[Federal Register Volume 84, Number 242 (Tuesday, December 17, 2019)]
[Proposed Rules]
[Pages 68829-68833]
[FR Doc No: 2019-27045]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 814

[Docket No. FDA-2019-N-3101]

Revised Procedures for the Announcement of Approvals and Denials
of Premarket Approval Applications and Humanitarian Device Exemption
Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
proposing to amend the medical device regulations regarding the
procedures for the announcement of approvals and denials of premarket
approval applications (PMAs) and humanitarian device exemption
applications (HDEs). We are proposing to discontinue publishing in the
Federal Register after each quarter a list of PMA and HDE approvals and
denials announced in that quarter. We will continue to post approval
and denial notices for PMAs and HDEs on FDA's home page on the internet
and will also continue to make available on the internet and place on
public display summaries of safety and effectiveness data (SSED) for
PMAs and summaries of safety and probable benefit (SSPB) for HDEs. FDA
is proposing to take this action to improve the efficiency of
announcing approvals and denials of PMAs and HDEs and to eliminate
duplication in the current process for announcing this information. We
are also proposing to update Agency contact information and statutory
references in certain sections of the PMA and HDE regulations for
purposes of accuracy, clarity, and consistency.

DATES: Submit either electronic or written comments on the proposed
rule by March 2, 2020.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before March 2, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of March 2, 2020. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): 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-2019-N-3101 for ``Revised Procedures for the Announcement of
Approvals and Denials of Premarket Approval Applications and
Humanitarian Device Exemption Applications.'' 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.govinfo.gov/content/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.

FOR FURTHER INFORMATION CONTACT:
    For information concerning the proposed rule as it relates to
devices regulated by the Center for Biologics Evaluation and Research:
Jessica Walker Udechukwu, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.
    For information concerning the proposed rule as it relates to
devices regulated by the Center for Devices and Radiological Health:
Joshua Nipper, Center for Devices and Radiological Health, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1650,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose of the Proposed Rule
    B. Summary of the Major Provisions of the Proposed Rule

    C. Legal Authority
    D. Costs and Benefits
II. Background
    A. Need for the Regulation
    B. History of the Rulemaking
III. Legal Authority
IV. Description of the Proposed Rule
V. Proposed Effective Date
VI. Preliminary Economic Analysis of Impacts
    A. Introduction
    B. Summary of Benefits and Costs
VII. Paperwork Reduction Act of 1995
VIII. Federalism
IX. Consultation and Coordination With Indian Tribal Governments
X. Reference

I. Executive Summary

A. Purpose of the Proposed Rule

    FDA is proposing to amend its medical device regulations regarding
the procedures for the announcement of approvals and denials of PMAs
and HDEs to discontinue the quarterly publication in the Federal
Register of a list of approvals and denials of both PMAs and HDEs. FDA
will continue to post approval and denial notices for PMAs and HDEs on
FDA's home page on the internet (https://www.fda.gov) and will also
continue to make available on the internet and place on public display
SSED for PMAs and SSPB for HDEs. FDA is proposing to take this action
to improve the efficiency of announcing approvals and denials of PMAs
and HDEs and eliminate duplication in the current process for
announcing this information. We are also proposing to update Agency
contact information and statutory references in certain of the PMA and
HDE regulations for purposes of accuracy, clarity, and consistency.

B. Summary of the Major Provisions of the Proposed Rule

    FDA is proposing to amend its regulations regarding the
announcement procedures for the approval and denial of PMAs and HDEs.
FDA is proposing to discontinue publishing in the Federal Register
after each quarter a list of PMA and HDE approvals and denials
announced for that quarter. We will continue to post approval and
denial notices for PMAs and HDEs on FDA's home page on the internet,
and we will also continue to make SSED for PMAs and SSPB for HDEs
available on the internet and place them on public display.

C. Legal Authority

    FDA is issuing this proposed rule under sections 515, 520(h),
520(m), and 701(a) of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360e, 360j(h), 360j(m), and 371(a)).

D. Costs and Benefits

    The benefit of this proposed rule, if finalized, is that it would
result in cost savings to FDA from discontinuing publishing in the
Federal Register on a quarterly basis, a list of medical device PMA and
HDE approvals and denials. Annualized over 10 years, the estimated
benefits (i.e., cost savings) to FDA would range from $0.008 million to
$0.013 million at both 3 and 7 percent discount rate, with a primary
estimate of $0.010 million. This proposed rule, if finalized, would
result in no costs to industry because the rule would not require
performance of any additional tasks and, therefore, would not impose
any additional regulatory burden on the industry.

II. Background

A. Need for the Regulation

    FDA is proposing to amend its medical device regulations regarding
the procedures for the announcement of approvals and denials of PMAs
and HDEs to discontinue the quarterly publication in the Federal
Register of a list of approvals and denials of both PMAs and HDEs. FDA
is proposing to take this action to improve the efficiency of
announcing approvals and denials of PMAs and HDEs and eliminate
duplication in announcing this information. The proposed rule, if
finalized, would allow FDA staff to focus on other Agency priorities
and utilize FDA staff resources more efficiently. FDA is also proposing
to revise Sec.  814.44(d)(2) (21 CFR 814.44(d)(2)) to be consistent
with Sec.  814.45(d)(2) (21 CFR 814.45(d)(2)), which states that
requests for copies of the current PMA approvals and denials document
and copies of SSED must be sent in writing to FDA's Freedom of
Information Staff. In addition, FDA is proposing to update outdated
references to section 515(d)(3) of the FD&C Act in the PMA (Sec. Sec.
814.40 (21 CFR 814.40), 814.44, and 814.45) and HDE (Sec.  814.118 (21
CFR 814.118)) regulations.

B. History of the Rulemaking

    Section 515(d)(4) of the FD&C Act permits an interested person to
obtain review of an order approving a PMA in accordance with section
515(g) of the FD&C Act. The statute does not require the Agency to
publish the approval of a PMA in the Federal Register; however, FDA
issued in the Federal Register of July 22, 1986 (51 FR 26342) a final
rule that provided, among other things, that notice of approval of a
PMA, notice of an order denying approval of a PMA, and notice of an
order withdrawing approval of a PMA will be published in the Federal
Register. In the Federal Register of June 26, 1996 (61 FR 33232), FDA
issued a final rule prescribing, among other things, the procedures for
submitting HDEs, HDE amendments, and HDE supplements, and the criteria
for FDA review and approval of HDEs. Furthermore, the final rule of
June 26, 1996, provided that the notice of approval of an HDE be
published in the Federal Register in accordance with the rules and
policies applicable to PMAs submitted under 21 CFR 814.20. That final
rule also provided that, if FDA issues an order denying approval of an
HDE, FDA will comply with the same notice and disclosure provisions
required for PMAs under Sec.  814.45(b) and (d), as applicable.
    In the Federal Register of January 30, 1998 (63 FR 4571), FDA
issued a final rule discontinuing the publication of individual PMA
approvals and denials in the Federal Register. The final rule provided
that FDA would notify the public of PMA approvals and denials by
posting them on FDA's home page on the internet, by placing SSED on the
internet and in FDA's Dockets Management Branch, and by publishing in
the Federal Register after each quarter a list of the PMA approvals and
denials announced in that quarter. FDA stated that it believed that
this procedure would expedite public notification of these actions
because announcements could be placed on the internet more quickly than
they could be published in the Federal Register, and FDA believed that
the internet would be accessible to more people than the Federal
Register.

