[Federal Register Volume 78, Number 115 (Friday, June 14, 2013)]
[Proposed Rules]
[Pages 35798-35801]
[FR Doc No: 2013-14125]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2013-0322]
RIN 1625-AA00

Safety Zones; Swim Around Charleston; Charleston, SC

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard proposes to establish temporary moving safety
zones during the Swim Around Charleston, a swimming race occurring on
the Wando River, the Cooper River, Charleston Harbor, and the Ashley
River, in Charleston, South Carolina. The Swim Around Charleston is
scheduled on Sunday, September 29, 2013. The temporary safety zones are
necessary to protect swimmers, participant vessels, spectators, and the
general public during the event. Persons and vessels would be
prohibited from entering the safety zones unless authorized by the
Captain of the Port Charleston or a designated representative.

DATES: Comments and related material must be received by the Coast
Guard on or before July 15, 2013. Requests for public meetings must be
received by the Coast Guard on or before June 28, 2013.

ADDRESSES: You may submit comments identified by docket number using
any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail or Delivery: Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE., Washington, DC 20590-0001. Deliveries
accepted between 9 a.m. and 5 p.m., Monday through Friday, except
federal holidays. The telephone number is<PHONE_NUMBER>.

See the ``Public Participation and Request for Comments'' portion of
the SUPPLEMENTARY INFORMATION section below for further instructions on
submitting comments. To avoid duplication, please use only one of these
three methods.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Chief Warrant Officer Christopher Ruleman, Sector
Charleston Office of Waterways Management, Coast Guard; telephone
(843)-740-3184, email<EMAIL_ADDRESS>If you have
questions on viewing or submitting material to the docket, call Barbara
Hairston, Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking

A. Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided.

1. Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation. You may submit your comments and material online at
http://www.regulations.gov, or by fax, mail, or hand delivery, but
please use only one of these means. If you submit a comment online, it
will be considered received by the Coast Guard when you successfully
transmit the comment. If you fax, hand deliver, or mail your comment,
it will be considered as having been received by the Coast Guard when
it is received at the Docket Management Facility. We recommend that you
include your name and a mailing address, an email address, or a
telephone number in the body of your document so that we can contact
you if we have questions regarding your submission.
    To submit your comment online, go to http://www.regulations.gov,
type the docket number USCG-2013-0322 in the ``SEARCH'' box and click
``SEARCH.''
    If you submit your comments by mail or hand delivery, submit them
in an unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit comments by mail and would
like to know that they reached the Facility, please enclose a stamped,
self-addressed postcard or envelope. We will consider all comments and
material received during the comment period and may change the rule
based on your comments.

2. Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
type the docket number USCG-2013-0322 in the ``SEARCH'' box and click
``SEARCH.'' Click on Open Docket Folder on the line associated with
this rulemaking. You may also visit the Docket Management Facility in
Room W12-140 on the ground floor of the Department of Transportation
West Building, 1200 New Jersey Avenue SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.

3. Privacy Act

    Anyone can search the electronic form of comments received into any
of our dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

4. Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request for one, using one of the methods specified under ADDRESSES.
Please explain why you believe a public meeting would be beneficial. If
we determine that one would aid this rulemaking, we will hold one at a
time and place announced by a later notice in the Federal Register.

B. Basis and Purpose

    The legal basis for the proposed rule is the Coast Guard's
authority to establish regulated navigation areas and other limited
access areas: 33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50
U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Public Law 107-
295, 116 Stat. 2064; Department of Homeland Security Delegation No.
0170.1.
    On Sunday, September 29, 2013, the Swim Around Charleston is
scheduled to take place on the Wando River, the Cooper River,
Charleston Harbor, and the Ashley River, in Charleston, South Carolina.
The Swim Around Charleston will consist of a 12 mile swim that starts
at Remley's Point on the Wando River, crosses the main shipping channel
of Charleston Harbor, and finishes at the I-526 bridge and boat landing
on the Ashley River.
    The purpose of the proposed rule is to ensure the safety of the
swimmers, participant vessels, spectators, and the general public
during the Swim Around Charleston.

C. Discussion of Proposed Rule

    The proposed rule would establish temporary moving safety zones of
50 yards in front of the lead safety vessel preceding the first race
participant, 50 yards behind the safety vessel trailing the last race
participants, and at all times extend 100 yards on either side of the
race participants and safety vessels. The temporary safety zones would
be enforced from 9 a.m. until 3:30 p.m. on September 29, 2013.
    Persons and vessels would be prohibited from entering or transiting
through the safety zones unless authorized by the Captain of the Port
Charleston or a designated representative. Persons and vessels would be
able to request authorization to enter or transit through the safety
zones by contacting the Captain of the Port Charleston by telephone at
(843) 740-7050, or a designated representative via VHF radio on channel
16.

D. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and executive orders related to rulemaking. Below we summarize our
analyses based on a number of these statutes or executive orders.

1. Regulatory Planning and Review

    This proposed rule is not a significant regulatory action under
section 3(f) of Executive Order 12866, Regulatory Planning and Review,
as supplemented by Executive Order 13563, Improving

Regulation and Regulatory Review, and does not require an assessment of
potential costs and benefits under section 6(a)(3) of Executive Order
12866 or under section 1 of Executive Order 13563. The Office of
Management and Budget has not reviewed it under those Orders.
    The economic impact of this proposed rule is not significant for
the following reasons: (1) The safety zones would only be enforced for
a total of seven hours; (2) the safety zones would move with the
participant vessels so that once the swimmers clear a portion of the
waterway, the safety zones would no longer be enforced in that portion
of the waterway; (3) although persons and vessels would not be able to
enter or transit through the safety zones without authorization from
the Captain of the Port Charleston or a designated representative, they
would be able to operate in the surrounding area during the enforcement
period; (4) persons and vessels would still be able to enter or transit
through the safety zones if authorized by the Captain of the Port
Charleston or a designated representative; and (5) the Coast Guard
would provide advance notification of the safety zones to the local
maritime community by Local Notice to Mariners and Broadcast Notice to
Mariners.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this
proposed rule will not have a significant economic impact on a
substantial number of small entities.
    This proposed rule may affect the following entities, some of which
may be small entities: the owners or operators of vessels intending to
enter, transit through, anchor in, or remain within that portion of the
Wando River, the Cooper River, Charleston Harbor, and the Ashley River
in Charleston, South Carolina encompassed within the safety zones from
9 a.m. until 3:30 p.m. on September 29, 2013. For the reasons discussed
in the Regulatory Planning and Review section above, this proposed rule
would not have a significant economic impact on a substantial number of
small entities. If you think that your business, organization, or
governmental jurisdiction qualifies as a small entity and that this
rule would have a significant economic impact on it, please submit a
comment (see ADDRESSES) explaining why you think it qualifies and how
and to what degree this rule would economically affect it.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the rule would affect
your small business, organization, or governmental jurisdiction and you
have questions concerning its provisions or options for compliance,
please contact the person listed in the FOR FURTHER INFORMATION
CONTACT, above. The Coast Guard will not retaliate against small
entities that question or complain about this proposed rule or any
policy or action of the Coast Guard.

