[Federal Register Volume 80, Number 54 (Friday, March 20, 2015)]
[Notices]
[Pages 14999-15001]
[FR Doc No: 2015-06508]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9924-35-OGC]

Proposed Consent Decree, Clean Air Act Citizen Suit

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of proposed consent decree; request for public comment.

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SUMMARY: In accordance with section 113(g) of the Clean Air Act, as
amended (``CAA'' or the ``Act''), notice is hereby given of a proposed
consent decree to address a lawsuit filed by Sierra Club: Sierra Club
v. McCarthy, No. 4:14-cv-00643-JLH (E.D. AK). In 2012, the
Environmental Protection Agency (EPA) issued a rule partially
disapproving a revision to a state implementation plan (SIP) submitted
by Arkansas to address the requirements of the regional haze program.
EPA also at the same time partially disapproved that portion of the
Arkansas SIP submittal addressing the interstate transport visibility
requirements associated with the promulgation of the 1997 national
ambient air quality standards (NAAQS) for ozone and fine particulate
matter (PM2.5). In its lawsuit, Sierra Club alleged that EPA
has failed to meet the

requirement of the Clean Air Act that the Agency promulgate a federal
implementation plan (FIP) within two years of partially disapproving a
SIP, in whole or in part. The proposed consent decree establishes
proposed and final deadlines for EPA to take action to meet its
obligations with respect to Arkansas.

DATES: Written comments on the proposed consent decree must be received
by April 20, 2015.

ADDRESSES: Submit your comments, identified by Docket ID number EPA-HQ-
OGC-2015-0162, online at www.regulations.gov (EPA's preferred method);
by email to<EMAIL_ADDRESS>by mail to EPA Docket Center,
Environmental Protection Agency, Mailcode: 2822T, 1200 Pennsylvania
Ave. NW., Washington, DC 20460-0001; or by hand delivery or courier to
EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave. NW.,
Washington, DC, between 8:30 a.m. and 4:30 p.m. Monday through Friday,
excluding legal holidays. Comments on a disk or CD-ROM should be
formatted in Word or ASCII file, avoiding the use of special characters
and any form of encryption, and may be mailed to the mailing address
above.

FOR FURTHER INFORMATION CONTACT: M. Lea Anderson, Air and Radiation Law
Office (2344A), Office of General Counsel, U.S. Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460;
telephone:<PHONE_NUMBER>; fax number<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Additional Information About the Proposed Consent Decree

    On October 17, 2011, EPA proposed to partially approve and to
partially disapprove a revision to the Arkansas SIP intended to address
the regional haze requirements of the Clean Air Act. 76 F R 64186. In
that same action, EPA also proposed to partially disapprove the portion
of the Arkansas' interstate transport SIP submittal addressing the
visibility requirement of section 110(a)(2)(D)(i)(II) of the Clean Air
Act for the 1997 ozone NAAQS and the 1997 PM2.5 NAAQS. On
March 12, 2012, EPA finalized its partial approval and disapproval of
the Arkansas Regional Haze and Interstate Transport SIP submittals. 77
F R 14604. When EPA disapproves a SIP submission in whole or in part,
section 110(c) of the Act requires EPA to promulgate a FIP within two
years unless the State corrects the deficiency and EPA approves the
plan revision. Sierra Club filed a complaint in the United States
District Court for the Northern District of California in August 2014
alleging that EPA had failed to promulgate a FIP for Arkansas as
required by the Clean Air Act. That case was transferred to the United
State District Court for the Eastern District of Arkansas in October
2014.
    The proposed consent decree would resolve the lawsuit filed by the
Sierra Club by establishing that EPA must take proposed action by March
16, 2015 and final action by December 15, 2015 to address the
deficiencies in the Arkansas SIP that were identified by EPA in its
March 12, 2012 action. See the proposed consent decree for the specific
details.
    For a period of thirty (30) days following the date of publication
of this notice, the Agency will accept written comments relating to the
proposed consent decree from persons who were not named as parties or
intervenors to the litigation in question. EPA or the Department of
Justice may withdraw or withhold consent to the proposed consent decree
if the comments disclose facts or considerations that indicate that
such consent is inappropriate, improper, inadequate, or inconsistent
with the requirements of the Act. Unless EPA or the Department of
Justice determines that consent to this consent decree should be
withdrawn, the terms of the decree will be affirmed.

II. Additional Information About Commenting on the Proposed Consent
Decree

A. How can I get a copy of the consent decree?

    The official public docket for this action (identified by Docket ID
No. EPA-HQ-OGC-2015-0162) contains a copy of the proposed consent
decree. The official public docket is available for public viewing at
the Office of Environmental Information (OEI) Docket in the EPA Docket
Center, EPA West, Room 3334, 1301 Constitution Ave. NW., Washington,
DC. 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 Public Reading Room is<PHONE_NUMBER>, and the
telephone number for the OEI Docket is<PHONE_NUMBER>.
    An electronic version of the public docket is available through
www.regulations.gov. You may use www.regulations.gov to submit or view
public comments, access the index listing of the contents of the
official public docket, and to access those documents in the public
docket that are available electronically. Once in the system, key in
the appropriate docket identification number then select ``search''.
    It is important to note that EPA's policy is that public comments,
whether submitted electronically or in paper, will be made available
for public viewing online at www.regulations.gov without change, unless
the comment contains copyrighted material, CBI, or other information
whose disclosure is restricted by statute. Information claimed as CBI
and other information whose disclosure is restricted by statute is not
included in the official public docket or in the electronic public
docket. EPA's policy is that copyrighted material, including
copyrighted material contained in a public comment, will not be placed
in EPA's electronic public docket but will be available only in
printed, paper form in the official public docket. Although not all
docket materials may be available electronically, you may still access
any of the publicly available docket materials through the EPA Docket
Center.

