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54360 Federal Register / Vol. 72, No.

185 / Tuesday, September 25, 2007 / Rules and Regulations

operating schedule immediately at the mailpiece most often used by medical 10.17.5b Packaging
end of the designated time period. This professionals. However, we will include * * * * *
deviation from the operating regulations language in the Domestic Mail Manual [Revise first sentence to 10.17.5b5 as
is authorized under 33 CFR 117.35. (DMM) that clarifies that individuals as follows]
Dated: September 13, 2007. well as other entities can use ‘‘Medical Each mailpiece must not weigh more
Professional Packaging.’’ than 25 pounds, except for Medical
David M. Frank,
2. Comment: Require that pre-primary Professional Packages as identified in
Bridge Administrator. receptacles comply with Food and Drug
[FR Doc. E7–18881 Filed 9–24–07; 8:45 am] 10.17.5c, that may not weigh more than
Administration (FDA) 510(k) approval 35 pounds.* * *
BILLING CODE 4910–15–P rather than Occupational Safety and
Health Administration (OSHA) * * * * *
standards. [Add a new 10.17.5c, and renumber
POSTAL SERVICE The Postal Service believes that current items 5c through 5f as new 5d
requiring pre-primary receptacles to through 5g:]
39 CFR Part 111 meet OSHA standards as identified in 10.17.5c Medical Professional
29 CFR 1910.1030 is the best method of Packages
New Standards for Mailing Sharps verifying governmental compliance for
Waste and Other Regulated Medical sharps and other regulated medical Medical Professional Packages, while
Waste waste receptacles containing bloodborne intended for use by small medical
pathogens. These pre-primary offices, are not limited to use by medical
AGENCY: Postal Service. offices only. One primary receptacle
receptacles are then triple packaged in
ACTION: Final rule. larger than 5 gallons in volume may be
accordance with further parcel
preparation requirements for the used for mailing pre-primary sharps
SUMMARY: The Postal ServiceTM is receptacles (sharps receptacles normally
revising its standards for mailing mailing of sharps mailpieces. Therefore,
the final rule adopts the requirement used in doctors’ offices) and other
medical waste so that medical regulated medical waste under the
professionals as well as individuals can that pre-primary receptacles meet OSHA
compliance standards as published in following conditions:
use a larger container to mail medical 1. The mailpiece must meet all the
waste to disposal sites. The new the proposed rule.
We adopt the following amendments requirements in 601.10.17.5 except for
standards allow a maximum mailpiece the primary receptacle capacity limits of
weight limit of 35 pounds for packages to Mailing Standards of the United
States Postal Service, Domestic Mail 10.17.5b1.
approved as ‘‘Medical Professional 2. Only rigid, securely closed,
Packaging.’’ Manual (DMM), incorporated by
reference in the Code of Federal puncture and leak-resistant pre-primary
EFFECTIVE DATE:September 25, 2007. Regulations. See 39 CFR 111.4. sharps receptacles that meet or exceed
FOR FURTHER INFORMATION CONTACT: Bert Occupational Safety and Health
Olsen, 202–268–7276. List of Subjects in 39 CFR Part 111 Administration standards as identified
SUPPLEMENTARY INFORMATION: Administrative practice and in 29 CFR 1910.1030, may be placed
procedure, Postal Service. inside the primary receptacle. Each pre-
Background ■ Accordingly, 39 CFR part 111 is primary sharps container may contain
We published a proposed rule in the amended as follows: no more than 50 ml (1.66 ounces) of
Federal Register (72 FR 20462, April 25, residual waste liquid. Several pre-
2007) to revise the standards for mailing PART 111—[AMENDED] primary sharps receptacles may be
sharps and other regulated medical enclosed in the single primary
■ 1. The authority citation for 39 CFR
waste containers. Our proposal allowed receptacle.
part 111 continues to read as follows: 3. Multiple tie-closed plastic bags of
for a single, larger primary receptacle
Authority: 5 U.S.C. 552(a); 39 U.S.C. 101, regulated medical waste may be placed
that could accommodate several pre- 401, 403, 414, 416, 3001–3011, 3201–3219,
primary sharps receptacles (sharps inside the single primary receptacle.
3403–3406, 3621, 3626, 5001. 4. The primary receptacle must be
receptacles normally used in doctors’
offices), as well as several tie-closed ■ 2. Revise the following sections of the lined with a plastic bag at least 4 mil in
bags of other regulated medical waste. Mailing Standards of the United States thickness and must include sufficient
The weight limit of the mailpiece would Postal Service, Domestic Mail Manual absorbent material within the liner to
be 35 pounds. (DMM), as follows: absorb all residual liquid in the primary
* * * * * receptacle.
Comments Received 5. The mailpiece must not weigh more
We received comments from two 600 Basic Standards for All Mailing than 35 pounds.
entities: a USPS-authorized sharps Services * * * * *
vendor and a coalition of parties 601 Mailability
601.10.17.5d Mailpiece Labeling,
interested in the safe disposal of * * * * * Marking, and Documentation
needles. Both were in support of the
changes and offered the following 601.10 Hazardous Materials [Add new number 1, and renumber
comments: * * * * * current items 1 through 7 as new 2
1. Comment: The term ‘‘Medical through 8:]
Professional Packaging’’ implies that 10.17 Infectious Substances (Hazard 1. For Medical Professional Packages,
only medical professionals can use it. Class 6, Division 6.2) the additional marking ‘‘Medical
yshivers on PROD1PC62 with RULES

