[Federal Register Volume 73, Number 171 (Wednesday, September 3, 2008)]
[Proposed Rules]
[Pages 51384-51386]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-20280]


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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 [email protected], 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 [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 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