New Standards for Mailing Sharps Waste and Other Regulated Medical Waste, 54360-54361 [E7-18626]
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54360
Federal Register / Vol. 72, No. 185 / Tuesday, September 25, 2007 / Rules and Regulations
operating schedule immediately at the
end of the designated time period. This
deviation from the operating regulations
is authorized under 33 CFR 117.35.
Dated: September 13, 2007.
David M. Frank,
Bridge Administrator.
[FR Doc. E7–18881 Filed 9–24–07; 8:45 am]
BILLING CODE 4910–15–P
POSTAL SERVICE
39 CFR Part 111
New Standards for Mailing Sharps
Waste and Other Regulated Medical
Waste
Postal Service.
Final rule.
AGENCY:
ACTION:
The Postal ServiceTM is
revising its standards for mailing
medical waste so that medical
professionals as well as individuals can
use a larger container to mail medical
waste to disposal sites. The new
standards allow a maximum mailpiece
weight limit of 35 pounds for packages
approved as ‘‘Medical Professional
Packaging.’’
SUMMARY:
September 25, 2007.
Bert
Olsen, 202–268–7276.
SUPPLEMENTARY INFORMATION:
EFFECTIVE DATE:
FOR FURTHER INFORMATION CONTACT:
Background
We published a proposed rule in the
Federal Register (72 FR 20462, April 25,
2007) to revise the standards for mailing
sharps and other regulated medical
waste containers. Our proposal allowed
for a single, larger primary receptacle
that could accommodate several preprimary sharps receptacles (sharps
receptacles normally used in doctors’
offices), as well as several tie-closed
bags of other regulated medical waste.
The weight limit of the mailpiece would
be 35 pounds.
yshivers on PROD1PC62 with RULES
Comments Received
We received comments from two
entities: a USPS-authorized sharps
vendor and a coalition of parties
interested in the safe disposal of
needles. Both were in support of the
changes and offered the following
comments:
1. Comment: The term ‘‘Medical
Professional Packaging’’ implies that
only medical professionals can use it.
Change the name so it is clear that it can
be used by anyone.
The Postal Service believes the term,
‘‘Medical Professional Packaging’’ is an
appropriate term that represents a
VerDate Aug<31>2005
15:17 Sep 24, 2007
Jkt 211001
mailpiece most often used by medical
professionals. However, we will include
language in the Domestic Mail Manual
(DMM) that clarifies that individuals as
well as other entities can use ‘‘Medical
Professional Packaging.’’
2. Comment: Require that pre-primary
receptacles comply with Food and Drug
Administration (FDA) 510(k) approval
rather than Occupational Safety and
Health Administration (OSHA)
standards.
The Postal Service believes that
requiring pre-primary receptacles to
meet OSHA standards as identified in
29 CFR 1910.1030 is the best method of
verifying governmental compliance for
sharps and other regulated medical
waste receptacles containing bloodborne
pathogens. These pre-primary
receptacles are then triple packaged in
accordance with further parcel
preparation requirements for the
mailing of sharps mailpieces. Therefore,
the final rule adopts the requirement
that pre-primary receptacles meet OSHA
compliance standards as published in
the proposed rule.
We adopt the following amendments
to Mailing Standards of the United
States Postal Service, Domestic Mail
Manual (DMM), incorporated by
reference in the Code of Federal
Regulations. See 39 CFR 111.4.
List of Subjects in 39 CFR Part 111
Administrative practice and
procedure, Postal Service.
I Accordingly, 39 CFR part 111 is
amended as follows:
PART 111—[AMENDED]
1. The authority citation for 39 CFR
part 111 continues to read as follows:
I
Authority: 5 U.S.C. 552(a); 39 U.S.C. 101,
401, 403, 414, 416, 3001–3011, 3201–3219,
3403–3406, 3621, 3626, 5001.
2. Revise the following sections of the
Mailing Standards of the United States
Postal Service, Domestic Mail Manual
(DMM), as follows:
*
*
*
*
*
I
600 Basic Standards for All Mailing
Services
601
Mailability
*
*
601.10
*
*
*
*
*
Hazardous Materials
*
*
*
10.17 Infectious Substances (Hazard
Class 6, Division 6.2)
*
*
*
*
*
10.17.5 Sharps Waste and Other
Mailable Regulated Medical Waste
*
PO 00000
*
*
Frm 00020
*
Fmt 4700
*
Sfmt 4700
10.17.5b
Packaging
*
*
*
*
*
[Revise first sentence to 10.17.5b5 as
follows]
Each mailpiece must not weigh more
than 25 pounds, except for Medical
Professional Packages as identified in
10.17.5c, that may not weigh more than
35 pounds.* * *
*
*
*
*
*
[Add a new 10.17.5c, and renumber
current items 5c through 5f as new 5d
through 5g:]
10.17.5c Medical Professional
Packages
Medical Professional Packages, while
intended for use by small medical
offices, are not limited to use by medical
offices only. One primary receptacle
larger than 5 gallons in volume may be
used for mailing pre-primary sharps
receptacles (sharps receptacles normally
used in doctors’ offices) and other
regulated medical waste under the
following conditions:
1. The mailpiece must meet all the
requirements in 601.10.17.5 except for
the primary receptacle capacity limits of
10.17.5b1.
