[Federal Register: July 3, 2007 (Volume 72, Number 127)]
[Notices]
[Page 36528-36529]
[DOCID:fr03jy07-111]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon written request, copies available from: Securities and Exchange

Commission, Office of Filings and Information Services, Washington, DC
20549.

Extension: Rule 206(4)-2; SEC File No. 270-217; OMB Control No.
3235-0241.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit this
collection of information to the Office of Management and Budget
(``OMB'') for extension and approval.
    Rule 206(4)-2 (17 CFR 275.206(4)-2) under the Investment Advisers
Act of 1940 (15 U.S.C. 80b-1 et seq.) governs the custody of funds or
securities of clients by Commission-registered investment advisers.
Rule 206(4)-2 requires each investment adviser that has custody of
client funds or securities to maintain those client funds or securities
with a broker-dealer, bank or other ``qualified custodian.'' The rule
also requires the adviser to promptly notify the clients as to the
place and manner of custody, to send quarterly account statements to
each client whose assets are in the adviser's custody, and to have an
independent public accountant conduct an annual surprise examination of
the custodied assets. If the qualified custodian sends monthly account
statements directly to an adviser's clients, however, the adviser is
relieved from sending its own account statements and undergoing an
annual surprise examination. The rule exempts advisers from the rule
with respect to clients that are registered investment companies. The
rule also exempts advisers to limited partnerships and limited
liability companies from the account statement delivery and annual
surprise examination requirements if the limited partnerships or
limited liability companies they advise are subject to annual audit by
an independent public accountant.
    Advisory clients use this information to confirm proper handling of
their accounts. The Commission's staff uses the information obtained
through this collection in its enforcement, regulatory and examination
programs. Without the information collected under the rule, the
Commission would be less efficient and effective in its programs and
clients would not have information valuable for monitoring an adviser's
handling of their accounts.
    The respondents to this information collection are investment
advisers registered with the Commission and have custody of clients'
funds or securities. We estimate that 3352 advisers would be subject to
the information collection burden under rule 206(4)-2. The number of
responses under rule 206(4)-2 will vary considerably depending on the
number of clients for which an adviser has custody of funds or
securities. It is estimated that the average number of responses
annually for each respondent would be 247.794, and the average time of
.5 hour per response would remain the same. The annual aggregate burden
for all respondents to the requirements of rule 206(4)-2 is estimated
to be 415,303 hours.
    The estimated average burden hours are made solely for purposes of
the Paperwork Reduction Act and are not derived from a comprehensive or
even representative survey or study of the cost of Commission rules and
forms.
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information shall
have practical utility; (b) the accuracy of the agency's estimate of
the burden of the proposed collection of information; (c) ways to
enhance the quality, utility, and clarity of the information to be
collected; and (d) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted in
writing within 60 days of this publication.
    Please direct your written comments to R. Corey Booth, Director/
Chief Information Officer, Securities and Exchange Commission, c/o
Shirley Martinson, 6432 General Green Way, Alexandria, VA 22312; or
send an e-mail to<EMAIL_ADDRESS>
    June 25, 2007.
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E7-12781 Filed 7-2-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register: March 6, 2006 (Volume 71, Number 43)]
[Notices]
[Page 11249-11250]
[DOCID:fr06mr06-75]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

FEDERAL REGISTER CITATION OF PREVIOUS ANNOUNCEMENT: [71 FR 10085,
February 28, 2006].

STATUS: Closed Meeting.

PLACE: 100 F Street, NE., Washington, DC.

DATE AND TIME OF PREVIOUSLY ANNOUNCED MEETING: Thursday, March 2, 2006
at 2 p.m.

Change in the Meeting: Additional Item.
    The following item has been added to the 2 p.m. Closed Meeting
scheduled for Thursday, March 2, 2006: a matter involving investigative
techniques and procedures.
    The Commission voted to consider the item listed for the closed
meeting in closed session and determined that no earlier notice thereof
was possible.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items. For further information and to
ascertain what, if any, matters have been added, deleted or postponed,
please contact the Office of the Secretary at<PHONE_NUMBER>.

    Dated: March 1, 2006.
Nancy M. Morris,
Secretary.
[FR Doc. 06-2122 Filed 3-2-06; 11:16 am]

BILLING CODE 8010-01-P


[Federal Register: March 31, 2009 (Volume 74, Number 60)]
[Notices]
[Page 14545]
[DOCID:fr31mr09-51]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. CP07-398-005; CP07-403-001]

Gulf Crossing Pipeline Company LLC; Enogex LLC; Notice of
Application

March 24, 2009.
    Take notice that on March 17, 2009, Gulf Crossing Pipeline Company
LLC (Gulf Crossing), and Enogex LLC (Enogex) filed a request to amend
its certificate of public convenience and necessity pursuant to section
7(c) of the Natural Gas Act (NGA) which authorized the siting,
construction, and operation of facilities on April 30, 2008. In its
amendment, the applicants seek to amend an operating lease agreement
between the two parties to amend a range of quantities specified in the
existing Operating Lease dated February 28, 2007 to specific quantities
as stated in the application of amendment to certificate authorization.
The Commission staff will determine if this amendment will have an
effect on the schedule for the environmental review of this project. If
necessary, a revised Notice of Schedule for Environmental Review will
be issued within 90 days of this Notice. The instant filing may be also
viewed on the Web at http://www.ferc.gov using the ``eLibrary'' link.
Enter the docket number excluding the last three digits in the docket
number field to access the document. For assistance, call (866) 208-
3676 or TTY,<PHONE_NUMBER>.
    Any questions regarding this application may be directed to J. Kyle
Stephens, Vice President of Regulatory Affairs, Boardwalk Pipeline
Partners, LP, 9 Greenway Plaza, Houston, Texas 77046 or by telephone at
713-479-8803 or telecopy to<PHONE_NUMBER> or e-mail to
<EMAIL_ADDRESS>or to Patricia D. Horn, Vice President and
General Counsel, Legal, Regulatory, Environmental, Health and Safety,
Enogex LLC, 515 Centrla Park Drive, Suite 600, Oklahoma City, OK 73105;
by phone to<PHONE_NUMBER> or by e-mail to<EMAIL_ADDRESS>    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the below listed comment date, file with the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 14 copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenters will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commenters will not be required to serve copies of filed
documents on all other parties. However, the non-party commenters will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    Motions to intervene, protests and comments may be filed
electronically via the Internet in lieu of paper; see, 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. The Commission strongly encourages
electronic filings.
    Comment Date: 5 p.m. Eastern Time on Friday, April 17, 2009.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-7084 Filed 3-30-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 213 (Friday, November 4, 2022)]
[Notices]
[Pages 66771-66773]
[FR Doc No: 2022-24032]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. DOT-NHTSA-2022-0011]

Agency Information Collection Activities; Notice and Request for
Comment; Record Retention

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

ACTION: This is a reinstatement of a previous approved information
collection.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995 (PRA),
this notice announces that the Information Collection Request (ICR)
abstracted below is being forwarded to the Office of Management and
Budget (OMB) for review and approval. A Federal Register Notice with a
60-day comment period soliciting comments on the following information
collection was published on July 20, 2022. No comments were received.

