[Federal Register Volume 84, Number 120 (Friday, June 21, 2019)]
[Rules and Regulations]
[Pages 29076-29078]
[FR Doc No: 2019-13185]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2019-0472]
RIN 1625-AA00

Safety Zones; Milwaukee's July 3rd Fireworks, Milwaukee Harbor,
Milwaukee, WI

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone around
three barges moored in Milwaukee Harbor in the vicinity of Pier
Wisconsin. The safety zone is needed to protect personnel and vessels
from potential hazards created by the outfall of the fireworks display.
Entry of vessels or persons into this zone is prohibited unless
specifically authorized by the Captain of the Port Lake Michigan or a
designated representative.

DATES: This rule is effective from 8 p.m. through 11 p.m. July 3, 2019.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2019-0472 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email the marine event coordinator, MSTC Kaleena Carpino,
Prevention Department, Coast Guard Sector Lake Michigan, Milwaukee, WI
at<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because doing so would be impracticable and
contrary to the public interest. The final details for this event were
not known to the Coast Guard until there was insufficient time
remaining before the event to publish an NPRM. Delaying the effective
date of this rule to wait for a comment period to run would be both
impracticable and contrary to the public interest because it would
inhibit the Coast Guard's ability to protect the public, vessels,
mariners, and property from the hazards associated with the fireworks
display on July 3, 2019.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register for the same reasons discussed in
the preceding paragraph, waiting for a 30 day notice period to run
would be impracticable and contrary to the public interest.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034 (previously 33 U.S.C. 1231). The Captain of the Port Lake
Michigan will enforce a safety zone from 8 p.m. through 11 p.m. on July
3, 2019, for a fireworks display on Lake Michigan in Milwaukee, WI. The
Captain of the Port Lake Michigan has determined that this fireworks
display will pose a significant risk to public safety and property.
Such hazards include premature and accidental detonations, falling and
burning debris, and collisions among spectator vessels.

IV. Discussion of the Rule

    With the aforementioned hazards in mind, the Captain of the Port
Lake Michigan has determined that this temporary safety zone is
necessary to protect persons and vessels during the fireworks display
in the waters of Milwaukee Harbor, on Lake Michigan. This zone is
effective and will be enforced from 8 p.m. through 11 p.m. on July 3,
2019. The safety zone will be enforced for all navigable waters within
an area bounded by the following coordinates; at 43[deg]02'32.9'' N
087[deg]53'34.9'' W (NAD 83) continuing East across Milwaukee Harbor to
43[deg]02'42.0'' N 087[deg]53'06.0'' W (NAD 83) then South to
43[deg]02'00.00'' N 087[deg]53'06.0'' W (NAD 83) then West across the
Milwaukee Harbor to 43[deg]02'00.00'' N 087[deg]53'41.0'' W (NAD 83)
then North returning to the point of origin on Lake Michigan in
Milwaukee, WI.
    Entry into, transiting, or anchoring within the safety zone is
prohibited unless authorized by the Captain of the Port Lake Michigan
or his or her designated on-scene representative. The Captain of the
Port or his or her designated on-scene representative may be contacted
via VHF Channel 16.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size,
location, duration, and time-of-year of the safety zone. The safety
zone created by this rule will be relatively small and enforced for
only three hours. Under certain conditions, vessels may still transit
through the safety zone when permitted by the Captain of the Port.
Moreover, the Coast Guard will issue Broadcast Notice to Mariners via
VHF-FM marine channel 16 about the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their

fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01 and Environmental Planning COMDTINST 5090.1 (series),
which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have
determined that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule involves a safety zone lasting only three hours
that will prohibit entry within the established safety zone for the
firework display. It is categorically excluded from further review
under paragraph L[60](a) in Table 3-1 of U.S. Coast Guard Environmental
Planning Implementing Procedures 5090.1. A Record of Environmental
Consideration supporting this determination is available in the docket
where indicated under ADDRESSES.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No. 0170.1.

0
2. ADD Sec.  165.T09-0472 to read as follows:

Sec.  165.T09-0472   Safety Zone; Milwaukee's July 3rd Fireworks,
Milwaukee Harbor, Milwaukee WI.

    (a) Location. All navigable waters bounded by the following
coordinates; at 43[deg]02'32.9'' N 087[deg]53'34.9'' W (NAD 83)
continuing East across Milwaukee Harbor to 43[deg]02'42.0'' N
087[deg]53'06.0'' W (NAD 83) then South to 43[deg]02'00.00'' N
087[deg]53'06.0'' W (NAD 83) then West across the Milwaukee Harbor to
43[deg]02'00.00'' N 087[deg]53'41.0'' W (NAD 83) then North returning
to the point of origin on Lake Michigan in Milwaukee, WI.
    (b) Effective and enforcement period. This rule is effective and
will be enforced from 8 p.m. through 11 p.m. on July 3, 2019.
    (c) Regulations. (1) In accordance with the general regulations in
Sec.  165.23 of this part, entry into, transiting, or anchoring within
this safety zone is prohibited unless authorized by the Captain of the
Port Lake Michigan or a designated on-scene representative.
    (2) This safety zone is closed to all vessel traffic, except as may
be permitted by the Captain of the Port Lake Michigan or a designated
on-scene representative.
    (3) The ``on-scene representative'' of the Captain of the Port Lake
Michigan is any Coast Guard commissioned, warrant or petty officer who
has been designated by the Captain of the Port Lake Michigan to act on
his or her behalf.
    (4) Vessel operators desiring to enter or operate within the safety
zone must contact the Captain of the Port Lake Michigan or an on-scene
representative to obtain permission to do so. The Captain of the Port
Lake Michigan or an on-scene representative may be contacted via VHF
Channel 16. Vessel operators given permission to enter or operate in
the safety zone must comply with all directions given to them by the
Captain of the Port Lake Michigan or an on-scene representative.

    Dated: June 14, 2019.
Thomas J. Stuhlreyer,
Captain, U.S. Coast Guard, Captain of the Port, Lake Michigan.
[FR Doc. 2019-13185 Filed 6-20-19; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 81, Number 186 (Monday, September 26, 2016)]
[Rules and Regulations]
[Pages 65897-65899]
[FR Doc No: 2016-22981]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R07-OAR-2015-0835; FRL 9952-79-Region 7]

Approval of Air Quality Implementation Plans; Missouri State
Implementation Plan for the 2008 Lead Standard

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking final
action to approve a revision to the State Implementation Plan (SIP) for
the State of Missouri. This final action will approve Missouri's SIP
for the lead National Ambient Air Quality Standard (NAAQS) received by
EPA on October 20, 2014. EPA proposed approval of this plan on February
29, 2016. The applicable standard addressed in this action is the lead
NAAQS promulgated by EPA in 2008. EPA believes that the SIP submitted
by the state satisfies the applicable requirements of the Clean Air Act
(CAA) identified in EPA's Final Rule published in the Federal Register
on October 15, 2008, and will bring the area surrounding the Exide
Technologies Canon Hollow facility in Forest City, Missouri, into
attainment of the 0.15 microgram per cubic meter (ug/m\3\) lead NAAQS.

