[Federal Register Volume 59, Number 203 (Friday, October 21, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-26122]
[[Page Unknown]]
[Federal Register: October 21, 1994]
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DEPARTMENT OF TRANSPORTATION
Research and Special Programs Administration
49 CFR Part 171
[Docket No. HM-181G; Notice No. 94-10]
RIN 2137-AC36
Infectious Substances; Confirmation of Effective Date and
Compliance Dates
AGENCY: Research and Special Programs Administration (RSPA), DOT.
ACTION: Final rule; confirmation of effective date and compliance
dates.
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SUMMARY: On September 22, 1994, RSPA published a final rule to extend
the compliance dates for classification, hazard communication, and
packaging requirements of the Hazardous Materials Regulations
applicable to infectious substances, including regulated medical waste.
The effective date of the rule was September 22, 1994, unless RSPA
received, by September 30, 1994, any comments illustrating that an
extension of the compliance dates is not in the public interest. RSPA
received two comments opposing the extension, but containing no
specific information to support that an extension of the compliance
dates is not in the public interest. Therefore, this document confirms
that the compliance dates are extended as set forth in the September
22, 1994 final rule, and the effective date of that final rule is
September 22, 1994.
EFFECTIVE DATE: September 22, 1994.
FOR FURTHER INFORMATION CONTACT: Eileen Martin or Jennifer Antonielli,
Office of Hazardous Materials Standards, Research and Special Programs
Administration, 400 Seventh St., SW., Washington, DC 20590-0001,
telephone: (202) 366-8553.
SUPPLEMENTARY INFORMATION: On September 22, 1994, RSPA issued a final
rule under Docket HM-181G (59 FR 48762) to extend the compliance dates
for classification, hazard communication, and packaging requirements
for infectious substances, including regulated medical waste (RMW). In
the final rule, RSPA amended 49 CFR 171.14(b) to extend the compliance
date from October 1, 1994, to October 1, 1995, for regulatory
requirements applicable to RMW and materials infectious to animals
only. This extension was provided to allow RSPA sufficient time to
publish a Notice of Proposed Rulemaking (NPRM), evaluate comments
received in response to the NPRM, and make any necessary changes to the
HMR based on the merits of those comments. RSPA stated that, without an
extension of the compliance date, shippers and transporters of these
materials would have to comply with regulations that are likely to be
changed in the near future and thereby incur unnecessary costs. For
other infectious substances, i.e., for cultures and stocks of
substances infectious to humans, the September 22, 1994 final rule
extended the compliance date from October 1, 1994, to January 1, 1995.
The requirements for these materials generally have not been at issue
in comments or petitions filed with RSPA. The principal impacts of the
January 1, 1995 compliance date will be a nomenclature change from the
old ``etiologic agent'' hazard class to the new ``Division 6.2''
classification, elimination of the 50 milliliter exception for cultures
and stocks of infectious substances, and expansion of the definition of
infectious substances to cover substances, such as the human
immunodeficiency virus (HIV) and Lyme disease, which are not listed in
the Centers for Disease Control regulations (42 CFR 72.3).
In the preamble of the September 22, 1994 rule, RSPA stated that
the compliance dates would be extended unless RSPA received comments by
September 30, 1994, that illustrated that an extension of the
compliance dates would not be in the public interest. RSPA received two
comments opposed to and one comment in support of extending the
compliance date for provisions applicable to RMW. The comment
advocating the extension was submitted by the American Hospital
Association (AHA). The AHA fully supported RSPA's decision to extend
the compliance date for RMW and encouraged continued coordination with
other Federal agencies involved in the regulation of infectious
substances. The comments opposing the extension were submitted by a
manufacturer of an exemption packaging used for transporting RMW and
one of its customers, a waste transporter. Both commenters requested
that the requirements for RMW be implemented without further delay. The
manufacturer stated that it has spent in excess of $2 million
developing its packaging, and that large transporters of RMW have
``done little or nothing to help toward the safety of RMW
transportation.'' The waste transporter stated that, by using the
manufacturer's exemption packaging, it has an edge over many of the
large transporters that are not and possibly may elect not to comply
with the new requirements. The waste transporter stated that Federal
regulations are necessary if safeguards are to be put in place for the
safety and health of the public. Neither commenter provided any
specific data or information suggesting that RMW is being transported
unsafely, nor did they demonstrate that the extension would jeopardize
safety or be contrary to the public interest. Based on these comments,
and on the lack of any evidence indicating that a limited extension
would adversely affect public health and safety, RSPA has determined
that it is appropriate to extend the compliance dates. Therefore, RSPA
is confirming the compliance dates set forth in the September 22, 1994
final rule.
Issued in Washington, DC on October 14, 1994, under authority
delegated in 49 CFR part 106, appendix A.
Alan I. Roberts,
Associate Administrator for Hazardous Materials Safety.
[FR Doc. 94-26122 Filed 10-20-94; 8:45 am]
BILLING CODE 4910-60-P
