Federal Motor Vehicle Safety Standards; Occupant Crash Protection |
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Topics: Federal Motor Vehicle Safety Standards
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Raymond R. Posten
National Highway Traffic Safety Administration
6 April 2016
[Federal Register Volume 81, Number 66 (Wednesday, April 6, 2016)]
[Proposed Rules]
[Pages 19944-19950]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-07827]
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DEPARTMENT OF TRANSPORTATION
National Highway Traffic Safety Administration
49 CFR Part 571
[Docket No. NHTSA-2016-0021]
Federal Motor Vehicle Safety Standards; Occupant Crash Protection
AGENCY: National Highway Traffic Safety Administration (NHTSA), DOT.
ACTION: Denial of petition for rulemaking.
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SUMMARY: This document denies a rulemaking petition submitted by Mr.
James E. Hofferberth on April 1, 2013. His petition includes two
requests: (1) To regulate the performance of supplementary automotive
restraint systems that are marketed specifically for pregnant women;
and (2) to require prominent warning labels in all vehicles with the
intent of informing pregnant women that ``seat belts could injure or
kill their unborn child,'' specifically by crushing the unborn baby in
a frontal crash. NHTSA is denying the petition to regulate the
performance of these systems because the agency does not have
sufficient information at this time to state whether there is an
additional net safety benefit/disbenefit to be derived from their use
or whether one type of device is superior to another. NHTSA is denying
the petition for labeling because this would provide advice that, if
followed, would threaten the safety of both the mother and the unborn
child in a crash.
FOR FURTHER INFORMATION CONTACT:
[[Page 19945]]
For Non-Legal Issues: Mr. Louis Molino, Office of Crashworthiness
Standards, National Highway Traffic Safety Administration, 1200 New
Jersey Avenue SE., Washington, DC 20590, Telephone: (202) 366-1740,
Facsimile: (202) 493-2990.
For Legal Issues: Mr. John D. Piazza, Office of Chief Counsel,
National Highway Traffic Safety Administration, 1200 New Jersey Avenue
SE., Washington, DC 20590, Telephone: (202) 366-2992, Facsimile: (202)
366-3820.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background
A. Past Petition for Rulemaking
B. Agency Position: Pregnant Women Should Wear Their Seat Belts
C. Pregnant Women in Motor Vehicle Crashes
1. Past Studies
2. Available Field Data
(a) Data Sources
(b) NASS CDS Data
(c) NHTSA Case Studies
II. Current Petition
III. NHTSA's Consideration of the Petition
A. General Principles
B. Analysis of the Petition
IV. Future Plans
V. Conclusion
I. Background
In a letter dated April 1, 2013, Mr. James E. Hofferberth
petitioned NHTSA to regulate the performance of supplementary
automotive restraint systems for pregnant women and to also require
prominent warning labels in all vehicles with the intent of informing
pregnant women that ``seat belts could injure or kill their unborn
child.'' This is the petitioner's second request for rulemaking
regarding the safety of seat belts for pregnant women.
A. Past Petition for Rulemaking
In 2005, NHTSA received a petition for rulemaking from this same
petitioner, Mr. James E. Hofferberth, requesting that the agency
initiate rulemaking to require an advisory placard warning occupants
that seat belts should not be worn by pregnant women. On March 23,
2006, NHTSA published a Federal Register notice (71 FR 14675) denying
that petition because the requested warning label would provide advice
that, if followed, would threaten the safety of both the mother and the
unborn child in a crash.
B. Agency Position: Pregnant Women Should Wear Their Seat Belts
NHTSA recommends that pregnant women wear their seat belts, as does
the American College of Obstetricians and Gynecologists (ACOG).\1\
NHTSA publishes a flyer \2\ developed in conjunction with ACOG and the
National Healthy Babies Coalition that addresses this topic. The flyer
describes the proper way for a pregnant woman to position her seat and
to wear both the shoulder and lap belt portion of her seat belt, and it
also explains that pregnant women should wear their seat belts even in
vehicles equipped with air bags.
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\1\ American College of Obstetricians and Gynecologists. ``Car
Safety for You and Your Baby, Frequently Asked Questions: FAQ018,
Pregnancy,'' August 2011, http://www.acog.org/~/media/
For%20Patients/faq018.pdf?dmc=1&ts=20130603T1624145840.
\2\ NHTSA, The Pregnant Woman's Guide to Buckling Up, Your Top 5
Seat Belt Questions Answered, March 2010, http://www.trafficsafetymarketing.gov/newtsm/tk-bua/PregnantWomenSeatBeltFlyer.pdf.
