[Federal Register Volume 81, Number 66 (Wednesday, April 6, 2016)]
[Proposed Rules]
[Pages 19944-19950]
[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:

    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:<PHONE_NUMBER>,
Facsimile:<PHONE_NUMBER>.
    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:<PHONE_NUMBER>, 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

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

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

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.''
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    Additionally, the agency performed an updated review of crash data
available from the NHTSA field databases, including NASS CDS. Although
the petitioner asserts that

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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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

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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

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


[Federal Register Volume 81, Number 156 (Friday, August 12, 2016)]
[Notices]
[Pages 53530-53531]
[FR Doc No: 2016-19170]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-78501; File No. SR-ICC-2016-007]

Self-Regulatory Organizations; ICE Clear Credit LLC; Order
Approving Proposed Rule Change To Revise the ICC End-of-Day Price
Discovery Policies and Procedures

August 8, 2016

I. Introduction

    On April 22, 2016, ICE Clear Credit LLC (``ICC'') filed with the
Securities and Exchange Commission (``Commission''), pursuant to
Section 19(b)(1) of the Securities Exchange Act (``Act'') \1\ and Rule
19b-4 thereunder,\2\ a proposed rule change relating to ICC's End-of-
Day Price Discovery Policies and Procedures (the ``EOD Policy''). The
proposed rule change was published for comment in the Federal Register
on May 11, 2016.\3\ On June 23, 2016, the Commission extended the time
period in which to either approve, disapprove, or institute proceedings
to determine whether to disapprove the proposed rule change to August
9, 2016.\4\ The Commission did not receive comments on the proposed
rule change. For the reasons discussed below, the Commission is
approving the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Securities Exchange Act Release No. 34-77771 (May 5, 2016),
81 FR 29309 (May 11, 2016) (SR-ICC-2016-007).
    \4\ Securities Exchange Act Release No. 34-78144 (June 23,
2016), 81 FR 42018 (June 28, 2016) (SR-ICC-2016-007).
---------------------------------------------------------------------------

II. Description of the Proposed Rule Change

    The principal purpose of the proposed rule change is to revise the
EOD Policy to change the calculation of single name firm trade (``Firm
Trade'') notional limits to be at a Clearing Participant (``CP'')
affiliate group level.
    As part of ICC's end-of-day price discovery process, ICC CPs are
required to submit end-of-day prices for specific instruments related
to their open interest at ICC. ICC determines end-of-day levels
directly from these CP price submissions using a proprietary algorithm.
To encourage CPs to provide high quality end-of-day submissions, on
random days, ICC selects a subset of instruments which are eligible for
Firm Trades. In order to determine Firm Trade requirements, the
algorithm sorts and ranks all CP submissions and identifies ``crossed
and/or locked markets.'' Crossed markets are pairs of CP submitted
prices generated by the sorting and ranking process for which the bid
price of one CP is above the offer price of the matched CP. The
algorithm identifies locked markets, where the bid and the offer are
equal, in a similar fashion.
    ICC designates certain crossed and/or locked markets as Firm Trades
and CPs are entered into cleared transactions. ICC establishes pre-
defined notional amounts for Firm Trades. According to ICC, no single
Firm Trade can have a larger notional amount than specified by the pre-
defined notional amount for the relevant instrument. On a given Firm
Trade day, all potential-trades resulting from the cross-and-lock
algorithm in any Firm Trade eligible instrument are designated Firm
Trades, unless they breach a CP's notional limits.
    Currently single name Firm Trade notional limits are set at the CP
level. According to ICC, it designed the Firm Trade system to
incentivize trading desks to provide quality end-of-day price
submissions for use in its end-of-day price discovery process, while
limiting the total overnight risk that a given institution may be
required to manage in case of submission errors or outlying pricing
submissions which may lead to Firm Trades. One mechanism introduced to
provide these protections was single name Firm Trade notional limits
per CP. ICC believes that at the time of its introduction, this
mechanism achieved its goal of limiting overnight risk limits per
institution. However, with the increase in client clearing and in
multiple CP memberships per holding company, ICC asserts that the limit
provided to a given institution is multiples of that originally
contemplated.
    In addition, because of recent changes to the EOD Policy to extend
the process for determining Firm Trades to include all submissions,
including those classified as outlying pricing submissions (or
``obvious errors''),\5\ ICC asserts that CPs are eligible to receive
Firm Trades on a wider range of price submissions. Due to the broadened
scope of the Firm Trade process, ICC asserts a heightened interest in
adjusting the allocation process so that CPs are not over-penalized for
Firm Trades in terms of overnight risk exposure.
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 34-74053 (January
14, 2015), 80 FR 2985 (January 21, 2015) (SR-ICC-2015-001).
---------------------------------------------------------------------------

    In order to maintain the original intent of the end-of-day price
discovery process, ICC has proposed changes to its EOD Policy to
implement single name Firm Trade notional limits at the CP affiliate
group level, as opposed to the

