[Federal Register: September 3, 2008 (Volume 73, Number 171)]
[Proposed Rules]
[Page 51384-51386]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03se08-16]
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CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Part 1500
Exemption From Classification as Banned Hazardous Substance;
Proposed Exemption for Boston Billow Nursing Pillow and Substantially
Similar Nursing Pillows
AGENCY: Consumer Product Safety Commission.
ACTION: Notice of proposed rulemaking.
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SUMMARY: The Commission is proposing to exempt the Boston Billow
Nursing Pillow and substantially similar nursing pillows from the
Commission's regulations banning infant cushions/pillows set forth in
the Commission's regulations at 16 CFR 1500.18(a)(16)(i).
DATES: Written comments in response to this notice must be received by
October 3, 2008.
ADDRESSES: Comments should be submitted to the Office of the Secretary
by e-mail at cpsc-os@cpsc.gov, or mailed or delivered, preferably in
five copies, to the Office of the Secretary, Consumer Product Safety
Commission, 4330 East West Highway, Bethesda, Maryland 20814. Comments
may also be filed by facsimile to (301) 504-0127. Comments should be
captioned ``Infant Cushions/Pillows NPR.''
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 determine 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
[[Page 51385]]
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 advance notice of proposed rulemaking
(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. After review of the comments, incident
reports and other available information, the Commission determined
there was insufficient data or product information on infant cushions
or pillow-like products, other than the Boston Billow Nursing Pillow,
to proceed with further rulemaking on those products at this time.
Accordingly, a notice terminating the rulemaking on infant cushions/
pillows or pillow-like products intended for use by infants, other than
with respect to the Boston Billow Nursing Pillow and substantially
similar nursing pillows, appears elsewhere in this Federal Register.
C. The Proposed Exemption
The ban on infant cushions/pillows was promulgated pursuant to the
Federal Hazardous Substances Act (FHSA), 15 U.S.C. 1261 et seq. Section
2(f)(1)(D) of the FHSA defines ``hazardous substance'' to include any
toy or other article intended for use by children which the Commission
determines, by regulation, presents an electrical, mechanical, or
thermal hazard. 15 U.S.C. 1261(f)(1)(D). An article may present a
mechanical hazard if its design or manufacture presents an unreasonable
risk of personal injury or illness during normal use or when subjected
to reasonably foreseeable damage or abuse. 15 U.S.C. 1261(s). To grant
Boston Billows' request for an exemption, the Commission must find that
the Boston Billow Nursing Pillow does not present an unreasonable risk
of injury from the mechanical hazard that the banning rule was intended
to prevent.
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 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 four-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 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
[[Page 51386]]
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.
In light of the ongoing risks posed by infant cushions/pillows when
used in the sleep environment, the Commission found no justification
for repealing the ban on infant cushions/pillows at this time. However,
nursing pillows perform a related but different function than infant
cushions/pillows. The purpose of nursing pillows is to provide a place
for the mother to rest her arms while breastfeeding. The nursing pillow
may also serve to give moldable but firm support to enhance comfort
during extended periods when changing position during breastfeeding is
difficult. The main risk of suffocation arises if the nursing pillow
enters into the infant sleeping environment because suffocation can
occur if children fall asleep on them in the prone position. However,
an infant placed to sleep on any pillow or cushion, including a nursing
pillow, in the prone position, is at risk for suffocation, regardless
of size, type, shape of pillow or filling. Staff's review showed that
when used for its intended purpose--nursing--the risk of infant
suffocation on nursing pillows, including the Boston Billow Nursing
Pillow, is very low. Staff estimates that 900,000 new nursing pillows
are sold annually and that nursing pillows were used by approximately
1.8 million mothers in 2004. Exempting the Boston Billow Nursing Pillow
would increase consumer choice by allowing consumers an alternative to
the nursing pillows already in the marketplace. Based on the staff's
assessment, the Commission preliminarily concludes that an exemption
from the ban on infant cushions/pillows should be granted for the
Boston Billow Nursing Pillow and substantially similar nursing
pillows.\1\
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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 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.
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D. Regulatory Flexibility Act Certification
Under the Regulatory Flexibility Act (RFA), when an agency issues a
proposed rule, it generally must prepare an initial regulatory
flexibility analysis describing the impact the proposed rule is
expected to have on small entities. 5 U.S.C. 603. The RFA does not
require a regulatory flexibility analysis if the head of the agency
certifies that the rule will not have a significant effect on a
substantial number of small entities.
The proposed exemption gives all companies more flexibility in the
choice of material used in manufacturing nursing pillows. The exemption
is deregulatory in nature and will not impose any additional costs on
businesses of any size. Consequently, the Commission concludes that the
proposed amendment exempting the Boston Billow Nursing Pillow and
substantially similar nursing pillows would not have a significant
impact on a substantial number of small entities.
E. Environmental Considerations
Generally, CPSC rules are considered to ``have little or no
potential for affecting the human environment,'' and environmental
assessments are not usually prepared for these rules (see 16 CFR
1021.5(c)(1)). Nothing in this proposed rule alters that expectation.
Therefore, the Commission does not expect the proposal to have any
negative environmental impact.
F. Executive Orders
According to Executive Order 12988 (February 5, 1996), agencies
must state in clear language the preemptive effect, if any, of new
regulations. The preemptive effect of this proposed regulation is
stated in section 18 of the FHSA. 15 U.S.C. 1261n.
List of Subjects in 16 CFR Part 1500
Consumer protection, Hazardous materials, Hazardous substances,
Imports, Infants and children, Labeling, Law enforcement, and Toys.
G. Conclusion
For the reasons stated above, the Commission proposes to amend
title 16 of the Code of Federal Regulations as follows:
PART 1500--HAZARDOUS SUBSTANCES AND ARTICLES: ADMINISTRATION AND
ENFORCEMENT REGULATIONS
1. The authority for part 1500 continues to read as follows:
Authority: 15 U.S.C. 1261-1278.
2. Section 1500.86 is amended by adding a new paragraph (a)(9) to
read as follows:
Sec. 1500.86 Exemptions from classification as banned toy or other
banned article for use by children.
(a) * * *
(9) Boston Billow Nursing Pillow and substantially similar nursing
pillows that may otherwise meet the criteria of the banned infant
cushion/pillow at 16 CFR 1500.18(a)(16)(i).
Dated: August 27, 2008.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. E8-20280 Filed 9-2-08; 8:45 am]
BILLING CODE 6355-01-P