DATES: Comments must be submitted on or before December 5, 2022.

ADDRESSES: Written comments and recommendations for the proposed
information collection, including suggestions for reducing burden,
should be submitted to the Office of Management and Budget at
www.reginfo.gov/public/do/PRAMain. To find this particular information
collection, select ``Currently under Review--Open for Public Comment''
or use the search function.

FOR FURTHER INFORMATION CONTACT: For additional information or access
to background documents, contact Paul Simmons, Office of Defect
Investigation (NEF-110),<PHONE_NUMBER>, National Highway Traffic
Safety Administration, Department of Transportation, 1200 New Jersey
Avenue SE, Washington, DC 20590, email [email protected]. Please
identify the relevant collection of information by referring to its OMB
Control Number 2121-0042.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501 et seq.), a
Federal agency must receive approval from the Office of Management and
Budget (OMB) before it collects certain information from the public and
a person is not required to respond to a collection of information by a
Federal agency unless the collection displays a valid OMB control
number. In compliance with these requirements, this notice announces
that the following information collection request will be submitted
OMB.
    Title of Collection: Record Retention--49 CFR part 576.
    OMB Control Number: 2127-0042.
    Form Numbers(s): N/A.
    Type of Request: This is a reinstatement of a previous approved
Information Collection.
    Type of Review Requested: Regular.
    Length of Approval Requested: Three years.

Summary of the Collection of Information

    Under 49 U.S.C. 30166(e), NHTSA ``reasonably may require a
manufacturer of a motor vehicle or motor vehicle equipment to keep
records, and a manufacturer, distributor or dealer to make reports, to
enable [NHTSA] to decide whether the manufacturer, distributor, or
dealer has complied or is complying with this chapter or a regulation
prescribed under this chapter.''
    To ensure that NHTSA will have access to this type of information,
the agency exercised the authority granted in 49 U.S.C. 30166(e) and
promulgated 49 CFR part 576 Record Retention, initially published on
August 20, 1974 and most recently amended on July 10, 2002 (67 FR
45873), requiring manufacturers to retain one copy of all records that
contain information concerning malfunctions that may be related to
motor vehicle safety for a period of five calendar years after the
record is generated or acquired by the manufacturer. Manufacturers are
also required to retain for five years the underlying records related
to early warning reporting (EWR) information submitted under 49 CFR
part 579. The information collections support NHTSA's mission by
increasing the effectiveness of NHTSA's investigations into potential
safety related defects.

Description of the Need for the Information and Proposed Use of the
Information

    The records that are required to be retained per 49 CFR part 576
are used to promptly identify potential safety-related defects in motor
vehicles and motor vehicle equipment in the United States. When a trend
in incidents arising from a potentially safety-related defect is
discovered, NHTSA relies on this information, along with other agency
data, to determine whether or not to open a formal defect investigation
(as authorized by Title 49 U.S.C. chapter 301--Motor Vehicle Safety).
NHTSA normally becomes aware of possible safety-related defects because
it receives consumer complaints.
    Agency experience has shown that manufacturers receive
significantly more consumer complaints than does the agency. This is
because the consumer with the product does not know whether their
particular vehicle or equipment has a problem that is common with an
entire group of vehicles or equipment. Whereas consumers know the
manufacturer of their vehicle or equipment, relatively few know how to
file a complaint with the National Highway Traffic Safety
Administration's Auto Safety Hotline. The complaints filed with the
manufacturer give the agency a fair indication of how widespread the
potential problem may be.
    If the manufacturer did not retain its records, NHTSA would be
unable to enforce the statutory requirements that the manufacturer
notify the agency and other persons of a safety-related defect when the
manufacturer ``learns'' of the defect, and notify the agency and other
persons of a noncompliance when it ``decides in good faith'' that the
noncompliance exists. Without access to the manufacturer's records, it
would be impossible for anyone other than the manufacturer to show when
or if that manufacturer had obtained knowledge of a potential defect or
had determined in good faith that the noncompliance did or did not
exist. Without access to manufacturers' records, NHTSA's examinations
of potential defects and non-compliances would be seriously
handicapped. NHTSA could conduct surveys of vehicle owners or use other
means to learn of problems with vehicles and equipment, but any of
these other methods would require significantly more information
collections by the agency and necessitate a larger staff of the
agency's Office of Defect Investigations.
    60-Day Notice: A Federal Register Notice with a 60-day comment
period soliciting comments on the following information collection was
published on July 20, 2022. No comments were received.
    Affected Public: Manufacturers of motor vehicles and motor vehicle
equipment.
    Estimated Number of Respondents: 1,030.
    NHTSA estimates that approximately 1,030 manufacturers of vehicles
and equipment (including tires, child restraint systems and trailers)
are required to maintain records under Part 576.
    Frequency: As needed.
    Number of Responses: 1,030.
    Estimated Total Annual Burden Hours: 40,225.
    NHTSA estimates the total annual burden for each vehicle, tire, and
child restraint manufacturer to be 40 hours for a subtotal of 40,200
hours (1,005 respondents x 40 hours). In addition, there are
approximately 23,660 equipment manufacturers (excluding tires, child
seat restraint systems and trailer manufacturers) whose record
retention requirements under part 576 are limited to the documents
underlying their part 579 reporting requirements. Their part 579
requirements include only the reporting of incidents involving deaths.
Therefore, based on the number of death reports submitted to date by
these equipment manufacturers, we estimate that an additional 25
equipment manufacturers have record retention requirements imposed by
part 576. We estimate that it will take one hour each to maintain the
necessary records each year for a subtotal burden of 25 hours (25
respondents x one hour). Accordingly, NHTSA estimates that the total
annual burden hours is 40,225 hours ((1,005 respondents x 40 hours) +
(25 respondents x 1 hour)).
    To calculate the labor cost associated with maintaining, NHTSA
looked at wage estimates for the type of personnel involved with
compiling and submitting the documents. NHTSA estimates the total labor
costs associated with these burden hours by looking at the average wage
for clerical workers. The Bureau of Labor Statistics (BLS) estimates
that the average hourly wage for office clerks (BLS Occupation code 43-
9061) in the Motor Vehicle Manufacturing Industry is $20.98.\1\ The
Bureau of Labor Statistics estimates that private industry workers'
wages represent 70.2% of total labor compensation costs.\2\ Therefore,
NHTSA estimates the hourly labor costs to be $29.89 and NHTSA estimates
the total labor cost associated with the 40,225 burden hours to be
$1,202,325.25. Table 1 provides a summary of the estimated burden hours
and labor costs associated with those submissions.
---------------------------------------------------------------------------

    \1\ May 2020 National Industry-Specific Occupational Employment
and Wage Estimates, NAICS 336100--Motor Vehicle Manufacturing,
available at https://www.bls.gov/oes/2020/may/naics4_336100.htm#43-0000 (accessed March 25, 2022).
    \2\ See Table 1. Employer Costs for Employee Compensation by
ownership (Mar. 2020), available at https://www.bls.gov/news.release/archives/ecec_06182020.pdf (accessed March 25, 2022).

