[Federal Register Volume 73, Number 171 (Wednesday, September 3, 2008)]
[Proposed Rules]
[Pages 51386-51388]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-20282]


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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 [email protected].

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