[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]
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