4. Collection of Information

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

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this proposed rule under that Order and
determined that this rule does not have implications for federalism.

6. Protest Activities

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

7. Unfunded Mandates Reform Act

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

8. Taking of Private Property

    This proposed rule would not cause a taking of private property or
otherwise have taking implications under Executive Order 12630,
Governmental Actions and Interference with Constitutionally Protected
Property Rights.

9. Civil Justice Reform

    This proposed rule meets applicable standards in sections 3(a) and
3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize
litigation, eliminate ambiguity, and reduce burden.

10. Protection of Children From Environmental Health Risks

    We have analyzed this proposed rule under Executive Order 13045,
Protection of Children from Environmental Health Risks and Safety
Risks. This rule is not an economically significant rule and would not
create an environmental risk to health or risk to safety that might
disproportionately affect children.

11. Indian Tribal Governments

    This proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.

12. Energy Effects

    This proposed rule is not a ``significant energy action'' under
Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use.

13. Technical Standards

    This proposed rule does not use technical standards. Therefore, we
did not consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01 and Commandant Instruction
M16475.lD, which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and

have made a preliminary determination that this action is one of a
category of actions that do not individually or cumulatively have a
significant effect on the human environment. A preliminary
environmental analysis checklist supporting this determination is
available in the docket where indicated under ADDRESSES. This proposed
rule involves establishing temporary moving safety zones as described
in figure 2-1, paragraph (34)(g), of the Commandant Instruction. We
seek any comments or information that may lead to the discovery of a
significant environmental impact from this proposed rule.

List of Subjects in 33 CFR Part 165

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

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

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority: 33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50
U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub. L. 107-
295, 116 Stat. 2064; Department of Homeland Security Delegation No.
0170.1.

0
2. Add Sec.  165.T07-0322 to read as follows:

Sec.  165.T07-0322  Safety Zones; Swim Around Charleston, Charleston,
SC.

    (a) Regulated Areas. The following regulated area is a moving
safety zone: All waters 50 yards in front of the lead safety vessel
preceding the first race participants, 50 yards behind the safety
vessel trailing the last race participants, and at all times extend 100
yards on either side of the race participants and safety vessels. The
Swim Around Charleston swimming race consists of a 12 mile course that
starts at Remley's Point on the Wando River in approximate position
32[deg]48'49'' N, 79[deg]54'27'' W, crosses the main shipping channel
of Charleston Harbor, and finishes at the I-526 bridge and boat landing
on the Ashley River in approximate position 32[deg]50'14'' N,
80[deg]01'23'' W. All coordinates are North American Datum 1983.
    (b) Definition. The term ``designated representative'' means Coast
Guard Patrol Commanders, including Coast Guard coxswains, petty
officers, and other officers operating Coast Guard vessels, and
Federal, state, and local officers designated by or assisting the
Captain of the Port Charleston in the enforcement of the regulated
areas.
    (c) Regulations.
    (1) All persons and vessels are prohibited from entering or
transiting through the regulated areas unless authorized by the Captain
of the Port Charleston or a designated representative.
    (2) Persons and vessels desiring to enter or transit through the
regulated areas may contact the Captain of the Port Charleston by
telephone at<PHONE_NUMBER>, or a designated representative via VHF
radio on channel 16, to request authorization. If authorization to
enter or transit through the regulated areas is granted by the Captain
of the Port Charleston or a designated representative, all persons and
vessels receiving such authorization must comply with the instructions
of the Captain of the Port Charleston or a designated representative.
    (3) The Coast Guard will provide notice of the regulated areas by
Local Notice to Mariners, Broadcast Notice to Mariners, and on-scene
designated representatives.
    (d) Effective Date. This rule is effective from 9 a.m. until 3:30
p.m. on September 29, 2013.

    Dated: May 29, 2013.
M.F. White,
Captain, U.S. Coast Guard, Captain of the Port Charleston.
[FR Doc. 2013-14125 Filed 6-13-13; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: May 16, 2008 (Volume 73, Number 96)]
[Notices]
[Page 28441-28442]
[DOCID:fr16my08-42]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12551-001]

Salvatore and Michelle Shifrin; Notice of Application Accepted
for Filing and Soliciting Motions To Intervene and Protests

May 9, 2008.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: Exemption From Licensing.
    b. Project No.: P-12551-001.
    c. Date Filed: January 25, 2008.
    d. Applicant: Salvatore and Michelle Shifrin.
    e. Name of Project: Mansfield Hollow Hydro Power Project.
    f. Location: On the Natchaug River in Tolland County, Connecticut.
The project would occupy United States land managed by the U.S. Army
Corps of Engineers.
    g. Filed Pursuant to: Public Utilities Regulatory Policies Act of
1978, 16 U.S.C. 2705, 2708.
    h. Applicant Contact: Salvatore or Michelle Shifrin, 78 Bricktop
Road, Windham, CT 06280,<PHONE_NUMBER>.
    i. FERC Contact: Tom Dean,<PHONE_NUMBER>.
    j. Deadline for filing motions to intervene and protests: 60 days
from the issuance date of this notice.
    All documents (original and eight copies) should be filed with:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426.
    The Commission's Rules of Practice require all intervenors filing
documents with the Commission to serve a copy of that document on each
person 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.
    Motions to intervene and protests may be filed electronically via
the Internet in lieu of paper. The Commission strongly encourages
electronic filings. See 18 CFR 385.2001(a)(1)(iii) and the

instructions on the Commission's Web site (http://www.ferc.gov) under
the ``eFiling'' link.
    k. This application has been accepted for filing, but is not ready
for environmental analysis at this time.
    l. Description of Project: The Mansfield Hollow Hydro Power Project
would consist of: (1) The existing 80-foot-long, 10-foot-high Kirby
Mill Dam; (2) the existing 1.6-acre reservoir; (3) the existing
headgate structure; (4) the existing 12-foot-wide, 8-foot-high, 330-
foot-long head race channel; (5) a new powerhouse containing five
generating units with a total installed capacity of 500 kilowatts; (6)
the existing 5-foot-wide, 7-foot-high, 100-foot-long conduit and 75-
foot-long open tailrace; and (7) appurtenant facilities. The project
would have an average annual generation of about 2,500 megawatt-hours.
    In addition to a new powerhouse, project reconstruction would
consist of: (1) A new 12-foot-wide, 8-foot-high, 330-foot-long head
race channel; (2) a new 20-foot-wide, 8-foot-high, 20-foot-long box
culvert connected to a new 25-foot-wide, 4-foot-high, 153-foot-long
open channel tail race; and (3) a new 275-foot-long transmission line.
    m. A copy of the application is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the three digits in the docket
number field to access the document. For assistance, please contact
FERC Online Support at<EMAIL_ADDRESS>or toll free at (866)
208-3676, or for TTY, contact<PHONE_NUMBER>. A copy is also available
for inspection and reproduction at the address in item h above.
    You may also register online at http://www.ferc.gov/docs-filing/
esubscription.asp to be notified via e-mail of new filings and
issuances related to this or other pending projects. For assistance,
contact FERC Online Support.
    n. Anyone may submit a protest or a motion to intervene in
accordance with the requirements of Rules of Practice and Procedure, 18
CFR 385.210, 385.211, and 385.214. In determining the appropriate
action to take, the Commission will consider all protests 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 protests
or motions to intervene must be received on or before the specified
deadline date for the particular application.
    All filings must: (1) Bear in all capital letters the title
``PROTEST'' or ``MOTION TO INTERVENE;'' (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 protesting or intervening; and (4) otherwise
comply with the requirements of 18 CFR 385.2001 through 385.2005.
Agencies may obtain copies of the application directly from the
applicant. A copy of any protest or motion to intervene must be served
upon each representative of the applicant specified in the particular
application.
    o. Procedural schedule and final amendments: The application will
be processed according to the following Hydro Licensing Schedule.
Revisions to the schedule will be made as appropriate. The Commission
staff proposes to issue one environmental assessment rather than issue
a draft and final EA. Comments, terms and conditions, recommendations,
prescriptions, and reply comments, if any, will be addressed in an EA.
Staff intents to give at least 30 days for entities to comment on the
EA, and will take into consideration all comments received on the EA
before final action is taken on the license application.
    Notice of application ready for environmental analysis: September
2008.
    Notice of availability of the EA: March 2009.