DATES: This final rule is effective on October 26, 2016.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-R07-OAR-2015-0835. All documents in the docket are listed on
the http://www.regulations.gov Web site. Although listed in the index,
some information is not publicly available, i.e., 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 through www.regulations.gov or
please contact the person identified in the FOR FURTHER INFORMATION
CONTACT section for additional information.

FOR FURTHER INFORMATION CONTACT: Stephanie Doolan, Environmental
Protection Agency, Air Planning and Development Branch, 11201 Renner
Boulevard, Lenexa, Kansas 66219 at<PHONE_NUMBER>, or by email at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' or
``our'' refer to EPA.

Table of Contents

I. What is being addressed in this document?
II. Have the requirements for approval of a SIP revision been met?
III. EPA's Response to Comments
IV. What action is EPA taking?

I. What is being addressed in this document?

    In this document, EPA is granting final approval of Missouri's SIP
to address violations of the lead NAAQS near the Exide Technologies--
Canon Hollow facility in Holt County, Missouri. The applicable standard
addressed in this action is the lead NAAQS promulgated by EPA in 2008.
The applicable requirements of the CAA identified in EPA's Final Rule
(73 FR 66964, October 15, 2008), and will bring the area into
compliance with the 0.15 microgram per cubic meter (ug/m\3\) lead
NAAQS. EPA's proposal containing the background information for this
action can be found at 81 FR 10182, February 29, 2016.

II. Have the requirements for the approval of a SIP revision been met?

    The state submission has met the public notice requirements for SIP
submissions in accordance with 40 CFR 51.102. The submission also
satisfied the completeness criteria of 40 CFR part 51, appendix V. In
addition, the revision meets the substantive SIP requirements of the
CAA, including section 110 and implementing regulations.

III. EPA's Response to Comments

    The public comment period on EPA's proposed rule opened February
29, 2016, the date of its publication in the Federal Register, and
closed on March 30, 2016. During this period, EPA received two comments
posted anonymously to the Regulations.gov Web site.
    One comment pertains to mold in indoor air and not the subject of
the proposed approval of the SIP revision to address lead in ambient
air. Because the comment is anonymous, EPA is unable to contact the
commenter directly to offer assistance. However, EPA offers that the
commenter may contact Ms. Gina Grier of EPA Region 7 directly at (913)
551-7078 for more information and assistance on the commenter's
concerns about mold.
    The second comment states that he/she is in agreement with EPA's
proposed action to approve the revision to the SIP and the commenter
offers two suggestions. The first suggestion is to estimate the cost of
water washing to clean haul routes on the facility property and the
second is a concern that limiting truck traffic on the facility
property may reduce the resources purchased in the state of Missouri.
    EPA's response to the first suggestion regarding water washing to
clean the on-site haul routes is that the use of water to remove lead
from on-site roads was studied and determined to be a cost-effective
and necessary strategy to control lead during the development of the
National Emissions Standards for Hazardous Air Pollutants (NESHAP) for
Secondary Lead Smelters, promulgated January 5, 2012 (77 FR 580).
Because the Exide Canon Hollow facility is a secondary lead smelter, it
must comply with the requirements of this rule, including, among other
things, the requirement to conduct twice daily water washing of on-site
haul routes. This cleaning is necessary to control lead-containing dust
in order to meet the 2008 lead NAAQS. The NESHAP is related to the
NAAQS in that the NESHAP requires attainment of the same 0.15 ug/m\3\
standard for lead at the fenceline. No change has been made to address
this suggestion.
    Regarding the concern that limiting truck traffic may reduce the
resources purchased in the state of Missouri, the state and facility
arrived at the limitations on truck traffic using EPA's AERMOD
computer-based modeling. Truck traffic along haul routes is known to
increase the amount of lead-containing dust that becomes re-entrained
in ambient air. Modeling was used to estimate the amount of truck
traffic along facility haul routes that could be allowed without
causing a NAAQS violation at the fenceline. Thus, the limitations are
necessary to safeguard the NAAQS level which EPA has determined to be
protective of human health and the environment. It also should be noted
that the restrictions on truck traffic that are required by the SIP
only pertain to traffic on the facility property; there are no
limitations on the amount of truck traffic on public roads. No change
has been made to address this concern.

IV. What action is EPA taking?

    EPA is taking final action to amend the Missouri SIP to approve the
SIP

revision for the 2008 lead NAAQS. The applicable standard addressed in
this action is the lead NAAQS promulgated by EPA in 2008 (73 FR 66964).

Incorporation by Reference

    In this rule, EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, EPA is finalizing the incorporation by reference of the EPA-
Approved Kansas Source-Specific Requirements. Therefore, these
materials have been approved by EPA for inclusion in the State
implementation plan, have been incorporated by reference by EPA into
that plan, are fully Federally enforceable under sections 110 and 113
of the CAA as of the effective date of the final rulemaking of EPA's
approval, and will be incorporated by reference by the Director of the
Federal Register in the next update to the SIP compilation.\1\ EPA has
made, and will continue to make, these documents generally available
electronically through www.regulations.gov and at the appropriate EPA
office (see the ADDRESSES section of this preamble for more
information).
---------------------------------------------------------------------------

    \1\ 62 FR 27968 (May 22, 1997).
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Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, the rule does
not have tribal implications and will not impose substantial direct
costs on tribal governments or preempt tribal law as specified by
Executive Order 13175 (65 FR 67249, November 9, 2000).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this proposed action
and other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register.
    A major rule cannot take effect until 60 days after it is published
in the Federal Register. This proposed action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by November 25, 2016. Filing a petition for
reconsideration by the Administrator of this proposed rule does not
affect the finality of this rulemaking for the purposes of judicial
review nor does it extend the time within which a petition for judicial
review may be filed, and shall not postpone the effectiveness of such
future rule or action. This proposed action may not be challenged later
in proceedings to enforce its requirements. (See section 307(b)(2))

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

    Dated: September 13, 2016.
Mark Hague,
Regional Administrator, Region 7.

    For the reasons stated in the preamble, EPA amends 40 CFR part 52
as set forth below:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et.seq.