2. Only rigid, securely closed,
puncture and leak-resistant pre-primary
sharps receptacles that meet or exceed
Occupational Safety and Health
Administration standards as identified
in 29 CFR 1910.1030, may be placed
inside the primary receptacle. Each preprimary sharps container may contain
no more than 50 ml (1.66 ounces) of
residual waste liquid. Several preprimary sharps receptacles may be
enclosed in the single primary
receptacle.
3. Multiple tie-closed plastic bags of
regulated medical waste may be placed
inside the single primary receptacle.
4. The primary receptacle must be
lined with a plastic bag at least 4 mil in
thickness and must include sufficient
absorbent material within the liner to
absorb all residual liquid in the primary
receptacle.
5. The mailpiece must not weigh more
than 35 pounds.
*
*
*
*
*
601.10.17.5d Mailpiece Labeling,
Marking, and Documentation
[Add new number 1, and renumber
current items 1 through 7 as new 2
through 8:]
1. For Medical Professional Packages,
the additional marking ‘‘Medical
Professional Packaging’’ must be clearly
printed in lettering at least 2 inches high
on the address side of the outer
shipping container.
*
*
*
*
*
E:\FR\FM\25SER1.SGM
25SER1
Federal Register / Vol. 72, No. 185 / Tuesday, September 25, 2007 / Rules and Regulations
[Add two new sentences to the
introductory text at the beginning of
redesignated 10.17.5f as follows:]
601.10.17.5f
Testing Criteria
Packages tested for approval as
Medical Professional Packages may not
be tested using pre-primary containers
that are currently or have previously
been approved as USPS primary
containers. Test reports must identify by
brand name the pre-primary containers
used during testing. * * *
*
*
*
*
*
Neva R. Watson,
Attorney, Legislative.
[FR Doc. E7–18626 Filed 9–24–07; 8:45 am]
BILLING CODE 7710–12–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 52 and 81
[EPA–R03–OAR–2007–0174; FRL–8473–1]
Technical Amendments to Approval
and Promulgation of Air Quality
Implementation Plans; Pennsylvania;
Correction of Effective Date Under
Congressional Review Act
Environmental Protection
Agency (EPA).
ACTION: Final rule; correction of
effective date under Congressional
Review Act.
yshivers on PROD1PC62 with RULES
AGENCY:
SUMMARY: On July 25, 2007 (72 FR
40746), the EPA published in the
Federal Register a final rule that
approved a request that the Franklin
County nonattainment area (‘‘Franklin
County Area’’ or ‘‘Area’’) be
redesignated as attainment for the 8hour ozone national ambient air quality
standard (NAAQS) and that approved
the maintenance plan and the 2002
base-year emissions inventory as
revisions to the Pennsylvania SIP in
accordance with the requirements of the
Clean Air Act (CAA). That July 25, 2007
final rule established an effective date of
July 25, 2007. This document corrects
the effective date of the rule to July 27,
2007 to be consistent with sections 801
and 808 of the Congressional Review
Act, enacted as part of the Small
Business Regulatory Enforcement
Fairness Act, 5 U.S.C. 801 and 808.
EFFECTIVE DATE: This rule is effective on
September 25, 2007.
ADDRESSES: EPA has established a
docket for this action under Docket ID
Number EPA–R03–OAR–2007–0174. All
documents in the docket are listed in
the www.regulations.gov Web site.
VerDate Aug<31>2005
15:17 Sep 24, 2007
Jkt 211001
Although listed in the electronic docket,
some information is not publicly
available, i.e., confidential business
information (CBI) or other information
whose disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available either electronically through
www.regulations.gov or in hard copy for
public inspection during normal
business hours at the Air Protection
Division, U.S. Environmental Protection
Agency, Region III, 1650 Arch Street,
Philadelphia, Pennsylvania 19103.
Copies of the State submittal are
available at the Pennsylvania
Department of Environmental
Protection, Bureau of Air Quality
Control, P.O. Box 8468, 400 Market
Street, Harrisburg, Pennsylvania 17105.