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The safety benefits to pregnant women from wearing seat belts are
supported by a research study,\3\ which concluded that ``[p]roper
restraint use, with and without air bag deployment, generally leads to
acceptable fetal outcomes in lower severity crashes, while it does not
affect fetal outcome in high-severity crashes.'' The study concluded
that ``compared to properly restrained pregnant occupants, improperly
restrained occupants have a higher risk of adverse fetal outcome in
lower severity crashes.'' It is also recommended that all pregnant
women seek medical attention after a car crash regardless of the
severity of maternal injury. NHTSA and other experts agree that the
best way to protect an unborn child is to protect the mother.\4\
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\3\ Klinich, K. D., Schneidier, L. W., Moore, J. L., Pearlman,
M. D., entitled ``Investigations of Crashes Involving Pregnant
Occupants,'' dated 1999. This work was supported by General Motors
Corporation, pursuant to an agreement with the U.S. Department of
Transportation.
\4\ Duma, S., Moorcroft, D., Stitzel, J., Duma, G., entitled ``A
Computational Model of the Pregnant Occupant: Effects of Restraint
Usage and Occupant Position in Fetal Injury Risk,'' published June
2005 in the Proceedings of the 19th International Technical
Conference on the Enhanced Safety of Vehicles.
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C. Pregnant Women in Motor Vehicle Crashes
The agency conducted an extensive review in its analysis of the
petition. This included a review of technical literature, including a
study by the University of Michigan Transportation Research Institute
(UMTRI), as well as the papers cited by the petitioner. The agency also
conducted a full review of the NHTSA field data repositories for
evidence of supplementary automotive restraints causing harm to
pregnant women in motor vehicle crashes (MVCs). The agency's findings
are provided in the following sections of this notice, and they
reaffirm the position stated in the 2006 denial notice.
1. Past Studies
NHTSA has sponsored research studying and demonstrating the
effectiveness of properly adjusted restraint systems for pregnant women
from as early as 1971,\5\ when seat belts composed of both a lap and
shoulder portion were not as prevalent as they are today. Other
research, independent of NHTSA, has also been conducted, and both
biomedical research and restraint technologies have advanced over time.
For example, a 1998 paper written by researchers at UMTRI explains that
the unborn baby is protected by amniotic fluid, which isolates the
unborn baby by acting as a shock absorber.\6\ This amniotic fluid is
what naturally resists the forces from the lap portion of a seat belt,
and it prevents the belt from penetrating through the unborn baby's
body. Mr. Hofferberth's petition claims that the belt penetrates
through the unborn baby's body.
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\5\ King, A. I., Crosby, W. M., Stout, L. C., Eppinger, R. H.,
entitled ``Effects of Lap Belt and Three-Point Restraints on
Pregnant Baboons Subjected to Deceleration,'' published in 1971 in
the 15th Stapp Crash Conference Proceedings and the Society of
Automotive Engineers as paper #710850.
\6\ Klinich, K. D., Schneidier, L. W., Moore, J. L., Pearlman,
M. D., entitled ``Injuries to Pregnant Occupants in Automotive
Crashes,'' published October 1998 in the 42nd Annual Proceedings of
the Association for the Advancement of Automotive Medicine.
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More recently, a 2008 paper written by these same researchers at
UMTRI \7\ summarized a study in which in-depth investigations of MVCs
involving pregnant women were conducted, with a focus on determining
how restraint conditions and specific crash characteristics had
affected the outcome of the unborn baby. Studies conducted up to this
point generally did not include complete and accurate information about
crash severity and restraint use, or they emphasized crashes with
adverse outcomes for the unborn babies in order to illustrate unusual
and/or severe injuries. By including crashes with both positive and
adverse outcomes for the unborn baby and also studying both belted and
unbelted pregnant women, this study provided medical practitioners and
safety engineers more of a comprehensive, quantitative analysis for
giving advice to pregnant women and
[[Page 19946]]
improving the design of vehicle restraints.
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\7\ Klinich, K. D., Flannagan, C. A., Rupp, J. D., et al,
entitled, ``Fetal outcome in motor-vehicle crashes: effects of crash
characteristics and maternal restraint,'' published April 2008 in
the American Journal of Obstetrics & Gynecology.
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The 57 investigated cases all involved women of at least 20 weeks
gestation who were involved in a motor vehicle crash that was not a
rollover and who agreed to participate. Natural spontaneous pregnancy
loss before 20 weeks of gestation being not uncommon, which made
association of fetal loss so early in pregnancy with an MVC
questionable, and the difficulty in determining injury causation to
occupants during a rollover event \8\ resulted in cases with these two
factors being excluded. Case subject interviews and examinations of
physical evidence were used to determine seat belt use, and estimated
change in velocity (delta-V) from a crash reconstruction program was
used to determine crash severity. The outcome of the unborn baby was
studied for a period of one month after the crash took place, and these
outcomes were classified as either good, minor complications, major
complications, or fetal loss. Injuries to the mothers were classified
using the Injury Severity Score (ISS), excluding injuries to the
placenta or uterus, and these scores were used to classify the mothers'
injuries as either nonexistent, minor, moderate, or major. Maternal
death was also tracked, regardless of the mother's ISS. Restraints were
classified as either proper (3-point belt or 3-point belt plus air bag)
or improper (unrestrained, air bag only, and shoulder belt only with
air bag, and shoulder belt only without air bag).\9\
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\8\ Excluding rollover events may have created a slight bias in
the database. The paper states that ``. . . rollovers account for
only 2 percent of all crashes annually in the United States. The
effect of this exclusion is therefore expected to have minimal
impact on the study findings.''
