Notice2024-17251
Supplemental Initial Decision That Certain Frontal Driver and Passenger Air Bag Inflators Manufactured by ARC Automotive Inc. and Delphi Automotive Systems LLC, and Vehicles in Which Those Inflators Were Installed, Contain a Safety Defect
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 5, 2024
Issuing agencies
Transportation DepartmentNational Highway Traffic Safety Administration
Abstract
NHTSA is confirming its initial decision that certain frontal driver and passenger air bag inflators manufactured by ARC Automotive Inc. and Delphi Automotive Systems LLC, and vehicles in which those inflators were installed, contain a defect related to motor vehicle safety. NHTSA is issuing this supplemental initial decision to address in greater detail the basis for the agency's initial decision and to ensure that all vehicles and manufacturers that would be impacted by any recall order are included within the scope of the initial decision.
Full Text
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<title>Federal Register, Volume 89 Issue 150 (Monday, August 5, 2024)</title>
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[Federal Register Volume 89, Number 150 (Monday, August 5, 2024)]
[Notices]
[Pages 63473-63490]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-17251]
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DEPARTMENT OF TRANSPORTATION
National Highway Traffic Safety Administration
[Docket No. NHTSA-2023-0038]
Supplemental Initial Decision That Certain Frontal Driver and
Passenger Air Bag Inflators Manufactured by ARC Automotive Inc. and
Delphi Automotive Systems LLC, and Vehicles in Which Those Inflators
Were Installed, Contain a Safety Defect
AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).
ACTION: Notice of supplemental initial decision; request for public
comments.
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SUMMARY: NHTSA is confirming its initial decision that certain frontal
driver and passenger air bag inflators manufactured by ARC Automotive
Inc. and Delphi Automotive Systems LLC, and vehicles in which those
inflators were installed, contain a defect related to motor vehicle
safety. NHTSA is issuing this supplemental initial decision to address
in greater detail the basis for the agency's initial decision and to
ensure that all vehicles and manufacturers that would be impacted by
any recall order are included within the scope of the initial decision.
DATES: Comments must be received on or before September 4, 2024.
ADDRESSES: You may submit written submissions to the docket number
identified in the heading of this document by any of the following
methods:
<bullet> Federal eRulemaking Portal: Go to <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Follow the online instructions for submitting
comments.
<bullet> Mail: Docket Management Facility: U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
<bullet> Hand Delivery or Courier: 1200 New Jersey Avenue SE, West
Building Ground Floor, Room W12-140, between 9 a.m. and 5 p.m. ET,
Monday through Friday, except Federal holidays.
<bullet> Fax: (202) 493-2251.
Instructions: All submissions must include the agency name and
docket number. Note that all written submissions received will be
posted without change to <a href="https://www.regulations.gov">https://www.regulations.gov</a>, including any
personal information provided. Please see the Privacy Act discussion
below. We will consider all written submissions received before the
close of business on September 4, 2024.
Docket: For access to the docket to read background documents or
written submissions received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> at any
time or to 1200 New Jersey Avenue SE, West Building Ground Floor, Room
W12-140, Washington, DC 20590, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays. Telephone 202-366-9826.
Privacy Act: In accordance with 49 U.S.C. 30118(b)(1), NHTSA will
make a final decision only after providing an opportunity for
manufacturers and any interested person to present information, views,
and arguments. DOT posts written submissions submitted by manufacturers
and
[[Page 63474]]
interested persons, without edit, including any personal information
the submitter provides, to <a href="http://www.regulations.gov">www.regulations.gov</a>, as described in the
system of records notice (DOT/ALL-14 Federal Docket Management System
(FDMS)), which can be reviewed at <a href="http://www.transportation.gov/privacy">www.transportation.gov/privacy</a>.
Confidential Business Information: If you wish to submit any
information under a claim of confidentiality, you must submit your
request directly to NHTSA's Office of the Chief Counsel. Requests for
confidentiality are governed by 49 CFR part 512. NHTSA is currently
treating electronic submission as an acceptable method for submitting
confidential business information (CBI) to the agency under part 512.
If you would like to submit a request for confidential treatment, you
may email your submission to Allison Hendrickson in the Office of the
Chief Counsel at <a href="/cdn-cgi/l/email-protection#0f6e6363667c606121676a616b7d666c647c60614f6b607b21686079"><span class="__cf_email__" data-cfemail="97f6fbfbfee4f8f9b9fff2f9f3e5fef4fce4f8f9d7f3f8e3b9f0f8e1">[email protected]</span></a> or you may contact her for
a secure file transfer link. At this time, you should not send a
duplicate hardcopy of your electronic CBI submissions to DOT
headquarters. If you claim that any of the information or documents
provided to the agency constitute confidential business information
within the meaning of 5 U.S.C. 552(b)(4) or are protected from
disclosure pursuant to 18 U.S.C. 1905, you must submit supporting
information together with the materials that are the subject of the
confidentiality request, in accordance with part 512, to the Office of
the Chief Counsel. Your request must include a cover letter setting
forth the information specified in NHTSA's confidential business
information regulation (49 CFR 512.8) and a certificate, pursuant to
Sec. 512.4(b) and part 512, appendix A. In addition, you should submit
a copy, from which you have redacted the claimed confidential business
information, to the Docket at the address given above.
FOR FURTHER INFORMATION CONTACT: Allison Hendrickson, Office of the
Chief Counsel, National Highway Traffic Safety Administration, 1200 New
Jersey Avenue SE, Washington, DC 20590; (202) 366-2992.
The publicly available information on which this supplemental
initial decision is based is available on the agency's website at
<a href="https://www.nhtsa.gov/recalls?nhtsaId=EA16003">https://www.nhtsa.gov/recalls?nhtsaId=EA16003</a>, <a href="https://www.nhtsa.gov/recalls?nhtsaId=PE15027">https://www.nhtsa.gov/recalls?nhtsaId=PE15027</a>, and on the public docket under Docket No.
NHTSA-2023-0038.
The information in the investigative file for which confidential
treatment has been requested was shared with the manufacturers that
would be affected in the event of a recall order, as required under 49
U.S.C. 30118(a) and 49 CFR 554.10(b). That information was shared with
the manufacturers under a protective agreement. The information subject
to confidentiality requests remains unredacted in this document
pursuant to 49 U.S.C. 30167(b). File-path citations to the
investigative file have been shared with the manufacturers in a
confidential appendix to this decision.
SUPPLEMENTARY INFORMATION: Pursuant to 49 U.S.C. 30118(a) and 49 CFR
554.10, NHTSA confirms its initial decision that certain frontal driver
and passenger air bag inflators manufactured by ARC Automotive Inc.
(ARC) and Delphi Automotive Systems LLC (Delphi), and vehicles in which
those inflators were installed, contain a defect related to motor
vehicle safety.
NHTSA previously issued an initial decision on September 5,
2023.\1\ After additional consideration of the totality of the
evidence, including comments previously submitted in this proceeding,
NHTSA is issuing this supplemental initial decision to address in
greater detail the basis for the agency's initial decision and to
ensure that all vehicles and vehicle manufacturers that would be
impacted by any recall order are included within the scope of the
initial decision. This action allows for additional transparency and
additional comment from any interested persons.\2\
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\1\ 88 FR 62140 (Sept. 8, 2023).
\2\ NHTSA is addressing certain comments in this supplemental
initial decision to describe the basis of its initial decision more
fully and, in certain instances, to update certain information,
including its calculation of predicted future ruptures. NHTSA
reviewed and considered all written and oral comments previously
submitted in this proceeding. NHTSA intends to further and more
fully address all comments it ultimately receives if and when it
issues a final decision in this proceeding.
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The additional information provided in this notice confirms the
agency's initial decision that certain frontal driver- and passenger-
side hybrid toroidal air bag inflators manufactured by ARC and Delphi
from 2000 through the full implementation of the automated borescope
(the subject inflators) contain a defect related to motor vehicle
safety. The implementation of the borescope, beginning in August of
2017, was fully completed in June of 2018. The latter date is a
correction from the January 2018 completion date identified in the
September 5, 2023 initial decision.\3\
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\3\ ARC completed implementation of the automated borescope
process on lines producing PH7 inflators (which are passenger-side
inflators) in January 2018, and then completed implementation on the
remaining lines producing toroidal inflators in June 2018.
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Based on available information, approximately 51 million subject
inflators were manufactured and installed in approximately 49 million
vehicles in the United States.\4\ The subject inflators were
incorporated into air bag modules manufactured by five air bag module
suppliers and ultimately used in vehicles manufactured by 13 vehicle
manufacturers: BMW of North America, LLC (BMW), FCA US LLC (FCA), Ford
Motor Company (Ford), General Motors LLC (GM), Hyundai Motor America,
Inc. (Hyundai), Jaguar Land Rover North America (JLR), LLC, Kia
America, Inc. (Kia), Maserati North America, Inc., Mercedes-Benz USA
LLC, Porsche Cars North America, Inc. (Porsche), Tesla Inc., Toyota
Motor North America, Inc. (Toyota), and Volkswagen Group of America,
Inc. (Volkswagen).\5\ Although JLR was not included in the September
2023 initial decision, the agency has confirmed that it has vehicles in
the U.S. with the subject inflators.
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\4\ While the correction to June 2018 increases the number of
subject inflators, based on best available information, the agency
is adjusting its estimate to approximately 51 million inflators. The
exact number of recalled inflators and vehicles would be confirmed
by the manufacturers as part of any recall filings that may result.
\5\ In the event of a recall order, BMW would be responsible for
recalling vehicles manufactured by Rolls Royce Motor Cars, General
Motors would be responsible for recalling vehicles manufactured by
Isuzu Motors Limited, and Volkswagen would be responsible for
recalling vehicles manufactured by Audi AG.
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These air bag inflators are at risk of rupturing when the vehicle's
air bag is commanded to deploy, causing metal debris to be forcefully
ejected into the occupant compartment of the vehicle. A rupturing air
bag inflator poses an unreasonable risk of serious injury or death to
vehicle occupants. At least seven people have been injured and one
person has been killed by these rupturing air bag inflators within the
United States. NHTSA has identified evidence during its investigation
that connects these ruptures to the friction welding process, which has
created, in some instances, blockage material, including excessive weld
flash, and, in others, insufficient friction weld bonds. Upon air bag
deployment, any loose debris in the center support, including weld
flash, can block the exit orifice, causing over-pressurization and
rupture. Additionally, friction welds with insufficient bonds have also
led to inflator ruptures. The same friction welding process was used
across ARC and Delphi's various manufacturing plants and lines to
produce the subject inflators. When an inflator ruptures, shrapnel or
metal fragments from the
[[Page 63475]]
inflator are forcefully propelled through the air bag cushion and into
the occupant compartment. Additional inflator ruptures are expected to
occur in the future, risking more serious injuries and deaths, if they
are not recalled and replaced.
I. Investigation and Proceeding Background
On July 13, 2015, NHTSA's Office of Defects Investigation (ODI)
opened a Preliminary Evaluation (PE) defect investigation, designated
PE15-027, to investigate an alleged safety defect in hybrid toroidal
inflators designed by ARC and manufactured by ARC and Delphi for use in
vehicles sold or leased in the United States. NHTSA opened the
investigation after receiving reports of ruptures in vehicles (field
ruptures). Specifically, driver-side air bag inflators in a model year
(MY) 2002 Chrysler Town & Country and a MY 2004 Kia Optima ruptured
upon air bag deployment during crashes.
In the early stages of the investigation, NHTSA collected
information from ARC regarding the design and manufacturing process for
frontal driver- and passenger-side hybrid toroidal inflators. Frontal
driver-side and passenger-side inflators are used to inflate air bags
immediately in front of vehicle occupants in those seats. A hybrid
inflator uses stored gas that is excited by propellant to fill the air
bag cushion, and toroidal inflators are round, non-cylindrical
inflators. NHTSA's investigation involved both single-stage and dual-
stage inflators. Single-stage inflators deploy at a preset speed and at
full force. Dual-stage inflators deploy at two different stages
depending on the size of the occupant as measured by the load sensor in
the front seat and the severity of the impact.\6\ ARC licensed its
design and manufacturing specifications to Delphi, which manufactured
approximately 11 million of the approximate 51 million subject
inflators using the same friction welding process at issue.\7\ ARC
manufactured the other subject inflators at several different
manufacturing facilities.
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\6\ The two inflation stages can deploy sequentially or
simultaneously. Typically, the first stage is approximately 80% of
the full force of the air bag, and the second stage is approximately
20% of the full force of the air bag. The second stage can deploy
simultaneously with the first stage should the severity of the
impact warrant dual deployment. The second stage can deploy
subsequent to the deployment of the first stage for lower severity
impacts.
\7\ Delphi stopped manufacturing the inflators in 2004. The
Delphi entity that manufactured these inflators no longer exists.
NHTSA indicated in its April 27, 2023 recall request letter that the
entity was acquired by Autoliv ASP, Inc. (``Autoliv''). Autoliv has
since provided NHTSA with some information indicating that it may
not have legal liability for the Delphi-manufactured inflators. At
this time, NHTSA has not verified the entity that has legal
responsibility under 49 U.S.C. chapter 301 for those inflators.
However, regardless of that responsibility, the vehicle
manufacturers that used the inflators as original equipment would be
responsible for carrying out any recalls.
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NHTSA learned that, based on ARC's inflator design, part of the
manufacturing process for these inflators involves a welding method
known as friction welding. Through this method, once certain pieces of
the inflator are ready to be joined together, they are aligned. One
piece is held stationary while the other is rotated at a high velocity
and simultaneously pressed together with the stationary piece. The
friction generated by the high-velocity rotation creates heat, which
melts the metal. Once the proper temperature has been reached, the
rotation is stopped, and the pressure is increased to weld the parts
together. Each inflator undergoes three friction welds at two points in
the manufacturing process.\8\ Friction welding produces a byproduct
called ``weld flash'' or ``weld slag'' that accumulates along the weld
seam. In an attempt to prevent weld flash from blocking the gas flow
during deployment, a pin, known as a flash-dam pin, is inserted through
the exit orifice during the friction welding process between the center
support and upper half of the inflator housing. The flash-dam pin is
removed after the weld is complete. This friction welding process was
used in all five ARC plants where the subject inflators were made--
located in Knoxville, Tennessee; Reynosa, Mexico; Xi'an, China; Ningbo,
China; and Skopje, Macedonia--and on all manufacturing lines that
produced the subject inflators. It was also used by Delphi when it
produced subject inflators under a license agreement.
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\8\ See ARC Presentation on CADH Inflator Design; ARC
Presentation on PH7 Inflator Process Details.
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During a crash that triggers an air bag deployment, a signal is
sent to the inflator. When it receives this signal, the inflator's
initiator ignites the propellant that is stored inside the inflator.\9\
The propellant burns and excites pressurized gas stored in the
inflator.\10\ To fill the air bag cushion, the gas flows through the
inflator's hollow center support and exits through the exit orifice at
the top of the center support.\11\ The inflator's exit orifice is the
single path for the gas to exit the inflator and fill the air bag
cushion. If the exit orifice is blocked during deployment such that the
gas cannot escape, the inflator will likely over-pressurize and
rupture. In this event, the center support typically elongates, splits
into two pieces, and ejects from the inflator housing. These
characteristics indicate that a rupture was caused by over-
pressurization of the inflator.\12\ In some instances, the blockage can
still be seen in the upper half of the center support after the
rupture. In others, the blockage may become knocked loose by the force
of the rupture but can leave small indentations on the edge of the exit
orifice, which are known as ``witness marks.'' \13\
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\9\ See ARC Response to Request 1 of NHTSA Aug. 25, 2015 IR
Letter at p. 16.
\10\ See id.
\11\ See id.
\12\ See ARC Presentation dated Mar. 1, 2016 on MY 2004 Kia
Optima Rupture at pp. 5, 22; ARC Presentation dated Aug. 25, 2017 on
SGO 2016-01/2017-01 Report 39 at pp. 6, 11, 37; ARC Response to
Request 1 of NHTSA Aug. 25, 2015 IR Letter at p. 72.
\13\ See ARC Presentation dated Apr. 1, 2017 on SGO 2016-01/
2017-01 Report 80 at pp. 8-11; ARC Presentation dated Nov. 10, 2017
on SGO 2016-01/2017-01 Report 120 at p. 7; ARC Presentation dated
Apr. 5, 2017 on SGO 2016-01/2017-01 Report 130 at pp. 8-11; ARC
Presentation dated Nov. 8, 2017 on SGO 2016-01/2017-01 Report 178 at
pp. 13-14.