                                            Table 1--Burden Estimates
----------------------------------------------------------------------------------------------------------------
                   Estimated  burden per    Average hourly   Labor cost per    Total burden
Annual responses     response  (hours)        labor cost        response          hours        Total labor costs
----------------------------------------------------------------------------------------------------------------
          1,030                    39.05           $29.89        $1,167.31           40,225       $1,202,325.25
----------------------------------------------------------------------------------------------------------------

    Estimated Total Annual Burden Cost: $0.
    NHTSA estimates that there are no costs resulting from this
collection of information other than labor costs associated with the
burden hours.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) whether the proposed
collection of information is necessary for the proper performance of
the functions of the Department, including whether the information will
have practical utility; (b) the accuracy of the Department's estimate
of the burden of the proposed information collection; (c) ways to
enhance the quality, utility and clarity of the information to be
collected; and (d) ways to minimize the burden of the collection of
information on respondents, including the use of automated collection
techniques or other forms of information technology.
    A comment to OMB is most effective if OMB receives it within 30
days of publication.
    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C. chapter
35, as amended; 49 CFR 1.49; and DOT Order 1351.29A.

Stephen A. Ridella,
Director, Office of Defects Investigation.
[FR Doc. 2022-24032 Filed 11-3-22; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 83, Number 21 (Wednesday, January 31, 2018)]
[Notices]
[Pages 4540-4543]
[FR Doc No: 2018-01941]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2016-0407]

Agency Information Collection Activities; Approval of a New
Information Collection Request: National Consumer Complaint Database

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

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FMCSA
announces its plan to submit the Information Collection Request (ICR)
described below to the Office of Management and Budget (OMB) for review
and approval and invites public comment. This new collection of
information is for the National Consumer Complaint Database (NCCDB),
which is an online interface allowing consumers, drivers and others to
file complaints against unsafe and unscrupulous motor carriers and/or
their employees. The NCCDB also allows complaints to be filed about
shippers, receivers and transportation intermediaries. Complaints cover
a wide range of issues, including but not limited to safety, driver
harassment, coercion, movement of household goods (HHG), financial
responsibility instruments for brokers and freight forwarders, and
Americans with Disabilities Act (ADA) complaints.

DATES: Please send your comments by March 2, 2018. OMB must receive
your comments by this date in order to act quickly on the ICR.

ADDRESSES: All comments should reference Federal Docket Management
System (FDMS) Docket Number FMCSA-2016-0407. Interested persons are
invited to submit written comments on the proposed information
collection to the Office of Information and Regulatory Affairs, Office
of Management and Budget. Comments should be addressed to the attention
of the Desk Officer, Department of Transportation/Federal Motor Carrier
Safety Administration, and sent via electronic mail to
[email protected], or faxed to<PHONE_NUMBER>, or mailed to
the Office of Information and Regulatory Affairs, Office of Management
and Budget, Docket Library, Room 10102, 725 17th Street NW, Washington,
DC 20503.

FOR FURTHER INFORMATION CONTACT: James Dubose, Department of
Transportation, Federal Motor Carrier Safety Administration, 6th Floor,
West Building, 1200 New Jersey Avenue SE, Washington, DC 20590-0001.
Telephone:<PHONE_NUMBER>; Email: [email protected]. Office hours
are from 9 a.m. to 5 p.m., Monday through Friday, except Federal
Holidays.

SUPPLEMENTARY INFORMATION:

Federal Register Notice and Summary of Public Comment Received

    On November 29, 2016, FMCSA published a notice in the Federal
Register announcing a new Information Collection Request (ICR)
pertaining to the National Consumer Complaint Database (NCCDB). 81 FR
86068 (November 29 Notice). FMCSA sought public comment on the ICR,
including (1) input on whether the proposed collection is necessary to
support the agency's mission, (2) comments on the accuracy of the
agency's burden estimates, (3) suggestions for improving the quality,
utility and clarity of the collected information and (4) ideas on how
the agency can minimize the collection burden without sacrificing the
usefulness of the collected information.
    On January 30, 2017, the Owner Operator Independent Drivers
Association, Inc. filed a comment (OOIDA Comments) in response to the
November 29 Notice.\1\ In its comments, OOIDA acknowledged that ``the
ICR is necessary for the Agency to perform its mission. . . .'' OOIDA
Comments, at 1. However, OOIDA indicated that FMCSA ``must enhance the
quality of the collected information, and thereby improve the
effectiveness of the NCCDB, by addressing (1) the overall
administration of the program, (2) the name of the program, and (3) the
inefficiencies of the online portal.'' Id. Moreover, OOIDA raised
concerns about the agency's response to complaints, follow-up with
drivers after the filing of complaints and consistency and efficiency
in complaint handling. Id. at 1-2. Finally, while OOIDA understood that
estimates associated with coercion complaints could not be included in
this ICR, it indicated that it ``is aware of coercion complaints
submitted to the NCCDB and recommends the Agency work quickly to
include such data in future renewals for the NCCDB.'' Id. at 9.
---------------------------------------------------------------------------

    \1\ Comments of the Owner Operator Independent Drivers
Association, Inc.; In Response to an Agency Information Collection
Request; National Consumer Complaint Database. No other comments
have been filed in the docket.
---------------------------------------------------------------------------

    More specifically, OOIDA's comment consists of the following
sections: (A) Coercion complaint example, (B) Confirmation and tracking
must be provided, (C) NCCDB Name, (D) The inefficiencies of the online
portal and (E) Other Concerns. Id. at 2-9. FMCSA will address each
section of OOIDA's comments and provide its response.