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-11026 Filed 5-15-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 113 (Wednesday, June 14, 2017)]
[Notices]
[Pages 27259-27261]
[FR Doc No: 2017-12328]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0622]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Color Additive Certification Requests and
Recordkeeping

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the information collection provisions of
FDA's regulations governing batch certification of color additives
manufactured for use in foods, drugs, cosmetics, or medical devices in
the United States.

DATES: Submit either electronic or written comments on the collection
of information by August 14, 2017.

ADDRESSES: You may submit comments as follows. Late, untimely filed
comments will not be considered. Electronic comments must be submitted
on or before August 14, 2017. The https://www.regulations.gov
electronic filing system will accept comments until midnight Eastern
Time at the end of August 14, 2017. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are postmarked or the delivery service acceptance
receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2010-N-0622 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Color Additive Certification
Requests and Recordkeeping.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov/ and insert the docket number, found in brackets in
the

heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, FDA PRA Staff,
Office of Operations, Food and Drug Administration, Three White Flint
North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-
3794.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Color Additive Certification Requests and Recordkeeping--21 CFR Part
80--OMB Control Number 0910-0216--Extension

    We have regulatory oversight for color additives used in foods,
drugs, cosmetics, and medical devices. Section 721(a) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379e(a)) provides that a color
additive shall be deemed to be unsafe unless it meets the requirements
of a listing regulation, including any requirement for batch
certification, and is used in accordance with the regulation. We list
color additives that have been shown to be safe for their intended uses
in Title 21 of the Code of Federal Regulations (CFR). We require batch
certification for all color additives listed in 21 CFR part 74 and for
all color additives provisionally listed in 21 CFR part 82. Color
additives listed in 21 CFR part 73 are exempted from certification.
    The requirements for color additive certification are described in
21 CFR part 80. In the certification procedure, a representative sample
of a new batch of color additive, accompanied by a ``request for
certification'' that provides information about the batch, must be
submitted to FDA's Office of Cosmetics and Colors. FDA personnel
perform chemical and other analyses of the representative sample and,
providing the sample satisfies all certification requirements, issue a
certification lot number for the batch. We charge a fee for
certification based on the batch weight and require manufacturers to
keep records of the batch pending and after certification.
    Under Sec.  80.21, a request for certification must include: Name
of color additive, manufacturer's batch number and weight in pounds,
name and address of manufacturer, storage conditions, statement of
use(s), certification fee, and signature of person requesting
certification. Under Sec.  80.22, a request for certification must
include a sample of the batch of color additive that is the subject of
the request. The sample must be labeled to show: Name of color
additive, manufacturer's batch number and quantity, and name and
address of person requesting certification. Under Sec.  80.39, the
person to whom a certificate is issued must keep complete records
showing the disposal of all of the color additive covered by the
certificate. Such records are to be made available upon request to any
accredited representative of FDA until at least 2 years after disposal
of all of the color additive.
    The purpose for collecting this information is to help us assure
that only safe color additives will be used in foods, drugs, cosmetics,
and medical devices sold in the United States. The required information
is unique to the batch of color additive that is the subject of a
request for certification. The manufacturer's batch number is used for
temporarily identifying a batch of color additive until FDA issues a
certification lot number and for identifying a certified batch during
inspections. The manufacturer's batch number also aids in tracing the
disposal of a certified batch or a batch that has been denied
certification for noncompliance with the color additive regulations.
The manufacturer's batch weight is used for assessing the certification
fee. The batch weight also is used to account for the disposal of a
batch of certified or certification-denied color additive. The batch
weight can be used in a recall to determine whether all unused color
additive in the batch has been recalled. The manufacturer's name and
address and the name and address of the person requesting certification
are used to contact the person responsible should a question arise
concerning compliance with the color additive regulations. Information
on storage conditions pending certification is used to evaluate whether
a batch of certified color additive is inadvertently or intentionally
altered in a manner that would make the sample submitted for
certification analysis unrepresentative of the batch. We check storage
information during inspections. Information on intended uses for a
batch of color additive is used to assure that a batch of certified
color additive will be used in accordance with the requirements of its
listing regulation. The statement of the fee on a certification request
is used for accounting purposes so that a person requesting
certification can be notified promptly of any discrepancies.
    We estimate the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
           21 CFR section/activity               Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
80.21; Request for Certification............              38             198           7,524  0.17 (10 minutes).........................           1,279
80.22; Sample to Accompany Request..........              38             198           7,524  0.05 (3 minutes)..........................             376
--------------------------------------------------------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  0.22 (13 minutes).........................           1,655
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
           21 CFR section/activity               Number of      records per    Total annual        Average burden per recordkeeping         Total hours
                                               recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
80.39; Record of Distribution...............              38             198           7,524  .25 (15 minutes)..........................           1,881
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    We base our estimate on our review of the certification requests
received over the past 3 fiscal years (FY). The annual burden estimate
for this information collection is 3,536 hours. The estimated reporting
burden for this information collection is 1,655 hours and the estimated
recordkeeping burden for this information collection is 1,881 hours.
From FY 2014 to FY 2016, we processed an average of 7,524 responses
(requests for certification of batches of color additives) per year.
There were 38 different respondents, corresponding to an average of
approximately 198 responses from each respondent per year. Using
information from industry personnel, we estimate that an average of
0.22 hour per response is required for reporting (preparing
certification requests and accompanying samples) and an average of 0.25
hour per response is required for recordkeeping.
    Our Web-based Color Certification information system allows
submitters to request color certification online, follow their
submissions through the process, and obtain information on account
status. The system sends back the certification results electronically,
allowing submitters to sell their certified color before receiving
hardcopy certificates. Any delays in the system result only from
shipment of color additive samples to FDA's Office of Cosmetics and
Colors for analysis.