\9\ None of the maternal occupants in the cases studied wore
only a lap belt.
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The database created by this study became the largest collection of
MVCs involving pregnant women including detailed quantitative
information about both the crash event and the outcome for the unborn
baby, with a focus on crashes with both positive and negative fetal
outcomes. The seat belt usage rate in the database was reported as 72
percent,\10\ and the study results showed a positive effect on fetal
outcome from the mother's proper use of a seat belt during a crash. The
statistical risk curves from this study's data analysis ``indicate[d]
that an 84 percent reduction in risk of adverse fetal outcome is
obtained by properly wearing a seatbelt. On the basis of this relative
risk and an overall belt use rate of 80 percent, unbelted pregnant
women sustain an estimated 62 percent of all fetal losses in motor
vehicle crashes . . . Crash severity is the factor most strongly
associated with fetal outcome . . . Claims that restraints cause
adverse fetal outcomes cannot be substantiated without reliable
information on crash severity . . . [M]aternal injury is predictive of
fetal outcome, and proper restraint use reduces maternal injury
severity.''
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\10\ This statistic was reported in the 2008 Klinich paper,
referring to the 2005 NHTSA report, DOT HS 810 623, Traffic Safety
Facts 2005. A more specific comparison would be the seat belt use
rate for women of likely childbearing age.
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2. Available Field Data
(a) Data Sources
To analyze the claims in the petition, the agency studied crashes
involving pregnant women in the applicable NHTSA data repositories:
Artemis,\11\ the Fatality Analysis Reporting System (FARS),\12\ the
National Automotive Sampling System (NASS) Crashworthiness Data System
(CDS),\13\ and the Special Crash Investigations (SCI) program.\14\
Artemis does not currently contain any entries related to complaints or
reported injuries resulting from the use of supplemental restraint
devices. Although FARS does capture information about fetal demise, its
fetal demise data-capturing capabilities are limited because it
utilizes the American National Standards Institute (ANSI) definition
\15\ of a person as ``any living human . . . [A] fetus is considered to
be part of a pregnant woman rather than a separate individual.'' \16\
Hence, FARS only captures information about fetal demise if someone
else involved in the crash also expired. NASS CDS and SCI cases were
also consulted for the following analysis. Though the sample of
pregnant women in NASS CDS is relatively small, it is an appropriate
and applicable source of data to explore the crash risks for this
cohort because it is from a nationally representative sample.\17\ SCI
cases are intended to provide an engineering perspective on anecdotal
data, examining special crash circumstances or outcomes. As discussed
below, an examination of NASS CDS and SCI data reaffirmed NHTSA's
current position that pregnant women should wear a seat belt.
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\11\ Artemis is the agency's repository of motor vehicle and
motor vehicle equipment defects. It contains consumer complaints and
manufacturer early warning and reporting information, recalls, and
safety defect investigations.
\12\ FARS is a census of fatal motor vehicle crashes from 1975
to the present from the fifty States, the District of Columbia, and
Puerto Rico. To qualify as a FARS case, the death of either a non-
motorist or a motorist must occur within 30 days of the crash and
the vehicle must be traveling on a trafficway customarily open to
the public.
\13\ NASS CDS is a database containing a probability sample of
all police reported crashes in the U.S. Cases are chosen from all
police reported crashes involving a harmful event (property damage
and/or personal injury) resulting from a crash and involving at
least one towed passenger car, light truck, or van in transport on a
trafficway.
\14\ SCI cases are selective, highly detailed and in-depth crash
investigations using data from police and insurance reports as well
as medical records, site and vehicle inspections, and interviews.
\15\ DOT HS 811 694, 2011 Fatality Analysis Reporting System
(FARS) and National Automotive Sampling System (NASS) General
Estimates System (GES) Coding and Validation Manual, Page 5, Section
103.1, published 2012.
\16\ Section 2.1.1 of standard ANSI D16.1-2007, the Manual on
Classification of Motor Vehicle Traffic Accidents, Seventh Edition,
prepared by the D16 Committee on Classification of Motor Vehicle
Traffic Accidents under the direction of the Association of
Transportation Safety Information Professionals of the National
Safety Council Highway Traffic Safety Section and approved on August
2, 2007 by the American National Standards Institute, Inc. Board of
Standards Review.
