[Federal Register Volume 81, Number 42 (Thursday, March 3, 2016)]
[Notices]
[Pages 11351-11354]
[FR Doc No: 2016-04605]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

Denial of Motor Vehicle Defect Petition

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

ACTION: Denial of a petition for a defect investigation.

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SUMMARY: This notice sets forth the reasons for denying a petition
(DP15-007) submitted to NHTSA under 49 U.S.C. 30162 and 49 CFR part
552, requesting that the agency ``have Toyota correct software defects
in their electronic throttle control software'' and then ``issue a
national recall of all effected [sic] vehicles and have Toyota replace
the old faulty code with the new safer code.''

FOR FURTHER INFORMATION CONTACT: Mr. Stephen McHenry, Vehicle Control
Division, Office of Defects Investigation, NHTSA, 1200 New Jersey
Avenue SE., Washington, DC 20590. Telephone<PHONE_NUMBER>. Email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

1.0 Introduction

    Interested persons may petition NHTSA requesting that the agency
initiate an investigation to determine

whether a motor vehicle or item of replacement equipment does not
comply with an applicable motor vehicle safety standard or contains a
defect that relates to motor vehicle safety. 49 U.S.C. 30162(a)(2); 49
CFR 552.1. Upon receipt of a properly filed petition, the agency
conducts a technical review of the petition, material submitted with
the petition, and any additional information. 49 U.S.C. 30162(c); 49
CFR 552.6. The technical review may consist solely of a review of
information already in the possession of the agency, or it may include
the collection of information from the motor vehicle manufacturer and/
or other sources. After considering the technical review and taking
into account appropriate factors, which may include, among others,,
agency priorities, the likelihood of uncovering sufficient evidence to
establish the existence of a defect, and the likelihood of success in
any necessary enforcement litigation, the agency will grant or deny the
petition. See 49 U.S.C. 30162(d); 49 CFR 552.8.

2.0 Petition Background Information

    In a letter dated September 15, 2015, Dr. James Stobie (the
petitioner) requested that NHTSA ``have Toyota correct software defects
in their electronic throttle control software'' and then ``issue a
national recall of all effected [sic] vehicles and have Toyota replace
the old faulty code with the safer code.'' Dr. Stobie references two
previous defect petitions related to unintended acceleration in Toyota
vehicles that NHTSA recently evaluated and denied. The petitioner
stated that his petition contains new information affecting NHTSA's
conclusions in the previous petition evaluations. This includes: (1)
Information related to a crash that occurred as his wife was attempting
to park their model year 2010 Lexus HS250H; (2) the source of EDR data
in Toyota vehicles; (3) alleged defects in the Toyota Electronic
Throttle Control (ETC) software; and (4) a recall conducted by Honda in
Japan. NHTSA has reviewed the material cited by the petitioner. The
results of this review and our evaluation of the petition are set forth
in the DP15-007 Petition Analysis Report, published in its entirety as
an appendix to this notice.
    After a thorough assessment of the material submitted by the
petitioner, the information already in NHTSA's possession, and the
potential risks to safety implicated by the petitioner's allegations,
it is unlikely that an order concerning the notification and remedy of
a safety-related defect would result from any proceeding initiated by
granting Dr. Stobie's petition. After full consideration of the
potential for finding a safety related defect in the vehicle, and in
view of NHTSA's enforcement priorities and its previous investigations
into this issue, the petition is denied.

Appendix--Petition Analysis--DP15-007

1.0 Introduction

    On September 23, 2015, the National Highway Traffic Safety
Administration (NHTSA) received a September 15, 2015 letter from Dr.
James Stobie, Ph.D. (the petitioner), petitioning the agency to
``have Toyota correct software defects in their electronic throttle
control software'' and then ``issue a national recall of all
effected [sic] vehicles and have Toyota replace the old faulty code
with the safer code.'' The petition cites a crash that occurred as
his wife was attempting to park their model year 2010 Lexus HS250H
in an angled parking space facing a brick building and references
two previous Toyota unintended acceleration defect petitions that
NHTSA evaluated and denied. Dr. Stobie's petition also alleges that
new information not considered by the Agency in those prior
petitions should be evaluated by NHTSA. This new information
includes: (1) The facts and circumstances of a crash that occurred
as his wife was attempting to park their model year 2010 Lexus
HS250H; (2) the source of EDR data in Toyota vehicles; (3) alleged
defects in the Toyota Electronic Throttle Control (ETC) software;
and (4) a recall conducted by Honda in Japan.

