80 FR 68491 - Management Standards for Hazardous Waste Pharmaceuticals

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 214 (November 5, 2015)

Page Range		68491-68491
FR Document		2015-28100

The Environmental Protection Agency (EPA or the Agency) is announcing an extension to the comment period for the proposed rule on the management and disposal of hazardous waste pharmaceuticals published in the Federal Register on September 25, 2015. EPA is proposing new hazardous waste pharmaceutical regulations under the Resource Conservation and Recovery Act (RCRA) to improve compliance and thereby enhance protection of human health and the environment. Specifically, EPA proposed to revise the regulations to improve the management and disposal of hazardous waste pharmaceuticals and tailor them to address the specific issues that hospitals, pharmacies and other healthcare-related facilities face. The revisions are also intended to clarify the regulation of the reverse distribution mechanism used by healthcare facilities for the management of unused and/or expired pharmaceuticals. The comment period is being extended to December 24, 2015.

Federal Register, Volume 80 Issue 214 (Thursday, November 5, 2015)

[Federal Register Volume 80, Number 214 (Thursday, November 5, 2015)]
[Proposed Rules]
[Page 68491]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-28100]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 261, 262, 266, 268, and 273

[EPA-HQ-RCRA-2007-0932; FRL-9936-49-OSWER]
RIN 2050-AG39


Management Standards for Hazardous Waste Pharmaceuticals

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; extension of comment period.

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SUMMARY: The Environmental Protection Agency (EPA or the Agency) is 
announcing an extension to the comment period for the proposed rule on 
the management and disposal of hazardous waste pharmaceuticals 
published in the Federal Register on September 25, 2015. EPA is 
proposing new hazardous waste pharmaceutical regulations under the 
Resource Conservation and Recovery Act (RCRA) to improve compliance and 
thereby enhance protection of human health and the environment. 
Specifically, EPA proposed to revise the regulations to improve the 
management and disposal of hazardous waste pharmaceuticals and tailor 
them to address the specific issues that hospitals, pharmacies and 
other healthcare-related facilities face. The revisions are also 
intended to clarify the regulation of the reverse distribution 
mechanism used by healthcare facilities for the management of unused 
and/or expired pharmaceuticals. The comment period is being extended to 
December 24, 2015.

DATES: Comments on the proposed rule published September 25, 2015 (80 
FR 58014) must be received on or before December 24, 2015.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
RCRA-2007-0932, to the Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting 
comments. Once submitted, comments cannot be edited or withdrawn. The 
EPA may publish any comment received to its public docket. Do not 
submit electronically any information you consider to be Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Multimedia submissions (audio, video, etc.) must 
be accompanied by a written comment. The written comment is considered 
the official comment and should include discussion of all points you 
wish to make. The EPA will generally not consider comments or comment 
contents located outside of the primary submission (i.e. on the web, 
cloud, or other file sharing system). For additional submission 
methods, the full EPA public comment policy, information about CBI or 
multimedia submissions, and general guidance on making effective 
comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: For more detailed information on 
specific aspects of this rulemaking, contact Kristin Fitzgerald, Office 
of Resource Conservation and Recovery (5304P), Environmental Protection 
Agency, 1200 Pennsylvania Avenue NW., Washington, DC 20460; telephone 
number: 703-308-8286; email address: [email protected] or 
Joshua Smeraldi, Office of Resource Conservation and Recovery (5304P), 
Environmental Protection Agency, 1200 Pennsylvania Avenue NW., 
Washington, DC 20460; telephone number: 703-308-0441; email address: 
[email protected].

SUPPLEMENTARY INFORMATION: This document extends the public comment 
period established in the Federal Register for 30 days. In that Federal 
Register notice, EPA proposed new regulations for the management of 
hazardous waste pharmaceuticals. The purpose of this proposed 
regulation is to improve the management and disposal of hazardous waste 
pharmaceuticals and tailor them to address the specific issues that 
hospitals, pharmacies and other healthcare-related facilities face. The 
revisions are also intended to clarify the regulation of the reverse 
distribution mechanism used by healthcare facilities for the management 
of unused and/or expired pharmaceuticals. Several requests were 
received from potential commenters to extend the comment period to 
allow greater time to comment. EPA is hereby extending the comment 
period, which was set to end on November 24, 2015, to December 24, 
2015. Please note that late comments on this rule making may not be 
considered.
    To submit comments or access the docket, please follow the detailed 
instructions as provided under ADDRESSES. If you have questions, 
consult the individuals listed under FOR FURTHER INFORMATION CONTACT.

    Dated: October 22, 2015.
Barnes Johnson,
Director, Office of Resource Conservation and Recovery, Office of Solid 
Waste and Emergency Response.
[FR Doc. 2015-28100 Filed 11-4-15; 8:45 am]
 BILLING CODE 6560-50-P

Federal Register / Vol. 80, No. 214 / Thursday, November 5, 2015 / Proposed Rules 68491

