UNITED STATES OF AMERICA

DEPARTMENT OF TRANSPORTATION

OFFICE OF THE SECRETARY

WASHINGTON, DC

Issued by the Department of Transportation on September 2, 2005

   NOTICE OF ACTION TAKEN -- DOCKET OST-2005-21781

________________________________________________________________________
_________________________________

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   Northwest Airlines, Inc., filed 7/1/05 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 (1) the terminal point Detroit, Michigan, and the terminal point
Mazatlan, Mexico; (2) the terminal point Detroit, Michigan, and the
terminal point Zihuatanejo/Ixtapa, Mexico; (3) the terminal point
Memphis, Tennessee, and the terminal point Cozumel, Mexico; (4) the
terminal point Memphis, Tennessee, and the terminal point Puerto
Vallarta, Mexico; (5) the terminal point Memphis, Tennessee, and the
terminal point San Jose del Cabo, Mexico; and (6) the terminal point
Minneapolis/St. Paul, Minnesota, and the terminal point Manzanillo,
Mexico.  Northwest proposes to offer seasonal service in each of the
subject city-pair markets.

Applicant rep: Ronald P. Brower<PHONE_NUMBER>   DOT Analyst: Linda
Lundell<PHONE_NUMBER>

D I S P O S I T I O N

XX	Granted (subject to conditions, see below)

The above action was effective when taken: September 2, 2005, through
September 2, 2007.

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)

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 the notice requirements for seasonal/intermittent
services as set forth in Order 96-11-24, at 5.  Consistent with our
standard policy, the dormancy notice period for the exemption authority
will begin January 2, 2006, Northwest’s proposed start-up date for the
subject services.

Remarks:  Brendan Airways, LLC d/b/a USA 3000 Airlines (USA 3000) filed
an answer stating that it has an application pending before the
Department for exemption authority to serve the
Detroit-Zihuatanejo/Ixtapa market (Docket OST-2005-21816).  USA 3000
states that it does not oppose Northwest’s request for
Detroit-Zihuatanejo authority in the instant application, as long as USA
3000’s exemption application for Detroit-Zihuatanejo/Ixtapa authority,
in Docket OST-2005-21816, is granted contemporaneously.

Northwest replied that the Department can grant both carriers’
requests to serve the Detroit-Zihuatanejo/Ixtapa market, because no
other U.S. carriers currently serve the route, and two designations are
available for the service under the U.S.-Mexico aviation agreement.

We have decided to grant Northwest’s application.  We note that we are
granting USA 3000’s application to serve the
Detroit-Zihuatanejo/Ixtapa market contemporaneously with our grant of
Northwest’s application here.

________________________________________________________________________
______

On the basis of data officially noticeable under Rule 24(g) of the
Department's regulations, we found the applicant qualified to provide
the exemption 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 authority 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:

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

U.S. Carrier Exemption Conditions

In the conduct of the operations authorized, the U.S. carrier
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 203, concerning
waiver of Warsaw Convention liability limits and defenses;

(6)  Comply with all applicable requirements of the Federal Aviation
Administration and with all applicable U.S. Government requirements
concerning security, including, but not limited to, 49 CFR Part 1544.
To assure compliance with all applicable U.S. Government requirements
concerning security, the holder shall, before commencing any new service
(including charter flights) to or from a foreign airport, contact its
International Principal Security Inspector (IPSI) to advise the IPSI of
its plans and to find out whether the Transportation Security
Administration has determined that security is adequate to allow such
airport(s) to be served; 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.

05/2004

   In its application, Northwest also requested authority to serve
between the terminal point Omaha, Nebraska, and the terminal point
Cancun, Mexico.  By letter dated July 26, 2005, Northwest withdrew its
request for the Omaha-Cancun market.

   In its application, Northwest stated that it will commence seasonal
service “beginning this coming winter” (Application, at 2).  By way
of clarification, Northwest advised us on September 1, 2005, that it
intends to commence service on or about January 2, 2006.

 American Airlines, Inc. (American) filed an answer opposing
Northwest’s application and then subsequently withdrew its objection.
Following American’s answer, but prior to withdrawal of its objection,
the Wayne County Airport Authority and Memphis International Airport
filed in support of Northwest’s application.

 See Notice of Action Taken, dated September 2, 2005, in Docket
OST-2005-21816.

 PAGE

 PAGE   3


[Federal Register Volume 78, Number 115 (Friday, June 14, 2013)]
[Notices]
[Pages 35937-35939]
[FR Doc No: 2013-14137]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0790]

Food and Drug Administration Decisions for Investigational Device
Exemption Clinical Investigations; Draft Guidance for Industry and Food
and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``FDA Decisions for
Investigational Device Exemption (IDE) Clinical Investigations.'' This
guidance document was initially issued in draft on November 10, 2011,
and was developed to promote the initiation of clinical investigations
to evaluate medical devices under FDA's IDE regulations. The guidance
was also intended to provide clarification

regarding the regulatory implications of the decisions that FDA may
render based on review of an IDE and to provide a general explanation
of the reasons for those decisions. This guidance has been revised and
is being reissued for comment because the Food and Drug Administration
Safety and Innovation Act (FDASIA), which became law on July 9, 2012,
amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to
specify certain situations in which FDA cannot disapprove an IDE. This
draft guidance is not final nor is it in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by September 12, 2013.

ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``FDA Decisions for Investigational Device
Exemption (IDE) Clinical Investigations'' to the Division of Small
Manufacturers, International, and Consumer Assistance, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002 or
Office of Communication, Outreach and Development (HFM-40), Center for
Biologics Evaluation and Research (CBER), Food and Drug Administration,
1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. Send one
self-addressed adhesive label to assist that office in processing your
request, or fax your request to<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for information on electronic access to the
guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Owen Faris, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1108, Silver Spring, MD 20993-0002,<PHONE_NUMBER>;
or Stephen Ripley, Center for Biologics Evaluation and Research, Food
and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD
20852,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA approval of an IDE submission allows the initiation of a
clinical investigation of a significant risk device. This guidance is
intended to provide clarification regarding the regulatory implications
of the decisions that FDA may render based on review of an IDE and to
provide a general explanation of the reasons for those decisions. In an
effort to promote timely initiation of enrollment in clinical
investigations in a manner that protects study subjects, FDA has
developed methods to allow a clinical investigation of a device to
begin under certain circumstances, even when there are outstanding
issues regarding the IDE submission. These mechanisms, including
approval with conditions, staged approval, and communication of
outstanding issues related to the IDE through study design
considerations and future considerations, are described in this
guidance.
    FDA has traditionally referred to IDE approvals that have
conditions as ``conditional approvals.'' FDA believes that the term
``approval with conditions'' is more appropriate because the term
conveys that the IDE has been approved and the study may begin without
awaiting further FDA review. An IDE may be approved with conditions if
FDA has determined that, despite outstanding issues, the information
provided is sufficient to justify human clinical evaluation of the
device and the proposed study design is acceptable with regard to
protection of study subjects.
    FDA may now also communicate ``future considerations'', which are
issues and recommendations that FDA believes the sponsor should
consider in preparation for a marketing application or a future
clinical investigation. Future considerations are intended to provide
helpful, non-binding advice to sponsors regarding important elements of
the future application that the IDE may not specifically address. FDA
is considering whether future considerations should be communicated in
our IDE decision letters or whether they should be sent to the sponsor
in a separate communication. The Agency is specifically seeking comment
on this issue.
    Consistent with the November 2011 draft guidance, this guidance
also proposes two other mechanisms for approving studies or approving
studies with conditions: ``Staged approval'' and ``staged approval with
conditions,'' by which FDA may grant IDE approval or approval with
conditions, while certain outstanding questions are answered concurrent
with enrollment of a limited number of subjects in the clinical
investigation. Staged approval and staged approval with conditions
permit the clinical investigation to begin in a timely manner while
maintaining appropriate subject protections. Staged approval or staged
approval with conditions is most common for pivotal studies in which
many subjects will be enrolled over an extended period of time, but may
be applicable to other clinical investigations as well.
    Section 601 of FDASIA amended section 520(g) of the FD&C Act (21
U.S.C. 360j(g)) to specify certain situations in which FDA cannot
disapprove an IDE. Section 520(g)(4)(C) of the FD&C Act states that,
consistent with section 520(g)(1), FDA shall not disapprove an IDE
because: (1) The investigation may not support a substantial
equivalence or de novo classification determination or approval of the
device; (2) the investigation may not meet a requirement, including a
data requirement, relating to the approval or clearance of a device; or
(3) an additional or different investigation may be necessary to
support clearance or approval of the device. The draft guidance has
been revised in light of this new provision and to introduce the
communication to the sponsor of study design-related issues. If FDA
believes that additional modifications to the study design are needed,
which are unrelated to subject safety, for the study design to be
adequate and ultimately support a marketing application, if that is the
intent of the sponsor, these suggested modifications will be noted in
the ``study design considerations'' section of FDA's letter. Sponsors
are not required to modify the investigational plan to address study
design considerations. However, if these considerations are not
addressed, the study design may not support the study goals (e.g., a
future marketing application). FDA is considering whether study design
considerations should be communicated in our IDE decision letters or
whether they should be sent to the sponsor in a separate communication.
The Agency is specifically seeking comment on this issue.
    Section 601 of FDASIA specifies certain situations in which FDA
cannot disapprove an IDE. However, the Agency recognizes that some IDE
sponsors may wish to determine whether the pivotal study design may
support a marketing application if it is successfully executed and
meets its stated endpoints without raising unforeseen safety concerns.
To meet this

interest, FDA is proposing a new, voluntary program intended to
encourage device manufacturers to engage with the Agency in the
development of trial designs that may support a marketing approval or
clearance. The Agency recognizes that this type of voluntary program
will not likely be suitable for all IDE sponsors and does not intend
that this program become a routine step prior to submission of an IDE.
This program is not intended to replace or be a substitute for the Pre-
Submission process (Refer to the draft guidance entitled ``Medical
Devices: The Pre-Submission Program and Meetings with FDA Staff''
(http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm310375.htm, which, when finalized, will represent
FDA's current thinking on this topic).
    This program, referred to as the ``Pre-Decisional IDE Process,'' is
a voluntary approach to enable sponsors to obtain timely feedback from
review staff on a near-final IDE application, with the opportunity for
a midcycle interaction with the review team to promote clearer
understanding and quicker resolution of major issues with device or
subject safety as well as study design. The Pre-Decisional IDE process
is different from the Pre-Submission process, which is appropriate for
focused discussions with FDA early in device development or when
nonclinical testing is underway. Pre-Submission discussions are
generally limited in nature, as they focus on the proposed protocol and
the specific questions for which the sponsor is requesting FDA
feedback. Additionally, FDA does not typically review data from
nonclinical bench, animal, or other studies when providing feedback on
a clinical study protocol as part of a Pre-Submission. In contrast,
Pre-Decisional IDEs will include data and full study protocols and
reports where appropriate, and will be reviewed in a similar manner as
an IDE, allowing for more complete and meaningful feedback from review
staff. FDA intends to adhere to the feedback and decisions reached
during the Pre-Decisional IDE review. FDA intends that modifications to
our feedback will be limited to situations in which FDA concludes that
the feedback given previously does not adequately address important
issues materially relevant to a determination of safety or
effectiveness that have been identified since the time of the Pre-
Decisional IDE. In such cases, FDA should acknowledge a change in our
advice, document the rationale for the change, and support the
determination with appropriate management concurrence.
    Although this process, as proposed, would occur over a 65-day
timeframe (from submission of the Pre-Decisional IDE to complete FDA
feedback, inclusive of the midcycle interaction), FDA believes that
this process could result in faster approval without conditions of IDE
submissions with study designs that are sufficiently robust to support
market approval or clearance. Currently, many IDE submissions are
approved with conditions only after an initial disapproval and
submission of one or more responses, and may remain approved with
conditions over many months while the outstanding issues are addressed.
The Pre-Decisional IDE process is intended to reach an unconditional
approval more quickly, and will help to address several commonly
reported challenges in the initiation of clinical trials, such as
delays in institutional review board approvals and reimbursement from
third-party payers. In addition to seeking comments on the revised
draft guidance as a whole, the Agency is specifically seeking comment
on this new proposed program, as outlined in section 10 of the
guidance.
    As a result of this draft guidance, FDA, where appropriate, seeks
to offer flexibility in how outstanding issues can be addressed to
allow clinical investigations to commence without unnecessary delay,
while ensuring that human subjects are adequately protected.
    FDA issued this guidance document as draft on November 10, 2011.
The Agency has considered the comments received during the comment
period and incorporated modifications, as appropriate. This guidance
has also been revised to reflect the changes to the FD&C Act described
in this document and is being reissued in draft in order to solicit
comment on these significant revisions.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on FDA
decisions for IDE clinical investigations. It does not create or confer
any rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by using the Internet. A search capability for all Center for
Devices and Radiological Health guidance documents is available at
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at
http://www.regulations.gov. To receive ``FDA Decisions for
Investigational Device Exemption (IDE) Clinical Investigations,'' you
may either send an email request to<EMAIL_ADDRESS>to receive an
electronic copy of the document or send a fax request to<PHONE_NUMBER>
to receive a hard copy. Please use the document number 1783 to identify
the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 812 have been approved under
OMB control number 0910-0078.

V. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: June 10, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-14137 Filed 6-13-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 82, Number 115 (Friday, June 16, 2017)]
[Rules and Regulations]
[Pages 27622-27624]
[FR Doc No: 2017-12470]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2016-0653; FRL-9963-43-Region 9]

Approval of Nevada Air Plan Revisions, Clark County Department of
Air Quality and Washoe County Health District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Environmental Protection Agency (EPA) is taking final
action to approve revisions to the Clark County Department of Air
Quality (CCDAQ) and Washoe County Health District (WCHD) portions of
the Nevada State Implementation Plan (SIP). These revisions concern
emissions of particulate matter (PM) from fugitive dust and wood
burning. We are approving local rules that regulate these emission
sources under the Clean Air Act (CAA or the Act).

DATES: These rules are effective on July 17, 2017.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R09-OAR-2016-0683. 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, e.g., 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 through http://www.regulations.gov, or please contact the person identified in the FOR
FURTHER INFORMATION CONTACT section for additional availability
information.

FOR FURTHER INFORMATION CONTACT: Christine Vineyard, EPA Region IX,
(415) 947-4125<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to the EPA.

Table of Contents

I. Proposed Action
II. Public Comments and EPA Responses
III. EPA Action
IV. Incorporation by Reference
V. Statutory and Executive Order Reviews

I. Proposed Action

    On March 10, 2017 (82 FR 13278), the EPA proposed to approve the
following rules into the Nevada SIP.

