[Federal Register Volume 77, Number 39 (Tuesday, February 28, 2012)]
[Rules and Regulations]
[Pages 11748-11750]
[FR Doc No: 2012-4476]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 70

[EPA-R07-OAR-2011-0995; FRL-9634-8]

Approval and Promulgation of Implementation Plans; State of
Missouri

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule; notice of administrative change and correction.

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SUMMARY: EPA is taking final action on administrative changes to the
State Implementation Plan (SIP) and the Operating Permits Program. The
first revision is an administrative change that codifies EPA's prior
approval of a SIP submission which re-numbers references to the St.
Louis City Code local ordinance. The second revision is a correction
which reinserts text that

was inadvertently removed and re-letters a paragraph which codifies a
recent approval of revisions to Missouri's Title V operating permits
program related to the Submission of Emission Data, Emission Fees and
Process Information.

DATES: This action is effective February 28, 2012.

FOR FURTHER INFORMATION CONTACT: Amy Bhesania at<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' or
``our'' refer to EPA.

Outline

I. What is being addressed in this document?
II. What action is EPA taking?

I. What is being addressed in this document?

    EPA is taking final action on administrative changes to the State
Implementation Plan (SIP) and the Operating Permits Program. On April
5, 2011, Missouri submitted a SIP revision requesting to local
ordinance numbers in the St. Louis City Code. EPA determined that the
revision was a minor SIP revision without any substantive changes and
complied with all applicable requirements of the CAA and EPA
regulations concerning such SIP revisions. EPA approved this revision
through letter notice to Missouri dated November 23, 2011 consistent
with the procedures outlined in EPA's Notice of Procedural Changes on
SIP processing published on January 19th, 1989 at 54 FR 2214 and
consistent with the procedures outlined in an April 6, 2011 memo from
Janet McCabe, Deputy Assistant Administrator for the Office of Air and
Radiation, regarding Regional Consistency for the Administrative
Requirements of State Implementation. Today's action merely codifies
the November 23, 2011 administrative amendment to the SIP.
    The second revision is a correction which reinserts text that was
inadvertently removed and re-letters a paragraph which codifies a
recent approval of revisions to Missouri's Title V operating permits
program related to the Submission of Emission Data, Emission Fees and
Process Information that was finalized in 76 FR 77701, December 14,
2011. In that rule, EPA inadvertently removed the text in 40 CFR part
70, app. A, from paragraph (v) for Missouri, and replaced it with new
text which was the subject of that rule. EPA's intent was to add the
new text in a new paragraph rather than to replace existing text. This
action reinstates the removed text in paragraph (v) and moves the
current text in paragraph (v) to new paragraph (z).

II. What action is EPA taking?

    EPA is taking final action on administrative changes to the
Missouri SIP and Operating Permits Program. EPA has determined that
today's action falls under the ``good cause'' exemption in the section
553(b)(3)(B) of the Administrative Procedure Act (APA) which, upon
finding ``good cause,'' authorizes agencies to dispense with public
participation and section 553(d)(3) which allows an agency to make an
action effective immediately (thereby avoiding the 30-day delayed
effective date otherwise provided for in the APA). With respect to the
SIP revision described above, today's administrative action simply
codifies provisions which are already in effect as a matter of law in
Federal and approved state programs. With respect to the revision to
the Missouri Title V operating permit program, this action merely
corrects an error in the designation of paragraphs reflecting
previously approved revisions to the Missouri program. Under section
553 of the APA, an agency may find good cause where procedures are
``impractical, unnecessary, or contrary to the public interest.''
Public comment for this administrative action is ``unnecessary''
because the revisions are administrative and non-substantive in nature.
Immediate notice of this action in the Federal Register benefits the
public by providing the public notice of the updated Missouri SIP and
Title V program.
    Approval of these revisions will ensure consistency between state
and Federally-approved rules. EPA has determined that these changes
will not relax the SIP or adversely impact air emissions.

Statutory and Executive Order Reviews

    Under the Clean Air Act (CAA), the Administrator is required to
approve a SIP submission that complies with the provisions of the Act
and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the CAA. Accordingly,
this action merely approves state law as meeting Federal requirements
and does not impose additional requirements beyond those imposed by
state law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this

action must be filed in the United States Court of Appeals for the
appropriate circuit by April 30, 2012. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. (See section 307(b)(2).)

List of Subjects

40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference.

40 CFR Part 70

    Environmental protection, Air pollution control, Operating permits.

    Dated: February 9, 2012.
Karl Brooks,
Regional Administrator, Region 7.

    Chapter I, title 40 of the Code of Federal Regulations is amended
as follows:

PART 52--[AMENDED]

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

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

Subpart AA--Missouri

0
2. In Sec.  52.1320 the table in paragraph (c) is amended by revising
the title, ``St. Louis City Ordinance 65645'' to read as follows.

Sec.  52.1320  Identification of plan.

* * * * *
    (c) * * *

                                        EPA-Approved Missouri Regulations
----------------------------------------------------------------------------------------------------------------
                                                       State effective
       Missouri citation                Title                date          EPA approval date      Explanation
----------------------------------------------------------------------------------------------------------------
                                    Missouri Department of Natural Resources
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                         St. Louis City Ordinance 68657
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

PART 70--[AMENDED]

0
3. The authority citation for Part 70 continues to read as follows:

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

Appendix A--[Amended]

0
4. Appendix A to Part 70, Missouri, is amended by redesignating
existing paragraph (v) as new paragraph (z) and by adding a new
paragraph (v) to read as follows:

Appendix A to Part 70--Approval Status of State and Local Operating
Permits Programs

* * * * *

Missouri

* * * * *
    (v) The Missouri Department of Natural Resources submitted
revisions to Missouri rule 10 CSR 10-6.110, ``Submission of Emission
Data, Emission Fees, and Process Information'' on December 21, 2007;
approval of section (3)(D) effective November 14, 2008.
* * * * *
[FR Doc. 2012-4476 Filed 2-27-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 214 (Wednesday, November 5, 2014)]
[Notices]
[Pages 65656-65658]
[FR Doc No: 2014-26176]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2010-0751; FRL-9918-46]

Methomyl; Notice of Receipt of Requests To Voluntarily Amend
Registrations To Terminate Certain Uses

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In accordance with the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), EPA is issuing a notice of receipt of requests
by the registrants to voluntarily to amend their methomyl product
registrations to delete one or more uses. The requests would delete
methomyl use in or on barley, oats, and rye. The requests would not
terminate the last methomyl products registered for use in the United
States. EPA intends to grant these requests at the close of the comment
period for this announcement unless the Agency receives substantive
comments within the comment period that would merit its further review
of the requests, or unless the registrants withdraw its requests. If
these requests are granted, any sale, distribution, or use of products
listed in this notice will be permitted after the use is deleted only
if such sale, distribution, or use is consistent with the terms as
described in the final order.