2.0 Petition Analysis

2.1 Background

2.1.1 EDR Data Limitations

    The Toyota EDR collects pre-trigger data (vehicle speed, engine
speed, brake switch status, and accelerator pedal position sensor #1
voltage) from the vehicle's High Speed Controller Area Network (HS-
CAN), which is refreshed either periodically or immediately by the
respective control modules.

           Table 1--EDR Pre-Crash Parameters, by Refresh Rate
------------------------------------------------------------------------
            Parameter                Refresh rate         Resolution
------------------------------------------------------------------------
Brake Switch....................  Immediately.......  On/Off.
Engine RPM......................  24 ms.............  400 RPM.\1\
Vehicle Speed...................  500 ms............  2 km/h.\2\
Accelerator Rate................  512 ms............  0.039 volts.
------------------------------------------------------------------------

    The EDR continuously performs 1 Hz sampling of HS-CAN pre-
trigger data and stores the data in a temporary buffer. The EDR only
saves this data, along with the trigger data, when it detects a
triggering event such as a crash.\2\ Table 1 shows the refresh rates
and resolutions for the pre-crash data signals. Any analysis of EDR
data for Toyota vehicles should apply these data time tolerances and
resolutions at each of the pre-crash data points.
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    \1\ EDR recorded data are rounded down in the indicated
resolution increments.
    \2\ An event is triggered by detection of a deceleration of
approximately 2 g's.
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    In 2010, NHTSA's Vehicle Research and Test Center (VRTC)
conducted testing to validate the EDR pre-crash data used in NHTSA
field investigations.\3\ The testing found that the pre-crash data
recorded by the Toyota EDR were accurate within the known
limitations resulting from the data resolution and sampling rates.
The testing also demonstrated that the EDR does not necessarily
capture all accelerator pedal applications during an event and the
accelerator pedal voltage recorded at each EDR time interval may not
be the actual accelerator pedal voltage at that interval. Subsequent
studies have confirmed the limitations of stored EDR pre-crash data
in capturing the entire crash event due to the data refresh rates,
data resolutions and EDR sampling rates.4 5 6
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    \3\ ``Event Data Recorder--Pre Crash Data Validation of Toyota
Products,'' NHTSA-NVS-20ll-ETC-SR07, February 2011.
    \4\ Brown, R., White, S., ``Evaluation of Camry HS-CAN Pre-Crash
Data,'' SAE Technical Paper 2012-01-0996, 2012, doi: 10.4271/2012-
01-0996.
    \5\ Brown, R., Lewis, L., Hare, B., Jakstis, M. et al.,
``Confirmation of Toyota EDR Pre-crash Data,'' SAE Technical Paper
2012-01-0998, 2012, doi: 10.4271/2012-01-0998.
    \6\ Ruth, R., Bartlett, W., Daily, J., ``Accuracy of Event Data
in the 2010 and 2011 Toyota Camry During Steady State and Braking
Conditions,'' SAE Technical Paper 2012-01-0999, 2012, doi: 10.4271/
2012-01-0999.
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    The EDR download report clearly notes these issues in the first
two items of Data Limitations section on page one of the report:
     Due to limitations of the data recorded by the airbag
ECU, such as the resolution, data range, sampling interval, time
period of the recording, and the items recorded, the information
provided by this data may not be sufficient to capture the entire
crash.
     Pre-Crash data is recorded in discrete intervals. Due
to different refresh rates within the vehicle's electronics, the
data recorded may not be synchronous to each other.

2.1.2 National Research Council Report

    In 2012, the National Research Council released a report that
included a review of NHTSA's processes for investigating allegations
of sudden unintended acceleration in Toyota and other vehicles.\7\
As noted in the agency's denial of DP14-003, the report concluded
that NHTSA's decision to close its investigations of Toyota's ETC
were justified based on the initial investigations, complaint
analyses, field investigations using EDR data and NASA's examination
of the Toyota ETC. With regard to allegations of low-speed surging
with ineffective brakes, the report stated:
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    \7\ NRC. 2011. TRB Special Report 308: The Safety Challenge and
Promise of Automotive Electronics: Insights from Unintended
Acceleration. Washington, DC: National Academies Press, (164).

