[Federal Register Volume 85, Number 188 (Monday, September 28, 2020)]
[Rules and Regulations]
[Pages 60716-60718]
[FR Doc No: 2020-20622]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0335; FRL-10013-27]

Pseudomonas fluorescens Strain ACK55; 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 Pseudomonas fluorescens strain ACK55 in
or on all food commodities when used in accordance with label
directions and good agricultural practices. The IR-4 Project 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 Pseudomonas fluorescens strain ACK55
under FFDCA.

DATES: This regulation is effective September 28, 2020. Objections and
requests for hearings must be received on or before November 27, 2020
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-2017-0335, is available at
https://www.regulations.gov or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket) in the EPA 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 (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805.
    Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Anne Overstreet, 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 Publishing Office's e-CFR site at
https://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-2017-0335 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
November 27, 2020. 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-2017-0335, by one of
the following methods:
     Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets/about-epa-dockets.

II. Background

    In the Federal Register of October 28, 2019 (84 FR 57685) (FRL-
10001-11), EPA issued a document pursuant to FFDCA section 408(d)(3),
21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
exemption petition (PP 9E8784) by the IR-4 Project, Rutgers, The State
University of New Jersey, 500 College Rd. East, Suite 201W, Princeton,
NJ 08540. The petition requested that 40 CFR part 180 be amended by
establishing an exemption from the requirement of a tolerance for
residues of the herbicide Pseudomonas fluorescens strain ACK55 in or on
all food commodities. That document referenced a summary of the
petition prepared by the petitioner, the IR-4 Project, and is available
in the docket via https://www.regulations.gov. There were no comments
received in response to the notice of filing.

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 toxicological and exposure data on
Pseudomonas fluorescens strain ACK55 and considered their validity,
completeness, and reliability, as well as the relationship of this
information to human risk. An 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 Pseudomonas fluorescens strain ACK55.'' This
document, as well as other relevant information, is available in the
docket for this action as described under ADDRESSES. In sum, the
available data indicate a lack of toxicity, infectivity, and
pathogenicity from exposure to Pseudomonas fluorescens strain ACK55.
Due primarily to the lack of any toxicity and adverse effects, 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 Pseudomonas fluorescens strain ACK55.
Therefore, an exemption from the requirement of a tolerance is
established for residues of Pseudomonas fluorescens strain ACK55 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.

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 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 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: September 4, 2020.
Edward Messina,
Acting Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD

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.  180.1379 to subpart D to read as follows:

Sec.  180.1379  Pseudomonas fluorescens strain ACK55; exemption from
the requirement of a tolerance.

    Residues of Pseudomonas fluorescens strain ACK55 are exempt from
the requirement of a tolerance in or on all food commodities when used
in accordance with label directions and good agricultural practices.

[FR Doc. 2020-20622 Filed 9-25-20; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 222 (Thursday, November 17, 2011)]
[Notices]
[Pages 71410-71411]
[FR Doc No: 2011-29676]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65730; File No. SR-NYSEArca-2011-79]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change Amending the NYSE
Arca Options Fee Schedule To Modify the Fees Relating to Qualified
Contingent Cross Orders

