[Federal Register Volume 88, Number 27 (Thursday, February 9, 2023)]
[Notices]
[Pages 8506-8509]
[FR Doc No: 2023-02716]

-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-96799; File No. SR-DTC-2023-001]

Self-Regulatory Organizations; The Depository Trust Company;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Amend the Clearing Agency Risk Management Framework

February 3, 2023.
    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on January 30, 2023, The Depository Trust Company (``DTC'') filed with
the Securities and Exchange Commission (``Commission'') the proposed
rule change as described in Items I, II and III below, which Items have
been prepared by the clearing agency. DTC filed the proposed rule
change pursuant to section 19(b)(3)(A) of the Act \3\ and Rule 19b-
4(f)(4) thereunder.\4\ 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.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(4).
---------------------------------------------------------------------------

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

    The proposed rule change amends the Clearing Agency Risk Management
Framework (``Risk Management Framework'', or ``Framework'') of DTC and
its affiliates, Fixed Income Clearing Corporation (``FICC'') and
National Securities Clearing Corporation (``NSCC,'' and together with
FICC, the ``CCPs'' and the CCPs together with DTC, the ``Clearing
Agencies'').\5\ Specifically, the proposed rule change would amend the
Risk Management Framework to (1) update the description of the
dashboards used by the Clearing Agencies as internal performance
management tools to measure the effectiveness of their various
operations; and (2) clarify and revise the descriptions of certain
matters within the Framework and correct errors in those descriptions,
as further described below. The proposed changes would update and
clarify the Risk Management Framework but do not reflect changes to how
the Clearing Agencies comply with the applicable requirements of Rule
17Ad-22(e), as described in greater detail below.
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release Nos. 81635 (September
15, 2017), 82 FR 44224 (September 21, 2017) (File Nos. SR-DTC-2017-
013; SR-FICC-2017-016; SR-NSCC-2017-012) (``Initial Filing'') and
Securities Exchange Act Release No. 89271 (July 09, 2020), 85 FR
42933 (July 15, 2020) (File No. SR-NSCC-2020-012); Securities
Exchange Act Release No. 89269 (July 09, 2020), 85 FR 42954 (July
15, 2020) (File No. SR-DTC-2020-009); and Securities Exchange Act
Release No. 89270 (July 09, 2020), 85 FR 42927 (July 15, 2020) (File
No. SR-FICC-2020-007) (together with the Initial Filing, the
``Framework Filings'').
---------------------------------------------------------------------------

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

    In its filing with the Commission, the clearing agency 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 clearing agency has prepared summaries,
set forth in sections A, B, and C below, of the most significant
aspects of such statements.

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

1. Purpose
    The Clearing Agencies adopted the Risk Management Framework \6\ to
provide an outline for how each of the Clearing Agencies (i) maintains
a well-founded, clear, transparent and enforceable legal basis for each
aspect of its activities; (ii) comprehensively manages legal, credit,
liquidity, operational, general business, investment, custody, and
other risks that arise in or are borne by it; (iii) identifies,
monitors, and manages risks related to links it establishes with one or
more clearing agencies, financial market utilities, or trading markets;
(iv) meets the requirements of its participants and the markets it
serves efficiently and effectively; (v) uses, or at a minimum
accommodates, relevant internationally accepted communication
procedures and standards in order to facilitate efficient payment,
clearing and settlement; and (vi) publicly discloses certain
information, including market data. In this way, the Risk Management
Framework currently supports the Clearing Agencies' compliance with
Rules 17Ad-22(e)(1), (3), (20), (21), (22)

and (23) of the Standards,\7\ as described in the Framework Filings. In
addition to setting forth the manner in which each of the Clearing
Agencies addresses these requirements, the Risk Management Framework
also contains a section titled ``Framework Ownership and Change
Management'' that, among other matters, describes the Framework
ownership and the required governance process for review and approval
of changes to the Framework. In connection with the annual review and
approval of the Framework by the Board of Directors of each of NSCC,
DTC and FICC (each a ``Board'' and collectively, the ``Boards''), the
Clearing Agencies are proposing to make certain revisions to the
Framework.
---------------------------------------------------------------------------

    \6\ Supra note 5.
    \7\ 17 CFR 240.17Ad-22(e)(1), (3), (20), (21), (22) and (23).
---------------------------------------------------------------------------