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During the PE phase of the investigation, NHTSA collected a list of
air bag module (or Tier 1) manufacturers to which ARC sold the
inflators from 2000 through 2004, which covered the timeframe between
when ARC had begun manufacturing hybrid toroidal inflators and the
manufacture dates of the two inflators that ruptured in vehicles. NHTSA
then obtained information from the air bag module manufacturers to
identify the vehicle manufacturers that had purchased those air bag
modules and incorporated them into their vehicles. In addition, NHTSA
ordered vehicle and inflator manufacturers, including ARC, to report
any alleged or suspected inflator field rupture under Standing General
Orders (SGO) 2015-01 and 2015-02.\14\ Manufacturers subject to these
orders must submit an initial report upon notification of an alleged
field rupture incident, as well as ongoing supplemental reports as the
investigation into the incident progresses and until it is complete.
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\14\ Those orders were not limited to ARC or the vehicle
manufacturers that used ARC inflators. They were intended to help
NHTSA learn of any alleged inflator ruptures, including inflators
not designed or manufactured by ARC. Since their original issuance,
these orders have been updated and superseded by SGO 2015-01A and
SGO 2015-02A. <a href="https://static.nhtsa.gov/odi/inv/2015/INLM-EA15001-62640.pdf">https://static.nhtsa.gov/odi/inv/2015/INLM-EA15001-62640.pdf</a>; <a href="https://static.nhtsa.gov/odi/inv/2015/INLM-EA15001-62642.pdf">https://static.nhtsa.gov/odi/inv/2015/INLM-EA15001-62642.pdf</a>.
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On July 11, 2016, an ARC-manufactured inflator in a MY 2009 Hyundai
Elantra ruptured in Canada. The driver was killed. ARC confirmed that
this inflator was manufactured using the same manufacturing processes
[[Page 63476]]
described above in this section. ODI upgraded the investigation to an
Engineering Analysis, designated EA16-003, on August 4, 2016. During
this phase of the investigation, ODI issued information request letters
to ARC, Delphi, air bag module manufacturers, and vehicle manufacturers
in 2016, 2020, 2021, and 2022. These letters requested information for
an expanded timeframe on the production volume of the subject
inflators, air bag modules with the subject inflators and vehicles with
the subject inflators, testing procedures and results, complaints, and
air bag deployments.
Also during this phase of the investigation, NHTSA issued Standing
General Order 2016-01. Standing General Order 2016-01 required ARC to
notify the agency of non-field ruptures of inflators. It was superseded
by SGO 2017-01, which revised the reportable rupture incidents to
include only those occurring during lot acceptance tests. Lot
acceptance tests (also referred to as ``LATs'') are random tests of
completed air bag inflators produced for use in consumer vehicles.\15\
If an inflator ruptures or fails in some way during a lot acceptance
test, the entire lot of inflators is quarantined. Under these SGOs, ARC
reported thirty-four ruptures of frontal driver- and passenger-side
hybrid toroidal inflators during lot acceptance testing.\16\
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\15\ A lot acceptance test is conducted at the beginning,
middle, and end of a manufacturing shift, or at any time the
assembly line is shifted to production of a different part. The term
``lot'' refers to the inflators that were manufactured in an
identified manufacturing plant on a specific assembly line for a
specific shift.
\16\ Two vehicle manufacturers have conducted small inflator
recalls associated with lot acceptance testing. First, BMW recalled
thirty-six vehicles after learning that the production lot in which
there had been a rupture was not fully contained, and some inflators
from the lot were shipped by ARC to a module supplier and ultimately
were incorporated into vehicles. NHTSA Recall Nos. 17V-189
(describing the safety risk as ``impaired gas flow could create
excessive internal pressure, which could result in the body of the
inflator rupturing upon deployment''). Second, Ford recalled 650
vehicles after its air bag module supplier notified Ford of ``an
abnormal deployment'' of an inflator during a lot acceptance test at
the supplier's engineering facility. NHTSA Recall Nos. 17V-529
(``Preliminary analysis indicates that weld flash from the inflator
canister welding process at the Tier 2 inflator supplier may
obstruct the gas exhaust port.'').
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ARC's lot acceptance testing process evidenced a problem, but the
problem was not addressed by actions limited to specific lots. Since
NHTSA issued SGOs 2015-01 and 2015-02, manufacturers have reported to
the agency and confirmed five ruptures in vehicles in the United States
of ARC-manufactured frontal driver- and passenger-side hybrid toroidal
inflators, for a total of seven confirmed field ruptures in the United
States, plus the fatal rupture in Canada. In response to some of the
field ruptures, the relevant vehicle manufacturer issued a small recall
targeted at the production lot of the ruptured inflator.\17\ Such
recalls, like the quarantine process for lot acceptance test ruptures,
are premised on the idea that there is some sort of manufacturing
problem limited to that short period of production at that particular
facility. As detailed below, however, the evidence collected in NHTSA's
investigation shows that ruptures have occurred in inflators
manufactured across different time periods, plants, and manufacturing
lines, thus warranting a broader recall.
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\17\ See NHTSA Recall Nos. 19V-019 (recalling 1,145 vehicles),
21V-782 (recalling 555 vehicles), 22E-040 (recalling 74 replacement
air bag modules), 22V-246 (recalling 2,687 vehicles), and 22V-543
(recalling 1,216 vehicles). Following the most recent rupture, GM
also expanded on its earlier lot recalls by recalling four model
years of three vehicle makes. NHTSA Recall No 23V-334.
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In a recall request letter sent to ARC on April 27, 2023, the
agency tentatively concluded that the subject inflators present a
defect related to motor vehicle safety.\18\ NHTSA explained that a
defect resulting in metal fragments being projected toward vehicle
occupants creates an unreasonable risk of death and injury.\19\ The
agency, therefore, demanded that ARC file a recall identifying the
subject inflators as defective.\20\ In its response on May 11, 2023,
ARC described the seven U.S. field ruptures as ``random `one-off'
manufacturing anomalies'' that had been properly addressed by the lot
recalls.\21\ ARC refused to acknowledge the safety defect or file a
recall.\22\
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\18\ See NHTSA Recall Request Letter to ARC, <a href="https://static.nhtsa.gov/odi/inv/2016/INRM-EA16003-90615.pdf">https://static.nhtsa.gov/odi/inv/2016/INRM-EA16003-90615.pdf</a>.
\19\ See id.
\20\ See id.
\21\ See ARC Response to NHTSA Recall Request Letter, <a href="https://static.nhtsa.gov/odi/inv/2016/INRR-EA16003-90616.pdf">https://static.nhtsa.gov/odi/inv/2016/INRR-EA16003-90616.pdf</a> at p. 2.
\22\ See id. at p. 1.
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When a safety defect exists in original equipment used by more than
one vehicle manufacturer, as in this case, the equipment supplier and
each vehicle manufacturer must notify the agency by filing a recall
report. 49 CFR 573.3(f). A defect in original equipment (meaning
equipment originally installed in or on a vehicle) is considered a
defect in the vehicle. 49 U.S.C. 30102(b)(1)(C), (F). Therefore,
vehicle manufacturers are generally responsible for carrying out
recalls of their vehicles containing defective parts, such as air bag
inflators, by notifying vehicle owners and providing a free remedy. See
id. sections 30118-20. An equipment manufacturer is also responsible
under the Safety Act for recalling its replacement equipment. See id.
30118. Replacement equipment is ``motor vehicle equipment . . . that is
not original equipment.'' Id. section 30102(b)(1)(D).
The National Traffic and Motor Vehicle Safety Act (Safety Act)
imposes an affirmative obligation on a manufacturer to initiate a
recall if it ``learns the vehicle or equipment contains a defect and
decides in good faith that the defect is related to motor vehicle
safety.'' Id. section 30118(c)(1). To date, the manufacturers of the
subject inflators, and the manufacturers of the vehicles containing the
subject inflators, have not commenced broader recalls addressing the
full scope of the problem. Thus, NHTSA is using its authority under the
Safety Act to consider ordering a recall.
The Safety Act authorizes NHTSA to order a recall when the
Administrator \23\ determines that a vehicle or replacement equipment
``contains a defect related to motor vehicle safety.'' Id. section
30118(b). The Safety Act defines a ``defect'' as ``any defect in
performance, construction, a component, or material of a motor vehicle
or motor vehicle equipment.'' Id. section 30102(a)(3). A defect is
related to motor vehicle safety if it presents an unreasonable risk of
an accident or of death or serious injury in an accident. Id. section
30102(a)(9).
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\23\ As authorized by statute, the Secretary has delegated the
authority in the Safety Act to the NHTSA Administrator. 49 U.S.C.
105(d); 49 CFR 1.95(a). In the absence of an Administrator, the
Deputy Administrator performs the functions and duties of the
Administrator. 49 CFR 501.4(a), 501.5(a).
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Before it can order a recall, the agency first issues an initial
decision finding a defect in a vehicle or replacement equipment,
notifies the manufacturer of the decision and provides it with the
information on which the decision was based, and publishes notice of
the decision in the Federal Register. Id. section 30118(a); 49 CFR
554.10. The manufacturer and the public are afforded an opportunity to
present information, views, and arguments at a public meeting, in
written comments, or both. 49 CFR 554.10. After considering the
available information, the Administrator may make a final decision
finding a safety defect and ordering a recall. 49 U.S.C. 30118(b); 49
CFR 554.11.
In the instant proceeding, NHTSA issued an initial decision of a
safety defect on September 5, 2023 regarding frontal driver- and
passenger-side hybrid toroidal inflators manufactured
[[Page 63477]]
by ARC and Delphi from 2000 through January 2018. 88 FR 62140 (Sept. 8,
2023). NHTSA held a public meeting on October 5, 2023, during which the
agency presented information about its investigation and initial
decision, and manufacturers and members of the public were invited to
make their own statements.\24\ ARC and certain other members of the
public, including the son of the person killed by a subject inflator
rupture, made statements at the public meeting.\25\ NHTSA also provided
manufacturers and the public the opportunity to submit written comments
in response to the initial decision,\26\ which were due December 18,
2023.\27\
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\24\ See Public Meeting Transcript and Addenda, Docket No.
NHTSA-2023-0038, <a href="https://www.regulations.gov/document/NHTSA-2023-0038-0003">https://www.regulations.gov/document/NHTSA-2023-0038-0003</a>.
\25\ Id.
\26\ Public versions of all written comments are posted on the
public docket at <a href="https://www.regulations.gov/docket/NHTSA-2023-0038/comments">https://www.regulations.gov/docket/NHTSA-2023-0038/comments</a>.
\27\ See Second Extension of Deadline for Written Submissions,
<a href="https://www.regulations.gov/document/NHTSA-2023-0038-0005">https://www.regulations.gov/document/NHTSA-2023-0038-0005</a>.
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II. Initial Determination of Defect Related to Motor Vehicle Safety
After further consideration of all available information, including
from its investigation and this proceeding, NHTSA is confirming its
initial determination that the subject inflators contain a defect and
that the defect is related to motor vehicle safety. The subject
inflators may rupture upon deployment and project shrapnel into the
occupant compartment, which is likely to cause and has caused serious
injury and death to vehicle occupants.
A. The Subject Inflators Are Defective
Air bag inflators that have an established risk of rupturing when
commanded to deploy are defective within the meaning of the Safety Act.
The Safety Act defines ``defect'' as including ``any defect in
performance, construction, a component, or material of a motor vehicle
or motor vehicle equipment.'' 49 U.S.C. 30102(a)(3). ``Defect'' must be
understood by its plain meaning: a flaw, shortcoming, or
abnormality.\28\ An inflator that is at risk of rupturing when
commanded to deploy is flawed. It turns a lifesaving device into one
that can do great harm, including causing death or serious injury.
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\28\ <a href="https://www.merriam-webster.com/dictionary/defect">https://www.merriam-webster.com/dictionary/defect</a>.
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Air bags and related components can be defective in multiple ways.
Among other things, the air bag may fail to deploy when appropriate,
deploy when it should not, or only partially deploy. All of these
defects are issues that the agency takes seriously and that have
resulted in recalls.\29\ An air bag inflator that has a risk of
rupturing when commanded to deploy--sending shrapnel into the occupant
compartment--presents a particularly dangerous type of defect. This is
why the industry standard calls for tests to confirm that ``an inflator
shall not eject any components or fragments.'' \30\ In other words, an
inflator rupture is not an industry-accepted failure mode.
---------------------------------------------------------------------------
\29\ See, e.g., NHTSA Recall 24V-064 (recall issued by Honda
addressing air bags that may deploy in a crash when they should have
been suppressed); NHTSA Recall 23V-865 (recall issued by Toyota
addressing air bags that may not deploy in a crash when intended);
NHTSA Recall No. 12V-055 (recall issued by Nissan for vehicles
equipped with curtain air bags with incorrect propellant mixture,
possibly resulting in partial deployment); NHTSA Recall No. 01V-318
(recall issued by Ford for vehicles with replacement inflators
having insufficient welds, possibly preventing proper inflation of
the air bag).
\30\ See USCAR Inflator Technical Requirements and Validation,
p. 7 ] 3.2.2 (SAE Int'l, 2023). See also USCAR Inflator Technical
Requirements and Validation, p. 10 ] 3.2.2 (SAE Int'l, 2013).
---------------------------------------------------------------------------
The subject inflators exhibit this especially dangerous defect,
which warrants NHTSA's taking the significant step of proposing to
order a recall. To date, there have been seven confirmed field ruptures
of the subject inflators in vehicles in the United States, each of
which presented evidence of over-pressurization or weld insufficiency
as a likely cause of the failure. In addition, there have been twenty-
three reported ruptures during lot acceptance testing that share over-
pressurization or weld insufficiency commonalities with the seven field
ruptures. Moreover, at least an additional four inflators have ruptured
in vehicles outside the United States, killing at least one person.
To be sure, the overwhelming majority of the subject inflators will
not rupture upon deployment. However, based on the evidence linking
past ruptures to the same friction welding process, all of the subject
inflators are at risk of rupturing. The unpredictable nature of this
defect has played out with some inflators passing lot acceptance
testing but later rupturing in a vehicle and causing injury or death.
The only way to know which of the subject inflators remaining in
vehicles will rupture is for them to deploy. The Safety Act does not
allow such a defect to go unaddressed.
In recognition of the commonsense understanding that an inflator
that may rupture is defective, some vehicle manufacturers have already
issued limited recalls following field ruptures.\31\ This approach is
insufficient to address the defect. The evidence shows that the risk of
rupture pervades the entire subject inflator population and, as such, a
recall for all subject inflators is needed. Ruptures have continued to
occur outside the scope of these lot-based recalls and in lots that
passed lot acceptance testing. There is no reasonable basis to conclude
that the recalls issued to this point have captured the full scope of
the defect. Instead, NHTSA has preliminarily concluded, based on the
available evidence, that all the subject inflators are defective.
---------------------------------------------------------------------------
\31\ After the most recent rupture, GM apparently recognized
that a lot-based recall was no longer sufficient. However, the
ensuing recall was limited to specific model years and models of
vehicles and fails to address the full population of GM vehicles
containing the subject inflators. See Recall No. 23V-334 (recalling
2014-2017 Buick Enclave, Chevrolet Traverse, and GMC Acadia
vehicles).
---------------------------------------------------------------------------
Whether there is a ``defect'' depends on the specific facts and
circumstances of each case, including the nature of the component
involved and its importance to the safe operation of the vehicle, the
circumstances in which failures occurred, and the number of failures
experienced. U.S. v. General Motors Corp., 518 F.2d 420, 427, 438 n.84
(D.C. Cir. 1975) (``Wheels''). Considering all of the available
information, NHTSA finds that there is sufficient evidence that the
total population of subject inflators is defective within the meaning
of the Safety Act.
1. An Air Bag Is Critical to the Safe Operation of a Vehicle
Factors to be considered in determining whether a defect exists
include the relationship between the component and safe vehicle
operation and the circumstances of the failures involved. An air bag is
vital to the safe operation of a vehicle. It is a required safety
device.\32\ In the event of a crash where the air bag is commanded to
deploy, which can include a minor crash, the air bag helps protect the
occupant's upper body and head from impact with hard objects such as
the windows, dashboard, and steering wheel. NHTSA estimates that air
bags saved more than fifty thousand lives between 1987 and 2017. The
defect in this case turns this life-saving purpose on its head, instead
introducing a risk of serious injury or death from flying metal
fragments ejected into the occupant compartment. As described below in
section II.A.3, rupturing inflators have caused severe injuries, the
most common of which are injuries to
[[Page 63478]]
the face, head, jaw, and neck. In three instances, a piece of the
inflator became lodged in the driver's neck or arm and had to be
surgically removed.\33\ In another, the shrapnel caused permanent
muscle and nerve damage to the driver.\34\ In two instances, the driver
died after being struck by a piece of the inflator. By forcefully
propelling metal shrapnel into the occupant compartment, often aimed
directly at an occupants' face, the rupturing inflator creates a high
risk of severe injury or death, potentially converting a minor crash
into a life-threatening event.