Subpart AA--Missouri

0
2. Amend Sec.  52.1320 by adding paragraphs (d)(31) and (e)(71) to read
as follows:

Sec.  52.1320   Identification of Plan

    (d) * * *

                            EPA-Approved Missouri Source-Specific Permits and Orders
----------------------------------------------------------------------------------------------------------------
                                                            State
          Name of source             Order/permit  No.    effective     EPA approval date        Explanation
                                                             date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
(31) Exide Technologies Canon      Consent Judgment         10/10/14  9/26/16 and [Insert
 Hollow, MO.                        14H0-CC00064.                      Federal Register
                                                                       citation].
----------------------------------------------------------------------------------------------------------------

* * * * *
    (e) * * *

                               EPA-Approved Missouri Nonregulatory SIP Provisions
----------------------------------------------------------------------------------------------------------------
                                        Applicable          State
   Name of  nonregulatory  SIP         geographic or      submittal    EPA approval  date        Explanation
            provision               nonattainment  area      date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
(71) Exide Technologies            Forest City.........     10/15/14  9/26/16 and [Insert   [EPA-R07-OAR-2015-08
 Compliance Plan 2008 lead NAAQS.                                      Federal Register      35; FRL 9952-79-
                                                                       citation].            Region 7].
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2016-22981 Filed 9-23-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 90 (Tuesday, May 10, 2022)]
[Rules and Regulations]
[Pages 27925-27926]
[FR Doc No: 2022-09754]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2022-0043; Airspace Docket No. 21-ASW-25]
RIN 2120-AA66

Amendment of Class E Airspace; Weatherford, OK

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends the Class E airspace at Weatherford, OK.
This action as the result of an airspace review caused by the
decommissioning of the Weatherford non-directional beacon (NDB). The
geographic coordinates of the airport are also being updated to
coincide with the FAA's aeronautical database.

DATES: Effective 0901 UTC, July 14, 2022. The Director of the Federal
Register approves this incorporation by reference action under 1 CFR
51, subject to the annual revision of FAA Order JO 7400.11 and
publication of conforming amendments.

ADDRESSES: FAA Order JO 7400.11F, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at https://www.faa.gov/air_traffic/publications/. For further information, you can
contact the Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

FOR FURTHER INFORMATION CONTACT: Rebecca Shelby, Federal Aviation
Administration, Operations Support Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX 76177; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends the Class E airspace extending upward from 700 feet above
the surface at Thomas P. Stafford Airport, Weatherford, OK, to support
instrument flight rule operations at this airport.

History

    The FAA published a notice of proposed rulemaking in the Federal
Register (87 FR 8992; February 17, 2022) for Docket No. FAA-2022-0043
to amend the Class E airspace at Weatherford, OK. Interested parties
were invited to participate in this rulemaking effort by submitting
written comments on the proposal to the FAA. No comments were received.
Class E airspace designations are published in paragraph 6005 of FAA
Order JO 7400.11F, dated August 10, 2021, and effective September 15,
2021, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designations listed in this document will be published
subsequently in FAA Order JO 7400.11.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order JO 7400.11F, Airspace Designations
and Reporting Points, dated August 10, 2021, and effective September
15, 2021. FAA Order JO 7400.11F is publicly available as listed in the
ADDRESSES section of this document. FAA Order JO 7400.11F lists Class
A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    This amendment to 14 CFR part 71 amends the Class E airspace
extending upward from 700 feet above the surface to within a 6.5-mile
(reduced from a 7.1-mile) radius at Thomas P. Stafford Airport,
Weatherford, OK, by removing the Weatherford NDB and updates the
geographic coordinates of the airport to coincide with the FAA's
aeronautical database, removing the city associated with the airport in
the header of the airspace legal description to comply with changes to
FAA Order JO 7400.2N, Procedures for Handling Airspace Matters. This
action is necessary due to an airspace review caused by the
decommissioning of the Weatherford NDB which provided navigation
information for the instrument procedures this airport.
    FAA Order JO 7400.11, Airspace Designations and Reporting Points,
is published yearly and effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore: (1) Is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that only affects air traffic procedures and air navigation, it is
certified that this rule, when promulgated, does not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, ``Environmental Impacts: Policies and
Procedures,'' paragraph 5-6.5.a. This airspace action is not expected
to cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

Lists of Subjects in 14 CFR 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority:  49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO
7400.11F, Airspace Designations and Reporting Points, dated August 10,
2021, and effective September 15, 2021, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ASW OK E5 Weatherford, OK [Amended]

Thomas P. Stafford Airport, OK
    (Lat. 35[deg]32'45'' N, long. 98[deg]40'07'' W)

    That airspace extending upward from 700 feet above the surface
within a 6.5-mile radius of Thomas P. Stafford Airport.

    Issued in Fort Worth, Texas, on May 2, 2022.
Martin A. Skinner,
Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2022-09754 Filed 5-9-22; 8:45 am]
BILLING CODE 4910-13-P


SUPPORTING STATEMENT FOR

EPA INFORMATION COLLECTION REQUEST NUMBER 2324.01 REPORTING AND
RECORDKEEPING REQUIREMENTS FOR THE PROPOSED RULE ON ADDING
PHARMACEUTICALS TO THE UNIVERSAL WASTE RULE (Proposed Rule)

September 2008

Table of Contents

 TOC \f

1.	IDENTIFICATION OF THE INFORMATION COLLECTION	1

1(a)	Title and Number of the Information Collection	1

1(b)	Short Characterization	1

2.	NEED FOR AND USE OF THE COLLECTION	2

2(a)	Need and Authority for the Collection	2

2(b)	Practical Utility and Users of the Data	2

3.	NONDUPLICATION, CONSULTATIONS, AND OTHER

	COLLECTION CRITERIA 	3

3(a)	Nonduplication	3

3(b)	Public Notice	3

3(c)	Consultations	3

3(d)	Effects of Less Frequent Collection	3

3(e)	General Guidelines	3

3(f)	Confidentiality	4

3(g)	Sensitive Questions	4

4.	THE RESPONDENTS AND THE INFORMATION REQUESTED	4

4(a)	Respondents and SIC/NAICS Codes	4

4(b)	Information Requested	4

5.	THE INFORMATION COLLECTED -- AGENCY ACTIVITIES, COLLECTION
METHODOLOGY, AND INFORMATION MANAGEMENT	7

5(a)	Agency Activities	7

5(b)	Small Entity Flexibility	7

6.	ESTIMATING THE HOUR AND COST BURDEN OF THE COLLECTION	8

6(a)	Estimating Respondent Burden	8

6(b)	Estimating Respondent Costs	8

6(c)	Estimating Agency Burden and Costs	9

6(d)	Estimating the Respondent Universe and Total Burden and Costs	9

6(e)	Bottom Line Burden Hours and Costs	12

6(f)	Reasons for Change in Burden	12

6(g)	Burden Statement	13

	EXHIBITS

Estimated Annual Respondent Burden and Cost (Exhibit
1).............................................14

Estimated Annual Respondent Burden for Existing ICRs

(Including Net Impact from Pharmaceutical Rule
ICR)....................................................15

1.	IDENTIFICATION OF THE INFORMATION COLLECTION

1(a)	Title and Number of the Information Collection

This information Collection Request (ICR) is entitled “Reporting and
Recordkeeping Requirements for the Proposed Rule on Adding
Pharmaceuticals to the Universal Waste Rule (Proposed Rule),” EPA ICR
Number 2324.01.