III. Legal Authority

    We are issuing this proposed rule under the authority of sections
515, 520(h), and 520(m) of the FD&C Act, which set forth requirements
for device premarket approval, release of detailed summaries of
information respecting the safety and effectiveness of devices, and
humanitarian device exemptions, and under section 701(a) of the FD&C
Act, which provides FDA the authority to issue regulations for the
efficient enforcement of the FD&C Act.

IV. Description of the Proposed Rule

    We are proposing to amend 21 CFR part 814 to revise the PMA and HDE
approval and denial announcement procedures.
    FDA would discontinue publishing in the Federal Register after each
quarter a list of PMA and HDE approvals and denials announced in that
quarter (see proposed revisions to Sec. Sec.  814.44, 814.45, and
814.116). FDA will continue to give the public notice of PMA and HDE

approvals and denials by placing notices of approval and denial on
FDA's home page on the internet. Notices of PMA and HDE approval will
continue to include a notice of opportunity for interested persons to
request review. FDA considers the 30-day period for requesting
reconsideration of an FDA action under Sec.  10.33(b) (21 CFR 10.33(b))
for notices of PMA and HDE approval to begin on the day the notice is
placed on the internet. Section 10.33(b) provides that FDA may, for
good cause, extend this 30-day filing period. In addition, we will
continue to make available on the internet and place on public display
SSED and SSPB.
    We are also proposing to revise Sec.  814.44(d)(2), regarding
requests for copies of the current PMA approvals and denials document
and copies of SSED, to state that such requests must be sent to the
Freedom of Information Staff, rather than to the Division of Dockets
Management. We are proposing this revision because these requests are
currently handled by the Freedom of Information Staff. Revised Sec.
814.44(d)(2) would be consistent with current Sec.  814.45(d)(2).
    In addition, FDA is proposing to update outdated references to
section 515(d)(3) of the FD&C Act in the PMA (Sec. Sec.  814.40,
814.44, and 814.45) and HDE (Sec.  814.118) regulations. FDA is
proposing to make this update because section 515(d)(3) of the FD&C Act
was redesignated as section 515(d)(4) by section 202 of the Food and
Drug Administration Modernization Act of 1997 (Pub. L. 105-115).

V. Proposed Effective Date

    FDA is proposing that any final rule based on this proposed rule
become effective 30 days after the date of its publication in the
Federal Register.

VI. Preliminary Economic Analysis of Impacts

A. Introduction

    We have examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, Executive Order 13771, the
Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and
13563 direct us to assess all costs and benefits of available
regulatory alternatives and, when regulation is necessary, to select
regulatory approaches that maximize net benefits (including potential
economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). Executive Order 13771
requires that the costs associated with significant new regulations
``shall, to the extent permitted by law, be offset by the elimination
of existing costs associated with at least two prior regulations.'' We
believe that this proposed rule is not a significant regulatory action
as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because this proposed rule, if finalized, would not impose
any additional regulatory burden on the industry, we propose to certify
that the proposed rule will not have a significant economic impact on a
substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $154 million, using the most current (2018) Implicit
Price Deflator for the Gross Domestic Product. This proposed rule would
not result in an expenditure in any year that meets or exceeds this
amount.

B. Summary of Benefits and Costs

    The benefit of this proposed rule, if finalized, is that it would
result in cost savings to FDA from discontinuing publishing in the
Federal Register, on a quarterly basis, a list of medical device PMA
and HDE approvals and denials. Discontinuing publishing Federal
Register notices with these approval and denial lists would eliminate
duplication in announcing this information; information on these
approvals and denials would continue being readily available to the
public on FDA's home page on the internet (https://www.fda.gov). We
estimate no additional benefits beyond these cost savings to FDA.
    We estimate that this proposed rule, if finalized, would result in
no additional costs to industry because the rule would not require
performance of any additional tasks. This proposed rule, therefore,
would not impose any additional regulatory burden on the industry.
    Table 1 summarizes the estimated benefits and costs of the proposed
rule, if finalized. Annualized over 10 years, the estimated benefits
(i.e., cost savings) of the proposed rule, if finalized, would range
from $0.008 million to $0.013 million at both 3 and 7 percent discount
rate, with a primary estimate of $0.010 million. The present value of
the estimated benefits (i.e., cost savings) of the proposed rule, if
finalized, would range from $0.068 million to $0.111 million at a 3
percent discount rate and from $0.056 million to $0.091 million at a 7
percent discount rate. The annualized costs of the proposed rule, if
finalized, would be $0 at both 3 and 7 percent discount rate. The
present value of costs of the proposed rule, if finalized, would also
be $0 at both 3 and 7 percent discount rate.

                                    Table 1--Summary of Benefits, Costs, and Distributional Effects of Proposed Rule
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                                                                                Units
                                                                           ------------------------------------
               Category                   Primary       Low        High                               Period                      Notes
                                         estimate    estimate    estimate      Year      Discount     covered
                                                                              dollars    rate  (%)    (years)
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Benefits:
    Annualized Monetized $millions/         $0.010      $0.008      $0.013        2018           7          10  Benefits are cost savings.
     year.
                                             0.010       0.008       0.013        2018           3          10  Benefits are cost savings.
                                       ------------------------------------------------------------------------
    Annualized Quantified.............  ..........  ..........  ..........  ..........  ..........  ..........
    Qualitative.......................  ..........  ..........  ..........  ..........  ..........  ..........
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
    Annualized Monetized $millions/              0           0           0        2018           7          10
     year.
                                                 0           0           0        2018           3          10
                                       ------------------------------------------------------------------------

    Annualized Quantified.............  ..........  ..........  ..........  ..........  ..........  ..........
                                       ------------------------------------------------------------------------
    Qualitative.......................  ..........  ..........  ..........  ..........  ..........  ..........
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
    Federal Annualized Monetized        ..........  ..........  ..........  ..........  ..........  ..........
     $millions/year.
                                       ------------------------------------------------------------------------
    From/To...........................  From:
                                        To:
                                       ------------------------------------------------------------------------
    Other Annualized Monetized          ..........  ..........  ..........  ..........  ..........  ..........
     $millions/year.
                                       ------------------------------------------------------------------------
    From/To...........................  From:
                                        To:
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Effects:
    State, Local or Tribal Government: No significant effect............................................................................................
    Small Business: No significant effect...............................................................................................................
    Wages: N/A..........................................................................................................................................
    Growth: N/A.........................................................................................................................................
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    In line with Executive Order 13771, in table 2 we discuss
annualized and present values of costs and cost savings over an
infinite time horizon. The present value of the net costs would be $0
at both 3 and 7 percent discount rate. The total annualized cost
savings would range from $0.008 million to $0.013 million at both 3 and
7 percent discount rates.