    Reports of braking ineffectiveness in controlling a vehicle
experiencing the onset of unintended acceleration from a stopped
position or when moving slowly requires an explanation for the
ineffectiveness, such as

physical evidence of damage to the brake system. Under these
circumstances, investigating for phenomena other than pedal
misapplication absent an explanation for the ineffectiveness of the
brakes, which are independent of the throttle control system and are
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designed to dominate engine torque, is not likely to be useful.

2.2 Crash Incident

    The crash identified by the petitioner involved a sudden
acceleration incident experienced by his wife as she attempted to
park the family's 2010 Lexus HS250H on June 20, 2015, while on the
grounds of the United States Naval Academy.

2.2.1 Driver's Statement

    Mrs. Stobie described the sudden unintended acceleration
incident in several complaints submitted to ODI from June 21, 2015
to August 17, 2015 (VOQ's 10726415, 10726781, and 10749195). She
provided the following statement in the most recent complaint (VOQ
10749195):

    My accident was caused by unintended acceleration. As I was
slowly turning right into a parking place, the car suddenly
accelerated and crashed into a brick building. The force of the
crash caused the air bags to deploy. There was so much damage to the
car that it was a total loss. After the crash I obtained the event
data recorder (EDR) reading from a contractor hired by Toyota. It
showed that for the last 5 seconds before the crash, I was applying
very light pressure to the gas pedal up until the last .8 seconds.
For the last .8 second the EDR shows that my foot was on the brake
and the throttle was at nearly maximum value. During the last .8
seconds the car went from 5 mph to 9.9 mph and the engine rpm went
from 1200 to 2800. I did not apply pressure to the gas pedal at this
time. I was applying pressure to the brake pedal . . .

2.2.2 Event Data Recorder Data

    The petitioner provided a copy of the EDR download data (Table
2).

                                                        Table 2--Pre-Crash Data for VOQ 10749195
--------------------------------------------------------------------------------------------------------------------------------------------------------
           Time (sec)                    -4.8                -3.8                -2.8                -1.8                -0.8               0 (TRG)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Vehicle Speed (MPH [km/h])......  2.5 [4]...........  1.2 [2]...........  2.5 [4]...........  3.7 [6]...........  5 [8].............  9.9 [16].
Brake Switch....................  OFF...............  OFF...............  OFF...............  OFF...............  OFF...............  ON.
Accelerator Rate (V [% full       0.78 [0]..........  0.98 [8]..........  1.45 [27].........  1.41 [26].........  1.33 [22].........  3.32 [106].
 apply]).
Engine RPM (RPM)................  800...............  800...............  800...............  1,200.............  1,200.............  2,800.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The EDR data shows that at the most recent EDR sample prior to
impact (t = -0.8 s), the vehicle is nominally within 10 ft. of the
building, travelling approximately 7 ft./s, the accelerator is at
approximately 22 percent of full apply and the brake is not applied.
The recorded data at the airbag trigger point (t = 0 s), shows that
the accelerator pedal was fully applied \8\ at sometime within 0.512
seconds prior to the trigger point (see Section 2.1.1 EDR Data
Limitations for the source and refresh rate of Accelerator Rate) and
the brake switch is ``On.''
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    \8\ According to Toyota, an Accelerator Rate of 3.188 volts
corresponds with a 100% accelerator pedal application resulting in
wide-open throttle. Any further application of the pedal may produce
higher voltage, but will not result in any additional throttle
opening.
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    In support of his allegation that data provided to the EDR was
corrupted by an undefined software error, the petitioner notes that
the EDR erroneously states that the brake pedal and accelerator were
both being pressed at the same time. Other vehicle data shows that
they were not: This information does not validate the conclusion
adopted in the petition. Separate data downloaded from the Hybrid
Control Unit (HCU) for the petitioner's vehicle indicates that the
brake pedal and the accelerator pedal were not applied
simultaneously at any time during the key cycle in which the
petitioner's accident occurred.\9\ As noted above, the EDR reads the
position of the brake light switch instantaneously while there can
be a time lag as long as 0.512 seconds in writing accelerator
position to the EDR. Since the brake light switch was in the ON
state at the air bag trigger point, this indicates that the brake
was not applied until after the accelerator pedal was released,
which must have occurred in the final half second of travel.
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    \9\ The HCU receives data directly from the Accelerator Pedal
Position Sensor and Brake Stop Lamp Switch and records any instance
in which the pedals are applied at the same time in a particular
drive cycle. Hybrid motor protection logic will override accelerator
pedal signals that occur when the brake is applied.
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    In addition, as noted by the petitioner, brake testing conducted
by Toyota field inspectors after the incident found that the system
performed normally and was capable of stopping a vehicle at full
throttle:

    During the test drive they floored the accelerator and then
quickly slammed on the brakes. The car behaved as expected. Nowhere
did they find a safety defect.