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\32\ Federal Motor Vehicle Safety Standard 208 sets requirements
for occupant crash protection, including air bags. 49 CFR 571.208.
\33\ See Email dated Apr. 5, 2023 to NHTSA from Hurley Medical
Center; Photos attached to email dated Apr. 5, 2023 to NHTSA from
Hurley Medical Center; Medical Discharge Summaries, Report ID
****8352 at p. 3; Information package provided by the Saudi Ministry
of Commerce and Industry; Hyundai Report submitted for MY 2011
Hyundai Elantra Rupture.
\34\ See VOQ dated Dec. 20, 2014.
---------------------------------------------------------------------------
The circumstances in which these failures occur are also severe.
The ruptures occur with no warning to the driver or other vehicle
occupants.\35\ A vehicle owner can neither prevent this failure from
occurring nor take action to mitigate the severity of its outcome,
given the rapid pace of an air bag deployment and the already
vulnerable position of the occupants in the midst of a collision. A
vehicle's air bags can deploy even in minor crashes, meaning this
defect can turn an incident from which the occupants could have walked
away unscathed into one that will likely cause serious injury or death.
There is no way for a vehicle owner, or anyone else, to know that a
particular subject inflator will rupture until it is too late. The
safety of vehicle occupants is significantly compromised by the rupture
of the subject inflators--a considerable factor in the agency's
determination that the subject inflators are defective under the Safety
Act.
---------------------------------------------------------------------------
\35\ Severity, frequency, and detectability are factors that
NHTSA and manufacturers consider when deciding whether there is a
safety defect requiring a recall. See Risk-Based Process for Safety
Defect Analysis and Management of Recalls, DOT HS 812 984 (Nov.
2020), <a href="https://www.nhtsa.gov/sites/nhtsa.gov/files/documents/14895_odi_defectsrecallspubdoc_110520-v6a-tag.pdf">https://www.nhtsa.gov/sites/nhtsa.gov/files/documents/14895_odi_defectsrecallspubdoc_110520-v6a-tag.pdf</a>. These factors are
interrelated so high severity and non-detectible failures warrant a
recall with a lower frequency of occurrence. See id.
---------------------------------------------------------------------------
2. Problems That Lead to Over-Pressurization and Weld Failure May Be
Present Throughout the Entire Population of Inflators
While the actual occurrence of ruptures is rare, the subject
inflators' risk of rupture nevertheless constitutes a defect,
especially when considering the nature and purpose of an inflator and
the severity of the risk to vehicle occupants. For a component that is
designed to function without replacement, courts have found that a
defect may be established by showing that a significant--or non-de
minimis--number of failures occurred in normal operation. E.g., Wheels,
518 F.2d at 427, 438 n.84. As mentioned in the section above, the
number of failures is one of the factors among the various facts and
circumstances that assists in the agency's determination of whether
there is a defect related to motor vehicle safety, requiring a recall.
Indeed, ``[t]he purpose of the Safety Act . . . is not to protect
individuals from the risks associated with defective vehicles only
after serious injuries have already occurred; it is to prevent serious
injuries stemming from established defects before they occur.'' United
States v. General Motors Corp., 565 F.2d 754, 759 (D.C. Cir. 1977)
(``Carburetors'').
Air bags are not subjected to wear and do not require maintenance.
As such, they are not replaced unless and until they deploy. The
subject inflators are hermetically sealed, protecting the interior from
elements that may cause propellant degradation.\36\ Nevertheless,
ruptures have continued to occur despite manufacturers' assertions that
narrower recalls have addressed the safety defect. NHTSA's
investigation and analysis of the ruptures supports its preliminary
determination that all subject inflators are at risk of rupturing and,
therefore, contain a defect.
---------------------------------------------------------------------------
\36\ See USCAR Inflator Technical Requirements and Validation at
] 3.2.11 (SAE Int'l, 2023).
---------------------------------------------------------------------------
During its investigation, NHTSA obtained evidence of issues in the
friction welding process of the subject inflators that resulted in
either over-pressurization or weld failure when the inflators were
commanded to deploy. This propensity for over-pressurization or weld
failure, based on one or more variables, can cause and has caused
repeated ruptures of the subject inflators. All seven known field
ruptures in vehicles in the United States, along with at least twenty-
three lot acceptance testing ruptures, were caused by over-
pressurization or weld failure. Thus, the evidence demonstrates that
the same friction welding process used to manufacture all of the
subject inflators creates a risk of rupture. Stated more plainly, any
of the subject inflators is subject to over-pressurization or weld
failure leading to rupture when commanded to deploy. There is no
evidence-based means to predict which specific subject inflators will
rupture when commanded to deploy. Limited-scope recalls initiated in
response to some of the ruptures were reactionary and narrowly focused
and did not proactively address the propensity of the larger population
of subject inflators to rupture. As a result, ruptures continued to
occur.
The ruptures that have already occurred in vehicles have
demonstrated the unpredictable nature of the defect. As detailed below,
these ruptures have involved inflators manufactured at different times
and in different manufacturing facilities, both single-stage and dual-
stage air bag inflators, driver-side and passenger-side inflators,
inflators incorporated into air bag modules by different module
suppliers, and inflators used in different vehicle manufacturers'
vehicles. The inflators that ruptured due to over-pressurization or
weld failure in lot acceptance testing likewise had been manufactured
at different times in different manufacturing facilities, included both
single-stage and dual-stage air bag inflators, driver-side and
passenger-side inflators, and were intended to be sold to different air
bag module suppliers. The critical element that the subject inflators
have in common is the friction welding process--significant evidence
indicates that this process has led to ruptures caused by over-
pressurization and weld failure.
3. The Inflators Have Ruptured in the Field Seven Times
The defect in the subject inflators has manifested in seven
confirmed ruptures in vehicles in the United States, injuring at least
seven people and killing another.
First Field Rupture--January 2009, Ohio
The first known field rupture of a subject inflator in the United
States occurred on January 29, 2009 in Ohio. The driver of a MY 2002
Chrysler Town & Country was turning into a driveway and collided with
another vehicle. The crash triggered air bag deployment, and the
driver-side, dual-stage air bag inflator--manufactured in ARC's
Knoxville, Tennessee plant--ruptured, sending pieces of metal through
the air bag cushion and into the occupant compartment. The driver
sustained severe injuries to the face, neck, shoulder, and jaw, causing
permanent muscle and nerve damage.\37\
---------------------------------------------------------------------------
\37\ See VOQ dated Dec. 20, 2014.
---------------------------------------------------------------------------
During an inspection of the vehicle, ARC took photographs of the
pieces of the ruptured inflator, including the center support. When the
inflator in the MY 2002 Chrysler Town & Country ruptured, the center
support elongated, split into two pieces, and ejected from
[[Page 63479]]
the inflator housing.\38\ These characteristics indicate that a rupture
was caused by over-pressurization of the inflator.\39\ The photos of
the upper portion of the center support show a blockage in the exit
orifice.\40\ NHTSA and ARC agree that because this blockage prevented
the gas from escaping through the exit orifice, the pressure inside the
inflator built and exceeded the inflator's strength limit and,
ultimately, the inflator over-pressurized and broke apart (i.e.,
ruptured). ARC posited that the blockage was caused by a piece of the
flash-dam pin, a tool that is inserted through the exit orifice during
the friction welding process in an attempt to prevent weld flash from
blocking the gas flow. The flash-dam pin is normally removed after
completion of the weld, but based on visual inspection of the
photographs, ARC suggested that a piece of this pin broke off during
the manufacturing process and, during deployment, blocked the
inflator's exit orifice.\41\ No metallurgical testing was done to
determine the composition of the blockage material.
---------------------------------------------------------------------------
\38\ See Photos of air bag parts from MY 2002 Chrysler Town &
Country Rupture at pp. 6-9.
\39\ See ARC Presentation dated Mar. 1, 2016 on MY 2004 Kia
Optima Rupture at pp. 5, 22; ARC Presentation dated Aug. 25, 2017 on
SGO 2016-01/2017-01 Report 39 at pp. 6, 11, 37; ARC Response to
Request 1 of NHTSA Aug. 25, 2015 IR Letter at p. 72.
\40\ See Photos of air bag parts from MY 2002 Chrysler Town &
Country Rupture at pp. 6-9.
\41\ See Written Response of ARC Automotive, Inc. to the
September 5, 2023, Initial Decision Docket No. NHTSA-2023-0038 at p.
32, <a href="https://www.regulations.gov/comment/NHTSA-2023-0038-0027">https://www.regulations.gov/comment/NHTSA-2023-0038-0027</a>.
---------------------------------------------------------------------------
The vehicle manufacturer, FCA,\42\ has not advanced any contrasting
potential explanation for this field rupture.
---------------------------------------------------------------------------
\42\ Then known as Chrysler.
---------------------------------------------------------------------------
Second Field Rupture--April 2014, New Mexico
The second known field rupture of a subject inflator occurred on
April 8, 2014 in New Mexico. The driver of a MY 2004 Kia Optima
collided with a roadside barrier, triggering air bag deployment. The
driver-side, single stage air bag inflator--manufactured in ARC's
Knoxville, Tennessee plant--ruptured, and fragments were propelled
through the air bag cushion and into the occupant compartment. At the
hospital, a piece of the shrapnel was removed from the driver's
neck.\43\ The driver was also treated for head trauma, a jaw fracture,
and lacerations to the lip, neck, and cheek.\44\
---------------------------------------------------------------------------
\43\ See Medical Discharge Summaries, Report ID ****8352 at p.
3.
\44\ See id.
---------------------------------------------------------------------------
ARC conducted a visual, on-site inspection of the vehicle and
inflator parts and took photographs of the vehicle and inflator pieces.
As with the MY 2002 Chrysler Town & Country rupture, the center support
of the inflator elongated, broke into two pieces, and ejected from the
inflator housing.\45\ ARC concluded that the inflator ruptured due to
over-pressurization,\46\ a conclusion with which NHTSA agrees. ARC's
analysis identified exit orifice blockage as the most likely cause of
the over-pressurization and rupture.\47\ The photographs of the center
support taken after the rupture occurred do not show that a blockage
remained in the exit orifice.\48\ ARC surmised that an internal
blockage of the exit orifice was unlikely based on this observation and
three additional indicators: (1) during manufacturing, the inflator had
been filled with the stored, internal gas through the exit orifice, (2)
the lot acceptance test data for the associated lot of inflators was
compliant, and (3) the exit orifice diameter was an acceptable
size.\49\ ARC hypothesized, instead, that the over-pressurization was
caused by an external blockage of the exit orifice and conducted tests
to mimic this condition.\50\
---------------------------------------------------------------------------
\45\ See ARC Presentation dated Mar. 1, 2016 on MY 2004 Kia
Optima Rupture at pp. 5, 22.
\46\ See id.
\47\ See id. at pp. 5, 7, 32.
\48\ See id. at pp. 8-9.
\49\ See id. at p. 68.
\50\ See id. at pp. 70-71, 74.
---------------------------------------------------------------------------
The photos of the center support in this instance do not show exit
orifice blockage; however, the blockage could have been knocked out of
the exit orifice when the inflator ruptured, as likely happened in
several of the lot acceptance test ruptures believed to have been
caused by internal exit orifice blockage.\51\ Debris found inside the
air bag cushion after this rupture was of a sufficient size to block
the exit orifice.\52\ Therefore, the evidence does not undermine
internal blockage as the underlying reason for the over-pressurization
in this incident. The three additional indicators listed above and
cited by ARC are present for each of the U.S. field ruptures and do
not, separately or combined, refute internal blockage of the exit
orifice as the cause of over-pressurization.
---------------------------------------------------------------------------
\51\ See ARC Presentation dated Apr. 1, 2017 on SGO 2016-01/
2017-01 Report 80 at pp. 8-11; ARC Presentation dated Nov. 10, 2017
on SGO 2016-01/2017-01 Report 120 at p. 7; ARC Presentation dated
Apr. 5, 2017 on SGO 2016-01/2017-01 Report 130 at pp. 8-11; ARC
Presentation dated Nov. 8, 2017 on SGO 2016-01/2017-01 Report 178 at
pp. 13-14.
\52\ See Photo 25 from inspection of MY 2004 Kia Optima rupture;
Photo 27 from inspection of MY 2004 Kia Optima rupture; Photo 29
from inspection of MY 2004 Kia Optima rupture; Photo 31 from
inspection of MY 2004 Kia Optima rupture; Photo 33 from inspection
of MY 2004 Kia Optima rupture; Photo 34 from inspection of MY 2004
Kia Optima rupture.
---------------------------------------------------------------------------
In comments, Kia disputed that the rupture may have been caused by
weld slag blocking the inflator orifice and noted a number of
observations. However, in attempting to explain the rupture, Kia could
only conclude that it was ``an isolated case of unknown cause.''
Third Field Rupture--September 2017, Pennsylvania
The third known field rupture occurred on September 22, 2017 in
Pennsylvania. The driver of a MY 2011 Chevrolet Malibu rear-ended
another vehicle, triggering air bag deployment. The driver-side, dual
stage air bag inflator--manufactured in ARC's Reynosa, Mexico plant
\53\--ruptured. Pieces of the inflator shot through the air bag cushion
and into the occupant compartment. The shrapnel caused multiple
fractures to the driver's face, nose, and jaw as well as other trauma,
lacerations, and nerve damage to the face.\54\
---------------------------------------------------------------------------
\53\ In the September 5, 2023 Initial Decision, the description
of this field rupture incorrectly stated that the vehicle was a MY
2010 Chevrolet Malibu and that the inflator had been manufactured in
Xi'an China.
\54\ See Complaint filed in lawsuit arising from the crash on
Sept. 22, 2017 at pp. 11-12.
---------------------------------------------------------------------------
General Motors (GM) took photographs of the vehicle and inflator
during an on-site inspection. A visual inspection of photos of the
inflator shows that the center support did not elongate, split in two,
or eject from the inflator.\55\ These characteristics are unique to
this field rupture. Based on observations made during physical
inspections on December 13, 2018 and January 22, 2019, GM noted the
lack of center support elongation as an indication that the exit
orifice was not blocked in this rupture.\56\ Neither GM nor ARC nor
NHTSA were able to conduct destructive testing on the inflator, so all
conclusions and hypotheses were based on visual inspection of the
photographs.
---------------------------------------------------------------------------
\55\ See Photos from inspection of MY 2011 Chevrolet Malibu
rupture at p. 65; GM Presentation dated Jan. 29, 2019 on MY 2011
Chevrolet Malibu rupture at pp. 4-6.
\56\ See GM Presentation dated Jan. 29, 2019 on MY 2011
Chevrolet Malibu rupture at pp. 1, 3.
---------------------------------------------------------------------------
Based on information available to it, ARC proffered a potential
explanation that partially attributed the rupture to issues with
Operation 50 of the inflator manufacturing process.\57\ Similarly, GM
[[Page 63480]]
noted that the inflator ruptured specifically at the Operation 50 weld,
along with another weld.\58\ For driver-side subject inflators,
Operation 50 is the point in the manufacturing process at which two
friction welds occur: The center support is friction welded to the
inside of the lower half of the inflator housing, and, at the same
time, the lower and upper halves of the inflator housing are friction
welded together.\59\ In their analyses of this field rupture, ARC and
GM identified issues with this particular friction weld and posited
those issues as potential causes of the rupture. These descriptions are
repeated in ARC's analyses of certain ruptures that occurred during lot
acceptance testing where deficiencies in this same friction weld were
identified as having contributed to each failure.\60\
---------------------------------------------------------------------------
\57\ See ARC Presentation dated Mar. 21, 2019 on MY 2011
Chevrolet Malibu rupture at p. 4.
\58\ See GM Presentation dated Jan. 29, 2019 on MY 2011
Chevrolet Malibu rupture at p. 3.
\59\ See ARC Presentation on CADH Inflator Design at slide 12.