    First, the proposed changes would update the Risk Management
Framework to reflect a change to the dashboards used by the Clearing
Agencies as internal performance management tools to measure the
effectiveness of various aspects of their operations, as described in
greater detail below.
    The proposed changes would also clarify and enhance the
descriptions in the Risk Management Framework and correct errors in
those descriptions by, for example, (1) enhancing the description of
the Clearing Agencies processes for management of certain risks through
risk tolerance statements; (2) clarifying the description of the
``Three Lines of Defense,'' including but not limited to updating the
descriptions of the ``first line of defense,'' the ``second line of
defense,'' and the ``third line of defense,'' (3) clarifying the
definition of Rules; (4) enhancing the description of the purpose and
approval process of ``Risk Management Frameworks;'' (5) updating the
name of the Operational Risk Management group and the Third Party Risk
function.
    Finally, the proposed changes would capitalize terms that
mistakenly were not previously capitalized but refer to a specific
term, remove an unnecessary citation and make certain grammatical
changes.
i. Proposed Amendments To Update the Description of Performance
Measurement Tools
    The proposed changes would update the Risk Management Framework to
reflect a recent change to the dashboards that are used by the Clearing
Agencies as internal performance management tools and address their
compliance with the requirements of Rule 17Ad-22(e)(21).\8\ Section 4.3
of the Framework identifies certain processes implemented by the
Clearing Agencies to be efficient and effective in meeting the
requirements of their respective participants and the markets they
serve.\9\ This list of processes is not meant to be exhaustive, and the
Clearing Agencies may use other methods to achieve their goals and meet
their regulatory requirements. The proposed change would update the
Framework to remove reference to a process that was previously used by
the Clearing Agencies to monitor their performance and the review
standards for such processes.
---------------------------------------------------------------------------

    \8\ 17 CFR 240.17Ad-22(e)(21).
    \9\ Id.
---------------------------------------------------------------------------

    The Clearing Agencies previously used the DTCC Core Balanced
Scoreboard (``BBS'') to provide insight into the effectiveness of their
various operations in meeting the needs of their participants and the
markets they serve. The Clearing Agencies have eliminated the BBS and
now utilize multiple other dashboards to measure the outcomes that were
previously measured by the BBS. The elimination of the BBS is not a
material change in how the Clearing Agencies approach risk management,
as they are simply using other methods to continue to comply with the
requirements of Rule 17Ad-22(e)(21).\10\ The use of multiple dashboards
allows for a more holistic view of the performance of the Clearing
Agencies and their subsidiaries. The proposed change would also enhance
the descriptions of these processes by describing the annual review of
this process and how results are tracked.
---------------------------------------------------------------------------

    \10\ Supra note 8.
---------------------------------------------------------------------------

ii. Proposed Amendment To Clarify, Enhance, and Correct Descriptions in
the Framework
    The proposed changes would improve the clarity and
comprehensiveness of the descriptions of certain matters within the
Risk Management Framework and correct grammatical errors in certain
descriptions. Some specific examples of such proposed changes include:
1. Proposed Change To Describe the Clearing Agencies' Assessment and
Review of Risk Tolerance Statements
    Section 3 of the Framework describes management's responsibility to
establish risk tolerance statements for the range of risks that arise
in or are borne by the Clearing Agencies. Section 3 also outlines the
review and approval process for such risk tolerance statements and the
Clearing Agencies' performance relative to those statements. The
proposed change would clarify that the Clearing Agencies' performance
relative to those risk tolerance statements is assessed quarterly and
is shared with senior management and the Board Risk Committees of the
Clearing Agencies.
2. Proposed Changes To Clarify the Description of the ``Three Lines of
Defense''
    Section 3.1 of the Framework describes the ``three lines of
defense'' approach adopted by each of the Clearing Agencies for
identifying, assessing, measuring, monitoring, mitigating, and
reporting the risks that arise in or are borne by it. A proposed change
would remove the last sentence of this Section, which states, ``While
the Framework provides a general description of the Three Lines of
Defense approach for risk management, the Three Lines of Defense
approach may be used by the Clearing Agencies for managing specific
risks, for example operational risk, which is addressed in the
Operational Risk Management Framework (see Section 3 below)'' This
sentence is unnecessarily duplicative of the statements in Section
3.3.3 of the Framework which provides details of the various
frameworks, separate and apart from this Framework, used by the
Clearing Agencies to manage specific risks and, therefore, may cause
confusion to a reader. The deletion of the sentence would resolve any
such possible confusion, thereby clarifying the entirety of Section 3.
The Clearing Agencies are also proposing a change to enhance the
examples provided in Section 3.1.1 to illustrate the Clearing Agency
Business/Support Areas role as the first line of defense in managing
risk by adding two additional examples: (a) ``Defining and monitoring
business risk metrics applicable to their function;'' and (b) ``Clearly
understanding and reporting the residual, unmitigated risk that is
acceptable to their function.'' Additionally, a proposed change to
Section 3.1.3 would update the description of the responsibilities of
internal audit to be in line with the internal audit charter.
3. Proposed Change To Clarify the Definition of ``Rules''
    Section 3.3.2 of the Framework includes a defined term for the
``Rules'' of the Clearing Agencies. The proposed change would clarify
that the ``Rules'' referred to for purposes of this Framework are filed
with the Commission. Therefore, the proposed change would update the
definition of Rules for clarification purposes and