DATES: Comments must be received on or before December 5, 2014.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2010-0751, by one of the following methods:

     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Tom Myers, Pesticide Re-Evaluation
Division (7508P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, and agricultural advocates; the chemical industry; pesticide
users; and members of the public interested in the sale, distribution,
or use of pesticides. Since others also may be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

II. Background on the Receipt of Requests To Amend Registrations to
Delete Uses

    This notice announces receipt by EPA of requests from registrants
to delete certain uses of methomyl product registrations. Methomyl is a
broad-spectrum carbamate insecticide registered for use on a wide range
of field crops, vegetables, fruits, and turf. In letters to EPA, the
registrants have requested EPA to amend their methomyl product labels
to delete certain uses of their pesticide product registrations
identified in Table 1 of Unit III. Specifically, the registrants have
submitted letters to EPA to voluntarily amend their methomyl product
registrations to delete the use of methomyl in or on barley, oats, and
rye. This action on the registrant's requests will terminate the last
methomyl pesticide products registered in the United States for these
uses.

III. What action is the Agency taking?

    This notice announces receipt by EPA of requests from registrants
to delete certain uses of methomyl product registrations. The affected
products and the registrants making the requests are identified in
Tables 1 and 2 of this unit.
    Unless a request is withdrawn by the registrant or if the Agency
determines that there are substantive comments that warrant further
review of this request, EPA intends to issue an order amending the
affected registrations.

                   Table 1--Methomyl Product Registrations With Pending Requests for Amendment
----------------------------------------------------------------------------------------------------------------
        Registration No.               Product name               Company               Uses to be deleted
----------------------------------------------------------------------------------------------------------------
352-342........................  Dupont Lannate SP        Dupont................  Barley, Oats, Rye.
                                  Insecticide.
352-361........................  Dupont Methomyl          Dupont................  Barley, Oats, Rye.
                                  Composition.
352-366........................  Dupont Methomyl          Dupont................  Barley, Oats, Rye.
                                  Technical.
352-384........................  Dupont Lannate LV        Dupont................  Barley, Oats, Rye.
                                  Insecticide.
400-597........................  Annihilate LV..........  MacDermid Agricultural  Barley, Oats, Rye.
                                                           Solutions.
400-598........................  Annihilate SP..........  MacDermid Agricultural  Barley, Oats, Rye.
                                                           Solutions.
70552-2........................  Methomyl Technical.....  Sinon Corporation.....  Barley, Oats, Rye.
81598-9........................  Rotam Methomyl           Rotam Limited.........  Barley, Oats, Rye.
                                  Technical.
82557-2........................  Methomyl 29% SL          Sinon USA Inc.........  Barley, Oats, Rye.
                                  Insecticide.
82557-3........................  Methomyl 90% SP........  Sinon USA Inc.........  Barley, Oats, Rye.
83100-27.......................  Rotam Methomyl 29 LV     Rotam Agrochemical      Barley, Oats, Rye.
                                  Insecticide.             Company, Ltd.
83100-28.......................  Rotam Methomyl 90 SP     Rotam Agrochemical      Barley, Oats, Rye.
                                  Insecticide.             Company, Ltd.
----------------------------------------------------------------------------------------------------------------

    Table 2 of this unit includes the names and addresses of record for
the registrants of the products listed in sequence by EPA company
number. This corresponds to EPA registration numbers in Table 1 of this
unit.

          Table 2--Registrants Requesting Voluntary Amendments
------------------------------------------------------------------------
            EPA Company No.                 Company name and address
------------------------------------------------------------------------
352...................................  E. I. Du Pont de Nemours and
                                         Company, 1007 Market Street,
                                         Wilmington, DE 19898-0001.
400...................................  MacDermid Agricultural
                                         Solutions, Inc., c/o Chemtura
                                         Corporation, 199 Benson Road,
                                         Middlebury, CT 06749.
70552.................................  Sinon Corporation, c/o Biologic,
                                         Inc., 115 Obtuse Hill Road,
                                         Brookfield, CT 06804.
81598.................................  Rotam Limited, c/o Wagner
                                         Regulatory Associates, Inc.,
                                         P.O. Box 640, 7217 Lancaster
                                         Pike, Suite A, Hockessin, DE
                                         19707.
82557.................................  Sinon USA Inc., c/o Biologic,
                                         Inc., 115 Obtuse Hill Road,
                                         Brookfield, CT 06804.

83100.................................  Rotam Agrochemical Company,
                                         Ltd., c/o Wagner Regulatory
                                         Associates, Inc., P.O. Box 640,
                                         7217 Lancaster Pike, Suite A,
                                         Hockessin, DE 19707.
------------------------------------------------------------------------

IV. What is the Agency's authority for taking this action?

    Section 6(f)(1) of FIFRA provides that a registrant of a pesticide
product may at any time request that any of its pesticide registrations
be canceled or amended to terminate one or more uses. FIFRA further
provides that, before acting on the request, EPA must publish a notice
of receipt of any such request in the Federal Register.
    Section 6(f)(1)(B) of FIFRA requires that before acting on a
request for voluntary cancellation, EPA must provide a 30-day public
comment period on the request for voluntary cancellation or use
termination. In addition, FIFRA section 6(f)(1)(C) requires that EPA
provide a 180-day comment period on a request for voluntary
cancellation or termination of any minor agricultural use before
granting the request, unless:
    1. The registrants request a waiver of the comment period, or
    2. The EPA Administrator determines that continued use of the
pesticide would pose an unreasonable adverse effect on the environment.
    The methomyl registrants have requested that EPA waive the 180-day
comment period. Accordingly, EPA will provide a 30-day comment period
on the proposed requests.

V. Procedures for Withdrawal of Requests

    Registrants who choose to withdraw a request for product
cancellation or use deletion should submit the withdrawal in writing to
the person listed under FOR FURTHER INFORMATION CONTACT. If the
products(s) have been subject to a previous cancellation action, the
effective date of cancellation and all other provisions of any earlier
cancellation action are controlling.

VI. Provisions for Disposition of Existing Stocks

    Existing stocks are those stocks of registered pesticide products
that are currently in the United States and that were packaged,
labeled, and released for shipment prior to the effective date of the
action. If the requests for amendments to delete uses are granted, the
Agency intends to publish the cancellation order in the Federal
Register.
    In any order issued in response to these requests for amendments to
delete uses, EPA proposes to include the following provisions for the
treatment of any existing stocks of the products listed in Table 1 of
Unit III.
    Once EPA has approved product labels reflecting the requested
amendments to delete uses, registrants will be permitted to sell or
distribute products under the previously approved labeling for a period
of 18 months after the date of Federal Register publication of the
cancellation order, unless other restrictions have been imposed.
Thereafter, registrants will be prohibited from selling or distributing
the products whose labels include the deleted uses identified in Table
1 of Unit III., except for export consistent with FIFRA section 17 or
for proper disposal.
    Persons other than the registrant may sell, distribute, or use
existing stocks of products whose labels include the deleted uses until
supplies are exhausted, provided that such sale, distribution, or use
is consistent with the terms of the previously approved labeling on, or
that accompanied, the deleted uses.