B. How and to whom do I submit comments?

    You may submit comments as provided in the ADDRESSES section.
Please ensure that your comments are submitted within the specified
comment period. Comments received after the close of the comment period
will be marked ``late.'' EPA is not required to consider these late
comments.
    If you submit an electronic comment, EPA recommends that you
include your name, mailing address, and an email address or other
contact information in the body of your comment and with any disk or CD
ROM you submit. This ensures that you can be identified as the
submitter of the comment and allows EPA to contact you in case EPA
cannot read your comment due to technical difficulties or needs further
information on the substance of your comment. Any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,
and made available in EPA's electronic public docket. If EPA cannot
read your comment due to technical difficulties and cannot contact you
for clarification, EPA may not be able to consider your comment.
    Use of the www.regulations.gov Web site to submit comments to EPA
electronically is EPA's preferred method for receiving comments. The
electronic public docket system is an ``anonymous access'' system,
which means EPA will not know your identity, email address, or other
contact information unless you provide it in the body of your comment.
In contrast to EPA's electronic public docket, EPA's electronic mail
(e-mail)

system is not an ``anonymous access'' system. If you send an email
comment directly to the Docket without going through
www.regulations.gov, your email address is automatically captured and
included as part of the comment that is placed in the official public
docket, and made available in EPA's electronic public docket.

    Dated: March 12, 2015.
Lorie J. Schmidt,
Associate General Counsel.
[FR Doc. 2015-06508 Filed 3-19-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 175 (Friday, September 9, 2016)]
[Rules and Regulations]
[Pages 62395-62397]
[FR Doc No: 2016-21204]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 127

[FRL-9951-76-OECA]

NPDES Electronic Reporting Rule Implementation Guidance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of guidance.

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SUMMARY: The U.S. Environmental Protection Agency (EPA) recently
promulgated the NPDES Electronic Reporting Rule (``final rule'') to
modernize Clean Water Act reporting for municipalities, industries, and
other facilities by converting to an electronic data reporting system.
This final rule requires regulated entities and state and Federal
regulators to use existing, available information technology to
electronically report data required by the National Pollutant Discharge
Elimination System (NPDES) permit program instead of filing written
paper reports.
    This action will save time and resources for permittees, states,
tribes, territories, and the U.S. Government while increasing data
accuracy, improving compliance, and supporting EPA's goal of providing
better protection of the nation's waters. This regulation will help
provide greater clarity on who is and who is not in compliance and
enhances transparency by providing a timelier, complete, more accurate,
and nationally-consistent set of data about the NPDES program.
    The final rule requires EPA to publish in the Federal Register a
listing of the initial recipients for electronic NPDES information from
NPDES-regulated facilities by state, tribe, and territory and by NPDES
data group. This listing must identify for NPDES-regulated facilities
the initial recipient of their NPDES electronic data submissions and
the due date for these NPDES electronic data submissions. This Federal
Register document provides an overview of the ``initial recipient''
term as well as the listing of the initial recipients by state, tribe,
and territory and by NPDES data group and the due date for NPDES
electronic data submissions. In accordance with the final rule, EPA
will update this listing on its Web site and in the Federal Register if
there are any changes.

DATES: September 9, 2016.

FOR FURTHER INFORMATION CONTACT: For additional information, please
contact Mr. Carey A. Johnston<PHONE_NUMBER>), Office of Compliance
(mail code

2222A), Environmental Protection Agency, 1200 Pennsylvania Avenue NW.,
Washington, DC 20460; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Overview of the Initial Recipient Designation Process