CP level. ICC represents that the proposed changes will return the
process to its original design and limit the total overnight risk that
a given institution may be required to manage in the case of submission
errors or outlying pricing submissions which may lead to Firm Trades.
    A ``CP affiliate group'' will be defined as the set of all
affiliated CPs (i.e. any CPs that own, are owned by, or are under
common ownership with another CP). According to ICC, as the sequence of
crosses is considered, the executed single name Firm Trade notional
value will be tracked for all CPs in a CP affiliate group. ICC states
that no additional single name Firm Trades will be executed against any
CP in a CP affiliate group once the CP affiliate group notional limit
for single name Firm Trades is reached. ICC asserts there are no
changes to the Firm Trade algorithm as a result of these changes. ICC
further asserts that setting single name Firm Trade notional limits on
an affiliate group basis is consistent with price submission practices
where end-of-day submissions from multiple affiliated entities often
reflect the institution's overall view on the market.
    ICC states that the proposal returns single name Firm Trade
notional limits to the original design while maintaining the system's
price submission incentives. ICC represents that all CPs within an
affiliate group will still be subject to potential Firm Trades for any
given submission, on a randomized basis. ICC also asserts that though
Firm Trade notional limits will be implemented at the CP affiliate
group level, the potential implication for a given trading desk of
providing an off-market submission for a given instrument remains the
same. ICC believes there will be no change in price submission behavior
as a result of the changes, and the Firm Trade process will remain an
effective tool for ensuring quality price submissions.

III. Discussion and Commission Findings

    Section 19(b)(2)(C) of the Act \6\ directs the Commission to
approve a proposed rule change of a self-regulatory organization if the
Commission finds that the proposed rule change is consistent with the
requirements of the Act and the rules and regulations thereunder
applicable to such self-regulatory organization. Section 17A(b)(3)(F)
of the Act \7\ requires, among other things, that the rules of a
clearing agency be designed to promote the prompt and accurate
clearance and settlement of securities transactions, and to the extent
applicable, derivative agreements, contracts and transactions, to
assure the safeguarding of securities and funds which are in the
custody or control of the clearing agency or for which it is
responsible and, in general, to protect investors and the public
interest. Section 17A(b)(3)(F) \8\ of the Act also requires that the
rules of a clearing agency are not designed to permit unfair
discrimination among participants in the use of the clearing agency.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(b)(2)(C).
    \7\ 15 U.S.C. 78q-1(b)(3)(F).
    \8\ Id.
---------------------------------------------------------------------------

    The proposed application of the Firm Trade notional limit to CP
affiliate groups is intended to manage what is, in ICC's view, an
inappropriate overnight risk to its members without negatively
impacting the integrity of its price discovery process. Moreover, the
proposed rule change is intended to apply the EOD Policy fairly to
participants, and ICC has represented that the proposed rule change is
consistent with price submission practices where end-of-day submissions
from multiple affiliated entities often reflect the institution's
overall view on the market. As such, the Commission believes that the
proposed rule change is designed to promote the prompt and accurate
clearance and settlement of securities transactions, derivatives
agreements, contracts, and transactions within the meaning of Section
17A(b)(3)(F) \9\ of the Act.
---------------------------------------------------------------------------

    \9\ Id.
---------------------------------------------------------------------------

IV. Conclusion

    On the basis of the foregoing, the Commission finds that the
proposal is consistent with the requirements of the Act and in
particular with the requirements of Section 17A of the Act \10\ and the
rules and regulations thereunder.\11\
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78q-1.
    \11\ 17 CFR 240.17Ad-22.
---------------------------------------------------------------------------

    IT IS THEREFORE ORDERED, pursuant to Section 19(b)(2) of the
Act,\12\ that the proposed rule change (File No. SR-ICC-2016-007) be,
and hereby is, approved.\13\
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78s(b)(2).
    \13\ In approving the proposed rule change, the Commission
considered the proposal's impact on efficiency, competition and
capital formation. 15 U.S.C. 78c(f).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-19170 Filed 8-11-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 99 (Wednesday, May 22, 2013)]
[Notices]
[Pages 30300-30302]
[FR Doc No: 2013-12229]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2010-0050, FRL-9816-7]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Implementation of Ambient Air Protocol Gas
Verification Participation Survey; EPA ICR No. 2375.02

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document announces that the EPA is planning
to submit a request for a renewal Information Collection Request (ICR)
to the Office of Management and Budget (OMB). Before submitting the ICR
to the OMB for review and approval, the EPA is soliciting comments on
specific aspects of the proposed information collection as described
below.