    Authority: 7 U.S.C. 136 et seq.

    Dated: October 24, 2014.
Richard P. Keigwin, Jr.,
Director, Pesticide Re-Evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2014-26176 Filed 11-4-14; 8:45 am]
BILLING CODE 6560-50-P


EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: Mary Waller,<PHONE_NUMBER>

TEMPLATE:

United Phosphorus, Inc.

Petition Number:

	EPA has received a pesticide petition ([1F7935]) from United Phosphorus, Inc., 630 Freedom Business Center, King of Prussia, PA 19406, requesting, 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 by establishing a tolerance for residues of
mancozeb in or on the raw agricultural commodity walnuts at 0.75 parts per million (ppm) of carbon disulfide equivalents.  EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of  FDDCA; 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 plant metabolism of mancozeb is understood.  Plant metabolism has been evaluated in five diverse crops, including potato, soybean, sugar beet, tomato, and wheat.  These studies demonstrate that mancozeb is extensively metabolized to natural products (proteins, carbohydrates, lipids, lignins, etc.) with minor amounts of degradation products including ethylenethiourea (ETU), ethyleneurea, ethylene bisisocyanate sulfide, and ethylenediamine.

	2. Analytical method.  Residues of mancozeb are determined by decomposing the residue with a strong acid to release carbon disulfide (CS2).  The CS2 can be measured by gas chromatography or by absorbance of a colored copper dithiocarbamate complex formed by sweeping the CS2 through a trap and into a reaction tube containing a solution of copper acetate and an amine.  Adequate methodology for enforcement is available in the Pesticide Analytical Manual (PAM), Volume II, Methods II and III.

	3. Magnitude of residues.  Residue field trials in California demonstrated that the highest residue in mancozeb equivalents was 0.67 ppm, which translates to 0.40 ppm of mancozeb in CS2 equivalents.  The highest residue will be less than the proposed tolerance of 0.75 ppm of mancozeb in CS2 equivalents.

B. Toxicological Profile

	1. Acute toxicity.   Mancozeb is not acutely toxic, with Category IV toxicity for the oral, dermal, and inhalation routes.  Mancozeb is not a skin irritant (Category IV) and it is not a skin sensitizer.  Mancozeb is classified as Category III for eye irritation.

	2. Genotoxicty.   A weight of the evidence evaluation demonstrates that mancozeb is not genotoxic in mammalian systems.

	3. Reproductive and developmental toxicity. i. Developmental toxicity in the rat.  In the developmental study in rats, the maternal (systemic) no observed adverse effect level (NOAEL) was 32 mg/kg/day, with a maternal lowest observed effect level (LOAEL) of 128 mg/kg/day. The developmental NOAEL was 128 mg/kg/day and the developmental LOAEL was 512 mg/kg/day.  The effects at the LOAEL occurred only at doses that produced significant maternal toxicity, including mortality, and are not considered relevant for human risk assessment.  There were no developmental effects at doses below those which were maternally toxic, so mancozeb was not uniquely toxic to the conceptus.
	ii. Developmental toxicity in the rabbit.  In the developmental study in rabbits, the maternal (systemic) NOAEL was 30 mg/kg/day and the maternal LOAEL was 80 mg/kg/day based on reduced feed intake, weight loss, mortality, and clinical signs.  The developmental NOAEL was greater than 80 mg/kg/day because no effects were seen without severe maternal toxicity.  Mancozeb was not developmentally toxic in this study.
	iii. Reproductive toxicity.  In the 2-generation reproduction study in rats, the maternal (systemic) NOAEL was 6.95/7.47 mg/kg/day males/females and the parental LOAEL was 68.90/79.37 mg/kg/day males/females.  The reproductive NOAEL is greater than or equal to 69.90/79.37 mg/kg/day males/females (the highest dose tested).  There were no adverse reproductive or offspring effects.  Mancozeb does not show reproductive toxicity.  In conclusion, mancozeb is not a reproductive toxicant and developmental effects occurred only at doses that were maternally toxic and the effects are secondary to excessive maternal toxicity.

	4. Subchronic toxicity.  i. Rat 90-day feeding study.  A subchronic feeding study in rats conducted for 13 weeks had a NOAEL of 9.24/14.98 mg/kg/day in females/males and a LOAEL of 17.82/57.34 mg/kg/day in females/males.  In males, the LOAEL was 57.34 mg/kg/day.
	ii. Mouse 90-day feeding study.  A 90-day subchronic study resulted in a NOAEL of 18.13/21.68 mg/kg/day in males/females and a LOAEL of 166.9/233.8 mg/kg/day in males/females.
	iii. Dog 90-day feeding study.  A subchronic feeding study in dogs conducted for three months had a NOAEL of 2.98/3.35 mg/kg/day in males/females and a LOAEL of 28.62/28.91 mg/kg/day in males/females.
	iv. Rat 28-day dermal study.  No toxicity, including no changes in thyroid hormones, was seen at the limit dose of 1000 mg/kg/day.  The NOAEL is greater than 1000 mg/kg/day.
	v. Rat 90 day neuropathology study.  A subchronic feeding study in rats conducted for three months had a NOAEL of 8.2 mg/kg/10.5 mg/kg in males/females and a LOAEL of 49.7/63.3 mg/kg in males/females.

	5. Chronic toxicity. . i. Rat.  A 24-month chronic/carcinogenicity study in male and female rats was conducted at 20, 60, 125, or 750 ppm of mancozeb.  The NOAEL was 125 ppm (4.83/6.72 mg/kg/day in males/females) with a LOAEL of 750 ppm (30.9/40.2 mg/kg/day in males/females).
	ii. Mouse.  A 78-week chronic/oncogenicity study was conducted in male and female mice dosed at 0, 30, 100, or 1000 ppm.  The NOAEL was 100 ppm (13/18 mg/kg/day in males/females) and a LOAEL of 1000 ppm (131/180 mg/kg/day in males/females).  There was no evidence of carcinogenicity.
	iii. Dog.  A 1-year feeding study in dogs resulted in a NOAEL of 50 ppm (1.75 mg/kg/day) for males and 200 ppm (7.02 mg/kg/day) for females.  The LOAEL was 200 ppm (7.26 mg/kg/day) in males and 800 ppm (29.24 mg/kg/day) in females.

	6. Animal metabolism. .  The absorption, distribution, excretion, and metabolism of mancozeb in rats, goats, and hens were investigated.  Following oral administration, mancozeb was rapidly and essentially completely excreted.  The bulk of the residue is incorporated into natural products.