\60\ See ARC Presentation dated Oct. 17, 2016 on SGO 2016-01/
2017-01 Report 3 at pp. 14-16; ARC Report dated Nov. 4, 2016 under
SGO 2016-01/2017-01 Report 5 at p. 2; ARC Report dated Nov. 4, 2016
under SGO 2016-01/2017-01 Report 5 at p. 2; ARC Presentation dated
Nov. 7, 2016 on SGO 2016-01/2017-01 Report 12 at slides 39-40; ARC
Report dated Dec. 12, 2016 under SGO 2016-01/2017-01 Report 13; ARC
Report dated Dec. 12, 2016 under SGO 2016-01/2017-01 Report 18; ARC
Presentation dated Feb. 8, 2017 on A9/ZB Model Inflators at pp. 2-3;
ARC Presentation dated May 14, 2017 on SGO 2016-01/2017-01 Report 20
at slides 27-30; ARC Report dated Dec. 14, 2016 under SGO 2016-01/
2017-01 Report 22 at p. 2.
---------------------------------------------------------------------------
While NHTSA acknowledges that characteristics of this field rupture
differ from those seen in the other U.S. field ruptures, they do not
undermine the agency's defect determination. These characteristics are
not anomalous or isolated; they also appear in several lot acceptance
test ruptures. After studying each such rupture, ARC attributed all of
these ruptures partially to friction weld failures.\61\ Moreover,
manufacturers attributed other field and lot acceptance test ruptures
to additional issues related to the friction welding process, including
excessive weld flash--created by friction welding--that blocked the
exit orifice, and a broken piece of the flash-dam pin--a tool used to
try to prevent weld flash blockage--that blocked the exit orifice. In
fact, the extent to which the MY 2011 Chevrolet Malibu rupture differs
from other field ruptures serves as evidence that there are variations
in the friction welding process, intentional or unintentional, that can
lead and have led to ruptures.
---------------------------------------------------------------------------
\61\ See id.
---------------------------------------------------------------------------
Appearing to recognize these variations, several commenters
suggested that more testing and analysis of the variables in the
subject inflators' design and manufacturing process is needed to
support NHTSA's initial decision. However, in the many years since the
first ruptures occurred and the investigation opened, the agency and
the manufacturers have conducted extensive analyses. To the extent some
commenters point to a lack of confirmed root cause for every incident,
the agency notes that a root cause determination is not required to
determine that a defect exists, as discussed further below in section
II.A.6. The agency also does not believe that additional analysis is
likely to shed meaningful light on issues that remain unsettled at this
point. In light of the severe safety risk, the Safety Act warrants a
recall based on the already clear evidence of a defect.
Fourth Field Rupture--August 2021, Michigan
The fourth known field rupture occurred on August 15, 2021. In
Michigan, the driver of a MY 2015 Chevrolet Traverse vehicle, returning
from a family outing with her children,\62\ was turning onto a highway
and was struck by another vehicle. The air bags deployed, and the
driver-side, dual stage air bag inflator--manufactured in ARC's
Reynosa, Mexico plant--ruptured, sending fragments of metal through the
air bag cushion and into the occupant compartment. The pieces of the
center support struck the driver in the neck, and the driver died from
the injury.
---------------------------------------------------------------------------
\62\ Public Meeting Transcript and Addenda at pp. 73-74, Docket
No. NHTSA-2023-0038, <a href="https://www.regulations.gov/document/NHTSA-2023-0038-0003">https://www.regulations.gov/document/NHTSA-2023-0038-0003</a>.
---------------------------------------------------------------------------
One of the driver's children traveled from Michigan to Washington,
DC to speak at the public meeting on October 5, 2023 in support of
NHTSA's initial determination that the subject inflators are defective
and should be recalled. During the meeting, he described in detail his
presence at the crash scene and how the air bag, rather than protecting
his mother from injury, exploded, sent metal shrapnel into her face and
neck, and ultimately killed her.\63\
---------------------------------------------------------------------------
\63\ Id.
---------------------------------------------------------------------------
Photos taken by Michigan State Police personnel after the crash
show that the center support elongated, split in two, and ejected from
the inflator,\64\ demonstrating that over-pressurization caused the
rupture. The Michigan State Police also performed X-rays of the
inflator pieces and provided the images to GM.\65\ The X-rays do not
show any obstruction in the exit orifice.\66\ NHTSA does not believe
the X-ray images negate the possibility of exit orifice blockage. The
force of the rupture could have knocked any blockage material loose, as
the evidence suggests happened in lot acceptance test ruptures. \67\
Moreover, an X-ray image is not always detailed enough to identify
witness marks caused by debris in the exit orifice.
---------------------------------------------------------------------------
\64\ See Photos from inspection of MY 2015 Chevrolet Traverse
rupture in Michigan at pp. 188-229.
\65\ See GM Presentation dated Oct. 6, 2021 on MY 2015 Chevrolet
Traverse rupture in Michigan at p. 10.
\66\ See id.
\67\ See ARC Presentation dated Apr. 1, 2017 on SGO 2016-01/
2017-01 Report 80 at pp. 8-11; ARC Presentation dated Nov. 10, 2017
on SGO 2016-01/2017-01 Report 120 at p. 7; ARC Presentation dated
Apr. 5, 2017 on SGO 2016-01/2017-01 Report 130 at pp. 8-11; ARC
Presentation dated Nov. 8, 2017 on SGO 2016-01/2017-01 Report 178 at
pp. 13-14.
---------------------------------------------------------------------------
GM noted that the X-ray images for this field rupture did not show
material in the exit orifice and that CT scans of inflators retrieved
from the same lot did not show exit orifice blockage.\68\ As explained
above, X-ray images cannot rule out exit orifice blockage as the cause
of over-pressurization, and, furthermore, lot-based comparisons are not
broad enough to guarantee that the risk is contained. GM studied this
rupture in tandem with the subsequent fifth field rupture (discussed in
more detail below) and a lot acceptance test rupture.\69\ The remainder
of GM's analysis related to propellant was not specifically applicable
to this field rupture.\70\ ARC likewise has not offered any potential
explanations for this fatal field rupture incident, though it is
undisputed that over-pressurization ultimately caused the rupture.
---------------------------------------------------------------------------
\68\ See GM Presentation dated Jun. 15, 2022 on DAB ARC Inflator
Ruptures at p. 2.
\69\ See id. at p. 1.
\70\ GM enlisted the help of an independent research firm to
study propellant-related issues more broadly. The group studied 329
driver-side subject inflators manufactured between 2013 and 2021.
While the study identified ``[m]any areas of manufacturing
variability,'' it concluded that ``moisture migration into the
propellant,'' which is the cause of propellant degradation, ``is not
a concern in this inflators design.'' See Northrop Grumman
Presentation dated May 5, 2023 on GM ARC Inflator Investigation at
p. 48. GM did not identify a specific explanation for the inflator
ruptures but proposed that too much propellant, low propellant
density, and ``possible other unknown factors'' may be considered as
contributors. See GM Presentation dated Jun. 15, 2022 on DAB ARC
Inflator Ruptures at p. 1.
---------------------------------------------------------------------------
Fifth Field Rupture--October 2021, Kentucky
The fifth known field rupture occurred on October 20, 2021. In
Kentucky, the driver of a MY 2015 Chevrolet Traverse vehicle collided
with another vehicle at an intersection, which triggered the air bags
to deploy.
[[Page 63481]]
The driver-side, dual stage air bag inflator--manufactured in ARC's
Reynosa, Mexico plant--ruptured, and fragments of the metal inflator
were projected through the air bag cushion and into the occupant
compartment. The driver sustained injuries to the face.
Photographs were taken of the vehicle as well as the ruptured
inflator pieces. The photos show that the center support elongated,
split in two, and ejected from the inflator,\71\ demonstrating that
over-pressurization caused the rupture. The upper portion of the broken
center support shot through the air bag cushion and into the driver-
seat head rest.\72\ The photos of this piece of the center support show
material blocking the exit orifice.\73\ GM suggests the material may be
fabric from the head rest,\74\ however, a determination of the blockage
material has not been confirmed as the manufacturers were not able to
perform an analysis of the material to identify its makeup.
---------------------------------------------------------------------------
\71\ See GM Presentation dated Apr. 6, 2022 on MY 2015 Chevrolet
Traverse rupture in Kentucky at p. 3.
\72\ See id. at p. 4.
\73\ See id. at p. 3.
\74\ See id.
---------------------------------------------------------------------------
GM assessed this field rupture in tandem with the previous field
rupture and a lot acceptance test rupture, as explained above in
discussing the fourth rupture (2021 Michigan). As GM stated in that
analysis, no parts from the same lot as the inflator in this field
rupture were available for analysis,\75\ so the conclusions in its
report are not particularly relevant. GM did not perform a separate
analysis for this field rupture. Similarly, ARC has not provided a
potential explanation for this rupture.
---------------------------------------------------------------------------
\75\ See GM Presentation dated Jun. 15, 2022 on DAB ARC Inflator
Ruptures at p. 2.
---------------------------------------------------------------------------
Sixth Field Rupture--December 2021, California
The sixth known field rupture occurred on December 18, 2021 in
California. The driver of a MY 2016 Audi A3 e-Tron collided with
another vehicle. The air bags deployed, and the passenger-side, dual
stage inflator--manufactured in ARC's Reynosa, Mexico plant--ruptured,
with some of the fragments projecting through the air bag cushion and
into the occupant compartment. The passenger suffered serious injuries
to the face and ear.\76\ The pieces of the inflator also struck the
driver, causing lacerations to the right hand and right shin.\77\
---------------------------------------------------------------------------
\76\ See Complaint filed in lawsuit arising from the crash on
Dec. 18, 2021 at p. 2.
\77\ See State of California Crash Report dated Dec. 18, 2021 at
p. 3.
---------------------------------------------------------------------------
Photos from the vehicle inspection indicate that the center support
split in two and ejected from the inflator,\78\ demonstrating that
over-pressurization caused the rupture. The upper portion of the center
support ultimately ejected through the windshield and the lower portion
became lodged in the instrument panel.\79\ The upper portion of the
center support was never recovered and, therefore, never analyzed for
blockage. Neither ARC nor Volkswagen has offered potential explanations
for this rupture.
---------------------------------------------------------------------------
\78\ See Photos from inspection of MY 2016 Audi A3 e-Tron
rupture.
\79\ See id.
---------------------------------------------------------------------------
Seventh Field Rupture--March 2023, Michigan
The seventh, and most recent, known field rupture occurred on March
22, 2023 in Michigan. The driver of a MY 2017 Chevrolet Traverse
vehicle collided with a tree, causing the air bags to deploy. The
driver-side, dual stage inflator--manufactured in ARC's Reynosa, Mexico
plant--ruptured, sending fragments through the air bag cushion and into
the occupant compartment. The driver suffered injuries to the face,
teeth, and neck. A child in the back seat also suffered lacerations to
the face, potentially caused by shrapnel from the inflator rupture or
other debris from the crash. The upper portion of the center support
struck the driver in the neck and had to be surgically removed from the
driver's airway.\80\
---------------------------------------------------------------------------
\80\ See Email dated Apr. 5, 2023 to NHTSA from Hurley Medical
Center; Photos attached to email dated Apr. 5, 2023 to NHTSA from
Hurley Medical Center.
---------------------------------------------------------------------------
Photos taken of the vehicle and pieces of the inflator show that
the center support elongated, split in two, and ejected from the
inflator,\81\ once again demonstrating that over-pressurization caused
the rupture. Photos of the removed upper center support show that the
exit orifice was completely blocked.\82\ No further explanation for
this rupture has been advanced by ARC or GM.
---------------------------------------------------------------------------
\81\ See Photo 10 from inspection of MY 2017 Chevrolet Traverse
rupture; Photo 35 from inspection of MY 2017 Chevrolet Traverse
rupture; Photo 38 from inspection of MY 2017 Chevrolet Traverse
rupture; Photo 17 from inspection of MY 2017 Chevrolet Traverse
rupture.
\82\ See Photos attached to email dated Apr. 5, 2023 to NHTSA
from Hurley Medical Center; Photo 38 from inspection of MY 2017
Chevrolet Traverse rupture; Photo 36 from inspection of MY 2017
Chevrolet Traverse rupture; Photo 48 from inspection of MY 2017
Chevrolet Traverse rupture; Photo 45 from inspection of MY 2017
Chevrolet Traverse rupture.
---------------------------------------------------------------------------
Foreign Field Ruptures
In addition to the seven confirmed field ruptures in the U.S.,
there are four confirmed ruptures of frontal driver- and passenger-side
hybrid toroidal ARC inflators that occurred in other countries. In July
of 2016, a driver-side hybrid toroidal ARC inflator manufactured in
ARC's Xi'an, China plant ruptured in a MY 2009 Hyundai Elantra in
Canada.\83\ The center support split into two pieces and ejected, a
piece of which struck and killed the driver.\84\ In October of 2017, a
passenger-side hybrid toroidal ARC inflator manufactured in ARC's
Knoxville, Tennessee plant ruptured in a MY 2015 Volkswagen Golf in
Turkey.\85\ The center support split in two and ejected from the
inflator housing, and Volkswagen hypothesized that weld flash blockage
of the exit orifice caused the rupture.\86\ Fortunately, there was no
passenger in the vehicle, and no one was injured.\87\ In March of 2020,
a passenger-side hybrid toroidal ARC inflator manufactured in ARC's
Xi'an, China plant ruptured in a 2009 Hyundai Elantra in Saudi Arabia,
sending fragments of metal into the occupant compartment.\88\ The
driver sustained injuries in the incident.\89\ In October of 2021, a
driver-side hybrid toroidal ARC inflator manufactured in ARC's Xi'an,
China plant ruptured in a MY 2011 Hyundai Elantra Touring in Saudi
Arabia.\90\ The center support broke into two pieces and ejected from
the inflator housing.\91\ The driver was seriously injured when a piece
of the center support struck the driver's arm and had to be surgically
removed.\92\
---------------------------------------------------------------------------
\83\ See Hyundai Report dated Jul. 20, 2016 under SGO 2015-01/
2015-02; Hyundai Letter to NHTSA dated Apr. 15, 2020 at p. 2.
\84\ See Hyundai Report dated Jul. 20, 2016 under SGO 2015-01/
2015-02; Hyundai Letter to NHTSA dated Apr. 15, 2020 at p. 2; Photo
1 from inspection of MY 2009 Hyundai Elantra rupture; Photo 2 from
inspection of MY 2009 Hyundai Elantra rupture; Photo 375 from
inspection of MY 2009 Hyundai Elantra rupture.
\85\ See Key Safety Systems Report dated Dec. 1, 2017 under SGO
2015-01/2015-02.
\86\ See Photos from inspection of MY 2015 Volkswagen Golf
rupture; Volkswagen Presentation on MY 2015 Volkswagen Golf rupture.
\87\ See Key Safety Systems Report dated Dec. 1, 2017 under SGO
2015-01/2015-02.
\88\ See Hyundai Letter to NHTSA dated Apr. 15, 2020 at p. 2.
\89\ See Hyundai Report dated Mar. 30, 2020 under SGO 2015-01/
2015-02.
\90\ See Hyundai Report dated Apr. 7, 2023 under SGO 2015-01/
2015-02; Hyundai Report dated May 26, 2023 on Canada Safety Recall
R0239 ARC Inflator.
\91\ See Information package provided by the Saudi Ministry of
Commerce and Industry.
\92\ See id.
---------------------------------------------------------------------------
[[Page 63482]]
4. A Comparison to Peer Inflators Supports a Defect Determination
While the overall incidence of rupture is rare, these failures can
result and have resulted in severe injury or death. As such, and
considering the evidence of problems in the friction welding process,
the subject inflators present a defect. Moreover, the number of field
ruptures in the United States described here stands in stark contrast
to the near absence of such occurrences from other manufacturers of
frontal air bag inflators. In assessing a defect, courts have
considered how the number of failures compares to the number seen from
other manufacturers particularly in situations where--unlike here--the
circumstances of failure do not reveal an obvious defect. See, e.g.,
Wheels, 518 F.2d at 438 n.84. Such a comparison further bolsters the
conclusion that the subject inflators are defective.
As previously discussed in section I, SGOs 2015-01A and 2015-02A
require all manufacturers to report alleged inflator field ruptures to
NHTSA. Out of all of the field ruptures reflected in reports received
as of July 2024,\93\ NHTSA identified only one comparable U.S. field
rupture of a non-ARC air bag inflator, which has resulted in three
recalls.\94\ The agency recognizes that the predecessor SGOs, 2015-01
and 2015-02 (with similar reporting requirements), were first issued on
July 27, 2015. NHTSA believes it likely, however, that if other alleged
ruptures had occurred before the SGOs' issuance, the agency would have
been made aware of them through various channels. For example, the
first Takata inflator ruptures occurred in 2007-2008,\95\ and the first
Takata recall was initiated in 2008, so it is likely that, due to the
publicity, any inflator ruptures after that time would have been
reported to NHTSA through a complaint, which is how NHTSA learned of
the subject inflator rupture in the MY 2002 Chrysler Town &
Country.\96\
---------------------------------------------------------------------------
\93\ This does not include field ruptures--based on the agency's
review of these reports and field incidents--that involved inflators
manufactured by Takata, many of which have long been under recall.