    Under the NPDES Electronic Reporting Rule (``final rule''), NPDES-
regulated entities are required to submit NPDES program data to the
designated initial recipient, as defined in 40 CFR 127.2(b) (see 22
October 2015; 80 FR 64064). For the final rule, the term ``initial
recipient'' means the governmental entity, either the authorized state,
territory, or tribe, or EPA, who first receives the NPDES program data
listed in Appendix A to 40 CFR 127. The initial recipient designation
is made separately for each state and by each NPDES data group, which
is defined in 40 CFR 127.2(c). EPA is using the initial recipient term
to help NPDES-regulated entities properly identify the recipient for
their electronic NPDES program data submissions. The initial recipient
provision will also help ensure that authorized NPDES programs and EPA
are properly sharing these NPDES program data with each other. EPA is
required by the rule to maintain the initial recipient list for each
state and by each NPDES data group and publish this list on its Web
site and in the Federal Register [see 40 CFR 127.27(c)]. Identification
of the initial recipient for each NPDES data group is also included as
a new NPDES permit standard condition, which authorized NPDES programs
must include in NPDES permits [see 40 CFR part 122.41(l)(9)].
    As necessary, the initial recipient designation can switch back and
forth between the authorized state, tribe, or territory NPDES programs
and EPA. EPA's goal is to help all authorized NPDES programs be the
initial recipient for any data group (e.g., DMRs) for which they would
like to first receive the data. Below is the process for identifying
the initial recipient.
     As of the effective date of the final rule (21 December
2015), the initial recipient determination is an `opt-out' process for
authorized state, tribe, or territory NPDES programs. Per section
127.27(a), an authorized NPDES program must notify EPA within 120 days
of the effective date of the final rule (19 April 2016) if it wishes
EPA to be the initial recipient for a particular NPDES data group. EPA
received six such notices from authorized NPDES programs. For all other
authorized NPDES programs, EPA is designating the authorized state,
tribe, or territorial NPDES program as the initial recipient for all
NPDES data groups.
     An authorized NPDES program can initially elect for EPA to
be the initial recipient and then, at a later date, seek EPA approval
to change the initial recipient status for one or all of the NPDES data
groups from EPA to the authorized state, tribe, or territory. To make
this switch, the authorized state, tribe, or territory must send a
request to EPA. This request shall identify the specific NPDES data
groups for which the state, tribe, or territory would like to be the
initial recipient of electronic NPDES information, include a
description of how its data system will be compliant with 40 CFR part 3
(including, in all cases, subpart D) and 40 CFR part 127, and the date
or dates when the state, tribe, or territory will be ready to start
receiving this information. Section 127.27 outlines the process for
requesting the designation of initial recipient. After EPA approval of
the request, EPA will update the initial recipient list and will
publish the revised initial recipient listing on its Web site and in
the Federal Register.
     An authorized NPDES program can initially elect to be the
initial recipient for one or all of the NPDES data groups and then at a
later date request that EPA become the initial recipient for one or all
of the NPDES data groups. To make this switch the authorized state,
tribe, or territory will send a request to EPA. After coordination with
the state, EPA will update the initial recipient list and will publish
the revised initial recipient listing on its Web site and in the
Federal Register [see 127.27(c)].
     There is also a process in Section 127.27(d) for ensuring
that authorized NPDES programs share the minimum set of NPDES program
data with EPA (see Appendix A to 40 CFR part 127). This process will
switch the initial recipient status from the authorized state, tribe,
or territory to EPA if the authorized NPDES program is not sharing the
minimum set of NPDES program data with EPA. Section 127.27(d)(4) states
that, ``EPA will work with the Director of the authorized NPDES program
to remediate all issues identified by EPA that prevent the authorized
NPDES program from being the initial recipient.'' When the issues
identified by EPA are satisfactorily resolved, EPA must update the
initial recipient listing and publish the revised initial recipient
listing on its Web site and in the Federal Register.
    It should be noted that authorized NPDES programs will continue to
retain their responsibilities to facilitate electronic reporting even
when an authorized NPDES program elects for EPA be the initial
recipient for one or more NPDES data groups. Regardless of the initial
recipient status, EPA does not take over any permitting, compliance
monitoring, or enforcement activities from the authorized NPDES
program. In particular, the authorized NPDES program will:
     Maintain the primary roles and responsibility for
implementing and enforcing the NPDES program;
     Retain the responsibility for outreach and training NPDES-
regulated entities on how to register and use the appropriate
electronic reporting tools;
     Retain data steward responsibilities (including review and
processing error correction requests); and
     Retain the responsibility for review and processing
electronic reporting waiver requests.

EPA will continue to assist authorized NPDES programs with their
training and outreach needs as well as provide other support so that
authorized NPDES programs can fully understand and use EPA's electronic
reporting systems and thereby provide effective support to NPDES-
regulated entities.
    The interaction between the CROMERR requirements and the initial
recipient requirements in the final rule should be noted.\1\ For
example, if the initial recipient status for a particular state for a
particular data group switches from the state to EPA, then the NPDES-
regulated entities in that data group in that state would need to
ensure they register with the appropriate CROMERR-compliant system. In
this example, NPDES-regulated entities will switch from using the state
electronic reporting systems to EPA's electronic reporting systems
(e.g., NetDMR, NeT). This means that these regulated entities will need
to register and obtain the necessary signing credentials for EPA's
electronic reporting systems. Similarly, if the initial recipient
status for a particular state, territory, or tribe for a particular
data group switches from EPA to the state, then those NPDES-regulated
entities in that data group in that state, territory, or tribe would
switch from using an EPA electronic reporting system to a state
electronic reporting system. Under this scenario, regulated entities
will need to register and obtain the necessary signing credentials for
the

authorized NPDES program's electronic reporting systems. However, if a
state, territory, or tribe is already using EPA's electronic reporting
systems, the regulated entities would not need to register again as the
NPDES-regulated entity will be using the same electronic reporting tool
(i.e., no change in the subscriber agreement that accompanies the
electronic reporting tool).
---------------------------------------------------------------------------

    \1\ EPA seeks to ensure that electronic reporting has at least
the same level of legal defensibility and dependability as
information that EPA would obtain through hard-copy paper
submission. The Cross-Media Electronic Reporting Regulation
(CROMERR), promulgated October 13, 2005, provides the legal
framework for electronic reporting requirements established under
all EPA environmental regulations (40 CFR part 3). See the proposed
rule for more background detail on CROMERR (30 July 2013; 78 FR
46035).
---------------------------------------------------------------------------

II. Listing of the Initial Recipients for NPDES Electronic Reporting

    The final rule requires EPA to publish in the Federal Register a
listing of the initial recipients for electronic NPDES information from
NPDES-regulated facilities by state, tribe, and territory and by NPDES
data group [see 40 CFR 127.27(c)]. This listing must identify for
NPDES-regulated facilities the initial recipient of their NPDES
electronic data submissions and the due date for these NPDES electronic
data submissions. The final rule requires authorized NPDES programs to
send EPA an opt-out notice by 19 April 2016. The following is a list of
the six states that sent an opt-out notice to EPA. These notices are
posted on EPA's Web site that provides implementation information.

