[Federal Register Volume 82, Number 192 (Thursday, October 5, 2017)]
[Notices]
[Pages 46506-46508]
[FR Doc No: 2017-21438]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0655]

Animal Generic Drug User Fee Act; Public Meeting; Request for
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the forthcoming public meeting entitled ``Animal Generic
Drug User Fee Act.'' The topic to be discussed is proposed
recommendations for the reauthorization of the Animal Generic Drug User
Fee Act (AGDUFA III). The meeting will be open to the public.

DATES: The public meeting will be held on November 2, 2017, from 1 p.m.
to 4 p.m. Submit either electronic or written comments on this public
meeting by November 17, 2017. See the SUPPLEMENTARY INFORMATION section
for registration date and information.

ADDRESSES: The public meeting will be held at 7500 Standish Pl., Rm.
N149 (first floor), Rockville, MD 20855. Free parking is available
onsite. Attendees must provide a valid government issued photo ID
(driver's license, identification card, or passport) to enter the
facility. Entrance for the public meeting participants (non-FDA
employees) is through the front of the building where routine security
check procedures will be performed.
    You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Comments must be submitted on or
before November 17, 2017.\1\ The https://www.regulations.gov electronic
filing system will accept comments until midnight Eastern Time at the
end of November 17, 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.
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    \1\ This date corrects the comment closing date of December 1,
2017, stated in the Federal Register notice announcing the initial
AGDUFA reauthorization public meeting held on May 16, 2016 (81 FR
23311, April 20, 2016).
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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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, 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-2011-N-0655 for ``Animal Generic Drug User Fee Act; Public Meeting;
Request for Comments.'' 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 Dockets Management Staff 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 Dockets Management Staff. 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: https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    In addition to being publicly viewable at https://www.regulations.gov, comments will also be published on https://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/ucm270232.htm.

FOR FURTHER INFORMATION CONTACT: Cassie Ravo, Center for Veterinary
Medicine (HFV-10), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing a public meeting to discuss proposed
recommendations for the reauthorization of AGDUFA, which authorizes FDA
to collect user fees and use them for the process of reviewing new
animal generic drug applications and associated submissions. The
authority for AGDUFA expires September 30, 2018. Without new
legislation, FDA will no longer have the authority to collect user fees
to fund the new animal generic drug review process for future fiscal
years. Section 742(d)(4) of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 379j-22(d)(4)) requires that, after holding
negotiations with regulated industry and periodic consultations with
stakeholders, and before transmitting the Agency's final

recommendation to Congress for the reauthorized program (AGDUFA III),
we do the following: (1) Present the recommendation to the relevant
Congressional committees, (2) publish such recommendations in the
Federal Register, (3) provide for a period of 30 days for the public to
provide written comments on such recommendations, (4) hold a meeting at
which the public may present its views on such recommendations, and (5)
consider such public views and comments and revise such recommendations
as necessary. This notice, the 30-day comment period, and the public
meeting will satisfy certain of these requirements. After the public
meeting, we will revise the draft recommendations as necessary. In
addition, the Agency will present the draft recommendations to the
Congressional committees.
    FDA considers the timely review of abbreviated new animal drug
applications (ANADAs) to be central to the Agency's mission to protect
and promote human and animal health. Prior to 2009, the timeliness and
predictability of the generic new animal drug review program was a
concern. The Animal Generic Drug User Fee Act enacted in 2008 (Pub. L.
110-316; hereinafter referred to as ``AGDUFA I'') amended the FD&C Act
to authorize the FDA's first-ever generic animal drug user fee program.
AGDUFA I provided FDA with additional funds to enhance the performance
and predictability of the generic new animal drug review process.
Furthermore, the authorization of AGDUFA I enabled FDA's continued
assurance that generic new animal drug products are safe and effective.
    Under AGDUFA I, FDA agreed to meet review performance goals for
certain submissions over 5 years from fiscal year (FY) 2009 through FY
2013. The purpose of establishing these review performance goals was to
ensure the timely review of ANADAs and reactivations, supplemental
ANADAs, and generic investigational new animal drug (JINAD)
submissions, and as a result FDA has been able to reduce the time for
the application review process for generic new animal drugs without
compromising the quality of the Agency's review.
    AGDUFA I established increasingly stringent review performance
goals over a 5-year period from FY 2009 through FY 2013. Based on those
performance goals, in the final year of AGDUFA I (FY 2013) FDA agreed
to review and act on 90 percent of the following submission types
within the specified time frames:
     Original ANADAs and reactivations within 270 days after
the submission date.
     Administrative ANADAs within 100 days after the submission
date.
     Manufacturing supplemental ANADAs and reactivations within
270 days after the submission date.
     JINAD study submissions within 270 days after the
submission date.
     JINAD protocol submissions within 100 days after
submission date.
    With the reauthorization of AGDUFA for an additional 5 years under
AGDUFA II (FY 2014 to FY 2018), FDA agreed to further enhance and
improve the review process.
    The AGDUFA II reauthorization enhancements included developing
Question Based Review Process for Bioequivalence Submissions and
shortening review time for key submission types. Additionally, there
were chemistry, manufacturing, and controls (CMC) enhancements,
including: Permitting manufacturing supplements to be resubmitted as
``Supplement-Changes Being Effected in 30 Days'' if deficiencies are
not substantial for manufacturing supplements requiring prior approval
according to 21 CFR 514.8(b); permitting comparability protocols as
described in 21 CFR 514.8(b)(2)(v) to be submitted as protocols without
substantial data in a JINAD file; and developing guidance for a two-
phased CMC technical section submission and review process under the
JINAD file. Finally, the proportion of revenue collected from user fees
was redistributed as follows: Application fees from 30 percent to 25
percent; product fees from 35 percent to 37.5 percent; and sponsor fees
from 35 percent to 37.5 percent.
    FDA has published a number of reports that provide useful
background on AGDUFA I and AGDUFA II. AGDUFA-related Federal Register
notices, guidances, legislation, performance reports, and financial
reports can be found at: https://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/default.htm.

II. Topics for Discussion at the Public Meeting

    In preparing the proposed recommendations to Congress for AGDUFA
reauthorization (AGDUFA III), we have conducted discussions with the
regulated industry, and we have consulted with stakeholders as required
by the law. We began the AGDUFA reauthorization process with a public
meeting held on May 16, 2016 (81 FR 23311, April 20, 2016). Following
the May 2016 public meeting, FDA conducted negotiations with regulated
industry and continued regular consultations with public stakeholders
from August 2016 through January 2017. As directed by Congress, FDA
posted minutes of these discussions on its Web site at https://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/ucm270232.htm. The proposed enhancements from AGDUFA III address many
of the top priorities identified by public stakeholders, the top
concerns identified by regulated industry, and the most important
challenges identified within FDA. The full descriptions of these
proposed recommendations can be found in the proposed AGDUFA III
Performance Goals and Procedures Letter. FDA intends to publish in the
Federal Register the full text of the proposed AGDUFA III Performance
Goals and Procedures Letter and a summary of proposed statutory
changes, as well as post them at https://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/ucm270232.htm, before the
public meeting, and will provide for a period of 30 days for the public
to provide written comments.
    FDA will post the agenda approximately 5 days before the meeting at
https://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/ucm270232.htm.

III. Participating in the Public Meeting

    Registration: To register for the public meeting, please contact
Cassie Ravo (see FOR FURTHER INFORMATION CONTACT). Please provide
complete contact information for each attendee, including name, title,
affiliation, address, email, and telephone. Also, please self-identify
as a member of one of the following stakeholder categories: Scientific
or academic experts; veterinary professionals; patients and consumer
advocacy groups; or the regulated industry, and whether you are
requesting a scheduled presentation.
    Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
meeting must register by October 26, 2017, midnight Eastern Time. Early
registration is recommended because seating is limited; therefore, FDA
may limit the number of participants from each organization.
Registrants will receive confirmation when they have been accepted. If
time and space permit, onsite registration on the day of the public
meeting will be provided beginning at 12:30 p.m. We will let
registrants know if registration closes before the day of the public
meeting.
    If you need special accommodations due to a disability, please
contact Cassie