1(b)	Short Characterization

Section 3001 of the Resource Conservation and Recovery Act (RCRA) of
1976, as amended, requires the Environmental Protection Agency (EPA) to
identify which solid wastes are hazardous wastes and therefore must be
managed as hazardous waste during treatment, storage, or disposal.
Under this authority, EPA established four hazardous waste
characteristics (toxicity, reactivity, ignitability, and corrosivity),
and listed specific wastes that must be managed as hazardous wastes.
Some pharmaceutical wastes are hazardous because they contain listed
hazardous waste chemicals or they exhibit one of the four hazardous
waste characteristics.  As a result, these pharmaceutical wastes are
currently subject to strict controls under RCRA Subtitle C hazardous
waste regulations.  However, health care facilities report that they
struggle to familiarize their time-constrained workers with the RCRA
hazardous waste regulations.  The lack of time and hazardous waste
management knowledge on the part of health care workers makes it
difficult for them to determine which wastes are RCRA hazardous, whether
they are listed or characteristic hazardous wastes, and what the proper
management techniques are for those wastes.

After consideration of the issues, EPA is proposing to add hazardous
pharmaceutical wastes to the existing universal waste rule (UWR) at 40
CFR Part 273.  The existing universal waste regulations, published on
May 11, 1995, provide streamlined procedures for certain widely
generated wastes identified as universal wastes (60 FR 25492).  The
universal waste standards are designed to accomplish the following
general goals:

• Encourage resource conservation while ensuring protection of human
health and the environment.

• Improve implementation of the current RCRA Subtitle C hazardous
waste regulatory program.

• Simplify the hazardous waste regulatory requirements and to
encourage individuals and organizations to collect the unregulated
portion of these wastes and manage them using the same system developed
for the regulated portion.  That is, this removes otherwise unregulated
wastes from the municipal waste stream, minimizing the placement of
hazardous constituents into municipal landfills, combustors and
composting projects, as well as to wastewater treatment plants.

The UWR is specifically designed to reduce the complexity of the RCRA
hazardous waste generator regulations for universal wastes.  It
streamlines the collection and handling requirements for
widely-dispersed hazardous wastes and facilitates their inclusion in the
hazardous waste management system.  By proposing to incorporate
hazardous pharmaceutical waste in the universal waste regulations, EPA
expects improved management of hazardous and non-hazardous
pharmaceutical wastes, as well as decreased regulatory burden for many
hazardous pharmaceutical waste generators.  This proposal thus provides
a solution to many of the issues facing health care facilities and other
pharmaceutical waste generators.

Furthermore, while the UWR regulates only RCRA hazardous wastes, the
Agency anticipates that including hazardous pharmaceutical wastes in the
UWR will encourage persons to manage other pharmaceutical wastes in the
same manner as universal wastes, particularly those wastes that are not
hazardous under RCRA but which may nonetheless pose risks.  Moreover,
EPA expects that including hazardous pharmaceutical wastes in the UWR
will ease the regulatory burden on generators that want to collect these
wastes, facilitating the implementation of pharmaceutical take-back
programs.  The proposed rule is also designed to reduce the quantity of
RCRA hazardous waste pharmaceuticals managed in municipal solid waste
systems.  Thus, expansion of the universal waste system to include
hazardous pharmaceutical wastes would lead to better management of these
wastes by providing a more streamlined, but effective waste management
system.

This ICR is a comprehensive description of the information collection
requirements for handlers of hazardous pharmaceutical wastes under the
universal waste requirements.

2.	NEED FOR AND USE OF THE COLLECTION

2(a) 	Need and Authority for the Collection

The requirements covered in this ICR are necessary for EPA to obtain
general information on universal pharmaceutical waste regulated entities
and to facilitate enforcement of Part 273 regulations.  The notification
requirements are needed to assist the Agency in identifying and tracking
large quantity handlers of universal pharmaceutical waste.  EPA requires
large quantity handlers to mark and track pharmaceutical waste shipments
to help ensure these wastes are being accumulated responsibly.  EPA also
requires tracking of universal pharmaceutical waste shipments to help
ensure these wastes are being properly treated, recycled, or disposed.

2(b) 	Practical Utility and Users of the Data

EPA will use the collected information to ensure that universal
pharmaceutical wastes are being managed in a protective manner.  This
information aids the Agency in tracking universal pharmaceutical waste
shipments and identifying improper management practices.  In addition,
information kept in facility records will help handlers demonstrate, and
on-site inspectors ensure, that facilities are managing pharmaceutical
wastes properly.  Information marked on pharmaceutical waste containers
will assist handlers and transporters in ensuring proper management
during storage and shipment.

3.	NONDUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA

3(a)	Nonduplication

None of the information required by the proposed rule would duplicate
information required by existing RCRA regulations.

3(b)	Public Notice

In compliance with the Paperwork Reduction Act of 1995, EPA will open a
60-day public comment period at the time that this proposed rule is
published in the Federal Register.  To assist the public in commenting
on the proposal, EPA raised a number of issues in the preamble to the
proposed rule and asked for the public to comment on them.  At the end
of the comment period, EPA will review public comments received in
response to the notice and will address comments received, as
appropriate.

3(c)	Consultations tc \l2 "3(c)	Consultations

EPA consulted and collected information from interested parties over
several years to support the amendment to the UWR.  EPA staff made site
visits to hospitals and other pharmaceutical waste generators, met with
reverse distributors, and communicated with states and other interested
parties.  The summaries of the site visits, meetings, and telephone
conversations with interested parties are available in the docket for
the proposed rule (Docket ID No. EPA-HQ-RCRA-2007-0932).

 3(d)	Effects of Less Frequent Collection tc \l2 "3(d)	Effects of Less
Frequent Collection

EPA has carefully considered the burden imposed upon the regulated
community by the proposed rule.  EPA is confident that those activities
required of respondents are necessary, and to the extent possible, the
Agency has attempted to minimize the burden imposed.  EPA believes
strongly that, if the minimum information collection requirements of the
proposed rule are not met, neither the industry nor EPA will be able to
ensure that pharmaceutical wastes are being managed in a manner
protective of human health and the environment.

3(e)	General Guidelines tc \l2 "3(e)	General Guidelines

This ICR adheres to the guidelines stated in the Paperwork Reduction Act
of 1995, OMB’s implementing regulations, EPA’s ICR Handbook, and
other applicable OMB guidance.