DATES: Comments must be submitted on or before July 22, 2013.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2010-0050, by one of the following methods:
     www.regulations.gov: Follow the on-line instructions for
submitting comments.
     Email<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>
     Mail: Docket No. EPA-HQ-OAR-2010-0050, Environmental
Protection Agency, Mail Code 2822T, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460. Please include a total of two copies.
     Hand Delivery: Docket No. EPA-HQ-OAR-2010-0050,
Environmental Protection Agency, EPA West, Room 3334, 1301 Constitution
Avenue NW., Washington, DC. Such deliveries are only accepted during
the Docket's normal hours of operation, and special arrangements should
be made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2010-0050. The EPA's policy is that all comments received will be
included in the public docket without change and may be made available
on-line at www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through www.regulations.gov
or email. The www.regulations.gov Web site is an ``anonymous access''
system, which means the EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an email comment directly to the EPA without going through
www.regulations.gov, your email address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the Internet. If you submit an electronic
comment, the EPA recommends that you include your name and other
contact information in the body of your comment and with any disk or
CD-ROM you submit. If the EPA cannot read your comment due to technical
difficulties

and cannot contact you for clarification, the EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses. For additional information about the EPA's public docket,
visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.

FOR FURTHER INFORMATION CONTACT: For further information, contact Mrs.
Laurie Trinca, Air Quality Assessment Division, Office of Air Quality
Planning and Standards, U.S. Environmental Protection Agency, Mail Code
C304-06, Research Triangle Park, NC 27711; telephone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

How can I access the docket and/or submit comments?

    The EPA has established a public docket for this ICR under Docket
ID No. EPA-HQ-OAR-2010-0050 which is available for on-line viewing at
www.regulations.gov, or in person viewing at the Air and Radiation
Docket in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301
Constitution Ave. NW., Washington, DC. The EPA/DC Public Reading Room
is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The telephone number for the Reading Room is 202-566-
1744, and the telephone number for the Air and Radiation Docket is 202-
566-1742.
    Use www.regulations.gov to obtain a copy of the draft collection of
information, submit or view public comments, access the index listing
of the contents of the docket, and to access those documents in the
public docket that are available electronically. Once in the system,
select ``search,'' then key in the docket ID number identified in this
document.

What information is the EPA particularly interested in?

    Pursuant to section 3506(c)(2)(A) of the PRA, the EPA specifically
solicits comments and information to enable it to:
    (i) Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the Agency,
including whether the information will have practical utility;
    (ii) Evaluate the accuracy of the agency's estimate of the burden
of the proposed collection of information, including the validity of
the methodology and assumptions used;
    (iii) Enhance the quality, utility, and clarity of the information
to be collected; and
    (iv) Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses. In particular, the EPA is requesting comments
from small businesses (especially those that employ less than 25) on
examples of specific additional efforts that the EPA could make to
reduce the paperwork burden for very small businesses affected by this
collection.

What should I consider when I prepare my comments for the EPA?

    You may find the following suggestions helpful for preparing your
comments:
    (i) Explain your views as clearly as possible and provide specific
examples.
    (ii) Describe any assumptions that you used.
    (iii) Provide copies of any technical information and/or data you
used that support your views.
    (iv) If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
    (v) Offer alternative ways to improve the collection activity.
    (vi) Make sure to submit your comments by the deadline identified
under DATES.
    (vii) To ensure proper receipt by the EPA, be sure to identify the
docket ID number assigned to this action in the subject line on the
first page of your response. You may also provide the name, date, and
Federal Register citation.

What information collection activity or ICR does this apply to?

    Affected entities: Entities potentially affected by this action are
state, local, and tribal governments that are currently operating and
maintaining established ambient air quality networks.
    Title: Implementation of Ambient Air Protocol Gas Verification
Participation Survey.
    ICR numbers: EPA ICR No. EPA-HQ-OAR-2010-0050, OMB Control No.
2060-0648.
    ICR status: This ICR is for a renewal information collection
activity. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information, unless it displays
a currently valid OMB control number. The OMB control numbers for the
EPA's regulations in title 40 of the CFR, after appearing in the
Federal Register when approved, are listed in 40 CFR part 9, are
displayed either by publication in the Federal Register or by other
appropriate means, such as on the related collection instrument or
form, if applicable. The display of OMB control numbers in certain EPA
regulations is consolidated in 40 CFR part 9.
    Abstract: This ICR includes ambient air monitoring data reporting
and recordkeeping activities associated with the 40 CFR part 58
Appendix A, Ambient Air Quality Surveillance Quality Assurance
Regulations. These data and information are collected by state, local,
and tribal air quality management agencies and reported to the EPA.
    The EPA Ambient Air Quality Monitoring Program's quality assurance
requirements in 40 CFR part 58, Appendix A, require: ``2.6 Gaseous and
Flow Rate Audit Standards. Gaseous pollutant concentration standards
(permeation devices or cylinders of compressed gas) used to obtain test
concentrations for CO, SO2, NO, and NO2 must be
traceable to either a National Institute of Standards and Technology
(NIST) Traceable Reference Material (NTRM), NIST Standard Reference
Materials (SRM), and Netherlands Measurement Institute (NMI) Primary
Reference Materials (valid as covered by Joint Declaration of
Equivalence) or a NIST-certified Gas Manufacturer's Internal Standard
(GMIS), certified in accordance with one of the procedures given in
reference 4 of this appendix. Vendors advertising certification with
the procedures provided in reference 4 of this appendix and
distributing gases as ``EPA Protocol Gas'' must participate in the EPA
Protocol Gas Verification Program or not use ``EPA'' in any form of
advertising.''
    These requirements give assurance to end users that all specialty
gas producers selling EPA Protocol Gases are participants in a program
that provides an independent assessment of the accuracy of their gases'
certified concentrations. In 2010, the EPA developed an Ambient Air
Protocol Gas Verification Program (AA-PGVP) that provides end users
with information about participating producers and verification
results.
    Each year, the EPA will attempt to compare gas cylinders from every
specialty gas producer being used by ambient air monitoring
organizations. The EPA's Regions 2 and 7 have agreed to provide
analytical services for verification of 40 cylinders/lab or 80
cylinders total/year. Cylinders will be