----------------------------------------------------------------------------------------------------------------
                                                                                Adopted/
           Local agency                Rule No.              Rule title              amended/        Submitted
                                                                                revised
----------------------------------------------------------------------------------------------------------------
WCHD..............................         010.000  Definitions.................        05/26/16        08/15/16
WCHD..............................         040.051  Wood-Burning Devices........        05/26/16        08/15/16
CCDAQ.............................              26  Emission of Visible Air             05/05/16        06/29/15
                                                     Contaminants.
----------------------------------------------------------------------------------------------------------------

    CCDAQ Rule 26 was revised to reference EPA Test Method 9 to
determine compliance. WCHD Rules 010.000 and 040.051 were revised to
add requirements from another WCHD rule and from national wood heater
requirements. We proposed to approve these revised rules because we
determined that they complied with the relevant CAA requirements. Our
proposed action contains more information on the rules and our
evaluation.

II. Public Comments and EPA Responses

    The EPA's proposed action provided a 30-day public comment period.
During this period, we received no comments.

III. EPA Action

    No comments were submitted. Therefore, as authorized in section
110(k)(3) of the Act, the EPA is fully approving these rules into the
Nevada SIP.

IV. Incorporation by Reference

    In this rule, the EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, the EPA is finalizing the incorporation by reference of the WCHD
and CCDAQ rules described in the amendments to 40 CFR part 52 set forth
below. Therefore, these materials have been approved by EPA for
inclusion in the SIP, 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\ The EPA
has made, and will continue to make, these documents available through
www.regulations.gov and at the EPA Region IX Office (please contact the
person identified in the FOR FURTHER INFORMATION CONTACT section of
this preamble for more information).
---------------------------------------------------------------------------

    \1\ 62 FR 27968 (May 22, 1997).
---------------------------------------------------------------------------

V. Statutory and Executive Order Reviews

    Under the Clean Air Act, 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, the EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
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 the 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).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where the 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. The EPA will submit a report containing this
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 action is not a ``major rule'' as defined by
5 U.S.C. 804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by August 15, 2017. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action 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 rule or action.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Particulate matter, Reporting
and recordkeeping requirements.

    Dated: May 23, 2017.
Alexis Strauss,
Acting Regional Administrator, Region IX.

    Part 52, Chapter I, Title 40 of the Code of Federal Regulations is
amended as follows:

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 DD--Nevada

0
2. In Sec.  52.1470(c), Table 3 is amended by revising the entry for
``Section 26:'' and Table 7 is amended by revising the entries for
``010.000'' and ``040.051'' to read as follows:

Sec.  52.1470  Identification of plan.

* * * * *
    (c) * * *

                                 Table 3--EPA-Approved Clark County Regulations
----------------------------------------------------------------------------------------------------------------
                                                              County                              Additional
        County citation               Title/subject       effective date  EPA approval date      explanation
----------------------------------------------------------------------------------------------------------------

----------------------------------------------------------------------------------------------------------------
                                                   * * * * * *
Section 26.....................  Emission of Visible Air      05/05/2016  [INSERT Federal    Submitted on June
                                  Contaminants.                            Register           29, 2015.
                                                                           CITATION], 06/16/
                                                                           2017.
----------------------------------------------------------------------------------------------------------------

                                                   * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

                                 Table 7--EPA-Approved Washoe County Regulations
----------------------------------------------------------------------------------------------------------------
                                                             District                             Additional
       District citation              Title/subject       effective date  EPA approval date      explanation
----------------------------------------------------------------------------------------------------------------

                                                   * * * * * *
----------------------------------------------------------------------------------------------------------------
010.000........................  Definitions............      05/26/2016  [INSERT Federal    Submitted on August
                                                                           Register           15, 2016.
                                                                           CITATION], 06/16/
                                                                           2017.
----------------------------------------------------------------------------------------------------------------

                                                   * * * * * *
----------------------------------------------------------------------------------------------------------------
040.051........................  Wood-Burning Devices...      05/26/2016  [INSERT Federal    Submitted on August
                                                                           Register           15, 2016.
                                                                           CITATION], 06/16/
                                                                           2017.
----------------------------------------------------------------------------------------------------------------

                                                   * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2017-12470 Filed 6-15-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: November 24, 2008 (Volume 73, Number 227)]
[Notices]
[Page 71088-71089]
[DOCID:fr24no08-161]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Admnistration

Office of Hazardous Materials Safety; Notice of Applications for
Modification of Special Permit

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: List of applications for modification of special permit.

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SUMMARY: In accordance with the procedures governing the application
for, and the processing of, special permits from the Department of
Transportation's Hazardous Material Regulations (49 CFR part 107,
subpart B), notice is hereby given that the Office of Hazardous
Materials Safety has received the application described herein. This
notice is abbreviated to expedite docketing and public notice. Because
the sections affected, modes of transportation, and the nature of
application have been shown in earlier Federal Register publications,
they are not repeated here. Request of modifications of special permits
(e.g., to provide for additional hazardous materials, packaging design
changes, additional mode of transportation, etc.) are described in
footnotes to the application number. Application numbers with the
suffix ``M'' denote a modification request. There applications have
been separated from the new application for special permits to
facilitate processing.

DATES: Comments must be received on or before December 9, 2008.
    Address Comments to: Record Center, Pipeline and Hazardous
Materials Safety Administration, U.S. Department of Transportation,
Washington, DC 20590.
    Comments should refer to the application number and be submitted in
triplicate. If confirmation of receipt of comments is desired, include
a self-addressed stamped postcard showing the special permit number.

FOR FURTHER INFORMATION CONTACT: Copies of the applications are
available for inspection in the Records Center, East Building, PHH-30,
1200 New Jersey Avenue, SE., Washington, DC or at http://dms.dot.gov.
    This notice of receipt of applications for modification of special
permit is published in accordance with Part 107 of the Federal
hazardous materials transportation law (49 U.S.C. 5117(b); 49 CFR
1.53(b)).

    Issued in Washington, DC, on November 13, 2008.
Delmer F. Billings,
Director, Office of Hazardous Materials Special Permits and Approvals.

                                          Modification Special Permits
----------------------------------------------------------------------------------------------------------------
                                                                                Nature of special permit
 Application No./  Docket No.           Applicant          Regulation(s) affected              thereof
----------------------------------------------------------------------------------------------------------------
12516-M.......................  Poly-Coat Systems, Inc.   49 CFR 107.503(b)(c);     To modify the special permit
                                 Houston, TX.              172.1 02(c)(3) B15 and    that authorizes the
                                                           B23; 173.241; 173.242;    manufacture, mark, sale and
                                                           178.345-1; -2; -3; -4; -  use of non-DOT
                                                           7; -14; -15; 178.347-1;   specification cargo tanks
                                                           -2; 178.348-1; 178.348-   constructed of fiberglass
                                                           2; 180.405; 180.4 13(d).  reinforced plastic by
                                                                                increasing the volumetric
                                                                                capacity.
14702-M.......................  CRI/Criterion, Inc. and   49 CFR 178.8 12(a) and    To reissue the special
                                 its affiliate             178.801(1).               permit originally issued on
                                 businesses Houston, TX.                             an emergency basis for the
                                                                                transportation in commerce
                                                                                of approximately 2,500
                                                                                UN1IHG2W, UN11HH2 and
                                                                                UN11HH2W certified
                                                                                intermediate bulk
                                                                                containers that do not meet
                                                                                all the requirements of the
                                                                                competent authority
                                                                                approval that authorized
                                                                                their manufacture.
----------------------------------------------------------------------------------------------------------------

[FR Doc. E8-27594 Filed 11-21-08; 8:45 am]

BILLING CODE 4909-60-M


[Federal Register Volume 84, Number 157 (Wednesday, August 14, 2019)]
[Rules and Regulations]
[Pages 40269-40271]
[FR Doc No: 2019-17309]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0641; FRL-9996-35]

Clonostachys rosea Strain CR-7; Exemption From the Requirement of
a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of Clonostachys rosea strain CR-7 in or on
all food commodities when used in accordance with label directions and
good agricultural practices. Bee Vectoring Technology, Inc. submitted a
petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA),
requesting an exemption from the requirement of a tolerance. This
regulation eliminates the need to establish a maximum permissible level
for residues of Clonostachys rosea strain CR-7 in or on all food
commodities under FFDCA.