A. Coercion Complaint Example

    OOIDA provided an example of a coercion \2\ complaint which was
entered into the NCCDB by a member of their association. Id. at 2-3. In
its comments, OOIDA raised concerns with FMCSA's processing of the
complaint. It indicated that ``the Agency lacks the proper mechanisms
to accurately track the status of a complaint, and second, that the
Agency lacks appropriate measures to ensure that a vacant position does
not lead to the improper management of a filed complaint.'' Id. at 3.
FMCSA agrees with OOIDA that complaints need to be tracked and that
complaints must be properly handled despite any staffing issues. In
this particular situation, FMCSA determined that the tracking issues
resulted from the complainant's initial filing of the complaint. To
address the initial concern from OOIDA, FMCSA manually updated the
NCCDB to include the coercion complaint. Ultimately, an FMCSA field
office addressed the complaint.
---------------------------------------------------------------------------

    \2\ The Coercion rule prohibits motor carriers, shippers,
receivers, or transportation intermediaries or their respective
agents, officers or representatives from threatening drivers with
loss of work or other adverse employment actions or taking action to
punish drivers for refusing to operate a commercial motor vehicle in
violation of certain provisions of the Federal Motor Carrier Safety
Regulations, Hazardous Materials Regulations, and Federal Motor
Carrier Commercial Regulations. 80 FR 74695 (Nov. 30, 2015).
---------------------------------------------------------------------------

B. Confirmation and Tracking Must Be Provided

    In its comments, OOIDA indicates that ``[o]ften times, driver do
not receive a tracking number and are unaware of the status of their
grievances.'' Id. at 3. OOIDA argues that ``[t]he Agency should provide
a confirmation that the complaint has been accepted as well as a
specific tracking number or other case identifier to assist with
follow-up.'' Id. at 4.
    FMCSA has resolved OOIDA's concerns. Once a complaint is submitted,
the system will assign and display the Complaint Identification Number
and provide an option to print the complaint.

C. NCCDB Name

    OOIDA indicates that the term ``National Consumer Complaint
Database'' is causing confusion about the types of complaints that can
be filed. OOIDA argues that the title does not support the Agency's
safety mandate. Id. at 4-5. OOIDA submits that FMCSA can improve its
outreach to drivers about the NCCDB to make ``sure they are aware that
the NCCDB is a beneficial tool that can promote safety and eliminate
bad actors from the industry. OOIDA would look forward to working with
and helping the Agency achieve this objective.'' Id. at 5.
    FMCSA is open to considering a name change for the complaint
database. Given that many stakeholders file

complaints, such a name would need to cover complaints from all
stakeholders. FMCSA looks forward to working with OOIDA on outreach to
drivers about the NCCDB.

D. The Inefficiencies of the Online Portal

    OOIDA provides recommendations for modifications to the NCCDB
online portal. According to OOIDA, ``[t]hese changes would improve the
portal's efficiency and the overall experience for the user.'' Id. at
5.

Sequence of Information

    OOIDA states a typical OOIDA member would select the category of
``Driver'' to file a complaint on the NCCDB home page. OOIDA also
states the home page does not clarify the heading of ``Truck
Complaint'' or its category for ``Truck Safety.'' OOIDA states a driver
could follow the prompts and spend considerable time typing an incident
description to discover they did not select the correct category. This
could result in a driver giving up on the complaint filing process. Id.
at 5-6.
    FMCSA acknowledges OOIDA's concern and will work to improve future
releases of the NCCDB system to address the issue.

Knowledge of DOT Number

    OOIDA states that it is problematic for a driver to know the USDOT
number of a motor carrier when attempting to file a complaint. It
states that if the individual does not know the USDOT number of the
entity he/she is filing against, the next step may be to enter the
Company Information. OOIDA explains that upon completing the relevant
information, the logical step would be to click the ``NEXT'' button.
However, it states the required action is to click ``Add Company'' and
suggests this sequence implies that a driver enter another company.
OOIDA recommends changing this language to ``Select this Company'' or
``Use This Company Information'' as the next logical step. OOIDA
further suggests that the heading ``Complaint on Carrier(s)'' be
changed to ``Company You Have Entered'' or some similar language. Id.
at 6.
    FMCSA acknowledges the proposed amendments to the language and
agrees with the recommendations. FMCSA will work with OOIDA on its
suggestions and make the changes referenced above in a future release
of the NCCDB.

Lack of Consistent Language

    OOIDA states the language in the NCCDB is inconsistent in the
complaint filing process. At one step, the term ``Company Information''
is used; however, in the next step, the term ``Complaint on
Carrier(s)'' is used. Id. at 6. According to OOIDA, since complaints
could also involve brokers, the term ``Company Information'' is the
most appropriate choice. Id. at 6-7.
    FMCSA looks forward to working with OOIDA on its suggestions and
will incorporate this recommendation in a future release of the
website.

Selecting the Company

    OOIDA points out a number of issues associated with a complainant
searching the NCCDB by USDOT number. In particular, OOIDA points out
that redundant information appears after a complainant clicks on the
``Select'' option after the search result appears. OOIDA recommends
that the heading ``You Have Selected'' followed by the company name and
associated information be substituted for the redundant information.
Id. At 7.
    FMCSA accepts this recommendation and will incorporate in a future
release of the NCCDB. The Agency is also committed to working with
OOIDA on other concerns it raises in this portion of its comments.

Acceptable Media Files

    While OOIDA notes that the NCCDB permits ``a variety of file types
to be uploaded, it is missing critical file types such as MP4 video.''
Id. at 7. Moreover, OOIDA raises a concern that FMCSA's 10-megabyte
file size limit is too low. According to OOIDA, ``[u]sing common smart
phones, OOIDA staff found that a video would exceed 10 megabytes after
only 6 seconds of footage.'' Id. at 8.
    FMCSA has updated its capabilities to accommodate up to 20-megabyte
file sizes and video formats that are compatible with NCCDB software.

Back Button Warning

    OOIDA notes that a ``Back Button Warning'' should be displayed when
individuals file complaints in the NCCDB. Presently, when the back
button is used, it returns the filer to the home page and the
individual must reenter their complaint. Id.
    FMCSA accepts OOIDA's suggestion to include a ``Back Button
Warning'' and will include this change in a future release of the
NCCDB.

Conditional Logic is Needed

    OOIDA indicates that when a complaint is being entered, the NCCDB
should not allow the complainant to continue in the online process if
any fields remain blank. A process such as this would have notified
their member to complete the online process for a successful submission
of the complaint. Id. FMCSA acknowledges OOIDA's comments and
implemented updates to the NCCDB that corrects this issue.

Ample Time

    OOIDA states that one of the NCCDB's stronger points is the ample
time allowed before a user is automatically logged out of a session
when there is a pause in data input. Id. at 8.
    FMCSA will continue to maintain the current login time for entering
complaints.

E. Other Concerns

    OOIDA expresses concern that the ICR states, ``[t]here is no
complaint history for the recently added coercion and harassment
complaint categories, or for complaints regarding financial
responsibility instruments for brokers and/or freight forwarders.'' Id.
at 9. In response to the Agency's statement in the November 29 Notice
that ``[t]his data will be collected and included in future renewals
for the NCCDB,'' 81 FR at 86069, OOIDA indicates that it ``recommends
the Agency work quickly to include such data in future renewals for the
NCCDB.''
    FMCSA did not have data to provide in the November 29 Notice. The
coercion, harassment, and the financial responsibility categories were,
at that time, only recently added. However, in Fiscal Year 2016,
complainants filed complaints in the NCCDB as follows: 362 financial
responsibility; 96 harassment; and 224 coercion. This 2016 data is
included in the cost calculation.