Ravo (see FOR FURTHER INFORMATION CONTACT) no later than October 26,
2017.
    Requests for Oral Presentations: When registering, you may indicate
if you wish to present during a public comment session or participate
in a specific session, and which topic(s) you wish to address. We will
do our best to accommodate requests to make public comments.
Individuals and organizations with common interests are urged to
consolidate or coordinate their presentations, and request time for a
joint presentation, or submit requests for designated representatives
to participate in the focused sessions. Following the close of
registration, we will determine the amount of time allotted to each
presenter and the approximate time each oral presentation is to begin,
and will select and notify participants by October 27, 2017. All
requests to make oral presentations must be received by the close of
registration on October 26, 2017. If selected for presentation, any
presentation materials must be emailed to Cassie Ravo (see FOR FURTHER
INFORMATION CONTACT) no later than October 31, 2017. No commercial or
promotional material will be permitted to be presented or distributed
at the public meeting.
    Streaming Webcast of the Public Meeting: This public meeting will
also be webcast.
    Event: AGDUFA III Public Meeting. Event address for attendees:
https://fda.webex.com/fda/onstage/g.php?MTID=ec1c356734bcf010b59e0b885726ccad0. Date and time: Thursday,
November 2, 2017, 1 p.m. Eastern Daylight Time (New York, GMT-4).
Duration: 3 hours. Event number: 817 527 611. Event password: 110217.
Teleconference: Provide your number when you join the event to receive
a call back. (1) Call one of the following numbers: Local: 1-301-796-
7777; toll free: 1-855-828-1770. (2) Follow the instructions that you
hear on the phone. Cisco Unified MeetingPlace meeting ID: 817 527 611.
    FDA has verified the Web site addresses in this document, as of the
date this document publishes in the Federal Register, but Web sites are
subject to change over time.
    Transcripts: Please be advised that as soon as a transcript of the
public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript will also be available on the
internet at https://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/ucm270232.htm.

    Dated: September 29, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-21438 Filed 10-4-17; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 91 (Monday, May 12, 2014)]
[Rules and Regulations]
[Pages 26843-26846]
[FR Doc No: 2014-10753]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2014-0134]
RIN 1625-AA00

Safety Zone; Sabine River, Orange, TX

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone on the
navigable waters of the Sabine River in Orange, TX in support of Deep
South Racing Association (DSRA) boat races. This temporary safety zone
is necessary to protect the surrounding public and vessels from the
hazards associated with a boat race competition. Persons and vessels
are prohibited from entering into, transiting through, or anchoring
within this safety zone unless authorized by the COTP or his designated
representative.

DATES: This rule is effective May 31, 2014 through June 1, 2014. This
rule will be enforced from 8:30 a.m. until 6:00 p.m. on May 31, 2014,
and from 8:30 a.m. until 6:00 p.m. on June 1, 2014.

ADDRESSES: Documents mentioned in this preamble are part of docket
[USCG-2014-0134]. To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type the
docket number 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.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Mr. Scott Whalen, U.S. Coast Guard MSU Port Arthur, (409)
719-5086 or email<EMAIL_ADDRESS>If you have questions on
viewing or submitting material to the docket, call Cheryl Collins,
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. Regulatory History and Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule. The Coast Guard received notice on March 3,
2014 that this event is planned to take place May 31 and June 1, 2014.
This is the first time this event has taken place in Orange, TX, and
upon full review of the event details, the Coast Guard determined that
additional safety measures are necessary.
    Completing the full NPRM process would be impracticable, delaying
the effective date for this safety zone. Immediate action is necessary
to protect event participants and members of the public from hazards
associated with high speed boat races on the waterway. This event is
advertised and the local community has planned for this event. Delaying
the safety zone may also unnecessarily interfere with the planned event
and possible contractual obligations.
    For the same reasons, under 5 U.S.C. 553(d)(3), the Coast Guard
finds that good cause exists for making this rule effective less than
30 days after publication in the Federal Register. Providing a full 30
days notice and delaying the effective date for this safety zone would
be impracticable because immediate action is necessary to protect event
participants and members of the public from the hazards present during
a personal watercraft race competition.
    The Coast Guard will notify the public and maritime community that
the safety zone will be in effect and of its enforcement periods via
broadcast notices to mariners (BNM) and will be published in the Local
Notice to Mariners (LNM).

B. Basis and Purpose

    The Deep South Racing Association (DSRA) is holding a two day
watercraft race competition on the Sabine River in Orange, TX on May 31
and June 1, 2014. This event poses a hazard to life and property as it
involves high speed watercraft racing in a narrow waterway frequented
by other commercial and recreational vessel traffic. Additionally, the
race event is likely to attract spectator craft to the area. The Coast
Guard determined that a temporary safety zone is needed to protect
spectators as well as persons participating in the event. The legal
basis and authorities for this rulemaking establishing a safety zone
are found in 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, and 160.5; Pub. L. 107-
295, 116 Stat. 2064; and Department of Homeland Security Delegation No.
0170.1, which collectively authorize the Coast Guard to establish and
define regulatory safety zones. A safety zone is necessary to protect
vessels and mariners from the hazards associated with this high speed
boat race on the waterway.

C. Discussion of the Temporary Final Rule

    The Coast Guard is establishing a temporary safety zone
encompassing all waters of the Sabine River, shoreline to shoreline,
adjacent to the Naval Reserve Unit and the Orange public boat ramps
located in Orange, TX. The northern boundary is from the end of Navy
Pier One at 30[deg]05'45'' N 93[deg]43'24'' W then easterly to the
rivers eastern shore. The southern boundary is a line shoreline to
shoreline at latitude 30[deg]05'33'' N (NAD83).
    This safety zone is needed to protect mariners and event
participants from hazards associated with high speed boat races. No
person or vessel may enter into or remain in the zone without
permission of the Captain of the Port.

D. Regulatory Analyses

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

1. Regulatory Planning and Review

    This 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 Coast Guard has determined that this rule is not a significant
regulatory action for the following reasons: (1) The rule will be
enforced for 9.5 hours each day for two days; (2) scheduled breaks will
be provided to allow waiting vessels to transit safely through the
affected area; (3) persons and vessels may enter, transit through,
anchor in, or remain within the regulated area if they obtain
permission from the COTP or the designated representative; and (4)
advance notification will be made to the maritime community via
broadcast notice to mariners (BNM) and Local Notice to Mariners (LNM).
Therefore, the Coast Guard enforcement of this safety zone is not a
significant regulatory action.

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. This rule may affect the following entities, some of which
might be small entities: the owners or operators of vessels intending
to transit through or remain in the safety zone area. The Coast Guard
certifies under 5 U.S.C. 605(b) that this rule will not have a
significant economic impact on a substantial number of small entities
for the following reasons: (1) This rule will only be enforced from
8:30 a.m. until 6 p.m. each day that it is effective; (2) during non-
enforcement hours all vessels will be allowed to transit through the
safety zone without having to obtain permission from the Captain of the
Port, Port Arthur or a designated representative; and (3) vessels will
be allowed to pass through the zone with permission of the Coast Guard
Patrol Commander during scheduled break periods between races and at
other times when permitted by the Coast Guard Patrol Commander.

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 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.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to

the Small Business and Agriculture Regulatory Enforcement Ombudsman and
the Regional Small Business Regulatory Fairness Boards. The Ombudsman
evaluates these actions annually and rates each agency's responsiveness
to small business. If you wish to comment on actions by employees of
the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard
will not retaliate against small entities that question or complain
about this rule or any policy or action of the Coast Guard.

4. Collection of Information

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

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 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 rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

8. Taking of Private Property

    This rule will 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 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

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

11. Indian Tribal Governments

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

12. Energy Effects

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

14. Environment

    We have analyzed this 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 determined
that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule involves a safety zone established for the
protection of spectators from the hazards associated with a personal
watercraft race competition. This rule is categorically excluded from
further review under paragraph 34(g) of Figure 2-1 of the Commandant
Instruction. A checklist and categorical exclusion determination will
be provided in the docket accessible as indicated under ADDRESSES.

List of Subjects in 33 CFR Part 165

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

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

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority:  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. A new temporary section Sec.  165.T08-0134 is added to read as
follows:

Sec.  165.T08-0134  Safety Zone; Sabine River, Orange, TX.