FOR FURTHER INFORMATION CONTACT:
Christopher Cripps, (215) 814–2179, or
by e-mail at cripps.christopher@epa.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Section 801 of the Congressional
review Act precludes a rule from taking
effect until the agency promulgating the
rule submits a rule report, which
includes a copy of the rule, to each
House of Congress and to the
Comptroller General of the Government
Accountability Office (GAO). After
publication of the July 25, 2007 final
rule (72 FR 40746) EPA discovered that
it had inadvertently failed to submit the
above rule as required; thus, although
the rule was promulgated on July 25,
2007 (72 FR 40746), by operation of law,
the rule did not take effect on July 25,
2007, as stated therein. After EPA
discovered this error, EPA complied
with its obligations under the
Congressional Review Act by submitting
the rule to both Houses of Congress and
the GAO on July 27, 2007. This
document corrects certain dates
displayed in 40 CFR parts 52 and 81 to
reflect the date on which EPA satisfied
the procedural requirements of the
Congressional Review Act.
Section 553 of the Administrative
Procedure Act, 5 U.S.C. 553(b)(3)(B),
provides that, when an agency for good
cause finds that notice and public
procedure are impracticable,
unnecessary or contrary to the public
interest, an agency may issue a rule
without providing notice and an
opportunity for public comment. EPA
has determined that there is good cause
for making today’s rule final without
prior proposal and opportunity for
comment because EPA merely is
PO 00000
Frm 00021
Fmt 4700
Sfmt 4700
54361
memorializing in this action that EPA’s
compliance with the congressional
review requirements of the
Congressional Review Act, has as a
matter of law, changed the effective date
of the July 25, 2007 action, and EPA has
no discretion in this matter. Thus,
notice and public procedure are
unnecessary. The Agency finds that this
constitutes good cause under 5 U.S.C.
553(b)(B). Moreover, because today’s
action does not create any new
regulatory requirements and the
submittal of the rule to Congress has, by
operation of law, changed the effective
date of the July 25, 2007 rule to July 27,
which this action merely memorializes,
EPA finds that good cause exists to
provide for an immediate effective date
pursuant to 5 U.S.C. 553(d)(3). Because
the delay in the effective date was
caused by EPA’s inadvertent failure to
submit the rule under the Congressional
Review Act, EPA does not believe that
affected entities that acted in good faith
relying upon the effective date stated in
the July 25, 2007, Federal Register
should be penalized if they were
complying with the rule as
promulgated.
II. Statutory and Executive Order
Reviews
A. General Requirements
Under Executive Order 12866 (58 FR
51735, October 4, 1993), this action is
not a ‘‘significant regulatory action’’ and
therefore is not subject to review by the
Office of Management and Budget. For
this reason, this action is also not
subject to Executive Order 13211,
‘‘Actions Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use’’ (66 FR 28355, May
22, 2001). This action merely approves
state law as meeting Federal
requirements and imposes no additional
requirements beyond those imposed by
state law. Redesignation of an area to
attainment under section 107(d)(3)(e) of
the Clean Air Act does not impose any
new requirements on small entities.
Redesignation is an action that affects
the status of a geographical area and
does not impose any new regulatory
requirements on sources.
Accordingly, the Administrator
certifies that this rule will not have a
significant economic impact on a
substantial number of small entities
under the Regulatory Flexibility Act (5
U.S.C. 601 et seq.). Because this rule
approves pre-existing requirements
under state law and does not impose
any additional enforceable duty beyond
that required by state law, it does not
contain any unfunded mandate or
significantly or uniquely affect small
E:\FR\FM\25SER1.SGM
25SER1
]]>Agencies
[Federal Register Volume 72, Number 185 (Tuesday, September 25, 2007)]
[Rules and Regulations]
[Pages 54360-54361]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-18626]
=======================================================================
-----------------------------------------------------------------------
POSTAL SERVICE
39 CFR Part 111
New Standards for Mailing Sharps Waste and Other Regulated
Medical Waste
AGENCY: Postal Service.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Postal Service\TM\ is revising its standards for mailing
medical waste so that medical professionals as well as individuals can
use a larger container to mail medical waste to disposal sites. The new
standards allow a maximum mailpiece weight limit of 35 pounds for
packages approved as ``Medical Professional Packaging.''
EFFECTIVE DATE: September 25, 2007.
FOR FURTHER INFORMATION CONTACT: Bert Olsen, 202-268-7276.
SUPPLEMENTARY INFORMATION:
Background
We published a proposed rule in the Federal Register (72 FR 20462,
April 25, 2007) to revise the standards for mailing sharps and other
regulated medical waste containers. Our proposal allowed for a single,
larger primary receptacle that could accommodate several pre-primary
sharps receptacles (sharps receptacles normally used in doctors'
offices), as well as several tie-closed bags of other regulated medical
waste. The weight limit of the mailpiece would be 35 pounds.