November 10, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that, on November 1, 2011, NYSE Arca, Inc. (``NYSE Arca'' or the
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend the NYSE Arca Options Fee Schedule
(``Fee Schedule'') to modify the fees relating to Qualified Contingent
Cross (``QCC'') orders. The text of the proposed rule change is
available at the Exchange, the Commission's Public Reference Room, and
www.nyse.com.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The purpose of the proposal is to modify the fees relating to QCC
orders. Specifically, the Exchange intends to adopt a rebate of $.10
per contract for executed QCC orders. The rebate will be credited to
the executing Floor Broker.
    The Exchange notes that the terms of a QCC order are negotiated and
agreed to prior to being brought to an exchange for possible execution.
In bringing a QCC order to the Exchange for execution, OTP Holders have
two primary means of doing so. They can configure their systems to
deliver the QCC order to the Exchange matching engines for validation
and execution. Alternatively they can utilize the services of another
OTP Holder acting as a Floor Broker. In turn, the Floor Broker who is
in receipt of such an order can enter the order through an Exchange-
provided system \3\ to be delivered to the Exchange matching engine for
validation and potential execution. In light of the fact that the
Exchange does not offer a front-end for order entry, unlike some of the
competing exchanges,\4\ the Exchange believes it is necessary from a
competitive standpoint to offer this rebate to the executing Floor
Broker on a QCC order. The Exchange expects that the rebate offered to
executing Floor Brokers will allow them to price their services at a
level that will enable them to attract QCC order flow from participants
who would otherwise utilize an existing front-end order entry mechanism
offered by the Exchange's competitors instead of incurring the cost in
time and money to develop their own internal systems to be able to
deliver QCC orders directly to the Exchange systems. To the extent that
Floor Brokers are able to attract these QCC orders, they will gain
important information that will allow them to solicit the parties to
the QCC orders for participation in other trades, which will in turn
benefit all other Exchange participants through the additional
liquidity and price discovery that may occur as a result. The Exchange
notes that at least two other exchanges offer a similar rebate.\5\
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    \3\ Floor Brokers are required by NYSE Arca Options Rule 6.67 to
have systematized orders prior to representing them in open outcry.
Using the same Electronic Order Capture System, Floor Brokers will
be able to enter QCC orders for validation by the Exchange matching
engines and potential execution.
    \4\ The International Securities Exchange offers PRECISE TRADE
as a means for users to enter orders and Chicago Board Options
Exchange has a similar front-end order entry system called PULSE.
Such systems do not require users to develop their own internal
front-end order entry systems and may provide savings to users in
terms of development time and costs.
    \5\ See Securities Exchange Act Release No. 65472 (October 3,
2011), 76 FR 62887 (October 11, 2011) (SR-NYSEAmex-2011-72) and
NASDAQ OMX PHLX fee schedule dated September 12, 2011, page 21
(describing a Floor Broker Subsidy that can range as high as $.09
per contract), available at http://www.nasdaqtrader.com/content/marketregulation/membership/phlx/feesched.pdf.
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    The proposed change will be operative on November 1, 2011.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of Section 6(b) \6\ of the Securities Exchange Act
of 1934 (the ``Act''), in general, and Section 6(b)(4) \7\ of the Act,
in particular, in that it is designed to provide for the equitable
allocation of reasonable dues, fees, and other charges among its
members and other persons using its facilities.
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    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(4).
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    The Exchange believes the proposed $.10 per contract rebate for
Floor Brokers who enter QCC orders that execute is reasonable because
it will allow Floor Brokers the opportunity to compete for QCC orders
that would otherwise be entered into front-end order entry systems of
competing exchanges.\8\ The proposed rebate is comparable to that found
on other exchanges \9\ in that it is being offered to Floor Brokers as
an inducement that may allow them to competitively price their services
offered to all participants. To the extent that the rebate is
successful in attracting additional order flow to the Exchange, all
participants should benefit. As such, the Exchange believes that the
rebate is appropriate and reasonable.
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    \8\ See supra note 4.
    \9\ See supra note 5.
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    The Exchange believes the proposal to adopt a $.10 per contract
rebate is equitable and not unfairly discriminatory because it would
uniformly apply to all QCC orders entered by a Floor Broker for
validation by the system and potential execution. The rebate is not
unfairly discriminatory to firms that enter QCC orders directly into
the NYSE Arca System through electronic connection, because the fee for
the QCC order is the same whether it is entered electronically or
through a Floor Broker. In addition, under Commentary .01 to Arca
Options Rule 6.90, only Floor Brokers may enter a QCC order from the
Floor; therefore,