DATES: This regulation is effective August 14, 2019. Objections and
requests for hearings must be received on or before October 15, 2019
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2016-0641, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The 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 Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Robert McNally, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:

     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2016-0641 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
October 15, 2019. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2016-0641, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Background

    In the Federal Register of February 7, 2017 (82 FR 9555) (FRL-9956-
86), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide tolerance exemption
petition (PP 6F8508) by Bee Vectoring Technology, Inc., 4160 Sladeview
Crescent #7, Mississauga, Ontario L5L 0A1, Canada (c/o Technology
Sciences Group, Inc., 1150 18th St. NW, Suite 1000, Washington, DC
20036). The petition requested that 40 CFR part 180 be amended by
establishing an exemption from the requirement of a tolerance for
residues of the fungicide Clonostachys rosea strain CR-7 in or on all
food commodities. That notice referenced a summary of the petition
prepared by the petitioner Bee Vectoring Technology, Inc. and available
in the docket via http://www.regulations.gov. Comments were received on
the notice of filing. EPA's response to these comments is discussed in
Unit III.C.

III. Final Rule

A. EPA's Safety Determination

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement of a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings but does not include
occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
FFDCA section 408(b)(2)(C), which require EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance or tolerance exemption and
to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue. . . .'' Additionally, FFDCA section 408(b)(2)(D)
requires that EPA consider ``available information concerning the
cumulative effects of [a particular pesticide's] . . . residues and
other substances that have a common mechanism of toxicity.''
    EPA evaluated the available toxicity and exposure data on
Clonostachys rosea strain CR-7 and considered their validity,
completeness, and reliability, as well as the relationship of this
information to human risk. A full explanation of the data upon which
EPA relied and its risk assessment based on those data can be found
within the document entitled ``Federal Food, Drug, and Cosmetic Act
(FFDCA) Safety Determination for Clonostachys rosea strain CR-7''
(Safety Determination). This document, as well as other relevant
information, is available in the docket for this action as described
under ADDRESSES.
    The available data demonstrated that, with regard to humans,
Clonostachys rosea strain CR-7 is not toxic via the pulmonary, oral, or
dermal routes of exposure and is not pathogenic or infective via the
pulmonary route of exposure. Although there may be some exposure to
residues when Clonostachys rosea strain CR-7 is used on food
commodities in accordance with label directions and good agricultural
practices, dietary exposure to such residues presents no concern for
adverse effects. EPA also determined that a Food Quality Protection Act
safety factor (FQPA SF) was not necessary as part of the qualitative
assessment conducted for Clonostachys rosea strain CR-7. These findings
are discussed in more detail in the Safety Determination.
    Based upon its evaluation in the Safety Determination, EPA
concludes that there is a reasonable certainty that no harm will result
to the U.S. population, including infants and children, from aggregate
exposure to residues of Clonostachys rosea strain CR-7. Therefore, an
exemption from the requirement of a tolerance is established for
residues of Clonostachys rosea strain CR-7 in or on all food
commodities when used in accordance with label directions and good
agricultural practices.

B. Analytical Enforcement Methodology

    An analytical method is not required because EPA is establishing an
exemption from the requirement of a tolerance without any numerical
limitation.

C. Response to Comments

    Two comments were received in response to the notice of filing. EPA
reviewed the comments and to the extent that they are relevant to the

tolerance exemption in this action, they asked EPA to ensure the public
health against adverse effects of pesticides. EPA has evaluated the
available information on Clonostachys rosea strain CR-7, including
toxicological and potential exposure information, and concluded, in
accordance with the statutory requirements of FFDCA, that the exemption
would be safe. The commenters provided no basis for a different
conclusion.

IV. Statutory and Executive Order Reviews

    This action establishes a tolerance exemption under FFDCA section
408(d) in response to a petition submitted to EPA. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001), or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), nor is it considered a
regulatory action under Executive Order 13771, entitled ``Reducing
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3,
2017). This action does not contain any information collections subject
to OMB approval under the Paperwork Reduction Act, 44 U.S.C. 3501 et
seq., nor does it require any special considerations under Executive
Order 12898, entitled ``Federal Actions to Address Environmental
Justice in Minority Populations and Low-Income Populations'' (59 FR
7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance
exemption in this action, do not require the issuance of a proposed
rule, the requirements of the Regulatory Flexibility Act (5 U.S.C. 601
et seq.) do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes. As a result, this
action does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, EPA has determined that this
action will not have a substantial direct effect on States or tribal
governments, on the relationship between the national government and
the States or tribal governments, or on the distribution of power and
responsibilities among the various levels of government or between the
Federal Government and Indian tribes. Thus, EPA has determined that
Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 10,
1999), and Executive Order 13175, entitled ``Consultation and
Coordination with Indian Tribal Governments'' (65 FR 67249, November 9,
2000), do not apply to this action. In addition, this action does not
impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act (2 U.S.C.
1501 et seq.).
    This action does not involve any technical standards that would
require EPA's consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (15 U.S.C. 272 note).

V. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule 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. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: July 31, 2019.
Richard Keigwin,
Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Add Sec.  180.1368 CFR cite to subpart D to read as follows:

Sec.  180.1368  Clonostachys rosea strain CR-7; exemption from the
requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for
residues of Clonostachys rosea strain CR-7 in or on all food
commodities when used in accordance with label directions and good
agricultural practices.

[FR Doc. 2019-17309 Filed 8-13-19; 8:45 am]
BILLING CODE 6560-50-P


1 SF 83 SUPPORTING STATEMENT ENVIRONMENTAL PROTECTION AGENCY STANDARDS OF PERFORMANCE National Emission Standards for Hazardous Air Pollutants Subpart R: Gasoline Distribution Facilities ( Stage I)

1. Identification of the Information Collection 1( a) Identification of the Information Collection ICR for NESHAP, Subpart R  Information Requirements for Gasoline Distribution Facilities.

1( b) Short Characterization/ Abstract Respondents are owners or operators of new or existing pipeline breakout stations or bulk gasoline terminals subject to the NESHAP. Respondents are required to submit one time reports of start of construction, anticipated and actual startup dates, and physical or operational changes to existing facilities. Reports of initial performance tests at bulk terminal loading racks are also required and are necessary to show that the installed control devices are meeting the emission limitations required by the NESHAP. Annual reports of storage vessel inspections at all affected facilities are required. In addition, respondents must submit semiannual startup, shutdown, and malfunction reports, semiannual excess emissions and continuous monitoring system performance reports, and semiannual reports of equipment leaks not repaired within 5 days or loadings of gasoline cargo tanks for which vapor tightness documentation is not on file. Quarterly excess 2 emissions reports are required for control device monitoring parameter exceedances, equipment leaks for which timely repair is not made, and reloadings of nonvapor tightness certified cargo tanks. All affected bulk terminals must maintain records of the cargo tank vapor tightness test data on the facility premises. All records are to be maintained for at least 5 years.

