[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

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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