would not substantively change the definition.
4. Enhance the Description of the Purpose and Approval Process of
``Risk Management Frameworks''
    Section 3.3.3 describes the system of frameworks, maintained by the
Clearing Agencies, separate and apart from this Framework to manage a
range of risks. This Section outlines in greater detail certain of
these risk management frameworks and their purpose. The proposed
changes to this Section 3.3.3 would enhance the description of one of
these frameworks; clarify that such frameworks are in support of this
Framework; and clarify that such frameworks may be approved by an
applicable Board committee as delegated by the Boards, pursuant to the
Document Standards described in this Framework.
5. Stating a Change to the Name of the Vendor Risk Management Group and
to the Third-Party Risk Function Group
    The Framework describes the role of the Operational Risk Management
Group as the group that manages incidents, and the Third-Party
Management Function manages third party risks to the Clearing Agencies.
The proposed change would update the Framework to reflect a change in
the name of these two groups. The Operational Risk Management Group is
now referred to as Operational and Technology Risk and the Third-Party
Risk Management group is now referred to as Third Party Risk. This
proposed change would reflect a recent organizational name change.
6. Proposed Changes To Capitalize Defined Terms and Correct Grammatical
and Formatting Errors, Removal of Citation
    These proposed changes would fix grammatical errors and capitalize
terms that should be defined terms in the Framework or removes
inconsistent wording. Some of these changes include: (i) make IOSCO a
defined term in footnote 2 for clarification purposes; (ii) change the
word ``settlement'' to ``settling'' in Section 4.2 for consistency; (3)
remove the words ``and Liquidity Providers'' from the heading ``Risks
Related to Investment Counterparties and Liquidity Providers'' in
Section 4.2.1 as the paragraph does not discuss liquidity providers and
(4) deletion of footnote 21 as unnecessary.
    The proposed rule change would make additional immaterial edits to
the Framework that do not alter how the Clearing Agencies comply with
the applicable requirements of Rule 17Ad-22(e).
2. Statutory Basis
    The Clearing Agencies believe that the proposed changes are
consistent with section 17A(b)(3)(F) of the Act \11\ for the reasons
described below. Section 17A(b)(3)(F) of the Act requires, in part,
that the rules of a registered clearing agency be designed to promote
the prompt and accurate clearance and settlement of securities
transactions, and to assure the safeguarding of securities and funds
which are in the custody or control of the clearing agency or for which
it is responsible.\12\ The proposed changes would (1) update the Risk
Management Framework to remove reference to the BBS and include a
description of the governance around the dashboards used by the
Clearing Agencies to measure the effectiveness of their operations, and
(2) clarify the descriptions of certain matters within the Framework to
improve comprehensiveness and correct errors, as described above. By
creating clearer, updated descriptions and correcting errors, the
Clearing Agencies believe that the proposed changes would make the Risk
Management Framework more effective in providing an overview of the
important risk management activities of the Clearing Agencies, as
described therein.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78q-1(b)(3)(F).
    \12\ Id.
---------------------------------------------------------------------------

    As described in the Framework Filings, the risk management
functions described in the Risk Management Framework allow the Clearing
Agencies to continue to promote the prompt and accurate clearance and
settlement of securities transactions and continue to assure the
safeguarding of securities and funds which are in their custody or
control or for which they are responsible notwithstanding the default
of a member of an affiliated family. The proposed changes to improve
the clarity and accuracy of the descriptions of risk management
functions within the Framework would assist the Clearing Agencies in
carrying out these risk management functions. Therefore, the Clearing
Agencies believe these proposed changes are consistent with the
requirements of section 17A(b)(3)(F) of the Act.\13\
---------------------------------------------------------------------------

    \13\ Id.
---------------------------------------------------------------------------

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

    The Clearing Agencies do not believe that the proposed changes to
the Framework described above would have any impact, or impose any
burden, on competition. As described above, the proposed rule change
would improve the comprehensiveness of the Framework by creating
clearer, updated descriptions and correcting errors, thereby making the
Risk Management Framework more effective in providing an overview of
the important risk management activities of the Clearing Agencies. As
such, the Clearing Agencies do not believe that the proposed rule
change would have any impact on competition.

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

    DTC has not received or solicited any written comments relating to
this proposal. If any written comments are received, they will be
publicly filed as an Exhibit 2 to this filing, as required by Form 19b-
4 and the General Instructions thereto.
    Persons submitting comments are cautioned that, according to
Section IV (Solicitation of Comments) of the Exhibit 1A in the General
Instructions to Form 19b-4, the Commission does not edit personal
identifying information from comment submissions. Commenters should
submit only information that they wish to make available publicly,
including their name, email address, and any other identifying
information.
    All prospective commenters should follow the Commission's
instructions on how to submit comments, available at https://www.sec.gov/regulatory-actions/how-to-submitcomments. General questions
regarding the rule filing process or logistical questions regarding
this filing should be directed to the Main Office of the Commission's
Division of Trading and Markets at [email protected] or 202-
551-5777.
    DTC reserves the right not to respond to any comments received.