verified at a pre-determined time each quarter.
    In order to make the appropriate selection, the EPA needs to know
what specialty gas producers are being used by the monitoring
organizations. Therefore, the EPA needs to survey each primary quality
assurance organization every year to collect information on specialty
gas producers being used and whether the monitoring organization would
like to participate in the verification for the upcoming calendar year.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 20
minutes per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    The annual public reporting and recordkeeping burden for this
collection of information is estimated to average 20 minutes per
response with a cost of $22.15 per year. The total number of
respondents is assumed to be 211.
    The ICR provides a detailed explanation of the agency's estimate,
which is only briefly summarized here:
    Estimated total number of potential respondents: 211.
    Frequency of response: Annual.
    Estimated total average number of responses for each respondent: 1.
    Estimated total annual burden hours: 70.3.
    Estimated total annual costs: $4674.00.

What is the next step in the process for this ICR?

    The EPA will consider the comments received and amend the ICR as
appropriate. The final ICR package will then be submitted to OMB for
review and approval pursuant to 5 CFR 1320.12. At that time, the EPA
will issue another Federal Register notice pursuant to 5 CFR
1320.5(a)(1)(iv) to announce the submission of the ICR to OMB and the
opportunity to submit additional comments to OMB. If you have any
questions about this ICR or the approval process, please contact the
technical person listed under FOR FURTHER INFORMATION CONTACT.

    Dated: May 16, 2013.
Mary E. Henigin,
Acting Director, Air Quality Assessment Division.
[FR Doc. 2013-12229 Filed 5-21-13; 8:45 am]
BILLING CODE 6560-50-P


Development of Pooled Method Detection Limits (MDLs) and

Minimum Levels of Quantitation (MLs) for EPA Method 1668C.

May 18th, 2010

Introduction

This document describes how EPA used MDL data from three (3) laboratories to produce pooled MDLs and MLs for EPA Method 1668C.

Method detection limit (MDL) data were received from three laboratories.  LAB 1’s MDLs and LAB 2’s MDLs were from spikes of each congener into water at a concentration of 10 pg/L; Lab 3’s MDLs were from spikes of various congeners into water at concentrations of 50 to 150 pg/L.  LAB 1’s MDLs were from analyses run in 2009; LAB 2’s MDLs were from analyses run in 2005; Lab 3's MDLs were from analyses run in 2006.

Table 2 of Method 1668 (Revisions A and B) list retention times for individual congeners and for coeluted congener groups (coelutions).  Coelutions exist because the gas chromatographic (GC) column does not resolve all 209 congeners; in fact, and in spite of repeated attempts, no GC column resolves all 209 congeners.  Because of slight differences in GC columns, LAB 2’s and Lab 3's coelutions are different than LAB 1’s coelutions and those in Table 2 of Method 1668 (LAB 1’s coelutions and those in Method 1668 agree).  The difference in LAB 2’s and Lab 3's coelutions necessitated deconvolution of LAB 2’s and Lab 3's MDLs in coelutions that differed from the coelutions in Table 2 of Method 1668.

The process of producing pooled MDLs and MLs involved three steps:

1)  Deconvoluting LAB 2’s and Lab 3's MDLs in coelutions that did not match the coelutions in Table 2 of Method 1668.

2)  Combining the individual congener MDLs deconvoluted from LAB 2’s and Lab 3's coelutions into MDLs for the coelutions in Table 2 of Method 1668, and

3)  Combining LAB 1, LAB 2, and Lab 3 individual MDLs and MDLs for the coelutions in Table 2 of Method 1668 to produce pooled MDLs and MLs for individual congeners and coelutions.

The MDLs and MLs calculated by these three steps are in Table 2 of Method 1668C.

Determination of Laboratory MDLs for individual Congeners

For MDLs determined for an individual congener (i.e., a congener not involved in a coelution), the laboratory-reported MDLs were not adjusted; however, all applicable calculations were reviewed to confirm that the MDL procedure was followed correctly.