    (a) Location. The following area is a safety zone: all waters of
the Sabine River, shoreline to shoreline, adjacent to the Naval Reserve
Unit and the Orange public boat ramps located in Orange, TX. The
northern boundary is from the end of Navy Pier One at 30[deg]05'45'' N
93[deg]43'24'' W then easterly to the rivers eastern shore. The
southern boundary is a line shoreline to shoreline at latitude
30[deg]05'33'' N (NAD83).
    (b) Effective dates and enforcement times. This rule is effective
on May 31, 2014 and on June 1, 2014. This rule will be enforced from
8:30 a.m. until 6:00 p.m. on May 31, 2014, and from 8:30 a.m. until
6:00 p.m. on June 1, 2014.
    (c) Regulations. (1) In accordance with the general regulations in
Sec.  165.23, no person or vessel may enter into or remain in the zone
without permission of the Captain of the Port.
    (2) Persons or vessels requiring entry into or passage through the
zone may contact the Captain of the Port, Port Arthur, or a designated
representative. They may be contacted on VHF-FM Channels 16, or by
phone at<PHONE_NUMBER>.
    (3) All persons and vessels shall comply with the instructions of
the Captain of the Port, Port Arthur and designated on-scene U.S. Coast
Guard patrol personnel. On-scene U.S. Coast Guard patrol personnel
include commissioned, warrant, and petty officers of the U.S. Coast
Guard.
    (d) Information Broadcasts. The Captain of the Port, Port Arthur or
a designated representative will inform the public through broadcast
notices to mariners of the enforcement period for the safety zone as
well as any changes in the planned schedule.

    Dated: April 9, 2014.
G.J. Paitl,
Captain, U.S. Coast Guard, Captain of the Port, Port Arthur.
[FR Doc. 2014-10753 Filed 5-9-14; 8:45 am]
BILLING CODE 9110-04-P


Slide 1 of 75 Preliminary N Methyl Carbamate Cumulative Risk Assessment Preliminary N Methyl Carbamate Cumulative Risk Assessment FIFRA Scientific Advisory Panel August 23 26, 2005 FIFRA Scientific Advisory Panel August 23 26, 2005  Session 1 ° Public Comments ° Hazard Assessment  Session 2 ° Drinking Water Exposure Assessment  Session 3 ° Food & Residential Exposure Assessment  Session 4 ° Model Results Comparison, Cumulative (

Multipathway Analysis, & Risk Characterization Sessions Roadmap Slide 2 of 75 Slide 3 of 75 Session 3b Preliminary N Methyl Carbamate Cumulative Risk Assessment:

Residential Assessment Session 3b Preliminary N Methyl Carbamate Cumulative Risk Assessment:

Residential Assessment Health Effects Division Office of Pesticide Programs Health Effects Division Office of Pesticide Programs  Residential Exposure Inputs ° Jeff Evans & Dana Vogel  Distributional Analysis ° Philip Villanueva  Residential Pesticide Use Data ° Steve Nako Session 3b Roadmap Slide 4 of 75 Slide 5 of 75 Session 3b Preliminary N Methyl Carbamate Cumulative Risk Assessment:

Residential Exposure Inputs Session 3b Preliminary N Methyl Carbamate Cumulative Risk Assessment:

Residential Exposure Inputs Jeff Evans & Dana Vogel Health Effects Division Office of Pesticide Programs Jeff Evans & Dana Vogel Health Effects Division Office of Pesticide Programs Slide 6 of 75 Overview  Residential Inputs ° Discuss overview of the residential assessment and a discussion of the model inputs for the hand to mouth exposure pathway ° Jeff Evans & Dana Vogel  Distributional Analysis ° Philip Villanueva  Pesticide Use Data ° Residential Exposure Joint Venture ( REJV)

Survey ° Steve Nako Slide 7 of 75 Introduction  Incorporation of SAP Comments  Scenarios  Routes  Data Categories ° Non Dietary Ingestion  Hand to mouth behavior Slide 8 of 75 Incorporation of SAP Comments from NMC CRA Case Study  Added two scenarios ° Separated fruit trees from ornamentals ° Golf course scenario added  Reconsidered overhead and below waist exposure patterns based on data measuring exposure while making applications to vegetables, ornamentals and fruit trees ° Data evaluated used accounts for overhead and below waist applications for hose end sprayers and hand wand sprayers ° Used data resulting in the highest unit exposures for each scenario ( hand wand) Slide 9 of 75 Incorporation of SAP Comments from NMC CRA Case Study  Increased Use of Distributional Analysis ° Appendix II. E. 2 contains description of studies used and explanation of distributional analysis  Considered soil ingestion contribution to overall oral nondietary exposure ° Provided an approach for inclusion of professional applications Slide 10 of 75 Future Plans  Continue to conduct sensitivity analysis for selected parameters and distributions  Investigate additional data sources to better assess timing of exposure  Further investigate the use patterns and application schedule information used in residential assessment  Further investigate co occurrence issues  Continued development of nonstandard residential scenarios such as track in  Continue to evaluate alternative methods to assess oral non dietary exposures ( Hand to Mouth)

° Participate in September ORD workshop  Continue to develop residential assessments using CARES   , LIFELINE   and SHEDs Slide 11 of 75 Stochastic Human Exposure and Dose Simulation Model ( SHEDS)

Developed by ORD and was used by the Agency to assess exposure to treated wood.

° Valerie Zartarian, Jianping Xue, Haluk Ozkaynak

Originally designed to utilize micro activity data such as hand to mouth frequencies ° Micro activity modeling is difficult and time consuming

The SHEDS modelers now rely on the macro activity approach

However, they were able to address some of the hand

tomouth modeling issues we have encountered ° Also noted the problem of fixed upper percentile values for long exposure durations ° Enables inter and intra person variability for hand to mouth frequencies ° You can change the hand to mouth frequencies for each hour ° Hands are not necessarily replenished with residues between hand to mouth contacts Slide 12 of 75 Scope of Regional Assessment Slide 13 of 75 Residential Scenarios

Lawn Care ° Carbaryl  Applicator and post application

Vegetable Gardens ° Carbaryl  Applicator and post application

Fruit Trees ° Carbaryl  Applicator and post application

Ornamentals ° Carbaryl and Methiocarb  Applicator  Post application for carbaryl uses

Indoor Crack and Crevice ° Propoxur  Applicator and post application

Pet Collars ° Carbaryl and Propoxur  Post application

Golf Course ° Carbaryl  Post application Slide 14 of 75 Exposure Routes/ Scenarios  Non Dietary Ingestion ( Children: 1 2, 3 5)

° Lawn Care ° Crack and Crevice ° Pet Collars  Inhalation ( Adults, Youths, Children: 1 2, 3 5)

° Lawn Care ° Vegetable Gardens, Fruit Trees, and Ornamentals ° Crack and Crevice Slide 15 of 75 Exposure Routes/ Scenarios  Dermal ( Adults and Youths: Applicator and Post Application)

( Children 1 2, 3 5: Post Application)

° Lawn Care ° Vegetable Gardens, Fruit Trees, and Ornamentals ° Crack and Crevice ° Pet Collars ( post application only)

° Golf Course ( post application only) Slide 16 of 75 Data Categories  Pesticide Use Data  Unit Exposure Data  Residue Concentration Data  Exposure Contact Factors Data Slide 17 of 75 Pesticide Use Data  Percent of Household Use and Timing of Application ° Data presented in the Residential Exposure Joint Venture ( REJV) survey ° Label Information ° State Extension Service Recommendations on timing of pesticide applications based on the appearance of pests by region  Co occurrence ° Assumed independence ° Sensitivity analysis performed for alternative approach Slide 18 of 75 Applicator Exposure Data  Unit Exposure ° ORETF and chemical specific studies used ° Surrogate data used for ornamental snail bait scenario Slide 19 of 75 Residue Concentration Data  Relied on chemical specific residue dissipation data  Residue data are based on the maximum rate Slide 20 of 75 Residue Concentration Data  Leaf foliage residue data ° Liquid TTR used in absence of granular data for lawn care scenarios ° Deposition data following crack and crevice treatments ° Air concentrations following crack and crevice treatments ° Pet fur residue data Slide 21 of 75 Exposure Contact Factors  Duration of Exposure  Area Treated ° e. g., lawn sizes, garden sizes  Breathing Rates Slide 22 of 75 Exposure Contact Factors  Post Application Contact ° Dermal Exposure  Transfer factors ° Hand to Mouth Exposure  Frequency of contacts  Surface area mouthed  Saliva extraction factor  Non dietary ingestion via hand

tomouth behavior has been discussed at several SAPs Slide 23 of 75 Hand to Mouth Contact Factors Previous Assumptions  Based on discussions at August 1999 SAP ° 20 cm2 surface area of hand mouthed  Palmer surface area of 3 fingers ( 4 year old)

° 20 hand to mouth events per hour  90th percentile from videography data collected and analyzed by Reed et. al., 1999  Considered removal by saliva  Assumed complete replenishment of hands between events Slide 24 of 75 What We Used in the Case Study  Hand to mouth Frequency ° Triangular Distribution ( Reed, 1999)

 Range from 0 to 26 events per hour  Mean 9.5  Surface area of the hand ( fingers)

° Uniform Distribution  0   20 cm2 per event Slide 25 of 75 Considered Additional Data to Address this Pathway  Available Micro Activity Data and their Applicability to Aggregate Exposure Modeling ° Valerie Zartarian's SRA Presentation, Dec. 2003 ° Analyzed hand to mouth data based on six studies

Including Reed ° Relied on observational data using video tape analysis, trained observers, or parental observers ° All hand contacts were recorded as hand to mouth events, regardless of the fraction of hand mouthed ° One study ( Letkie) was used to estimate the percent area of hand mouthed Available Micro Activity Data and their Applicability to Aggregate Exposure Modeling ( Zartarian et al. , December 2003) These data were used to enumerate area of hand mouthed;

Median: 2.3 hand to mouth contacts/ hour; mean: 7.3 contacts/ hour 33 34 hours of children " in view"

Video observations of suburban children ages 1 to 6 years of age.