As one commenter asserted (albeit in the context of discussing how
to define the defective population) it is difficult to make ``direct
rate comparisons'' between the inflators here and those in the
Takata recalls, and the Takata recalls ``have limited comparative
value'' given, among other things, the apparent failure mechanisms
and the number of reported deaths and injuries associated with
Takata air bag inflators. Comments of Jay Logel at p. 7 (Dec. 18,
2023).
\94\ NHTSA Recall Nos. 20V-681, 21V-766, and 21V-800.
\95\ Approximately 67 million non-desiccated Takata PSAN air bag
inflators, across nineteen vehicle manufacturers, are under recall
because they may rupture when deployed, causing serious injury or
even death. Certain other types of Takata inflators are also under
recall. For more information about the Takata air bag inflator
recalls, see Takata Recall Spotlight (NHTSA), <a href="https://www.nhtsa.gov/vehicle-safety/takata-recall-spotlight">https://www.nhtsa.gov/vehicle-safety/takata-recall-spotlight</a>.
\96\ In addition, since 2002, manufacturers have been required
under NHTSA's early warning reporting regulations to report on
incidents involving injury or death. See 49 CFR part 579, subpart C.
---------------------------------------------------------------------------
A collection of all SGO reports involving confirmed ruptures of
frontal driver and passenger air bag inflators thus yielded a total of
eighteen potentially relevant reports involving non-ARC inflators. Of
these eighteen, ten of the reported ruptures occurred outside of the
United States. Relative to the U.S. market, the agency does not have
the requisite depth of information (e.g., the total inflator population
manufactured for each additional relevant foreign market) to enable an
effective peer comparison that would encompass inflators manufactured
for the various foreign markets. In addition, the considerations
relevant to determining whether a defect exists under U.S. law may not
be the same in other countries. The foreign ruptures are, therefore,
not included in a comparison with seven U.S. subject inflator field
ruptures.\97\
---------------------------------------------------------------------------
\97\ To the extent any of the foreign field ruptures evidence a
pattern, the agency is taking a closer look to ensure such trends do
not implicate vehicles or equipment in the U.S.
---------------------------------------------------------------------------
Of the remaining eight ruptures in the collection of reports, six
inflators appear to be substandard or imitation products not designed
or manufactured to meet U.S. safety standards or based on the same
industry standards as legitimate inflators. For this reason, they
should not be used as peer comparators. Of the remaining two ruptures,
one involved reported damage--scratching--on the inflator housing that
appeared to have been caused by a tool and not by deployment or
rupture. Further, while the reporting inflator manufacturer confirmed a
rupture, the reporting vehicle manufacturer did not.\98\ Given that
none of the seven ruptures involving the subject inflators contained
similar evidence, it is inappropriate to use this event in a
comparison.
---------------------------------------------------------------------------
\98\ Compare Air Bag Inflator Rupture Incident Report (Initial &
Final), Autoliv (Dec. 2, 2016) (confirming rupture but noting that
``scratching'' on areas of the inflator are ``not consistent with
Autoliv's quality requirements and the inflator exhibits damage/
scratches inconsistent with normal deployment or a rupture'') with
Air Bag Inflator Rupture Incident Report (Final), Nissan (Dec. 20,
2016) (``There is damage on the outside of the housing which appears
to be caused by an external tool, as evidenced by the multiple
witness marks surrounding the hole in the inflator. Nissan does not
believe that a rupture occurred in this incident.'').
---------------------------------------------------------------------------
Appropriately filtering the list of confirmed ruptures of frontal
driver- and passenger-side air bag inflators to include true peer
incidents, there is only a single field rupture from all other inflator
manufacturers to compare to the seven subject inflator field ruptures.
As noted above, that rupture already resulted in three recalls, and the
scope of vehicles under these recalls is broader than just a particular
lot. NHTSA is not aware of further ruptures of that type of inflator,
which is distinguishable from the repeated ruptures of the subject
inflators. After each lot recall of subject inflators, another inflator
outside the scope of the recall eventually ruptured in a vehicle,
supporting the need for a more comprehensive recall to address the full
defective population.
5. ARC's Addition of an Automated Borescope Examination Process
Recognizes and Mitigates the Risk of a Field Rupture Due to Exit
Orifice Blockage
In August of 2017, ARC began adding an automated borescope to the
manufacturing process.\99\ After the last friction weld is complete,
the borescope inspects the inside of the center support to detect any
debris, including weld flash.\100\ By June of 2018, ARC had fully
implemented this process by installing these automated borescopes on
all assembly lines used to manufacture the subject inflators. ARC
rejects any inflator for which the borescope detects material or debris
in excess of the specified parameters,\101\ and, from the first
borescope installation to March 2023, ARC rejected 195,166 inflators
based on the borescope's inspection.\102\
---------------------------------------------------------------------------
\99\ See ARC Presentation dated Oct. 2017 on Automated
Borescope.
\100\ See id.
\101\ See id.
\102\ See ARC Response to Request 8 of NHTSA May 31, 2023
Special Order.
---------------------------------------------------------------------------
The automated borescope examination process, which detects
excessive weld flash or other debris in the inflator center support,
recognizes and mitigates the risk of a field rupture due to exit
orifice blockage. The agency is unaware of a field rupture of a
frontal, driver- or passenger-side hybrid toroidal inflator
manufactured using the borescope examination process. Thus, the subject
inflators subject to this initial determination are the inflators
manufactured before the full implementation of this process change.
The borescope process provides additional evidence of the
likelihood that problematic levels of debris are present in the subject
inflator population. Inflators built after the
[[Page 63483]]
borescope process was introduced continued to otherwise undergo the
same friction welding process as before the borescope inspection began.
This means that the rejection rates from the borescope inspections
provide insight into the extent of debris present in the subject
inflators, which were produced under similar manufacturing procedures.
Before implementation of the borescope process, there was no analogous
mechanism in place for detecting--and removing from the manufacturing
line--inflators with excessive and dangerous levels of debris.
Moreover, ARC's representations during this investigation suggest
that the number of inflators with excessive debris before 2017 was
potentially even higher than the extent of debris present in inflators
manufactured after borescope implementation. By 2017, ARC claims that
it had already taken numerous other steps to update the manufacturing
process for the inflators, such as upgrading the welding equipment on
several production lines and refining welding tolerances in response to
field and testing ruptures.\103\ In this investigation, ARC has claimed
that the manufacturing procedures and equipment in place by 2017 were
improvements on the procedures and equipment in place in the preceding
years of inflator production. If so, the rate of unacceptable inflators
due to debris as revealed by the borescope inspections likely would
have been even higher for inflators built during the years in which the
manufacturing processes were less stringent. At the very least, the
nearly 200,000 inflators rejected between the start of the borescope
implementation process and March 2023 corroborate the other evidence
from analyses of the field ruptures and lot acceptance testing ruptures
that suggests a large number of inflators in the subject population
contain unacceptable levels of debris, posing a risk of rupture.
---------------------------------------------------------------------------
\103\ See, e.g., ARC Working Group Meeting Minutes dated Dec. 5,
2017.
---------------------------------------------------------------------------
6. The Field and LAT Ruptures Show a Defect Common to All of the
Subject Inflators
The evidence demonstrates that the friction welding process is
responsible for debris and weld insufficiencies, which have led to
over-pressurization and weld failures, causing ruptures. The seven
confirmed ruptures of the subject inflators in vehicles in the United
States each presented evidence of over-pressurization or weld
insufficiency as a likely cause of the rupture. In addition, at least
twenty-three of the reported lot acceptance test ruptures share over-
pressurization or weld insufficiency commonalities with the seven field
ruptures. These instances of over-pressurization and weld insufficiency
are linked to the friction welding process.
As described in section II.A.3, ARC and GM identified problems with
one of the friction welds in their analyses of the rupture of the MY
2011 Chevrolet Malibu inflator, attributing the rupture as most likely
caused by a failure of the friction weld.\104\ ARC reiterated the cause
of the rupture as a ``welding issue'' in its response to the agency's
September 2023 initial decision.\105\ In six of the subject inflator
ruptures that occurred during lot acceptance tests, ARC identified
similar issues related to the same friction weld, again noting that
friction weld failure as a potential causes of the ruptures.\106\ In
addition, the investigative file contains significant evidence that the
friction welding process has led to exit orifice blockage, causing
over-pressurization and rupture. Information gathered in three of the
U.S. field incidents includes evidence of material in the exit orifice:
photos of the upper portion of the center support in the MY 2002
Chrysler Town & Country show an unmistakable blockage in the exit
orifice; \107\ photos of the upper piece of the center support in the
MY 2015 Chevrolet Traverse in Kentucky show material blocking the exit
orifice; \108\ and photos of the upper portion of the center support in
the MY 2017 Chevrolet Traverse show that the exit orifice was
completely blocked.\109\ Exit orifice blockage remains a possible cause
based on the evidence for three other incidents--the MY 2004 Kia
Optima, the MY 2015 Chevrolet Traverse in Michigan, and the MY 2016
Audi A3 e-Tron. In addition, Volkswagen attributed weld flash blockage
leading to over pressurization as a potential cause for the inflator
rupture in the MY 2015 Volkswagen Golf in Turkey.
---------------------------------------------------------------------------
\104\ See ARC Presentation dated Mar. 21, 2019 on MY 2011
Chevrolet Malibu rupture at p. 4; GM Presentation dated Jan. 29,
2019 on MY 2011 Chevrolet Malibu rupture at p. 3.
\105\ See Written Response of ARC Automotive, Inc. to the
September 5, 2023, Initial Decision Docket No. NHTSA-2023-0038 at p.
32, <a href="https://www.regulations.gov/comment/NHTSA-2023-0038-0027">https://www.regulations.gov/comment/NHTSA-2023-0038-0027</a> at n.
31.
\106\ See ARC Presentation dated Oct. 17, 2016 on SGO 2016-01/
2017-01 Report 3 at pp. 14-16; ARC Report dated Nov. 4, 2016 under
SGO 2016-01/2017-01 Report 5 pdf at p. 2; ARC Report dated Nov. 9,
2016 under SGO 2016-01/2017-01 Report 8 at p. 2; ARC Presentation
dated Nov. 7, 2016 on SGO 2016-01/2017-01 Report 12 at slides 39-40;
ARC Report dated Dec. 12, 2016 under SGO 2016-01/2017-01 Report 13;
ARC Report dated Dec. 12, 2016 under SGO 2016-01/2017-01 Report 18;
ARC Presentation dated Feb. 8, 2017 on A9/ZB Model Inflators at pp.
2-3; ARC Presentation dated May 14, 2017 on SGO 2016-01/2017-01
Report 20 at slides 27-30; ARC Report dated Dec. 14, 2016 under SGO
2016-01/2017-01 Report 22 at p. 2.
\107\ See id.
\108\ See id. at p. 3.
\109\ See Photos attached to email dated Apr. 5, 2023 to NHTSA
from Hurley Medical Center; Photo 38 from inspection of MY 2017
Chevrolet Traverse rupture; Photo 36 from inspection of MY 2017
Chevrolet Traverse rupture; Photo 48 from inspection of MY 2017
Chevrolet Traverse rupture; Photo 45 from inspection of MY 2017
Chevrolet Traverse rupture.
---------------------------------------------------------------------------
Other data support exit orifice blockage as a common factor in
these ruptures. In May of 2017, a group of manufacturers involved in
the investigation that has been described as the ``Collaboration
Group'' joined together to study the subject inflators. The
Collaboration Group analyzed fourteen reports submitted pursuant to
SGOs 2016-01 and 2017-01 of passenger-side hybrid toroidal inflator
ruptures during lot acceptance test deployments and conducted related
testing. The Collaboration Group concluded that all fourteen ruptures
were caused by over-pressurization; in all fourteen incidents, the
center support elongated, split in two, and ejected from the inflator
housing; and, in all fourteen incidents, the upper portion of the
center support had material in the exit orifice, witness marks around
the exit orifice (indicating debris was forced into the exit orifice
upon deployment but was subsequently knocked loose), or other evidence
of exit orifice blockage or obstruction.\110\ ARC has acknowledged the
exit orifice blockage issue by implementing changes in its Failure Mode
and Effects Analysis (FMEA) \111\ and manufacturing process
[[Page 63484]]
to mitigate it.\112\ In fact, ARC implemented the automated borescope
to identify excessive weld flash and other debris inside the inflator
on all of its toroidal air bag inflator manufacturing lines as a direct
response to the Collaboration Group's findings.\113\ The borescope
inspection process has identified unacceptable levels of debris in
inflators produced on all ARC production lines using friction welding
to manufacture hybrid toroidal inflators, which include 20 different
production lines across five different ARC manufacturing plants. This
extensive range illustrates that problems with excessive debris apply
broadly across the subject inflators.
---------------------------------------------------------------------------
\110\ See ARC Presentation dated Feb. 8, 2017 on SGO 2016-01/
2017-01 Report 4; ARC Presentation dated Dec. 8, 2016 on Inflator
Incidents Update at p. 17; ARC Presentation dated Jan. 10, 2017 on
SGO 2016-01/2017-01 Report 39; ARC Presentation dated Mar. 9, 2017
on ZC Anomaly; ARC Presentation dated Apr. 1, 2017 on SGO 2016-01/
2017-01 Report 80; ARC Presentation dated Apr. 1, 2017 on SGO 2016-
01/2017-01 Report 94; ARC Presentation dated Apr. 5, 2017 on SGO
2016-01/2017-01 Report 95; ARC Presentation dated Nov. 10, 2017 on
SGO 2016-01/2017-01 Report 120; ARC Presentation dated Apr. 5, 2017
on SGO 2016-01/2017-01 Report 130; ARC Presentation dated Nov. 10,
2017 on SGO 2016-01/2017-01 Report 158; ARC Presentation dated Nov.
10 2017 on SGO 2016-01/2017-01 Report 176; ARC Presentation dated
Nov. 8, 2017 on SGO 2016-01/2017-01 Report 178; ARC Presentation
dated Nov. 10 2017 on SGO 2016-01/2017-01 Report 184; ARC
Presentation dated Nov. 10 2017 on SGO 2016-01/2017-01 Report 186;
ARC Presentation dated Nov. 10 2017 on SGO 2016-01/2017-01 Report
192.
\111\ In general, a Failure Mode and Effects Analysis is a
qualitative tool associated with the design and manufacturing
process that businesses use to identify and analyze potential
failures in processes, such as those involving equipment, systems,
and personnel. The goal of this analysis is to prevent failures,
improve processes, and reduce the likelihood of failure causes and
effects.
\112\ See ARC Presentation dated Apr. 5, 2017 on SGO 2016-01/
2017-01 Report 95 at p. 86.
\113\ See ARC Working Group 8D Technical Closure Statement at p.
1.
---------------------------------------------------------------------------
Some commenters suggested that the results of a field recovery
program conducted by certain manufacturers during NHTSA's investigation
show there is no defect in the subject inflator population. This
program was initiated in the early stages of the investigation during
the Preliminary Evaluation. During the field recovery program, 918
inflators from a subpopulation of the total subject inflator population
were collected from salvage yards and deployed, with none of the
inflators rupturing. Given the fact that this testing program was
developed after just the first two U.S. field ruptures (the MY 2002
Chrysler Town & Country and the MY 2004 Kia Optima), the inflators
tested represent a limited portion of the total subject population.
They were selected based on (1) production date, with the vast majority
being manufactured between 2001 and 2004, and (2) the vehicles into
which the inflators were incorporated, which were Chrysler, Kia, and GM
vehicles.\114\ As such, the overall number of inflators recovered and
deployed under the field recovery program was low compared to what
ultimately became the total number of inflators in the subject
population. While there were no ruptures under the field recovery
program, ruptures in the field continued: after the program's
initiation, there were five additional U.S. ruptures of the subject
inflators.
---------------------------------------------------------------------------
\114\ See Field Recovery Program Data Sheet dated May 10, 2018.
---------------------------------------------------------------------------
The field recovery program confirmed, however, that some inflators
in the field contain large amounts of debris. Prior to their
deployment, the recovered inflators underwent X-ray imaging and, in
some cases, CT scanning to determine whether debris intruded upon the
exit orifice opening.\115\ Seven of the recovered inflators were
identified as containing such debris, including from weld flash.\116\
All of those inflators deployed normally, which is consistent with the
large number of complex variables that may factor into whether debris
in the inflator leads to over-pressurization. The existence of this
debris around the exit orifice of inflators in the field demonstrates
the prevalence of this issue in the subject inflator population.