\17\ In 2009, NASS CDS started collecting only partial occupant
assessment records and no occupant injury records for vehicles more
than 10 model years old. Information about occupant seat belt usage,
a woman's pregnancy and the status of a fetus comes solely from a
police report for these vehicles more than 10 model years old, and
typically police reports subscribe to Section 2.1.1 of standard ANSI
D16.1-2007 in regards to the fetus being considered an occupant.
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(b) NASS CDS Data
NASS CDS started tracking fetal demise in 2006. The sampling is
designed in such a way that it is possible to use the data to compute
estimates representative of the entire country through application of a
multiplier (case weight) to each NASS CDS case.\18\ During this six-
year time period there was a weighted estimate of 18,859,898 occupants
of passenger vehicles involved in crashes qualifying as NASS CDS cases
across the United States. Of these occupants, 0.6 percent [112,341/
18,859,898] were pregnant women. The maternal fatality rate for this
data set was 0.22 percent [245/112,341]. Where seat belt use was known,
85.0 percent of the pregnant women were reportedly wearing a seat belt
and 15.0 percent were not.\19\ Of the pregnant women reported to be
wearing a seat belt, 99.7 percent [87,065/87,365] did not suffer a
uterine or placental injury.
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\18\ DOT HS 811 675, National Automotive Sampling System--
Crashworthiness Data System 2011 Analytical User's Manual, Page 6,
Section 3, ``The Sampling System and Sample Design,'' published
October 2012.
\19\ The seat belt wearing status of 8.5 percent [9,533/112,341]
of the pregnant females was reported as unknown. It should also be
noted that those coded as wearing a seat belt were not necessarily
wearing the seat belt correctly.
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The weighted estimate of 112,341 pregnant women was derived from
439 unweighted cases. Twenty-four of these 439 cases were coded as
involving the death of an unborn child. However, the
[[Page 19947]]
agency believes that four of these cases were miscoded with respect to
fetal demise.\20\ In addition, one of the twenty-four cases involved a
crash for which a NASS investigator inspection of the vehicle was not
permitted due to a pending legal case.\21\ These five cases were
excluded from the data set used for the analysis, and the 19 remaining
cases correspond to a weighted estimate of 2,460 pregnant women who
lost their unborn baby following a crash. The weighted data show that
2.2 percent of pregnant women lost an unborn child after being involved
in a crash during this 6 year period, and 99.9 percent [87,251/87,365]
of those known to be wearing a seat belt did not lose an unborn child
due to a seat belt-caused uterine or placental injury.
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\20\ Cases 2007-43-199, 2008-43-24, 2009-43-188, and 2010-78-43
were flagged in the database as involving fetal demise, but they
were excluded because examination of the case files provided
convincing evidence that these were likely miscoded.
\21\ Because both vehicle occupants perished in the crash,
occupant interviews could not be conducted.
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Due to the small number of cases involving pregnant women who lost
an unborn child after a crash and variation in the NASS CDS case weight
factors applied to small numbers,\22\ the following statistics
associated with the data are provided for illustration only. The known
belt use rate \23\ for the fetal demise data set was 85.1 percent
[2,094/2,460], which is nearly identical to the known belt use rate for
the data set of 112,341 pregnant women previously described. The
maternal fatality rate was 9.1 percent [223/2,460]. This is more than
forty times the maternal fatality rate for the data set of all pregnant
women (0.22 percent). The rate of placental injury in this data set was
42.4 percent [155/366] for the unbelted pregnant women, but only 5.4
percent [114/2,094] for the belted. Placental injuries sustained by the
unbelted women were caused by contact with either the steering wheel or
the ground after ejection from the vehicle. The maternal fatality rate
for the unbelted occupants with fetal demise was 30.3 percent [111/366]
but only 5.3 percent [112/2,094] for the belted occupants. For belted
occupants, 94.6 percent [1,980/2,094] of the pregnant women who lost an
unborn child did not suffer a uterine or placental injury from the seat
belt.\24\ In other words, 94.6 percent of the time when a pregnant
woman was wearing her seat belt and her unborn baby died in an MVC, the
seat belt did not injure her uterus or placenta. Moreover, NASS CDS, a
nationally representative sample, contains few cases of fetal demise,
illustrating the rarity of this event.
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\22\ The weight factor for the remaining 19 cases ranges from
8.35 to 594.
\23\ Though all of these women did wear a seat belt, not all of
them wore their seat belts correctly with the lap belt portion snug
and low, across the hips.
\24\ Injuries to the mother not caused by a seat belt tended to
be from contact to other interior vehicle parts or from other
sources such as the striking vehicle. In some cases injury causation
could not be determined, and these cases were not included in
calculating this value.
