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

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URL: https://www.frixlaw.com/law-library/documents/fr%3A97-7558

## Record

- **Collection:** Federal Register
- **Document type:** Rule
- **Published:** March 26, 1997
- **Citation:** 62 FR 14334

## Text

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

[[Page 14338]]

``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

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A97-7558. Public record. Not legal advice.