	7. Metabolite toxicology. The mancozeb metabolite of toxicological concern is ethylenethiourea (ETU).  ETU is classified as a B2 carcinogen with a Q* of 0.06 (mg/kg/day)-1 based on mouse liver tumors and (3/4) scaling factor.  The non-cancer chronic toxicity of ETU is based on a NOAEL of 0.18 mg/kg/day in a chronic dog study.  Using a 1000X safety factor (100X based on inter- and intra-species uncertainty and 10X database uncertainty factor), the cPAD is 0.0002 mg/kg/day.  The acute endpoint is based on a rat developmental study with a NOAEL of 5 mg/kg/day, resulting in an aPAD of 0.005 mg/kg/day with a 1000X safety factor.   The ETU developmental effects are species-specific.  ETU is not developmentally toxic in rabbits, guinea pigs or cats and has equivocal effects in mice and hamsters.

	8. Endocrine disruption. The endocrine system includes the reproductive hormones estrogen and androgens as well as the thyroid hormone system.  Mancozeb and ETU are not known to interfere with reproductive hormones and mancozeb and ETU do not have reproductive toxicity.  While thyroid effects were seen in testing in rodents, it is well known and accepted that rats are more sensitive to thyroid effects than humans.  Mancozeb and ETU are not expected to show thyroid effects at the levels of human or environmental exposure.  Additionally, the chronic risk assessments are based on thyroid effects and the %cPAD is substantially below the level of concern.

C. Aggregate Exposure

	1. Dietary exposure.   The acute and chronic dietary food exposures utilized anticipated residue values from a market basket survey for ethylenebisdithiocarbamates (EBDCs) and ETU and field trial and food processing data when market basket survey data were not available. Field trial data were used for walnuts.  The acute and chronic exposure assessments for mancozeb and ETU derived from mancozeb uses described in this Notice of Filing are from an April 17, 2007 EPA memorandum titled "PP#4F4324 and 4F4333 Mancozeb Acute, Chronic, and Cancer Dietary Exposure Assessments for New Tolerances on Almonds, Broccoli, Cabbage, Lettuce, and Peppers, from Christina L. Olinger to Cynthia Giles-Parker, DP Number 323878 and 323879.  The assessments for ETU from all EBDCs used in this Notice of Filing are described in EPA's April 17, 2007 memorandum titled:  PP# 9E6006, PP# 4F4324 and 4F4333 Aggregate Dietary Assessment of the Common Metabolite/Degradate Ethylene Thiourea (ETU) to Support New Tolerances on Imported Grapes and Bananas for Metiram and for New Tolerances for Mancozeb on Almonds, Broccoli, Cabbage, Lettuce, and Peppers, from Christine L. Olinger to Cynthia Giles-Parker, DP Barcode: D337240.  The petitioned-for tolerance and the existing mancozeb tolerances in 40 CFR 180.176 were included in EPA's assessments.  EPA used 1% crop treated for mancozeb and 30% crop treated for maneb.  Future exposures will come from 31% crop treated with mancozeb and 0% crop treated for maneb.  Incorporation of this change and use of all of the walnut data described in this petition will not impact the conclusions in the aforementioned EPA documents or the risk assessments described herein.    Numerous refinements can be made with actual percent of crop treated data for some crops and corrections to anticipated residue calculations.  These adjustments will lead to considerable reduction of the acute and chronic exposures.

	i. Food. Dietary exposure assessments for mancozeb and ETU from mancozeb were conducted using the Dietary Exposure Evaluation Model (DEEM) software with the Food Commodity Intake Database (DEEM-FCID(TM) , Version 1.3), which incorporates consumption data from USDA's Continuing Survey of Food Intakes by Individuals (CSFII), 1994-1996 and 1998.  The exposure and risk assessments described in this Notice of Filing include all crops currently on the mancozeb labels plus walnuts.  For the purposes of this Notice of Filing, exposures calculated by EPA in the above-mentioned documents have been used to describe the acute and chronic exposures.
	a.  Acute dietary exposure.  Mancozeb.  The acute exposure for mancozeb is for females 13-49 years of age, the only population group of concern.  The acute risk assessment is based only on residues in food because mancozeb residues are not expected in drinking water.  EPA calculated that the exposure to mancozeb in food including all of the crops on the current label and walnuts with 1% crop treated would be only 0.008926 mg/kg/day at the 99.9th percentile.  This is 6.9% of the aPAD.  (76 Fed. Reg. 18912, April 6, 2011)  As described above, use of 31% crop treated for walnuts will not change the overall assessment..
	ETU.  The acute risk assessment for ETU is a risk from food and water for females 13-49 years of age.  For ETU from mancozeb uses, including all crops currently on the mancozeb label and walnuts with 1% crop treated, EPA calculated that the exposure from food only would be 0.00123 mg/kg/day, or 25% of the aPAD.   The ETU exposure for females 13-49 years old from food and water is 0.00356 mg/kg/day, or 71% aPAD.

	b.  Chronic dietary exposure.  The chronic reference dose for mancozeb is based on a NOAEL of 4.83 mg/kg/day and an uncertainty factor of 1000, resulting in a cPAD of 0.005 mg/kg/day.  The cPAD for ETU is 0.0002 mg/kg/day based on a NOAEL of 0.18 mg/kg/day and an uncertainty factor of 1000, which includes an extra 10X database uncertainty factor.  For food only, the mancozeb chronic (non-cancer) dietary exposure to the general U.S. population is 0.000073 mg/kg/day, or 1.5% cPAD.  For children 1-2 years old, the most highly exposed group, the exposure is 0.000167 mg/kg/day, or 3.3% cPAD.  For ETU derived from mancozeb, the food exposure is 0.00028 mg/kg/day, or 14% cPAD for the U.S. population and 0.000065 mg/kg/day, or 32% cPAD for children 1-2 years old, the most sensitive subgroup.   For food and water, the ETU exposures are 0.000032 mg/kg/day, or 16% cPAD for the U.S. population and 0.000071 mg/kg/day, or 36% cPAD for children 1-2 years old.

	c.  Cancer dietary exposure.  The theoretical cancer dietary exposure is based on ETU, with a Q* of 0.06 (mg/kg/day)[-1].  The relevant population is the general U.S. population.  The aggregate theoretical cancer risk is from food and drinking water exposures from the general U.S. population and the lifetime average daily dose for golfers, home gardeners and athletes.   EPA calculated a theoretical cancer risk of approximately 3 X 10[-6] for ETU from mancozeb and other EBDC uses.  This risk is in the negligible risk range.  (76 Fed. Reg. 18913, April 6, 2011). EPA also stated that "even if it is assumed that all walnuts in the US are treated, the cancer risk from walnuts is in the range of 1-3 X 10[-9], which is considerably below the level of concern".  (EPA Memorandum July 16, 2009, Christina L. Olinger to Libby Pemberton, DB Barcode D366095).  Therefore, the ETU cancer risk will not increase with establishment of the mancozeb tolerance.    EPA's theoretical cancer risk number includes all of the crops on the maneb label.  All maneb registrations have been cancelled, therefore it is appropriate to calculate the theoretical cancer risk without the maneb crops.  Deletion of the crops only on the maneb label reduces the theoretical cancer risk to 2.2 X 10[-6].

	ii. Drinking water. i. Mancozeb.  Mancozeb is very short-lived in soil and water and therefore humans are not exposed to mancozeb from either surface water or ground water sources.
	ii. ETU.  ETU residues were measured in a surface water and ground water monitoring study conducted by the EBDC/ETU Task Force.   From this survey, the estimated ground water concentration (EDWC) for chronic exposure was 0.21 ppb.  The EDWC for chronic surface water exposures was 0.1 ppb.  Based on PRZM/EXAMS modeling, the EDWC of ETU acute exposure was estimated to be 25.5 ppb.  The water concentration of 0.21 ppb was used to estimate the theoretical cancer risk from ground water exposure.