providing the rebate to Floor Brokers does not discriminate against
other QCC orders entered into the NYSE Arca System from on the Floor.
Any participant will be able to engage a rebate-receiving Floor Broker
in a discussion surrounding the appropriate level of fees that they may
be charged for entrusting the entry of the QCC order to the Floor
Broker into the Exchange systems for validation and execution. The
additional order flow attracted by this rebate should benefit all
participants. The rebate is meant to assist Floor Brokers to recruit
business on an agency basis from both OTP Holders and non-OTP Holder
firms. The Floor Broker may use all or part of the rebate to offset the
Floor Brokerage charges billed to the Firm. For this reason the
Exchange believes the adoption of the proposed rebate is both equitable
and not unfairly discriminatory.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were solicited or received with respect to the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change is effective upon filing pursuant to
Section 19(b)(3)(A) \10\ of the Act and subparagraph (f)(2) of Rule
19b-4 \11\ thereunder, because it establishes a due, fee, or other
charge imposed by the NYSE Arca.
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    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f)(2).
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    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEArca-2011-79 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSEArca-2011-79. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSEArca-2011-79 and should
be submitted on or before December 8, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\

    \12\ 17 CFR 200.30-3(a)(12).
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Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-29676 Filed 11-16-11; 8:45 am]
BILLING CODE 8011-01-P


TABLE 1a AVERAGE ANNUAL EPA RESOURCE REQUIREMENT NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS ( NESHAPS)

/ MAXIMUM ACHIEVABLE CONTROL TECHNOLOGY ( MACT) SUBPART DDD  MINERAL WOOL PRODUCTION  YEAR 1 REPORTING/ RECORDKEEPING REQUIREMENT EPA Hours/

Occurence ( A) Occurences/

Plant/ Year ( B) EPA Hours/

Year ( C= A* B)

( C) Plants/

Year ( D) Technical Hours/ Year ( E) Management Hours/ Year ( E* 0.05) Admin.

Hours/ Year ( E* 0.1) EPA Hours/ Year ( E= C* D)

( F)

INITIAL PERFORMANCE TESTS New or Modified Facility 40 1 40 4.3 172 8.6 17.2 198 REPEAT PERFORMANCE TEST New or Modified Facility 40 0.2 8 4.3 34.4 1.72 3.44 40 REPORT REVIEW New or Modified Facility Notification of Applicability** 2 1 2 4.3 8.6 0.43 0.86 10 Notification of Construction/

Reconstruction 2 1 2 0 0 0 0 0 Notification of Actual Startup 2 1 2 0 0 0 0 0 Notification of Special Compliance Requirements 1 1 1 0 0 0 0 0 Notification of Initial Performance Test 2 1 2 4.3 8.6 0.43 0.86 10 Notification of Compliance Status 2 1 2 4.3 8.6 0.43 0.86 10 Request for Extension of Compliance,

Adjustments to Time Periods, and Changes in Information 2 1 2 0.3 0.6 0.03 0.06 1 Quality Improvement Plan 40 1 40 0.9 36 1.8 3.6 41 Operations Maintenance and Monitoring Plan 40 1 40 4.3 172 8.6 17.2 198 Startup, Shutdown, and Malfunction 40 1 40 4.3 172 8.6 17.2 198 Report of Performance Test 40 1 40 4.3 172 8.6 17.2 198 Excess Emissions Reports 20 2 40 1.7 68 3.4 6.8 78 Report of No Excess Emissions 2 2 4 6.9 27.6 1.38 2.76 32 Startup, Shutdown, and Malfunction Reports 20 2 40 0.3 12 0.6 1.2 14 TOTAL ANNUAL HOURS 1,026 ANNUAL TRAVEL EXPENSES $ 1,720.00 ( 1 person x 4.3 plants/ yr. x 3 days/ plant x $ 50 per diem) + ($ 250 round trip/ plant x 4.3 plants/ yr.) =

SALARY BURDEN ( per year) $ 35,600.96 1 person x $ 34.69/ hr x 1,242 hrs/ yr.