----------------------------------------------------------------------------------------------------------------
                                                                                State elected for EPA
                                     State elected for EPA                                     to be initial
                                         to be initial       State elected for EPA to be   recipient for program
               State                 recipient for general    initial recipient for DMRs    reports (NPDES Data
                                     permit reports (NPDES     (NPDES Data Group No. 3)     Group Nos. 4 through
                                       Data Group No. 2)                                            10)
----------------------------------------------------------------------------------------------------------------
Georgia............................  Yes (All)............  Yes..........................  Yes (All).
Nebraska...........................  Yes (All)............  Yes..........................  Yes (All).
New Jersey.........................  No...................  No...........................  Yes (only for CAFO
                                                                                Annual Program
                                                                                Report).
North Carolina.....................  Yes (only for Low      No...........................  No.
                                      Erosivity Waivers
                                      and No Exposure
                                      Certifications).
Oregon.............................  Yes (All)............  Yes..........................  Yes (All).
Rhode Island.......................  Yes (All)............  Yes..........................  Yes (All).
----------------------------------------------------------------------------------------------------------------
Note: Although not required as the initial recipient process is an `opt-out' process, Tennessee sent notice to
  EPA that they intend to be the Initial Recipient for all NPDES data groups.

    State that have elected for EPA to be the Initial Recipient for all
of the NPDES data groups will be using EPA's electronic reporting tools
(e.g., NetDMR, NeT) and NPDES data system (ICIS-NPDES). It should be
noted that Georgia and Rhode Island elected to use EPA's NetDMR and
NPDES data system (ICIS-NPDES) prior to the effective date of the final
rule. Consequently, NPDES-regulated entities in these two states that
are already using NetDMR will not need to take any additional actions
in response to Georgia and Rhode Island designating EPA as the Initial
Recipient for DMRs (NPDES Data Group No. 3). In accordance with the
final rule (see 40 CFR 127.16), NPDES-regulated entities in Nebraska
and Oregon will need to register and start using NetDMR prior to the
Phase 1 electronic reporting deadline (21 December 2016). New Jersey
has elected for EPA to be the Initial Recipient for the Concentrated
Animal Feeding Operation (CAFO) Annual Program Report [see 40 CFR
122.42(e)(4)]. In accordance with the final rule, CAFOs in New Jersey
will need to register and start using NeT to submit their CAFO Annual
Program Report prior to the Phase 2 electronic reporting deadline (21
December 2020). Finally, North Carolina has elected for EPA to be the
Initial Recipient for Low Erosivity Waivers (LEWs) [see Exhibit 1 to 40
CFR 122.26(b)(15)] and No Exposure Certifications (NOEs) [see
122.26(g)]. In accordance with the final rule, facilities in North
Carolina will need to register and start using NeT to submit their LEWs
and NOEs prior to the Phase 2 electronic reporting deadline (21
December 2020).
    For all other authorized NPDES programs not in the above table, the
authorized state, tribe, or territorial NPDES program is the initial
recipient for the NPDES programs and NPDES permits that it administers.
For example, Arkansas will be the initial recipient for all NPDES Data
Groups except for the Sewage Sludge/Biosolids Annual Program Reports
[40 CFR part 503], as Arkansas is not authorized for the Federal
Biosolids NPDES program. Likewise, Colorado will be the initial
recipient for all NPDES Data Groups except for:
     Sewage Sludge/Biosolids Annual Program Reports [40 CFR
part 503],
     Pretreatment Program Reports [40 CFR 403.12(i)],
     Significant Industrial User Compliance Reports in
Municipalities Without Approved Pretreatment Programs [40 CFR 403.12(e)
and (h)], and
     All NPDES reporting for Federal facilities.
    Colorado is not authorized for the Federal Biosolids or
Pretreatment NPDES programs and Colorado is not the NPDES permitting
authority for Federal facilities in Colorado. It should be noted that
EPA will be the initial recipient for all NPDES-regulated entities
where EPA is the permitting authority or authorized NPDES program. A
full listing of NPDES program authorization for each state is available
on EPA's Web site (https://www.epa.gov/npdes/npdes-state-program-information).

    Dated: August 24, 2016.
David Hindin,
Director, Office of Compliance, Office of Enforcement and Compliance
Assurance.
[FR Doc. 2016-21204 Filed 9-8-16; 8:45 am]
BILLING CODE 6560-50-P


In-Process and Final Inspection

Assembly and test traveler forms:

Testing Procedure PR-WI-0024-AC

File Attachment

Test Procedure

Inspection and test reports and checklists:

Final Inspection QA-FM-0054-AC

File Attachment

Final Inspection Checklist

Other(s), specify:

9.2 Alternate Quality Control Procedures

If formal quality control and testing procedures have not been implemented or are not sufficient to assure that your product(s) will comply with the standard, explain how you assure that your products comply and submit supporting documentation:

PART 10: INSTRUMENTATION AND CALIBRATION

Note:

In this section, you will describe the instrumentation used for compliance testing your product and the instrumentation calibration procedures.