	2. Non-dietary exposure. i.  Mancozeb.  The registered residential uses of mancozeb are home gardens, golf courses, and sod farms.  EPA aggregated chronic exposure through food with short-and intermediate-term residential exposures to mancozeb (76 Fed. Reg. 18911, April 6, 2011) to determine the short- and intermediate-term risks.  There is no drinking water exposure to mancozeb and there are no long-term residential exposure scenarios for mancozeb.  Therefore, the chronic aggregate risk for mancozeb is only for food.  The mancozeb short and intermediate-term MOEs for adults and toddlers are greater than 1000, thus the MOEs do not raise risk concerns. (76 Fed. Reg. 18913, April 6, 2011).
	ii. ETU.  ETU aggregate exposure sources are from food, drinking water, home gardening, and golfing.  EPA's scenarios for aggregate exposures from these applications have been described (id.).  The chronic ETU exposures are from food and water only because golfing and toddler exposures are short-term.  The aggregate chronic exposure to ETU from food and water is 58% of the cPAD for children 1-2 years old, the most sensitive subpopulation.  The MOE's for ETU short and intermediate-term risks for adults and toddlers are greater than 1000, thus the MOEs do not raise risk concerns. (id.)

D. Cumulative Effects

	The cumulative effects from mancozeb and the other EBDC chemicals are from ETU.  EPA concluded that mancozeb does not share a common mechanism of toxicity with other substances.  EPA calculated the acute and chronic aggregate, cumulative dietary assessment for ETU in an April 17, 2007 document, titled PP# 9E6006 PP#4F4324 and 4F4333  Aggregate Dietary Assessment of the Common Metabolite/Degradate Ethylene Thiourea (ETU) to Support New Tolerances on Imported Grapes and Bananas for Metiram and for New Tolerances for Mancozeb on Almonds, Broccoli, Cabbage, Lettuce, and Peppers, from Christine L. Olinger to Cynthia Giles-Parker.  The ETU cumulative aggregate dietary risk from food and water is 87% of the aPAD.  The aggregate cumulative chronic risk estimate is 83% of the cPAD for food alone and 86% for food and water combined for the most sensitive subgroup, children ages 1-2.  For the general U.S. population, the ETU exposure is 28% of the cPAD for food alone and 30% cPAD for food and water.  As described above, the aggregate, cumulative theoretical cancer risk is in the negligible risk range.  Mancozeb is the only EBDC with registrations that have residential exposures.  Thus, the risks for short/intermediate exposures from mancozeb are also the cumulative exposures for residential uses.

E. Safety Determination

	1. U.S. population. Based on the risks described above, there is a reasonable certainty that no harm will result to the general population from aggregate exposures to mancozeb and aggregate cumulative exposures to ETU.  The MOEs for short and intermediate term exposures do not raise a risk concern.

	2. Infants and children. The risk assessments demonstrate that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to mancozeb residues or from cumulative aggregate exposure to ETU residues.

F. International Tolerances

	The Codex Alimentarius tolerances are established for the dithiocarbamate group rather than for mancozeb.  There are no proposed or established Codex tolerances for walnuts in the dithiocarbamate group.


[Federal Register Volume 85, Number 206 (Friday, October 23, 2020)]
[Notices]
[Pages 67604-67605]
[FR Doc No: 2020-23512]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2020-0064; Notice 1]

Mercedes-Benz USA, LLC, Receipt of Petition for Decision of
Inconsequential Noncompliance

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Receipt of petition.

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SUMMARY: Mercedes-Benz AG and Mercedes-Benz USA, LLC, (collectively,
``Mercedes-Benz'') have determined that certain model year (MY) 2020
Mercedes-Benz GLS 580 motor vehicles do not fully comply with Federal
Motor Vehicle Safety Standard (FMVSS) No. 118, Power-operated Window,
Partition, and Roof Panel Systems. Mercedes-Benz filed a noncompliance
report dated May 11, 2020, and subsequently petitioned NHTSA on June 3,
2020, for a decision that the subject noncompliance is inconsequential
as it relates to motor vehicle safety. This notice announces receipt of
Mercedes-Benz's petition.

DATES: Send comments on or before November 23, 2020.

ADDRESSES: Interested persons are invited to submit written data,
views, and arguments on this petition. Comments must refer to the
docket and notice number cited in the title of this notice and
submitted by any of the following methods:
     Mail: Send comments by mail addressed to the U.S.
Department of Transportation, Docket Operations, M-30, West Building
Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC
20590.
     Hand Delivery: Deliver comments by hand to the U.S.
Department of Transportation, Docket Operations, M-30, West Building
Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC
20590. The Docket Section is open on weekdays from 10 a.m. to 5 p.m.
except for Federal holidays.
     Electronically: Submit comments electronically by logging
onto the Federal Docket Management System (FDMS) website at https://www.regulations.gov/. Follow the online instructions for submitting
comments.
     Comments may also be faxed to<PHONE_NUMBER>.
    Comments must be written in the English language, and be no greater
than 15 pages in length, although there is no limit to the length of
necessary attachments to the comments. If comments are submitted in
hard copy form, please ensure that two copies are provided. If you wish
to receive confirmation that comments you have submitted by mail were
received, please enclose a stamped, self-addressed postcard with the
comments. Note that all comments received will be posted without change
to https://www.regulations.gov, including any personal information
provided.
    All comments and supporting materials received before the close of
business on the closing date indicated above will be filed in the
docket and will be considered. All comments and supporting materials
received after the closing date will also be filed and will be
considered to the fullest extent possible.
    When the petition is granted or denied, notice of the decision will
also be published in the Federal Register pursuant to the authority
indicated at the end of this notice.
    All comments, background documentation, and supporting materials
submitted to the docket may be viewed by anyone at the address and
times given above. The documents may also be viewed on the internet at
https://www.regulations.gov by following the online instructions for
accessing the docket. The docket ID number for this petition is shown
in the heading of this notice.
    DOT's complete Privacy Act Statement is available for review in a
Federal Register notice published on April 11, 2000 (65 FR 19477-78).