    Based on the recorded vehicle speeds, the vehicle was inside the
parking space when the most significant acceleration occurred. At
this time and distance from impact, a driver would normally be
applying the brake or coasting and not applying the accelerator to
full throttle. Although the driver alleged that the brakes were not
effective during the incident, the brakes had no prior history of
malfunction and the post-incident inspection did not identify any
issues with the brake system. Review of the EDR and HCU data
indicate very late activation of the Brake Stop Lamp Switch after
full application of the accelerator pedal. These data do not support
the driver's statement that the brake was applied when the
acceleration occurred. Based on the foregoing information, this
incident appears to be a case of pedal misapplication.

2.3 Source of EDR Data

    The petitioner correctly notes that the EDR receives the
Accelerator Rate voltage from the engine computer and not directly
from the pedal and asserts that this is ``new critical information
about EDR data.'' In the petitioner's view, the analog to digital
conversion of the accelerator pedal signal and subsequent processing
by the engine computer creates a potential pathway for an unknown
software error to create erroneous accelerator position data.
However, this is not ``new'' information about the source of the
accelerator pedal position data sampled and recorded by the EDR. All
prior work by the agency related to Toyota EDR data dating back to
the joint NHTSA/NASA study, including the two previous petitions and
other studies referenced in that work, recognized and reported that
the EDR samples Accelerator Rate voltage data from the HS-CAN bus.
Further, as discussed below, the engine computer software has been
exhaustively examined, including analysis in the NHTSA/NASA study,
and no one, even consultants who have offered testimony asserting
the software is defective, has identified a specific and
reproducible mechanism or set of conditions that produces unintended
acceleration or the ``false'' data phenomenon put forward in the
petition. As noted in the prior work and in Section 2.1.1 of this
report, the HS-CAN bus receives the Accelerator Rate data from the
engine control module, which refreshes the data every 512 ms (see
Table 1).
    The EDR continuously samples the HS-CAN data once per second and
stores the data in a temporary buffer. The EDR only saves this data,
along with the trigger data, when it detects a triggering event such
as a crash. Because of the manner in which the ECM updates/refreshes
the data to the HS-CAN, the ``recorded'' Accelerator Rate data saved
by the EDR is not necessarily the ``actual'' data at the precise
time intervals captured by the EDR. For example, the Accelerator
Rate recorded by the EDR for the petitioner's crash at the trigger
point (t = 0 s) is not necessarily the actual data at the trigger
point, but the most recent value refreshed to the HS-CAN over the
prior 512 ms. This explains why it is possible for the EDR data to
show that the accelerator appeared to be applied fully at the same
time the brake switch was in the ON position when the HCU data shows
that the brake and the accelerator were not applied simultaneously.

2.4 Alleged Software Defects

    The petitioner states that software defect theories posited by
plaintiff experts in

unintended acceleration litigation against Toyota is new evidence
since the joint NHTSA/NASA study. However, ODI has previously
reviewed this information during its evaluation of DP14-003. The
petitioner does not provide any new information about the theories
or his allegations of defects in the Toyota ETC software. As noted
in ODI's denial report for DP14-003, the software defect theories
failed to identify a precise cause for sudden acceleration, the
software experts did not reproduce the alleged software defects in
testing, and the theorized conditions did not result in sudden
acceleration when artificially simulated. We find no basis for
concluding that the software defect theories constitute
scientifically valid evidence or could explain the incident alleged
by the petitioner.
    ODI's assessment of the software defect theories is not
substantially different from that of one of the plaintiff attorneys
who hired the software experts. These plaintiff attorneys provided
the following characterization of the software experts' work and
findings in a document related to the Toyota SUA property loss
settlement in 2013:

    While Plaintiffs' software experts raised certain software
design and architecture issues, they have not been able to identify
a defect that is responsible for the vast array of SUAs reported to
Toyota and NHTSA by vehicle owners. More specifically, Plaintiffs
have been unable to reproduce a UA in a Subject vehicle under
driving conditions.\10\
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    \10\ Berman, S., Seltzer, M., and Pitre,. F. (2013, April 23).
Plaintiff's Memorandum in Support of Plaintiffs' Motion for an Award
of Attorneys' Fees, Reimbursement of Expenses, and Compensation to
Named Plaintiffs, page 12. In Re: Toyota Motor Corp. Unintended
Acceleration Marketing, Sales Practices, and Products Liability
Litigation. United States District Court, Central District of
California. Case No. 8:10ML2151. Retrieved from https://www.toyotaelsettlement.com/Home/CaseDocs.

    In addition, an October 2013 order from the presiding judge in
the Toyota ETC multi-district litigation provided the following
characterization of the software defect theories cited by the
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petitioner when issuing a ruling in a sudden acceleration case:

    Toyota's Motion for Summary Judgment is premised on the
uncontroverted fact that Plaintiff has been unable to identify a
precise software design or manufacturing defect and point to
physical or otherwise traceable evidence that the defect actually
caused the Camry throttle to open from an idle position to a much
wider angle without analog input from the driver via the accelerator
pedal. To a lesser extent, it is also premised upon the fact that
Plaintiff cannot prove the actual failure of Toyota's fail-safe
mechanisms in the Camry on the day of the collision.

2.5 The Honda Example

    The petitioner references a 2014 recall of 175,000 Honda Fit
vehicles in Japan as an example of a software defect causing
unintended acceleration accidents (Honda Foreign Campaign Number
14F-057). The Honda recall addressed programming flaws that may
result in unintended acceleration during specific operating
conditions. Honda's Foreign Recall Report to NHTSA described the
programming flaws and operating conditions:

    The vehicle may lurch forward due to excessive driving force
generated by the motor if the accelerator pedal is pressed strongly
when the vehicle is in Engine mode and shifted into Drive or
Reverse, or the vehicle is in EV mode and being operated on a slope.
The vehicle may also lurch forward momentarily due to excessive
driving force generated by the motor when switching from EV mode to
Engine mode after being in stop and go traffic.

    Honda was able to reproduce the conditions described in the
recall and develop a software update to address the ``lurching''
concerns. The conditions addressed by the Honda recall are
associated with brief surges that occur when the accelerator pedal
is being applied under specific operating conditions and, thus, are
not related to the petitioner's incident or allegations (which claim
sustained acceleration during brake application), nor have they been
observed in the general population of Toyota ETC vehicles. Finally,
ODI is not aware of any vehicle defect theories, from the software
experts cited by the petitioner or anyone else, that have similarly
documented and reproduced a sudden unintended acceleration condition
in the Toyota vehicles that would be attributable to the electronic
throttle control software in those vehicles.

3.0 Conclusion

    The petitioner does not provide any new evidence in support of
his petition. In our view, a defects investigation is unlikely to
result in a finding that a defect related to motor vehicle safety
exists, or a NHTSA order for the notification and remedy of a safety
related defect as alleged by the petitioner, at the conclusion of
the requested investigation. Therefore, given a thorough analysis of
the potential for finding a safety related defect in the vehicle,
and in view of NHTSA's enforcement priorities and its previous
investigations into this issue, the petition is denied. This action
does not constitute a finding by NHTSA that a safety related defect
does not exist. The agency will take further action if warranted by
future circumstances.

    Authority:  49 U.S.C. 30162(d); delegations of authority at 49
CFR 1.50 and 501.8.

Frank S. Borris II,
Acting Associate Administrator for Enforcement.

[FR Doc. 2016-04605 Filed 3-2-16; 8:45 am]
BILLING CODE 4910-59-P


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The email address field on the Registration section is made available to
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The email address field collection for the Regulations.gov ‘feedback
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The support or oppose comments will be linked from the comment page of
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[Federal Register Volume 79, Number 190 (Wednesday, October 1, 2014)]
[Rules and Regulations]
[Pages 59119-59121]
[FR Doc No: 2014-23112]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0277; FRL-9916-44]

Tetraacetylethylenediamine and Its Metabolite,
Diacetylethylenediamine; Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of tetraacetylethylenediamine (TAED), and
its metabolite, diacetylethylenediamine (DAED), when used as a
fungicide and a bactericide on rice and strawberries. This regulation
eliminates the need to establish a maximum permissible level for
residues of TAED and DAED under the Federal Food, Drug, and Cosmetic
Act (FFDCA).