10.1 Component Testing

Do you purchase components or services from contractors or original equipment manufacturers in lieu of conducting your own in-house testing?

Provide certificates or sample test/inspection records from suppliers or original equipment manufacturers, etc. to assure that those entities are operating in a state of control.

Describe those tests and controls used to determine whether the reported product is producedto be in compliance with the Federal laser product performance standard:

Do you conduct in-house compliance testing for your product?

Do you have testing done by an outside contractor?

*

No

10.2 Compliance Testing

Describe those tests and controls used to determine whether the reported product is produced to be in compliance with the Federal laser product performance standard:

*

ParticleView V19 Test Procedure

File Attachment

Test Procedure

List the instruments you use to determine compliance of the reported product with the standard.  Describe these instruments or provide copies of specification sheets.  Identify each detector's aperture size, if applicable.

*

Not applicable. Output powers are well below class 1 limits by design and verified by independent testing.

Indicate how the measurement system collects or accounts for the total radiant energy or power specified in Section 1040.10(e):

*

Not applicable. Output powers are well below class 1 limits by design and verified by independent testing.

Provide a measurement error analysis (for all sources of error identified) and an uncertainty statement for all measurement data reported. (If it isclear from the measurement data, including the total estimated uncertainty, that the levels are well below the applicable class limit, then an error analysis and uncertainty statement are not required.  For example, an error analysis and uncertainty statement would not be required for a 1.5 milliwattHeNe laser product classified in Class IIIa.):

Not applicable. Output powers are well below class 1 limits by design and verified by independent testing.

10.3 Calibration

Provide instrument calibration schedules and indicate how your instruments are calibrated (e.g.,calibrated by your company against a working standard, returned to the manufacturer of the instrument, sent to an independent calibration laboratory)  [If your laser product operates at a level closely approaching a specified limit, high accuracy and traceabilty to the National Institute of Standards and Technology (previously known as the National Bureau of Standards) are important]:

Not applicable. Output powers are well below class 1 limits by design and verified by independent testing.

General Variance Request

Intended Use and Variance Description

Describe the product and its intended use.

*

File Attachment

ParticleView V19 Safety Manual

Details

The ParticleView V19 is an in-situ microscope. It is designed to
      acquire microscope images directly inside a fluid medium.  A video
      camera and microscope optics are mounted inside a metal probe body. The
      fluid medium is viewed through a sapphire probe window at the distal end
      of the probe.  The illumination system is housed inside a metal
      enclosure mounted to the proximal end of the probe.

      The Introduction section of the attached Safety Manual provides a
      more in-depth description.

Explain how compliance with the standard would restrict or be inappropriate for this intended use.  Please attach any additional information if necessary.

*

File Attachment

ParticleView V19 Safety Manual

Details

      The ParticleView V19 uses an illumination system comprising eight laser
      diodes, each permanently coupled to a multimode optical fiber. Each of
      the laser diodes is enclosed in a metal housing, no collateral radiation
      is emitted at this point. A gradient index lens is used to focus the
      light emitted from the multimode fiber through a sapphire probe window
      on to the field of view, the diameter being 1.5mm. Each beam is tilted
      with respect to the probe axis. Under normal operating conditions the
      operator is never exposed to light from the instrument. If an operator
      could turn the instrument to look straight in the probe, the eye will
      not be exposed to light from more than one beam at a time. The image is
      observed by a digital camera; there is no viewport for direct
      observation. Information is given in the Safety Manaul -- see attached.

Describe the manner in which it is proposed to deviate from the requirements of the applicable standard.  Attach any supporting files if necessary.

*

File Attachment

V19 Product Label

Details

      The area for product labeling is too small. We will put the
      certification label in the Safety Manual in the certifications chapter.
      See attached drawing of the current product label which is too small for
      the certification information.

»

Describe the advantages to be derived from such deviation.

*

Details

      Important information regarding laser safety and certification will be
      placed with other certification statements in the safety manual. This
      will alert the user to all certifications.

Radiation Protection and Variance Duration

Provide a detailed explanation of how alternate or suitable means of radiation protection will be provided.  Click on the Add... button below to attach any supporting files.

*

Details

      not applicable

Provide the period of time it is desired that the variance be in effect.

*

Other...

If "Other" has been selected, please specify further.

*

not applicable

If appropriate, provide the number of units the applicant plans to manufacture.

Prototype or Experimental Design

Is the product a prototype or experimental design?

*

No

Remarks

Certification

The manufacturer certifies the following:

All of the above information and statements are true, complete, and correct to the best of my knowledge.  The manufacturer acknowledges that the variance application may be denied or the variance may be revoked if this application is found to be false, misleading or incorrect in any material way.  The manufacturer has submitted and will submit all reports required by 21 CFR Part 1002.  The manufacturer further understands that they may be required by regulation or by the Director, Center for Devices and Radiological Health, to supply such other information as may be necessary to evaluate and act on this application.

*

Yes

Copy from the contact address book.