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(c) NHTSA Case Studies
In order to be consistent with previous research in studying the
deaths of unborn babies in frontal crashes, NHTSA aligned the NASS CDS
data with that of the 2008 UMTRI study. This eliminated 18 of the 19
cases from the 2006-2011 NASS CDS dataset involving the death of an
unborn child: Eight cases \25\ because they involved pregnant women in
their first trimester, four cases \26\ because they involved a rollover
or other multi-event crash scenario, and six cases \27\ because their
principal direction of force (PDOF) did not indicate a frontal
collision.\28\ This left one case that was consistent with the UMTRI
study's criteria. In addition, the agency included one case from the
multi-event crash group in which the first event was a frontal impact
and the second event was relatively minor. These cases are discussed
below. This exercise demonstrated both the rarity of fetal demise in a
vehicle crash as well as the complex nature of injury causation for a
pregnant woman, further supporting the agency's position that pregnant
women should wear a seat belt.
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\25\ NASS CDS cases 2006-47-56, 2006-75-212, 2007-41-1, 2007-48-
128, 2007-72-119, 2008-11-21, 2008-75-5, and 2008-75-20.
\26\ NASS CDS cases 2006-12-69, 2008-09-26, 2009-74-143, and
2011-13-152.
\27\ NASS CDS cases 2006-73-35, 2006-73-106, 2007-76-25, 2008-
75-84, 2010-48-127, and 2011-49-15.
\28\ In addition to keeping an occupant inside of the vehicle
during a rollover or side impact, a seat belt also holds an occupant
into the seat during an event which would send an unrestrained
occupant forward toward the steering wheel and windshield. It is
during these forward motions that the seat belt becomes a potential
source of injury to an unborn child, and these forward occupant
motions are caused by frontal collisions where the vehicle's PDOF is
pushing the car backwards. For this assessment a case was determined
to be a frontal collision if the PDOF for the pregnant woman's
vehicle was within 45[deg] of normal to the vehicle's
frontal plane.
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Case 2006-78-71
The one NASS CDS case that matched the 2008 UMTRI study criteria
was case 2006-78-71. In this case, two vehicles were involved in a
head-on collision. The 32 year old driver of the second vehicle, a 1993
Mazda 626 equipped with air bags, was 9 months pregnant and not wearing
a seat belt. She was 150 cm tall and weighed 64 kg, with a Body Mass
Index (BMI) \29\ of 28.4. Crash reconstruction estimated the Delta-V to
be 34 km/h longitudinally, and the NASS CDS investigator noted that
there was no steering wheel rim/spoke deformation. The driver air bag
did not deploy in this crash. The driver's most severe injury was an
AIS 5 \30\ complex uterus laceration, judged to have certainly \31\
been caused by direct contact with the steering wheel. She also had an
AIS 2 minor mesentery laceration and an AIS 1 abrasion to her right
hip, both also certain to have been caused by direct contact with the
steering wheel. She was discharged from the hospital after 12 days, and
medical records confirmed the death of the unborn baby.
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\29\ Centers for Disease Control and Prevention (CDC). Healthy
Weight--it's not a diet, it's a lifestyle!. September 13, 2011.
http://www.cdc.gov/healthyweight/assessing/bmi/adult_bmi/.
\30\ An AIS 5 is the highest survivable AIS score, with an AIS 6
indicating that a particular injury was unsurvivable.
\31\ NASS CDS investigators must assign a confidence level to
all injury sources. The choices for these levels in descending order
of investigator confidence are ``Certain,'' ``Probable,''
``Possible,'' and ``Unknown.''
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Case 2008-09-26
This multi-event case from NASS CDS was also the focus of a NHTSA
SCI investigation due to the concern that placental abruption was
possibly caused by the seat belt. In this case, the vehicle containing
the 40 year old pregnant woman, a 2006 Mercedes Benz E350, collided
with a 2005 Ford Explorer Sport Trac attempting to make a left-hand
turn. Crash reconstruction estimated the pregnant woman's vehicle to
have a longitudinal Delta-V of 37 km/h. The Mercedes struck the Ford
forward of its center of gravity, causing the Ford to quickly rotate
and strike the Mercedes in a side-slap impact. The pregnant woman was
seated in the first row passenger seat and was wearing her seat belt,
though it is unknown whether the seat belt was worn correctly. She was
165 cm tall and weighed 91 kg at the time of the crash, corresponding
to a BMI of 33.4, placing her in the obese category.
The pregnant woman had 11 injuries with AIS scores ranging from 1
to 3. The most critical six were determined to have possibly resulted
from contact with the driver and the center console during the side-
slap, the most severe being an AIS 3 cerebrum subarachnoid hemorrhage.
These injuries did not occur in the uterine area, and they were not
directly related to the death of the unborn child. Injury number 7 of
11 was
[[Page 19948]]
an AIS 3 lower placental abruption,\32\ possibly caused by the belt
webbing/buckle. The only other injury to the pregnant woman's uterine
area was an abdominal skin contusion with the precise location unknown,
possibly caused by the belt webbing/buckle.