All reports are to be submitted to the respondent's State or local agency, whichever has been delegated enforcement authority by the EPA. The information is to be used to determine whether all sources subject to the NESHAP are achieving the standards.

2. Need for and Use of the Collection 2( a) Need/ Authority for the Collection The U. S. Environmental Protection Agency ( EPA) is charged under Section 112 of the Clean Air Act ( CAA or Act) ( Attachment 1), as amended, to establish national emission standards for hazardous air pollutants ( NESHAP). Section 114 of the Act allows the Administrator to require inspections, monitoring, and entry into facilities to ensure compliance with a Section 112 emission standard.

Section 114( a) specifically states that:

. . . the Administrator may require any owner or operator subject to any requirement of this Act to ( A) establish and maintain such records, ( B) make such reports, ( C)

install, use, and maintain such monitoring equipment or methods ( in accordance with such methods at such locations, at such intervals, and in such manner as the Administrator shall prescribe), and ( D) sample such emissions, ( E) keep records on control equipment parameters, production variables or other indirect data when direct monitoring of emissions is impractical, ( F) submit 3 compliance certifications, and ( G) provide such other information as he may reasonably require.

Effective enforcement of this rule is necessary due to the hazardous nature of benzene ( a known human carcinogen) and the toxic nature of the other 10 HAP's emitted from gasoline distribution facilities. Certain records and reports are necessary: ( 1) to enable the EPA to identify new and existing sources subject to the standards, and ( 2) to assist the EPA and State agencies to which enforcement has been delegated in determining compliance with the standards.

2( b) Practical Utility/ Users of the Data The information will be used by agency enforcement personnel to: ( 1) identify sources subject to the standards; ( 2) ensure that leakage emissions from cargo tanks and process piping equipment components ( both liquid and vapor) during loading are being minimized; ( 3) ensure that emission control devices are being properly operated and maintained; and ( 4) ensure that emissions from storage vessels are minimized and rim seal and fitting defects are repaired on a timely basis.

In addition, records and reports are necessary to enable the EPA to identify facilities that may not be in compliance with the standards. Based on reported information, the EPA can decide which facilities should be inspected and what records or specific emission sources should be inspected at each facility. Also, the records that facilities maintain provide an indication to the EPA as to whether facility personnel are operating and maintaining control equipment properly.

3. Non duplication, Consultations, and Other Collection Criteria 3( a) Non duplication Some of the facilities subject to this NESHAP will also be subject to requirements under NSPS Subparts K, Ka, Kb, VV, and XX. The burden requested for this NESHAP does not 4 duplicate any of the burden accounted for under those NSPS subparts.

Certain reports required by State or local agencies may duplicate information required by the standards. In such cases, a copy of the report submitted to the State or local agency may be sent to the Administrator in lieu of the report required by the standards.

3( b) Public Notice Required Prior to ICR Submission to OMB A federal register notice was published on August 17, 2000 soliciting comments on burden estimates for this ICR. No comments were received.

3( c) Consultations The bulk terminal and pipeline breakout station reporting and record keeping requirements were discussed with numerous representatives of the petroleum marketing industry ( including owners of pipeline breakout stations) during the development of the NSPS for bulk terminals,

during the development of national standards for benzene emissions from gasoline marketing operations, and during this NESHAP development.

3( d) Effects of Less Frequent Collection The reporting requirements for facilities subject to the NESHAP consist of certain onetime reports and a minimal amount of periodic record keeping and reporting. At new and existing bulk terminals, monthly visual ( non instrument) inspections and corresponding records and reports of the loading racks and process piping equipment components are required ( storage vessels require annual inspections and associated records and reports). If this information were collected less frequently, the main consequence would be poor operation and maintenance of equipment components and storage vessels. Consequently, increased HAP emissions could result.

The same is true for visual inspections of equipment components and the inspection of storage vessels at pipeline breakout stations. 5 At bulk gasoline terminals, monitoring an operating parameter of the control device on a continuous basis is the only means of ensuring that the device is continuing to meet the emission limit. The effect of not requiring this monitoring could be increased HAP emissions.

3( e) General Guidelines The final rule requires records to be retained for 5 years, which is consistent with the Part 63 General Provisions and the Part 70 operating permit requirements ( Title V). All of the facilities affected by this NESHAP are required to obtain an operating permit ( with or without the issuance of this NESHAP). None of the other guidelines in 5 C. F. R. § 1320.6 is being exceeded.

3( f) Confidentiality Any information submitted to the Agency for which a claim of confidentiality is made will be safeguarded according to Agency policies as set forth in Title 40, Chapter 1, Part 2, Subpart B

 Confidentiality of Business Information ( see 40 C. F. R. Part 2; 40 FR 36902, September 1, 1976;

amended by 43 FR 39999, September 28, 1978; 43 FR 42251, September 28, 1978; 44 FR 17674, March 23, 1979).

3( g) Sensitive Questions This section is not applicable. Information to be collected has been determined not to be of a sensitive nature.

4. The Respondents and the Information Requested 4( a) Respondents/ SIC Codes Respondents are owners or operators of affected pipeline breakout stations and bulk terminals subject to the NESHAP. The SIC codes for the respondents affected by the standards 6 include 4226, 4400, 5169, 5171, and 5172.

4( b) Information Requested ( i) Data items, including record keeping requirements ( 1) Bulk Gasoline Terminals. The following types of one time reports are required for bulk terminals affected by the NESHAP.

° For existing sources, a report filed within 1 year subsequent to the effective date of the NESHAP, notifying the Administrator that the facility is subject to the relevant standards. Information to be provided in the report is detailed in 40 C. F. R. § 63.9( b)( 2) of Subpart A, General Provisions.

° For new sources [ for which approval of construction or reconstruction is not required under 40 C. F. R. § 63.5( d)], a report filed within 15 days after startup of the source, notifying the Administrator that the facility is subject to the relevant standards. Information to be provided in the report is detailed in 40 C. F. R § 63.9( b)( 3).

° Notification of anticipated construction or reconstruction of a source subject to a relevant standard not later than 180 days prior to commencement of construction or reconstruction as indicated in 40 C. F. R § 63.9( b)( 5).

° Notification of anticipated date of initial startup not more than 60 days nor less than 30 days prior to such date. 40 C. F. R § 63.9( b)( 4)( iv).

° Notification of the actual date of startup, within 15 days after such date. 40 C. F. R § 63.9( b)( 4)( v).

° Notification of construction or reconstruction not later than 30 days after the change is commenced. 40 C. F. R. § 63.9( b)( 4)( iii).

° Notification of installation of a new control device or reconstruction of an existing control device within 180 days before the installation or reconstruction is planned to commence. 40 C. F. R. § 63.5( b)( 6) and 40 C. F. R. § 63.5( d)( 1).

° Within 180 days after initial startup, installation of a control device, or refurbishment of an existing control device, the owner or operator of the facility must conduct a performance test and furnish the Administrator with a written report. 40 C. F. R. § 63.7( a).