TOTAL ANNUAL BURDEN $ 37,320.96 TABLE 1b AVERAGE ANNUAL EPA RESOURCE REQUIREMENT NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS ( NESHAPS)

/ MAXIMUM ACHIEVABLE CONTROL TECHNOLOGY ( MACT) SUBPART DDD  MINERAL WOOL PRODUCTION  YEAR 2 REPORTING/ RECORDKEEPING REQUIREMENT EPA Hours/

Occurence ( A) Occurences/

Plant/ Year ( B) EPA Hours/

Year ( C= A* B)

( C) Plants/

Year ( D) Technical Hours/ Year ( E) Management Hours/ Year ( E* 0.05) Admin.

Hours/ Year ( E* 0.1) EPA Hours/ Year ( E= C* D)

( F)

INITIAL PERFORMANCE TESTS New or Modified Facility 40 1 40 4.3 172 8.6 17.2 198 REPEAT PERFORMANCE TEST New or Modified Facility 40 0.2 8 4.3 34.4 1.72 3.44 40 REPORT REVIEW New or Modified Facility Notification of Applicability 2 1 2 4.3 8.6 0.43 0.86 10 Notification of Construction/

Reconstruction 2 1 2 0 0 0 0 0 Notification of Actual Startup 2 1 2 0 0 0 0 0 Notification of Special Compliance Requirements 1 1 1 0 0 0 0 0 Notification of Initial Performance Test 2 1 2 4.3 8.6 0.43 0.86 10 Notification of Compliance Status 2 1 2 4.3 8.6 0.43 0.86 10 Request for Extension of Compliance,

Adjustments to Time Periods, and Changes in Information 2 1 2 0.3 0.6 0.03 0.06 1 Quality Improvement Plan 40 1 40 0.9 36 1.8 3.6 41 Operations Maintenance and Monitoring Plan 40 1 40 4.3 172 8.6 17.2 198 Startup, Shutdown, and Malfunction 40 1 40 4.3 172 8.6 17.2 198 Report of Performance Test 40 1 40 4.3 172 8.6 17.2 198 Excess Emissions Reports 20 2 40 2.6 104 5.2 10.4 120 Report of No Excess Emissions 2 2 4 10.4 41.6 2.08 4.16 48 Startup, Shutdown, and Malfunction Reports 20 2 40 0.3 12 0.6 1.2 14 TOTAL ANNUAL HOURS 1,084 ANNUAL TRAVEL EXPENSES $ 1,720.00 ( 1 person x 4.3 plants/ yr. x 3 days/ plant x $ 50 per diem) + ($ 250 round trip/ plant x 4.3 plants/ yr.) =

SALARY BURDEN ( per year) $ 37,595.63 1 person x $ 34.69/ hr x 1,084 hrs/ yr.

TOTAL ANNUAL BURDEN $ 39,315.63 TABLE 1c AVERAGE ANNUAL EPA RESOURCE REQUIREMENT NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS ( NESHAPS)

/ MAXIMUM ACHIEVABLE CONTROL TECHNOLOGY ( MACT) SUBPART DDD  MINERAL WOOL PRODUCTION  YEAR 3 REPORTING/ RECORDKEEPING REQUIREMENT EPA Hours/

Occurence ( A) Occurences/

Plant/ Year ( B) EPA Hours/

Year ( C= A* B)

( C) Plants/

Year ( D) Technical Hours/ Year ( E) Management Hours/ Year ( E* 0.05) Admin.