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\32\ The emergency personnel response time could not be
determined for this case, though upon arrival at the scene, it was
noted that the pregnant woman complained of head, chest, and
abdominal pain with vaginal bleeding. She was transported by ground
ambulance to a trauma center 10 miles away, where an ultrasound was
immediately conducted, and a reduced fetal heartbeat was noted. The
pregnant woman then had an emergency caesarian section, about 120
minutes post-crash, and a live 24.2 oz female baby was delivered in
critical condition and transported to the Neonatal Intensive Care
Unit (NICU). The baby died about 26 hours post-delivery due to
premature birth as a consequence of the placental abruption.
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While the crash was assigned to NHTSA's SCI team, the SCI
investigators were not able to conduct interviews or inspect the
vehicle until approximately 6 months after the crash. Though it was
certain that the pregnant woman had been wearing her seat belt,
investigators were not able to conclusively determine whether or not
she had been wearing it correctly.
II. Current Petition
Mr. Hofferberth petitions for two rulemakings. First, he requests
that the agency initiate a rulemaking for Supplementary Automotive
Restraint Systems for Pregnant Women. Second, the petitioner requests
that the agency initiate rulemaking to require the warning of pregnant
women that the seat belts could injure or kill their unborn
children.\33\ The petition includes a proposed performance
specification and validation test procedure for supplementary restraint
systems for pregnant women, including labelling, fit, position
retention, strength, and stiffness requirements, as well as a design
for a test platform. The petition also includes an unpublished report,
``Prevention of Fetal Injury in Motor Vehicle Crashes,'' written by the
petitioner.\34\ The petitioner makes a number of factual assertions and
arguments regarding his belief that the lap belt presents a significant
hazard for the unborn child of a pregnant woman.
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\33\ As explained above, and discussed in more detail below,
this is contrary to NHTSA's considered view and the available
evidence which establishes that pregnant women should wear their
seat belts.
\34\ In this report, the petitioner also states, as a
``Recommendation,'' that NHTSA should update its recommended usage
of the lap and shoulder belt by pregnant women to reflect the
petitioner's views, as well as research the petitioner cites as
supporting his views. Although this request is not a petition for
rulemaking, the agency's decision on the petition for a warning
label rulemaking is responsive to this suggestion. The petitioner
also recommends that NHTSA initiate rulemaking requiring pregnant
motor vehicle occupants to use a supplemental restraint system.
NHTSA does not have statutory authority for such a rulemaking.
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The petitioner, in both his letter and the attached report, states
his beliefs that unborn babies are in danger of being crushed by the
lap belt portion of a seat belt during a frontal collision and that
seat belts are not appropriate for use by pregnant women. He cites
research that he asserts shows that the lap belt portion of the
restraint system has been implicated in causing specific trauma to the
placenta and unborn child in relatively minor vehicular accidents. He
also cites other research that he argues shows a high rate of fetal and
placental injury and asserts that research shows that the fetus of a
pregnant woman is approximately five times more likely to receive
serious injury than a 0-1 year old child using a supplementary infant
or child restraint riding in the same car.
The petitioner also states that there are many supplementary
restraint products on the market for pregnant women, which are not all
equally effective and in some cases dangerous. The petitioner presents
depictions and makes assertions regarding the effectiveness of several
of these restraints, including a restraint which he patented.
III. NHTSA's Consideration of the Petition
A. General Principles
Motor vehicle safety standards must be practicable, meet the need
for motor vehicle safety, and be stated in objective terms. 49 U.S.C.
30111(a). Petitions for rulemaking are governed by 49 CFR part 552.
Pursuant to Part 552, the agency conducts a technical review of the
petition, which may consist of an analysis of the material submitted,
together with information already in possession of the agency. In
deciding whether to grant or deny a petition, the agency considers this
technical review as well as appropriate factors, which may include,
among others, allocation of agency resources and agency priorities.
B. Analysis of the Petition
The agency's technical review of the petition had several main
parts. First, the agency reviewed the petition and the sources it cited
before conducting a comprehensive literature review, which included
material from the early 1970s through the present. Additionally, the
agency, as described above, conducted an updated review of crash data
available from the NHTSA field databases, including NASS CDS. The
agency considered all of the information contained in the petition, and
for the reasons stated below, the agency is denying the petition.
The first part of Mr. Hofferberth's petition asks that NHTSA
regulate the performance of supplementary automotive restraint systems
for pregnant women. In assessing this aspect of the petition, NHTSA
first attempted to quantify the safety problem, i.e., whether there is
an unreasonable risk of death or injury to pregnant women or to unborn
children in a belted condition when exposed to a crash that would lead
NHTSA to propose a performance requirement for supplemental restraint
devices. The agency could not establish this through the technical
review of the submitted petition materials.