3(f)	Confidentiality tc \l2 "3(f)	Confidentiality

Section 3007(b) of RCRA and 40 CFR Part 2, Subpart B, which defines
EPA’s general policy on public disclosure of information, contain
provisions for confidentiality.  However, the Agency does not anticipate
that businesses will assert a claim of confidentiality covering all or
part of the proposed rule.  If such a claim were asserted, EPA must and
will treat the information in accordance with the regulations cited
above.  EPA also will assure that this information collection complies
with the Privacy Act of 1974 and OMB Circular 108.

3(g)	Sensitive Questions tc \l2 "3(g)	Sensitive Questions

No questions of a sensitive nature are included in the information
collection requirements associated with the proposed rule.

4.	THE RESPONDENTS AND THE INFORMATION REQUESTED tc \l1 "4.	THE
RESPONDENTS AND THE INFORMATION REQUESTED

4(a)	Respondents and NAICS Codes tc \l2 "4(a)	Respondents and SIC/NAICS
Codes

The following is a list of North American Industrial Classification
System (NAICS) codes associated with the facilities most likely to be
affected by the information collection requirements covered in this ICR.

NAICS	Facility Type

44611	Pharmacies

622	Hospitals

6211	Physicians’ Offices

6212	Dentists’ Offices

6213	Other Health Practitioners

(e.g., chiropractors)

6214	Outpatient Care Centers

6219	Other Ambulatory Health Care Services

623	Residential Care Facilities

Various NAICS3	Reverse Distributors

54194	Veterinary Clinics

4(b)	Information Requested

This section describes information collection requirements applicable to
universal pharmaceutical waste regulated entities that would be affected
by the rule.

Notification

(i) Data items:

The proposed rule, based on the existing UWR regulations for large
quantity handlers, requires that large quantity handlers of universal
pharmaceutical waste must send written notification of their universal
waste management to the Regional Administrator, and receive an EPA
identification number.  Specifically, the large quantity handlers must
send written notification before meeting or exceeding the 5,000 kilogram
accumulation limit of universal waste. Large quantity handlers who have
already notified EPA of their hazardous waste management activities
under RCRA or pesticide management under FIFRA and have received an EPA
Identification number are not required to re-notify.

The notification must include the following data items:

The universal waste handler's name and mailing address;

The name and business telephone number of the person at the universal
waste handler's site who should be contacted regarding universal waste
management activities;

The address or physical location of the universal waste management
activities;

A list of all types of universal waste managed by the handler; and

A statement indicating that the handler is accumulating 5,000 kilograms
or more of universal waste at one time.

(ii) Respondent activities:

Large quantity handlers of universal pharmaceutical waste must prepare
and submit written notification of their universal waste management to
the Regional Administrator.  However, it is reasonable to assume that
large quantity handlers have previously notified EPA of their hazardous
waste management activities under RCRA or pesticide management under
FIFRA and have received an EPA Identification number.  Therefore, they
would not be required to re-notify under the proposed rule.

Labeling/Marking

(i) Data items:

Small and large quantity handlers are required to mark or label their
universal pharmaceutical waste materials in accordance with the
following procedures:

All containers must be marked with the words “Universal Waste -
Pharmaceuticals” or “Waste Pharmaceuticals.”

(ii) Respondent Activities:

Handlers must mark or label the universal pharmaceutical waste or the
containers holding universal pharmaceutical waste.  However, the small
and large quantity generators under RCRA Subtitle C requirements must
also mark all containers with the words “Hazardous Waste” and the
accumulation start date.  Therefore, the labeling requirements under the
proposed rule would not result in any additional burden to the handlers.

Accumulation Time Limits

(i) Data items:

Small quantity and large quantity handlers are required to demonstrate
the length of time that the pharmaceutical material has been accumulated
from the date it was received or became a waste.

(ii) Respondent Activities:

Handlers must demonstrate the length of time that pharmaceutical
material has been accumulated from the date it was received or became a
waste.  As with the Labeling/Marking requirements for small and large
quantity generators under RCRA Subtitle C that are described above, the
handlers can continue to mark all containers with the accumulation start
date.  Therefore, this activity should not result in any additional
burden to the handlers.

Tracking Pharmaceutical Waste Shipments

(i) Data items:

The rule requires large quantity handlers to keep records of each
incoming or outgoing universal pharmaceutical waste shipment.  Records
of shipments must be kept for a period of three years from the day of
receipt or the day the shipment left the facility.

The data items required are:

Records of incoming and outgoing shipments must contain the following
information:

Name and address of the originating or destination facility;

Quantity of universal pharmaceutical waste received or sent; and

Date the shipment was sent or received.

(ii) Respondent activities:

Large quantity handlers must:

Maintain records of all shipments for a period of three years.

Exports

(i) Data Items:

The proposed rule, based on the existing UWR regulations for exports,
requires that shipments of universal pharmaceutical waste to a foreign
destination must comply with the same requirements as shipments of
hazardous waste (i.e., 40 CFR 262, Subparts E or H).  These reporting
and recordkeeping activities are not evaluated in this ICR because they
already are addressed in the "Requirements for Generators, Transporters,
and Waste Management Facilities under the RCRA Hazardous Waste Manifest
System" (ICR No. 801) and in the "Exports from and Imports to the U.S.
under the Organization for Economic Cooperation and Development (OECD)
Decision" (ICR No. 1647).

5.	THE INFORMATION COLLECTED --AGENCY ACTIVITIES, COLLECTION
METHODOLOGY, AND INFORMATION MANAGEMENT

5(a)	Agency Activities

Most of the information that is required of universal pharmaceutical
waste handlers would be kept on site and not be submitted to EPA for
review.  The exception is a notification requirement for large quantity
handlers of universal pharmaceutical waste.  However, as stated earlier,
it is being assumed that large quantity handlers have previously
notified EPA of their hazardous waste management activities under RCRA
or pesticide management under FIFRA and have received an EPA
Identification number.  Therefore, they would not be required to
re-notify the Agency under the proposed rule, and the Agency does not
have to review any new notifications.

5(b)	Small Entity Flexibility

By adding hazardous pharmaceutical waste to the federal list of
universal wastes, the proposed rule will provide regulatory relief from
the full Subtitle C management requirement for entities involved in
pharmaceutical waste management.  These entities include generation and
transportation facilities.  Small quantity generators (SQGs) of
hazardous pharmaceutical waste will become small quantity handlers
(SQHs) of universal pharmaceutical waste.  Regulatory requirements for
small quantity handlers of universal waste are considerably simpler than
those applicable to small quantity generators of hazardous waste.

Further, EPA relieved small quantity handlers from several
administrative requirements applicable to large quantity handlers.  For
example, the proposed rule does not require small quantity handlers to
submit notifications of universal pharmaceutical waste management or to
obtain an EPA identification number.  EPA also does not require small
quantity handlers to keep records of their universal pharmaceutical
waste shipments.   EPA believes these exemptions would encourage small
businesses to safely manage universal pharmaceutical waste in compliance
with the regulation.  In addition, EPA allows conditionally exempt small
quantity generators (CESQGs) to manage their hazardous pharmaceutical
waste either under the specific provisions of the proposed rule or under
the existing CESQG exemption in 40 CFR 261.5.