° The owner or operator of an affected facility must notify the Administrator at least 60 days prior to the date of a performance test. 40 C. F. R. § 63.9( e). 7 ° A request for an extension of compliance report must be submitted if the owner or operator cannot comply with the standard by the designated date. 40 C. F. R. § 63.9( c).

° The owner or operator must report any reconstruction of an affected facility as defined in 40 C. F. R. § 63.5.

The following periodic reports and record maintenance are required for the affected sources:

° At new and existing facilities, monthly visual inspection data on gasoline transfer and vapor collection and processing equipment. Records and reports are to be kept as specified in 40 C. F. R. § 63.428( e) and ( f).

° Annual inspections of storage vessels are to be made and records kept and reports filed as specified in 40 C. F. R. § 60.115b.

° Records are to be maintained and kept up to date of the cargo tank vapor tightness data in accordance with 40 C. F. R. § 63.428( b).

° A continuous record of operating parameter monitoring data is to be kept, and exceedances of the monitored operating parameter are to be reported semiannually pursuant to 40 C. F. R. § 63.428( c)( 1) and 40 C. F. R. § 63.428( g)( 1).

° Records required by this NESHAP must be retained by the owner or operator for 5 years 40 C. F. R. § 63.10( b).

° Annual reports stating non applicability of the regulation are required from area sources within 50 percent of the major source threshold as specified in 40 C. F. R. § 63.428( i).

These data will be viewed and analyzed by Agency personnel during periodic visits,

approximately once a year, to the respondents' terminals.

( 2) Pipeline breakout stations. The following types of one time reports are required for pipeline breakout stations subject to the NESHAP.

° For existing sources, a report filed within 1 year subsequent to the effective date of the NESHAP, notifying the Administrator that the facility is subject to the relevant standards. Information to be provided in the report is detailed in 40 C. F. R. § 63.9( b)( 2) of Subpart A, General Provisions. 8 ° For new sources [ for which approval of construction or reconstruction is not required under 40 C. F. R. § 63.5( d)], a report filed within 15 days after startup of the source, notifying the Administrator that the facility is subject to the relevant standards. Information to be provided in the report is detailed in 40 C. F. R. § 63.9( b)( 3).

° Notification of anticipated construction or reconstruction of a source subject to a relevant standard not later than 180 days prior to commencement of construction or reconstruction. 40 C. F. R. § 63.9( b)( 5).

° Notification of anticipated date of initial startup not more than 60 days nor less than 30 days prior to such date. 40 C. F. R. § 63.9( b)( 4)( iv).

° Notification of actual date of initial startup within 15 days after such date. 40 C. F. R. § 63.9( b)( 4)( v).

° Notification of construction or reconstruction not later than 30 days after the change is commenced. 40 C. F. R. § 63.9( b)( 4)( iii).

° A request for an extension of compliance report must be submitted if the owner or operator cannot comply with the standards by the designated date. 40 C. F. R. § 63.9( c).

° The owner or operator must report any reconstruction of an affected facility as defined in 40 C. F. R § 63.5.

The following periodic reports and record maintenance are required for the affected sources:

° At new and existing facilities, monthly visual inspection data on gasoline transfer and vapor collection and processing equipment. Records and reports are to be kept as specified in 40 C. F. R. § 63.428( e) and ( f).

° Annual inspections of storage vessels are to be made and records kept and reports filed as specified in 40 C. F. R. § 60.115b.

° Records required by this NESHAP must be retained by the owner or operator for 5 years. 40 C. F. R. § 63.10( b).

° Annual reports stating non applicability of the regulation are required from area sources within 50 percent of the major source threshold as specified in 40 C. F. R. § 63.428( i).

These data will be viewed and analyzed by Agency personnel during periodic visits, 9 approximately once a year, to the respondents' pipeline stations.

( ii) Respondent Activities.

The respondent activities required by the standards are provided under the first column of Tables 1A and 1B of Section 6( a).

5. The Information Collected   Agency Activities, Collection Methodology, and Information Management 5( a) Agency Activities EPA conducts the following activities in connection with the acquisition, analysis, storage,

and distribution of the information required under 40 C. F. R. Subpart " R", National Emissions Standards for Hazardous Air Pollutants for Source Categories: Gasoline Distribution ( Stage I).

 Observes initial and repeat performance tests  Reviews notifications and reports, including excess emissions reports, required to be submitted by industry.

 Audits facility records  Compiles data in the AIRS database 5( b) Collection Methodology and Management Following notification of startup, the reviewing authority might inspect the source to check if the pollution control devices are properly installed and operated. Performance test reports are used by the Agency to discern a source's initial capability to comply with the emission standard, and note the operating conditions under which compliance was achieved. Data obtained during periodic visits by Agency personnel from records maintained by the respondents are 10 tabulated and published for internal Agency use in compliance and enforcement programs. The semiannual reports are used for problem identification, as a check on source operation and maintenance, and for compliance determinations.

Information contained in the reports is entered into the Aerometric Information Retrieval System ( AIRS) Facility Subsystem ( AFS) which is operated and maintained by EPA's Office of Air Quality Planning and Standards. The AFS is EPA's database for the collection, maintenance,

and retrieval of compliance and annual emission inventory data for over 100,000 industrial and government owned facilities. EPA uses AFS for tracking air pollution compliance and enforcement by local and State regulatory agencies, EPA Regional Offices and Headquarters.

EPA can edit, store, retrieve and analyze the data via PC terminals.

5( c) Small Entity Flexibility ( i) Bulk Gasoline Terminals Even though the record keeping requirements are the same for small and large businesses,

the Agency considers these requirements the minimum needed to ensure compliance and,

therefore, cannot reduce them further for small businesses. Construction, modification, and reconstruction reports take very little time to complete and are filed only once. Equipment leak monitoring and storage vessel inspection records are brief and tank truck vapor tightness documentation will be supplied by cargo tank operators and kept at the terminal for each tank currently using the terminal.

( ii) Pipeline Breakout Stations Owners or operators of small pipeline breakout stations are required to maintain records and report inspections of storage vessels in the same manner as bulk gasoline terminals, and,

therefore, the same level of flexibility applies. 11 5( d) Collection Schedule Information contained in the one time only reports will be entered into the AIRS facility subsystem. Data obtained during periodic visits by Agency personnel from records maintained by the respondents and reports submitted by the respondents to the EPA will be tabulated and published for internal EPA use in compliance enforcement programs. A schedule for the collection of information and publication of data is not applicable because reports and record keeping are triggered by action of the respondents.

6. Estimating the Burden and Cost of the Collection Tables 1A and 1B document the computation of individual burdens for each of the record keeping and reporting requirements applicable to the respondents complying with this standard.

The individual burdens are expressed under standardized headings believed to be consistent with the concept of burden under the Paperwork Reduction Act. Where appropriate, specific tasks and major assumptions have been identified. Responses to this information collection are mandatory.

The 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.

6( a) Estimating Respondent Burden ( i) Bulk Gasoline Terminals The average annual burden for bulk gasoline terminals over the next three years from these record keeping and reporting requirements is estimated at 31,797 person hours, as indicated in Table 1B. These hours are based on Agency studies and background documents from the development of the standards or test methods, Agency knowledge and experience with the 12 NESHAP program, the previously approved ICR, and any comments received about time to prepare reports.

For the purposes of these estimates, a controlled bulk terminal is one that has a vapor processor installed at its loading racks which complies with an emission limit of 80 mg of total organic compounds per liter of gasoline loaded. Cargo tanks that are presently required to have annual vapor tightness tests are classified as currently tested. The number of terminals estimated to be constructed or changed was based on industry growth projections.