    Dated: June 9, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12328 Filed 6-13-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 75 (Thursday, April 18, 2019)]
[Notices]
[Pages 16327-16328]
[FR Doc No: 2019-07791]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2019-0004]

Qualification of Drivers; Exemption Applications; Vision

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of final disposition.

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SUMMARY: FMCSA announces its decision to exempt 12 individuals from the
vision requirement in the Federal Motor Carrier Safety Regulations
(FMCSRs) to operate a commercial motor vehicle (CMV) in interstate
commerce. They are unable to meet the vision requirement in one eye for
various reasons. The exemptions enable these individuals to operate
CMVs in interstate commerce without meeting the vision requirement in
one eye.

DATES: The exemptions were applicable on March 26, 2019. The exemptions
expire on March 26, 2021.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER>, [email protected], FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE, Room W64-224,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
ET, Monday through Friday, except Federal holidays. If you have
questions regarding viewing or submitting material to the docket,
contact Docket Services, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Viewing Documents and Comments

    To view comments, as well as any documents mentioned in this notice
as being available in the docket, go to http://www.regulations.gov.
Insert the docket number, FMCSA-2019-0004, in the keyword box, and
click ``Search.'' Next, click the ``Open Docket Folder'' button and
choose the document to review. If you do not have access to the
internet, you may view the docket online by visiting the Docket
Management Facility in Room W12-140 on the ground floor of the DOT West
Building, 1200 New Jersey Avenue SE, Washington, DC 20590, between 9
a.m. and 5 p.m., ET, Monday through Friday, except Federal holidays.

B. Privacy Act

    In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its rulemaking process. DOT posts these
comments, without edit, including any personal information the
commenter provides, to www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

II. Background

    On February 21, 2019, FMCSA published a notice announcing receipt
of applications from 12 individuals requesting an exemption from vision
requirement in 49 CFR 391.41(b)(10) and requested comments from the
public (84 FR 5550). The public comment period ended on March 25, 2019,
and no comments were received.
    FMCSA has evaluated the eligibility of these applicants and
determined that granting the exemptions to these individuals would
achieve a level of safety equivalent to, or greater than, the level
that would be achieved by complying with the current regulation 49 CFR
391.41(b)(10).
    The physical qualification standard for drivers regarding vision
found in 49 CFR 391.41(b)(10) states that a person is physically
qualified to drive a CMV if that person has distant visual acuity of at
least 20/40 (Snellen) in each eye without corrective lenses or visual
acuity separately corrected to 20/40 (Snellen) or better with
corrective lenses, distant binocular acuity of a least 20/40 (Snellen)
in both eyes with or without corrective lenses, field of vision of at
least 70[deg] in the horizontal meridian in each eye, and the ability
to recognize the colors of traffic signals and devices showing red,
green, and amber.

III. Discussion of Comments

    FMCSA received no comments in this proceeding.

IV. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
for up to five years from the vision standard in 49 CFR 391.41(b)(10)
if the exemption is likely to achieve an equivalent or greater level of
safety than would be achieved without the exemption. The exemption
allows applicants to operate CMVs in interstate commerce. FMCSA grants
exemptions from the FMCSRs for a two-year period to align with the
maximum duration of a driver's medical certification.
    The Agency's decision regarding these exemption applications is
based on medical reports about the applicants' vision, as well as their
driving records and experience driving with the vision deficiency. The
qualifications, experience, and medical condition of each applicant
were stated and discussed in detail in the February 21, 2019, Federal
Register notice (84 FR 5550) and will not be repeated in this notice.
    FMCSA recognizes that some drivers do not meet the vision
requirement but have adapted their driving to accommodate their
limitation and demonstrated their ability to drive safely. The 12
exemption applicants listed in this notice are in this category. They
are unable to meet the vision requirement in one eye for various
reasons, including amblyopia, chorioretinal scar, macular degeneration,
macular hole, macular scar, prosthesis, and retinal vein occlusion. In
most cases, their eye conditions were not recently developed. Six of
the applicants were either born with their vision impairments or have
had them since childhood. The six individuals that sustained their
vision conditions as adults have had it for a

range of 4 to 20 years. Although each applicant has one eye that does
not meet the vision requirement in 49 CFR 391.41(b)(10), each has at
least 20/40 corrected vision in the other eye, and, in a doctor's
opinion, has sufficient vision to perform all the tasks necessary to
operate a CMV.
    Doctors' opinions are supported by the applicants' possession of a
valid license to operate a CMV. By meeting State licensing
requirements, the applicants demonstrated their ability to operate a
CMV with their limited vision in intrastate commerce, even though their
vision disqualified them from driving in interstate commerce. We
believe that the applicants' intrastate driving experience and history
provide an adequate basis for predicting their ability to drive safely
in interstate commerce. Intrastate driving, like interstate operations,
involves substantial driving on highways on the interstate system and
on other roads built to interstate standards. Moreover, driving in
congested urban areas exposes the driver to more pedestrian and
vehicular traffic than exists on interstate highways. Faster reaction
to traffic and traffic signals is generally required because distances
between them are more compact. These conditions tax visual capacity and
driver response just as intensely as interstate driving conditions.
    The applicants in this notice have driven CMVs with their limited
vision in careers ranging for 3 to 80 years. In the past three years,
no drivers were involved in crashes, and two drivers were convicted of
moving violations in CMVs. All the applicants achieved a record of
safety while driving with their vision impairment that demonstrates the
likelihood that they have adapted their driving skills to accommodate
their condition. As the applicants' ample driving histories with their
vision deficiencies are good predictors of future performance, FMCSA
concludes their ability to drive safely can be projected into the
future.
    Consequently, FMCSA finds that in each case exempting these
applicants from the vision requirement in 49 CFR 391.41(b)(10) is
likely to achieve a level of safety equal to that existing without the
exemption.

V. Conditions and Requirements

    The terms and conditions of the exemption are provided to the
applicants in the exemption document and includes the following: (1)
Each driver must be physically examined every year (a) by an
ophthalmologist or optometrist who attests that the vision in the
better eye continues to meet the standard in 49 CFR 391.41(b)(10) and
(b) by a certified Medical Examiner who attests that the individual is
otherwise physically qualified under 49 CFR 391.41; (2) each driver
must provide a copy of the ophthalmologist's or optometrist's report to
the Medical Examiner at the time of the annual medical examination; and
(3) each driver must provide a copy of the annual medical certification
to the employer for retention in the driver's qualification file, or
keep a copy in his/her driver's qualification file if he/she is self-
employed. The driver must also have a copy of the exemption when
driving, for presentation to a duly authorized Federal, State, or local
enforcement official.

VI. Preemption

    During the period the exemption is in effect, no State shall
enforce any law or regulation that conflicts with this exemption with
respect to a person operating under the exemption.