Background

    The FMCSA maintains online information and resources to assist
drivers, others in the motor carrier industry and members of the public
in filing safety complaints regarding HHG carriers, hazardous materials
(HM) carriers, property carriers, cargo tank facilities, and passenger
carriers. There is also information pertaining to the filing of
complaints regarding brokers, freight forwarders, and financial
responsibility. Finally, there is information regarding consumer
complaints, particularly regarding HHG transportation and ADA
compliance. This online interface is known as the NCCDB. When
effectively applied, the NCCDB can contribute to safer motor carrier
operations on our nation's highways and improved consumer protection.
    The NCCDB grew out of a telephone hotline known as the Safety
Violation Hotline Service. Congress mandated this hotline in Section
4017 of the ``Transportation Equity Act of the 21st

Century,'' Public Law 105-178, 112 Stat. 107, June 9, 1998. The Motor
Carrier Safety Improvement Act of 1999, Public Law 106-159, 113 Stat.
1748, December 9, 1999, created the FMCSA and section 213 of the Act
expanded the Safety Violation Hotline Service to include a 24-hour
operation. On August 10, 2005, Congress enacted the Safe, Accountable,
Flexible, and Efficient Transportation Equity Act: A Legacy for Users,
(SAFETEA-LU), Public Law 109-59, 119 Stat. 1144. Section 4214 of
SAFETEA-LU requires DOT to create a system to record and log aggregate
complaint information regarding violations of the Federal Motor Carrier
Safety Regulations.
    The NCCDB fulfills the requirements of these mandates. Complaints
will be accepted through the NCCDB in connection with other statutory
mandates, including, but not limited to, protection of drivers against
harassment and coercion under sections 32301(b) and 32911,
respectively, of the Moving Ahead for Progress in the 21st Century Act,
Public Law 112-141, 126 Stat. 405. The NCCDB will also accept
complaints from interested parties regarding third party intermediaries
(brokers and freight forwarders) and their associated financial
responsibility instruments.
    Title: National Consumer Complaint Database OMB Control Number:
2126-NEW.
    Type of Request: New information collection.
    Respondents: Consumers, Drivers, and Others, Participants in the
Motor Carrier Industry.
    Estimated Number of Respondents: 12,165 respondents [8,030 Moving
Complaint respondents + 3,449 Truck Complaint respondents + 685 Bus
Complaint respondents].
    Estimated Time per Response: 15 Minutes.
    Expiration Date: N/A. This is a new information collection.
    Frequency of Response: On occasion.
    Estimated Total Annual Burden: 3,041 hours [8,030 Moving Complaint
respondents x 15 minutes = 2,008 hours; 3,449 Truck Complaint
respondents x 15 minutes = 863 hours; 685 Bus Complaint respondents x
15 minutes = 171 hours].

Public Comments Invited

    You are asked to comment on any aspect of this information
collection, including: (1) Whether the proposed collection is necessary
for the FMCSA to perform its functions; (2) the accuracy of the
estimated burden; (3) ways for the FMCSA to enhance the quality,
usefulness, and clarity of the collected information; and (4) ways that
the burden could be minimized without reducing the quality of the
collected information.

    Issued under the authority delegated in 49 CFR 1.87 on: January
23, 2018.
G. Kelly Regal,
Associate Administrator for Office of Research and Information
Technology.
[FR Doc. 2018-01941 Filed 1-30-18; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 81, Number 87 (Thursday, May 5, 2016)]
[Rules and Regulations]
[Pages 27019-27025]
[FR Doc No: 2016-10581]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0324; FRL-9945-48]

Fluxapyroxad; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of
fluxapyroxad in or on multiple commodities which are identified and
discussed later in this document. BASF Corporation requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 5, 2016. Objections and
requests for hearings must be received on or before July 5, 2016, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2015-0324, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

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

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP
test guidelines referenced in this document electronically, please go
to http://www.epa.gov/ocspp and select ``Test Methods and Guidelines.''

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2015-0324 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
July 5, 2016. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2015-0324, 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 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.

II. Summary of Petitioned-for Tolerance

    In the Federal Register of August 26, 2015 (80 FR 51759) (FRL-9931-
74), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
5F8344) by BASF Corporation, 26 Davis Drive, Research Triangle Park, NC
27709. The petition requested that 40 CFR 180.666 be amended by
establishing tolerances for residues of the fungicide fluxapyroxad, in
or on citrus, dried pulp at 2.7 parts per million (ppm); citrus oil at
19 ppm; fruit, citrus group 10-10 at 1.0 ppm; grass forage, fodder and
hay group 17 at 30 ppm; non-grass animal feed, group 18 at 30 ppm; and
poultry, fat at 0.005 ppm. The petition also requested that the
existing tolerance for residues of fluxapyroxad on egg be amended from
0.002 ppm to 0.01 ppm and that the tolerance for inadvertent residues
of fluxapyroxad on nongrass animal feeds, group 18 at 0.3 ppm be
removed upon establishment of the superceding group 18 tolerance. That
document referenced a summary of the petition prepared by BASF
Corporation, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing.
    Based upon review of the data supporting the petition, EPA has
recommended tolerances for poultry meat, poultry meat byproduct, and
milk fat for which there were no established tolerances previously due
to low dietary burden and falling under category 3 of CFR 180.6(a). The
reason for these changes are explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue.* *
*''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for fluxapyroxad including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with fluxapyroxad follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    Fluxapyroxad is of low acute toxicity by the oral, dermal and
inhalation routes, is not irritating to the eyes and skin, and is not a
dermal sensitizer. The primary target organ for fluxapyroxad exposure
via the oral route is the liver with secondary toxicity in the thyroid
for rats only. Liver toxicity was observed in rats, mice, and dogs,
with rats as the most sensitive species for all durations of exposure.
In rats, adaptive effects of hepatocellular hypertrophy and increased
liver weights and changes in liver enzyme activities were first
observed. As the dose or duration of exposure to fluxapyroxad
increased, clinical chemistry changes related to liver function also
occurred, followed by hepatocellular necrosis, neoplastic changes in
the liver, and tumors. Thyroid effects were observed only in rats.
These effects were secondary to changes in liver enzyme regulation,
which increased metabolism of thyroid hormone, resulting in changes in
thyroid hormones, thyroid follicular hypertrophy and hyperplasia, and
thyroid tumor formation. Tumors were not observed in species other than
rats or in organs other than the liver and thyroid.
    Fluxapyroxad is classified as ``Not likely to be Carcinogenic to
Humans'' based on convincing evidence that carcinogenic effects are not
likely below a defined dose range. There is no mutagenicity concern
from in vivo or in vitro assays. The hypothesized mode of action (i.e.,
a non-genotoxic) for treatment related tumors (i.e., the liver and
thyroid) was supported by a full panel of in vitro and in vivo studies
that showed no evidence of genotoxicity, together with mechanistic
studies in the liver and thyroid of rats that satisfied stringent
criteria for establishing tumorigenic modes of action. The studies
clearly identified the sequence of key events, dose-response
concordance and temporal relationship to the tumor types. The Agency
has determined that the chronic population adjusted dose (PAD) will
adequately account for all chronic effects, including carcinogenicity
that could result from exposure to fluxapyroxad because the points of
departure (POD) for the chronic population adjusted dose (cPAD) is
based on the most sensitive endpoint, liver effects. Effects in the
liver preceded liver tumors and the effects observed in the thyroid (in
rats only) were believed to be secondary to the liver effects.
    No evidence of neurotoxicity was observed in response to repeated
administration of fluxapyroxad. An acute neurotoxicity study showed
decreased rearing and motor activity. This occurred on the day of
dosing only and in the absence of histopathological effects or
alterations in brain weights. This indicated that any neurotoxic
effects of fluxapyroxad are likely to be transient and reversible due
to alterations in neuropharmacology and not from neuronal damage. There
were no neurotoxic effects observed in the subchronic dietary toxicity
study. No evidence of reproductive toxicity was observed. Developmental
effects observed in both rats and mice (thyroid follicular hypertrophy
and hyperplasia in rats and decreased defecation, food consumption,
body weight/body weight gain, and increased litter loss in rabbits)
occurred at the same doses as those that caused adverse effects in
maternal animals, indicating no quantitative susceptibility. Since the
maternal toxicities of thyroid hormone perturbation in rats and
systemic toxicity in rabbits likely contributed to the observed
developmental effects there is low concern for qualitative
susceptibility. An immunotoxicity study in mice showed no evidence of
immunotoxic effects from fluxapyroxad.
    Subchronic oral toxicity studies in rats, developmental toxicity
studies in rabbits, and in vitro and in vivo genotoxicity studies were
performed for fluxapyroxad metabolites F700F001, M700F002, and
M700F048. Like