---------------------------------------------------------------------------
\115\ See ARC Inspection Procedure and Evaluation dated Feb. 28,
2017.
\116\ See Field Recovery Program Deployment Data Sheet; ARC
Presentation dated Aug. 1, 2017 on Field Recovery Program.
---------------------------------------------------------------------------
ARC's own failure analysis throughout the investigation has also
indicated that, even if the company has been unable to identify the
full universe of variables that can lead to a rupture, the
commonalities in the failures are sufficient to reveal the nature of
the problem--including the failure mode and the aspects of the inflator
design and welding process most likely to contribute to it. In 2016,
ARC was even able to conduct testing that replicated four ruptures out
of 50 deployments.\117\ In doing so, ARC identified five manufacturing
variables in the assembly process that, when out of limits, appeared to
contribute to the likelihood of a rupture.\118\ ARC's fault trees and
failure mode effects analyses similarly isolate the specific steps in
the manufacturing process most likely relevant to the ruptures. The
existence of factual differences or different variables that led to the
ruptures does not establish that the ruptures lacked a common defect.
---------------------------------------------------------------------------
\117\ See ARC Presentation on Design of Experiment #5.
\118\ Id. Additional efforts in 2017 to replicate the failure
mode in a more precise manner were unsuccessful, further indicating
that different variables may combine to contribute to the risk of
rupture. See ARC Working Group Meeting Minutes dated Feb. 13, 2018.
---------------------------------------------------------------------------
Outside of this investigation, ARC has openly acknowledged the
problems with its friction welding process that have led to the defect
NHTSA seeks to remedy. For instance, in representations to the United
States government outside of this investigation, ARC has acknowledged
that the ``problematic'' characteristics of the subject inflators are
not limited to isolated production lots. Specifically, in a patent
application filed with the United States Patent and Trademark Office in
2020, ARC requested a patent on an improved air bag inflator design.
When explaining the background of existing designs that prompted the
need for an improved design, ARC's application represented that
``[s]ome existing inflator assemblies utilize a center support
structure that requires two simultaneous welds, which is problematic in
respect of manufacturing and also increases the potential for weld
particles to exit the inflator upon deployment. Existing designs have
also been configured to fragment during deployment as a consequence, in
the event of excessive pressure increase within the inflator due to
some failure or external condition or the like, these existing inflator
designs can be potentially hazardous for vehicle occupants.'' \119\
---------------------------------------------------------------------------
\119\ U.S. Pat. App. Pub. No. 2022/0185224 A1 to Rose et al., at
]] 0005-06.
---------------------------------------------------------------------------
The claimed improvements to mitigate these problems with prior
inflators focused on the precise aspects of the inflator that are at
issue in NHTSA's proceeding. Specifically, ARC intentionally redesigned
its inflator in a way that would avoid the friction welding process
that caused problems for the subject inflator, such as the step of
simultaneously friction welding the top and bottom of the inflator
housing to the center support.\120\ As ARC explained in the patent
application, ``[t]he described inflator also eliminates the requirement
for simultaneous welds, which facilitates manufacturing and reduces
potential weld particles.'' \121\ In addition, the redesigned inflator
included a pressure relief valve to create a failure mode that would
avoid rupture if over pressurization occurred.\122\ These
representations and redesign efforts demonstrate that, at the same time
ARC was insisting in the NHTSA investigation that the subject inflators
were neither defective nor inappropriate in their performance, the
company was actively trying to correct the problems with its inflators
and conceding the existence of those problems to another agency in the
United States government.
---------------------------------------------------------------------------
\120\ For the subject inflators, ARC refers to this step of the
manufacturing process as Operation 50 for the driver-side inflator
and Operation 42 for the passenger-side inflator. See, e.g., ARC
Presentation on CADH Inflator Design.
\121\ U.S. Pat. App. Pub. No. 2022/0185224 A1 to Rose et al., at
] 0047.
\122\ ``The inflator also advantageously includes a pressure
relief in the event of an elevated system internal pressure without
any rupture of the inflator.'' Id.
---------------------------------------------------------------------------
Ignoring the evidence of a common defect attributable to the
friction welding process, certain commenters have nevertheless argued
that there is, as of yet, no definitive, established ``root cause.''
\123\ While comments from two
[[Page 63485]]
individuals supported NHTSA's identification of weld-flash evidence
\124\ common to several of the ruptures, other commenters incorrectly
suggested that, to establish a defect here, NHTSA must identify a more
specific cause that is identical in each of the failures. Some of these
comments hinge, at least in part, on the notion that a specific root
cause of the defect in the Takata air bag inflators had been
identified.\125\ For example, Hyundai asserted that the agency's
September 2023 initial decision was ``entirely inconsistent with its
decision-making in the Takata case,'' citing in part a consensus root
cause at the time of the Takata recall request letter.\126\ Whether a
particular recall had an identified cause before or at the time it was
filed does not establish that such a particularized root cause is a
requirement for a recall. It is not.\127\A `` `defect' includes any
defect in performance, construction, component, or material of a motor
vehicle or motor vehicle equipment.'' 49 U.S.C. 30102(a)(3) (emphasis
added). Accordingly, ``a determination of `defect' does not require any
predicate of a finding identifying engineering, metallurgical, or
manufacturing failures. A determination of `defect' may be based
exclusively on the performance record of the vehicle or component.''
Wheels, 518 F.2d at 432 (emphasis added); see also United States v.
General Motors Corp., 841 F.2d 400, 413 (D.C. Cir. 1988) (explaining
that a defect can be established by the performance record alone and
does not require an engineering explanation).\128\ A non-defective
inflator does not rupture when it is commanded to deploy, absent some
extraordinary circumstance such as tampering.\129\ The repeated
ruptures of the subject inflators would not have occurred absent a
defect.\130\
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\123\ See, e.g., Comments of Kia America Inc. at pp. 1-2;
Written Comments of General Motors LLC at p. 13; Comments from
Hyundai Motor America at pp. 2, 20; Public Comment Submitted by
Jacqueline Glassman at p. 10 (stating that while the root cause
``may not necessarily be a prerequisite to understanding that there
is a safety related defect,'' there must ``be some meaningful
relationship in order to infer that the underlying problem is a
`class-wide' problem.'').
This is despite the years of analysis the industry has
undertaken during the agency's investigation. The agency does not
believe that it is either necessary or appropriate to allow for
additional time for such analysis.
\124\ See John Keller P.E., Comments on NHTSA's Initial decision
to Declare ARC Automotive Toroidal Airbag Inflators Defective (Dec.
6, 2023) at p. 1; Jerry W. Cox, Esq., Comments in Support of the
National Highway Traffic Safety Administration's Initial Decision to
Declare 52 Million ARC Automotive Airbag Inflators Defective at p.
2.
\125\ Commenters appear to overstate NHTSA's reliance on the
Takata recalls as a basis for the initial decision here. Takata was
discussed essentially twice in the initial decision: in a section
providing general background on air bags and in another providing
background on the agency's past practices regarding recall request
letters. NHTSA's references to Takata in the initial decision were
made to provide context on recalls involving inflator ruptures and
not as a particularized substantive argument.
\126\ In fact, NHTSA's recall request letter to Takata makes
clear that the agency believed that multiple variables could result
in propellant degradation, which caused ruptures. Letter from F.
Borris, NHTSA, to K. Higuchi, TK Holdings Inc. (Nov. 26, 2014),
<a href="https://static.nhtsa.gov/odi/inv/2014/INRM-PE14016-60978.pdf">https://static.nhtsa.gov/odi/inv/2014/INRM-PE14016-60978.pdf</a>
(describing high absolute humidity as one variable, but explaining
that other ruptures occurred outside areas of high absolute
humidity). That is also the case here, where the evidence points to
multiple variables that may result in over pressurization, causing
rupture.
\127\ Pointing to the specific facts in the Takata recalls as
precedent for necessary elements to order a recall, among other
things, ignores that each recall is fact specific--and suggests,
incorrectly, that the agency must match the bases for the Takata
recalls to order a recall here.
\128\ It is well established that a safety defect determination
does not require an engineering explanation or root cause. See NHTSA
Enforcement Guidance Bulletin 2016-02: Safety-Related Defects and
Automated Safety Technologies, 81 FR 65705, 65708 (Sept. 23, 2016).
\129\ See NHTSA, Special Crash Investigations: On-Site Air Bag
Inflator Rupture Crash Investigation; Vehicle: 2009 Honda Civic;
Location: Maryland; Crash Date: September 2017 (June 2020), <a href="https://crashstats.nhtsa.dot.gov/Api/Public/Publication/812972">https://crashstats.nhtsa.dot.gov/Api/Public/Publication/812972</a> (explaining,
in investigation into ruptured inflator, that ``[t]he wiring harness
for the driver's frontal air bag inflator had been tampered with
since the vehicle's date of manufacture'').
\130\ In much of the prior litigation under Safety Act the issue
of whether there was a defect was not in question, in part due to
the obvious nature of the defect. See, e.g., United States v.
General Motors Corp., 561 F.2d 923, 924 (D.C. Cir. 1977) (``Pitman
Arms''); United States v. Ford Motor Co., 453 F. Supp. 1240, 1249
(D.D.C. 1978).
---------------------------------------------------------------------------
Manufacturers' arguments related to a ``root cause'' finding are
inconsistent with their legal obligations and actions they have taken
pursuant to those obligations. Under the Safety Act, a manufacturer is
required to initiate a recall once it ``learns the vehicle or equipment
contains a defect and decides in good faith that the defect is related
to motor vehicle safety.'' 49 U.S.C. 30118(c)(1). It is common for the
industry to recognize obvious defects without identifying a specific
cause when, based on the performance record, they present a severe risk
to safety.\131\ Related to air bags in particular, manufacturers have
recalled inflators susceptible to rupture without identifying the type
of particularized cause demanded by the commenters.\132\ In fact, ARC
and other manufacturers have done so here. For example, BMW, GM, and
Volkswagen initiated recalls without identifying a cause based on the
severity of the risk as shown by one rupture.\133\ ARC acknowledged
that it has ``supported targeted recalls by vehicle manufacturers
related to field ruptures and production lots with an identified
potential risk of defect.'' \134\ These actions are consistent with a
manufacturer's obligations under the Safety Act to recall vehicles when
it decides a defect related to motor vehicle safety exists. The Safety
Act does not allow a manufacturer to evade or delay a recall because it
has not identified a specific ``root cause.'' NHTSA routinely takes
enforcement actions against manufacturers for failure to timely make
recall determinations, including where the lack of an identified root
cause contributed to the delay.\135\
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\131\ See Defect Notices, NHTSA Recall Nos. 23V-867 (In
describing the cause of the defect that ``may lead to thermal
overload, possibly resulting in smoke or a fire,'' Volkswagen stated
that ``[t]he root cause is still under investigation, but the risk
is associated with the battery modules exhibiting the potentially
critical self-discharge behavior.''); 23V-840 (In its description of
the cause of a defect that ``can lead to thermal events and in some
cases fires,'' Porsche states that ``[t]he root cause is still under
investigation.''); 23V-369 (JLR provides ``NR,'' commonly understood
to mean `no response,' to describe the cause of a ``thermal
overload'' condition that ``may show as smoke or fire'' and ``can
result in increased risk of occupant injury.''); 23V-626 (In
determining a defect exists that can ``result in a loss of motive
power,'' Ford identified one contributing factor but stated that ``a
second factor must be present or induced,'' and that ``[t]his factor
is still unknown and under investigation.''); 24V-099 (For a defect
affecting seatbelt function that ``may result in injury in the event
of a crash,'' Ford attributed the issue to corrosion ``caused by an
undefined supplier manufacturing issue.''); and 24V-418 (For a
defect resulting in seatbelts becoming ``unavailable as an occupant
restraint'' and resulting in ``an increased risk of injury if the
vehicle is involved in a crash,'' GM describes the cause as ``[t]wo
internal components'' that ``may be slightly our of dimensional
specifications'' but does not explain how the components came to be
out of specifications.)
\132\ See Defect Notice, NHTSA Recall No. 16V-045 (``The cause
is yet not determined. Takata and Volkswagen are still under
investigation of the root cause.'').
\133\ See Defect Notices, NHTSA Recall Nos. 17V-189 (``The root
cause has not yet been determined and is still under
investigation.''); 19V-019 (providing no response (``NR'') as to the
description of the cause); 21V-782 (providing no response (``NR'')
as to the description of the cause); 22E-040 (``GM's investigation
has not identified the specific root cause of the LAT rupture'');
22V-246 (providing no response (``NR'') as to the description of the
cause); 22V-543 (``The root cause is currently unknown . . . .'').
Even in GM's most recent ARC-related recall, which it no longer
sought to limit to a specific production lot, it indicated as to
cause that ``GM is continuing its investigation into this
incident.'' See Defect Notice, NHTSA Recall No. 23V-334.
\134\ See Written Response of ARC Automotive, Inc. to the
September 5, 2023, Initial Decision Docket No. NHTSA-2023-0038 at p.
20, <a href="https://www.regulations.gov/comment/NHTSA-2023-0038-0027">https://www.regulations.gov/comment/NHTSA-2023-0038-0027</a>.
\135\ See, e.g., Consent Order between NHTSA and Daimler Trucks
North America, LLC, In re: AQ18-002 ] 29 (Dec. 29, 2020), <a href="https://www.nhtsa.gov/sites/nhtsa.gov/files/documents/aq18-002_consent_order_executed.pdf">https://www.nhtsa.gov/sites/nhtsa.gov/files/documents/aq18-002_consent_order_executed.pdf</a> (``DTNA acknowledges that the failure
to identify a specific root cause, develop an adequate repair or
remedy, or confirm the affected population of vehicles are not bases
for delaying the identification of a defect or noncompliance, the
determination of whether a defect related to motor vehicle safety,
or the timely reporting a defect or noncompliance to NHTSA.'');
Consent Order between NHTSA and General Motors Company, In re: TQ14-
001 ] 24 (May 16, 2014), <a href="https://www.nhtsa.gov/sites/nhtsa.gov/files/2021-11/TQ14-001-General-Motors-Consent-Order-5-6-2014-tag.pdf">https://www.nhtsa.gov/sites/nhtsa.gov/files/2021-11/TQ14-001-General-Motors-Consent-Order-5-6-2014-tag.pdf</a>
(``GM shall not delay holding any meeting . . . to decide whether or
not to recommend or. conduct a safety recall because GM has not yet
identified the precise cause of a defect, a remedy for the defect,
or prepared a plan for remedying the defect.'').
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[[Page 63486]]
Commenters' arguments regarding root cause also ignore the evidence
of a common defect collected during NHTSA's investigation and described
above in this section and II.A.2-3 & 5. The evidence indicates that
problems related to friction welding can lead to both over-
pressurization due to exit orifice blockage and insufficient friction
welds. All of the field ruptures and a majority of the lot acceptance
test ruptures share these commonalities.
The evidence collected in NHTSA's investigation establishes that
the subject inflators have an unacceptable risk of rupturing.
Therefore, the entire subject inflator population is defective and must
be recalled. As demonstrated by past ruptures, the occurrence of a
rupture is unpredictable. Ruptures have occurred outside of narrower
inflator populations previously identified by the manufacturers to be
the defective population. There is substantial evidence tying the
defect to the friction welding process, and this process was used
across all manufacturing lines and plants that produced the subject
inflators. After multiple years of thorough investigation and analysis,
the evidence does not identify another element linking the ruptures. As
such, the subject inflator population identified in this decision is
the narrowest defective population supported by the evidence.
ARC claims the subject inflator population is too broad due to
variations in design and manufacturing of the subject inflators.
Similarly, other commenters have pointed out these variations and
assert that certain subpopulations of the subject inflators should be
excluded from the scope of a recall, e.g., passenger-side subject
inflators and subject inflators installed in certain makes and models.
Despite years of comprehensive analysis, NHTSA has found no design or
manufacturing evidence that shows these subpopulations are less
susceptible to rupture. In addition to the field rupture of a
passenger-side inflator, passenger-side inflators also ruptured in
fourteen lot acceptance tests. While NHTSA recognizes there may be
practical and logistical challenges to implementing a recall for the
full defective population, these concerns do not warrant a narrower
scope. Under the Safety Act, unreasonable risks cannot be countenanced
simply because of logistical challenges that may be involved in
remedying them.
None of the manufacturers have provided compelling technical
evidence that connects any of these variations to the defect or to a
particular subset of inflators that rebuts the need to recall the
subject inflators, ``[a]nd there is justice in this allocation to the
manufacturer[s] of the burden of compiling significant data on the
causes and consequences of mishaps in [their] cars.'' United States v.