Hours/ Year ( E* 0.1) EPA Hours/ Year ( E= C* D)

( F)

INITIAL PERFORMANCE TESTS New or Modified Facility 40 1 40 0 0 0 0 0 REPEAT PERFORMANCE TEST New or Modified Facility 40 0.2 8 0 0 0 0 0 REPORT REVIEW New or Modified Facility Notification of Applicability 2 1 2 0 0 0 0 0 Notification of Construction/

Reconstruction 2 1 2 0 0 0 0 0 Notification of Actual Startup 2 1 2 0 0 0 0 0 Notification of Special Compliance Requirements 1 1 1 0 0 0 0 0 Notification of Initial Performance Test 2 1 2 0 0 0 0 0 Notification of Compliance Status 2 1 2 0 0 0 0 0 Request for Extension of Compliance,

Adjustments to Time Periods, and Changes in Information 2 1 2 0.3 0.6 0.03 0.06 1 Quality Improvement Plan 40 1 40 1.3 52 2.6 5.2 60 Operations Maintenance and Monitoring Plan 40 1 40 0 0 0 0 0 Startup, Shutdown, and Malfunction 40 1 40 0 0 0 0 0 Report of Performance Test 40 1 40 0 0 0 0 0 Excess Emissions Reports 20 2 40 2.6 104 5.2 10.4 120 Report of No Excess Emissions 2 2 4 10.4 41.6 2.08 4.16 48 Startup, Shutdown, and Malfunction Reports 20 2 40 0.3 12 0.6 1.2 14 TOTAL ANNUAL HOURS 242 ANNUAL TRAVEL EXPENSES $ 0.00 ( 1 person x 0 plants/ yr. x 3 days/ plant x $ 50 per diem) + ($ 250 round trip/ plant x 0 plants/ yr.) =

SALARY BURDEN ( per year) $ 8,385.61 1 person x $ 34.69/ hr x 242 hrs/ yr.

TOTAL ANNUAL BURDEN $ 8,385.61 Assumptions Number of new facilities 0 Rate of failed performance tests 20%

Time required to participate with performance test ( per facility) 40 Time require to review notifications ( hours) 2 Time required to review plans ( hours) 40 Time required to review performance test results ( hours) 40 Time required to review reports ( e. g.,

excess emissions, startup, shutdown,

and malfunctions) ( hours) 20 Number of startup, shutdowns, and malfunctions ( per year) 2 Percent of facilities required to prepare excess emissions reports 20%

Percent of facilities required to prepare no excess emissions reports 80%

Estimated number of facilities that will be required to submit startup, shutdown,

and malfunction reports 1 Estimated number of extensions,

adjustments to time periods, etc. ( per year) 1 EPA labor rate $ 34.69 Percentage of new facility visits 100%

* We are assuming that approximately 4.3 existing facilities will come into compliance each year during the first two years of this ICR. In addition, we are assuming that all exisiting facilities will be in compliance before the third year since the compliance deadline falls within the second year of this ICR. The first 4.3 facilities came into compliance during the previous ICR.


[Federal Register Volume 82, Number 149 (Friday, August 4, 2017)]
[Notices]
[Page 36390]
[FR Doc No: 2017-16464]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER17-2163-000]

SunE Beacon Site 5, LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding
SunE Beacon Site 5 LLC's application for market-based rate authority,
with an accompanying rate tariff, noting that such application includes
a request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is August 17, 2017.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the Web site that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For TTY,
call<PHONE_NUMBER>.

    Dated: July 28, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-16464 Filed 8-3-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: March 25, 2008 (Volume 73, Number 58)]
[Notices]
[Page 15759-15760]
[DOCID:fr25mr08-58]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0149] (formerly Docket No. 2007D-0031)

Global Harmonization Task Force, Study Group 4; Final Document;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a final document that has been prepared by Study Group
4 of the Global Harmonization Task Force (GHTF). This document
represents a harmonized proposal and recommendation from Study Group 4
of the GHTF that may be used by governments developing and updating
their regulatory requirements for medical devices. This document is
intended to provide information only and does not describe current
regulatory requirements; elements of this document may not be
consistent with current U.S. regulatory requirements.

