

transporting cultures and stocks of infectious substances to

backhaul non-food products in trailers that are properly

disinfected. The Institute asserted that these two requests were

within the scope of the rulemaking in Docket HM-181H and requested

that RSPA reconsider these ``dismissals.''

In support of its first request, the Institute asserted that

OSHA-authorized packaging has a ``proven track record'' in ensuring

that the public is protected from exposure to hazardous material and

that it is aware of no incident where a failure of an OSHA-

authorized packaging resulted in a harmful release of discarded

cultures and stocks. The Institute also maintained, in support of

its second request, that there is no evidence of a health risk nor

any recorded incident of disease transmission resulting from

backhauling.

In a September 20, 1995 final rule on infectious substances

(Docket HM-181G), waste cultures and stocks were excluded from the

definition of regulated medical waste and were subject to

requirements applicable to non-waste cultures and stocks of

infectious substances. In the preamble to that final rule, RSPA

noted that several commenters agreed that cultures and stocks

contain a high concentration of microorganisms that have the

potential to cause disease in humans or animals and require special

handling. The final rule required cultures and stocks of infectious

substances, including waste, to be in high integrity packagings

conforming to Section 178.609.

Subsequent to the Docket HM-181G final rule, RSPA issued an

exemption, DOT-E 11588, which authorized discarded cultures and

stocks in Biosafety Levels 1, 2, and 3 (as defined in HHS

Publication No. 93-8395) to be described and packaged as regulated

medical waste rather than infectious substances. As an alternative

to more stringent packagings for infectious substances prescribed in

Section 178.609, RSPA authorized UN standard packagings meeting

Packing Group II performance levels, but imposed additional safety

controls by requiring dedicated vehicles operated by specialized

(i.e., private and contract) carriers. In granting this exemption,

RSPA intentionally excluded non-specification OSHA-authorized

packaging permitted for other regulated medical waste under Section

173.134(b)(3)(ii), and specifically stated in the exemption that

this packaging was not authorized because these packagings provide a

lower level of safety than other packagings authorized for

infectious substances. In addition, RSPA evaluated modal

requirements prior to issuance of DOT-E 11588 and concluded that

only private or contract motor carriers using vehicles dedicated to

the transportation of medical waste are authorized.

The June 26, 1996 NPRM proposed only to incorporate the

provisions of DOT-E 11588 into Section 173.134 of the regulations.

The NPRM did not propose, nor request comments concerning, any

further relaxation of packaging requirements beyond that provided in

the exemption. There are no regulatory provisions for use of

packagings of lesser integrity and RSPA is not aware of a ``proven

track record'' for such packagings. The Institute's petition for a

lower level of packaging safety than adopted in the HM-181H final

rule is unjustified based on the information provided by the

Institute and presents safety concerns that have not been fully

analyzed. Similarly, the request to allow private carriers

transporting discarded cultures and stocks of infectious substances

to backhaul ``non-food products'' in trailers that are ``properly

disinfected'' raises technical issues not addressed in the NPRM

(e.g., standards for cleaning and defining criteria for ``non-food

products'') and raises safety concerns about the ``proper''

disinfection of trailers and allowing non-food products, including

consumer products, to come into contact with medical waste residue.

Both of these requested changes to the HMR raise technical and

safety issues that have not been fully analyzed and resolved. At the

present time, RSPA does not have the information required to analyze

and address these issues. Any further relaxation of packaging

performance level or revisions to authorize private carriers

transporting cultures and stocks of infectious substances to

backhaul non-food products in the same vehicles would necessitate

additional notice and opportunity for comment, as required by the

Administrative Procedure Act, 5 U.S.C. 553 (b) and (c). Therefore,

RSPA is denying the petition for reconsideration of the final rule

in Docket HM-181H.

A petition for rulemaking may be a more appropriate means to

address the two changes to the HMR proposed by the Institute. The

Institute may submit a petition

[[Page 14337]]

for rulemaking under Section 106.31 outlining any specific changes

it believes should be made to the HMR, and include information

sufficient to warrant further rulemaking action.

Sincerely,

Alan I. Roberts,

Associate Administrator for Hazardous Materials Safety.

Section 173.170. The first sentence in paragraph (c) is amended by

changing the maximum net capacity of each inner metal or plastic

receptacle from 450 g (15.9 ounces) to 454 g (16 ounces).

Part 178

Section 178.2. A new paragraph (f) is added to clarify that

packagings may no longer be manufactured and marked to old DOT

specifications which were removed in the final rule under Docket HM-

181. This new paragraph replaces a similar prohibition that was removed

from the transitional provisions in Sec. 171.14 in the September 26,

1996 final rule.

III. Rulemaking Analyses and Notices

A. Executive Order 12866 and DOT Regulatory Policies and Procedures

This final rule is not considered a significant regulatory action

under section 3(f) of Executive Order 12866 and therefore, was not

reviewed by the Office of Management and Budget. The rule is not

considered a significant rule under the Regulatory Policies and

Procedures of the Department of Transportation [44 FR 11034].

The economic impact of this rule is expected to result in only

minimal costs to certain persons subject to the HMR and may result in

modest cost savings to a small number of persons subject to the HMR and

to the agency. Because of the minimal economic impact of this rule,

preparation of a regulatory impact analysis or a regulatory evaluation

is not warranted.

B. Executive Order 12612

The September 26, 1996 final rule, as amended herein, was analyzed

in accordance with the principles and criteria contained in Executive

Order 12612 (``Federalism''). Federal law expressly preempts State,

local, and Indian tribe requirements applicable to the transportation

of hazardous material that cover certain subjects and are not

substantively the same as Federal requirements. 49 U.S.C. 5125(b)(1).