fluxapyroxad, no genotoxic effects were observed for any of these
metabolites. All three metabolites displayed lower subchronic toxicity
via the oral route than fluxapyroxad, with evidence of non-specific
toxicity (decreased body weight) observed only for M700F0048 at the
limit dose. Only M700F0048 exhibited developmental toxicity at doses
similar to those that caused developmental effects in rabbits with
fluxapyroxad treatment. However, these effects (abortions and
resorptions) were of a different nature than for fluxapyroxad (paw
hyperflexion) and are considered secondary to maternal toxicity. The
Agency considers these studies sufficient for hazard identification and
characterization and concludes that these metabolites do not have
hazards that exceed those of fluxapyroxad in nature, severity, or
potency.
    Specific information on the studies received and the nature of the
adverse effects caused by fluxapyroxad as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document, ``Human Health Risk Assessment for Use
of Fluxaproxad on Citrus Crop Group 10-10, Grass Crop Group 17, and
Non-Grass Crop Group 18.'' on pp. 56 in docket ID number EPA-HQ-OPP-
2012-0638.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    Summary of the toxicological endpoints for used for human risk
assessment is shown in Table 1 of this unit.

 Table 1--Summary of Toxicological Doses and Endpoints for Fluxapyroxad for Use in Dietary, Residential and Non-
                                   Occupational Human Health Risk Assessments
----------------------------------------------------------------------------------------------------------------
                                                  Uncertainty/   RfD, PAD, level
      Exposure/scenario            Point of       FQPA safety     of concern for      Study and toxicological
                                  departure         factors      risk assessment              effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (General         NOAEL = 125 mg/  UFA = 10x        Acute RfD =      Acute neurotoxicity study in
 Population, including          kg/day.         UFH = 10x......   1.25 mg/kg/day.  rats.
 Infants and Children and                       FQPA SF = 1x...  aPAD = 1.25 mg/  LOAEL = 500 mg/kg/day based on
 Females 13-49 years of age).                                     kg/day.          decreased motor activity
                                                                                (both sexes) and decreased
                                                                                rearing (males only).
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (All           NOAEL = 2.1 mg/  UFA = 10x        Chronic RfD =    Chronic toxicity/
 Populations).                  kg/day.         UFH = 10x......   0.021 mg/kg/     carcinogenicity study in
                                                FQPA SF = 1x...   day.             rats.
                                                                 cPAD = 0.021 mg/ LOAEL = 11 mg/kg/day based on
                                                                  kg/day.          non-neoplastic changes in the
                                                                                liver (foci, masses).
----------------------------------------------------------------------------------------------------------------
Incidental Oral Short-Term (1- NOAEL = 7.3mg/   UFA = 10x        Residential LOC  90-day dietary study in rats.
 30 days).                      kg/day.         UFH = 10x......   for MOE = 100.  MIRD 47923567.
                                                FQPA SF = 1x...                   LOAEL = 35.1 mg/kg/day based
                                                                                on thyroid follicular
                                                                                hypertrophy/hyperplasia.
----------------------------------------------------------------------------------------------------------------
Dermal Short- and                                            No hazard identified.
 Intermediate-Term.
----------------------------------------------------------------------------------------------------------------
Inhalation, Short-Term (1-30   NOAEL = 7.3 mg/  UFA = 10x        Residential LOC  90-day dietary study in rats.
 days) and Intermediate-term    kg/day.         UFH = 10x......   for MOE = 100.  MIRD 47923567.
 (1-6 months).                                  FQPA SF = 1x...                   LOAEL = 35.1 mg/kg/day based
                                                                                on thyroid follicular
                                                                                hypertrophy/hyperplasia.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal,             Classification: Not likely to be carcinogenic to humans below a defined dose
 inhalation).                                                        range.
----------------------------------------------------------------------------------------------------------------
Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data
  and used to mark the beginning of extrapolation to determine risk associated with lower environmentally
  relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect
  level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential
  variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor.
  PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOA = mode of action.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fluxapyroxad, EPA considered exposure under the petitioned-
for tolerances as well as all existing fluxapyroxad tolerances in 40
CFR 180.666. EPA assessed dietary exposures from fluxapyroxad in food
as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. Such effects were identified
for fluxapyroxad. In estimating acute dietary exposure, EPA used food
consumption information from the United States Department of
Agriculture (USDA) 2003-2008 Nationwide Continuing Surveys of Food
Intake by Individuals (CSFII). As to residue levels in food, EPA used
tolerance-level residues adjusted to account for the metabolites of
concern (M700F008, and M700F010 (milk only)) and 100 percent crop
treated (PCT) assumptions were used. DEEM default and empirical
processing factors were used to modify the tolerance values.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 2003-2008
CSFII. As to residue levels in food, a moderately refined chronic
dietary exposure analysis was performed for the general U.S. population
and various population subgroups. Combined average residue for parent
and highest residue for metabolite M700F008 and 100 PCT assumptions
were used. For livestock commodities tolerance-level residues adjusted
to account for the metabolites of concern (M700F008, M700F010) were
used. An assumption of 100 PCT was also used for the chronic dietary
analysis. DEEM default and empirical processing factors were used to
modify the tolerance values.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that fluxapyroxad does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
    The Agency did not use PCT information in the dietary assessment
for fluxapyroxad; 100 PCT was assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk
assessment for fluxapyroxad in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of fluxapyroxad. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model Ground Water (PRZM GW), the
estimated drinking water concentrations (EDWCs) of fluxapyroxad for
acute exposures are 127 ppb parts per billion (ppb) for surface water
and 203 ppb for ground water. The EDWCs for chronic exposures for non-
cancer assessments are 127 ppb for surface water and 188 ppb for ground
water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 203 ppb was used to assess
the contribution to drinking water. For chronic dietary risk
assessment, the water concentration value of 184 ppb was used to assess
the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    There are no residential exposure associated with the proposed uses
in this action; however, there are existing turf uses that were
previously assessed for fluxapyroxad. Although the Agency had conducted
a residential exposure assessment for previous fluxapyroxad actions,
the Agency completed an updated turf assessment to reflecting an update
in the single maximum application rate from 2.47 pounds active
ingredient/gallon (lb ai/gallon) to 0.005 lb ai/gallon. The present
assessment assumed the following exposure scenarios:
     Residential handler: The Agency assessed inhalation
exposures to adults from applications only because fluxapyroxad does
not pose a dermal risk. Residential handler exposure is expected to be
short-term in duration. Intermediate-term exposures are not likely
because of the intermittent nature of applications by homeowners.
     Post-application exposures: Dermal exposures were not
assessed because there is no identified systemic dermal hazard for
fluxapyroxad. Post-application inhalation exposure while engaged in
activities on or around previously treated turf is generally not
quantitatively assessed. The combination of low vapor pressure for
chemicals typically used as active ingredients in outdoor residential
pesticide products and dilution in outdoor air is likely to result in
minimal inhalation exposure. Incidental oral exposure for children is
anticipated. The quantitative oral exposure/risk assessment for
residential post-application exposures is based on the incidental oral
scenario for children 1<2.
    Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found fluxapyroxad to share a common mechanism of
toxicity with any other substances, and fluxapyroxad does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
fluxapyroxad does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