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

    The foregoing rule change has become effective pursuant to section
19(b)(3)(A) \14\ of the Act and paragraph (f) \15\ of Rule 19b-4
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.
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78s(b)(3)(A).
    \15\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

    The proposal shall not take effect until all regulatory actions
required with respect to the proposal are completed.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-DTC-2023-001 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE, Washington, DC 20549.
All submissions should refer to File Number SR-DTC-2023-001. 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 website (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 website 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 DTC and on DTCC's website
(http://dtcc.com/legal/sec-rule-filings.aspx). All comments received
will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-DTC-2023-001 and should be submitted on
or before March 2, 2023.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
---------------------------------------------------------------------------

    \16\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-02716 Filed 2-8-23; 8:45 am]
BILLING CODE 8011-01-P


FILE NAME: company. wpt ( 1/ 1/ 2005) ( xml) Template Number P25 ATTENTION:

All commodity terms must comply with the Food and Feed Commodity Vocabulary database ( http:// www. epa. gov/ pesticides/ foodfeed/).

All text in blue font ( instructions for preparing the document), should be removed prior to sending the document to the Federal Register Staff. Instructional text and prompts in green font should also be removed.

COMPANY FEDERAL REGISTER DOCUMENT SUBMISSION TEMPLATE ( 1/ 1/ 2005)

EPA Registration Division contact: [ insert name and telephone number with area code]

INSTRUCTIONS: Please utilize this outline in preparing tolerance petition documents. In cases where the outline element does not apply please insert " NA Remove" and maintain the outline. The comment notes that appear on the left margin represent hidden typesetting codes designed to expedite the processing of the Federal Register document. Please do not remove or alter these comment notes or change the margins, font, or format in your document. Simply replace the instructions that appear in italics and brackets, i. e., "[ insert company name]," with the information specific to your action.

TEMPLATE:

[ Bayer CropScience]

[ Insert petition number]

EPA has received a pesticide petition ([ insert petition number]) from [[ Bayer CropScience], [ P. O. Box 12014, 2 T. W. Alexander Drive, Research Triangle Park, NC 27709] proposing, pursuant to section 408( d) of the Federal Food, Drug, and Cosmetic Act ( FFDCA), 21 U. S. C. 346a( d), to amend 40 CFR part 180.

Options ( pick one)

by establishing a tolerance for residues of 2 [ trifloxystrobin] in or on the raw agricultural commodity [ soybean, seed] at [ 0.08] parts per million ( ppm); soybean, forage at 8 ppm; soybean, hay at 20 ppm; and grain, aspirated fractions at 4.2 ppm. EPA has determined that the petition contains data or information regarding the elements set forth in section 408( d)( 2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry 1. Plant metabolism. [ The metabolism of trifloxystrobin in plants ( cucumbers, apples, wheat, sugar beets and peanuts) is well understood. Identified metabolic pathways are substantially similar in plants and animals ( goat, rat and hen). EPA has determined that trifloxystrobin parent and its metabolite CGA 321113 are the residue of concern for tolerance setting purposes.]

2. Analytical method. [ A practical analytical methodology for detecting and measuring levels of trifloxystrobin in or on raw agricultural commodities has been submitted. The limit of detection ( LOD) for each analyte of this method is 0.08 ng injected, and the limit of quantitation ( LOQ) is 0.02 ppm. The method is based on crop specific cleanup procedures and determination by gas chromatography with nitrogen phosphorus detection.]

3. Magnitude of residues. [ Twenty field trials were conducted in major soybean growing areas of the United States using Stratego Fungicide. Bayer CropScience analyzed the samples for trifloxystrobin and propiconazole at the targeted PHI of 0 days for soybean forage and hay, and 21 days for soybean seed. For trifloxystrobin, the highest average field trial equivalent residues in soybean forage, hay, and seed were 6.42 ppm, 16.8 ppm, and 0.057 ppm, respectively. For propiconazole, the highest average field trial equivalent residues in soybean forage, hay, and seed were 8.43 ppm, 26.4 ppm, and 0.214 ppm, respectively.

Bayer CropScience conducted a processing study at 5X the maximum proposed rate on soybeans using Stratego Fungicide. Data from this study showed no concentration of the total trifloxystrobin or propiconazole residue in soybean hulls, meal, or refined oil. For aspirated grain fractions, the study showed a 70X concentration of total trifloxystrobin residue and a 23X concentration in propiconazole residue. ]

B. Toxicological Profile 1. Acute toxicity. [ Studies conducted with the technical material of trifloxystrobin: 3 rat acute oral toxicity study with a LD50 > 5000 mg/ kg mouse acute oral toxicity study with a LD50 > 5000 mg/ kg rabbit acute dermal toxicity study with a LD50 > 2000 mg/ kg rat acute dermal toxicity study with a LD50 > 2000 mg/ kg rat acute inhalation toxicity study with a LC50 > 4.65 mg/ L rabbit eye irritation study showing slight irritation ( Category III) rabbit dermal irritation study showing slight irritation ( Category IV) Guinea pig dermal sensitization study with the Buehler's method showing negative findings Guinea pig dermal sensitization study with the Maximization method showing some positive findings.]