                                                      Table 2--Executive Order 13771 Summary Table
                                               [in $ Millions 2016 Dollars, Over an Infinite Time Horizon]
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                                                              Primary          Lower           Upper          Primary          Lower           Upper
                          Item                            estimate  (7%)  estimate  (7%)  estimate  (7%)  estimate  (3%)  estimate  (3%)  estimate  (3%)
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Present Value of Costs..................................              $0              $0              $0              $0              $0              $0
Present Value of Cost Savings...........................           0.143           0.114           0.186           0.333           0.267           0.433
Present Value of Net Costs..............................         (0.143)         (0.114)         (0.186)         (0.333)         (0.267)         (0.433)
Annualized Costs........................................               0               0               0               0               0               0
Annualized Cost Savings.................................           0.010           0.008           0.013           0.010           0.008           0.013
Annualized Net Costs....................................         (0.010)         (0.008)         (0.013)         (0.010)         (0.008)         (0.013)
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Note: Net costs are calculated as costs minus cost savings. Values in parentheses denote net negative costs (i.e. cost-savings).

    We have developed a comprehensive Preliminary Economic Analysis of
Impacts that assesses the impacts of the proposed rule. The full
preliminary analysis of economic impacts is available in the docket for
this proposed rule (Ref. 1) and at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

VII. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no
collection of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.

VIII. Federalism

    We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. We have determined that
this proposed rule does not contain policies that have substantial
direct effects 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. Accordingly,
we conclude that the proposed rule does not contain policies that have
federalism implications as defined in the Executive Order and,
consequently, a federalism summary impact statement is not required.

IX. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13175. We have tentatively
determined that the rule does not contain policies that would 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. The Agency solicits comments from tribal
officials on any potential impact on Indian Tribes from this proposed
action.

X. Reference

    The following reference is on display at the Dockets Management
Staff (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also
available electronically at https://www.regulations.gov. FDA has
verified the website address, as of the date this document publishes in
the Federal Register, but websites are subject to change over time.

1. FDA/Economics Staff, ``Revised Procedures for the Announcement of
Approvals and Denials of Premarket Approval Applications and
Humanitarian Device Exemption Applications, Preliminary Regulatory
Impact Analysis, Preliminary Regulatory Flexibility Analysis,
Unfunded Mandates Reform Act Analysis,'' 2019 (available at: https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm).

List of Subjects in 21 CFR Part 814

    Administrative practice and procedure, Confidential business
information, Medical devices, Medical research, Reporting and
recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 814 be amended as follows:

PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES

0
1. The authority citation for part 814 continues to read as follows:

    Authority: 21 U.S.C. 351, 352, 353, 360, 360c-360j, 360bbb-8b,
371, 372, 373, 374, 375, 379, 379e, 381.

Sec.  814.40  [Amended]

0
2. In Sec.  814.40, remove ``515(d)(3)'' and add in its place
``515(d)(4)''

Sec.  814.44  [Amended]

0
3. Amend Sec.  814.44 as follows:
0
a. In the fourth sentence in paragraph (d)(1), remove ``515(d)(3)'' and
add in its place ``515(d)(4)'' and remove the sixth sentence;
0
b. In paragraph (d)(2), remove ``Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852'' and add in its place ``Freedom of Information
Staff's address listed on the Agency's website at https://www.fda.gov.''; and
0
c. In paragraphs (e)(2)(ii) and (f)(2), remove ``515(d)(3)'' and add in
its place ``515(d)(4)''.

Sec.  814.45  [Amended]

0
4. Amend Sec.  814.45 as follows:
0
a. In paragraph (d)(1), remove the third sentence and
0
b. In paragraph (e)(3), remove ``515(d)(3)'' and add in its place
``515(d)(4)''.
0
5. In Sec.  814.116 revise the fourth sentence in paragraph (b) to read
as follows:

[thinsp]Sec.  814.116  Procedures for review of an HDE.

    (b) * * * The notice of approval of an HDE will be placed on the
FDA's home page on the internet (https://www.fda.gov) in accordance
with the rules and policies applicable to PMAs submitted under Sec.
814.20. * * *

Sec.  814.118  [Amended]

0
6. In Sec.  814.118(c)(3), remove ``515(d)(3)'' and add in its place
``515(d)(4)''.

    Dated: December 9, 2019.
Brett P. Giroir,
Acting Commissioner of Food and Drugs.
[FR Doc. 2019-27045 Filed 12-16-19; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 40 (Wednesday, February 29, 2012)]
[Proposed Rules]
[Pages 12231-12233]
[FR Doc No: 2012-4876]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

49 CFR Parts 385, 390, and 395

[Docket No. FMCSA-2010-0167]
RIN 2126-AB20

Electronic On-Board Recorders and Hours of Service Supporting
Documents

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

ACTION: Notice of public listening session.

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SUMMARY: FMCSA announces that it will hold a public listening session
to solicit information, concepts, ideas, and comments on Electronic On-
Board Recorders (EOBRs) and the issue of driver harassment.
Specifically, the Agency wants to know what factors, issues, and data
it should consider as it addresses the distinction between productivity
and harassment: what will prevent harassment from occurring; what types
of harassment already exist; how frequently and to what extent
harassment happens; and how an electronic device such as an EOBR,
capable of contemporaneous transmission of information to a motor
carrier will guard against (or fail to guard against) harassment. This
session will be held in Louisville, Kentucky (KY), and will allow
interested persons to present comments, views, and relevant new
research that FMCSA should consider in development of the final rule.
This listening session will be recorded and a transcript of the session
will be placed in the docket for FMCSA's consideration. The listening
session will also be webcast via the Internet.

DATES: The listening session will be held on Friday, March 23, 2012, at
the Mid-America Trucking Show in Louisville, KY. The listening session
will run from 10 a.m.-12 p.m., with a break between 12 p.m. and 2 p.m.,
and continue from 2 p.m.-4 p.m. local time, or earlier, if all
participants wishing to express their views have done so.

ADDRESSES: The listening session will be held at the Kentucky
Exposition Center (KEC), 937 Phillips Lane, Louisville, KY 40209, South
Wing, Meeting Room C-101.
    Internet Address for Live Webcast. FMCSA will post specific
information on how to participate via the Internet on the FMCSA web
site at: http://www.fmcsa.dot.gov in advance of the listening session.
    You may submit comments bearing the Federal Docket Management
System (FDMS) Docket ID FMCSA-2010-0167 using any of the following
methods:
     Federal eRulemaking Portal: Go to www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and
5 p.m., ET, Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Each submission must include the Agency name and the docket number
for this notice. Note that DOT posts all comments received without
change to www.regulations.gov, including any personal information
included in a comment. Please see the Privacy Act heading below.
    Docket: For access to the docket to read background documents or
comments, go to www.regulations.gov at any time or visit Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., ET, Monday through Friday,
except Federal holidays. The on-line Federal document management system
is available 24 hours each day, 365 days each year. If you want
acknowledgment that we received your comments, please include a self-
addressed, stamped envelope or postcard or print the acknowledgement

page that appears after submitting comments on-line.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, etc.).
You may review DOT's Privacy Act Statement for the Federal Docket
Management System published in the Federal Register on January 17, 2008
(73 FR 3316), or you may visit http://edocket.access.gpo.gov/2008/pdf/E8-785.pdf.