Letkie et al., 2000 Mean = 9.5 events/ hr.

Single day videos ( 6, 7, 8, 10 waking hours)

4 Latino children in agricultural area in California Zartarian et al., 1998 Mean hand to mouth frequency 9.5 contacts per hour A total of 20 day care ( 3 6 yrs)

and 10 at home ( 2 5 years)

30 urban children living in Newark, NJ Reed et al., 1999 Median 3.5 hand to mouth contacts/ hour, 3 4 years Median 2.5 contacts/ hour, 5 6 Four hour videotaped observations ages 3 to 6 years living in Minnesota 19 children Freeman et al., 2001 Mean   16 hand to mouth contacts per hour No video tape ( parental and trained observers).

Observations for more than one day were available for 78%

of the children".

ages 11 to 60 months 72 urban Washington State children Tulve et al., 2002 indoors 13.5/ hour and 4.9/ hour outdoors Four hour videotaped observations 13 infants; 12, one year olds;

18 two year olds; 9 preschool)

living in the vicinity of Rio Bravo,

Texas 52 children in Laredo, TX Black et al., 2003 Median frequency/ Other Information Videotape time Description No. Subjects Author Slide 26 of 75 Slide 27 of 75 What We Used In The Preliminary Assessment  Increased the potential area of the hand that can be mouthed ( Letkie)

° Begin with surface area of 200 cm2 ° Multiply times percent area mouthed  Beta distribution  Mean: 0.13 ( std 0.06)

 99th % ile: 0.3  Increased hand to mouth frequency ° Weibull:

 Mean: 12.5 events/ hr ( std 16.4)

 90th % ile: 27.8  99th % ile: 84.8 Slide 28 of 75 Uncertainties in Modeling Hand to Mouth Exposure  Assumes residue replenishment between each hand to mouth event  Fixed values for exposure duration ° Up to 8 hours indoors ° Surface area ° Frequency  Fixed upper percentiles for long durations has the potential to create unrealistic exposure estimates Slide 29 of 75 Conclusions  Added two scenarios  Used REJV Survey information  Performed distributional analysis  Updated our hand to mouth exposure algorithm to include all of the currently available data ° Zartarian, 2003  Continuing our sensitivity analysis and other items discussed in our future plans ° e. g., SHEDs, co occurrence  Residential Exposure Inputs ° Jeff Evans & Dana Vogel  Distributional Analysis ° Philip Villanueva  Residential Pesticide Use Data ° Steve Nako Session 3b Roadmap Slide 30 of 75 Slide 31 of 75 Session 3b Preliminary N Methyl Carbamate Cumulative Risk Assessment:

Distributional Analysis Session 3b Preliminary N Methyl Carbamate Cumulative Risk Assessment:

Distributional Analysis Philip Villanueva Health Effects Division Office of Pesticide Programs Philip Villanueva Health Effects Division Office of Pesticide Programs Slide 32 of 75 Outline  Previous SAP Recommendations  Types of Data Sets  Lognormal Distributions and Assessing Fit  Censored Data Sets  Uniform Distributions/ Sensitivity Analyses  Truncation/ Sensitivity Analyses Slide 33 of 75 SAP Recommendations  The previous SAP recommended that distributions other than uniform and triangular be explored for residential input variables, and that distribution selection procedures be more fully explained ° OPP fitted lognormal distributions to several input datasets and assessed the appropriateness of the selected distributions ° OPP continues to use uniform distributions for certain input data Slide 34 of 75 Appendix II. E. 2 Objectives  Residential Exposure Scenarios Appendix ° Provide study summaries ° Describe estimation of residue decline data characteristics

Initial concentration and half life ° Describe lognormal distributions fitted to residential input datasets

Parametric estimates of mean and SD ° Assess the goodness of fit of the distributions

Probability plots and Shapiro Wilk test statistic Slide 35 of 75 Types of Datasets  Robust datasets ° Unit exposures and transfer coefficients for specific activities ° More amenable to statistically rigorous approach ° Potential for refining distribution selection  Sparse datasets ° Lawn sizes, area treated, duration of exposure,

and saliva extraction factors ° Difficult to characterize/ imperfect knowledge ° Important to perform sensitivity analyses Slide 36 of 75 Lognormal Distributions  Many types of environmental data are reasonably approximated by lognormal distributions ° Lognormal distribution selected as default for this assessment  Probability plots and test statistics were used to assess whether or not lognormality assumptions were reasonable ° Normal probability plots of log transformed data ° Shapiro Wilk normality test statistics of log transformed data Slide 37 of 75 Probability Plots  Probability plots provide ° Qualitative approach to assessing the goodness of fit of a particular distribution ° Comparison of empirical and parametrically estimated percentiles  If the probability plot is linear, this suggests that the data is reasonably approximated by the specified distribution Probability Plots  Example: dermal unit exposure ( mg/ lb ai handled) values for hose end sprayer on turf  Linear relationship indicates the data is reasonably approximated by a lognormal distribution ln_

OMA004_

SSSP 4 5 6 7 8 9 10 11 12 13 .01 .05 .10 .25 .50 .75 .90 .95 .99  3  2  1 0 1 2 3 Normal Quantile Slide 38 of 75 Slide 39 of 75 Normality Test Statistic  Shapiro Wilk statistic ( W) tests if an assumption of ( log) normality is reasonable given the observed data ° Used to assess the goodness of fit of normal ( or lognormal) distribution to sample  Values close to one indicate that there is no evidence to reject the assumption of normality ( or lognormality) Shapiro Wilk and Probability Plots  Example: dermal unit exposure values for hose end sprayer on turf ° W = 0.96, p value = 0.36  P value > 0.05 indicates that lognormal assumption should not be rejected  Assessment of probability plot agrees with Shapiro Wilk ln_

OMA004_

SSSP 4 5 6 7 8 9 10 11 12 13 .01 .05 .10 .25 .50 .75 .90 .95 .99  3  2  1 0 1 2 3 Normal Quantile Slide 40 of 75 CDF Comparison  Dermal unit exposure values for hose end sprayer on turf 0%

10% 20% 30% 40% 50% 60% 70% 80% 90%

100% 0.0 0.1 1.0 10.0 100.0 Dermal Unit Exposure ( mg/ lb ai)

Fitted Lognormal CDF Empirical CDF Slide 41 of 75 Slide 42 of 75 Censored Datasets  Some exposure values were below the limit of quantitation ( LOQ) resulting in censored datasets  Censored data are generally reported as ½ LOQ Censored Datasets  Probability plots are useful for identifying significant censoring of data  Example: inhalation unit exposure ( mg/ lb ai handled) values for trigger pump sprayer ln_

RTU_

gard_

inh 3 4 5 6 .01 .05 .10 .25 .50 .75 .90 .95 .99  3  2  1 0 1 2 3 Normal Quantile Slide 43 of 75 Slide 44 of 75 Maximum Likelihood Estimation  Imputing ½ LOD for censored data can bias parameter estimates of the distribution  Maximum likelihood estimation ( MLE)

was used to estimate the lognormal parameters for censored datasets  Example: inhalation unit exposure values for trigger pump sprayer ° MLE: mean = 0.10, std = 0.14 ° ½ LOD: mean = 0.10, std = 0.10 Probability Plot Comparison  Example: inhalation unit exposure values for trigger pump sprayer ln_

RTU_

gard_

inh_

MLE 2.5 3 3.5 4 4.5 5 5.5 6 .01 .05.10 .25 .50 .75 .90 .95 .99  3  2  1 0 1 2 3 Normal Quantile ln_