NUMBER OF EMISSION SOURCES AT BULK TERMINALS SUBJECT TO THE NESHAP Source Type Total Major* Only Number of Bulk Terminals 1,024 243 13 Number of Loading Racks Controlled Meeting 10 mg/ l Meeting NSPS level Meeting CTG level Uncontrolled 1,024 727 338 123 266 297 243 131 61 22 48 112 Number of Cargo Tanks Currently tested Not tested 43,900 31,169 12,731 10,439 7,412 3,027 Number of Storage Tanks Meeting NSPS & CTG levels External floating roof tanks with primary seals Uncontrolled fixed roof tanks 8,032 4,534 2,426 1,072 1,910 1,078 577 255 Number of Equipment Components**

100,000 gal/ day facility 250,000 gal/ day facility 500,000 gal/ day facility 1,000,000 gal/ day facility Pump Seals 10 15 15 20 Valves 290 350 450 500 *" Major" sources are those that emit 10 tons/ year or more of a listed pollutant or 25 tons or more of a combination of pollutants.

** Varies by facility. Values presented are model plant estimates. Additional components ( e. g., open ended lines and connectors) are not shown here.

( ii) Pipeline Breakout Stations The average annual burden for pipeline breakout stations over the next three years from these record keeping and reporting requirements is estimated at 778 person hours, as indicated in Table 1A. These hours are based on Agency studies and background documents from the development of the standards or test methods, Agency knowledge and experience with the NESHAP program, the previously approved ICR, and any comments received about time to 14 prepare reports.

NUMBER OF EMISSION SOURCES AT PIPELINE BREAKOUT STATIONS SUBJECT TO THE NESHAP Source Type Total Major* Only Number of Breakout Stations 270 20 Number of Storage Tanks Meeting NSPS & CTG levels External floating roof tanks with primary seals Uncontrolled fixed roof tanks 3,300 1,639 1,288 373 244 121 95 28 Number of Equipment Components**

Stations with 10 storage tanks Stations with 15 storage tanks Pump Seals 20 35 Valves 2,640 7,920 *" Major" sources are those that emit 10 tons/ year or more of a listed pollutant or 25 tons or more of a combination of pollutants.

** Varies by facility. Values presented are model plant estimates. Additional components are not shown here.

6( b) Estimating Respondent Costs ( i) Estimating Labor Costs This ICR uses the labor rate of $ 39.77 per hour from the United States Department of Commerce Bureau of Labor Statistics Employment Costs for Civilian Workers by Occupational and Industry Group. The costs to conduct this effort have been calculated on the basis of $ 18.94 per hour plus 110 percent overhead.

( ii) Estimating Capital and Operations and Maintenance Costs There are no new sources expected over the next three years, therefore, the capital startup costs for this regulation is estimated to be $ 0. 15 ( iii) Capital/ Start up Operating and Maintenance ( O& M) Costs A representative of the Petroleum Marketers Association of America ( PMAA) was consulted regarding the annual operation and maintenance costs associated with the continuous emission monitor requirement, number 14( b), form 83 I. PMAA indicated an annual cost of $ 3,500 per facility, to monitor and repair the equipment, as well as the energy cost to run the equipment. Please note, only 243 bulk gasoline terminals were counted towards the total number of facilities, due to the fact that there is no CEM requirement for the 20 pipeline breakout stations. Assume cost calculated as follows:

$ 3,500 X 243 facilities = $ 850,500 6( c) Estimating Agency Burden and Cost The only Federal costs are user costs associated with analysis of the reported information.

Publication and distribution of the information are part of the Aerometric Information Retrieval System ( AIRS) Facility Subsystem ( AFS) which is operated and maintained by EPA's Office of Air Quality Planning and Standards. Examination of records to be maintained by the respondents will occur as part of the periodic inspection of sources, which is part of EPA's overall compliance and enforcement program.

The average annual Federal Government cost during the next 3 years of the ICR is estimated to be $ 428,258. This cost is based on an average wage of a GS 10, step 1 employee for technical level work performed plus the average wage of a GS 14, step 1 employee for litigation work performed. The costs to conduct this effort have been calculated on the basis of $ 18.24 and $ 33.76 per hour, respectively, plus 110 percent overhead. Details upon which this estimate is based appear in Tables 2A and 2B.

6( d) Estimating the Respondent Universe and Total Burden and Costs 16 The number of existing sources subject to the National Emission Standards for Hazardous Air Pollutants for Source Categories: Gasoline Distribution ( Stage I), 40 C. F. R. Part 63, Subpart R is 263 ( 243 bulk gasoline terminals + 20 pipeline breakout stations) with no new sources expected due to no projected growth for the bulk gasoline terminal industry. The labor estimates used in Tables 1A and 1B were derived from standard estimates based on EPA's experience with other standards. The average annual burden to the industry over the next three years from these record keeping and reporting requirements is estimated at 32,575 person hours. The respondent costs have been calculated on the basis of $ 18.94 per hour, plus 110 percent overhead. The average annual burden to industry over the next three years of the ICR is estimated to be $ 1,295,518. Details upon which this estimate is based appear in Tables 1A and 1B.

6( e) Bottom Line Burden Hours And Costs Tables ( i) Respondent Tally See Tables 1A and 1B.

( ii) The Agency Tally See Tables 2A and 2B.

( iii) Variations in the Annual Bottom Line Annual burden costs for the industry ( tables 1A and 1B) and annual burden costs for the Federal Government ( tables 2A and 2B) increase for this ICR due to increase in current hourly wage rates only. 17 6( f) Reasons For Change In Burden Burden hours remain unchanged. However, the decrease in industry burden cost from the most recently approved ICR is due to more accurate hourly rate estimates obtained from the United States Department of Commerce Bureau of Labor Statistics, March 2000, Table 2:

Employment Costs for Civilian Workers by Occupational and Industry Group; Column 2, wages and salaries.

6( g) Burden Statement 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 C. F. R. Part 9 and 48 C. F. R. Chapter 15. 18 Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to the Sandy Farmer, U. S. Environmental Protection Agency, Collection Strategies Division ( Mail Code 2822), 1200 Pennsylvania Avenue,

N. W., Washington, D. C. 20460; and to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, N. W., Washington, D. C. 20503, Attention: Desk Officer for EPA. Include the EPA ICR number 1659.04 and OMB control number 2060 0325 in any correspondence. 19 TABLE 1A. ANNUAL RESPONDENT BURDEN AND COST OF REPORTING AND RECORDKEEPING REQUIREMENTS OF THE NESHAP AT PIPELINE BREAKOUT STATIONS Burden Item Hours per Occurrence ( A) Number of Occurrences per Respondent ( B) Number of Respondents ( C) Person hours ( D= AxBxC) Annual Cost, $

( E= Dx$ 39.77)

1. Applications NA 2. Surveys & studies NA 3. Reporting requirements A. Read instructions 1 1 20 20 795 B. Required activities Initial performance test NA Storage tank seal and seal gap inspectionsa 16 1 10 160 6,363 C. Create information see 3B D. Gather information see 3B E. Report preparation Initial notification 2 1 0 0 0 Notification of compliance status 8 1 0 0 0 Semiannual reports 8 2 20 320 12,726 Notification of constr./ reconstr. 2 1 2 4 159 Notification of anticipated startup 2 1 1 2 80 Notification of actual startup 2 1 1 2 80 Notification of perf. test and CMS evaluation NA Area source reporting of complianceb 1 1 125 125 4,971 4. Recordkeeping requirements A. Read instructions see 3A B. Plan activities see 3B C. Implement activities see 3B D. Develop record system 8 1 0 0 0 E. Record information TABLE 1A. ( Concluded)