These subjects are:

(1) The designation, description, and classification of hazardous

material;

(2) The packing, repacking, handling, labeling, marking, and

placarding of hazardous material;

(3) The preparation, execution, and use of shipping documents

pertaining to hazardous material, and requirements respecting the

number, content, and placement of such documents;

(4) The written notification, recording, and reporting of the

unintentional release in transportation of hazardous material; or

(5) The design, manufacturing, fabrication, marking, maintenance,

reconditioning, repairing, or testing of a package or container which

is represented, marked, certified, or sold as qualified for use in the

transportation of hazardous material.

This final rule preempts State, local, or Indian tribe requirements

concerning these subjects unless the non-Federal requirements are

``substantively the same'' (see 49 CFR 107.202(d)) as the Federal

requirements. RSPA lacks discretion in this area, and preparation of a

federalism assessment is not warranted.

Federal law (49 U.S.C. 5125(b)(2)) provides that if DOT issues a

regulation concerning any of the covered subjects, DOT 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. RSPA has determined that the

effective date of Federal preemption for these requirements in the

September 26, 1996 final rule will be January 1, 1997.

C. Regulatory Flexibility Act

This final rule responds to petitions for reconsideration and

agency review. It is intended to make editorial and technical

corrections, provide clarification of the regulations and relax certain

requirements. Therefore, I certify that this final rule will not have a

significant economic impact on a substantial number of small entities.

D. Paperwork Reduction Act

There are no new information collection requirements in this final

rule.

E. Regulation Identifier Number (RIN)

A regulation identifier number (RIN) is assigned to each regulatory

action listed in the Unified Agenda of Federal Regulations. The

Regulatory Information Service Center publishes the Unified Agenda in

April and October of each year. The RIN number contained in the heading

of this document can be used to cross-reference this action with the

Unified Agenda.

List of Subjects

49 CFR Part 172

Hazardous materials transportation, Hazardous waste, Labels,

Markings, Packaging and containers, Reporting and recordkeeping

requirements.

49 CFR Part 173

Hazardous materials transportation, Packaging and containers,

Radioactive materials, Reporting and recordkeeping requirements,

Uranium.

49 CFR Part 178

Hazardous materials transportation, Motor vehicle safety, Packaging

and containers, Reporting and recordkeeping requirements.

In consideration of the foregoing, 49 CFR Chapter I is amended as

follows:

PART 172--HAZARDOUS MATERIALS TABLE, SPECIAL PROVISIONS, HAZARDOUS

MATERIALS COMMUNICATIONS, EMERGENCY RESPONSE INFORMATION, AND

TRAINING REQUIREMENTS

1. The authority citation for Part 172 continues to read as

follows:

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

2. In Sec. 172.101, paragraph (c)(10)(iii) is revised to read as

follows:

Sec. 172.101 Purpose and use of hazardous materials table.

* * * * *

(c) * * *

(10) * * *

(iii) A mixture or solution not identified in the Table

specifically by name, comprised of two or more hazardous materials in

the same hazard class, shall be described using an appropriate shipping

description (e.g., ``Flammable liquid, n.o.s.''). The name that most

appropriately describes the material shall be used; e.g., an alcohol

not listed by its technical name in the Table shall be described as

``Alcohol, n.o.s.'' rather than ``Flammable liquid, n.o.s.''. Some

mixtures may be more appropriately described according to their

application, such as ``Coating solution'' or ``Extracts, flavoring

liquid'' rather than by an n.o.s. entry. Under the provisions of

subparts C and D of this part, the technical names of at least two

components most predominately contributing to the hazards of the

mixture or solution may be required in association with the proper

shipping name.

* * * * *

Sec. 172.101 [Amended]

3. In Sec. 172.101, in the Hazardous Materials Table, for the entry

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``Magnesium powder or Magnesium alloys, powder'' in PG I, in column 8A,

the entry ``151'' is revised to read ``None''.

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

PACKAGINGS

4. The authority citation for Part 173 continues to read as

follows:

Authority: 49 U.S.C. 5102-5127; 49 CFR 1.53.

5. In Sec. 173.28, in the table in paragraph (b)(4)(i), the

footnote is revised to read as follows:

Sec. 173.28 Reuse, reconditioning and remanufacture of packagings.

* * * * *

\1\ Metal drums or jerricans with a minimum thickness of 0.82 mm

body and 1.09 mm heads which are manufactured and marked prior to

January 1, 1997 may be reused. Metal drums or jerricans manufactured

and marked on or after January 1, 1997, and intended for reuse, must

be constructed with a minimum thickness of 0.82 mm body and 1.11 mm

heads.

* * * * *

Sec. 173.170 [Amended]

6. In Sec. 173.170, in the first sentence of paragraph (c), the

wording ``450 g (15.9 ounces)'' is revised to read ``454 g (16

ounces)''.

PART 178--SPECIFICATIONS FOR PACKAGINGS

7. The authority citation for part 178 continues to read as

follows:

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

8. In Sec. 178.2, a new paragraph (f) is added to read as follows:

Sec. 178.2 Applicability and responsibility.

* * * * *

(f) No packaging may be manufactured or marked to a packaging

specification that was in effect on September 30, 1991, and that was

removed from this part 178 by a rule published in the Federal Register

on December 21, 1990 and effective October 1, 1991.

Issued in Washington, DC on March 20, 1997, under authority

delegated in 49 CFR part 1.

Kelley S. Coyner,

Deputy Administrator.

[FR Doc. 97-7558 Filed 3-25-97; 8:45 am]

BILLING CODE 4910-60-P