RTU_

gard_

inh 3 4 5 6 .01 .05.10 .25 .50 .75 .90.95 .99  3  2  1 0 1 2 3 Normal Quantile Slide 45 of 75 Slide 46 of 75 Uniform Distributions  Uniform distributions continue to be used when ° General idea of expected range of data, but unable to determine which values within the range are more likely to occur than others ° Data is combined from multiple activities Slide 47 of 75 Uniform Distributions  Higher percentiles of exposure have been more sensitive to range of the input data rather than central estimates  OPP will continue to perform sensitivity analyses to determine the extent to which the selected ranges affect exposure estimates Slide 48 of 75 Truncation of Datasets  For distributions other than uniform ° Professional judgment was used to determine the percentile at which to truncate ° Generally the 99th percentile of the fitted distribution was used as the truncation point  Sensitivity analyses will continue to determine the extent to which truncation affects exposure estimates Slide 49 of 75 Future Activities  Explore the use of alternative distribution for residential input data as recommended by the SAP  Perform sensitivity analyses to determine the extent to which ranges of input data and truncation affect estimates of exposure  Residential Exposure Inputs ° Jeff Evans & Dana Vogel  Distributional Analysis ° Philip Villanueva  Residential Pesticide Use Data ° Steve Nako Session 3b Roadmap Slide 50 of 75 Slide 51 of 75 Session 3b Preliminary N Methyl Carbamate Cumulative Risk Assessment:

Residential Pesticide Use Data Session 3b Preliminary N Methyl Carbamate Cumulative Risk Assessment:

Residential Pesticide Use Data Steve Nako, Ph. D.

Health Effects Division Office of Pesticide Programs Steve Nako, Ph. D.

Health Effects Division Office of Pesticide Programs Slide 52 of 75 Background Information on Residential Use Inputs  Derived from Residential Exposure Joint Venture ( REJV)

Survey Data 1. Background of REJV Survey 2. Approach for Compiling REJV Residential Use Inputs 3. Notes Regarding Using REJV Data Slide 53 of 75 1. Background of the REJV Survey  NFO Panel Demographics ° Volunteer panel members ° Black and Hispanic populations are underrepresented  Screening Survey ° Approx. 76% of Respondents Apply Pesticides ° Recruited only ` Willing Users' to Maintain Diaries  Inventory & Application Diaries ° Study period, May 2001   April 2002 ° 1,217 households recorded 12 month diaries ` Valid' Applications defined as applications using products that were listed in that household's Inventory and/ or having reported label names and sites consistent with residential uses.

Participation is defined as the latest month in which a valid application was reported.

Therefore, all 1217 households reported at least one valid application in April 2002. Slide 54 of 75 Avg  All Households Avg  12 Month Households Slide 55 of 75 Slide 56 of 75 1. Background of REJV Survey  REJV Data ` Standardization'

° Logical inconsistencies, Missing Values, Completeness ( no reported use, Professional Applicators)

° All Data Provided   Transparency REJV Residential Use Profile Trees Garden Ornamentals Slide 57 of 75 Slide 58 of 75 2. Approach for Compiling REJV Residential Use Inputs  Appendix II. E. 1  Current versions of probabilistic models require pesticide use inputs to generate residential use patterns  General approach:

° Develop residential use inputs so models mimic 12 month diaries ° Sensitivity analysis to address data uncertainties Slide 59 of 75 3. Notes Regarding Use of REJV Data  Models require different inputs ° Table II. E. 1 3, Appendix II. E. 1, p. 9  Inputs depend upon modeling options used  Difficult to evaluate modeled use patterns  Counts ( N) provided for all tabulations  Residential Use Inputs based only on REJV data ° Appendix II. E. 1 ° Some estimates modified to reflect other information regarding homeowner use of NMC products Slide 60 of 75 Summary

The REJV data contains comprehensive information on the timing of application for many residential products/ uses

NMC Cumulative Risk Assessment used REJV based regional pesticide use inputs to model residential use in Calendex

Sensitivity analyses to see how changes in use inputs affect estimated exposure

Future work:

° Comparing REJV with other use data to evaluate representativeness and data uncertainties ° Developing CARES   and LifeLine   inputs based on recent REJV data*

* US EPA Pesticide Use Data Available

NHGPUS, C\ CPAS Slide 61 of 75 Session 3b Preliminary Cumulative Residential Assessment:

Questions to the Panel Session 3b Preliminary Cumulative Residential Assessment:

Questions to the Panel Health Effects Division Office of Pesticide Programs Health Effects Division Office of Pesticide Programs Slide 62 of 75 Residential Question # 1

Use of REJV Data and Professional Judgment ° To generate estimates of exposure from residential use of NMC pesticides, the probabilistic models use a variety of inputs to address potential exposure from multiple use scenarios. Critical inputs include the percent of households applying the various pesticide products, and the timing of those applications. These two inputs,

coupled with potential exposure from pesticide residues in drinking water and the diet, directly impact per capita estimates of cumulative exposure. In its February Case Study, the Agency presented background information on the Residential Exposure Joint Venture ( REJV) survey.

The Agency used this database as the primary source for data on the inputs relating to timing of applications and percent of households using NMC products. Details regarding the empirical details of the REJV survey are presented in Appendix II. E. 1. Slide 63 of 75 Residential Question # 1

Use of REJV Data and Professional Judgment ° As previously mentioned, the REJV survey can be used to generate empirically based estimates of percent of household use and the frequency of product specific applications. But, because the REJV did not collect information regarding the reason for the reported pesticide use ( pest treated) or how much of the product was used, the empirical timing and frequency information ( based on a national survey) may not provide a clear picture of regional use. Therefore, to establish the timing of pesticide applications for the scenarios likely to result in the highest exposure, OPP made these estimates based on a combination of REJV data, product label information, professional judgment, and pest pressure information available from the Cooperative State Extension Services. Specific examples of how these sources were used to determine timing and frequency of pesticide use for PNMC residential assessment are presented in Section E of the preliminary NMC CRA document. Slide 64 of 75 Residential Question # 1 R1. Please comment on the use of information sources other than REJV to establish periods of pesticide use and other use/ usage information. Does the Panel suggest an alternative method to improve the use of REJV in the NMC assessment? Does the Panel know of other data sources that may be available? Slide 65 of 75 Residential Question # 2  Uncertainties Associated with the Hand To Mouth Assessment ° To assess non dietary ingestion ( mg/ day), the following four key factors are used in the models:

 Residue Concentration ( turf residues, pet fur residues, and residues from hard indoor surfaces)

 Hand to mouth frequency ( number of events per hour)

 Surface area of the inserted hand parts ( cm2)

 Exposure time ( hours/ day)

° Other factors include both saliva extraction efficiency and wet hand adjustment factor. This exposure estimate is then used along with the Relative Potency Factor ( RPF) and Benchmark Dose to estimate risk. In the Preliminary N methyl carbamate assessment,

risk estimates for non dietary oral exposure result in the lowest Margins of Exposure ( MOEs), and would therefore be of greatest concern to the Agency; however, these low MOEs appear to be due in part to the incorporation of micro activity data into our macro activity models. As a result, the non dietary ingestion scenarios in the Preliminary N methyl carbamate cumulative risk assessment are the least refined. Slide 66 of 75 Residential Question # 2

Uncertainties Associated with the Hand To Mouth Assessment ° The residue concentration values are derived from individual residue dissipation or deposition studies which are discussed in the Residential Chapter ( Section E) of the Cumulative Risk Assessment document. The exposure durations are taken from the Agency's Exposure Factors Handbook. The hand to mouth frequencies and hand surface areas come from behavior studies relying either on observational data of young children using video tape analysis, trained observers, or parental observers. However, study data that evaluated hand to mouth frequency and surface area mouthed is difficult to interpret. Specifically,

comparison of study results can be difficult due to differences in study practices and methodologies. For example, there are no standard definitions of mouthing ( superficial contact, licking, biting, fraction of hand inserted) and thus the data for these behaviors likely differs among studies as a result of the investigators definitions. In addition, the degree to which ancillary data ( such as surface area of hand contacted or inserted, the duration of contact, and the length of videotaping) are collected and reported differ among studies. This makes broad based and generally applicable interpretation difficult. Nevertheless, Drs.