Deconvolution of LAB 2’s and Lab 3's coelutions

LAB 1’s 2009 MDLs are listed in Table 1; LAB 2’s 2005 MDLs are listed in Table 2; and Lab 3's 2006 MDLs are listed in Table 3.  For all three labs, MDLs were reported for at least one group of two or more coeluting congeners.  A spike of each of the 209 congeners at a constant concentration (e.g., 10 pg/L) results in combined spikes 2 to 6 times the concentration of the individual congeners (e.g., 20 - 60 pg/L for a spike of 10 pg/L for an individual congener) because 2 to 6 congeners elute from the GC as a single peak (see Table 2 of Method 1668 for the coelutions).  MDLs for these coelutions would be expected to be 2 to 6 times higher than for an individual congener that elutes as a single peak.  However, in reviewing MDLs from the three labs, it was noticed that the MDL for a coelution was not consistently higher by the multiple of the number of congeners in the coelution.  Therefore, to establish individual MDLs for the LAB 2 and Lab 3 coeluting congeners that were inconsistent with Table 2 coelutions, and to not underestimate the MDL for an individual congener in a coelution, we did the following.  The MDL for an individual congener in a coelution was estimated as the greater of the MDL for the coelution divided by the number of congeners in the coelution, or the mean of the MDLs for four individual congeners, two of which eluted most closely before, and two of which eluted most closely after, the coelution.

For example, for coeluted congeners 100/93, LAB 2’s MDL was 7.6 pg/L.  Dividing by 2 to produce an estimate for an individual MDL for each congener yields 3.8 pg/L.  However, the mean of the MDLs for congeners 94, 95, 84, and 89 (the 2 individual congeners that elute most closely before and the 2 individual congeners that elute most closely after the coelution) was 5.7 pg/L.  Therefore, we set the MDL for each congener (100 and 93) to 5.7 pg/L.

LAB 2 and Lab 3 coelutions that required deconvolution into individual congeners, and the choice of deconvolution (divide by the number of congeners or the average of the 4 most closely eluted individual congeners) are listed in Tables 4 and 5, respectively.

Determination of Laboratory MDLs for Coelutions

Once MDLs were determined for each individual congener for LAB 2’s and Lab 3's coelutions inconsistent with the coelutions in Table 2 of Method 1668, the individual MDLs were added to form MDLs for the coelutions in Table 2 of Method 1668.  LAB 1’s original coelutions already corresponded to the coelutions in Method 1668; therefore, LAB 1’s MDLs for the coelutions in Table 2 of Method 1668 were used as received.

Calculation of pooled MDLs and MLs

Pooled MDLs were calculated for each individual congener and each coelution by first calculating a pooled standard deviation.  If possible, this pooled standard deviation was calculated from the standard deviations in data from the three labs.  In cases where an MDL was determined by deconvolution, the standard deviation was “back-calculated” by dividing the MDL by the 99th percentile t-statistic with the appropriate degrees of freedom (i.e., the number of replicates analyzed by LAB 2 minus 1 (7 - 1 = 6)).  The pooled standard deviation was then calculated by weighting the labs' standard deviations by the number of replicates minus 1 (so LAB 1's standard deviation was weighted more because LAB 1 analyzed 9 replicates whereas LAB 2 and Lab 3 analyzed 7).  This additional weighting resulted in a slight increase in the pooled MDL above lab MDLs that were identical.

To form minimum levels of quantitation (MLs), the pooled MDLs were multiplied by 3.18 and rounded to the number nearest to 1, 2, or 5 x 10 n, where n is 0 or an integer, per the ML procedure (see 68 FR 11790).  MDLs and MLs for other media and MLs in the final extract were calculated by taking into account the sample and extract volumes.  The resulting MDLs and MLs were then inserted in Table 2 of Method 1668C.

MDLs for Future Coelutions Different from Those in Table 2 of Method 1668C

If, in the future, a laboratory has coelutions different from those in Table 2 of Method 1668C, the laboratory can use the information in this document to deconvolute its coelutions to obtain MDLs for individual congeners in a coelution, and reconstitute an MDL for a Method 1668 Table 2 coelution by adding the pertinent individual MDLs.