Comments Received
We received comments from two entities: a USPS-authorized sharps
vendor and a coalition of parties interested in the safe disposal of
needles. Both were in support of the changes and offered the following
comments:
1. Comment: The term ``Medical Professional Packaging'' implies
that only medical professionals can use it. Change the name so it is
clear that it can be used by anyone.
The Postal Service believes the term, ``Medical Professional
Packaging'' is an appropriate term that represents a mailpiece most
often used by medical professionals. However, we will include language
in the Domestic Mail Manual (DMM) that clarifies that individuals as
well as other entities can use ``Medical Professional Packaging.''
2. Comment: Require that pre-primary receptacles comply with Food
and Drug Administration (FDA) 510(k) approval rather than Occupational
Safety and Health Administration (OSHA) standards.
The Postal Service believes that requiring pre-primary receptacles
to meet OSHA standards as identified in 29 CFR 1910.1030 is the best
method of verifying governmental compliance for sharps and other
regulated medical waste receptacles containing bloodborne pathogens.
These pre-primary receptacles are then triple packaged in accordance
with further parcel preparation requirements for the mailing of sharps
mailpieces. Therefore, the final rule adopts the requirement that pre-
primary receptacles meet OSHA compliance standards as published in the
proposed rule.
We adopt the following amendments to Mailing Standards of the
United States Postal Service, Domestic Mail Manual (DMM), incorporated
by reference in the Code of Federal Regulations. See 39 CFR 111.4.
List of Subjects in 39 CFR Part 111
Administrative practice and procedure, Postal Service.
0
Accordingly, 39 CFR part 111 is amended as follows:
PART 111--[AMENDED]
0
1. The authority citation for 39 CFR part 111 continues to read as
follows:
Authority: 5 U.S.C. 552(a); 39 U.S.C. 101, 401, 403, 414, 416,
3001-3011, 3201-3219, 3403-3406, 3621, 3626, 5001.
0
2. Revise the following sections of the Mailing Standards of the United
States Postal Service, Domestic Mail Manual (DMM), as follows:
* * * * *
600 Basic Standards for All Mailing Services
601 Mailability
* * * * *
601.10 Hazardous Materials
* * * * *
10.17 Infectious Substances (Hazard Class 6, Division 6.2)
* * * * *
10.17.5 Sharps Waste and Other Mailable Regulated Medical Waste
* * * * *
10.17.5b Packaging
* * * * *
[Revise first sentence to 10.17.5b5 as follows]
Each mailpiece must not weigh more than 25 pounds, except for
Medical Professional Packages as identified in 10.17.5c, that may not
weigh more than 35 pounds.* * *
* * * * *
[Add a new 10.17.5c, and renumber current items 5c through 5f as
new 5d through 5g:]
10.17.5c Medical Professional Packages
Medical Professional Packages, while intended for use by small
medical offices, are not limited to use by medical offices only. One
primary receptacle larger than 5 gallons in volume may be used for
mailing pre-primary sharps receptacles (sharps receptacles normally
used in doctors' offices) and other regulated medical waste under the
following conditions:
1. The mailpiece must meet all the requirements in 601.10.17.5
except for the primary receptacle capacity limits of 10.17.5b1.
2. Only rigid, securely closed, puncture and leak-resistant pre-
primary sharps receptacles that meet or exceed Occupational Safety and
Health Administration standards as identified in 29 CFR 1910.1030, may
be placed inside the primary receptacle. Each pre-primary sharps
container may contain no more than 50 ml (1.66 ounces) of residual
waste liquid. Several pre-primary sharps receptacles may be enclosed in
the single primary receptacle.
3. Multiple tie-closed plastic bags of regulated medical waste may
be placed inside the single primary receptacle.
4. The primary receptacle must be lined with a plastic bag at least
4 mil in thickness and must include sufficient absorbent material
within the liner to absorb all residual liquid in the primary
receptacle.
5. The mailpiece must not weigh more than 35 pounds.
* * * * *
601.10.17.5d Mailpiece Labeling, Marking, and Documentation
[Add new number 1, and renumber current items 1 through 7 as new 2
through 8:]
1. For Medical Professional Packages, the additional marking
``Medical Professional Packaging'' must be clearly printed in lettering
at least 2 inches high on the address side of the outer shipping
container.
* * * * *
[[Page 54361]]
[Add two new sentences to the introductory text at the beginning of
redesignated 10.17.5f as follows:]
601.10.17.5f Testing Criteria
Packages tested for approval as Medical Professional Packages may
not be tested using pre-primary containers that are currently or have
previously been approved as USPS primary containers. Test reports must
identify by brand name the pre-primary containers used during testing.
* * *
* * * * *
Neva R. Watson,
Attorney, Legislative.
[FR Doc. E7-18626 Filed 9-24-07; 8:45 am]
BILLING CODE 7710-12-P