2. Genotoxicty. [ No genotoxic activity is expected of trifloxystrobin under in vivo or physiological conditions. The compound has been tested for its potential to induce gene mutation and chromosomal changes in five different test systems. The only positive finding was seen in the in vitro test system ( Chinese hamster V79 cells) as a slight increase in mutant frequency at a very narrow range ( 250  278 µ g/ ml) of cytotoxic and precipitating concentrations ( compound solubility in water was reported to be 0.61 µ g/ ml; precipitate was visually noted in culture medium at 150 µ g/ ml). The chemical was found to be non mutagenic in the in vivo system or all other in vitro systems. Consequently, the limited gene mutation activity in the V79 cell line is considered a nonspecific effect under non physiological in vitro conditions and not indicative of a real mutagenic hazard.]

3. Reproductive and developmental toxicity. [ FFDCA section 408 provides that EPA may apply an additional safety factor for infants and children in the case of threshold effects to account for pre and post natal toxicity and the completeness of the database. Based on the current toxicological data requirements, the database on trifloxystrobin relative to pre and post natal effects for children is complete.

In assessing the potential for additional sensitivity of infants and children to residues of trifloxystrobin, data were considered from teratogenicity studies in the rat and the rabbit and a 2 generation reproduction studies in the rat. The teratogenicity studies are designed to evaluate adverse effects on the developing embryo as a result of chemical exposure during the period of organogenesis. Reproduction studies provide information on effects from chemical exposure on the reproductive capability of mating animals and systemic and developmental toxicity from in utero exposure.

In the rat teratology study, reductions in body weight gain and food consumption were observed in the dam at $ 100 mg/ kg. No teratogenic effects or any other effects were seen on pregnancy or fetal parameters except for the increased incidence of enlarged thymus, which is a type of variation, at 1000 mg/ kg. The developmental NOEL was 100 mg/ kg. 4 In the rabbit teratology study, body weight loss and dramatically reduced food consumption were observed in the dam at $ 250 mg/ kg. No teratogenic effects or any other effects were seen on pregnancy or fetal parameters except for the increase in skeletal anomaly of fused sternebrae 3 and  4 at the top dose level of 500 mg/ kg. This finding is regarded as a marginal effect on skeletal development that could have resulted from the 40 65% lower food intake during treatment at this dose level. The developmental NOEL was 250 mg/ kg.

In the 2 generation rat reproduction study, body weight gain and food consumption were decreased at $ 750 ppm, especially in females during lactation. Consequently, the reduced pup weight gain during lactation ($ 750 ppm) and the slight delay in eye opening ( 1500 ppm) are judged to be a secondary effect of maternal toxicity. No other fetal effects or any reproductive changes were noted. The low developmental NOEL, 50 ppm ( 5 mg/ kg), seen in this study was probably due to the lack of intermediate dose levels between 50 and 750 ppm. Based on an evaluation of the dose response relationship for pup weight at 750 ppm and 1500 ppm, the NOEL should have been nearly ten fold higher if such a dose was available.

Based on all these teratology and reproduction studies, the lowest NOEL for developmental toxicity is 5 mg/ kg while the lowest NOEL in the subchronic and chronic studies is 2.5 mg/ kg/ day ( from the rat chronic study). Therefore, no additional sensitivity for infants and children to trifloxystrobin is suggested by the database.]

4. Subchronic toxicity. [ In subchronic studies, several mortality related changes were reported for the top dose in dogs ( 500 mg/ kg) and rats ( 800 mg/ kg). At these dose levels, excessive toxicity has resulted in body weight loss and mortality with the associated and nonspecific changes in several organs ( such as atrophy in the thymus, pancreas, bone marrow, lymph node, and spleen) which are not considered specific target organs for the test compound. In the dog, specific effects were limited to hepatocellular hypertrophy at $ 150 mg/ kg and hyperplasia of the epithelium of the gall bladder at 500 mg/ kg. Target organ effects in the rat were noted as hepatocellular hypertrophy ( $ 200 mg/ kg) and the related liver weight increase ($ 50 mg/ kg). In the mouse, target organ effects included single cell necrosis ($ 300 mg/ kg) and hypertrophy ( 1050 mg/ kg) in the liver and extramedullary hematopoiesis ($ 300 mg/ kg) and hemosiderosis in the spleen ( 1050 mg/ kg).

In general, definitive target organ toxicity, mostly in the liver, was seen at high feeding levels of over 100 mg/ kg for an extended treatment period. At LOEL, no serious toxicity was observed other than mostly non specific effects including a reduction in body weight and food consumption or liver hypertrophy.] 5 5. Chronic toxicity. [ The liver appears to be the major primary target organ based on the chronic studies conducted in mice, rats, and dogs. It was identified as a target organ in both the mouse and the dog studies with trifloxystrobin. However, no liver effect was seen in the chronic rat study which produced the lowest NOEL of 2.5 mg/ kg based on reduced body weight gain and food consumption seen at higher dose levels.