Table 1   LAB 1's 2009 MDLs (pg/L)*

Congener	MDL

Congener	MDL

Congener	MDL

Congener	MDL

1	3.9

48	3.3

108/124	4.0

164	3.4

2	2.5

69/49	8.1

107	2.1

165	2.4

3	3.8

50/53	5.0

110/115	13.2

167	2.7

4	2.8

52	5.6

111	4.4

169	2.9

5	3.0

54	3.1

112	5.1

170	4.7

6	1.5

55	2.4

114	2.2

171/173	6.3

7	1.9

56	3.1

118	6.0

172	3.8

8	3.6

57	1.8

120	3.1

174	5.7

9	2.1

58	2.5

121	4.7

175	4.1

10	2.1

59/62/75	8.4

122	1.8

176	3.6

11	36.4

60	2.4

123	2.4

177	4.7

12/13	5.3

61/70/74/76	9.6

126	2.1

178	5.0

14	2.2

63	2.8

127	2.0

179	4.8

15	4.0

64	3.5

128/166	3.3

180/193	12.7

16	3.2

66	4.9

138/163/129/160	16.1

181	4.3

17	3.7

67	3.1

130	2.1

182	4.5

30/18	7.5

68	3.0

131	2.7

183/185	8.4

19	3.3

72	2.2

132	3.5

184	2.8

28/20	5.8

73	3.1

133	3.0

186	5.3

21/33	4.0

77	2.0

134/143	3.5

187	11.7

22	3.1

78	2.2

151/135/154	15.8

188	2.2

23	3.2

79	2.4

136	3.3

189	2.0

24	2.8

80	2.3

137	2.9

190	2.4

25	1.8

81	2.0

139/140	3.9

191	3.4

26/29	2.7

82	4.3

141	5.2

192	2.5

27	3.5

83/99	10.6

142	2.1

194	2.3

31	4.5

84	3.8

144	3.6

195	2.7

32	1.5

117/116/85	8.7

145	3.8

196	4.0

34	2.5

109/119/86/97/125/87	22.8

146	3.8

197/200	7.7

35	3.6

88/91	6.6

147/149	20.8

198/199	5.1

36	2.2

89	4.3

148	3.2

201	2.8

37	2.4

113/90/101	19.6

150	3.2

202	3.5

38	1.5

92	4.6

152	3.5

203	2.5

39	2.4

95/100/93/102/98	19.2

153/168	19.9

204	3.1

41/40/71	8.5

94	3.7

155	3.0

205	2.2

42	4.7

96	3.6

156/157	4.1

206	1.8

43	5.0

103	2.7

158	1.7

207	1.6

44/47/65	10.4

104	3.2

159	1.7

208	3.3

45/51	4.6

105	3.4

161	1.9

209	2.6

46	2.6

106	4.1

162	2.9

	*From 9 replicate analyses of a spike of each of 209 congeners into water at a concentration of 10 pg/L.

Table 2   LAB 2's 2005 MDLs (pg/L)*

Congener	MDL

Congener	MDL

Congener	MDL

Congener	MDL

1	6.7

49/69	8.5

107	3.7

165	4.1

2	4.2

50/53	9.2

108/124	22.9

167	5.0

3	6.4

52	7.5

110/115	7.2

169	3.6

4	10.4

54	4.7

111	3.4

170	2.9

5	4.6

55	6.1

114	4.7

171/173	7.8

6	6.6

56	5.0

118	6.3

172	3.4

7	3.9

57	4.6

120	3.4

174	6.5

8	8.6

58	2.8

121	3.4

175	5.6

9	4.6

59/62/75	11.6

122	4.6

176	2.2

10	7.3

60	4.8

123	5.0

177	2.2

11	36.4

61/70/74/76	23.8

126	2.2

178	2.9

13/12	20.4

63	4.8

127	6.6

179	2.5

14	5.8

64	5.0

128/166	10.8

180/193	7.8

15	10.8

66	12.0

129/138/163	8.9

181	5.4

16	8.6

67	5.7

130	8.7

182	3.6

17	10.9

68	3.9

131	1.3

183/185	4.3

18/30	11.5

72	3.7

132	4.6

184	3.3

19	9.7

77	4.4

133	2.7

186	4.2

20/28	16.6

78	4.4

134/143	10.4

187	4.5

21/33	12.6

79	3.2

135/151	6.3

188	4.3

22	9.9

80	3.6

136	3.4

189	2.8

23	3.2

81	3.4

137/164	3.5

190	2.5

24	11.2

82	8.3

139/140	4.4

191	3.1

25	7.7

83	9.3

141	3.8

192	3.7

26/29	9.0

84	6.0

142	4.4

194	5.0

27	5.6

85/116/117	8.4

144	5.5

195	6.2

31	10.1

86/87/97/109/119/125	10.5

145	3.1

196	6.2

32	5.7

88/91	7.4

146	4.9

197/200	5.6

34	3.4

89	5.6

147/149	4.5

198/199	13.0

35	9.6

90/101/113	4.7

148	5.0

201	4.3

36	7.5

92	3.7

150	3.4

202	3.9

37	9.0

93/100	7.6

152	2.3

203	4.9

38	4.7

94	4.5

153/168	7.1

204	3.1

39	7.3

95	6.8

154	4.9

205	5.5

40/41/71	6.5

96	2.6

155	3.2

206	3.2

42	4.0

98/102	12.1

156/157	4.5

207	2.7

43/73	9.3

99/112	17.7

158	2.5

208	3.5

44/47/65	10.7

103	2.5

159	3.4

209	2.5

45/51	12.1

104	5.7

160	7.2

	46	2.6

105	4.4

161	2.6

	48	2.6

106	5.8

162	4.1

	*From 7 replicate analyses of a spike of each of 209 congeners into water at a concentration of 10 pg/L.