DATES: This regulation is effective October 1, 2014. Objections and
requests for hearings must be received on or before December 1, 2014,
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-2013-0277, 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: Robert McNally, Biopesticides and
Pollution Prevention Division (7511P), 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 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/
40tab02.tpl.

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-2013-0277 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
December 1, 2014. 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-2013-0277, 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. Background and Statutory Findings

    In the Federal Register of October 25, 2013 (78 FR 63938) (FRL-
9901-96), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 3F8148) by Technology Sciences Group, Inc. (TSG) (the
Petitioner), on behalf of Agri-Neo, Inc., 3485 Ashby Saint-Laurent
(Quebec), H4R 2K3, Canada. The petition requested that 40 CFR part 180
be amended by establishing an exemption from the requirement of a
tolerance for residues of TAED and its metabolite, DAED in or on all
food commodities. That document referenced a summary of the petition
prepared by the Petitioner, TSG, which is available in the docket,
http://www.regulations.gov. There were no comments received on the
notice of filing.
    Based upon the review of the data supporting the petition, EPA is
establishing a tolerance exemption on rice and strawberries rather than
all food commodities as requested.

III. Final Rule

A. The EPA's Safety Determination

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(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. Pursuant to FFDCA section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
FFDCA section 408(b)(2)(C), which require EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance or tolerance exemption 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. . . .'' Additionally, FFDCA section 408(b)(2)(D)
requires that 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.''
    The EPA evaluated the available toxicity and exposure data on TAED
and its metabolite, DAED and considered its validity, completeness, and
reliability, as well as the relationship of this information to human
risk. A full explanation of the data upon which the EPA relied and its
risk assessment based on that data can be found within the August 29,
2014 document entitled ``Federal Food, Drug, and Cosmetic Act (FFDCA)
Considerations for Tetraacetylethylenediamine (TAED) and its metabolite
Diacetylethylenediamine (DAED).'' This document, as well as other
relevant information, is available in the docket for this action as
described under ADDRESSES.
    Based upon that evaluation, the EPA concludes that there is a
reasonable certainty that no harm will result to the U.S. population,
including infants and children, from aggregate exposure to residues of
TAED and its metabolite, DAED. Therefore, an exemption from the
requirement of a tolerance is established for residues of TAED and its
metabolite, DAED when used as a fungicide and a bactericide on rice and
strawberries.

B. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation. The Agency believes that an
analytical enforcement method is not required for a tolerance exemption
on rice and strawberries and there are no risk concerns for these
crops. Further, residues are not expected on any other crops because
rice is typically grown in areas that are not near or next to other
crops. Additionally, the early planting of strawberries versus other
like crops and the use of buffers limits the potential for residues of
the pesticide on crops that may be near.

C. 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 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.
    The Codex has not established a MRL for TAED and its metabolite,
DAED.

IV. Statutory and Executive Order Reviews

    This final rule establishes a tolerance exemption 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
final rule has been exempted from review under Executive Order 12866,
this final rule 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
final rule does not contain any information collections subject to OMB
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., nor does it require any special considerations under Executive
Order 12898, entitled ``Federal Actions to Address Environmental
Justice in Minority Populations and Low-Income Populations'' (59 FR
7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance
exemption in this final rule, do not require the issuance of a proposed
rule, the requirements of the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.), do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of 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 final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (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 of 1995 (NTTAA) (15 U.S.C. 272 note).

V. 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: September 17, 2014.
Jack E. Housenger,
Director, 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. Add Sec.  180.1327 to subpart D to read as follows:

Sec.  180.1327  Tetraacetylethylenediamine (TAED) and its metabolite
Diacetylethylenediamine (DAED); exemption from the requirement of a
tolerance.

    An exemption from the requirement of a tolerance is established for
residues of the pesticide, tetraacetylethylenediamine (TAED), and its
metabolite diacetylethylenediamine (DAED), in or on rice and
strawberries, when used as a fungicide and bactericide in accordance
with label directions and good agricultural practices.

[FR Doc. 2014-23112 Filed 9-30-14; 8:45 am]
BILLING CODE 6560-50-P