Change the name so it is clear that it can * * * * * Professional Packaging’’ must be clearly
be used by anyone. printed in lettering at least 2 inches high
The Postal Service believes the term, 10.17.5 Sharps Waste and Other on the address side of the outer
‘‘Medical Professional Packaging’’ is an Mailable Regulated Medical Waste shipping container.
appropriate term that represents a * * * * * * * * * *

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Federal Register / Vol. 72, No. 185 / Tuesday, September 25, 2007 / Rules and Regulations 54361

[Add two new sentences to the Although listed in the electronic docket, memorializing in this action that EPA’s
introductory text at the beginning of some information is not publicly compliance with the congressional
redesignated 10.17.5f as follows:] available, i.e., confidential business review requirements of the
information (CBI) or other information Congressional Review Act, has as a
601.10.17.5f Testing Criteria
whose disclosure is restricted by statute. matter of law, changed the effective date
Packages tested for approval as Certain other material, such as of the July 25, 2007 action, and EPA has
Medical Professional Packages may not copyrighted material, is not placed on no discretion in this matter. Thus,
be tested using pre-primary containers the Internet and will be publicly notice and public procedure are
that are currently or have previously available only in hard copy form. unnecessary. The Agency finds that this
been approved as USPS primary Publicly available docket materials are constitutes good cause under 5 U.S.C.
containers. Test reports must identify by available either electronically through 553(b)(B). Moreover, because today’s
brand name the pre-primary containers www.regulations.gov or in hard copy for action does not create any new
used during testing. * * * public inspection during normal regulatory requirements and the
* * * * * business hours at the Air Protection submittal of the rule to Congress has, by
Division, U.S. Environmental Protection operation of law, changed the effective
Neva R. Watson, Agency, Region III, 1650 Arch Street, date of the July 25, 2007 rule to July 27,
Attorney, Legislative. Philadelphia, Pennsylvania 19103. which this action merely memorializes,
[FR Doc. E7–18626 Filed 9–24–07; 8:45 am] Copies of the State submittal are EPA finds that good cause exists to
BILLING CODE 7710–12–P available at the Pennsylvania provide for an immediate effective date
Department of Environmental pursuant to 5 U.S.C. 553(d)(3). Because
Protection, Bureau of Air Quality the delay in the effective date was
ENVIRONMENTAL PROTECTION Control, P.O. Box 8468, 400 Market caused by EPA’s inadvertent failure to
AGENCY Street, Harrisburg, Pennsylvania 17105. submit the rule under the Congressional
FOR FURTHER INFORMATION CONTACT: Review Act, EPA does not believe that
40 CFR Parts 52 and 81 Christopher Cripps, (215) 814–2179, or affected entities that acted in good faith
by e-mail at cripps.christopher@epa.gov. relying upon the effective date stated in
[EPA–R03–OAR–2007–0174; FRL–8473–1]
SUPPLEMENTARY INFORMATION: the July 25, 2007, Federal Register
Technical Amendments to Approval should be penalized if they were
and Promulgation of Air Quality I. Background complying with the rule as
Implementation Plans; Pennsylvania; Section 801 of the Congressional promulgated.
Correction of Effective Date Under review Act precludes a rule from taking II. Statutory and Executive Order
Congressional Review Act effect until the agency promulgating the Reviews
rule submits a rule report, which
AGENCY: Environmental Protection includes a copy of the rule, to each A. General Requirements