Table 3   Lab 3's 2006 MDLs (pg/L) *

Congener	MDL

Congener	MDL

Congener	MDL

Congener	MDL

1	17.1

65/47/44	71.2	 	111	24.8	 	169	26.1

2	11.2

62/75/59	64.8	 	120	24.0	 	188	26.3

3	18.6

42	28.7	 	108/124	47.7	 	179	25.2

4	20.5

41/71/40	75.6	 	107/123/106	88.8	 	184	25.4

10	22.7

64	22.0	 	118	53.0	 	176	22.1

9	12.1

72	22.4	 	122	21.7	 	186	25.3

7	13.7

68	24.2	 	114	26.3	 	178	24.4

6	11.8

57	20.3	 	105	30.3	 	175	25.2

5	14.3

58	26.0	 	127	24.3	 	187	26.0

8	25.4

67	21.7	 	126	29.9	 	182	22.7

14	12.4

63	20.9	 	155	25.2	 	183/185/174	75.0

11	20.4

61/70/76/74	104.0	 	152	25.3	 	177	19.4

13/12	27.2

66	27.0	 	150	26.8	 	181	23.2

15	27.5

55	21.3	 	136	29.0	 	171/173	54.0

19	10.2

56	27.2	 	145	28.2	 	172	23.3

30/18	25.9

60	25.8	 	148	25.2	 	192	23.5

17	11.2

80	19.8	 	151/135/154	80.0	 	193/180	52.6

27/16/24	39.0

79	23.8	 	144	25.6	 	191	23.7

32	13.1

78	28.6	 	147/149	57.3	 	170	21.4

34	11.2

81	32.8	 	134/143	58.3	 	190	24.6

23	10.8

77	24.9	 	139/140	52.0	 	189	23.8

29/26	20.2

104	23.9	 	131	31.5	 	202	44.2

25	13.2

96	27.0	 	142	29.7	 	201	35.9

31	31.5

103	20.2	 	132	29.4	 	204	37.9

28/20/21/33	72.3

94	22.4	 	133	22.0	 	197/200	77.2

22	13.4

95	36.5	 	165	22.6	 	198/199	65.2

36	13.2

100/93/102/98	85.7	 	146/161	48.0	 	196	35.4

39	13.3

88/91	38.9	 	153/168	49.0	 	203	32.7

38	12.3

84	18.1	 	141	29.9	 	195	38.7

35	13.7

89	21.5	 	130	22.7	 	194	32.7

37	15.0

121	20.7	 	137/164	50.2	 	205	27.5

54	25.7

92	23.6	 	138/163/129/160	112.5	 	208	28.2

50/53	44.0

113/90/101	82.9	 	158	28.7	 	207	33.7

45/51	38.1

83/99/112	66.4	 	166/128	52.1	 	206	28.7

46	18.6

119/109/86/97/125/87	131.7	 	159	24.8	 	209	28.8

73/52/43	69.1

117/116/85	68.1	 	162	22.8

	69/49	45.0

110/115	68.4	 	167	23.2

	48	25.8

82	26.4	 	156/157	42.3

	*From 7 replicate analyses of spikes into water of mono- thru tri- chloroCBs at 50 pg/L; tetra- thru hexa- chloroCBs at 100 pg/L and hepta- thru deca- chloroCBs at 150 pg/L.

Table 4   Individual Test America-Knoxville MDLs deconvoluted from MDLs for coelutions that do not match coelutions in Table 2 of Method 1668A

MDL for an individual congener was determined as the larger of the MDL for the coelution divided by the number of congeners in the coelution, or the mean of the MDLs for four individual congeners, two of which eluted most closely before, and two of which eluted most closely after, the coelution

Coelution	Congener numbers of congeners averaged

100,93	94,95,84,89 (means that MDLs for these 4 congeners were averaged)

102,98	/2 (means that the MDL for these congeners was divided by 2)

99,12	/2

151,135	145,148,154,144

137,164	141,130,160,158

138,163,129	141,130,160,158

Table 5   Individual Lab 3-Columbus MDLs deconvoluted from MDLs for coelutions that do not match coelutions in Table 2 of Method 1668A

MDL for an individual congener was determined as the larger of the MDL for the coelution divided by the number of congeners in the coelution, or the mean of the MDLs for four individual congeners, two of which eluted most closely before, and two of which eluted most closely after, the coelution

Coelution	Congener numbers of congeners averaged

27,16,24	/3 (means that the MDL for these congeners was divided by 3)

28,20,21,33	/4

52,73,43	54,46,48,42 (means that MDLs for these 4 congeners were averaged)