For example, the petitioner asserts that unborn babies are in
danger of being crushed by the lap belt portion of a seat belt during a
frontal collision and that seat belts are not appropriate for use by
pregnant women. However, the comprehensive UMTRI study showed that a
pregnant woman's proper use of a seat belt has a positive effect on
fetal outcome in a crash: ``an 84 percent reduction in risk of adverse
fetal outcome is obtained by properly wearing a seatbelt. On the basis
of this relative risk and an overall belt use rate of 80 percent,
unbelted pregnant occupants sustain an estimated 62 percent of all
fetal losses in motor vehicle crashes.'' In addition, the amniotic
fluid is capable of resisting the forces from the lap portion of a seat
belt, and can aid in preventing the belt from penetrating through the
unborn baby's body.
Similarly, the petitioner asserts that the lap belt portion of the
restraint system causes fetal trauma in relatively minor crashes.
However, as discussed above, a study \35\ found that ``[p]roper
restraint use, with and without air bag deployment, generally leads to
acceptable fetal outcomes in lower severity crashes,'' and went on to
conclude that ``compared to properly restrained pregnant occupants,
improperly restrained occupants have a higher risk of adverse fetal
outcome in lower severity crashes.''
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\35\ Klinich, K. D., Schneidier, L. W., Moore, J. L., Pearlman,
M. D., entitled ``Investigations of Crashes Involving Pregnant
Occupants,'' dated 1999. This work was supported by General Motors
Corporation, pursuant to an agreement with the U.S. Department of
Transportation.
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Additionally, the agency performed an updated review of crash data
available from the NHTSA field databases, including NASS CDS. Although
the petitioner asserts that
[[Page 19949]]
unborn babies are in danger of being crushed by the lap belt portion of
a seat belt and cites research that he argues shows a high rate of
fetal and placental injury, the agency found that a low percentage
(2.22 percent) of pregnant women lost their child after being exposed
to a crash. The detailed review of all fetal demise cases indicated
that all but one fell into the exclusion criteria used by UMTRI in
their field data analysis. This one case was of an unbelted woman who
sustained an AIS 5 complex uterus laceration caused by direct contact
with the steering wheel.\36\ Additional information regarding the
analysis of NHTSA data for placental injury to belted pregnant women
and the correlation of fetal mortality with higher crash severity,
illustrating the beneficial effects of seat belt use by pregnant women,
is provided above in section I.C.2. Accordingly, at this time the
analysis of the field data does not indicate a safety need to propose a
standard for supplemental restraints for pregnant women.
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\36\ Case 2008-09-26 did involve a pregnant woman who
experienced a placental abruption, but investigators were not able
to determine whether the occupant had been wearing the belt
correctly.
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With regard to establishing performance requirements for
supplemental restraints, NHTSA does not have sufficient information at
this time to state whether there is any additional net safety benefit/
disbenefit to be derived from their use or whether one type of device
is superior to another. The agency notes that these devices are
considered motor vehicle equipment, and manufacturers of these devices
are subject to the recall and remedy requirements of the Motor Vehicle
Safety Act (49 U.S.C. 30118-30120). To date NHTSA has not seen evidence
of these devices causing harm to pregnant women. Artemis, the agency's
central repository of data on motor vehicles and motor vehicle
equipment defects, does not currently contain entries related to
complaints or reported injuries resulting from the use of such devices.
Given the observed correlation between maternal and fetal outcome,
the agency believes that improvements in crashworthiness, particularly
advancements in occupant restraint systems, will serve to protect
pregnant women and their unborn children. NHTSA continues to work
towards these improvements through research efforts in the areas of
advanced restraints and improvements to the Federal motor vehicle
safety standards. The petitioner did not provide any data or testing to
support the benefits of supplemental devices or the merits of the
proposed test procedure to discriminate between good and bad
performance to serve as a basis for such a performance requirement.
The second request in the petition asks that the agency warn
pregnant women of the risk from the seat belt through a prominent
warning label required in every vehicle. As noted in the Federal
Register notice denying Mr. Hofferberth's 2005 petition to initiate
rulemaking on a similar advisory placard (71 FR 14675), the agency
disagrees with the claim that seat belts are hazardous to unborn
babies. The agency position regarding the benefits of seat belts for
both the mother and the unborn child has not changed since the
publication of the 2006 denial notice and is supported, as discussed
above, by the agency's review of the technical literature and field
data.
As noted above, the agency conducted an extensive literature review
and reviewed all sources cited by the petitioner. It is the agency's
view that this literature shows that the most effective way to protect
the unborn baby is to protect the pregnant woman. Technical studies
were discussed in the preceding sections of this notice of decision.
Additionally, the agency is not aware of any serious injuries to
pregnant women caused by seat belts in non-impact situations, and the
aforementioned 2008 Klinich paper showed that ``[c]laims that
restraints cause adverse fetal outcomes cannot be substantiated without
reliable information on crash severity.''
The agency's field data analysis shows, among other things, that
seat belt-caused uterine or placental injuries during crashes are
extremely rare (0.1 percent of cases) and that seat belt use
dramatically reduces the risk of dying in a crash for both pregnant
women and unborn children. Additional information regarding the
agency's field data analysis is provided above in section I.C.2.