The compound did not cause any treatment related increase in general tumor incidence, any elevated incidence of rare tumors, or shortened time to the development of palpable or rapidly lethal tumors in the 18 month mouse and the 24 month rat studies. Dosages in both studies were sufficient for identifying a cancer risk. In the absence of carcinogenicity, a Reference Dose approach is appropriate for quantitation of human risks.]

6. Animal metabolism. [ Trifloxystrobin is moderately absorbed from the gastrointestinal tract of rats and is rapidly distributed. Subsequent to a single oral dose, the half life of elimination is about 2 days and excretion is primarily via bile. Trifloxystrobin is extensively metabolized by the rat into about 35 metabolites, but the primary actions are on the methyl ester ( hydrolysis into an acid), the methoxyimino group ( O demethylation), and the methyl side chain ( oxidation to a primary alcohol). Metabolism is dose dependent as it was almost complete at low doses but only about 60% complete at high doses.

In the goat, elimination of orally administered trifloxystrobin is primarily via the feces. The major residues were the parent compound and the acid metabolite ( CGA 321113) plus its conjugates. In the hen, trifloxystrobin is found as the major compound in tissues and in the excreta, but hydroxylation of the trifluormethyl phenyl moiety and other transformations, including methyl ester hydrolysis and demethylation of the methoxyimino group, are also seen. In conclusion, the major pathways of metabolism in the rat, goat, and hen are the same.]

7. Metabolite toxicology. [ Metabolism of trifloxystrobin has been well characterized in plants, soil, and animals. In plants and soil, photolytically induced isomerization results in a few minor metabolites not seen in the rat; however, most of the applied materials remained as parent compound as shown in the apple and cucumber studies. All quantitatively major plant and/ or soil metabolites were also seen in the rat. The toxicity of the major acid metabolite, CGA 321113 ( formed by hydrolysis of the methyl ester), has been evaluated in cultured rat hepatocytes and found to be 20 times less cytotoxic than the parent compound. Additional toxicity studies were conducted for several minor metabolites seen uniquely in plants and/ or soil. The studies indicate that these metabolites, including CGA 357261, CGA 373466, and NOA 414412, are not mutagenic to bacteria and are of low acute toxicity ( LD50 > 2000 mg/ kg). In conclusion, the metabolism and toxicity profiles 6 support the use of an analytical enforcement method that accounts for parent trifloxystrobin.]

8. Endocrine disruption. [ Trifloxystrobin does not belong to a class of chemicals known for having adverse effects on the endocrine system. Developmental toxicity studies in rats and rabbits and reproduction study in rats gave no indication that trifloxystrobin might have any effects on endocrine function related to development and reproduction. The subchronic and chronic studies also showed no evidence of a long term effect related to the endocrine system.]

C. Aggregate Exposure 1. Dietary exposure. [ Assessments, using the DEEM FCID Version 2.0, 1994 1996,98 CSFII software, were conducted to evaluate potential risks due to chronic and acute dietary exposure of the U. S. population and selected population subgroups to residues of trifloxystrobin. These analyses cover all registered crops plus the pending uses on barley, oats, sweet corn, grasses grown for seed, and soybeans.

The EPA has established an acute Population Adjusted Dose ( aPAD) of 2.5 mg/ kg/ day for acute dietary risk assessments based on a NOAEL of 250 mg/ kg bwt/ day from a rabbit developmental toxicity study and an uncertainty factor or 100. For chronic dietary analyses, the EPA established a chronic Population Adjusted Dose ( cPAD) of 0.038 based on a NOAEL of 3.8 from a rat reproductive toxicity study and an uncertainty factor of 100.

Results from the acute and chronic dietary exposure analyses described below demonstrate a reasonable certainty that no harm to the overall U. S. population or any population subgroup will result from the use of trifloxystrobin on currently registered uses plus the pending uses on barley, oats, sweet corn, grasses grown for seed, and soybeans.]

I. Food. [ For food, a Tier 1 acute and a Tier 2 chronic dietary exposure assessments were performed. Acute exposure, expressed at the 95th percentile of exposure, was 0.55% of the aPAD for females 13 49 years old ( only population subgroup of concern). The chronic exposure was 2.5% cPAD for the total US population and 13.5% cPAD for the most sensitive population, children 1 2 years old.]

ii. Drinking water. [ The DEEM software was also used to calculate acute and chronic drinking water levels of concern ( aDWLOC and cDWLOC). The aDWLOC was 74,598 and the cDWLOC was 1,297 for the total US population and 329 for the most sensitive 7 population subgroup, children 1 2 years old. These values are above realistic estimated concentrations of trifloxystrobin and its metabolites in drinking water as published in the Federal Register ( 68 FR 53297). Therefore, there is reasonable certainty that exposure from trifloxystrobin will not result in harm to the adult U. S. population, females 13 49, or infants and children.]