FOR FURTHER INFORMATION CONTACT: For information concerning the
listening session or the live webcast, please contact Ms. Shannon L.
Watson, Senior Advisor for Policy, FMCSA,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    Should you need sign language interpretation or other assistance to
participate in this listening session, also contact Ms. Shannon L.
Watson, at the above phone number, by Thursday, March 8, 2012, to allow
us to arrange for such services. There is no guarantee that services
requested on short notice can be provided.

SUPPLEMENTARY INFORMATION:

I. Background

    On February 13, 2012, FMCSA published a notice of intent in the
Federal Register announcing the Agency's plan for the Electronic On-
Board Recorders and Hours of Service Supporting Documents rulemaking
(EOBR 2) by working towards preparing a Supplemental Notice of Proposed
Rulemaking (SNPRM) (77 FR 7562). In this notice, FMCSA stated it would
do the following: (1) Hold listening sessions on the issue of driver
harassment; (2) task the Motor Carrier Safety Advisory Committee
(MCSAC) to assist in developing material to support this rulemaking,
including technical specifications for EOBRs and their potential to be
used to harass drivers; and (3) conduct research by surveying drivers,
carriers, and vendors regarding harassment issues.
    The following discussion summarizes the recent regulatory history
of the agency's EOBR program:

EOBR 1

    On April 5, 2010, the Agency issued a final rule (EOBR 1) (75 FR
17208) that provided new technical requirements for EOBRs. The EOBR 1
final rule also required the limited, remedial use of EOBRs for motor
carriers with significant hours-of-service (HOS) violations. The EOBR 1
final rule required a motor carrier found to have a 10 percent
violation rate for any HOS regulation listed in Appendix C of 49 CFR
part 385 during a single compliance review to install and use EOBRs on
all of its CMVs for a period of 2 years. The compliance date for the
rule was June 4, 2012.
    The Owner-Operator Independent Drivers Association (OOIDA)
challenged the final rule in the United States Court of Appeals for the
Seventh Circuit. OOIDA raised several concerns relating to EOBRs and
their potential use for driver harassment. On August 26, 2011, the
Court vacated the entire final rule. Owner-Operator Indep. Drivers
Ass'n et al. v. Fed. Motor Carrier Safety Admin., 656 F.3d. 580 (7th
Cir. 2011). The Court held that, contrary to statutory requirements,
the Agency failed to address the issue of driver harassment, including
how EOBRs could potentially be used to harass drivers and ways to
ensure that EOBRs were not used to harass drivers. The basis for the
decision was FMCSA's failure to directly address a requirement in 49
U.S.C. 31137(a) which reads as follows:

    USE OF MONITORING DEVICES. If the Secretary of Transportation
prescribes a regulation about the use of monitoring devices on
commercial motor vehicles to increase compliance by operators of the
vehicles with hours of service regulations of the Secretary, the
regulation shall ensure that the devices are not used to harass
vehicle operators. However, the devices may be used to monitor
productivity of the operators.

    The court's expectation about how the Agency should address
harassment and productivity under the statutory directive included the
following:

    In addition, an adequate explanation that addresses the
distinction between productivity and harassment must also describe
what precisely it is that will prevent harassment from occurring.
The Agency needs to consider what types of harassment already exist,
how frequently and to what extent harassment happens, and how an
electronic device capable of contemporaneous transmission of
information to a motor carrier will guard against (or fail to guard
against) harassment. A study of these problems with EOBRs already in
use, and a comparison with carriers that do not use these devices,
might be one obvious way to measure any effect that requiring EOBRs
might have on driver harassment (Id. at 588-89).

    As a result of the vacatur, carriers relying on electronic devices
to monitor HOS compliance are currently governed by the Agency's
previous rules regarding the use of automatic on-board recording
devices (49 CFR 395.15). The requirements set forth in 49 CFR 395.15
were not affected by the Seventh Circuit's decision regarding the
technical specifications set out in 49 CFR 395.16 in the EOBR 1 Final
Rule.

Meeting Participation and Information FMCSA Seeks From the Public

    The listening session is open to the public. Speakers' remarks will
be limited to five minutes each. The public may submit material to the
FMCSA staff at the session for inclusion in the public docket, FMCSA-
2010-0167. FMCSA will docket the transcription of the listening session
that will be prepared by an official court reporter.
    FMCSA tasked the Motor Carrier Safety Advisory Committee (MCSAC)
with addressing harassment through Task 12-01, titled, ``Measures to
Ensure Electronic On-Board Recorders (EOBRs) Are Not Used to Harass
Commercial Motor Vehicle (CMV) Operators''. MCSAC held public meetings
on this task on February 7-8, 2012, and based on its deliberations,
submitted a report to the FMCSA Administrator on February 8, 2012. This
report is available for review at: http://mcsac.fmcsa.dot.gov/meeting.htm and the public docket, FMCSA-2010-0167. The questions posed
to MCSAC will be used as a template for public comment and discussion
at the listening session.
    The comments sought from the questions below may be submitted in
written form at the session and summarized verbally, if desired:
    1. In terms of motor carriers' and enforcement officials'
monitoring or review of drivers' records of duty status (RODS), what
would constitute driver harassment? Would that definition change based
on whether the system for recording HOS is paper or electronically
based? If so, how? As a starting point, the Agency is interested in
potential forms of harassment, including but not limited to those that
are: (1) Not prohibited already by current statutes and regulations;
(2) distinct from monitoring for legitimate business purposes (e.g.,
efforts to maintain or improve productivity); and (3) facilitated or
made possible solely by EOBR devices and not as a result of functions
or features that motor carriers may choose to purchase, such as fleet
management system capabilities. Is this interpretation appropriate?
Should it be broader? Or narrower?
    2. Are there types of driver harassment to which drivers are
uniquely vulnerable if they are using EOBRs rather than paper logs? If
so, what and how would use of an EOBR rather than a paper log make a
driver more susceptible to harassment? Are there ways in which the use
of an EOBR rather than a paper log makes a driver less susceptible to
harassment?

    3. What types of harassment are motor carrier drivers subjected to
currently, how frequently, and to what extent does this harassment
happen? How would an electronic device capable of contemporaneous
transmission of information to a motor carrier guard against (or fail
to guard against) this kind of harassment? What experience have motor
carriers and drivers had with carriers using EOBRs as compared to those
who do not use these devices in terms of their effect on driver
harassment or complaints of driver harassment?
    4. What measures should the Agency consider taking to eliminate the
potential for EOBRs to be used to harass drivers? Are there specific
functions and capabilities of EOBRs that should be restricted to reduce
the likelihood of the devices being used to harass vehicle operators?
    5. Motor carriers are often responsible for managing their drivers
and equipment to optimize efficiency and productivity and to ensure
transportation services are provided in accordance with a planned
schedule. Carriers commonly use electronic devices, which may include
but are not limited to EOBRs, to enhance productivity and optimize
fleet operation. Provided such devices are not used to coerce drivers
into violating Federal safety regulations, where is the line between
legitimate productivity measures and inappropriate oversight or actions
that may be construed as harassment?

II. Alternative Media Broadcasts During and Immediately After the
Listening Session on March 23, 2012

    FMCSA will webcast the listening session on the Internet. Specific
information on how to participate via the Internet and the telephone
access number will be on the FMCSA Web site at http://www.fmcsa.dot.gov. FMCSA will docket the transcripts of the webcast and
a separate transcription of the listening session that will be prepared
by an official court reporter.