Contact Information:

Contact Name

Brenda Desormeaux

Occupation Title

Quality Manager

Email Address

<font face="arial,helvetica,georgia,verdana"<EMAIL_ADDRESS>

Establishment Information:

Establishment Name

Mettler-Toledo AutoChem

Division Name

FDA Establishment Identifier (FEI)

Central File Number (CFN)

Registration Number

Owner/Operator Number

D&B D-U-N-S Number

Physical Location:

Address

7075 Samuel Morse Drive
Suite 100
Columbia, MD, 21046, US

Telephone Number

(410) 910-8100

Fax Number

Mailing Location:

Address

7075 Samuel Morse Drive
Suite 100
Columbia, MD, 21046, US

Telephone Number

(410) 910-8100

Fax Number

Packaging Instructions

Stop:

For all Variance requests, two submissions must be made to the FDA.

The electronic version should be submitted following the Packaging Files for Submission instructions located under Output in the Menu bar, and explained in subsection 4.3 of the User Manual.  If sending a CD & submittal letter, please mail to:

Center for Devices and Radiological Health
Attn: eSubmitter Team
Document Mail Center - WO66-G609
10903 New Hampshire Ave
Silver Spring, MD 20993-0002

Additionally, a paper version (hard-copy) of the signed Variance request document should be submitted to:

Food and Drug Administration
Division of Dockets Management (HFA-305)
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Note:

In a few weeks you should receive a Docket number from Dockets Management and a Variance number from CDRH.  Both of these numbers may be saved with this report in the following procedure:

1. Reopen this report
2. Click on the File Menu and select Properties
3. In the Comments field, you may enter these identifying numbers and any other pertinent information for future reference.

Stop:

You have reached the end of this report.  Please verify that all PDFs that are to be included in this submission are correctly attached to a specific file attachment question.  Otherwise, they will not be packaged with your report.  Check to make sure you have no missing data (select Missing Data Report from the Output menu). Once you have confirmed that there is no missing data and all your files are attached, click on the Package Submission icon on the tool bar.


[Federal Register Volume 86, Number 124 (Thursday, July 1, 2021)]
[Notices]
[Pages 35079-35080]
[FR Doc No: 2021-14065]

=======================================================================
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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 803-115]

Pacific Gas and Electric Company; Notice of Application Accepted
for Filing and Soliciting Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Application Type: Application for Temporary Variance of Flow
Requirements.
    b. Project No: 803-115.
    c. Date Filed: May 26, 2021, and supplemented June 2, 2021.
    d. Applicant: Pacific Gas and Electric Company (licensee).
    e. Name of Project: DeSabla-Centerville Project.
    f. Location: The project is located on Butte Creek, West Branch
Feather River, and their tributaries in Butte County, California.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Applicant Contact: Ms. Jackie Pope, License Coordinator, Pacific
Gas and Electric Company, Mail Code: N11D, P.O. Box 770000, San
Francisco, CA 94177, Phone:<PHONE_NUMBER>.
    i. FERC Contact: John Aedo,<PHONE_NUMBER><EMAIL_ADDRESS>    j. Deadline for filing comments, motions to intervene, and
protests: July 26, 2021.
    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, and protests using the Commission's
eFiling system at http://www.ferc.gov/docs-filing/efiling.asp.
Commenters can submit brief comments up to 6,000 characters, without
prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact
information at the end of your comments. For assistance, please contact
FERC Online Support at<EMAIL_ADDRESS>(866) 208-3676 (toll
free), or<PHONE_NUMBER> (TTY). In lieu of electronic filing, you may
submit a paper copy. Submissions sent via the U.S. Postal Service must
be addressed to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street NE, Room 1A, Washington, DC 20426.
Submissions sent via any other carrier must be addressed to: Kimberly
D. Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins
Avenue, Rockville, Maryland 20852. The first page of any filing should
include the docket number P-77-306. Comments emailed to Commission
staff are not considered part of the Commission record.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person whose name appears on the official service
list for the project. Further, if an intervenor files comments or
documents with the Commission relating to the merits of an issue that
may affect the responsibilities of a particular resource agency, they
must also serve a copy of the document on that resource agency.
    k. Description of Request: The licensee requests a temporary
variance of the minimum flow requirements in the West Branch Feather
River below the Hendricks Head Dam, in Butte Creek