aspects of this rulemaking, contact Jim Proposed rule; extension of
ACTION: aspects of this rulemaking, contact
O’Leary, Office of Resource comment period. Kristin Fitzgerald, Office of Resource
Conservation and Recovery, Materials Conservation and Recovery (5304P),
Recovery and Waste Management The Environmental Protection
SUMMARY:
Environmental Protection Agency, 1200
Division, MC 5304P, Environmental Agency (EPA or the Agency) is
announcing an extension to the Pennsylvania Avenue NW., Washington,
Protection Agency, 1200 Pennsylvania DC 20460; telephone number: 703–308–
Ave. NW., Washington, DC 20460, (703) comment period for the proposed rule
on the management and disposal of 8286; email address: fitzgerald.kristin@
308–8827, (oleary.jim@epa.gov) or epa.gov or Joshua Smeraldi, Office of
Kathy Lett, Office of Resource hazardous waste pharmaceuticals
published in the Federal Register on Resource Conservation and Recovery
Conservation and Recovery, Materials
September 25, 2015. EPA is proposing (5304P), Environmental Protection
Recovery and Waste Management
new hazardous waste pharmaceutical Agency, 1200 Pennsylvania Avenue
Division, MC 5304P, Environmental
Protection Agency, 1200 Pennsylvania regulations under the Resource NW., Washington, DC 20460; telephone
Ave. NW., Washington, DC 20460, at Conservation and Recovery Act (RCRA) number: 703–308–0441; email address:
(703) 605–0761 (lett.kathy@epa.gov). to improve compliance and thereby smeraldi.josh@epa.gov.
enhance protection of human health and
SUPPLEMENTARY INFORMATION: SUPPLEMENTARY INFORMATION: This
This document extends the public the environment. Specifically, EPA
proposed to revise the regulations to document extends the public comment
comment period established in the period established in the Federal
Federal Register for 30 days. In that improve the management and disposal
of hazardous waste pharmaceuticals and Register for 30 days. In that Federal
Federal Register notice, EPA proposed Register notice, EPA proposed new
revising and reorganizing the tailor them to address the specific issues
that hospitals, pharmacies and other regulations for the management of
regulations for generators of hazardous hazardous waste pharmaceuticals. The
waste. The purpose of these proposed healthcare-related facilities face. The
revisions are also intended to clarify the purpose of this proposed regulation is to
revisions is to make the rules easier to
regulation of the reverse distribution improve the management and disposal
understand, facilitate better compliance,
provide greater flexibility in how mechanism used by healthcare facilities of hazardous waste pharmaceuticals and
hazardous waste is managed, and for the management of unused and/or tailor them to address the specific issues
improve environmental protection by expired pharmaceuticals. The comment that hospitals, pharmacies and other
closing important gaps in the period is being extended to December healthcare-related facilities face. The
regulations. Several requests were 24, 2015. revisions are also intended to clarify the
received from potential commenters to DATES: Comments on the proposed rule regulation of the reverse distribution
extend the comment period to allow published September 25, 2015 (80 FR mechanism used by healthcare facilities
greater time to comment. EPA is hereby 58014) must be received on or before for the management of unused and/or
extending the comment period, which December 24, 2015. expired pharmaceuticals. Several
was set to end on November 24, 2015, ADDRESSES: Submit your comments, requests were received from potential
to December 24, 2015. Please note that identified by Docket ID No. EPA–HQ– commenters to extend the comment
late comments on this rule making may RCRA–2007–0932, to the Federal period to allow greater time to
not be considered. eRulemaking Portal: http:// comment. EPA is hereby extending the
To submit comments or access the www.regulations.gov. Follow the online comment period, which was set to end
docket, please follow the detailed instructions for submitting comments. on November 24, 2015, to December 24,
instructions as provided under Once submitted, comments cannot be
2015. Please note that late comments on
ADDRESSES. If you have questions, edited or withdrawn. The EPA may
this rule making may not be considered.
consult the individuals listed under FOR publish any comment received to its
FURTHER INFORMATION CONTACT. public docket. Do not submit To submit comments or access the
Dated: October 22, 2015. electronically any information you docket, please follow the detailed
consider to be Confidential Business instructions as provided under
Barnes Johnson,
Information (CBI) or other information ADDRESSES. If you have questions,
Director, Office of Resource Conservation and
Recovery, Office of Solid Waste and whose disclosure is restricted by statute. consult the individuals listed under FOR
Emergency Response. Multimedia submissions (audio, video, FURTHER INFORMATION CONTACT.
[FR Doc. 2015–28099 Filed 11–4–15; 8:45 am]
etc.) must be accompanied by a written Dated: October 22, 2015.
comment. The written comment is
BILLING CODE 6560–50–P Barnes Johnson,
considered the official comment and
should include discussion of all points Director, Office of Resource Conservation and
you wish to make. The EPA will Recovery, Office of Solid Waste and
ENVIRONMENTAL PROTECTION Emergency Response.
AGENCY generally not consider comments or
comment contents located outside of the [FR Doc. 2015–28100 Filed 11–4–15; 8:45 am]
40 CFR Parts 261, 262, 266, 268, and primary submission (i.e. on the web, BILLING CODE 6560–50–P
273 cloud, or other file sharing system). For
additional submission methods, the full
[EPA–HQ–RCRA–2007–0932; FRL–9936–49–
OSWER] EPA public comment policy,
jstallworth on DSK7TPTVN1PROD with PROPOSALS

information about CBI or multimedia
RIN 2050–AG39 submissions, and general guidance on
making effective comments, please visit
Management Standards for Hazardous http://www2.epa.gov/dockets/
Waste Pharmaceuticals commenting-epa-dockets.
AGENCY: Environmental Protection FOR FURTHER INFORMATION CONTACT: For
Agency (EPA). more detailed information on specific

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Document Created: 2015-12-14 15:03:30
Document Modified: 2015-12-14 15:03:30

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Proposed Rules
Action		Proposed rule; extension of comment period.
Dates		Comments on the proposed rule published September 25, 2015 (80 FR 58014) must be received on or before December 24, 2015.
Contact		For more detailed information on specific aspects of this rulemaking, contact Kristin Fitzgerald, Office of Resource Conservation and Recovery (5304P), Environmental Protection Agency, 1200 Pennsylvania Avenue NW., Washington, DC 20460; telephone
FR Citation		80 FR 68491
RIN Number		2050-AG39
CFR Citation		40 CFR 261 40 CFR 262 40 CFR 266 40 CFR 268 40 CFR 273