    Issued on: February 24, 2012.
William A. Bronrott,
Deputy Administrator.
[FR Doc. 2012-4876 Filed 2-28-12; 8:45 am]
BILLING CODE P


[Federal Register: July 9, 2008 (Volume 73, Number 132)]
[Rules and Regulations]
[Page 39256-39261]
[DOCID:fr09jy08-17]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0893; FRL-8370-9]

Sethoxydim; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues
of sethoxydim and its metabolites containing the 2-cyclohexen-1-one
moiety, in or on various oilseed commodities. Interregional Research
Project Number 4 (IR-4) requested these tolerances under the Federal
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 9, 2008. Objections and
requests for hearings must be received on or before September 8, 2008,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2007-0893. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at http://www.regulations.gov, or,
if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr.,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket Facility
telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Susan Stanton, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
     Crop production (NAICS code 111).

     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://
www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of EPA's tolerance regulations at
40 CFR part 180 through the Government Printing Office's pilot e-CFR
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, any person may file an objection to
any aspect of this regulation and may also request a hearing on those
objections. You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in 40 CFR part
178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2007-0893 in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk as required by 40 CFR part 178 on or
before September 8, 2008.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2007-0893, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.

II. Petition for Tolerance

    In the Federal Register of September 28, 2007 (72 FR 55204) (FRL-
8147-1), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
7E7232) by Interregional Research Project Number 4 (IR-4), 500 College
Road East, Suite 201W, Princeton, NJ 08540. The petition requested that
40 CFR 180.412 be amended by establishing tolerances for combined
residues of the herbicide sethoxydim, 2-[1-(ethoxyimino)butyl]-5-[2-
(ethylthio)propyl]-3-hydroxy-2-cyclohexen-1-one, and its metabolites
containing the 2-cyclohexen-1-one moiety (calculated as the herbicide),
in or on cuphea, seed at 35.0 parts per million (ppm); echium, seed at
35.0 ppm; gold of pleasure, seed at 35.0 ppm; gold of pleasure, meal at
40.0 ppm; hare's ear mustard, seed at 35.0 ppm; lesquerella, seed at
35.0 ppm; lunaria, seed at 35.0 ppm; meadowfoam, seed at 35.0 ppm;
milkweed, seed at 35.0 ppm; mustard, seed at 35.0 ppm; oil radish, seed
at 35.0 ppm; poppy, seed at 35.0 ppm; sesame, seed at 35.0 ppm; sweet
rocket, seed at 35.0 ppm; crambe, seed at 35.0 ppm; and crambe, meal at
40.0 ppm. That notice referenced a summary of the petition prepared by
BASF, the registrant, on behalf of IR-4, which is available to the
public in the docket, http://www.regulations.gov. There were no
comments received in response to the notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for the petitioned-for
tolerances for combined residues of sethoxydim and its metabolites
containing the 2-cyclohexen-1-one moiety on crambe, meal at 40.0 ppm;
crambe, seed at 35.0 ppm; cuphea, seed at 35.0 ppm; echium, seed at
35.0 ppm; gold of pleasure, meal at 40.0 ppm; gold of pleasure, seed at
35.0 ppm; hare's ear mustard, seed at 35.0 ppm; lesquerella, seed at
35.0 ppm; lunaria, seed at 35.0 ppm; meadowfoam, seed at 35.0 ppm;
milkweed, seed at 35.0 ppm; mustard, seed at 35.0 ppm; oil radish, seed
at 35.0 ppm; poppy, seed at 35.0 ppm; sesame, seed at 35.0 ppm; and
sweet rocket, seed at 35.0 ppm. EPA's assessment of exposures and risks
associated with establishing these tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    The acute toxicity data indicate that sethoxydim is minimally toxic
via oral, dermal and inhalation routes of exposure. It is neither
irritating to the eye nor the skin. With repeated dosing, the primary
target organ for this chemical is the liver. In the chronic toxicity
study in dogs, there were significantly increased absolute and

relative liver weights accompanied by supportive clinical chemistry and
histopathology. Dose-related clinical chemistry abnormalities were
observed in both sexes and included increased alkaline phosphatase and
aspartate aminotransferase (ALT) and decreased albumin and cholesterol
synthesis. Dose-related histopathologic lesions were found in the
liver, spleen and bone marrow. A mild hepatocellular cytoplasmic
alteration was found in males at all doses and in females at the mid
and high doses. Adverse liver effects were also observed via the oral
route in mice and via the inhalation route in rats. There was no
evidence of carcinogenicity in studies in rats and mice and no evidence
of mutagencity, immunotoxicity or endocrine disruption in the toxicity
database for sethoxydim. In the prenatal developmental studies in rats
and rabbits and reproductive toxicity study in rats, the primary
effects noted in the young were fetal skeletal variations and decreases
in body weight. Although effects suggestive of neurotoxicity were noted
in adult and young rats in the developmental and/or reproductive
toxicity studies, EPA has concluded that sethoxydim is not a neurotoxic
chemical. The weight of evidence EPA considered in making this
determination is discussed in more detail in Unit III.D.3.ii.
    Specific information on the studies received and the nature of the
toxic effects caused by sethoxydim as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies can be found in the final rule
published in the Federal Register of September 29, 2003 (68 FR 55858)
(FRL-7238-6)(http://www.epa.gov/EPA-PEST/2003/September/Day-29/
p24562.htm).

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the NOAEL in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the LOAEL or a Benchmark Dose (BMD)
approach is sometimes used for risk assessment. Uncertainty/safety
factors (UFs) are used in conjunction with the POD to take into account
uncertainties inherent in the extrapolation from laboratory animal data
to humans and in the variations in sensitivity among members of the
human population as well as other unknowns. Safety is assessed for
acute and chronic dietary risks by comparing aggregate food and water
exposure to the pesticide to the acute population adjusted dose (aPAD)
and chronic population adjusted dose (cPAD). The aPAD and cPAD are
calculated by dividing the POD by all applicable UFs. Aggregate short-
term, intermediate-term, and chronic-term risks are evaluated by
comparing food, water, and residential exposure to the POD to ensure
that the margin of exposure (MOE) called for by the product of all
applicable UFs is not exceeded. This latter value is referred to as the
Level of Concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk. Thus, the Agency estimates
risk in terms of the probability of an occurrence of the adverse effect
greater than that expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/
pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for sethoxydim used for
human risk assessment can be found at http://www.regulations.gov in the
document Sethoxydim: Amended human health risk assessment to support
uses on the Rapeseed Crop Subgroup 20A at page 10 in docket ID number
EPA-HQ-OPP-2007-0893.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to sethoxydim, EPA considered exposure under the petitioned-
for tolerances as well as all existing sethoxydim tolerances in 40 CFR
180.412. EPA assessed dietary exposures from sethoxydim in food as
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    In estimating acute dietary exposure, EPA used food consumption
information from the United States Department of Agriculture (USDA)
1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by
Individuals (CSFII). As to residue levels in food, EPA assumed that 100
percent of all crops with existing or pending tolerances are treated
with sethoxydim and contain tolerance-level residues.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA assumed that 100
percent of all crops with existing or pending tolerances are treated
with sethoxydim and contain tolerance-level residues.
    iii. Cancer. Based on the results of carcinogenicity studies in
rats and mice, EPA classified sethoxydim as ``not likely to be
carcinogenic to humans''; therefore, an exposure assessment for
evaluating cancer risk is not needed for this chemical.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue or PCT information in the dietary
assessment for sethoxydim. Tolerance level residues and 100 PCT were
assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for sethoxydim in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of sethoxydim. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST) and
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of sethoxydim for acute
exposures are estimated to be 130 parts per billion (ppb) for surface
water and 1.5 ppb for ground water; and for chronic exposures for non-
cancer assessments are estimated to be 16 ppb for surface water and 1.5
ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 130 ppb was used to assess
the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 16 ppb was used to assess
the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Sethoxydim is currently registered for the following uses that
could result in residential exposures: Ornamentals and flowering
plants, recreational areas, and buildings/structures (outdoor). EPA
assessed residential handler and