below the Butte Head Dam, and in Philbrook Creek below Philbrook Dam.
The licensee requests that the instantaneous dry year minimum flow
requirement of 7 cubic feet per second (cfs) at Hendricks Head and
Butte Head Diversion Dams be temporarily modified to a 7 cfs, 48-hour
average minimum flow. The licensee states that the temporary variance
would eliminate the need to release additional buffer flows of 4 to 5
cfs and instead, allocate those flows to the lower reaches of Butte
Creek, where Central Valley spring-run Chinook salmon are currently
holding. In addition, the licensee requests that the minimum flow
requirement in Philbrook Creek be reduced to 0.8 cfs, with a 0.2 cfs
buffer, for a total of 1 cfs.
    The licensee requests the variance due to exceptionally dry
conditions and limited water availability in the project area.
Additionally, the licensee states that the proposed variance would
preserve cold water storage in Philbrook Reservoir, increase flow to
Butte Creek via the Hendricks Canal, and decrease water residence time
in the DeSabla Forebay, thus providing additional water to Butte Creek
during the hot summer months to minimize high temperature effects to
spring-run Chinook salmon, and to preserve water for release later in
the summer months. The licensee would also provide monthly flow records
to the resource agencies and notify them of any flow disruptions
related to the variance. The licensee requests the variance until
February 28, 2022 to protect spawning and redds, but may end the
variance earlier if fall or winter rains bring precipitation to early
spring-run Chinook salmon life stages, and in consultation with the
project resource group. Due to the urgent nature of the variance
request, Commission staff is approving the variance for a limited time
(until August 12, 2021) until the public has an opportunity to review
and comment on the licensee's proposal. Following the close of the
public notice period and consideration of any comments received,
Commission staff will take action on the remaining timeline associated
with the licensee's request.
    l. Locations of the Application: This filing may be viewed on the
Commission's website at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. You may also register
online at http://www.ferc.gov/docs-filing/esubscription.asp to be
notified via email of new filings and issuances related to this or
other pending projects. For assistance, call 1-866-208-3676 or email
<EMAIL_ADDRESS>for TTY, call<PHONE_NUMBER>. Agencies may
obtain copies of the application directly from the applicant.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214, respectively. In determining the appropriate action to take, the
Commission will consider all protests or other comments filed, but only
those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any comments,
protests, or motions to intervene must be received on or before the
specified comment date for the particular application.
    o. Filing and Service of Documents: Any filing must (1) bear in all
capital letters the title ``COMMENTS'', ``PROTEST'', or ``MOTION TO
INTERVENE'' as applicable; (2) set forth in the heading the name of the
applicant and the project number of the application to which the filing
responds; (3) furnish the name, address, and telephone number of the
person commenting, protesting or intervening; and (4) otherwise comply
with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, motions to intervene, or protests must set forth their
evidentiary basis. Any filing made by an intervenor must be accompanied
by proof of service on all persons listed in the service list prepared
by the Commission in this proceeding, in accordance with 18 CFR
385.2010.

    Dated: Jun 25, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-14065 Filed 6-30-21; 8:45 am]
BILLING CODE 6717-01-P


    Stakeholder Meetings that Informed the Development of the Proposed Rule
Organization
Date
Hudson Technologies
March 13, 2018
Arkema
March 19, 2018
National Refrigerants
March 20, 2018
Ingersoll Rand
March 22, 2018
Chemours
April 5, 2018
American Pacific
Aril 6, 2018
Hudson Technologies

June 20, 2018
Chemours
August 20, 2018
A-Gas
September 11, 2018
American Pacific
October 23, 2018

Chemours
October 30, 2018
Hudson
December 17, 2018
Ingersoll Rand
January 30, 2019
Chemours
February 6, 2019
A-Gas
February 9, 2019
Ingersoll Rand
March 7, 2019
Halon Alternatives Research Corporation
March 12, 2019

NB: Many of these meetings informed both the rulemaking process and the development of an adjustment to the Montreal Protocol on Substances that Deplete the Ozone Layer.


[Federal Register Volume 74, Number 124 (Tuesday, June 30, 2009)]
[Notices]
[Pages 31333-31334]
[FR Doc No: E9-15350]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-60164; File No. SR-CBOE-2009-029]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Order Approving a Proposed Rule Change To Permanently
Establish the Quarterly Option Series Program

June 23, 2009.
    On May 7, 2009, the Chicago Board Options Exchange, Incorporated
(``Exchange'' or ``CBOE'') filed with the Securities and Exchange
Commission (``Commission''), pursuant to Section 19(b)(1) of the
Securities Exchange Act of 1934 (``Act''),\1\ and Rule 19b-4
thereunder,\2\ a proposed rule change to permanently establish its
Quarterly Option Series pilot program (the ``QOS Program''). The
proposed rule change was published for comment in the Federal Register
on May 21, 2009.\3\ The Commission received no comment letters on the
proposed rule change. This order approves the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 59601 (March 19,
2009), 74 FR 13281.
---------------------------------------------------------------------------

    The Exchange established the QOS Program on a pilot basis on July
7, 2006.\4\ The QOS Program allows CBOE to list and trade Quarterly
Option Series, which expire at the close of business on the last
business day of a calendar quarter. Under the QOS Program, CBOE may
select up to five (5) currently listed exchange traded fund (``ETF'')
or index option classes on which Quarterly Option Series may be opened.
The Exchange has selected the following five ETF option classes to
participate in the QOS Program: DIAMONDS Trust (DIA) options; Standard
and Poor's Depositary Receipts/SPDRs (SPY) options; iShares Russell
2000 Index Fund (IWM) options; PowerShares QQQ Trust (QQQQ) options;
and Energy Select SPDR (XLE) options. In addition, CBOE may also list
Quarterly Option Series on any options classes that are selected by
other securities exchanges that employ a similar pilot program under
their respective rules.
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release No. 54123 (July 11,
2006), 71 FR 40558, (July 17, 2006) (SR-CBOE-2006-65). The QOS
Program has since been extended and is currently scheduled to expire
on July 10, 2009. See Securities Exchange Act Release Nos. 56035
(July 10, 2007), 72 FR 38851, (July 16, 2007) (SR-CBOE-2007-70)
(immediately effective rule change extending the QOS Program through
July 10, 2008) and 58018 (June 25, 2008), 73 FR 38010 (July 2, 2008)
(SR-CBOE-2008-62) (immediately effective rule change extending the
QOS Program through July 10, 2009).
---------------------------------------------------------------------------