General Motors Corp., 561 F.2d 923, 931 (D.C. Cir. 1977) (``Pitman
Arms''). And contrary to Hyundai's comment that there is ``little
downside'' for the agency to ``complete the necessary investigation and
make a rational judgment as to whether'' and to what extent a recall is
needed, there is already sufficient evidence that the full population
of subject inflators is defective. There is significant ``downside'' at
this point to further investigation in lieu of a recall.\136\ Absent a
recall, vehicle owners are not notified of the defect or entitled to
have it addressed when a remedy is available. NHTSA has, accordingly,
initially determined that the full population of subject inflators is
defective.
---------------------------------------------------------------------------
\136\ Hyundai also noted that ``no other country with a similar
safety recall legal framework'' has required a recall for the
subject inflators. There are seven confirmed U.S. ruptures of the
subject inflators, and over 20 million fewer ARC inflators were
distributed globally (across all countries) than to the U.S. In any
case, NHTSA's action is based on U.S. law. NHTSA is not bound by
other jurisdictions and their respective authorities and is making
this decision based on the facts before it (all of which may, or may
not, be available to other jurisdictions).
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B. The Defect Is Related to Motor Vehicle Safety
NHTSA has also preliminarily concluded based on the available
evidence that the defect in the subject inflators (as described in
section II.A) is related to motor vehicle safety because a risk of
inflator rupture presents an unreasonable risk of death or injury in
the event of an accident. It is undisputed that rupturing inflators
have forcefully propelled pieces of metal at occupants, resulting in
grave, permanent injuries and death. Future rupture events likely would
have similar outcomes. An air bag's life-saving purpose also has
bearing on the unreasonableness of this defect.
The Safety Act defines ``motor vehicle safety'' as ``the
performance of a motor vehicle or motor vehicle equipment in a way that
protects the public against unreasonable risk of accidents occurring
because of the design, construction, or performance of a motor vehicle,
and against unreasonable risk of death or injury in an accident and
includes nonoperational safety of a motor vehicle.'' 49 U.S.C.
30102(a)(9). The statute does not further define what constitutes an
``unreasonable risk.'' Based on the ordinary meaning of that term, the
high severity of an inflator rupture coupled with the inability of a
vehicle owner or occupant to detect that the rupture will occur or
otherwise mitigate the risk warrants a finding that the risk is
unreasonable despite the low probability that a rupture will occur when
the inflator is commanded to deploy.
In considering this issue, courts have found that an assessment of
whether a risk is unreasonable requires a `` `commonsense' approach.''
Carburetors, 565 F.2d at 757. The most obvious, or ``commonsense,''
consideration in this assessment is, of course, the safety risk itself.
A defect that ``leads to failures in a vital component . . . is prima
facie an `unreasonable risk.' '' Pitman Arms, 561 F.2d at 929. In other
words, there is ``no question'' that a risk of an ``extremely
dangerous'' situation ``should be considered an unreasonable risk to
safety.'' Carburetors at 757. If the risk is sufficiently severe, even
an ``exceedingly small'' or ``negligible'' number of expected incidents
is ``unreasonably large.'' Id. at 759.\137\ This is so regardless of
whether any injuries have already occurred, or whether the projected
number of failures or injuries in the future is trending down. See id.
---------------------------------------------------------------------------
\137\ Commenters asserted that NHTSA did not use or follow risk
matrices used by NHTSA's Office of Defects Investigation (ODI).
NHTSA's risk matrices are not recall-determination tools. Rather,
the matrices are used ``[t]o assist in objectively evaluating
whether a potential defect issue should be advanced to the next
stage for an investigation. . . . ODI uses these matrices as
deliberative tools to assist in evaluating the risk posed by a
potential defect and identifying issues that should be elevated to
an investigation.'' Risk-Based Process for Safety Defect Analysis
and Management of Recalls, DOT HS 812 984 (Nov. 2020), <a href="https://www.nhtsa.gov/sites/nhtsa.gov/files/documents/14895_odi_defectsrecallspubdoc_110520-v6a-tag.pdf">https://www.nhtsa.gov/sites/nhtsa.gov/files/documents/14895_odi_defectsrecallspubdoc_110520-v6a-tag.pdf</a>. NHTSA decided
back in 2015 that this issue warranted investigation under its risk-
based processes. Further, ODI's risk matrices and their application
are not binding on NHTSA or any outside entity, and they are not
``guidance''; they are a tool for ODI personnel.
---------------------------------------------------------------------------
Courts have also considered certain particularly severe defects to
be ``per se'' safety-related defects regardless of how many injuries or
accidents are likely to occur in the future. These decisions have
involved defects that cause the failure of a critical component, a
vehicle fire, a loss of vehicle control, and a
[[Page 63487]]
defect that suddenly moves the driver away from the steering wheel,
accelerator, and brake controls. See Carburetors, 565 F.2d 754 (engine
fires); Pitman Arms, 561 F.2d 923 (loss of control); United States v.
Ford Motor Co., 453 F. Supp. 1240 (D.D.C. 1978) (``Wipers'') (loss of
visibility); United States v. Ford Motor Co., 421 F. Supp. 1239, 1243-
44 (D.D.C. 1976) (``Seatbacks'') (loss of control); see also NHTSA,
Motor Vehicle Safety Defects and Recalls: What Every Vehicle Owner
Should Know, available at <a href="https://www.nhtsa.gov/sites/nhtsa.gov//documents/14218-mvsdefectsandrecalls_041619-v2-tag.pdf">https://www.nhtsa.gov/sites/nhtsa.gov//documents/14218-mvsdefectsandrecalls_041619-v2-tag.pdf</a> (providing
examples of safety-related defects, including ``[a]ir bags that deploy
under conditions for which they are not intended to deploy'' and
``[c]ritical vehicle components that break, fall apart, or separate
from the vehicle, causing potential loss of vehicle control or injury
to people inside or outside the vehicle'').
1. The Risk Posed by an Inflator Rupture Is Severe
Here, there is no question that an inflator rupture presents an
extreme danger. As already described, a rupture turns a component with
the sole purpose of preventing serious injury and death into a device
that can cause serious injury or death; the defect simultaneously
undermines the component's life-saving purpose and introduces a life-
threatening danger. To reiterate, the consequences of these ruptures
thus far include lacerations to the legs, harm to the jaw and ear,
severe injuries to the face, neck, head, shoulder, and arm, injury to
the airway requiring a tracheostomy, and death. Commonsense dictates
that the defect here poses an unreasonable risk. See Carburetors, 565
F.2d at 757-59.
Even if a vehicle occupant is fortunate enough not to be struck by
the metal fragments ejected out of the inflator upon a rupture, the
rupture also undermines the intended effectiveness of the air bag in
protecting an occupant in a crash. An air bag is designed to deploy in
a precise manner under very strict timeframes. Over the course of
milliseconds, numerous vehicle systems working in tandem must perform a
multitude of functions in a particular order to ensure that the airbag
protects the occupant.\138\ An air bag inflator is a critically
important component in this sequence as it is responsible for ensuring
that an air bag inflates a precise amount at a precise time in order to
be in the right position when it meets the vehicle's occupant. When an
inflator ruptures, the pressure accumulating in the inflator to is
suddenly released, resulting in a complete disruption of the tightly
controlled gas flow intended for the inflator.\139\ This disrupts the
air bag inflation timing, undermining the air bag's ability to perform
its intended safety function. Thus, even apart from a rupture's
dangerous explosion of metal fragments towards a vehicle occupant, the
rupture deprives a vehicle occupant of the benefit of an air bag.\140\
Manufacturers have issued recalls to address the increased safety risk
to vehicle occupants when air bags do not properly inflate.\141\
---------------------------------------------------------------------------
\138\ Such functions include but are not limited to detecting an
impact, classifying the impact as severe enough to warrant an air
bag deployment, understanding the likely positioning of the vehicle
occupant based on the occupant's seating position and seatbelt
status, commanding deployment of the air bag at a specified
inflation rate to match the occupant's expected position, and
reaching a level of air bag inflation necessary for the cushion of
the air bag to reduce the expected crash forces. This is a very
complex dynamic in which numerous life-critical systems are
interdependent and all components must perform exactly as intended
to protect the vehicle occupants.
\139\ This release causes the gas flow rate into the air bag to
suddenly spike before dramatically dropping as the inflator's
pressure equalizes with the ambient air.
\140\ During the investigation, both ARC and at least one
vehicle manufacturer acknowledged that the rupture of one of the
subject inflators could cause an air bag to underinflate. See ARC
Presentation dated Mar. 1, 2016 on MY 2004 Kia Optima Rupture;
Hyundai Letter to NHTSA dated Apr. 15, 2020.
\141\ See NHTSA Recall Nos. 12V-055 and 01V-318.
---------------------------------------------------------------------------
Hundreds of recalls are issued each year for safety-related
defects. In 2023 alone, there were nearly 800 such vehicle recalls. The
vast majority of these recalls were uninfluenced by a NHTSA
investigation.\142\ The nature of the defects and potential
consequences ranged widely. While some involved fire risks or loss of
vehicle control (and certain such recalls were accompanied by a ``do
not drive'' advisory), others involved a variety of components and
other potential consequences: sun visors that may detach (may distract
or obstruct view); aluminum siding that may detach from a trailer;
incorrectly assembled door latches that may allow the door to open
unexpectedly during operation; incorrectly installed headlights
(reducing visibility); and detached rearview mirror lenses (reducing
visibility).\143\ When viewed broadly against the backdrop of the
hundreds of recalls issued each year for various types of components
and attendant consequences, the severity of an inflator rupture--where
the consequence of the defect is the projection of shrapnel into the
occupant compartment--is extreme. The latent nature of the defect
further exacerbates its severity. This defect cannot be discerned by a
diligent vehicle owner or even as the result of an inspection. The
defect only becomes apparent upon a deployment but, by then, the danger
has already manifested. As a result, this defect provides no
opportunity for a driver to take any mitigating actions absent a
recall--either ahead of manifestation of the defect, or when the defect
manifests.
---------------------------------------------------------------------------
\142\ NHTSA 2023 Annual Report: Safety Recalls (Mar. 2024),
available at <a href="https://www.nhtsa.gov/sites/nhtsa.gov/files/2024-03/NHTSA-2023-Annual-Recalls-Report_0.pdf">https://www.nhtsa.gov/sites/nhtsa.gov/files/2024-03/NHTSA-2023-Annual-Recalls-Report_0.pdf</a>. ``Uninfluenced'' recalls are
recalls issued by a manufacturer not influenced by NHTSA
investigation into the issue.
\143\ See NHTSA Recall Dashboard, <a href="https://datahub.transportation.gov/Automobiles/NHTSA-Recalls-by-Manufacturer/mu99-t4jn">https://datahub.transportation.gov/Automobiles/NHTSA-Recalls-by-Manufacturer/mu99-t4jn</a>; Recall Nos. 23V-781, 23V-612, 23V-373, 23V-
650, 23V-856. The recall dashboard is a user-friendly platform that
can be used to sort, filter, visualize, and export recall data.
---------------------------------------------------------------------------
The air bag inflator industry itself has long recognized the
severity of the risk posed by an inflator rupture and the importance of
preventing it. The United States Council for Automotive Research
(USCAR) has published specifications establishing performance and
validation requirements for air bag inflators. These requirements
include assurance against certain behaviors in the event of an inflator
rupture, which USCAR refers to as a burst. The specifications provide a
testing procedure to confirm the structural integrity of an inflator,
instructing the tester to block any exit orifices and increase the
pressure until the inflator ruptures.\144\ This test is to ensure that
``[a]n Inflator shall not eject any components or fragments during any
portion of [design validation] and [production validation] testing.''
\145\ In the event of a rupture, any separation must be ductile and
``the inflator shall not fragment or eject any part of the structural
components.'' \146\
---------------------------------------------------------------------------
\144\ USCAR Inflator Technical Requirements and Validation at p.
30 ] 5.2.3.1 (SAE Int'l, 2023).
\145\ Id. at p. 7 ] 3.2.2.
\146\ Id at p. 7 ] 3.2.2.1.
---------------------------------------------------------------------------
ARC's own design practices similarly recognize that inflator
ruptures present an unacceptable level of risk. Similar to the USCAR
specifications described above, ARC's own internal mistake proofing
protocol acknowledged that it was critical during the Operation 50 step
of the manufacturing process to ensure that ``no vent orifice or weld
flash blockage'' occurred.\147\ This is because ARC recognized that if
those conditions exist, ``[t]he inflator can ``over pressurize and
result in parts
[[Page 63488]]
ejecting.'' \148\ ARC assigned this type of over pressurization and
rupture an FMEA severity number of 10 out of 10--the highest level of
severity of all risks in ARC's FMEA. Any inflators in which such
blockage occurred were to be ``manually scrapped'' and prompt a
supervisor notification. As these materials illustrate, at the design
and manufacturing planning stages, ARC expected a strict lack of
tolerance for conditions that created a risk of ruptures, out of
concern for the precise dangers at issue in this proceeding.
---------------------------------------------------------------------------
\147\ See ARC Response to Requests 2 & 3 of NHTSA Aug. 25, 2015
IR Letter at p. 40.
\148\ Id.
---------------------------------------------------------------------------
As previously discussed in section II.A.6, manufacturers in the
instant case have also recognized the severity of the defective
inflators in several ways. A single rupture was enough to prompt BMW,
GM, and Volkswagen to issue recalls.\149\ Some manufacturers engaged
private research firms to try to better understand the defect.\150\ In
an effort to eliminate this severe risk from future inflators with the
same design as the subject inflators, ARC implemented the automated
borescope on all of its toroidal air bag inflator manufacturing
lines.\151\ Going a step further, ARC has taken steps to remove the
potential for this defect and the associated risk by considering other
inflator designs.\152\ All of these actions underscore the commonsense
recognition that a piece of equipment intended to protect people from
injury and save lives that, instead, explodes and propels metal toward
vehicle occupants presents an unreasonable risk to motor vehicle
safety.
---------------------------------------------------------------------------
\149\ See Defect Notices, NHTSA Recall Nos. 17V-189, <a href="https://static.bnhtsa.gov/odi/rcl/2017/RCLRPT-17V189-8204.PDF">https://static.bnhtsa.gov/odi/rcl/2017/RCLRPT-17V189-8204.PDF</a> (``The root
cause has not yet been determined and is still under
investigation.''); 19V-019, <a href="https://static.nhtsa.gov/odi/rcl/2019/RCLRPT-19V019-2023.PDF">https://static.nhtsa.gov/odi/rcl/2019/RCLRPT-19V019-2023.PDF</a> (providing no response (``NR'') as to the
description of the cause); 21V-782, <a href="https://static.bnhtsa.gov/odi/rcl/2021/RCLRPT-21V782-3621.PDF">https://static.bnhtsa.gov/odi/rcl/2021/RCLRPT-21V782-3621.PDF</a> (providing no response (``NR'') as
to the description of the cause); 22E-040, <a href="https://static.nhtsa.gov/odi/rcl/2022/RCLRPT-22E040-9723.PDF">https://static.nhtsa.gov/odi/rcl/2022/RCLRPT-22E040-9723.PDF</a> (``GM's investigation has not
identified the specific root cause of the LAT rupture''); 22V-246,
<a href="https://static.bnhtsa.gov/odi/rcl/2022/RCLRPT-22V246-3538.PDF">https://static.bnhtsa.gov/odi/rcl/2022/RCLRPT-22V246-3538.PDF</a>
(providing no response (``NR'') as to the description of the cause);
22V-543, <a href="https://static.nhtsa.gov/odi/rcl/2022/RCLRPT-22V543-3225.pdf">https://static.nhtsa.gov/odi/rcl/2022/RCLRPT-22V543-3225.pdf</a> (``The root cause is currently unknown . . . .''). Even in
GM's most recent ARC-related recall, which it no longer sought to
limit to a specific production lot, it indicated as to cause that
``GM is continuing its investigation into this incident.'' See
<a href="https://static.bnhtsa.gov/odi/rcl/2023/RCLRPT-23V334-3445.PDF">https://static.bnhtsa.gov/odi/rcl/2023/RCLRPT-23V334-3445.PDF</a>.
\150\ See Northrop Grumman Presentation dated May 5, 2023 on GM
ARC Inflator Investigation; Memorandum--Meeting with HMA with
Enclosure, Docket No. NHTSA-2023-0038, <a href="https://www.regulations.gov/document/NHTSA-2023-0038-0029">https://www.regulations.gov/document/NHTSA-2023-0038-0029</a>.
