[Federal Register: September 3, 2008 (Volume 73, Number 171)]
[Proposed Rules]
[Page 51386-51388]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03se08-17]
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CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Part 1500
Infant Cushions/Pillows; Termination of Rulemaking Other Than
With Respect to Boston Billow Nursing Pillow and Substantially Similar
Nursing Pillows
AGENCY: Consumer Product Safety Commission.
ACTION: Advance notice of proposed rulemaking; partial withdrawal.
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SUMMARY: On September 27, 2006, the Commission issued an advance notice
of proposed rulemaking (ANPR) to assess whether a rulemaking was
necessary to address any unreasonable risk of injury or death which may
be associated with the proliferation of infant cushions/pillows and
pillow-like products intended for infants in the marketplace, including
the Boston Billow Nursing Pillow. 71 FR 56418. After review of the
comments, incident reports and other available information, the
Commission has determined there is insufficient data or product
information on infant cushions/pillows or pillow-like
[[Page 51387]]
products, other than the Boston Billow Nursing Pillow and substantially
similar nursing pillows, to proceed with further rulemaking on those
products at this time. Based on these findings, the Commission
terminates the infant cushion/pillow rulemaking other than with respect
to the Boston Billow Nursing Pillow and substantially similar nursing
pillows.
DATES: The partial termination of the advance notice of proposed
rulemaking that published in the Federal Register September 27, 2006
(71 FR 56418) is effective September 3, 2008.
FOR FURTHER INFORMATION CONTACT: Suad Wanna-Nakamura, Directorate for
Health Sciences, U.S. Consumer Product Safety Commission, 4330 East
West Highway, Bethesda, Maryland 20814; telephone (301) 504-7252; e-
mail snakamura@cpsc.gov.
SUPPLEMENTARY INFORMATION:
A. Background
Between 1985 and 1992, there were 35 infant deaths associated with
the use of infant cushions/pillows (also known, among other names, as
``baby beanbag pillows'' and ``beanbag cushions''). In almost all of
the cases where the infant's position could be determined, the infant
was in a prone, face down, position. 55 FR 42202. The Commission
initiated a rulemaking proceeding to assess whether a ban was necessary
to address an unreasonable risk of injury and death associated with
these types of infant cushions/pillows. Due to the number of infant
deaths associated with these products, the Commission proposed a rule
to ban infant cushions/pillows with certain characteristics. 56 FR
32352. On June 23, 1992, the Commission issued a rule codified at 16
CFR 1500.18(a)(16)(i), banning infant cushions/pillows that: (1) Have a
flexible fabric covering; (2) are loosely filled with a granular
material, including but not limited to, polystyrene beads or pellets;
(3) are easily flattened; (4) are capable of conforming to the body or
face of an infant; and (5) are intended or promoted for use by children
under one year of age. 57 FR 27912.
On July 17, 2005, Boston Billows, Inc. (Boston Billows) submitted a
petition requesting an amendment to 16 CFR 1500.18(a)(16)(i)(A)-(E) to
allow an exception to the ban. The petitioner is the manufacturer of
the Boston Billow Nursing Pillow, a granularly filled, C-shaped pillow
intended for use by mothers when breastfeeding.
B. The ANPR
The Commission issued an ANPR on September 27, 2006, to assess
whether a rulemaking was necessary to address any unreasonable risk of
injury or death which may be associated with infant cushions/pillows.
71 FR 56418. In addition to the Boston Billow Nursing Pillow, which met
the criteria of the ban, there appeared to be a proliferation of other
infant cushions/pillows or pillow-like products in the marketplace,
including nursing pillows which met some, but not all, of the criteria
set forth in the ban. The potential regulatory alternatives noted
included whether to: (1) Amend the regulation to allow an exemption to
the ban; (2) delete, revise or add criteria to the ban; (3) leave the
existing regulation unchanged; or (4) repeal the existing regulation.
Nine written comments were received in response to the ANPR in support
of Boston Billows' request for exemption from the ban.
C. Incident Data
Commission staff reviewed the incident data on infant cushions and
nursing pillows for the period of January 1992 through June 2007. Staff
also reviewed additional data from July 2007 through May 2008. Since
1992, there have been no reported deaths associated with infant
cushions meeting the definition of a banned infant cushion/pillow.
However, staff identified 531 infant deaths associated with pillows and
cushions that did not meet the definition of a banned infant cushion/
pillow. (From January 1992 through June 2007, there were 484 deaths
reported and from July 2007 through May 2008, there were an additional
47 deaths reported.) The vast majority of these incidents involved
adult pillows and sofa cushions which possess many of the same
characteristics as the banned bean bag cushions. These products have
soft covers and flexible filling material that can conform to an
infant's face. A variety of pillow types and cushions with different
types of filling including foam, feathers, and polyester were involved
in the incidents. In this data set, two infant deaths have been
associated with a polyester filled nursing pillow (which does not meet
the definition of a banned infant cushion/pillow). One incident
occurred in 2001 when a 4-month-old infant was placed to sleep on his
stomach in a playpen with his head resting on the nursing pillow. The
second incident occurred in 2007, when a 46-day-old infant was placed
in a prone position inside a crib with his head propped on the nursing
pillow.