SUPPLEMENTARY INFORMATION:

I. Overview

    Mercedes-Benz has determined that certain MY 2020 Mercedes-Benz GLS
580 motor vehicles do not fully comply with the requirements of
paragraph S6(a)(1) of FMVSS No. 118, Power-operated Window, Partition,
and Roof Panel Systems (49 CFR 571.118). Mercedes-Benz filed a
noncompliance report dated May 11, 2020, pursuant to 49 CFR part 573,
Defect and Noncompliance Responsibility and Reports. Mercedes-Benz
subsequently petitioned NHTSA on June 3, 2020, for an exemption from
the notification and remedy requirements of 49 U.S.C. Chapter 301 on
the basis that this noncompliance is inconsequential as it relates to
motor vehicle safety, pursuant to 49 U.S.C. 30118(d) and 30120(h) and
49 CFR part 556, Exemption for Inconsequential Defect or Noncompliance.
    This notice of receipt of Mercedes-Benz's petition is published
under 49 U.S.C. 30118 and 30120 and does not represent any Agency
decision or other exercise of judgment concerning the merits of the
petition.

II. Vehicles Involved

    Approximately 22 MY 2020 Mercedes-Benz GLS 580 motor vehicles
manufactured between February 8, 2019, and September 20, 2019, are
potentially involved.

III. Noncompliance

    Mercedes-Benz explains that the noncompliance is that the automatic
reversal systems and actuation devices for the sunroofs in the subject
vehicles do not fully comply with paragraph S6(a)(1) of FMVSS No. 118.
Specifically, when the vehicle's ``car wash mode'' is activated by
using the central touch display in the center console, the sunroof may
close automatically.

IV. Rule Requirements

    Paragraph S6(a)(1) of FMVSS No. 118 includes the requirements
relevant to this petition. An actuation device must not cause a window,
partition, or roof panel to begin to close from any open position when
tested using a stainless steel sphere having a surface finish between 8
and 4 micro inches and a radius of 20 mm  0.2 mm, place the
surface of the sphere against any portion of the actuation device.

V. Summary of Mercedes-Benz's Petition

    The following views and arguments presented in this section, ``V.
Summary of Mercedes-Benz's Petition,'' are the views and arguments
provided by Mercedes-Benz. They have not been evaluated by the Agency
and do not reflect the views of the Agency. Mercedes-Benz describes the
subject noncompliance and contends that the noncompliance is
inconsequential as it relates to motor vehicle safety.
    In support of its petition, Mercedes-Benz submitted the following
reasoning:

    1. FMVSS No. 118 is intended to reduce the likelihood of
injuries that may arise due to the accidental operation of power-
operated windows, sunroofs, and other moveable partitions. The
particular provision at issue here, S6(a), is focused on preventing
the inadvertent movement of powered windows, partitions, and roof
panels if a child inadvertently leans on or against the actuation
device. The provisions were intended to simulate a child's knee
pressing against the actuation device at a particular level of force
to ensure that it does not close. By its terms, the standard applies
to vertically mounted switches, including those located in the
vehicle's console or central touch display as in this case.
    2. Due to their specific operating parameters, even though the
buttons used to activate car wash mode do not meet the performance
requirement of paragraph S6(a),

the condition does not create an increased safety risk. As an
initial matter, the car wash mode feature must first be activated by
the user. Car wash mode is not automatically enabled unless and
until the operator activates the feature by affirmatively accepting
the option and turning the feature on. Thus, unless car wash mode is
already active within the vehicle, the condition described above
cannot occur.
    3. Once the vehicle has initialized car wash mode, the feature
can only be activated through a series of steps using either the
vehicle's central touch display or from a touchpad located in the
center console. Activating car wash mode is a multi-step process and
the process varies depending on the current menu contained on the
display screen. For example, if car wash mode has been programmed by
the user inside the ``favorites'' menu, then a series of two touches
is needed to activate car wash mode. In all other cases, the
operator would first need to change the display screen to the
vehicle menu first and from there, navigate to the car wash mode
icon. In either case, car wash mode will not become active unless
each of these steps is executed in the corresponding order. Because
of the complexity involved in navigating through the required
sequence of events there is an extremely low likelihood of the car
wash mode being inadvertently activated in the first place.
    4. Further, the sunroofs in the subject vehicles contain an
auto-reverse feature. Upon detecting an object or obstruction inside
the sunroof, it will automatically stop and reverse course and fully
retract. While the sunroofs do not meet the requirements of
paragraph S5, they are certified to the European standard UN-R-21.
The European standard incorporates many of the performance features
included in the automatic reversal function contained in FMVSS No.
118, paragraph S5. The sunroofs in the subject vehicles will
automatically reverse prior to exerting 100 Newtons of pinch force,
and consistent with the options provided at paragraph S5.2, the
sunroof will either retract to a position at least as wide as the
initial position before closing or will allow a 200-mm rod to be
inserted in the gap.
    5. The Agency has previously granted petitions for
inconsequential treatment for FMVSS No. 118 involving similar
circumstances and vehicle features. NHTSA granted a petition by
General Motors involving a noncompliance with FMVSS No. 118,
paragraph S4(e), where for 60 seconds after the vehicles are
started, an issue with the sunroof module would allow the sunroof to
close via the control button if the engine is turned off and a front
door is opened. In that instance, in order to activate the sunroof,
a series of specific steps must be taken in order and the steps must
be completed within a 60-second time frame. See Decision Granting
Petition for Inconsequential Noncompliance by General Motors 73 FR
22459 (April 25, 2008). In granting the petition, the Agency found
that the potential for entrapment in a power operated sunroof
presented less of a risk of entrapment than power-operated windows
because, in general, sunroofs are less physically accessible than
power-operated windows. The decision also focused on the presence of
an auto-reverse feature, which would reverse the movement of the
sunroof before it exerted a pressure of 100 Newtons. In granting the
motion, the Agency noted the presence of this auto-reverse feature
as one that would further reduce the risk of entrapment.
    6. Much like the conditions present in the General Motors
vehicles, the noncompliance in the car wash mode feature of the
subject vehicles similarly does not create an increased safety risk.
Assuming that the function has been initialized by the operator, a
series of specific and coordinated steps must occur in order to
activate car wash mode. If those steps are not carried out in the
precise order required, then the car wash mode program will not be
activated. Even in the unlikely event that the car wash mode
function is inadvertently activated, there is no enhanced risk of
injury because of the sunroof auto-reverse feature.

    Mercedes-Benz concludes by again contending that the subject
noncompliance is inconsequential as it relates to motor vehicle safety,
and that its petition to be exempted from providing notification of the
noncompliance, as required by 49 U.S.C. 30118, and a remedy for the
noncompliance, as required by 49 U.S.C. 30120, should be granted.
    NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and
30120(h)) that permit manufacturers to file petitions for a
determination of inconsequentiality allow NHTSA to exempt manufacturers
only from the duties found in sections 30118 and 30120, respectively,
to notify owners, purchasers, and dealers of a defect or noncompliance
and to remedy the defect or noncompliance. Therefore, any decision on
this petition only applies to the subject vehicles that Mercedes-Benz
no longer controlled at the time it determined that the noncompliance
existed. However, any decision on this petition does not relieve
vehicle distributors and dealers of the prohibitions on the sale, offer
for sale, or introduction or delivery for introduction into interstate
commerce of the noncompliant vehicles under their control after
Mercedes-Benz notified them that the subject noncompliance existed.