95,100,93,102,98	94,95,84,89

83,99,112	121+92+82+111

107,123,106	111,120,118,122

146,161	133,165,141,130

137,164	141,130,158,159

183,185,174	/3

Engineering and Analysis Division		Brian Englert

Office of Science and Technology<PHONE_NUMBER>

05/18/2010

US EPA Engineering and Analysis Division		Brian Englert

Office of Science and Technology		May 18, 2010

 PAGE   2

 PAGE   7


[Federal Register Volume 87, Number 19 (Friday, January 28, 2022)]
[Notices]
[Pages 4586-4587]
[FR Doc No: 2022-01759]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2021-0114; FRL-9519-01-OMS]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; NESHAP for Source Categories: Gasoline
Distribution Bulk Terminals, Bulk Plants, Pipeline Facilities, and
Gasoline Dispensing Facilities (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), NESHAP for Source Categories:
Gasoline Distribution Bulk Terminals, Bulk Plants, Pipeline Facilities,
and Gasoline Dispensing Facilities (EPA ICR Number 2237.06, OMB Control
Number 2060-0620), to the Office of Management and Budget (OMB) for
review and approval in accordance with the Paperwork Reduction Act.
This is a proposed extension of the ICR, which is currently approved
through March 31, 2022. Public comments were previously requested, via
the Federal Register, on April 13, 2021 during a 60-day comment period.
This notice allows for an additional 30 days for public comments. A
fuller description of the ICR is given below, including its estimated
burden and cost to the public. An agency may neither conduct nor
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.

DATES: Additional comments may be submitted on or before February 28,
2022.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OAR-2021-0114, online using www.regulations.gov (our preferred method)
or by mail to: EPA Docket Center, Environmental Protection Agency, Mail
Code 28221T, 1200 Pennsylvania Ave. NW, Washington, DC 20460.
    EPA's policy is that all comments received will be included in the
public docket without change including any

personal information provided, unless the comment includes profanity,
threats, information claimed to be Confidential Business Information
(CBI), or other information whose disclosure is restricted by statute.
    Submit written comments and recommendations to OMB for the proposed
information collection within 30 days of publication of this notice to
www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under 30-day Review--Open for
Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Muntasir Ali, Sector Policies and
Program Division (D243-05), Office of Air Quality Planning and
Standards, U.S. Environmental Protection Agency, Research Triangle
Park, North Carolina, 27711; telephone number:<PHONE_NUMBER>; email
address: [email protected].

SUPPLEMENTARY INFORMATION: Supporting documents, which explain in
detail the information that the EPA will be collecting, are available
in the public docket for this ICR. The docket can be viewed online at
https://www.regulations.gov, or in person at the EPA Docket Center, WJC
West Building, Room 3334, 1301 Constitution Ave. NW, Washington, DC.
The telephone number for the Docket Center is<PHONE_NUMBER>. For
additional information about EPA's public docket, visit: http://www.epa.gov/dockets.
    Abstract: The NESHAP for Source Categories: Gasoline Distribution
Bulk Terminals, Bulk Plants, Pipeline Facilities, and Gasoline
Dispensing Facilities applies to owners or operators of any existing or
new gasoline distribution facilities that are an area source of
hazardous air pollutants (HAP) emissions. In addition to the initial
notification and notification of compliance status required by the
General Provisions (40 CFR part 63, subpart A), respondents are
required to submit one-time reports of start of construction,
anticipated and actual startup dates, and physical or operational
changes to existing facilities. Reports of initial performance tests on
control devices at gasoline distribution storage tanks, loading racks,
and vapor balance systems are also required and are necessary to show
that the installed control devices are meeting the emission limitations
required by the NESHAP. Annual reports of storage tank inspections at
all affected facilities are required. In addition, respondents must
submit semiannual compliance and continuous monitoring system
performance reports, and semiannual reports of equipment leaks not
repaired within 15 days or loadings of cargo tanks for which vapor
tightness documentation is not available.
    Form Numbers: None.
    Respondents/affected entities: Gasoline distribution bulk
terminals, bulk plants, pipeline facilities, and gasoline dispensing
facilities.
    Respondent's obligation to respond: Mandatory (40 CFR 63, subparts
BBBBBB and CCCCCC).
    Estimated number of respondents: 19,120 (total).
    Frequency of response: Initially and semiannually.
    Total estimated burden: 214,000 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
    Total estimated cost: $25,400,000 (per year), which includes
$110,000 in annualized capital/startup and/or operation & maintenance
costs.
    Changes in the Estimates: There is no change in burden from the
most-recently approved ICR as currently identified in the OMB Inventory
of Approved Burdens. This is due to two considerations. First, the
regulations have not changed over the past three years except to add
electronic reporting for notifications that were already required under
40 CFR 63.9(b) and (j), which is not expected to increase burden. Also,
the regulations are not anticipated to change over the next three
years. Second, the growth rate for this industry is very low or non-
existent, so there is no significant change in the overall burden.
Since there are no changes in the regulatory requirements and there is
no significant industry growth, there are also no changes in the
capital/startup and/or operation and maintenance (O&M) costs.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2022-01759 Filed 1-27-22; 8:45 am]
BILLING CODE 6560-50-P