Finally, the proposed rule to add pharmaceuticals to the universal waste
rule is a regulatory relief initiative that should reduce regulatory
burden and costs for all universal waste handlers, but should
particularly benefit small entities.

6.	ESTIMATING THE HOUR AND COST BURDEN OF THE COLLECTION

6(a)	Estimating Respondent Burden

	In exhibit 1, EPA estimates the respondent burden associated with the
new paperwork requirements in the proposed rule.  As shown in the
exhibit, EPA estimates that the total annual respondent burden for the
new paperwork requirements in the rule is approximately 960 hours per
year.

 	6(b)	Estimating Respondent Costs

EPA also estimates in Exhibit 1 that the total annual respondent cost
for the new paperwork requirements in the rule is approximately $54,000.
 This cost includes annual labor, capital, and operation and maintenance
(O&M) costs to be incurred by respondents affected by the information
collection requirements covered in this ICR.  Specific data and/or
assumptions used in developing these costs are described below.

Labor Costs

For purposes of this analysis, EPA estimates an average hourly
respondent labor cost of $102 for legal staff, $71 for managerial staff,
$48 for technical staff, and $26 for clerical staff.  These hourly labor
costs were obtained from the economics background document developed for
the proposed rule.

Annual Capital and Operation & Maintenance Costs

Capital costs usually include any produced physical good needed to
provide the needed information, such as machinery, computers, and other
equipment.  EPA does not anticipate that respondents will incur capital
costs in carrying out the information collection requirements of the
proposed rule.

O&M costs are those costs associated with paperwork requirements
incurred continually over the life of the ICR.  They are defined by the
EPA as “the recurring dollar amount of costs associated with O&M or
purchasing services.” For this ICR, O&M costs would be from
photocopying shipping papers.

6(c)	Estimating Agency Burden and Costs

The annual burden and costs to the Agency for collecting information
under the rule would be negligible.  This is because the Agency is not
requiring pharmaceutical universal waste handlers to submit any
information for its review and approval under the proposed rule.  Under
the proposed rule, large quantity handlers (LQHs) of universal waste
must notify EPA and obtain an EPA identification number.  However, a LQH
is not required to notify if it has previously notified EPA and obtained
an identification number as a large quantity generator (LQG) under RCRA
Subtitle C hazardous waste requirements.  We are assuming that all
existing/new LQHs of universal pharmaceutical waste have previously
notified EPA and obtained an identification number.  The pharmaceutical
universal waste handlers would keep all records required under the
proposed rule on site.

6(d)	Estimating the Respondent Universe and Total Burden and Costs

Respondent Universe

In Exhibit 1, EPA provides estimates of the annual number of respondents
that will likely choose to comply with the new paperwork requirements in
the proposed rule.  This is because the respondent paperwork
requirements for the existing small and large quantity handlers under
the UWR will be more streamlined (resulting in lower burden) compared to
the RCRA Subtitle C hazardous waste regulations.  In the same exhibit,
EPA estimates respondent burden and costs associated with the new
paperwork requirements.  Table 1 presents the number of respondents that
could potentially be affected by the proposed rule.  It shows that EPA
estimates 634,552 small and large facilities handle hazardous
pharmaceutical waste each year.  The conditionally-exempt small quantity
generators (CESQGs) of hazardous pharmaceutical waste are already
subject to very minimum waste management requirements under the existing
RCRA Subtitle C hazardous waste regulations.  Because the burden from
new paperwork requirements for CESQGs under the amended UWR would be
higher than the existing paperwork requirements, we are assuming that
CESQGs are unlikely to choose to manage their pharmaceutical wastes
under the amended UWR.

TABLE 1

NUMBER OF FACILITIES POTENTIALLY AFFECTED BY

THE PROPOSED RULE

Type of Respondent	Number of Facilities

Small Quantity Handlers (CESQGs under Subtitle C regulations)	633,433

Small Quantity Handlers (SQGs under Subtitle C regulations)	1,083

Large Quantity Handlers (LQGs under Subtitle C regulations)	36

Total 	634,552

Respondent Burden and Cost

Based on the universe data presented in Table 1, EPA estimated the
respondent burden associated with all of the new information collection
requirements covered in this ICR in Exhibit 1.  A discussion of the
assumptions used in developing these burden estimates follows.

Reading the Regulations

As shown in Exhibit 1, EPA estimates that 1,119 potentially affected
facilities will read the rule on adding pharmaceuticals to the universal
waste rule (facilities that are currently classified as CESQGs are
unlikely to read the rule because the proposed rule would not decrease
their paperwork burden).  In estimating the annual respondent burden and
cost over the three year period covered by this ICR, EPA annualized the
burden and cost of this one-time activity by dividing the number of
hours required for this activity by three.

Record of Shipments for Generators

The SQHs of universal waste are not required to maintain any records of
universal waste shipments.  LQHs, however, must record all shipments
received or shipped.  Logs, invoices, bills of lading, or other shipping
documents constitute acceptable forms of records.  These records must be
maintained for at least three years.  Based on the quantity of universal
pharmaceutical waste managed by LQHs, it was estimated that an average
of about eight shipments of universal pharmaceutical waste would be made
annually by each LQH.  The cost to complete and maintain a record of
universal waste shipment was estimated to be $10 per shipment in the
economics background document developed for the proposed rule.

	Total Respondent Burden and Cost

In Exhibit 2, EPA presents a summary of the total annual respondent
burden and costs associated with both new and existing paperwork
requirements.  The specific information collection activities of the new
paperwork requirements are described throughout this ICR, and the total
annual burden and cost estimates associated with them are calculated in
Exhibit 1, summarized in Exhibit 2, and briefly described below.  The
existing paperwork requirements are those that are contained in the
current RCRA regulations and that apply to generators of hazardous
pharmaceutical wastes.  These existing requirements, the existing ICRs
with which they are associated, and the total annual burden and cost
associated with them also are summarized in Exhibit 2 and briefly
described below.

New Paperwork Requirements

EPA presents the total respondent burden and costs for all of the new
information collection activities associated with the proposed rule in
exhibit 1.  As noted above, this exhibit presents the annual burden and
costs over the three-year effective life of the ICR.  The exhibit
calculates the burden and cost of one-time activities by dividing the
total number of burden hours by three.  In Exhibit 2, EPA summarizes the
total annual respondent burden and cost of these new paperwork
requirements derived in Exhibit 1.