(Authority: 49 U.S.C. 30118, 30120: delegations of authority at 49
CFR 1.95 and 501.8)

Otto G. Matheke III,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2020-23512 Filed 10-22-20; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 81, Number 90 (Tuesday, May 10, 2016)]
[Notices]
[Page 28876]
[FR Doc No: 2016-10913]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]

Clinical Trial Design Considerations for Malaria Drug Development
Media; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop regarding clinical trial design considerations for malaria
drug development. FDA is interested in discussing the scientific
challenges pertaining to malaria drug development and malaria parasite
detection methods used as endpoints in clinical trials. This public
workshop is intended to provide information for and gain perspective
from health care providers, other U.S. government agencies, public
health organizations, academic experts, and industry on various aspects
of the design of clinical trials evaluating new drugs to treat malaria.
The input from this public workshop will also help in developing topics
for future discussion.
    Dates and Times: The public workshop will be held on June 30, 2016,
from 8:30 a.m. to 4 p.m.
    Location: The public workshop will be held at FDA's White Oak
campus, 10903 New Hampshire Ave., Bldg. 31 Great Rm., Silver Spring, MD
20993. Entrance for the public workshop participants (non-FDA
employees) is through Building 1 where routine security check
procedures will be performed. For parking and security information,
please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. Seating
is limited and available only on a first-come, first-served basis.
    Contact Persons: Ms. Lori Benner and/or Ms. Jessica Barnes, Center
for Drug Evaluation and Research, Food and Drug Administration, Bldg.
22, Rm. 6221, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002,
301-796-1300.
    Registration: Registration is free for the public workshop.
Interested parties are encouraged to register early. Seating will be
available on a first-come, first-served basis. To register
electronically, email registration information (including name, title,
firm name, address, telephone, and fax number) to
<EMAIL_ADDRESS>Persons without access to the Internet
can call<PHONE_NUMBER> to register. Persons needing a sign language
interpreter or other special accommodations should notify Ms. Jessica
Barnes or Ms. Lori Benner (see Contact Persons) at least 7 days in
advance.

SUPPLEMENTARY INFORMATION: FDA is announcing a public workshop
regarding scientific and regulatory considerations in the design of
clinical trials of antimalarial drugs. Discussions will focus on
developing two or more drugs used in combination, human challenge
studies, issues/challenges associated with current detection methods,
use of polymerase chain reaction, and other emerging rapid diagnostic
tests in clinical trials.
    The Agency encourages individuals, industry, health care
professionals, researchers, public health organizations and other
interested persons to attend this public workshop.
    Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at http://www.regulations.gov. It may
be viewed at the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD. A
transcript will also be available in either hard copy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to Division of Freedom of Information (HFI-35), Office
of Management Programs, Food and Drug Administration, 5600 Fishers
Lane, Rm. 6-30, Rockville, MD 20857. Transcripts will also be available
on the Internet at http://wcms.fda.gov/FDAgov/Drugs/NewsEvents/ucm490084.htm?SSContributor=true approximately 45 days after the
workshop.

    Dated: May 4, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-10913 Filed 5-9-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 153 (Monday, August 10, 2015)]
[Notices]
[Page 47918]
[FR Doc No: 2015-19558]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Murphy Dam, LLC; Notice Granting Late Intervention

    On April 21, 2015, Commission staff issued a public notice for
Murphy Dam, LLC's preliminary permit application to study the
feasibility of the Murphy Dam Hydroelectric Project No. 14670. The
proposed project would be located on the Connecticut River, near
Pittsburg, Coos County, New Hampshire.
    The notice established June 20, 2015, as the deadline to file
motions to intervene. On July 22, 2015, the Connecticut River Watershed
Council, Inc. filed a late motion to intervene in the proceeding.
Pursuant to Rule 214 of the Commission's Rules of Practice and
Procedure,\1\ the late motion to intervene is granted, subject to the
Commission's Rules and Regulations.
---------------------------------------------------------------------------

    \1\ 18 CFR 385.214 (2014).

    Dated: August 4, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-19558 Filed 8-7-15; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 25 (Tuesday, February 7, 2023)]
[Rules and Regulations]
[Pages 7881-7883]
[FR Doc No: 2023-02349]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R06-OAR-2021-0802; FRL-9401-02-R6]

Air Plan Approval; Texas; Control of Air Pollution From Visible
Emissions and Particulate Matter

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: Pursuant to the Federal Clean Air Act (CAA or the Act), the
Environmental Protection Agency (EPA) is approving the revisions to the
Texas State Implementation Plan (SIP) submitted by the State of Texas
to EPA on October 22, 2021. The revisions pertain to particulate matter
and outdoor burning regulations. This action allows volunteer
firefighters to fulfill supervision requirements for the burning of
certain waste types generated from specific residential properties.

DATES: This rule is effective on March 9, 2023.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R06-OAR-2021-0802. All documents in the docket are
listed on the https://www.regulations.gov website. Although listed in
the index, some information is not publicly available, e.g.,
Confidential Business Information or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, is not placed on the internet. Publicly available docket
materials are available electronically through https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Randy Pitre, EPA Region 6 Office,
Infrastructure and Ozone Section,<PHONE_NUMBER>, [email protected].
Out of an abundance of caution for members of the public and our staff,
the EPA Region 6 office may be closed to the public to reduce the risk
of transmitting COVID-19. Please call or email the contact listed above
if you need alternative access to material indexed but not provided in
the docket.

SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' and
``our'' means the EPA.

I. Background

    The background for this action is discussed in detail in our
November 15, 2022, proposal (87 FR 68413). In that document, we
proposed to approve revisions to the Texas State Implementation Plan
(SIP) submitted by the State of Texas to EPA on October 22, 2021. The
revisions allow volunteer firefighters to fulfill supervision
requirements for the burning of trees, grass, leaves, branch trimmings,
or other plant growth generated from specific residential properties at
designated sites for consolidated burning of waste, located outside of
a municipality, and within a county with a population of less than
50,000 people. We did not receive any comments regarding our proposal.

II. Final Action

    The EPA is approving revisions to the Texas SIP submitted by the
State of Texas to EPA on October 22, 2021, that pertain to particulate
matter and outdoor burning regulations. This rulemaking action is being
taken under Section 110 of the CAA. Specifically, we are approving the
revision to 30 TAC 111.209(5).