 D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply

an additional tenfold (10X) margin of safety for infants and children
in the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. This additional margin of
safety is commonly referred to as the FQPA Safety Factor (SF). In
applying this provision, EPA either retains the default value of 10X,
or uses a different additional safety factor when reliable data
available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. No evidence of quantitative
susceptibility was observed in a reproductive and developmental
toxicity study in rats or in developmental toxicity studies in rats and
rabbits. Developmental toxicity data in rats showed decreased body
weight and body weight gain in the offspring at the same dose levels
that caused thyroid follicular hypertrophy/hyperplasia in parental
animals. Effects in rabbits were limited to paw hyperflexion, a
malformation that is not considered to result from a single exposure
and that usually reverses as the animal matures. Developmental effects
observed in both rats and rabbits occurred at the same doses as those
that caused adverse effects in maternal animals, indicating no
quantitative susceptibility. The Agency has low concern for
developmental toxicity because the observed effects were of low
severity, were likely secondary to maternal toxicity, and demonstrated
clear NOAELs. Further, the NOAELs for these effects were at dose levels
higher than the points of departure selected for risk assessment for
repeat-exposure scenarios. Therefore, based on the available data and
the selection of risk assessment endpoints that are protective of
developmental effects, there are no residual uncertainties with regard
to pre- and/or postnatal toxicity.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for fluxapyroxad is complete.
    ii. There is no indication that fluxapyroxad is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity. Although an acute
neurotoxicity study showed decreased rearing and motor activity, this
occurred on the day of dosing only in the absence of histopathological
effects or alterations in brain weights. This indicated that any
neurotoxic effects of fluxapyroxad are likely to be transient and
reversible due to alterations in neuropharmacology and not from
neuronal damage. The Agency has low concern for neurotoxic effects of
fluxapyroxad at any life stage.
    iii. Based on the developmental and reproductive toxicity studies
discussed in Unit III.D.2., there are no residual uncertainties with
regard to prenatal and/or postnatal toxicity.
    iv. There are no residual uncertainties identified in the exposure
databases. The residue database is adequate. The dietary risk
assessment is conservative and will not underestimate dietary exposure
to fluxapyroxad. There are residential uses proposed for fluxapyroxad
and the assessment will not underestimate residential exposure via
handler for adults and incidental oral for children. EPA made
conservative (protective) assumptions in the ground and surface water
modeling used to assess exposure to fluxapyroxad in drinking water. EPA
used similarly conservative assumptions to assess post application
exposure of children as well as incidental oral exposure of toddlers.
There are residential uses proposed for fluxapyroxad and the assessment
will not underestimate residential exposure via handler for adults and
incidental oral for children.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to fluxapyroxad will occupy 12% of the aPAD for children 1-2 years old,
the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
fluxapyroxad from food and water will utilize 66% of the cPAD for
infants (< 1 year old). Based on the explanation in Unit III.C.3.,
regarding residential use patterns, chronic residential exposure to
residues of fluxapyroxad is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    Fluxapyroxad is currently registered for uses that could result in
short-term residential exposure, and the Agency has determined that it
is appropriate to aggregate chronic exposure through food and water
with short-term residential exposures to fluxapyroxad. Using the
exposure assumptions described in this unit for short-term exposures,
EPA has concluded the combined short-term food, water, and residential
exposures result in aggregate MOEs of 1139 for adults and 431 for
children. Because EPA's level of concern for fluxapyroxad is a MOE of
100 or below, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). An intermediate-term adverse effect was identified; however,
fluxapyroxad is not registered for any use patterns that would result
in intermediate-term residential exposure. Intermediate-term risk is
assessed based on intermediate-term residential exposure plus chronic
dietary exposure. Because there is no intermediate-term residential
exposure and chronic dietary exposure has already been assessed under
the appropriately protective cPAD (which is at least as protective as
the POD used to assess intermediate-term risk), no further assessment
of intermediate-term risk is necessary, and EPA relies on the chronic
dietary risk assessment for evaluating intermediate-term risk for
fluxapyroxad.
    5. Aggregate cancer risk for U.S. population. As discussed in Unit
III.A., EPA has classified fluxapyroxad as ``Not likely to be
Carcinogenic to Humans'' based on convincing evidence that carcinogenic
effects are not likely below a defined dose range. The Agency has
determined that the quantification of risk using the cPAD for
fluxapyroxad will adequately account for all chronic toxicity,
including carcinogenicity that could result from exposure to
fluxapyroxad. Because the Agency has determined fluxapyroxad will not
cause a chronic risk, the Agency concludes that fluxapyroxad will not
pose a cancer risk for the U.S. population.
    6. Determination of safety. Based on these risk assessments, EPA
concludes