Existing Paperwork Requirements

In addition to the new paperwork requirements in the proposed rule, EPA
also estimated the burden and cost savings that hazardous pharmaceutical
waste handlers would expect for no longer following the existing RCRA
information collection requirements.  In Exhibit 2, EPA presents the
total annual respondent burden and cost savings under the existing
paperwork requirements, broken out by the four existing EPA ICRs that
are affected by the proposed rule.  In developing Exhibit 2, EPA
reviewed each of the affected ICRs to identify the existing information
collection activities that are currently undertaken by hazardous
pharmaceutical waste handlers, calculated the associated burden and
costs (or savings), and presented the totals in the exhibit.

The total costs in Exhibit 2 are broken down into labor and operation
and maintenance (O&M) costs.  In Section 6(b), EPA presents a discussion
of the capital and O&M costs associated with new paperwork requirements
from the proposed rule.  In the following paragraph, EPA presents a
brief discussion of the O&M costs associated with each of the existing
ICRs that are affected by the proposed rule.

For the Manifest ICR (ICR No. 801), the O&M costs are associated with
postage for sending and returning copies of the manifest form.  For the
Generator Standards ICR (ICR No. 820), O&M costs are associated with
copying training materials.  For the Biennial Report ICR (ICR No. 976),
O&M costs are associated with mailing costs and maintaining copies of
Waste Generation and Management (GM) and Waste Received from Off-Site
(WR) forms.  For the Land Disposal Restrictions ICR (ICR No. 1442), O&M
costs are associated with mailing costs and maintaining copies of
notification.

6(e)	Bottom Line Burden Hours and Costs

Respondent Tally

In Exhibit 2, EPA presents the total annual respondent burden and cost
for both new and existing paperwork requirements associated with the
proposed rule.  As described specifically in Section 6(d) above, these
new and existing paperwork requirements apply to universal
pharmaceutical waste handlers.  As shown in Exhibit 2, the total annual
respondent burden for these new paperwork requirements is approximately
960 hours, at an annual cost of approximately $54,000.  As also shown in
Exhibit 2, the total annual respondent burden savings under the existing
paperwork requirements, which are associated with four existing EPA
ICRs, is approximately 1,900 hours, at annual cost savings of
approximately $93,000.  In the same Exhibit 2, EPA then combines the
burden and cost impacts under both new and existing paperwork
requirements and estimates the total annual respondent burden savings
for all information collection activities at approximately 935 hours and
an annual cost savings of approximately $39,000.

The bottom line respondent burden hours saved over the three-year period
covered by this ICR is approximately 2,805 hours, at a total cost
savings of $117,000.

6(f)	Reasons for Change in Burden

As shown in exhibit 2, EPA expects that the proposed rule will result in
a reduction in burden to the hazardous pharmaceutical waste generators
complying with UWR requirements.  This is because universal
pharmaceutical waste generators no longer would be subject to full
Subtitle C requirements.  Following is a list of primary RCRA reporting
and recordkeeping requirements that hazardous pharmaceutical waste
generators may be relieved of:

Reporting and recordkeeping under the hazardous waste manifest
requirements, as covered in ICR No. 801, Manifest ICR;

Recordkeeping and/or reporting of personnel training, contingency plan,
and emergency procedures under the generator standards of 40 CFR Part
262, as covered in ICR No. 820, Hazardous Waste Generator Standards ICR.

Reporting waste generation data for the EPA’s Biennial Report, as
covered in ICR No. 976, Biennial Report ICR; and

Reporting and recordkeeping under the land disposal restrictions (LDRs)
program of 40 CFR Part 268, as covered in ICR No. 1442, Land Disposal
Restrictions ICR;

6(g)	Burden Statement

	The annual public reporting and recordkeeping burden for this
collection of information is estimated to average 0.8 hours per response
for a small quantity handler and 2.5 hours per response for a large
quantity handler.  However, in addition to the new paperwork
requirements in the proposed rule, the Agency also estimated the annual
respondent burden savings that generators could expect as result of no
longer having to follow information collection requirements under four
existing EPA ICRs (Manifest ICR, Generator Standards ICR, Biennial
Report ICR, and Land Disposal Restrictions ICR).  Taking both the new
proposed and existing RCRA information collection requirements into
account, EPA expects the proposed rule will result in a net reduction in
annual reporting and recordkeeping burden of approximately 0.5 hour per
response for a small quantity handler and 11 hours per response for a
large quantity handler.  Burden means the total time, effort, or
financial resources expended by persons to generate, maintain, retain,
or disclose or provide information to or for a Federal agency.  This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements; train personnel to be able to respond to
a collection of information; search data sources; complete and review
the collection of information; and transmit or otherwise disclose the
information.  An agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays a
currently valid OMB control number.  The OMB control numbers for EPA's
regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.

	To comment on the Agency's need for this information, the accuracy of
the provided burden estimates, and any suggested methods for minimizing
respondent burden, including the use of automated collection techniques,
EPA has established a public docket for this ICR under Docket ID Number
EPA-HQ-RCRA-2007-0932, which is available for online viewing at
HYPERLINK "http://www.regulations.gov"  www.regulations.gov , or in
person viewing at the RCRA Docket in the EPA Docket Center (EPA/DC), EPA
West, Room 3334, 1301 Constitution Avenue, NW, Washington, D.C.  The EPA
Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal holidays.  The telephone number
for the Reading Room is<PHONE_NUMBER>, and the telephone number for the
RCRA Docket is<PHONE_NUMBER>.  An electronic version of the public
docket is available at www.regulations.gov.  This site can be used to
submit or view public comments, access the index listing of the contents
of the public docket, and to access those documents in the public docket
that are available electronically.  When in the system, select
“search,” then key in the Docket ID Number identified above.  Also,
you can send comments to the Office of Information and Regulatory
Affairs, Office of Management and Budget, 725 17th Street, NW,
Washington, D.C. 20503, Attention: Desk Officer for EPA.  Please include
the EPA Docket ID Number EPA-HQ-RCRA-2007-0932 and OMB Control Number
2050-NEW in any correspondence.

	Exhibit 1 - Estimated Annual Respondent  Burden and Cost

                                                           Hours and
Costs per Respondent
                                                   Total Hours and Costs

INFORMATION COLLECTION

ACTIVITY

Leg.

$102/Hr

Mgr.

$71/Hr

Tech.

$48/Hr

Cler.

$26/Hr

Respon. Hours/Yr

Labor Cost/Yr

Capital/

Startup Cost

O & M

Cost

Number of Respondents

Total Hours/Yr

Total Cost/Yr

RULE FAMILIARIZATION – Read the rule

Small Quantity

Handler	0.0	0.3	0.5	0.0	0.8	$45.00	0.0	0.0	1,083	866	$48,735.00

Large Quantity Handler	0.2

	0.3	0.5	0.0	1.0	$66.00	0.0	0.0	36	36	$2,376.00

RECORDKEEPING – Keep records of shipments

Large Quantity Handlers 	0.0	0.0	1.5	0.0	1.5	$72.00	0.0	$29.00	36	54
$2621.00

Total	varies	varies 	varies	0.0	varies	varies	0.0	varies	Varies	956
$53,732.00

Agency Data Sources:

Wage Rate Data: 	 “Assessment of the Potential Costs, Benefits, and
Other Impacts of Adding Pharmaceuticals to the Universal Waste Rule, as
Proposed.”