DATES: Submit written or electronic comments on this guidance at any
time. General comments on agency guidance documents are welcome at any
time.

ADDRESSES: Submit written requests for single copies of the guidance
document to the Division of Small Manufacturers, International, and
Consumer Assistance (HFZ-220), Center for Devices and Radiological
Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD
20850. 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 written comments concerning this document to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to http://www.regulations.gov. Identify
comments with the docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Jan Welch, GHTF, Study Group 4, Office
of Compliance, Center for Devices and Radiological Health (HFZ-320),
Food

and Drug Administration, 2094 Gaither Rd., Rockville, MD 20850, 240-
276-0115.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA has participated in a number of activities to promote the
international harmonization of regulatory requirements. In September
1992, a meeting was held in Nice, France by senior regulatory officials
to evaluate international harmonization. This meeting led to the
development of the organization now known as the Global Harmonization
Task Force (GHTF) to facilitate harmonization. Subsequent meetings have
been held on a yearly basis in various locations throughout the world.
    The GHTF is a voluntary group of representatives from national
medical device regulatory authorities and the regulated industry. Since
its inception, the GHTF has been comprised of representatives from five
founding members grouped into three geographical areas: Europe, Asia-
Pacific, and North America, each of which actively regulates medical
devices using their own unique regulatory framework.
    The objective of the GHTF is to encourage convergence at the global
level of regulatory systems of medical devices to facilitate trade
while preserving the right of participating members to address the
protection of public health by regulatory means considered most
suitable. One of the ways this objective is achieved is by identifying
and developing areas of international cooperation to facilitate
progressive reduction of technical and regulatory differences in
systems established to regulate medical devices. In an effort to
accomplish these objectives, the GHTF formed five study groups to draft
documents and carry on other activities designed to facilitate global
harmonization. This notice is a result of a document that has been
developed by one of the Study Groups (4).
    Study Group 4 was initially tasked with the responsibility of
developing guidance documents on quality systems auditing practices. As
a result of its efforts, this group has developed document SG4/
N33R16:2007. The final document (SG4/N33R16:2007) entitled ``Guidelines
for Regulatory Auditing of Quality Management Systems of Medical Device
Manufacturers--Part 3: Regulatory Audit Reports'' provides a structure
for audit reports used in multiple jurisdictions, promoting consistency
and uniformity and should assist the auditor in preparing a report for
use by multiple regulators and/or auditing organizations. Having
reports that are consistent in content should facilitate the review and
exchange of audit reports. Acceptance of audit reports by multiple
regulators should eventually reduce the number of audits for
manufacturers. This document was announced as available for comment on
February 6, 2007 (72 FR 5443). GHTF received several comments on the
document proposed on February 6, 2007. In response to the comments,
GHTF made changes to clarify the document.

II. Significance of Guidance

    This document represents recommendations from the GHTF study groups
and does not describe regulatory requirements. FDA is making this
document available so that industry and other members of the public may
express their views and opinions.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
using the Internet. The Center for Devices and Radiological Health
(CDRH) maintains an entry on the Internet for easy access to
information including text, graphics, and files that may be downloaded
to a personal computer with Internet access. Updated on a regular
basis, the CDRH home page includes device safety alerts, Federal
Register reprints, information on premarket submissions (including
lists of approved applications and manufacturers' addresses), small
manufacturer's assistance, information on video conferencing and
electronic submissions, Mammography Matters, and other device-oriented
information. Information on the GHTF may be accessed at http://
www.ghtf.org. The CDRH Web site may be accessed at http://www.fda.gov/
cdrh.

IV. Paperwork Reduction Act of 1995

    For this final document, FDA concludes that there are no collection
of information requirements under the Paperwork Reduction Act of 1995.

V. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), written or electronic comments regarding this
document. Submit a single copy of electronic comments or two paper
copies of any mailed comments, except that individuals may submit one
paper copy. Comments are to be identified 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.
    Please note that on January 15, 2008, the FDA Web site transitioned
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will
be accepted by FDA through FDMS only.