postapplication exposures using the following assumptions:
    Homeowners who apply sethoxydim to ornamental gardens and turf may
be exposed for short-term durations via the dermal and inhalation
routes. Dermal endpoints of concern were not identified for sethoxydim;
therefore, dermal exposure and risk assessments are not appropriate.
Short-term inhalation exposure was assessed for residential handlers
who mix, load and apply liquid sethoxydim products using low-pressure
hand wands, backpack sprayers and garden hose-end sprayers.
    Sethoxydim can be used in areas, such as home lawns, that may be
frequented by adults and children. There is potential for dermal
exposure of adults and children as well as incidental oral exposure of
children following application of sethoxydim to such areas. Post-
application inhalation exposure of adults and children is expected to
be negligible. Since there are no dermal endpoints of concern for
sethoxydim, only post-application incidental oral exposure of children
was assessed. EPA assessed incidental oral exposure of toddlers from
hand-to-mouth, object-to-mouth and incidental soil ingestion activities
using Standard Operating Procedures for Residential Exposure
Assessments.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found sethoxydim to share a common mechanism of
toxicity with any other substances, and sethoxydim does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
sethoxydim does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at http://
www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA safety
factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. The prenatal and postnatal
toxicity database for sethoxydim includes rat and rabbit developmental
toxicity studies and a 2-generation reproduction toxicity study in
rats. There was no evidence of increased quantitative or qualitative
susceptibility of in utero rabbit fetuses following exposure to
sethoxydim in the rabbit developmental study; however, evidence of
increased susceptibility was noted in the rat developmental and
reproduction toxicity studies as described below:
    There was some evidence of qualitative susceptibility in the rat
developmental study with the occurrence of more severe effects in the
fetuses (delayed ossification and tail abnormalities) than in the
maternal animals (transient clinical signs including: Irregular gait
and decreased activity) at the same dose. The degree of concern for
increased susceptibility in this study is low and there are no residual
uncertainties for the following reasons: The effects in the pups were
of low incidence and only observed at a high dose that is considered to
be close to a limit dose. In addition, these effects were seen in the
presence of clear maternal toxicity and clear NOAELs and LOAELs were
established for both maternal and developmental toxicities.
    In the 2-generation reproduction study in rats, pups showed
decreases in body weight (11 to 13%) during lactation at the high dose.
At the same dose, adult female animals exhibited body weight losses (8
to 10%) that are considered too small to qualify as an adverse effect.
The determination that body weight effects occurred in pups at a dose
that did not result in maternal toxicity is technically an indication
of quantitative susceptibility. However, the degree of concern for the
body weight changes in pups is low, since the weight changes are
considered minimal and the differences observed in body weight losses
between the adult and young animals are marginal. Characterization of
the body weight changes as an adverse effect in the pups is considered
conservative (protective).
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for sethoxydim is complete.
    ii. Sethoxydim is not considered to be a neurotoxic chemical and
there is no need for a developmental neurotoxicity study or additional
UFs to account for neurotoxicity. Clinical signs suggestive of
neurotoxicity (including irregular gait, decreased activity, excessive
salivation, and anogenital staining) were observed in adult rats in the
developmental toxicity study. Because the clinical signs occurred
shortly after dosing, only occurred at very high treatment doses (over
one half the limit dose) and were transitory, it is unlikely that the
signs observed are the result of a primary systemic effect on the
nervous system but, rather, are reflective of the general toxicity at a
high dose. An increased incidence of fetal skeletal variations due to
delayed ossification was seen in young rats in the developmental and
reproductive toxicity studies. In the rat prenatal study, tail
abnormalities (filamentous tail or lack of a tail) were noted. These
abnormalities were observed at a very low incidence and at high
treatment doses. In the 2-generation reproduction study in rats, a tail
anomaly (short, thread-like tail, no anal opening, hindlimbs curved
toward central midline) was found in one pup in the F2b generation (1/
344 total pups; in 1/4 litters). Tail abnormalities are sometimes
thought to relate to central nervous system (CNS) malformations;
however, in this case, these tail abnormalities are not likely to be
the result of a primary neural tube effect. In the rat prenatal study,
there is no description of any effect on neural tube-derived
structures. No other effects suggestive of neurotoxicity were seen in
toxicology studies conducted with sethoxydim. Furthermore,
cyclohexones, the class of compounds that includes sethoxydim, are not
known to cause neurotoxicity or developmental malformations of the
nervous system. Based on the weight of the evidence, EPA concluded that
sethoxydim is not neurotoxic.
    iii. There is no evidence that sethoxydim results in increased
susceptibility in in utero rabbits in the prenatal developmental study.
Although there is qualitative evidence of increased susceptibility in
the prenatal developmental study in rats and equivocal evidence of
quantitative susceptibility in the 2-generation

reproduction study in rats, the degree of concern is low, and the
Agency did not identify any residual uncertainties after establishing
toxicity endpoints and traditional UFs to be used in the risk
assessment of sethoxydim.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed
assuming 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to sethoxydim in drinking water. EPA used similarly
conservative assumptions to assess postapplication exposure of children
as well as incidental oral exposure of toddlers. These assessments will
not underestimate the exposure and risks posed by sethoxydim.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases given the
estimated aggregate exposure. Short-term, intermediate-term, and
chronic-term risks are evaluated by comparing the estimated aggregate
food, water, and residential exposure to the POD to ensure that the MOE
called for by the product of all applicable UFs is not exceeded.
    1. Acute risk. An acute aggregate risk assessment takes into
account exposure estimates from acute dietary consumption of food and
drinking water. Using the exposure assumptions discussed in this unit
for acute exposure, the acute dietary exposure from food and water to
sethoxydim will occupy 17% of the aPAD for children, 1 to 2 years old,
the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
sethoxydim from food and water will utilize 94% of the cPAD for
children, 1 to 2 years old, the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
sethoxydim is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Sethoxydim is
currently registered for uses that could result in short-term
residential exposure and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to sethoxydim, except residential
inhalation exposures. It is not appropriate to aggregate dietary (i.e.,
oral) exposures and inhalation exposures because the toxic effects
identified for the oral and inhalation exposure pathways differ.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures aggregated result in an aggregate MOE of
1,300 for children 1 to 2 years old (toddlers). The aggregate MOE for
children includes food, drinking water and post-application incidental
oral exposures from entering turf areas previously treated with
sethoxydim. Adult residential handler MOEs, based on inhalation
exposure of adults who mix, load and apply liquid sethoxydim products
using low-pressure hand wands, backpack sprayers or garden hose-end
sprayers, range from 1.4 x 10\6\ to 1.6 x 10\6\, with hose-end sprayers
resulting in the lowest MOE. As noted in the previous paragraph, it is
not appropriate to aggregate chronic exposure from food and water with
inhalation exposures. Post-application inhalation exposure of adults
and children is expected to be negligible.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Sethoxydim is not registered for any use patterns that would
result in intermediate-term residential exposure. Therefore, the
intermediate-term aggregate risk is the sum of the risk from exposure
to sethoxydim through food and water, which has already been addressed,
and will not be greater than the chronic aggregate risk.
    5. Aggregate cancer risk for U.S. population. EPA has classified
sethoxydim into the category ``Not Likely to be Carcinogenic to
Humans.'' Sethoxydim is not expected to pose a cancer risk.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to sethoxydim residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography with flame
photometric detection in the sulfur mode; BASF Wyandotte Corporation's
Method No. 30; 3/15/82; MRID 44864501; Method I, Pesticide Analytical
Methods Vol. II) is available to enforce these oilseed tolerances.