2. Non dietary exposure. [ As published in the Federal Register ( 68 FR 53297), the EPA considered chronic, short term and intermediate term risk from residential uses of trifloxystrobin. The EPA determined that the risk did not exceed the Agency's level of concern.]

D. Cumulative Effects [ EPA has determined, as published in the Federal Register ( 68 FR 53297), that unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, trifloxystrobin does not appear to produce a toxic metabolite produced by other substances. Therefore EPA has not assumed that trifloxystrobin has a common mechanism of toxicity with other substances.]

E. Safety Determination 1. U. S. population. [ Based on the information supplied under Aggregate Exposure describe above, there is reasonable certainty that exposure from trifloxystrobin will not result in harm to the adult U. S. population.]

2. Infants and children. [ Based on the information supplied under Aggregate Exposure describe above, there is reasonable certainty that exposure from trifloxystrobin will not result in harm to infants and children.]

F. International Tolerances [ Brazil and Turkey have established MRLs for trifloxystrobin on soybeans. No Codex MRLs have been established for trifloxystrobin.]


[Federal Register Volume 82, Number 43 (Tuesday, March 7, 2017)]
[Notices]
[Pages 12901-12902]
[FR Doc No: 2017-04386]

-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2008-0071; FMCSA-2012-0044; FMCSA-2012-0107; FMCSA-
2014-0015; FMCSA-2014-0016]

Qualification of Drivers; Exemption Applications; Diabetes

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

ACTION: Notice of final disposition.

-----------------------------------------------------------------------

SUMMARY: FMCSA announces its decision to renew exemptions of 78
individuals from its prohibition in the Federal Motor Carrier Safety
Regulations (FMCSRs) against persons with insulin-treated diabetes
mellitus (ITDM) from operating commercial motor vehicles (CMVs) in
interstate commerce. The exemptions enable these individuals with ITDM
to continue to operate CMVs in interstate commerce.

DATES: Each group of renewed exemptions was effective on the dates
stated in the discussions below and will expire on the dates stated in
the discussions below.

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

SUPPLEMENTARY INFORMATION:

I. Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at: http://www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments, go to http//www.regulations.gov and/or 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., e.t., Monday through Friday,
except Federal holidays.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to http://www.regulations.gov, as described in
the system of records notice (DOT/ALL-14 FDMS), which can be reviewed
at http://www.dot.gov/privacy.

II. Background

    On December 29, 2016, FMCSA published a notice announcing its
decision to renew exemptions for 78 individuals from the insulin-
treated diabetes mellitus prohibition in 49 CFR 391.41(b)(3) to operate
a CMV in interstate commerce and requested comments from the public (81
FR 96176). The public comment period ended on January 30, 2017, and no
comments were received.
    As stated in the previous notice, FMCSA has evaluated the
eligibility of these applicants and determined that renewing these
exemptions would achieve a level of safety equivalent to or greater
than the level that would be achieved by complying with the current
regulation 49 CFR 391.41(b)(3).
    The physical qualification standard for drivers regarding diabetes
found in 49 CFR 391.41(b)(3) states that a person is physically
qualified to drive a CMV if that person has no established medical
history or clinical diagnosis of diabetes mellitus currently requiring
insulin for control.

III. Discussion of Comments

    FMCSA received no comments in this preceding.

IV. Conclusion

    Based upon its evaluation of the 78 renewal exemption applications
and that no comments were received, FMCSA confirms its' decision to
exempt the following drivers from the rule prohibiting drivers with
ITDM from driving CMVs in interstate commerce in 49 CFR 391.41(b)(3):
    As of June 3, 2016, and in accordance with 49 U.S.C. 31136(e) and
31315, the following 10 individuals have satisfied the renewal
conditions for obtaining an

exemption from the rule prohibiting drivers with ITDM from driving CMVs
in interstate commerce (73 FR 16946; 73 FR 31734):

Edward F. Connole (MA)
Gary D. Coonfield (MO)
Francis W. Devine (NJ)
Shannon D. Hanson (SD)
Aundra Menefield (MS)
James T. Rothwell (TN)
Randy A. Shannon (MT)
Dalton T. Smith, Jr. (IL)
Marvin D. Webster (KY)
Travis S. Wolfe (WV)

    The drivers were included in docket No. FMCSA-2008-0071. Their
exemptions are effective as of June 3, 2016, and will expire on June 3,
2018.
    As of June 5, 2016, and in accordance with 49 U.S.C. 31136(e) and
31315, the following 10 individuals have satisfied the renewal
conditions for obtaining an exemption from the rule prohibiting drivers
with ITDM from driving CMVs in interstate commerce (77 FR 20876; 77 FR
33264):

Steven W. Beaty (SD)
David D. Brown (MI)
Evan P. Hansen (WI)
Todd A. Heitschmidt (WA)
John M. Kennedy, Jr. (NC)
Jeremy A. Ludolph (KS)
Gerald N. Martinson (ND)
Glenn D. Taylor (NY)
Thomas R. Toews (OR)
James E. Waller, III (GA)