Burden Item Hours per Occurrence ( A) Number of Occurrences per Respondent ( B) Number of Respondents ( C) Person hours ( D= AxBxC) Annual Cost, $

( E= Dx$ 39.77)

20 Record equipment subject to visual inspection requirements 1 1 0 0 0 Record equipment leak data 0.1 12 20 24 954 Record storage tank seal inspections 1 1 10 10 398 Record startup, shutdowns, and malfunctions 1 4 10 40 1,591 Area source recordkeepingc 0.25 1 125 31.25 1,243 F. Personnel training 1 1 20 20 795 G. Time for audits 4 1 5 20 795 TOTAL BURDEN AND COST 778 30,950 aAssumes that 50% of the 20 estimated existing major source facilities are currently subject to requirements equivalent to the VOL Storage NSPS ( 40 CFR part 60, subparts K, Ka, and Kb) or storage tank CTG's.

bAssumes that 50% of area source facilities will be within 50% of major source threshold criteria and will be required to submit annual certification of area source status reports [( 270  20)/ 2 = 125 facilities].

cAssumes that 50% of area source facilities will be required to keep annual records of their area source status using the screening equation. 21 TABLE 1B. ANNUAL RESPONDENT BURDEN AND COST OF REPORTING AND RECORDKEEPING REQUIREMENTS OF THE NESHAP AT BULK GASOLINE TERMINALS Burden Item Hours per Occurrence ( A) Number of Occurrences per Respondent ( B) Number of Respondents ( C) Person hours ( D= AxBxC) Annual Cost, $

( E= Dx$ 39.77)

1. Applications NA 2. Surveys & studies NA 3. Reporting requirements A. Read instructions 2 1 243 486 19,328 B. Required activities Initial performance test 175 1 0 0 0 Repeat performance test 175 1 0 0 0 Storage tank seal and seal gap inspectionsa 16 1 122 1,952 77,631 C. Create information see 3B D. Gather information see 3B E. Report preparation Initial notification 3 1 0 0 0 Notification of compliance status 4 1 0 0 0 Semiannual reportsb 10 2 97 1,940 77,154 Notification of constr./ reconstr. 2 1 15 30 1,193 Notification of anticipated startup 2 1 5 10 398 Notification of actual startup 2 1 5 10 398 Notification of perf. test and CMS evaluation 4 1 28 112 4,454 Area source reporting of compliancec 1 1 391 391 15,550 TABLE 1B. ( Continued)

Burden Item Hours per Occurrence ( A) Number of Occurrences per Respondent ( B) Number of Respondents ( C) Person hours ( D= AxBxC) Annual Cost, $

( E= Dx$ 39.77)

22 4. Recordkeeping requirements A. Read instructions see 3A B. Plan activities see 4C C. Implement activities File cargo tank inspection recordsb 0.5 26 146 1,898 75,483 Update cargo tank inspection recordsb 6 1 146 876 34,839 Cross check cargo tank inspection fileb 6 26 146 22,776 905,802 D. Develop record system 8 1 0 0 0 E. Record information Record equipment subject to visual inspection requirements 1 1 0 0 0 Record equipment leak data 0.1 4 243 97 3,858 Record storage tank seal inspections 1 1 122 122 4,852 Record startups, shutdowns, and malfunctionsa 1 4 122 488 19,408 Area source recordkeepingd 0.25 1 391 98 3,897 TABLE 1B. ( Continued)

Burden Item Hours per Occurrence ( A) Number of Occurrences per Respondent ( B) Number of Respondents ( C) Person hours ( D= AxBxC) Annual Cost, $

( E= Dx$ 39.77)

23 F. Personnel training 1 1 97 97 3,858 G. Time for audits 6 1 69 414 16,465 TOTAL BURDEN AND COST 31,797 1,264,568 aAssumes that 50% of the 243 estimated major source facilities are currently subject to requirements equivalent to the VOL Storage NSPS ( 40 CFR part 60,

subparts K, Ka, and Kb) or storage tank CTG's.

bAssumes that 40% of the 243 estimated major source facilities are currently subject to requirements equivalent to the Bulk Gasoline Terminal NSPS ( 40 CFR part 60, subpart XX).

cAssumes that 50% of area sources will be within 50% of major source threshold criteria and will be required to submit annual certification of area source status reports [( 1024  243)/ 2 = 391 facilities].

dAssumes that 50% of area sources ( 391 facilities) will be required to keep annual records of their area source status using the screening equation. 24 TABLE 2A. ANNUAL BURDEN AND COST FOR THE FEDERAL GOVERNMENT TO IMPLEMENT THE NESHAP AT PIPELINE BREAKOUT STATIONS Activity EPA Hours per Occurrence ( A) Number of Occurrences ( B) EPA Person hours ( D= AxB) Annual Cost, $

( E= Dx$ 38.30/$ 70.75)

Review initial notification 1 0 0 0 Review notification of compliance status 8 0 0 0 Review semiannual reports 8 36 288 11,030 Review notification of constr./ reconstr. a 0 0 0 0 Review notification of anticipated startupa 0 0 0 0 Review notification of actual startupa 0 0 0 0 Litigationb 1,040 1 1,040 73,580 TOTAL BURDEN AND COST 1,328 84,610 aActivity already accounted for by the Organic Liquid Storage NSPS ( 40 CFR part 60, subparts K, Ka, and Kb).

bHourly wage is based on average of a GS 10, step 1 employee plus 110% overhead except for " Litigation" activity which is based on an average of a GS 14, step 1 employee plus 110% overhead. 25 TABLE 2B. ANNUAL BURDEN AND COST FOR THE FEDERAL GOVERNMENT TO IMPLEMENT THE NESHAP AT BULK GASOLINE TERMINALS Activity EPA Hours per Occurrence ( A) Number of Occurrences ( B) EPA Person hours ( D= AxB) Annual Cost, $

( E= Dx$ 38.30/$ 70.75)

Review initial notification 1 0 0 0 Review notification of compliance status 10 0 0 0 Review semiannual reports 10 486 4,860 186,138 Review notification of constr./ reconstr. a 0 0 0 0 Review notification of anticipated startupa 0 0 0 0 Review notification of actual startupa 0 0 0 0 Review notification of perf. test and CMS evaluation 1 0 0 0 Attend initial performance testb 8 0 0 0 Attend repeat performance testc 8 0 0 0 Litigationd 1,040 2 2,080 147,160 TOTAL BURDEN AND COST ( Salary) 6,940 333,298 Travele 10,350 TOTAL ANNUAL COST 343,648 aActivity already accounted for by the Bulk Gasoline Terminal NSPS ( 40 CFR 60, subpart XX).

bAssumes EPA personnel attend 10% of all performance tests [ only tests not covered by Bulk Gasoline Terminal NSPS ( 40 CFR 60, subpart XX) are accounted for here]. cAssumes that 10% of performance tests must be repeated.

dHourly wage is based on average of a GS 10, step 1 employee plus 110% overhead except for " Litigation" activity which is based on an average of a GS 14, step 1 employee plus 110% overhead.

eTravel cost based on 23 one day trips for one person at $ 400 per round trip plus $ 50 per diem. 26