    The Exchange may list series that expire at the end of the next
consecutive four (4) calendar quarters, as well as the fourth quarter
of the following calendar year. For example, if the Exchange is trading
Quarterly Options Series in the month of May 2009, it may list series
that expire at the end of the second, third, and fourth quarters of
2009, as well as the first and fourth quarters of 2010. Following the
second quarter 2009 expiration, the Exchange could add series that
expire at the end of the second quarter of 2010.
    For each class of ETF options selected for the QOS Program, the
Exchange may list strike prices within $5 from the

previous day's closing price of the underlying security at the time of
initial listing. Subsequently, the Exchange may list up to 60
additional strike prices that are within thirty percent (30%) of the
previous day's close, or more than 30% away from the previous day's
close provided demonstrated customer interest exists for such
series.\5\
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    \5\ ``Demonstrated customer interest'' includes interest
expressed by institutional, corporate or individual customers or
their brokers. Market-Makers trading for their own account may not
be considered when determining customer interest under this
provision.
---------------------------------------------------------------------------

    The Exchange has also adopted a delisting policy with respect to
QOS in ETF options.\6\ On a monthly basis, the Exchange reviews series
that are outside a range of five (5) strikes above and five (5) strikes
below the current price of the underlying ETF, and delists series with
no open interest in both the put and the call series having either: (i)
A strike price higher than the highest strike price with open interest
in the put and/or call series for a given expiration month; or (ii) a
strike price lower than the lowest strike price with open interest in
the put and/or call series for a given expiration month.
Notwithstanding the foregoing, the delisting policy also provides that
customer requests to add strikes and/or maintain strikes in QOS in ETF
options in series eligible for delisting shall be granted by the
Exchange.
---------------------------------------------------------------------------

    \6\ See Securities Exchange Act Release No. 57410 (March 3,
2008), 73 FR 12483 (March 7, 2008) (SR-CBOE-2007-96).
---------------------------------------------------------------------------

    The Exchange also may list Quarterly Option Series based on an
underlying index pursuant to similar provisions in Rule 24.9. There are
two noteworthy distinctions between the rules for listing QOS based on
an ETF versus QOS based on an index. First, whereas the initial listing
of QOS based on an underlying ETF is restricted to strike prices within
$5 from the previous day's closing price of the underlying security,
the initial listing of strikes for QOS based on an underlying index is
restricted to: (i) A price that is within thirty percent (30%) of the
previous day's close, and (ii) no more than five strikes above and five
strikes below the value of the underlying index. Second, whereas the
Exchange may list up to 60 additional strike prices for each QOS based
on an ETF, there is no firm cap on the additional listing of strikes
for QOS based on an underlying index; rather, additional strike prices
may be listed provided the new listings do not result in more than five
strike prices on the same side of the underlying index value as the new
listings. To date, the Exchange has not listed any Quarterly Option
Series based on an underlying index.
    In support of its proposal to permanently establish the QOS
Program, and as required by the terms of the Pilot Program,\7\ the
Exchange submitted to the Commission a report detailing the Exchange's
experience with the QOS Program (the ``Report'').\8\ In addition to the
Report, the Exchange represented that it has not experienced any
capacity-related problems with respect to Quarterly Option Series, and
that it has the necessary systems capacity to continue to support the
option series listed under the QOS Program. Finally, the Exchange
stated its belief that there is sufficient investor interest in, and
demand for, the QOS Program to warrant its permanent approval.
---------------------------------------------------------------------------

    \7\ See Securities Exchange Act Release No. 54123, supra note 4.
    \8\ The Report was submitted under separate cover and seeks
confidential treatment under the Freedom of Information Act.
---------------------------------------------------------------------------

    After careful review, the Commission finds that the proposal is
consistent with the Act and the rules and regulations thereunder
applicable to a national securities exchange,\9\ and, in particular,
the requirements of Section 6(b)(5) of the Act,\10\ which requires,
among other things, that the rules of a national securities exchange be
designed to remove impediments to and perfect the mechanism of a free
and open market and a national market system and, in general, to
protect investors and the public interest.
---------------------------------------------------------------------------

    \9\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. 15 U.S.C. 78c(f).
    \10\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Commission finds that the QOS Program, as evidenced by the
Report, has furthered the public interest by offering investors an
alternative means of managing their risk exposures and carrying out
their investment objectives. The Commission notes CBOE's representation
that there is sufficient investor interest in the QOS Program to
warrant its permanent approval. The Commission further notes CBOE's
representations that it has not experienced any capacity-related
problems with respect to Quarterly Option Series, and that the Exchange
has the necessary system capacity to continue to support the option
series listed under the QOS Program. Accordingly, the Commission finds
that the proposed QOS Program strikes a reasonable balance between the
Exchange's desire to offer a wider array of investment opportunities
and the need to avoid the unnecessary proliferation of option series
that could compromise systems capacity. The Commission expects CBOE to
continue to monitor the trading and quotation volume associated with
the QOS Program, and the effect the QOS Program has on the capacity of
the Exchange's, OPRA's, and vendors' systems. In addition, the
Commission expects the Exchange, consistent with its QOS delisting
policy, to continue to monitor for option series with little or no open
interest and trading activity and to act promptly to delist such
options in order to mitigate the number of options series with no open
interest.
    It is therefore ordered, pursuant to Section 19(b)(2) of the Act,
that the proposed rule change (SR-CBOE-2009-029) be, and it hereby is,
approved.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
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    \11\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-15350 Filed 6-29-09; 8:45 am]
BILLING CODE 8010-01-P