    The drivers were included in docket No. FMCSA-2012-0044. Their
exemptions are effective as of June 5, 2016, and will expire on June 5,
2018.
    As of June 12, 2016, and in accordance with 49 U.S.C. 31136(e) and
31315, John C. Fisher, Jr. (PA) has satisfied the renewal conditions
for obtaining an exemption from the rule prohibiting drivers with ITDM
from driving CMVs in interstate commerce (79 FR 22573; 79 FR 35855).
    This driver was included in docket No. FMCSA-2014-0015. His
exemption was effective as of June 12, 2016, and will expire on June
12, 2018.
    As of June 20, 2016, and in accordance with 49 U.S.C. 31136(e) and
31315,
    Gary R. Harper (IN) has satisfied the renewal conditions for
obtaining an exemption from the rule prohibiting drivers with ITDM from
driving CMVs in interstate commerce (79 FR 29484; 79 FR 42628).
    This driver was included in docket No. FMCSA-2014-0016. His
exemption was effective as of June 20, 2016, and will expire on June
20, 2018.
    As of June 24, 2016, and in accordance with 49 U.S.C. 31136(e) and
31315, the following 46 individuals have satisfied the renewal
conditions for obtaining an exemption from the rule prohibiting drivers
with ITDM from driving CMVs in interstate commerce (79 FR 22573; 79 FR
35855):

Joshua T. Adams (OH)
Dennis W. Athey II (KS)
John M. Behan, Jr. (MD)
Peterson Benally (NM)
Kirk B. Berridge (KS)
Francis P. Bourgeois (LA)
Randall T. Buffkin (NC)
Terry S. Bunge (WI)
Heladio Castillo (WA)
Purvis J. Chesson (VA)
Bonnie F. Craig (OR)
Jeff T. Enbody (WA)
Larry S. Gibson, II (NC)
James M. Halapchuk (PA)
Jeffery A. Hall (ME)
Henry W. Hartman (NY)
Marlin R. Hein (IA)
Clifford E. Hill (WA)
Robert E. Hunt (MT)
Vincenzo Ingrassellino (NY)
Davis Jansen van Beek (MT)
Baek J. Kim (MD)
Shawn N. Kimble (PA)
Darrel G. Klauer (WI)
Stephen D. Lewis (NY)
Kerry W. McCarthy (IN)
Alvin McClain (OR)
Kenneth D. Mehmen (IA)
Kyle B. Mitchell (CA)
Thomas R. Moore, Jr. (AZ)
Michael A. Murrell (KY)
Ryan R. Ong (CA)
Gregory Paradiso (OH)
Brian K. Patenaude (MA)
Traci L. Patterson (CA)
Chad A. Powell (MO)
Richard C. Schendel (MN)
William A. Schimpf (CA)
Frank J. Sciulli (PA)
Bryan J. Smith (ND)
Edward L. Stauffer (PA)
William H. Stone, Sr. (FL)
Kyle G. Streit (TX)
Joseph D. Stutzman (PA)
Raymond J. Vaillancourt (OH)
Robert L. Weiland (PA)

    The drivers were included in docket No. FMCSA-2014-0015. Their
exemptions are effective as of June 24, 2016, and will expire on June
24, 2018.
    As of June 26, 2016, and in accordance with 49 U.S.C. 31136(e) and
31315, Thomas R. Riley (IL) has satisfied the renewal conditions for
obtaining an exemption from the rule prohibiting drivers with ITDM from
driving CMVs in interstate commerce (79 FR 29484; 79 FR 42628).
    This driver was included in docket No. FMCSA-2014-0016. His
exemption was effective as of June 26, 2016, and will expire on June
26, 2018.
    As of June 27, 2016, and in accordance with 49 U.S.C. 31136(e) and
31315, the following 9 individuals have satisfied the renewal
conditions for obtaining an exemption from the rule prohibiting drivers
with ITDM from driving CMVs in interstate commerce (77 FR 27842; 77 FR
38383):

Matthew R. Bagwell (NY)
Eric J. Bright (IL)
Kyle D. Dale (MO)
Frank E. Glenn (IL)
Kevin N. Mitchell (GA)
Gerald Perkins (CA)
Donald L. Philpott (WA)
John Randolph (OK)
Courtney R. Schiebout (IA)

    The drivers were included in docket No. FMCSA-2012-0107. Their
exemptions are effective as of June 27, 2016, and will expire on June
27, 2018.
    In accordance with 49 U.S.C. 31315, each exemption will be valid
for two years from the effective date unless revoked earlier by FMCSA.
The exemption will be revoked if the following occurs: (1) The person
fails to comply with the terms and conditions of the exemption; (2) the
exemption has resulted in a lower level of safety than was maintained
prior to being granted; or (3) continuation of the exemption would not
be consistent with the goals and objectives of 49 U.S.C. 31136 and
31315.

    Issued on: February 27, 2017.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2017-04386 Filed 3-6-17; 8:45 am]
 BILLING CODE 4910-EX-P