Labor Hours:	“Supporting Statement for EPA Information Collection
Number 1597.07: Reporting and Recordkeeping Requirements for the final
Rule on Adding Mercury-Containing Equipment to the Universal Waste
Rule.”

O&M Cost:	“Supporting Statement for EPA Information Collection Number
1597.07: Reporting and Recordkeeping Requirements for the final Rule on
Adding Mercury-Containing Equipment to the Universal Waste Rule.”

	Exhibit 2 – Estimated Annual Respondent Burden for Existing ICRS
(Including Net Impact from Pharmaceutical Rule ICR)

ICR Name

ICR Number

Respondents

Total Labor Hours

Total Labor Cost

Total O&M Cost

Total Annual Cost

Manifest ICR	801	1,119	(1,591)	($76,368.00)	($2,258.00)	($ 78,626.00)

Generator Standards	820	36	(22)	($572.00)	($360.00)	($932.00)

Biennial Report	976	36	(170)	($8,172.00)	($84.00)	($8,256.00)

Land Disposal Restrictions	1442	36	(108)	($5,184.00)	($48.00)
($5,232.00)

	Subtotal Other ICRs 	(1,891)	($90,296.00)	($2,750.00)	($93,046.00)

Pharmaceutical ICR	2324.01	Varies	956	$53,703.00	$29.00	$53,732.00

	                 Net Impact (Pharmaceutical ICR + Other ICRs) =
                                	(935)	($36,593.00)	($2,721.00)	($39,314
.00)

Agency Sources:

Labor Hours & Cost:  	“Assessment of the Potential Costs, Benefits,
and Other Impacts of Adding Pharmaceuticals to the Universal Waste Rule,
as Proposed.”

“Supporting Statement for EPA Information Collection Number 1597.07:
Reporting and Recordkeeping Requirements for the final Rule on Adding
Mercury-Containing Equipment to the Universal Waste Rule.”

O&M Cost:	“Supporting Statement for EPA Information Collection Number
1597.07: Reporting and Recordkeeping Requirements for the final Rule on
Adding Mercury-Containing Equipment to the Universal Waste Rule.”

These universe assumptions are based on the document, “Assessment of
the Potential Costs, Benefits, and Other Impacts of Adding
Pharmaceuticals to the Universal Waste Rule, as Proposed.”

 PAGE

 PAGE   ii


			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on December 19, 2002

NOTICE OF ACTION TAKEN -- DOCKET OST-2002-14001

________________________________________________________________________
___________________This serves as notice to the public of the action
described below, taken by the Department official indicated (no
additional confirming order will be issued in this matter).

Application of  CONTINENTAL AIRLINES, INC., filed  12/3/02, for:

XX Exemption for two years under 49 U.S.C. 40109 to provide the
following service:

Scheduled foreign air transportation of persons, property, and mail
between Memphis, Tennessee, and Mexico City, Mexico.  Continental also
seeks to combine this exemption authority with Continental’s other
exemption and certificate authority.  Continental states that it intends
to provide this service pursuant to a code-share arrangement with
Northwest Airlines, Inc.

Applicant rep:  R.  Bruce Keiner, Jr.<PHONE_NUMBER>  DOT Analyst: Linda
Lundell<PHONE_NUMBER>

D I S P O S I T I O N

XX  Granted (See Conditions below)

The authority granted was effective when taken:  December 19, 2002 ,
through  December 19, 2004 .

Action taken by:	Paul L. Gretch, Director

			Office of International Aviation

XX  The authority granted is consistent with the aviation agreement
between the United States and Mexico.

Except to the extent exempted or waived, this authority is subject to
the terms, conditions, and limitations indicated:	XX Holder’s
certificates of public convenience and necessity

			XX  Standard Exemption Conditions (attached)

________________________________________________________________________
___________

Special Conditions:  The U.S.-Mexico exemption authority granted is
subject to the dormancy notice requirements set forth in condition 7 of
Appendix A of Order 88-10-2 and is limited to operations conducted on a
code-share basis only.  Consistent with our standard practice, the
dormancy notice period will begin on Continental’s proposed startup
date of February 13, 2003.

The route integration authority granted to Continental is subject to the
condition that any service provided under this exemption shall be
consistent with all applicable agreements between the United States and
the foreign countries involved.  Furthermore, (a) nothing in the award
of the route integration authority granted should be construed as
conferring upon Continental rights (including fifth-freedom intermediate
and/or beyond rights) to serve markets where U.S. carrier entry is
limited unless Continental notifies the Department of its intent to
serve such a market and unless and until the Department has completed
any necessary carrier selection procedures to determine which carrier(s)
should be authorized to exercise such rights); (b) should there be a
request by any carrier to use the limited-entry route rights that are
included in Continental’s authority by virtue of the route integration
exemption granted here, but that are not then being used by Continental,
the holding of such authority by route integration will not be
considered as providing any preference for Continental in a competitive
carrier selection proceeding to determine which carrier(s) should be
entitled to use the authority at issue.

________________________________________________________________________
________________________________________

On the basis of data officially noticeable under Rule 24(g) of the
Department’s regulations, we found the applicant qualified to provide
the services authorized.

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) grant of the application was consistent with the public
interest; and (3) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted, we denied all requests in the referenced
Docket.  We may amend, modify, or revoke the authority granted in this
Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

http://dms.dot.gov//reports/reports_aviation.asp

	APPENDIX A

U.S. CARRIER

Standard Exemption Conditions

In the conduct of operations authorized by the attached notice, the
applicant(s) shall:

(1)  Hold at all times effective operating authority from the government
of each country served;

(2)  Comply with applicable requirements concerning oversales contained
in 14 CFR 250 (for scheduled operations, if authorized);

(3)  Comply with the requirements for reporting data contained in 14 CFR
241;

(4)  Comply with requirements for minimum insurance coverage, and for
certifying that coverage to the Department, contained in 14 CFR 205;

(5)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR Part 203,
concerning waiver of Warsaw Convention liability limits and defenses;

(6)  Comply with the applicable requirements of the Federal Aviation
Administration Regulations and with all U.S. Government requirements
concerning security; and

(7)  Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department of Transportation, with all applicable orders and regulations
of other U.S. agencies and courts, and with all applicable laws of the
United States.

The authority granted shall be effective only during the period when the
holder is in compliance with the conditions imposed above.

											10/2002

 To assure compliance with all applicable U.S. Government requirements
concerning security, the holder should, before commencing any new
service (including charter flights) to or from a foreign airport, inform
its Principal Security Inspector of its plans.