VII. Conclusion

    Based upon its evaluation of the 12 exemption applications, FMCSA
exempts the following drivers from the vision requirement, 49 CFR
391.41(b)(10), subject to the requirements cited above:

Gary W. Brockway (IA)
Roger W. Estes (MO)
Gilbert J. Graybill (OK)
Richard D. Livingston, Jr. (WI)
Edgar H. Meraz Gardea (NM)
Joshua G. Millican (OH)
Daniel C. Reichert (GA)
Gregory D. Shirah (AL)
Balwant Singh (CA)
Tristan A. Twito (TX)
Michael L. Watters, Sr. (PA)
Dana J. York (PA)

    In accordance with 49 U.S.C. 31136(e) and 31315, each exemption
will be valid for two years from the effective date unless revoked
earlier by FMCSA. The exemption will be revoked if the following
occurs: (1) The person fails to comply with the terms and conditions of
the exemption; (2) the exemption has resulted in a lower level of
safety than was maintained prior to being granted; or (3) continuation
of the exemption would not be consistent with the goals and objectives
of 49 U.S.C. 31136 and 31315.

    Issued on: April 11, 2019.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2019-07791 Filed 4-17-19; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 77, Number 152 (Tuesday, August 7, 2012)]
[Rules and Regulations]
[Pages 46960-46961]
[FR Doc No: 2012-19138]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2011-0501; FRL9699-3]

Approval and Promulgation of Air Quality Implementation Plans;
Wisconsin; Forest County Potawatomi Community Reservation Class I Area

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is approving procedures for permitting certain sources in
relation to the Forest County Potawatomi Community (FCP Community)
Class I Area into the Wisconsin State Implementation Plan (SIP). These
provisions were submitted by the Wisconsin Department of Natural
Resources (WDNR) on May 12, 2011. The provisions include the regulation
of certain sources constructing near the FCP Community Class I Area, as
well as procedures for the FCP Community's demonstration regarding a
source that may have an adverse impact on the Class I Area. The
provisions implement portions of a Memorandum of Agreement (MOA)
entered into by Wisconsin and the FCP Community as part of a dispute
resolution related to the Class I Area redesignation.

DATES: This final rule is effective on September 6, 2012.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-R05-OAR-2011-0501. All documents in the docket are listed on
the www.regulations.gov web site. Although listed in the index, some
information is not publicly available, i.e., Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. Certain other material, such as copyrighted material, is
not placed on the Internet and will be publicly available only in hard
copy form. Publicly available docket materials are available either
electronically through www.regulations.gov or in hard copy at the
Environmental Protection Agency, Region 5, Air and Radiation Division,
77 West Jackson Boulevard, Chicago, Illinois 60604. This facility is
open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
Federal holidays. We recommend that you telephone Danny Marcus,
Environmental Engineer, at<PHONE_NUMBER> before visiting the Region 5
office.

FOR FURTHER INFORMATION CONTACT: Danny Marcus, Environmental Engineer,
Air Permits Section, Air Programs Branch (AR-18J), Environmental
Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago,
Illinois 60604,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA. This supplementary information
section is arranged as follows:

    I. What is being addressed by this document?
    II. What sections of Wisconsin's rules are we approving?
    III. What comments did we receive on the proposed rule?
    IV. What action is EPA taking?
    V. Statutory and executive order reviews.

I. What Is Being Addressed by This Document?

    On April 5, 2012, at 77 FR 20575, EPA proposed to approve
regulatory revisions that Wisconsin submitted for EPA's approval which
include defining the geographic center of the FCP Community Class I
Area for purposes of air quality management; provisions which require
proposed new major sources or major modifications of existing sources
locating within 22.25 miles of the geographic center of the FCP
Community Class I Area to conduct a Class I increment analysis; and
provisions which would require proposed new major sources or major
modifications of existing sources locating outside 22.25 miles of the
geographic center of the FCP Community Class I Area to conduct a Class
II increment analysis. The rules also include procedures for the FCP
Community to coordinate with the State regarding comments on sources
potentially impacting the Class I Area and to make a demonstration to
the State that a proposed source may have an adverse effect on Air
Quality Related Values(AQRVs). Finally, the rules provide the FCP
Community with the opportunity to review certain best available control
technology (BACT) and maximum achievable control technology (MACT)
determinations made by the State, and provide a dispute resolution
mechanism for resolving disagreements regarding those BACT or MACT
determinations.
    The changes to the Wisconsin SIP implement portions of an MOA
signed by Wisconsin and the FCP Community in 1999. This MOA was part of
a dispute resolution process related to the FCP Community Class I Area
redesignation in 2008. For additional background information on the
Class I Area redesignation, see 73 FR 23086, April 29, 2008, and 77 FR
20575, April 5, 2012.

II. What sections of Wisconsin's rules are we approving?

    EPA is approving revisions to chapters NR 400, 405, and 406 of the
Wisconsin Administration Code into the Wisconsin SIP. Specifically, we
are approving NR 400.02(66m), 405.19 and 406.08(4). The revisions
include adding a definition for the geographic center of the FCP
Community, as well as establishing the distance from this center point
at which a major source or major modification would be required to
comply with regulations regarding impacts to the Class I Area,
including a Class I increment analysis and consumption limits.
Additionally, the provisions establish procedures for the FCP Community
to have opportunities to review BACT and MACT determinations and to
demonstrate that impacts from a new source would have an adverse impact
on AQRV's of the FCP Community Class I Area.

III. What comments did we receive on the proposed rule?

    EPA provided a 30-day review and comment period. The comment period
closed on May 7, 2012. EPA received comments in support of the proposed
approval from the FCP Community. EPA received no adverse comments on
the proposed rule.

IV. What action is EPA taking?

    In today's action, EPA is approving NR 400.02(66m), 405.19 and
406.08(4) into the Wisconsin SIP relating to permitting for certain
sources with the potential to impact the FCP Community Class I Area. As
explained above, and at 77 FR 20575, the provisions will affect
permitting for those sources constructing within a certain distance to
the FCP Community as well as any source with the potential to have an
adverse impact on the increment or AQRVs associated with the FCP
Community's Class I Area. This action does not affect any permitting
within the FCP Community's reservation and EPA remains the federal
permitting authority for the FCP Community's reservation.

V. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Clean Air Act
and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as

meeting Federal requirements and does not impose additional
requirements beyond those imposed by state law. For that reason, this
action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the State, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law. In May 2011, EPA
issued its policy on consultation and coordination with Indian tribes.
EPA explained that its policy is to consult on a government-to-
government basis with Federally recognized tribal governments when EPA
actions and decisions may affect tribal interests. Accordingly, EPA
engaged in consultation with the FCP Community regarding the Wisconsin
proposed SIP revisions. This process is further described in 77 FR
20575, 20577.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under Section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by October 9, 2012. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See Section 307(b)(2).)

List of Subjects in 40 CFR Part 52

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

    Dated: June 27, 2012.
Susan Hedman,
Regional Administrator, Region 5.
    40 CFR part 52 is amended as follows:

PART 52--[AMENDED]

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

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

Subpart YY--Wisconsin

0
2. Section 52.2570 is amended by adding paragraph (c)(125) to read as
follows:

Sec.  52.2570  Identification of plan.