CPSC staff was also made aware of three additional deaths in 2006
where a nursing pillow was in the infant's sleep environment. The
pillows involved with these deaths were polyester filled crescent-
shaped nursing pillows not subject to the CPSC's infant cushion ban.
The cause of these deaths in all cases was initially determined by the
medical examiner to be Sudden Infant Death Syndrome (SIDS)/
undetermined. In 2008, the New York Westchester County Child Fatality
Review Team examined the case files for these deaths. Further
investigation of these incidents, including review of documents and
photographs from the New York Westchester County Child Fatality Review
Team and investigator interviews reveals that in two of the three
deaths, while nursing pillows were in the sleep environment, the deaths
were deemed to be caused by SIDS/undetermined and could not be causally
connected to nursing pillows. With regard to the third death, the
infant was propped to sleep in a prone position on a crescent-shaped
nursing pillow. In summary, from 1992 to the present, staff is aware of
a total of three cases where infants died from suffocation after being
placed to sleep in a prone position with their heads propped on
polyester filled crescent-shaped nursing pillows.
Staff's review revealed that in the vast majority of the 531 deaths
associated with pillows and cushions, the infants were found in the
prone position, lying on top of the pillow/cushion or with the head or
neck propped on the pillow/cushion. A quarter of the deaths occurred in
infant cribs, bassinets, cradles and playpens, while the rest occurred
outside the normal infant sleep areas, such as on adult beds, on sofas,
or on the floor. As with the banned infant bean bag cushion, these
pillows and cushions can cause death by suffocation/asphyxiation when
an infant is placed to sleep face down on them. According to staff, the
analysis of the data does not reveal an increased risk due to any
specific type of pillow or cushion filling, but rather it is the
softness and malleability which are inherent properties of pillows that
are the primary risk factors. The comparative risk of suffocation based
upon filling is unknown; however, the greatest common risk factor is
that infants were found in the prone position, face down, in the
majority of the 531 deaths.
Prone sleeping is a high risk factor for infant suffocation on
cushions/pillows. The limited physical and developmental capabilities
of infants render them susceptible to danger from suffocation
[[Page 51388]]
in certain sleeping environments. Physiological abnormalities and
delays in the development of vital systems can further hamper an
infant's ability to react to a hazardous condition. Infants who are not
placed on their backs are especially at risk for suffocation on any
type of soft pillow, regardless of the type of filling.
In 1992, the American Academy of Pediatrics, in an effort to reduce
the risk of SIDS, recommended that babies always be placed on their
backs when put to sleep. As a result of this campaign, Sudden Infant
Death Syndrome (SIDS) deaths between 1992 and 2004 in the United States
decreased from 5,000 per year to 2,246 per year (based on vital
statistics data of the United States). Although there has been a steady
decrease in SIDS deaths, staff found there has not been a similar
decrease in infant deaths associated with pillows and cushions. Even
though the recommendation to place infants to sleep on their backs is
being promoted, staff believes that the data indicates that there are
still a significant number of people who continue to place infants to
sleep in the prone position. For this reason, staff recommends
increased information dissemination targeted at the population of
caregivers whose infants are not placed to sleep in the supine
position. Increased compliance with the recommendation for supine
sleep, as well as continued vigilance in ensuring a safe sleeping
environment would have benefits in reducing the risk of infant
suffocation deaths caused by adult pillows, sofa cushions, and other
pillows as well as further reducing incidents involving SIDS.
D. Conclusion
In light of the ongoing risks posed by infant cushions/pillows when
used in the sleep environment, the Commission finds no justification
for repealing the ban on infant cushions/pillows at this time.
Moreover, after review of the comments, incident reports and other
available information, the Commission determines there is insufficient
data or product information on infant cushions/pillows or pillow-like
products intended for infants, other than with respect to the Boston
Billow Nursing Pillow and substantially similar nursing pillows, to
proceed with further rulemaking on those products at this time. Thus,
the Commission is terminating the rulemaking on infant cushions/pillows
or pillow-like products, other than with respect to the Boston Billow
Nursing Pillow and substantially similar nursing pillows effective upon
publication in the Federal Register for good cause shown in accordance
with 5 U.S.C. 553(d)(3).\1\ A proposed exemption from the ban for the
Boston Billow Nursing Pillow and substantially similar nursing pillows
appears elsewhere in this Federal Register.\2\
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\1\ On February 1, 2008, Acting Chairman Nancy Nord and
Commissioner Thomas Moore voted 2-0 to direct the Office of the
General Counsel to prepare a notice terminating the rulemaking other
than with respect to the Boston Billow Nursing Pillow and
substantially similar nursing pillows.
\2\ On February 1, 2008, Acting Chairman Nancy Nord and
Commissioner Thomas Moore voted 2-0 to direct the Office of the
General Counsel to prepare a notice of proposed rulemaking proposing
an exemption for the Boston Billow Nursing Pillow and substantially
similar nursing pillows. Acting Chairman Nord also voted to request
ASTM to develop a product warning label for the product class.
Dated: August 27, 2008.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. E8-20282 Filed 9-2-08; 8:45 am]
BILLING CODE 6355-01-P