Zartarian and Xue allowed us to use their preliminary distributional analyses of these children's video data in this assessment. The studies used in the hand to mouth frequency analysis performed by Zartarian and Xue are briefly summarized in a table provided in a memorandum dated August 8, 2005 and provided to the Panel under separate cover. Slide 67 of 75 Residential Question # 2

Uncertainties Associated with the Hand To Mouth Assessment ° The distributions of hand to mouth frequencies and surface area mouthed used in the Preliminary NMC CRA were based on the analysis performed by Zartarian and Xue ( as detailed above). In the aggregate models used in the NMC cumulative assessment, each separate iteration selects a single value for the hand to mouth events variable from a distribution of hand to mouth frequency values. Also, each separate iteration of the model selects a single surface area from a distribution of the fraction of hand mouthed. These values are multiplied by the residues and exposure durations which are similarly selected from a distribution of residue and exposure durations as described above. This relatively simple selection process, however,

ignores the numerous complexities and interrelationships involved in this critical behavior pattern. ( For example, the fraction of a hand which is mouthed during each mouthing event may be inversely correlated with the frequency with which the hand is mouthed. Specifically, a high frequency of hand to mouth events may be associated with a smaller fraction of the hand which is mouthed. The algorithms used in the NMC CRA however, ( as established by the OPP Residential Standard Operating Procedures ( SOP's)) assume independence between these two parameters. This assumption likely leads to overestimates of exposures when upper percentiles of the hand to mouth frequency and area of hand mouthed distributions are combined. In addition, the macroactivity approach used in the NMC CRA aggregate models is based on the following assumptions:

The mouthing frequency ( events per hour), as recorded during the course of observational studies, continues at the same rate for the entire exposure duration selected; in reality, a highend mouthing frequency recorded over a short time interval ( e. g., one hour) may be unlikely to continue at the same intensity over a longer time period ( e. g., 6 or 8 hours)

The hand is fully replenished with residues from a contaminated surface ( e. g., the lawn, pet or hard flooring) between each hand to mouth event

The contact frequency and surface area data used in this assessment are taken from observational studies in which all hand contacts were recorded as hand to mouth events,

regardless of the fraction of hand mouthed. Additionally, no adjustment was made for the duration of time the hand remained in the mouth. Slide 68 of 75 Residential Question # 2 R2a. The methodology used in the NMC CRA in which micro activity data are used in macro activity approach likely leads to systematic overestimates of exposure when upper percentiles of mouthing frequency and surface area of hand mouthed are combined. Does the Panel agree that this methodology does indeed overestimate exposure? Can the Panel suggest improvements to this methodology to further refine exposure estimates? Slide 69 of 75 Residential Question # 2 R2b. Does the Panel have suggestions for an alternative approach to the one used to estimate the nondietary oral exposure pathway in the Preliminary NMC CRA? For example, would the use of a time weighted frequency value based on random hourly draws of hand frequency distributions more accurately estimate hand to mouth exposures? Slide 70 of 75 Residential Question # 3

Distributional Analysis ° Assessing residential exposure to pesticides is a complex process that must consider exposure from a variety of sources via multiple routes. To account for exposure from different sources, the PNMC residential exposure assessment identifies scenarios where significant exposure may occur. Each of these scenarios is defined by a specific type of activity or set of activities that may result in exposure. Generally the relationships between these activities and the resulting exposures are well defined in that algorithms, equations, and standard operating procedures exist for calculating exposure based on the activity being performed. However the supporting data sets used to estimate exposure for various residential scenarios range from robust ( e. g. unit exposure values) to limited or sparse ( e. g. lawn sizes, area treated, duration of exposure, and saliva extraction factors). Additionally,

information characterizing the extent to which each activity contributes to exposure for a particular scenario does not always exist ( e. g. the amount of time spent in home gardens performing activities such as hand weeding versus staking tomatoes or harvesting sweet corn). Slide 71 of 75 Residential Question # 3

Distributional Analysis ° In general, the Agency has attempted to fit distributions ( as described in Appendix II. E. 2 of the NMC CRA) to the exposure measurements for residential activities when supporting information exists to characterize the extent to which the activity contributes to exposure for the residential scenario of interest. However, the Agency has employed uniform distributions to the data sets for which such supporting information does not exist, ( e. g.

lawn sizes, area treated, duration of exposure, and saliva extraction factors). The Agency has elected to create such distributions when the available data are limited to such an extent that it is uncertain how well they represent national variability. The Agency believes use of uniform distributions to be conservative in estimating potential exposure since uniform distributions tend to overestimate exposure. Slide 72 of 75 Residential Question # 3 R3a. Please comment specifically on the Agency's use of lognormal distributions to estimate residential exposure and the statistical methods and procedures by which the Agency has selected particular distributions ( e. g. probability plots and goodness of fit statistics). Slide 73 of 75 Residential Question # 3 R3b. Does the Panel agree that the Agency's approach to creating and using uniform distributions ( i. e. ranges of values) for residential scenarios lacking adequate supporting information tends to overestimate exposure? Is the Panel aware of other data sources that may be better suited for assessing residential exposure scenarios of interest? Does the Panel have any suggestions regarding alternative distributions to use for scenarios where supporting exposure information is inadequate? To what extent should sensitivity analyses be used to assess the appropriateness of alternative distributions? Slide 74 of 75 Residential Question # 3 R3c. When the Agency fits distributions to various exposure values, the maximum value entered into the probabilistic models for a particular distribution is usually defined to be an upper percentile value such as the 99th percentile in order to ensure realistic input parameters.

Recognizing that the Agency intends to perform sensitivity analyses to evaluate the effects of this truncation, please comment on the Agency's approach of truncating distributions that are input to the probabilistic models. Please comment on any other approaches that the Agency might use to evaluate uncertainties associated with choices about whether and where to truncate distributions. Slide 75 of 75 End of Residential


                           EPA Meeting with ASTSWMO                                 August 28, 2012

Attendees: EPA OUST:  Mark Barolo, Linda Gerber, Tim Smith, Paul Miller, Tim Roberts, Liz McDermott, Erin Knighton

ASTSWMO:  Bob McCoy (OR), Jennifer Pruett (NM), Rebecca Keyser (DE), Patricia Ellis (DE), Russ Brauksieck (NY), Therron Blatter (UT), Charles Reyes (ASTSWMO), Bob Daniel (NH), Paul Nelson (IA), Larry Brinkerhoff (AK), John Olko (NJ), Alison Hathcock (SC), Leslie Carr (KY), Mahesh Albuquerque (CO), Tara Rosie (AZ), Ken Koon (MO)

At this meeting, EPA and the states discussed questions related to the proposed regulations, including questions regarding new technologies, spill prevention and overfill prevention, deferrals, compatibility and interstitial monitoring, operator training, and ground water and vapor monitoring.  The questions discussed are attached.


[Federal Register Volume 82, Number 155 (Monday, August 14, 2017)]
[Notices]
[Pages 37939-37942]
[FR Doc No: 2017-17050]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-81345; File No. SR-ISE-2017-71]

Self-Regulatory Organizations; Nasdaq ISE, LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend ISE's
Schedule of Fees With Respect to the Options Regulatory Fee

August 8, 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 July 26, 2017, Nasdaq ISE, LLC (``ISE'' or ``Exchange'') filed with
the Securities and Exchange Commission (``SEC'' or ``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.
---------------------------------------------------------------------------

    \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 revise ISE's Schedule of Fees to: (i) Make
adjustments to the amount of the Options Regulatory Fee (``ORF''); (ii)
more closely reflect the manner in which ISE assesses and collects its
ORF; and (iii) remove rule text related to the timing when the Exchange
may increase or decrease the amount of the ORF.
    While the changes proposed herein are effective upon filing, the
Exchange has designated the amendments [sic] become operative on August
1, 2017.
    The text of the proposed rule change is available on the Exchange's
Web site at www.ise.com, at the principal office of the Exchange, and
at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
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    In its filing with the Commission, the Exchange 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. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