* * * * *
    (c) * * *
    (125) On May 12, 2011, the Wisconsin Department of Natural
Resources submitted a request to revise the State Implementation Plan
regarding procedures for permitting certain sources in relation to the
Forest County Potawatomi Community Class I Area.
    (i) Incorporation by reference. The following sections of the
Wisconsin Administrative Code are incorporated by reference:
    (A) NR 400.02 Definitions. NR 400.02(66m) ``Forest County
Potawatomi Community Class I area'' or ``FCPC Class I area'' as
published in the Wisconsin Administrative Register November 2010, No.
659, effective December 1, 2010.
    (B) NR 405.19 Forest County Potawatomi Class I area, as published
in the Wisconsin Administrative Register November 2010, No. 659,
effective December 1, 2010.
    (C) NR 406.08 Action on permit applications. NR 406.08(4)(a) and
(4)(b) as published in the Wisconsin Administrative Register November
2010, No. 659, effective December 1, 2010.
* * * * *
[FR Doc. 2012-19138 Filed 8-6-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 214 (Tuesday, November 7, 2017)]
[Notices]
[Pages 51663-51665]
[FR Doc No: 2017-24130]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-81994; File No. SR-ICEEU-2017-013]

Self-Regulatory Organizations; ICE Clear Europe Limited; Notice
of Filing of Proposed Rule Change, Security-Based Swap Submission or
Advance Notice Relating to the ICE Clear Europe Procyclicality
Framework

November 1, 2017.
    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 October 23, 2017, ICE Clear Europe Limited (``ICE Clear Europe'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule changes described in Items I, II, and III below, which
Items have been prepared primarily by ICE Clear Europe. The Commission
is publishing this notice to solicit comments on the proposed rule
change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Clearing Agency's Statement of the Terms of Substance of the
Proposed Rule Change

    The principal purpose of the changes is to adopt a new policy
framework for addressing the procyclicality of its risk management
policies by establishing such a framework that addresses the risk
appetite, model design, monitoring and assessment and management of
procyclicality in the risk models used by ICE Clear Europe to manage
default risk.

II. Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

    In its filing with the Commission, ICE Clear Europe 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 these statements may be examined at the places
specified in Item IV below. ICE Clear Europe has prepared summaries,
set forth in sections (A), (B), and (C) below, of the most significant
aspects of such statements.

(A) Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

(a) Purpose
    The purpose of the Procyclicality Framework is to establish an
overall framework for the risk appetite, model design, monitoring and
assessment and management of procyclicality in the risk models used by
ICE Clear Europe to manage default risk. The European Market
Infrastructure Regulation \3\ (``EMIR'') and related implementing
standards require that a central counterparty (``CCP'') ensure that its
margin framework provides, among other matters, stable and prudent
margin requirements that limit procyclicality to the extent that the
soundness and financial security of the central counterparty is not
negatively affected.\4\ Those standards also require that central
counterparties implement at least one of several specified options for
mitigating procyclicality with respect to margin requirements.\5\
---------------------------------------------------------------------------

    \3\ Regulation (EU) No 648/2012 of the European Parliament and
of the Council of 4 July 2012 on OTC derivatives, central
counterparties and trade repositories, as well as various
implementing regulations and technical standards.
    \4\ Article 28 of Commission Delegated Regulation (EU) No 153/
2013 of 19 December 2012 supplementing Regulation (EU) No 648/2012
of the European Parliament and of the Council with regard to
regulatory technical standards on requirements for central
counterparties.
    \5\ The CPMI-IOSCO Principles for Financial Market
Infrastructures (``PFMIs'') similarly provide that a clearing house
should limit procyclicality for margin requirements and haircuts.
See Principles 5 (Collateral) and 6 (Margin).
---------------------------------------------------------------------------

    Although ICE Clear Europe's current margin policies incorporate the
anti-procyclicality (``APC'') measures required by EMIR (and ICE Clear
Europe does not propose to change such measures at this time), it is
proposing to adopt the Procyclicality Framework in order to provide a
more defined framework for considering the impact of procyclicality on
margining, membership, collateral haircuts, stress testing and
concentration risk policies. The framework is designed to set out (1)
the aspects of ICE Clear Europe risk policies relevant to
procyclicality considerations, (2) how the clearing house will assess
procyclicality (both as a qualitative and a quantitative matter) and
(3) how the clearing house will factor considerations of procyclicality
into its response to emerging risks.
    Although ``procyclicality'' is not expressly defined in EMIR, ICE
Clear Europe considers procyclicality for purposes of the proposed
framework to be the extent to which changes in market conditions can
have an effect on a clearing member's ability to manage its liquidity
to meet ICE Clear Europe's changing margin requirements. For example, a
typical initial margin model would require increased margin in stressed
margin conditions, and such increases may potentially occur rapidly
and/or over-react to the change in conditions. Such margin increases,
in turn, may stress a clearing member's ability to obtain liquidity to
meet the increased requirements.
    The framework identifies sources of procyclicality, in particular
in margin models, stress testing, and collateral haircut policies, and
references existing mitigation strategies and stress testing
arrangements used by the clearing house. Stress testing scenarios that
are based on models similar to margin models but targeting a higher
confidence quantile may also be procyclical due to changing market
conditions, which may lead to increased stress shock results and
therefore in default fund requirements. The framework also addresses
how ICE Clear Europe intends to address procyclicality on an ongoing
basis. Under the framework, ICE Clear Europe will assess procyclicality
by monitoring the 95th percentile expected shortfall of the 5-day
percentage change in initial margin (or other relevant risk mitigant)
over a rolling 250-day window. ICE Clear Europe established this
period, in consultation with Clearing Members, as an appropriate period
to reflect short-term spikes in margin. ICE Clear Europe will also
monitor the largest percentage changes to facilitate observation of
both the maximum and a tail estimate to remove extreme outliers. A red-
amber-green (``R-A-G'') escalation framework will be used with respect
to implementing APC measures based on certain defined thresholds for
expected 95th percentile expected shortfall metric, which are detailed
in an appendix to the framework. The escalation framework specifies
appropriate responses where the expected shortfall level is at an amber
or green level. ICE Clear Europe will assess procyclicality both on a
regular basis in monitoring model performance and making margin rate
adjustments as part of risk model design.
    The framework requires that the model design process take into
consideration the procyclicality