that there is a reasonable certainty that no harm will result to the
general population, or to infants and children from aggregate exposure
to fluxapyroxad residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    There are suitable residue analytical methods available for
enforcement of fluxapyroxad tolerances (BASF Methods L0137/01 for
plants and L0140/02 for animal matrices) which have been radio-
validated and have underwent successful validation by an independent
laboratory. These are liquid chromatography with tandem mass
spectrometry (LC/MS/MS) methods and monitor two ion transitions. The
Limit of Quantitation (LOQ) for BASF method L0137/01 is 0.01 ppm for
various matrices. The LOQ for BASF method L0140/02 is 0.01 ppm for
liver and muscle, and 0.001 ppm for milk and eggs.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    There are no Codex MRLs for citrus or grass and non-grass animal
feed at present. US and Codex use different dietary burden evaluations
and calculations which result in US tolerances for residues in ruminant
meat byproduct, milk, and milk fat generally much lower than
corresponding Codex MRLs.

C. Revisions to Petitioned-for Tolerances

    EPA is establishing tolerances for milk fat and poultry meat, and
meat byproduct that the applicant did not request. There have been no
established tolerances for poultry tissues because residues were not
expected to be found in those tissues due to the low dietary burden;
i.e., category 3 of 40 CFR 180.6(a) applied for those poultry matrices
previously. However, because of expectation of higher residues on the
feed items associated with the proposed uses (mainly grass and non-
grass), the livestock dietary burdens have increased, and residues are
now expected to be transferred to poultry tissues. Consequently, the
Agency is establishing poultry tolerances. Similarly, due to the higher
livestock dietary burdens, EPA is establishing a new tolerance for
residues in milk fat, and increasing current tolerances on milk,
ruminant fat and meat byproduct (to include fat and meat byproduct of
cattle, goat, horse and sheep). EPA is also establishing higher
tolerances than what the applicant proposed for grass (group 17),
citrus oil, dried pulp, and poultry fat. The difference in the group 17
grass tolerance is due to the fact that EPA is using residues from 0-
day postharvest interval (PHI) from grass samples (instead of 14-day
PHI used by the applicant). With regard to citrus oil, the difference
between the petitioned-for and established tolerance is due to the use
of the highest average field trial (HAFT) data by EPA (instead of
median used by the applicant), times processing factor. Dried pulp
tolerance difference is due to EPA rounding of the calculated
tolerance. Lastly, the difference in the tolerance in poultry fat is
due to recalculating dietary burden for livestock, taking into account
residues on feed commodities from (0-day PHI) grass, alfalfa and clover
which resulted in higher than previously calculated dietary burdens and
therefore higher tolerances.

V. Conclusion

    Therefore, tolerances are established for residues of fluxapyroxad,
in or on cattle, fat at 0.06 ppm; cattle, meat byproduct at 0.04 ppm;
citrus, dried pulp at 3.0 ppm; citrus, oil at 40 ppm; fruit, citrus,
group 10-10 at 1.0 ppm; goat, fat at 0.06 ppm; goat, meat byproduct at
0.04 ppm; grass, forage, fodder, and hay, group 17 at 40 ppm; horse,
fat at 0.06 ppm; horse, meat byproduct at 0.04 ppm; milk at 0.01 ppm;
milk, fat at 0.15 ppm; non-grass animal feeds, group 18 at 30 ppm;
poultry, fat, poultry, meat and meat byproduct, each at 0.01 ppm;
sheep, fat at 0.06 ppm; and sheep, meat byproduct at 0.04 ppm. Finally,
the Agency is removing the tolerance for inadvertent residues of
fluxapyroxad on non-grass animal feeds, group 18 contained in paragraph
(d) of section 180.666, as it is subsumed by the tolerance for non-
grass animal feeds, group 18 being established in paragraph (a) of the
same section.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined

that Executive Order 13132, entitled ``Federalism'' (64 FR 43255,
August 10, 1999) and Executive Order 13175, entitled ``Consultation and
Coordination with Indian Tribal Governments'' (65 FR 67249, November 9,
2000) do not apply to this action. In addition, this action does not
impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act (UMRA) (2
U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: April 26, 2016.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. In Sec.  180.666, amend the table in paragraph (a) as follows:
0
i. Add alphabetically the entries ``Citrus, dried pulp'', ``Citrus,
oil'', ``Fruit, citrus, group 10-10'', ``Grass forage, fodder and hay,
group 17'', ``Milk, fat'', ``Non-grass animal feed, group 18'',
``Poultry, fat'', ``Poultry, meat'' and ``Poultry, meat byproduct''.
0
ii. Revise the following entries ``Cattle, fat'', ``Cattle, meat
byproduct'', ``Egg'', ``Goat, fat'', ``Goat, meat byproduct'', ``Horse,
fat'', ``Horse, meat byproduct'', ``Milk'', ``Sheep, fat,'' and
``Sheep, meat byproduct''.
0
iii. Remove from the table in paragraph (d) the entry ``non-grass
animal feeds, group 18''.
    The amendments read as follows:

Sec.  180.666  Fluxapyroxad; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Cattle, fat.............................................            0.06

                                * * * * *
Cattle, meat byproduct..................................            0.04
Citrus, dried pulp......................................             3.0
Citrus, oil.............................................              40

                                * * * * *
Egg.....................................................            0.01
Fruit, citrus, group 10-10..............................             1.0

                                * * * * *
Grass, forage, fodder and hay, group 17.................              40
Goat, fat...............................................            0.06

                                * * * * *
Goat, meat byproduct....................................            0.04

                                * * * * *
Horse, fat..............................................            0.06

                                * * * * *
Horse, meat byproduct...................................            0.04
Milk....................................................            0.01
Milk, fat...............................................            0.15
Non-grass animal feed, group 18.........................              30

                                * * * * *
Poultry, fat............................................            0.01
Poultry, meat...........................................            0.01
Poultry, meat byproduct.................................            0.01

                                * * * * *
Sheep, fat..............................................            0.06

                                * * * * *
Sheep, meat byproduct...................................            0.04

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

* * * * *

[FR Doc. 2016-10581 Filed 5-4-16; 8:45 am]
 BILLING CODE 6560-50-P