B. International Residue Limits

    There are no CODEX, Canadian or Mexican maximum residue limits
(MRLs) established on the commodities associated with this petition.

V. Conclusion

    Therefore, tolerances are established for combined residues of
sethoxydim, 2-[1-(ethoxyimino)butyl]-5-[2-(ethylthio)propyl]-3-hydroxy-
2-cyclohexen-1-one, and its metabolites containing the 2-cyclohexen-1-
one moiety, in or on crambe, meal at 40.0 ppm; crambe, seed at 35.0
ppm; cuphea, seed at 35.0 ppm; echium, seed at 35.0 ppm; gold of
pleasure, meal at 40.0 ppm; gold of pleasure, seed at 35.0 ppm; hare's
ear mustard, seed at 35.0 ppm; lesquerella, seed at 35.0 ppm; lunaria,
seed at 35.0 ppm; meadowfoam, seed at 35.0 ppm; milkweed, seed at 35.0
ppm; mustard, seed at 35.0 ppm; oil radish, seed at 35.0 ppm; poppy,
seed at 35.0 ppm; sesame, seed at 35.0 ppm; and sweet rocket, seed at
35.0 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, Actions Concerning Regulations
That Significantly Affect Energy Supply, Distribution, or Use (66 FR
28355, May 22, 2001) or Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). This final rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., nor does it require any special
considerations under Executive Order 12898, entitled Federal Actions to

Address Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: June 30, 2008.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. Section 180.412 is amended by alphabetically adding the following
commodities to the table in paragraph (a) to read as follows:

Sec.  180.412  Sethoxydim; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Crambe, meal.........................................               40.0
Crambe, seed.........................................               35.0
                                * * * * *
Cuphea, seed.........................................               35.0
                                * * * * *
Echium, seed.........................................               35.0
                                * * * * *
Gold of pleasure, meal...............................               40.0
Gold of pleasure, seed...............................               35.0
                                * * * * *
Hare's ear mustard, seed.............................               35.0
                                * * * * *
Lesquerella, seed....................................               35.0
                                * * * * *
Lunaria, seed........................................               35.0
Meadowfoam, seed.....................................               35.0
                                * * * * *
Milkweed, seed.......................................               35.0
Mustard, seed........................................               35.0
                                * * * * *
Oil radish, seed.....................................               35.0
                                * * * * *
Poppy, seed..........................................               35.0
                                * * * * *
Sesame, seed.........................................               35.0
                                * * * * *
Sweet rocket, seed...................................               35.0
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. E8-15519 Filed 7-8-08; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 82, Number 76 (Friday, April 21, 2017)]
[Notices]
[Pages 18802-18805]
[FR Doc No: 2017-08059]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-80470; File No. SR-CBOE-2017-030]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change To Amend the MDX Fees Schedule

April 17, 2017.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on April 3, 2017, Chicago Board Options Exchange, Incorporated
(the ``Exchange'' or ``CBOE'') filed with the Securities and Exchange
Commission (the ``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

    Chicago Board Options Exchange, Incorporated (the ``Exchange'' or
``CBOE'') proposes to amend its MDX fees schedule. The text of the
proposed rule change is available on the Exchange's Web site (http://www.cboe.com/AboutCBOE/CBOELegalRegulatoryHome.aspx), at the Exchange's
Office of the Secretary, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the 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
    The Exchange proposes to make a number of changes to the Fees
Schedule of the Exchange's affiliate Market Data Express, LLC
(``MDX''). The purpose of the proposed rule change is to amend fees for
the Best Bid and Offer (``BBO'') data feed. This data feed is made
available by MDX.
BBO Data Feed
    The BBO Data Feed is a real-time data feed that includes the
following information: (i) Outstanding quotes and standing orders at
the best available price level on each side of the market; (ii)
executed trades time, size, and price; (iii) totals of customer versus
non-customer contracts at the BBO; (iv) all-or-none contingency orders
priced better than or equal to the BBO; (v) expected opening price and
expected opening size; (vi) end-of-day summaries by product, including
open, high, low, and closing price during the trading session; (vi)
recap messages any time there is a change in the open, high, low or
last sale price of a listed option; (vii) Complex Order Book (``COB'')
information; and (viii) product IDs and codes for all listed options
contracts. The quote and last sale data contained in the BBO data feed
is identical to the data sent to the Options Price Reporting Authority
for redistribution to the public.
Background
    Fees for the BBO data feed are payable by all ``Customers.'' A
``Customer'' is any person, company or other entity that, pursuant to a
market data agreement with MDX, is entitled to receive data, either
directly from MDX or through an authorized redistributor (i.e., a
Customer or an extranet service provider), whether that data is
distributed externally or used internally.\3\ In addition to the BBO
Data Fee assessed to Customers, the Exchange assesses reduced ``user
fees'' for entities who access BBO data through a Display Only Service
or as a Floor Broker User.
---------------------------------------------------------------------------

    \3\ The MDX fee schedule for CBOE data is located at https://www.cboe.org/MDX/CSM/OBOOKMain.aspx.
---------------------------------------------------------------------------

    In March 2017, the Exchange adopted a fee of $100 per month, per
Approved Third-Party Device, for Floor Broker Users accessing the BBO
data feed on the Exchange floor.\4\ An ``Approved Third-Party Device''
means any computer, workstation or other item of equipment, fixed or
portable, that receives, accesses and/or displays data in visual,
audible or other form that has been provided by a third-party and that
has been approved, by CBOE, for use on the CBOE trading floor. A
``Floor Broker User'' is a person or entity registered with CBOE as a
floor broker pursuant to CBOE Rules.
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release No. 80286 (March 21,
2017), 82 FR 15247 (March 27, 2015) (SR-CBOE-2017-022).
---------------------------------------------------------------------------