characteristics of the model. This should include analysis of the
performance of APC measures during periods of increasing volatility (in
light of defined threshold conditions specified in the framework), in a
range of market conditions, including stress periods.
    In addition to the quantitative metrics, there are a number of
qualitative inputs that are given consideration under the framework.
For example, ICE Clear Europe will take into consideration the
periodicity of margin updates and will attempt to mitigate the effect
of such updates by communicating any such updates to the cleared
markets up to a week in advance. The framework also includes procedures
for considering the impact of prospective margin changes on the
portfolios of Clearing Members and communicating with Clearing Members
that may be significantly affected by such changes. The framework also
takes into account the activities of other CCPs in the relevant market
(including whether they are implementing APC measures), expectations of
market participants, the potential for moral hazard created by an
expectation of gradual margin changes (which may not be possible in
extreme situations), and the ability of the clearing house to override
normal APC measures in extreme circumstances. The framework recognizes
that different APC measures and thresholds may be appropriate in
different markets based on their historical performance. ICE Clear
Europe also takes into account the different liquidity resources and
practices of different types of Clearing Members, including banks,
broker-dealers and other traders, and the need for margin add-ons to
mitigate particular liquidity and/or concentration risks. The framework
also sets out APC considerations for new products and material changes
in existing products.
    Appendices to the framework set out more specific analysis of
procyclicality for F&O and CDS products. These analyses are calculated
using several different measures of procyclicality, on both whole
period and stressed period bases, and both taking into account price
change effects and without price change effects, among other factors.
The appendices also detail an ICE Clear Europe approach to back testing
initial margin calculations, both with and without anti-procyclicality
measures under its existing margin policies.
    Pursuant to the framework, ICE Clear Europe will disclose its APC
methodology on its Web site. The framework further provides for ongoing
governance, including the role of the chief risk officer, and review by
the relevant product risk committees and board risk committee, as
appropriate.
(b) Statutory Basis
    ICE Clear Europe believes that the proposed APC framework is
consistent with the requirements of Section 17A of the Act \6\ and the
regulations thereunder applicable to it, including the standards under
Rule 17Ad-22.\7\ Section 17A(b)(3)(F) of the Act \8\ requires, among
other things, that the rules of a clearing agency be designed to
promote the prompt and accurate clearance and settlement of securities
transactions and, to the extent applicable, derivative agreements,
contracts, and transactions, the safeguarding of securities and funds
in the custody or control of the clearing agency or for which it is
responsible, and the protection of investors and the public interest.
The proposed amendments are designed to enhance and formalize the
overall assessment and management of procyclicality in the clearing
house's margin and haircut models, among other matters, consistent with
regulatory requirements under EMIR. The model is thus intended to
strengthen the risk models and procedures already used by the clearing
house, particularly the margin model, and limit on an ongoing basis the
risks of procyclicality for Clearing Members and the clearing house
itself. The framework will also provide greater clarity and
transparency for Clearing Members and others as to the clearing house's
approach to managing procyclicality. As a result, ICE Clear Europe
believes that the proposed changes will promote the prompt and accurate
clearance and settlement of cleared transactions, and in general
protect investors and the public interest, within the meaning of
Section 17A(b)(3)(F).\9\ In addition, the changes are consistent with
the requirements of Rule 17Ad-22(e)(2),\10\ which requires that a
clearing agency have governance arrangements that are clear and
transparent, prioritize the safety and efficiency of the clearing
agency and support the public interest requirements of Section 17A of
the Act applicable to clearing agencies and the objectives of owners
and participants, among other matters. The amendments also generally
strengthen the clearing house's risk management procedures, consistent
with the requirements of Rule 17Ad-22(e)(3) and (6).\11\
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78q-1.
    \7\ 17 CFR 240.17Ad-22.
    \8\ 15 U.S.C. 78q-1(b)(3)(F).
    \9\ 15 U.S.C. 78q-1(b)(3)(F).
    \10\ 17 CFR 240.17Ad-22(e)(2).
    \11\ 17 CFR 240.17Ad-22(e)(3) and (6).
---------------------------------------------------------------------------

(B) Clearing Agency's Statement on Burden on Competition

    ICE Clear Europe does not believe the proposed amendments would
have any impact, or impose any burden, on competition not necessary or
appropriate in furtherance of the purposes of the Act. The proposed
changes are designed to provide additional protections against the
effects of procyclicality by setting forth a methodology to identify
and mitigate such risks, consistent with the requirements of EMIR. As
such, the changes are intended to reduce the potential liquidity burden
for Clearing Members of increases in margin requirements during
stressed scenarios. As a result, ICE Clear Europe does not believe the
changes will adversely affect the cost to clearing members or other
market participants of clearing services. The changes will otherwise
not affect the terms or conditions of any cleared contract or the
standards or requirements for participation in or use of the Clearing
House. The changes should not, in the Clearing House's view, adversely
affect competition among Clearing Members, or the ability of market
participants to access clearing services generally. As a result, ICE
Clear Europe believes that any impact on competition is appropriate in
furtherance of the purposes of the Act.

(C) Clearing Agency's Statement on Comments on the Proposed Rule Change
Received From Members, Participants or Others

    Written comments relating to the proposed changes to the rules have
not been solicited or received. ICE Clear Europe will notify the
Commission of any written comments received by ICE Clear Europe.

III. Date of Effectiveness of the Proposed Rule Change

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period up to 90 days (i) as the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove the proposed rule change or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

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 protected]. Please include
File Number SR-ICEEU-2017-013 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-ICEEU-2017-013 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, security-
based swap submission or advance notice that are filed with the
Commission, and all written communications relating to the proposed
rule change, security-based swap submission or advance notice 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 10:00 a.m. and 3:00 p.m.
Copies of such filings will also be available for inspection and
copying at the principal office of ICE Clear Europe and on ICE Clear
Europe's Web site at https://www.theice.com/notices/Notices.shtml?regulatoryFilings.
    All comments received will be posted without change. Persons
submitting comments are cautioned that we do not redact or edit
personal identifying information from comment submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-ICEEU-2017-013 and should be
submitted on or before November 28, 2017.
---------------------------------------------------------------------------

    \12\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-24130 Filed 11-6-17; 8:45 am]
 BILLING CODE 8011-01-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON D.C., 20460
                                   OFFICE OF
                              CHEMICAL SAFETY AND
                             POLLUTION PREVENTION
                                   OFFICE OF
                              CHEMICAL SAFETY AND
                             POLLUTION PREVENTION

June 28, 2016

MEMORANDUM

SUBJECT: 	Drinking Water Assessment of Flonicamid Use on Legume Vegetables, Citrus and Greenhouse Peppers. PC Code: 128016; DP Barcode: 431454. 433010

TO:		Barbara Madden, Team Leader 05
      Sidney Jackson, Risk Manager Reviewer
		Risk Integration Minor Use, and Emergency Response Branch
      Registration Division

	Richard Gebken, Product Manager 10
	Carmen Rodia, Reviewer
	Invertebrate-Vertebrate Branch 2
	Registration Division

	Christine Olinger, Chief
	Risk Assessment Branch 3
	Health Effects Division

FROM:	Colleen M. Rossmeisl, DVM, Biologist
	James A. Hetrick, Ph.D., Senior Science Advisor
	Environmental Risk Branch 3
	Environmental Fate and Effects Division (7507P)

THROUGH:	Dana Spatz, Branch Chief
      Environmental Risk Branch 3
            Environmental Fate and Effects Division (7507P)

REVIEWED	Rosanna Louie-Juzwiak, RAPL
BY:		Environmental Risk Branch 3
            Environmental Fate and Effects Division (7507P)

IR-4 is seeking the addition of new uses of flonicamid [Beleaf(TM)-50SG Insecticide ( EPA Reg. No. 71512-10) and Flonicamid 50WG (EPA Reg. No. 71512-9)] on legumes, citrus and greenhouse peppers for the control of aphids, leafhoppers, whitefly, and plant bugs. The proposed new use requests ground, aerial, or chemigation spray applications of flonicamid at a maximum seasonal application rate of  0.267 lb a.i./A and a maximum single application rate of 0.181 lb a.i./A. This represents an increase in the current maximum single application rate but does not increase the maximum seasonal rate.