III. Incorporation by Reference

    In this rule, the EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, the EPA is finalizing the incorporation by reference the
revisions to the Texas regulations as described in Section II of this
preamble, Final Action. The EPA has made, and will continue to make,
these materials generally available through www.regulations.gov (please
contact the person identified in the FOR FURTHER INFORMATION CONTACT
section of this preamble for more information). Therefore, these
materials have been approved by EPA for inclusion in the SIP, have been
incorporated by reference by EPA into that plan, are fully federally
enforceable under sections 110 and 113 of the CAA as of the effective
date of the final rulemaking of EPA's approval, and will be

incorporated in the next update to the SIP compilation.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, the EPA's role is to approve state choices,
provided they meet the criteria of the CAA. Accordingly, this action
merely approves state law as meeting Federal requirements and does not
impose additional requirements beyond those imposed by state law. For
that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
    This action is subject to the Congressional Review Act, and the EPA
will submit a rule report to each House of the Congress and to the
Comptroller General of the United States. This action is not a ``major
rule'' as defined by 5 U.S.C. 804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by April 10, 2023. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Particulate matter.

    Dated: January 30, 2023.
Earthea Nance,
Regional Administrator, Region 6.

    For the reasons stated in the preamble, the Environmental
Protection Agency amends 40 CFR part 52 as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart SS--Texas

0
2. In Sec.  52.2270(c), the table titled ``EPA Approved Regulations in
the Texas SIP'' is amended by revising the entry for Section 111.209.
    The revision reads as follows:

Sec.  52.2270  Identification of plan.

* * * * *
    (c) * * *

                                    EPA Approved Regulations in the Texas SIP
----------------------------------------------------------------------------------------------------------------
                                                    State approval/
        State citation            Title/subject         submittal    EPA approval date         Explanation
                                                         date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
           Chapter 111 (Reg 1)--Control of Air Pollution From Visible Emissions and Particulate Matter
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                          Subchapter B: Outdoor Burning
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Section 111.209..............  Exception for            10/22/2021  2/7/2023, [Insert    .......................
                                Disposal Fires.                      Federal Register
                                                                     citation].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2023-02349 Filed 2-6-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 161 (Monday, August 20, 2012)]
[Notices]
[Pages 50198-50199]
[FR Doc No: 2012-20398]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-67653; File No. SR-FICC-2012-06]

Self-Regulatory Organizations; The Fixed Income Clearing
Corporation; Notice of Filing Proposed Change To Move the Time at Which
the Mortgage-Backed Securities Division Runs Its Daily Morning Pass

August 14, 2012.
    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 August 6, 2012, the Fixed Income Clearing Corporation
(``FICC'') filed with the Securities and Exchange Commission
(``Commission'') the proposed change described in Items I, II and III,
below, which Items have been prepared primarily by FICC. The Commission
is publishing this Notice to solicit comments on the proposed change
from interested persons.
---------------------------------------------------------------------------

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

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Change

    FICC proposes to move the time at which its Mortgage-Backed
Securities Division (``MBSD'') runs its first processing pass of the
day from 2 p.m. to 4 p.m. Eastern Standard Time. The proposed change
does not require revisions to MBSD's rules because those rules do not
address the times of MBSD's processing passes. Even so, FICC is
notifying its members and the public of the proposed change via this
filing in an effort to provide them with adequate notice.

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

    In its filing with the Commission, FICC included statements
concerning the purpose and basis for the proposed change and discussed
any comments it received on the proposed change. The text of these
statements and comments may be examined at the places specified in Item
IV below. FICC has prepared summaries, set forth in sections A, B, and
C below, of the most significant aspects of these statements.\3\
---------------------------------------------------------------------------

    \3\ The Commission has modified the text of the summaries
provided by FICC.
---------------------------------------------------------------------------

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

    The purpose of this filing is to notify members that MBSD intends
to move the time at which it runs its first processing pass of the day
(historically referred to as the ``AM Pass'') from 2 p.m. to 4 p.m.
Eastern Standard Time. MBSD also executes an evening pass (referred to
as the ``PM Pass'') at 8 p.m. Eastern Standard Time, which will remain
unchanged. On days when MBSD executes its To-Be-Announced Netting
cycle, this cycle immediately follows the completion of the first pass
of the day. The proposed change to 4 p.m. for the first pass of the day
will allow more trades to be included into the To-Be-Announced Net,
which will assist in reducing both the amount of fails in the market
and the related operational risk. The above change is being made at the
request of the Securities Industry and Financial Markets Association
(``SIFMA'') MBS Operations Committee. MBSD advised members of the
proposed change via Important Notice dated August 1, 2012.
    The proposed change does not require amendments to the text of the
Rules of the MBSD. The effective date of this change will be announced
to MBSD members via Important Notice, and is anticipated to be November
2, 2012, subject to the Commission's approval.
    FICC believes the proposed change is consistent with the
requirements of the Act, including Section 17A,\4\ and the rules and
regulations thereunder applicable to FICC. Specifically, FICC believes
the proposed change will foster the prompt and accurate clearance and
settlement of securities transactions because a greater proportion of
transactions will be included in the net, fewer fails will result, and
operational risk will therefore be reduced.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78q-1.
---------------------------------------------------------------------------

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

    FICC does not believe that the proposed change will have any
impact, or impose any burden, on competition.

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

    FICC will notify the Commission of any written comments received by
FICC.

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

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

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposed
change is consistent with the Act. Comments may be submitted by any of
the following methods:
     Electronic comments may be submitted by using the
Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml), or by sending an email to<EMAIL_ADDRESS>Please
include File No. SR-FICC-2012-06 on the subject line.
     Paper comments should be sent in triplicate to Elizabeth
M. Murphy, Secretary, Securities and Exchange

Commission, 100 F Street NE., Washington, DC 20549-0609.
    All submissions should refer to File Number SR-FICC-2012-06. To
help the Commission process and review your comments more efficiently,
please use only one method of submission. 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 change that are
filed with the Commission, and all written communications relating to
the proposed change between the Commission and any person, other than
those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of FICC and on FICC's
Web site at: http://www.dtcc.com/downloads/legal/rule_filings/2012/ficc/SR-FICC-2012-06.pdf.
    All comments received will be posted without change; the Commission
does not edit personal identifying information from submissions. You
should submit only information that you wish to make available
publicly.
    All submissions should refer to File Number SR-FICC-2012-06 and
should be submitted on or before September 10, 2012.
---------------------------------------------------------------------------

    \5\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\5\
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2012-20398 Filed 8-17-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 167 (Tuesday, August 28, 2012)]
[Notices]
[Pages 52016-52017]
[FR Doc No: 2012-21127]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER12-2217-003]

Power Dave Fund LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding,
of Power Dave Fund LLC's application for market-based rate authority,
with an accompanying rate schedule, noting that such application
includes a request for blanket authorization, under 18 CFR part 34, of
future issuances of securities and assumptions of liability.

    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability is September 5, 2012.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding(s) are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive email notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please email<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: August 16, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2012-21127 Filed 8-27-12; 8:45 am]
BILLING CODE 6717-01-P