    Floor Brokers use the BBO Data Feed primarily to comply with
customer priority obligations, such as those outlined in CBOE Rule 6.45
(as mentioned above, the BBO data includes customer contracts at the
BBO). Floor Brokers who receive the BBO data feed via Approved Third
Party Device are not considered ``Customers'' of MDX to whom the BBO
Data Fee applies (unless the Floor Broker has a separate market data
agreement in place with MDX) and accordingly are not charged the BBO
Data Fee. Additionally, a third-party vendor of an Approved Third-Party
Device is not a Customer unless it has a market data agreement in place
with MDX.
    In addition to Floor Broker User Fees, the Exchange assesses User
fees payable for external Display Only Service users (Devices or user
IDs of Display Only Service users who receive data from a Customer and
are not employees or natural person independent contractors of the
Customer, the Customer's affiliates or an authorized service
facilitator). For the purpose of Display Only Service users, a
``Device'' means any computer, workstation or other item of equipment,
fixed or portable, that receives, accesses and/or displays data in
visual, audible or other form.
Fee Cap
    The Exchange is proposing Floor Broker User fees be subject to a
monthly cap of $1000 per Trading Permit Holder (``TPH'') firm. The cap
will limit the amount of Floor Broker User fees a TPH firm will pay in
a calendar month to $1000 in the event said TPH firm accesses the BBO
data feed through more than 10 Approved Third-Party Devices. As Floor
Broker Users are using the BBO data primarily to meet their priority
obligations (and not for proprietary trading purposes), the Exchange
believes it is appropriate to limit the amount of Floor Broker User
fees to be assessed to a TPH firm.
    By way of example, if a TPH firm accesses the BBO data feed through
14 Approved Third-Party Devices, said TPH firm would currently be
assessed Floor Broker User fees of $1400 per month (14 Approved Third-
Party Devices x $100 per Approved Third-Party Device = $1400). Under
the proposed cap, the same TPH firm accessing the BBO data feed through
14 Approved Third-Party Devices would be assessed Floor Broker User
fees of $1000 per month (14 Approved Third-Party Devices x $100 per
Approved Third-Party Device (subject to a monthly cap of $1000 per TPH
firm) = $1000).
Additional MDX Fee Schedule Updates
    The Exchange is proposing a number of additional updates to the MDX
fee schedule to clarify certain items as they relate to Floor Broker
User fees or User fees for Display Only Users. First, the Exchange is
specifying that a Floor Broker User, as defined below, is not a
Customer unless it has a market data agreement in place with MDX. In
addition, the Exchange is changing the name of ``User fees'' payable
for external Display Only Service Users to ``Display Only User fees''
in order to reduce confusion with the BBO Data fee or Floor Broker User
fees. Finally, the Exchange is deleting language on the MDX schedule
stating that ``Floor Broker Users may directly interact with the CBOE
Hybrid Order Handling System and view and manipulate data using their
Approved Third-Party Devices, but not save, copy, export or transfer
the data or any results of a manipulation to any other computer
hardware, software or media, except for printing it to paper or other
non-magnetic media''. The Exchange believes that, as outlined above,
``Floor Broker Users'' and ``Approved Third-Party Devices'' are
adequately defined elsewhere in the MDX fee schedule. The Exchange does
not believe the deleted language is necessary to further clarify or
limit what a Floor Broker User may or may not do with the BBO data it
receives via Approved Third-Party Device.
Display Only User and Floor Broker User Fee Reporting
    In addition to the clarifications above, the Exchange is adding
language to the MDX schedule to explain the reporting process used to
determine applicable Display Only User fees and Floor Broker User fees.
With regard to the Display Only User fees, the proposed language
states, ``Customers who distribute BBO Data to external users via a
Display Only service must report to MDX the number of authorized
external devices that

receive BBO data from the Customer during a calendar month within 15
days after such month in the manner and format specified by MDX from
time to time to determine applicable fees.'' With regard to the Floor
Broker User fees, the proposed language states, ``Third-party vendors
who distribute BBO Data to Floor Broker Users via Approved Third-Party
Devices must report to MDX the number of Approved Third-Party Devices
that receive BBO data from such third party vendor during a calendar
month within 15 days after such month in the manner and format
specified by MDX from time to time to determine applicable fees.''
Including the reporting processes used to determine applicable Display
Only User fees and Floor Broker User fees on the MDX fee schedule will
provide greater clarity to both Customers who provide Display Only
Services to users and third-party vendors of Approved Third-Party
Devices. Furthermore, including the reporting processes will ensure the
Exchange accurately charges fees for these services.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Securities Exchange Act of 1934 (the ``Act'') and the rules and
regulations thereunder applicable to the Exchange and, in particular,
the requirements of Section 6(b) of the Act.\5\ Specifically, the
Exchange believes the proposed rule change is consistent with Section
6(b)(4) of the Act,\6\ which requires that Exchange rules provide for
the equitable allocation of reasonable dues, fees, and other charges
among its Trading Permit Holders and other persons using its
facilities. The Exchange also believes the proposed rule change is
consistent with the Section 6(b)(5) \7\ requirement that the rules of
an exchange not be designed to permit unfair discrimination between
customers, issuers, brokers, or dealers.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(4).
    \7\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange believes the proposed Floor Broker User fee cap is
equitable and not unfairly discriminatory because it would apply
equally to all TPH firms using Approved Third-Party Devices on the
Exchange trading floor. Furthermore, the Exchange believes it is
reasonable, equitable and not unfairly discriminatory to cap Floor
Broker User Fees because Floor Broker Users generally use the data for
the limited purpose of meeting their order priority obligations (as
opposed to using the data for proprietary trading activity).
    The Exchange believes the additional updates to the MDX fee
schedule related to further defining Floor Broker users and the
reporting obligations of Customers and third-party vendors of Approved
Third Party Devices are designed to add clarity and reduce confusion
related to the BBO Data Feed and will therefore lead to the equitable
allocation of reasonable dues, fees, and other charges among its TPHs
and other persons using its facilities.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The proposed fee cap on
Floor Broker User Fees will not have an impact on intramarket
competition as it will apply to all TPH firms equally who use more than
10 Approved Third-Party Devices. The other clarifications made to the
fee schedule related to further defining Floor Broker users and the
reporting obligations of Customers and third-party vendors of Approved
Third Party Devices will not have an impact on intramarket competition
as they are non-substantive and only designed to add clarity to the fee
schedule and reduce confusion among TPHs and other persons accessing
the BBO data feed.
    Furthermore, the Exchange does not believe that the proposed fee
cap will cause any unnecessary burden on intermarket competition
because the proposed change only affects trading on the Exchange's
trading floor. To the extent that the proposed changes make the
Exchange a more attractive marketplace for market participants at other
exchanges, such market participants are welcome to become CBOE market
participants.

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

    The Exchange neither solicited nor received comments on the
proposed rule change.

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) of the Act \8\ and paragraph (f) of Rule 19b-4 \9\
thereunder. 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 necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission will institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

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-CBOE-2017-030 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-CBOE-2017-030. 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-CBOE-2017-030, and should be submitted on
or before May 12, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
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    \10\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Brent J. Fields,
Secretary.
[FR Doc. 2017-08059 Filed 4-20-17; 8:45 am]
BILLING CODE 8011-01-P