    Dated: March 14, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-5927 Filed 3-24-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 83, Number 179 (Friday, September 14, 2018)]
[Notices]
[Pages 46747-46748]
[FR Doc No: 2018-20049]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2018-0801]

Certificate of Alternative Compliance for the TUG JUDY MORAN Hull
123

AGENCY: Coast Guard, DHS.

ACTION: Notification of issuance of a certificate of alternative
compliance.

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SUMMARY: The Coast Guard announces that the U. S. Coast Guard First
District Prevention Division has issued a certificate of alternative
compliance from the International Regulations for Preventing Collisions
at Sea, 1972 (72 COLREGS), for the TUG JUDY MORAN, Hull 123. We are
issuing this notice because its publication is required by statute. Due
to the construction and placement of the vessel's side lights and stern
lights, TUG JUDY MORAN cannot fully comply with the light, shape, or
sound signal provisions of the 72 COLREGS without interfering with the
vessel's design and construction. This notification of issuance of a
certificate of alternative compliance promotes the Coast Guard's marine
safety mission.

DATES: The Certificate of Alternative Compliance was issued on 26 July,
2018.

FOR FURTHER INFORMATION CONTACT: For information or questions about
this notice call or email Mr. Kevin Miller, First District Towing
Vessel/Barge Safety Specialist, U.S. Coast Guard; telephone (617) 223-
8272, email [email protected].

SUPPLEMENTARY INFORMATION:
    The United States is signatory to the International Maritime
Organization's International Regulations for Preventing Collisions at
Sea, 1972 (72 COLREGS), as amended. The special construction or purpose
of some vessels makes them unable to comply with the light, shape, or
sound signal provisions of the 72 COLREGS. Under statutory law,
however, specified 72 COLREGS provisions are not applicable to a vessel
of special construction or purpose if the Coast Guard determines that
the vessel cannot comply fully with those requirements without
interfering with the special function of the vessel.\1\
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    \1\ 33 U.S.C. 1605.
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    The owner, builder, operator, or agent of a special construction or
purpose vessel may apply to the Coast Guard District Office in which
the vessel is being built or operated for a determination that
compliance with alternative requirements is justified,\2\ and the Chief
of the Prevention Division would then issue the applicant a certificate
of alternative compliance (COAC) if he or she determines that the
vessel cannot comply fully with 72 COLREGS light, shape, and sound
signal provisions without interference with the vessel's special
function.\3\ If the Coast Guard issues a COAC, it must publish notice
of this action in the Federal Register.\4\
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    \2\ 33 CFR 81.5.
    \3\ 33 CFR 81.9.
    \4\ 33 U.S.C. 1605(c) and 33 CFR 81.18.

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    The First District Prevention Department, U.S. Coast Guard,
certifies that the TUG JUDY MORAN, Washburn & Doughty Hull 123, is a
vessel of special construction or purpose, and that, with respect to
the position of the vessels side lights, it is not possible to comply
fully with the requirements of the provisions enumerated in the 72
COLREGS, without interfering with the normal operation, construction,
or design of the vessel. The First District Prevention Division further
finds and certifies that the vessel's sidelights (13' 5'' from the
vessel's side mounted on the pilot house) and the vessel's stern light
and towing lights (3' 6'' aft of frame 20) are in the closet possible
compliance with the applicable provisions of the 72 COLREGS.\5\
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    \5\ 33 U.S.C. 1605(a); 33 CFR 81.9.
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    This notice is issued under authority of 33 U.S.C. 1605(c) and 33
CFR 81.18.

    Dated: September 11, 2018.
Richard J. Schultz,
Captain, U.S. Coast Guard, Chief, Prevention Division, First Coast
Guard District.
[FR Doc. 2018-20049 Filed 9-13-18; 8:45 am]
 BILLING CODE 9110-04-P