\151\ See ARC Working Group 8D Technical Closure Statement at p.
1.
\152\ See U.S. Pat. App. Pub. No. 2022/0185224 A1 to Rose et
al., at ]] 0005-06.
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Some commenters contended that the ``commonsense'' approach to the
assessment of unreasonable risk requires a cost consideration, and that
NHTSA did not consider costs in issuing its decision. This contention
is essentially based on language in Wheels, in which the U.S. Court of
Appeals for the D.C. Circuit discussed an approach to safety in the
context of defects--specifically, a `` 'commonsense' balancing of
safety benefits and economic cost'' that recognizes that
``manufacturers are not required to design vehicles or components that
never fail.'' The court stated that ``[i]t would appear economically,
if not technologically, infeasible for manufacturers to use tires that
do not wear out, lights that never burn out, and brakes that do not
need adjusting or relining. Such parts cannot reasonably be termed
defective if they fail because of age and wear.'' Wheels, 518 F.2d at
435-36.
The subject air bag inflators are not the type of ``wear and tear''
component to which the cost consideration described in Wheels would be
apposite. Similar to the defective component in Carburetors, ``[h]ere
we do not deal with a part which is subject to failure because of age
and wear, or a part which drivers reasonably expect to have to check
and replace because of the particular problem involved.'' Carburetors,
565 F.2d at 759-60. The inflator industry already designs inflators
never to rupture. In any case, by requiring a recall of the subject
inflators, the agency is not requiring manufacturers to produce
``perfect, accident-free vehicles at any expense.'' See Carburetors,
565 F.2d at 760. Rather, it is requiring the notification of owners
about these inflators ``which did not, from the beginning, meet the
manufacturer's own standards.'' See id. at 760.
2. Future Inflator Ruptures Are Expected
As the agency observed in its September 2023 initial decision, new
ruptures have occurred outside of the sub-populations of vehicles
previously recalled, and it is expected that additional ruptures will
occur in the future. See Carburetors, 565 F.2d at 758 (``[W]here a
defect--a term used in the sense of an `error or mistake'--has been
established in a motor vehicle, and where this defect results in
hazards as potentially dangerous as a sudden engine fire, and where
there is no dispute that at least some such hazards, in this case
fires, can definitely be expected to occur in the future, then the
defect must be viewed as one `related to motor vehicle safety.' '')
(footnotes omitted). However, just as the agency (and manufacturers)
could not have predicted the vehicles in which ruptures have already
occurred, nor can it predict the vehicles in which ruptures will occur
for vehicles that remain equipped with subject inflators. Each of those
inflators remains at risk. What is predictable is that the consequences
of a rupture will be severe and possibly deadly. Thus, even though the
risk of any individual inflator rupturing is low, it is nevertheless
unreasonable. ``The purpose of the Safety Act . . . is not to protect
individuals from risks associated with defective vehicles only after
serious injuries have already occurred; it is to prevent serious
injuries stemming from established defects before they occur.'' Id. at
759.
NHTSA is supplementing its statistical evaluation of the rupture
risk of the subject inflators as a result of several adjustments made
since the initial decision and partially as informed by the comments
received.\153\ Upon additional analysis, NHTSA finds that the subject
inflators have a higher risk of rupture than initially believed, based
on a lowered estimate of the number of subject inflators that have
previously deployed in the field. NHTSA's estimate is based on
38,480,407 vehicles that have subject inflators in the driver-side air
bag only, 8,992,543 vehicles that have subject inflators in the
passenger-side air bag only, and 1,873,066 vehicles that have subject
inflators in both driver- and passenger-side air bags, totaling
approximately 49 million vehicles. NHTSA now estimates that 1,349,802
of the subject air bag inflators (combined driver-side and passenger-
side) deployed in vehicles between 2000 and 2023.\154\ Based on the
known field ruptures, the rupture rate of the subject inflators is
therefore 7 out of 1,349,802. In other words, the risk of any subject
inflator rupturing when commanded to deploy was and is 1 in
192,829.\155\ NHTSA is adding to the docket a report more fully
explaining its statistical considerations and findings. See NHTSA,
Estimating the Rupture Rate and Projecting Future Ruptures for
[[Page 63489]]
Subject Inflators in NHTSA's Proceeding Related to EA16-003.
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\153\ Changes include applying different deployment rates to
driver- and passenger-side inflators based on historical crash data,
refining the classification of vehicles for purposes of accounting
for attrition, and accounting for vehicles being driven fewer miles
as they age. These changes address a number of comments directed at
this analysis.
\154\ NHTSA previously estimated that approximately 2,600,000 of
the subject air bag inflators had deployed in the field.
\155\ This is an increase from the prior estimate of 7 in 2.6
million (or 1 in 371,429).
---------------------------------------------------------------------------
NHTSA does not conduct statistical analyses as a matter of course
in every defect investigation. Nor was a statistical analysis strictly
necessary here--particularly given that the unreasonable risk here is
self-evident and one of ``common sense.'' The analysis was initiated in
response to a statement by ARC. In its response to the agency's recall
request letter, ARC asserted that seven ruptures as compared to the
total subject inflator population was insufficient to determine that a
defect exists in the subject inflator population.\156\ However, a
rupture only occurs if the air bag deploys. As such, it is more
appropriate and accurate to compare the number of past field ruptures
to the number of past field deployments to determine the rate at which
the subject inflators have ruptured. Determining an estimated number of
past field deployments required statistical calculations, which yielded
the initial analysis. NHTSA disagrees with General Motors'
characterization of NHTSA's reliance on that statistical analysis as
``heavy.'' Indeed, the analysis was previously addressed in just a few
sentences of NHTSA's September 2023 initial decision.\157\ The
statistical analysis, now updated, is not a prediction of the future.
It is, rather, additional information that supplements the agency's
ordinary consideration of what constitutes an unreasonable risk,
including engineering and investigative evidence. Although it supports
NHTSA's conclusion, the statistical analysis was not necessary to
NHTSA's September 2023 initial decision. That remains the case here as
well.\158\
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\156\ ARC's May 11, 2023 Response to NHTSA's Recall Request
Letter, p. 2, <a href="https://static.nhtsa.gov/odi/inv/2016/INRR-EA16003-90616.pdf">https://static.nhtsa.gov/odi/inv/2016/INRR-EA16003-90616.pdf</a>.
\157\ A NHTSA statistician also further explained her work, in
the interest of transparency, at the October 2023 public meeting.
\158\ GM asserted that NHTSA's statistical analysis is
inconsistent with the agency's previous rejection of an earlier,
separate statistical analysis (which GM characterizes as a ``much
more sophisticated predictive model'') in a previously submitted
petition for inconsequentiality. See 85 FR 76159 (Nov. 27, 2020)
(decision on petition). The statistical analysis that GM provided in
its previous inconsequentiality petition was submitted to support
the argument that the defect in an air bag inflator (i.e., an air
bag inflator in which a defect had already been determined to exist)
was, nonetheless, inconsequential to motor vehicle safety as
installed in GM vehicles.
---------------------------------------------------------------------------
While NHTSA's updated statistical analysis confirms the commonsense
understanding that inflator ruptures will continue to be rare, the
severity of rupture renders that risk unacceptable under the Safety
Act. Unsurprisingly, the manufacturers who have continued to dispute
the need for a broader recall disagree that the risk is unreasonable. A
number of commenters challenged the persuasiveness of the future
rupture risk, asserting that the estimated number of future ruptures is
too low to present an unreasonable risk to motor vehicle safety.
Comments emphasizing the low number of expected future ruptures are
unconvincing. Up to this point, the subject inflators have ruptured
rarely, and yet they have still injured or killed at least eight people
in the United States. The evidence is sufficient for the agency to find
that the rare, though expected, occurrence of future rupture is
unreasonable given the severity. Under the plain language of the Safety
Act, such a severe, undetectable, and unpredictable risk of an inflator
rupturing and sending shrapnel at high speed into the occupant
compartment of a vehicle is ``unreasonable.'' Even a ``negligible''
number of future ruptures is unreasonable given that a foreseeable
outcome is severe injury or death. See Carburetors, 565 F.2d 754 at
759; Pitman Arms, 561 F.2d at 924.
While an inflator rupture occurs if the inflator has been commanded
to deploy in a crash, several commenters nevertheless asserted that the
relevant population of inflators from which to derive a rupture rate
should be the entire subject inflator population (51 million, rather
than the number of inflators estimated to have actually deployed). The
reasons were varied, including that all inflators have the same
potential to undergo deployment and rupture in a crash, that use of the
entire population best accounts for both the risk of a deployment and
the risk of a rupture and, as commented by ARC, ``permits a more
accurate comparison to peer inflator data and more appropriately
compares the risk to comparable peer populations.'' \159\
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\159\ Written Response of ARC Automotive, Inc. to the September
5, 2023, Initial Decision (Dec. 18, 2023 (Corrected--February 12,
2024), at p. 23. ARC also asserted that such an approach would be
based on two directly observable inputs (number of inflators and
known field events) instead of one (number of field events) with a
separate estimated input (deployments). See id. at p. 22. Whether an
input is ``directly observable'' has little import in determining
appropriate variables to use as a statistical matter in developing
risk assessments. While the total inflator population may be more
accurately estimated, that does not render it the more appropriate
metric.
---------------------------------------------------------------------------
NHTSA agrees that, in the event of a deployment, each of the
subject inflators is equally at risk of rupture. None can be eliminated
as not at risk, and it is not possible to know whether a particular
inflator will rupture unless a deployment occurs. But a deployment is a
necessary condition for a failure, and the vast majority of inflators
have not deployed. Including the entire population of manufactured
inflators in deriving a rupture rate--knowing that the overwhelming
majority have not deployed--vastly understates the prevalence of the
defect by ignoring the necessary condition for a failure. This would
lead to a vast understatement of the true rupture rate and predicted
future ruptures. For this reason, it is wholly appropriate to ground
the predicted future rupture rate with reference to ruptures
experienced in past deployments, and not to the total number of
manufactured inflators.\160\
---------------------------------------------------------------------------
\160\ General Motors refers to a previous investigation
regarding Mini Cooper S exhaust pipe tips in which the total
population was used to refer to a failure rate. The product at issue
there, however, did not involve a necessary condition like a
deployment of the subject air bags for the defect to manifest. And
notably, in previously evaluating certain statistical analyses in a
General Motors inconsequentiality petition regarding Takata air bag
inflators, NHTSA described the risk at issue in terms consistent
with that here. See 85 FR 76159 (Nov. 27, 2020) (describing the
fleet-level risk as ``the probability that at least one air bag will
rupture among the thousands of air bag deployments expected to occur
in the nearly 5.9 million affected GMT900 vehicles over the coming
years'').
---------------------------------------------------------------------------
The notion that the total population of inflators allows for better
peer comparison is also unconvincing. As explained above in II.A.4,
there has been only one U.S. rupture of a non-Takata air bag inflator
(other than an ARC air bag inflator), and any reference to the
comparative rupture rates is of limited import, because that inflator
was recalled after the first rupture. Therefore, it is unknown whether
ruptures would have continued to occur in the absence of a recall. As
is the case here, NHTSA believed the risk was unreasonable and a recall
was warranted. The severity of inflator ruptures was also evident
there, as the rupture resulted in a fatality. In that case, however,
the manufacturer agreed to broad recalls of entire models (all model
years) of vehicles that used the same type of inflator without the need
for the agency to exercise its statutory authority to order a
recall.\161\
---------------------------------------------------------------------------
\161\ See NHTSA Recall Nos. 20V-681, 21V-766, and 21V-800.
---------------------------------------------------------------------------
Some commenters asserted that NHTSA improperly assumed that
manufacturing variables in different variants of the subject inflators
have no impact on the rupture rate. However, there is no evidence-based
justification for treating any subpopulation of the subject inflators
as presenting more or less risk. FCA stated that certain field ruptures
should not be included in the analysis--the ruptures in the MY 2002
Chrysler Town & Country and the MY
[[Page 63490]]
2011 Chevrolet Malibu--because of these incidents did not have an
underlying cause or failure mode in common with the other
ruptures.\162\ NHTSA does not agree that these incidents lack
sufficient commonality to be considered, as described in section II.A.
Additionally, as previously explained, root cause is not necessary for
a defect determination. It is not appropriate to eliminate any of the
ruptures in vehicles--the very incidents where people have already been
harmed--from its evaluation of whether there is an unreasonable risk.
---------------------------------------------------------------------------
\162\ See Comments of FCA US LLC Regarding Initial Decision at
pp. 5-6.
---------------------------------------------------------------------------
Consumer safety ``would be most ill served by extending [a] delay
based on new predictions that the number of injuries caused by the
defect will diminish.'' Carburetors, 565 F.2d at 759. The agency also
does not believe that logistical and cost-related concerns raised by
commenters about a recall of the subject inflators warrants leaving the
unreasonable risk unaddressed by a recall. NHTSA acknowledges the
potential ramifications of a recall of this magnitude and does not take
its decision lightly. However, the crux of this issue is not a variety
of potential (or even attenuated or largely hypothetical)
reverberations stemming from a recall--it is that there is defect in
the subject inflators that presents an unreasonable risk of death or
injury in the event of a crash, and that defect must be addressed.
Every subject inflator that deploys is at risk of rupture, and
rupture events are unpredictable and dangerous. Three of the seven
field ruptures in the United States occurred between 2009 and 2017, and
three more field ruptures occurred in the span of just over four months
in 2021. The last field rupture occurred very recently, in 2023. While
it is impossible to predict when the next rupture will occur, each
inflator that deploys is at risk. NHTSA's statistical evaluation of the
future rupture risk, while not imperative to its decision here,
reinforces that field ruptures are expected to occur in the future, and
any hopes premised simply on the relatively low odds of an inflator
rupturing are insufficient to warrant inaction. Cf. Carburetors, 565
F.2d at 759 (``[T]he fact that in past reported cases good luck and
swift reactions have prevented many serious injuries does not mean that
luck will continue to work in favor of passengers of burning cars. As a
matter of statistics their chances may well . . . appear quite
favorable. The purpose of the Safety Act, however, is not to protect
individuals from the risks associated with defective vehicles only
after serious injuries have already occurred; it is to prevent serious
injuries stemming from established defects before they occur.''). With
each subject inflator that deploys, the vehicle occupants are at risk
of severe injury or death from a rupture. That risk is plainly
unreasonable under the Safety Act.
III. Conclusion
Every field rupture of the subject inflators in the United States
has resulted in at least one vehicle occupant being injured, several
have resulted in severe injury, and one has resulted in death. Seven of
the subject inflators have already ruptured in vehicles the United
States. The facts and circumstances surrounding these U.S. field
ruptures, the four foreign field ruptures, and the twenty-three lot
acceptance test ruptures underscore the severe impact of the defect on
motor vehicle safety. Based on its comprehensive analysis, NHTSA has
concluded that the evidence shows that the causes of these ruptures
stem from use of a friction welding process without adequate inspection
safeguards in place and that all of the subject inflators were produced
using this same process. As such, all of the subject inflators have a
risk of rupture and are defective. The pattern and evidence of these
ruptures confirms that the reactionary, limited-scope recalls are
insufficient to address the safety risk and that a recall for the full
subject inflator population is necessary. Given the severity of a
rupture and the known ruptures there is ample evidence of a defect in
the subject inflators. Common sense demands acknowledging that metal
shrapnel projecting at high speeds and causing injury or death presents
an unreasonable risk to safety, and the Safety Act does not allow for
such a risk to remain unaddressed.
Pursuant to the Safety Act, NHTSA may make a final decision ``only
after giving the manufacturer[s] an opportunity to present information,
views, and arguments showing that there is no defect or noncompliance
or that the defect does not affect motor vehicle safety. Any interested
person also shall be given an opportunity to present information,
views, and arguments.'' 49 U.S.C. 30118(b)(1). Given the more extensive
detail and discussion of the technical issues in this notice, and to
ensure opportunity for additional public feedback, NHTSA is providing
an additional 30-day comment period. No additional public meeting will
be held.
If NHTSA makes a final decision that the subject inflators contain
a safety defect, NHTSA will order ARC to comply with the obligation to
file notice of the safety defect with the agency and will order the
vehicle manufacturers to carry out recalls by providing notice and a
free remedy. See id. section 30118(b)(2).
Authority: 49 U.S.C. 30118(a), (b); 49 CFR 554.10; delegations of
authority at 49 CFR 1.50(a) and 49 CFR 501.8.
Eileen Sullivan,
Associate Administrator for Enforcement.
[FR Doc. 2024-17251 Filed 8-2-24; 8:45 am]
BILLING CODE 4910-59-P
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