Accordingly, for the reasons stated above, the petition is denied.
IV. Future Plans
A study showed that despite NHTSA recommending specific seat belt
best practices for pregnant women, approximately one quarter of the
pregnant women being studied did not follow the recommendation, and
nearly two thirds of them had not received the information.\37\ When
asked about the effects of seat belts on their unborn babies during a
motor vehicle collision, 34.0 percent of these same pregnant women were
not sure, and another 10.7 percent believed that the seat belts would
actually cause harm.\38\ A study supported by the Federal Highway
Administration reported that ``[e]ducational level is a factor
predicting seatbelt use. Among women with less than a high school
education, 41 percent did not employ seatbelt restraints as compared
with 18.8 percent who were high school graduates . . . [P]regnant women
of lower educational level and socioeconomic status are at particular
risk for failing to correctly employ seatbelts during pregnancy.'' \39\
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\37\ McGwin Jr., G., Willey, P., Ware, A., et al., entitled, ``A
Focused Educational Intervention Can Promote the Proper Application
of Seat Belts during Pregnancy,'' published May 2004 in The Journal
of Trauma Injury, Infection, and Critical Care.
\38\ McGwin, Jr., G., Russell, S., Rux, R., et al., entitled,
``Knowledge, Beliefs, and Practices Concerning Seat Belt Use During
Pregnancy,'' published March 2004 in The Journal of Trauma Injury,
Infection, and Critical Care.
\39\ Taylor, A. J., McGwin Jr., G., Sharp, C. E., et al.,
entitled, ``Seatbelt Use During Pregnancy: A Comparison of Women in
Two Prenatal Care Settings,'' published June 2005 in the Maternal
and Child Health Journal, Vol. 9, No. 2.
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Another recent study supported by the Eunice Kennedy Shriver
National Institute of Child Health and Human Development, of the
National Institutes of Health, reported that even though most pregnant
women wear seat belts, those who do are not necessarily wearing them
correctly. Additionally, this report states that despite ACOG's
recommendation that all pregnant women receive prenatal seat belt
counseling, not all women receive it. It also suggests that increased
educational efforts emphasizing not only the use of seat belts but also
their proper placement would be appropriate.\40\
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\40\ Vladutiu, C. J., Weiss, H. B., entitled, ``Motor Vehicle
Safety During Pregnancy,'' published October 2011 in the American
Journal of Lifestyle Medicine, Vol. 6, No. 3.
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The agency believes that it is very important to convey the
importance of proper seat belt use to pregnant women. As indicated by
the aforementioned studies, a large percentage of pregnant women are
not following the current recommendations; therefore, NHTSA has decided
to increase outreach efforts in this area. NHTSA currently posts the
agency's official brochure, If You are Pregnant: Seat Belt
Recommendations for Drivers and Passengers, on all official Web sites.
It is a popular download from TrafficSafetyMarketing.gov,\41\ the Web
site for all NHTSA partners to find official publicity material. To
increase the dissemination of this brochure, the agency plans to add it
to the social
[[Page 19950]]
networking outreach rotation of messages distributed through outlets
such as Facebook and Twitter, and its content has been more prominently
featured on Parents Central.\42\ Proper seat belt use and seat
positioning for pregnant women will also be the focus of an upcoming
Safety in Numbers feature on the NHTSA Web site.
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\41\ http://www.trafficsafetymarketing.gov/CAMPAIGNS/Seat+Belts/Buckle+Up+America/Thanksgiving+Weekend/Pregnant+Women's+Guide+To+Buckling+Up.
\42\ http://www.safercar.gov/parents/SeatBelts/Pregnancy-Seat-Belt-Safety.htm.
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V. Conclusion
After carefully considering the safety need for the requested
rulemaking and supporting information and in accordance with 49 CFR
part 552, NHTSA hereby denies Mr. James E. Hofferberth's April 1, 2013
petition to regulate the performance of supplementary automotive
restraint systems that are marketed specifically for pregnant women and
to require prominent warning labels in all vehicles with the intent of
informing pregnant women that ``seat belts could injure or kill their
unborn child.'' Research and real-world data show the substantial
benefits of seat belt use for both pregnant women and unborn children,
and the agency recommends that all pregnant women wear properly
adjusted seat belts.
The agency takes the safety of pregnant women very seriously and
has already begun to increase awareness and educational efforts related
to the proper use of seat belts while continuing to monitor the data
trends surrounding this issue.
In accordance with 49 CFR part 552, this concludes the agency's
review of the petition.
Authority: 49 U.S.C. 322, 30111, 30115, 30117, and 30162;
delegation of authority at 49 CFR 1.95.
Issued in Washington, DC, on: March 31, 2016 under authority
delegated in 49 CFR 1.95.
Raymond R. Posten,
Associate Administrator for Rulemaking.
[FR Doc. 2016-07827 Filed 4-5-16; 8:45 am]
BILLING CODE 4910-59-P