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

1. Purpose
    ISE initially filed to establish its ORF in 2010.\3\ The Exchange
has amended its ORF several times since the inception of this fee.\4\
At this time, the Exchange proposes to: (i) Amend the amount of its
ORF; (ii) more closely reflect the manner in which ISE assesses and
collects its ORF; and (iii) remove rule text related to the timing when
the Exchange may increase or decrease the amount of its ORF.
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    \3\ See Securities Exchange Act Release Nos. 61154 (December 11,
2009), 74 FR 67278 (December 18, 2009) (SR-ISE-2009-105) (Notice of
Filing and Immediate Effectiveness of Proposed Rule Change Relating
to the Registered Representative Fee and an Options Regulatory Fee).
    \4\ See Securities Exchange Act Release Nos. 62012 (April 30,
2010), 75 FR 25306 (May 7, 2010) (SR-ISE-2010-36); 67087 (May 31,
2012), 77 FR 33535 (June 6, 2012) (SR-ISE-2012-43); and 70859
(November 13, 2013), 78 FR 69501 (November 19, 2013) (SR-ISE-2014-
54).
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    The Exchange supports a common approach for the assessment and
collection of ORF among the various options exchanges that assess such
a fee. Furthermore, the Exchange supports guidance from the Commission
regarding regulatory cost structures to ensure equal knowledge and
treatment among options markets assessing ORF.
Proposal 1--Amend the Amount of the ORF
    The Exchange assesses an ORF of $0.0039 per contract side. The
Exchange proposes to decrease the ORF from $0.0039 per contract side to
$0.0016 per contract side as of August 1, 2017 to account for synergies
which resulted from Nasdaq's acquisition of the Exchange. On June 30,
2016, Nasdaq completed its acquisition of the International Securities
Exchange, which included acquiring three electronic options
exchanges.\5\ With the acquisition, ISE [sic] regulatory program has
been examined and conformed to certain best practices which exist today
on NASDAQ PHLX LLC, The NASDAQ Options Market LLC and NASDAQ BX, Inc.
(collectively ``Nasdaq Markets'') and Nasdaq GEMX, LLC. These synergies
in combination with conforming the expense and revenue review of ISE to
that of the Nasdaq Markets has resulted in a projected decreased in
regulatory expenses for ISE and therefore ISE is decreasing the amount
of its ORF. The Exchange believes that this decreased number reflects
efficiencies in the regulatory program today within the Nasdaq Markets.
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    \5\ On June 30, 2016, Nasdaq, Inc. acquired all of the capital
stock of U.S. Exchange Holdings, Inc., the ISE's indirect parent
company. As a result, ISE in addition to its affiliates, which are
now known as Nasdaq GEMX, LLC and Nasdaq MRX, LLC, became a wholly-
owned subsidiary of Nasdaq, Inc. See Securities Exchange Act Release
No. 78119 (June 21, 2016), 81 FR 41611 (June 27, 2016) (SR-ISE-2016-
11).
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    The Exchange's proposed change to the ORF should balance the
Exchange's regulatory cost [sic] against the anticipated revenue. The
Exchange regularly reviews its ORF to ensure that the ORF, in
combination with its other regulatory fees and fines, does not exceed
regulatory costs. The Exchange believes this adjustment will permit the
Exchange to cover a material portion of its regulatory costs, while not
exceeding regulatory costs.
    The Exchange notified members of this ORF adjustment thirty (30)
calendar days prior to the proposed operative date.\6\
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    \6\ See Options Trader Alert #2017-54.
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Proposal 2--Reflect the Manner in Which ISE Assesses and Collects its
ORF
    Currently, ISE assesses its ORF for each customer option
transaction that is either: (1) Executed by a member on ISE; or (2)
cleared by a ISE member at The Options Clearing Corporation (``OCC'')
in the customer range,\7\ even if the transaction was executed by a
non-member of ISE, regardless of the exchange on which the transaction
occurs.\8\ If the OCC clearing member is a ISE member, ORF is assessed
and collected on all cleared customer contracts (after adjustment for
CMTA \9\); and (2) if the OCC clearing member is not a ISE member, ORF
is collected only on the cleared customer contracts executed at ISE,
taking into account any

CMTA instructions which may result in collecting the ORF from a non-
member.
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    \7\ Members must record the appropriate account origin code on
all orders at the time of entry in order. The Exchange represents
that it has surveillances in place to verify that members mark
orders with the correct account origin code.
    \8\ The Exchange uses reports from OCC when assessing and
collecting the ORF.
    \9\ CMTA or Clearing Member Trade Assignment is a form of
``give-up'' whereby the position will be assigned to a specific
clearing firm at OCC.
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    By way of example, if Broker A, an ISE member, routes a customer
order to CBOE and the transaction executes on CBOE and clears in Broker
A's OCC Clearing account, ORF will be collected by ISE from Broker A's
clearing account at OCC via direct debit. While this transaction was
executed on a market other than ISE, it was cleared by an ISE member in
the member's OCC clearing account in the customer range, therefore
there is a regulatory nexus between ISE and the transaction. If Broker
A was not an ISE member, then no ORF should be assessed and collected
because there is no nexus; the transaction did not execute on ISE nor
was it cleared by an ISE member.
    In the case where a member both executes a transaction and clears
the transaction, the ORF is assessed to and collected from the member
only once. In the case where a member executes a transaction and a
different member clears the transaction, the ORF is assessed to and
collected from the member who clears the transaction and not the member
who executes the transaction. In the case where a non-member executes a
transaction at an away market and a member clears the transaction, the
ORF is assessed to and collected from the member who clears the
transaction. In the case where a member executes a transaction on ISE
and a non-member clears the transaction, the ORF is assessed to the
member that executed the transaction and collected from the non-member
who cleared the transaction. In the case where a member executes a
transaction at an away market and a non-member clears the transaction,
the ORF is not assessed to the member who executed the transaction or
collected from the non-member who cleared the transaction because the
Exchange does not have access to the data to make absolutely certain
that ORF should apply. Further, the data does not allow the Exchange to
identify the member executing the trade at an away market.
ORF Revenue and Monitoring of ORF
    The Exchange monitors the amount of revenue collected from the ORF
to ensure that it, in combination with other regulatory fees and fines,
does not exceed regulatory costs. In determining whether an expense is
considered a regulatory cost, the Exchange reviews all costs and makes
determinations if there is a nexus between the expense and a regulatory
function. The Exchange notes that fines collected by the Exchange in
connection with a disciplinary manner offset ORF.
    The ORF is designed to recover a material portion of the costs to
the Exchange of the supervision and regulation of its members,
including performing routine surveillances, investigations,
examinations, financial monitoring, and policy, rulemaking,
interpretive, and enforcement activities.
    The Exchange believes that revenue generated from the ORF, when
combined with all of the Exchange's other regulatory fees, will cover a
material portion, but not all, of the Exchange's regulatory costs. The
Exchange will continue to monitor the amount of revenue collected from
the ORF to ensure that it, in combination with its other regulatory
fees and fines, does not exceed regulatory costs. If the Exchange
determines regulatory revenues exceed regulatory costs, the Exchange
will adjust the ORF by submitting a fee change filing to the
Commission.
    Finally, the Exchange notes that it is amending ISE's Schedule of
Fees to remove certain rule text and include new rule text to make
clear the manner in which ORF is assessed and collected on ISE.
Proposal 3--Semi-Annual Changes to ORF
    The Exchange's current ORF rule text provides that, ``The Exchange
may only increase or decrease the Options Regulatory Fee semi-annually,
and any such fee change will be effective on the first business day of
February or August.'' The Exchange is proposing to eliminate the
requirement that its ORF may be only increased or decreased semi-
annually because the Exchange believes it requires the flexibility to
amend its ORF as needed to meet its regulatory requirements and adjust
its ORF to account for the regulatory revenue that it receives and the
costs that it incurs. While the Exchange is eliminating the requirement
to adjust only semi-annually, it will continue to submit a rule
proposal with the Commission for each modification to the ORF and
notify participants via an Options Trader Alert of any proposed change
in the amount of the fee at least thirty (30) calendar days prior to
the effective date. The Exchange believes that the prior notification
to market participants will provide guidance on the timing of any
changes to the ORF and ensure market participants are prepared to
configure their systems to properly account for the ORF.
    The Exchange also notes it now issues Options Trader Alerts instead
of circulars to provide notification to members. The Exchange is
amending the rule text to reflect this change.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \10\ in general, and furthers the objectives of
Sections 6(b)(4) and 6(b)(5) of the Act \11\ in particular, in that it
provides for the equitable allocation of reasonable dues, fees and
other charges among members and issuers and other persons using its
facility and is not designed to permit unfair discrimination between
customers, issuers, brokers, or dealers.
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    \10\ 15 U.S.C. 78f(b).
    \11\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

    The Exchange believes the proposed clarifications in the Fee
Schedule to the ORF further the objectives of Section 6(b)(4) of the
Act and are equitable and reasonable since they expressly describe the
Exchange's existing practices regarding the manner in which the
Exchange assesses and collects its ORF.
Proposal 1--Amend the Amount of the ORF
    The Exchange believes that decreasing the ORF from $0.0039 per
contract side to $0.0016 per contract side as of August 1, 2017 is
reasonable because the Exchange's collection of ORF needs to be
balanced against the amount of regulatory cost collected [sic] by the
Exchange. The decrease is a result of synergies among the Nasdaq owned
self-regulatory organizations. The synergies in combination with
conforming the expense and revenue review of ISE to that of the Nasdaq
Markets has resulted in a decreased ORF for ISE. The Exchange believes
that this decreased number reflects efficiencies in the regulatory
program today within the Nasdaq Markets. The Exchange's proposed change
to the ORF should balance the Exchange's regulatory cost against the
anticipated regulatory revenue. The Exchange regularly reviews its ORF
to ensure that the ORF, in combination with its other regulatory fees
and fines, does not exceed regulatory costs.
    The Exchange believes that decreasing the ORF from $0.0039 per
contract side to $0.0016 per contract side as of August 1, 2017 is
equitable and not unfairly discriminatory because this decrease will
serve to balance the Exchange's regulatory revenue against the
anticipated regulatory costs in light of recent synergies experienced
from the merger described herein. The ORF seeks to recover the costs of
supervising and regulating members, including performing routine
surveillances, investigations, examinations, financial monitoring, and
policy, rulemaking, interpretive, and enforcement activities.