Estimated drinking water concentrations (EDWC) were determined for legumes and citrus with appropriate rates and buffers as specified on the current label. The addition of greenhouse pepper use was not modeled as this represents an indoor use only and calculated EDWCs for legumes and citrus would be more conservative than those predicted for greenhouse peppers. A total toxic residue (TTR) approach, which considers the parent compound and its major degradates of concern previously identified by HED, were considered in this analysis. Tables 1  -  3 provide information on input parameters, application rates modeled and spray drift fractions. EDWCs were derived using the Pesticide in Water Calculator (PWC version 1.52). Based on this analysis, predicted EDWCs do not exceed EDWCs for existing uses of flonicamid in surface water or groundwater, as outlined in the most recent drinking water assessment, dated June 24, 2013, Drinking Water Assessment to Assess Flonicamid Use on Alfalfa and Clover Grown for Seed, Fruiting Vegetables, Mint, Tree Nuts, and the Expansion to the Full Crop Group for Pome Fruit and Stone Fruit. Based on the June 2013 drinking water assessment, the concentration of total toxic residues of flonicamid (flonicamid TTR) in ground water is predicted to not exceed 15.9 ug/L for the daily peak and 9.92 ug/L for the 30 year annual average, which was associated with a single application rate of 0.133 lb a.i./A (2 applications per year) on fruiting vegetables. As these EDWCs are greater than the maximum predicted surface water or groundwater concentrations associated with the proposed new uses, as reported in Tables 4 and 5 below, EFED recommends that HED continue to use the EDWCs provided in the June 2013 drinking water assessment.

Table 1. Proposed New Uses for Flonicamid

                                   Crop/Site

                           Application Type/ Method

                        Single Application Rate Range
                                  (lb a.i./A)

                      Maximum Application Rate Per Season
                                  (lb a.i./A)
                          Maximum Application Number

                      Minimum Retreatment Interval (days)
Legume Vegetables Subgroup
Ground/Aerial/Chemigation[A]
                                     0.133
                                     0.267
                                       2
                                       7
Citrus

                                0.089  -  0.181
                                     0.267
                                       3
                                       7
A Chemigation not modeled

Table 2. Input Parameters Used in PWC Modeling to Estimate Flonicamid and Total Toxic Residues (Flonicamid ,TFNA, TFNG, TFNA-AM, TFNA-OH) Concentrations in Drinking Water
Study Type
Flonicamid
(PC Code:128016)
Total Toxic Residues
Data Source
Molecular Weight
229 g/mole
229 g/mole (parent )
Calculated
Water Solubility
5.3 g/L

5.3 g/L (parent )
Product Chemistry
Vapor Pressure
7.07 x 10[-9] torr

7.07 x 10[-9] torr (mm Hg, parent molecule)
Product Chemistry
Hydrolysis
stable
stable
(parent molecule, no data available for degradation products)
MRID 45656801
Aqueous Photolysis
stable
stable
(parent molecule, no data available for degradation products)
MRID 45656802
Aerobic Soil Metabolism
2.58 days
(90[th] confidence bound on the mean half-life)
4.2 days
 (mean t1/2 + (t90 x s)/n[1/2])

MRID 45854818
MRID 45656804
Aerobic Aquatic Metabolism
 5.16 days
(2X from the aerobic soil metabolism half-life)
55.1 days
(mean t1/2 + (t90 x s)/n[1/2])
 MRID 45854821

Anaerobic Aquatic Metabolism
 482.1 days
(3X anaerobic aquatic metabolism half-life)
stable
MRID 45854821

Mobility
Avg Koc = 19.03
0 mL/g Koc for degradation products because there was no measurable sorption observed in batch equilibrium studies.
MRID 45656805 (parent only)
MRID 45854901
MRID 45854904
MRID 45854902

Table 3. Factors Required for Spray Drift Adjustment
                        Spray Drift Adjustment Factors
                             Spray Drift Fraction

                                    Ground
                                    Aerial
Spray Buffer (ft)
                                      25
                                      150
Streams
                                   0.083[A]
                                    0.0606
Reservoir
                                   0.0227[B]
                                    0.0352
Area of Streams (ha)
                                      0.6
Area of Reservoir (ha)
                                     5.25
                             Adjusted Spray Drift
                                  Fraction[C]
                                    Ground
                                    Aerial
Spray Buffer (ft)
                                      25
                                      150
Index reservoir
                                    0.0321
                                    0.0421

[A] AgDrift spray drift fraction calculated for 25 feet buffer assuming a stream
width of 4 meters (13 ft).
[B] AgDrift spray drift fraction calculated for 150 feet buffer assuming a reservoir
width of 82 meters (269 ft).
[C] Adjusted spray drift fraction calculated as per Guidance on Modeling Offsite Deposition of Pesticides via Spray Drift for Ecological and Drinking Water Assessments December 20, 2013.

Table 4. PCA1 corrected Estimated Drinking Concentrations for Flonicamid and Its Degradation Products (TFNA, TFNG, TFNA-AM, TFNA-OH)  in Surface Source Water Using PWC
                                HED Crop Group
                                     Model
                                   Scenario
                              Application Method
                                 1 in 10 year
                            30 year Annual Average

                                     Peak
                                Annual Average

                                     ug/L
                                    Citrus
                                   FL Citrus
                                 Ground Spray
                                     9.737
                                     1.001
                                    0.42133

                                 Aerial Spray
                                     9.373
                                    0.9646
                                    0.41587

                                   CA Citrus
                                 Ground Spray
                                    0.68341
                                    0.18837
                                    0.12558

                                 Aerial Spray
                                    0.70525
                                    0.20566
                                    0.14742
                                    Legumes
                                   MI beans
                                 Ground Spray
                                    12.285
                                    2.7755
                                     1.456

                                 Aerial Spray
                                    11.921
                                    2.6936
                                    1.4287

                             OR snbeans
                                 Ground Spray
                                    3.0394
                                    0.51051
                                    0.17836

                                 Aerial Spray
                                    2.9848
                                    0.5096
                                    0.19019

                                   IL beans
                                 Ground Spray
                                    7.6895
                                    1.3104
                                    0.63973

                                 Aerial Spray
                                    7.4529
                                    1.2831
                                    0.63336
[1] PCA = 0.91

Table 5. Estimated Drinking Water Concentrations of Total Toxic Residues (Flonicamid, TFNA, TFNG, TFNA-AM, TFNA-OH) in Ground Water Using PWC
                                    Residue
                                   Scenario
                              Peak Concentration
                      Average Breakthrough Concentration
                               Breakthrough Time

                                     ug/L
                                     Days
TTR (Flonicamid + Degradation Products)
                                   FL Citrus
                                     11.37
                                     2.36
                                      713