Agency (EPA). House of Congress and to the Under Executive Order 12866 (58 FR
ACTION: Final rule; correction of Comptroller General of the Government 51735, October 4, 1993), this action is
effective date under Congressional Accountability Office (GAO). After not a ‘‘significant regulatory action’’ and
Review Act. publication of the July 25, 2007 final therefore is not subject to review by the
rule (72 FR 40746) EPA discovered that Office of Management and Budget. For
SUMMARY: On July 25, 2007 (72 FR
it had inadvertently failed to submit the this reason, this action is also not
40746), the EPA published in the above rule as required; thus, although subject to Executive Order 13211,
Federal Register a final rule that the rule was promulgated on July 25, ‘‘Actions Concerning Regulations That
approved a request that the Franklin 2007 (72 FR 40746), by operation of law, Significantly Affect Energy Supply,
County nonattainment area (‘‘Franklin the rule did not take effect on July 25, Distribution, or Use’’ (66 FR 28355, May
County Area’’ or ‘‘Area’’) be 2007, as stated therein. After EPA 22, 2001). This action merely approves
redesignated as attainment for the 8- discovered this error, EPA complied state law as meeting Federal
hour ozone national ambient air quality with its obligations under the requirements and imposes no additional
standard (NAAQS) and that approved Congressional Review Act by submitting requirements beyond those imposed by
the maintenance plan and the 2002 the rule to both Houses of Congress and state law. Redesignation of an area to
base-year emissions inventory as the GAO on July 27, 2007. This attainment under section 107(d)(3)(e) of
revisions to the Pennsylvania SIP in document corrects certain dates the Clean Air Act does not impose any
accordance with the requirements of the displayed in 40 CFR parts 52 and 81 to new requirements on small entities.
Clean Air Act (CAA). That July 25, 2007 reflect the date on which EPA satisfied Redesignation is an action that affects
final rule established an effective date of the procedural requirements of the the status of a geographical area and
July 25, 2007. This document corrects Congressional Review Act. does not impose any new regulatory
the effective date of the rule to July 27, Section 553 of the Administrative requirements on sources.
2007 to be consistent with sections 801 Procedure Act, 5 U.S.C. 553(b)(3)(B), Accordingly, the Administrator
and 808 of the Congressional Review provides that, when an agency for good certifies that this rule will not have a
Act, enacted as part of the Small cause finds that notice and public significant economic impact on a
Business Regulatory Enforcement procedure are impracticable, substantial number of small entities
Fairness Act, 5 U.S.C. 801 and 808. unnecessary or contrary to the public under the Regulatory Flexibility Act (5
EFFECTIVE DATE: This rule is effective on interest, an agency may issue a rule U.S.C. 601 et seq.). Because this rule
September 25, 2007. without providing notice and an approves pre-existing requirements
yshivers on PROD1PC62 with RULES

ADDRESSES: EPA has established a opportunity for public comment. EPA under state law and does not impose
docket for this action under Docket ID has determined that there is good cause any additional enforceable duty beyond
Number EPA–R03–OAR–2007–0174. All for making today’s rule final without that required by state law, it does not
documents in the docket are listed in prior proposal and opportunity for contain any unfunded mandate or
the www.regulations.gov Web site. comment because EPA merely is significantly or uniquely affect small

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