    Moreover, the Exchange believes the ORF ensures fairness by
assessing fees to those members that are directly based on the amount
of customer options business they conduct. Regulating customer trading
activity is much more labor intensive and requires greater expenditure
of human and technical resources than regulating non-customer trading
activity, which tends to be more automated and less labor-intensive. As
a result, the costs associated with administering the customer
component of the Exchange's overall regulatory program are materially
higher than the costs associated with administering the non-customer
component (e.g. member proprietary transactions) of its regulatory
program.
    The ORF is designed to recover a material portion of the costs of
supervising and regulating member's customer options business including
performing routine surveillances, investigations, examinations,
financial monitoring, and policy, rulemaking, interpretive, and
enforcement activities. The Exchange will monitor the amount of revenue
collected from the ORF to ensure that it, in combination with its other
regulatory fees and fines, does not exceed the Exchange's total
regulatory costs. The Exchange has designed the ORF to generate
revenues that, when combined with all of the Exchange's other
regulatory fees, will be less than or equal to the Exchange's
regulatory costs, which is consistent with the Commission's view that
regulatory fees be used for regulatory purposes and not to support the
Exchange's business side. In this regard, the Exchange believes that
the proposed amount of the fee is reasonable.
Proposal 2--Reflect the Manner in Which ISE Assesses and Collects Its
ORF
    The Exchange believes it is reasonable and appropriate for the
Exchange to charge the ORF for options transactions regardless of the
exchange on which the transactions occur. The Exchange has a statutory
obligation to enforce compliance by members and their associated
persons under the Act and the rules of the Exchange and to surveil for
other manipulative conduct by market participants (including non-
members) trading on the Exchange. The Exchange cannot effectively
surveil for such conduct without looking at and evaluating activity
across all options markets. Many of the Exchange's market surveillance
programs require the Exchange to look at and evaluate activity across
all options markets, such as surveillance for position limit
violations, manipulation, front-running and contrary exercise advice
violations/expiring exercise declarations. The Exchange, because it
lacks access to information on the identity of the entering firm for
executions that occur on away markets, believes it is appropriate to
assess the ORF on its member's clearing activity, based on information
the Exchange receives from OCC, including for away market activity.
Among other reasons, doing so better and more accurately captures
activity that occurs away from the Exchange over which the Exchange has
a degree of regulatory responsibility. In so doing, the Exchange
believes that assessing ORF on member clearing firms in certain
instances equitably distributes the collection of ORF in a fair and
reasonable manner. Also, the Exchange and the other options exchanges
are required to populate a consolidated options audit trail (``COATS'')
\12\ system in order to surveil a member's activities across
markets.\13\
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    \12\ COATS effectively enhances intermarket options surveillance
by enabling the options exchanges to reconstruct the market promptly
to effectively surveil certain rules.
    \13\ In addition to its own surveillance programs, the Exchange
works with other SROs and exchanges on intermarket surveillance
related issues. Through its participation in the Intermarket
Surveillance Group (``ISG''), the Exchange shares information and
coordinates inquiries and investigations with other exchanges
designed to address potential intermarket manipulation and trading
abuses. The Exchange's participation in ISG helps it to satisfy the
requirement that it has coordinated surveillance with markets on
which security futures are traded and markets on which any security
underlying security futures are traded to detect manipulation and
insider trading. See Section 6(h)(3)(I) of the Act. ISG is an
industry organization formed in 1983 to coordinate intermarket
surveillance among the SROs by co-operatively sharing regulatory
information pursuant to a written agreement between the parties. The
goal of the ISG's information sharing is to coordinate regulatory
efforts to address potential intermarket trading abuses and
manipulations.
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    The Exchange believes that assessing the ORF to each Exchange
member for options transactions cleared by OCC in the customer range
where the execution occurs on another exchange and is cleared by a ISE
Member is an equitable allocation of reasonable dues, fees, and other
charges among its members and issuers and other persons using its
facilities. The ORF is collected by OCC on behalf of ISE from Exchange
clearing members for all customer transactions they clear or from non-
Members for all customer transactions they clear that were executed on
ISE. The Exchange believes that this collection practice is reasonable
and appropriate because higher fees are assessed to those Members that
require more Exchange regulatory services based on the amount of
customer options business they conduct.
    Regulating customer trading activity is more labor intensive and
requires greater expenditure of human and technical resources than
regulating non-customer trading activity, which tends to be more
automated and less labor intensive. As a result, the costs associated
with administering the customer component of the Exchange's overall
regulatory program are anticipated to be typically higher than the
costs associated with administering the non-customer component of its
regulatory program. The Exchange proposes assessing higher fees to
those members that will require more Exchange regulatory services based
on the amount of customer options business they conduct. Additionally,
the dues and fees paid by members go into the general funds of the
Exchange, a portion of which is used to help pay the costs of
regulation. The Exchange has in place a regulatory structure to
surveil, conduct examinations and monitor the marketplace for
violations of Exchange Rules. The ORF assists the Exchange to fund the
cost of this regulation of the marketplace.
Proposal 3--Semi-Annual Changes to ORF
    The Exchange believes that the proposed rule change to remove the
limit to amend the ORF only semi-annually, with advance notice, is
reasonable because the Exchange will continue to provide market
participants with thirty (30) days advance notice of amending the
amount of the ORF. Also, the Exchange is required to monitor the amount
of revenue collected from the ORF to ensure that it, in combination
with its other regulatory fees and fines, do not exceed regulatory
costs. Therefore, the Exchange believes it is reasonable to remove the
semi-annual limit to amend its ORF in order to permit the Exchange to
make amendments to its ORF as necessary to comply with the Exchange's
obligations. This proposed change would conform this rule with that of
NASDAQ PHLX LLC (``Phlx''), The NASDAQ Options Market LLC (``NOM'') and
NASDAQ BX, Inc. (``BX'').\14\
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    \14\ See Phlx's Pricing Schedule and NOM and BX Rules at Chapter
XV, Sections 5.
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    The Exchange believes that the proposed rule change to remove the
limit to amend the ORF only semi-annually, with advance notice, is
equitable and not unfairly discriminatory because it will apply in the
same manner to all members that are subject to the ORF. The Exchange
has in place a regulatory structure to surveil for, conduct
examinations and monitor

the marketplace for violations of Exchange Rules. The ORF assists the
Exchange to fund the cost of this regulation of the marketplace.

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 not necessary or appropriate in
furtherance of the purposes of the Act. The ORF is not intended to have
any impact on competition. Rather, it is designed to enable the
Exchange to recover a material portion of the Exchange's cost related
to its regulatory activities. The Exchange is obligated to ensure that
the amount of regulatory revenue collected from the ORF, in combination
with its other regulatory fees and fines, does not exceed regulatory
costs.

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

    No written comments were either solicited or received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\15\ At any time within 60 days of the
filing of the proposed rule change, the Commission summarily may
temporarily suspend such rule change if it appears to the Commission
that such action is: (i) necessary or appropriate in the public
interest; (ii) for the protection of investors; or (iii) otherwise in
furtherance of the purposes of the Act. If the Commission takes such
action, the Commission shall institute proceedings to determine whether
the proposed rule should be approved or disapproved.
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    \15\ 15 U.S.C. 78s(b)(3)(A)(ii).
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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 No. SR-ISE-2017-71 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 No. SR-ISE-2017-71. 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
10:00 a.m. and 3:00 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 No. SR-ISE-2017-71, and should be
submitted on or before September 5, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
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    \16\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-17050 Filed 8-11-17; 8:45 am]
 BILLING CODE 8011-01-P