[Federal Register: December 19, 2008 (Volume 73, Number 245)]
[Rules and Regulations]
[Page 77493-77495]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19de08-4]
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CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Part 1500
Exemption From Classification as Banned Hazardous Substance;
Exemption for Boston Billow Nursing Pillow and Substantially Similar
Nursing Pillows
AGENCY: Consumer Product Safety Commission.
ACTION: Final rule.
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SUMMARY: The Commission is issuing a rule 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: The rule becomes effective on December 19, 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 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
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.
B. Petition
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.
C. 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.
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, the Commission
issued a notice in the Federal Register on September 3, 2008,
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.
73 FR 51386.
[[Page 77494]]
D. 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.
The Commission preliminarily found that based on the incident data
on infant cushions and nursing pillows for the period of January 1992
through May 2008, there have been no reported deaths associated with
infant cushions meeting the definition of a banned infant cushion/
pillow since 1992. However, there were 531 infant deaths associated
with pillows and cushions that did not meet the definition of a banned
infant cushion/pillow. The majority of these incidents involved adult
pillows and sofa cushions which possessed 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.
The Commission also preliminarily found 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. The
Commission preliminarily determined that the analysis of the data does
not reveal an increased risk due to any specific type of pillow or
cushion filling, but rather it was the softness and malleability which
are inherent properties of pillows that are the primary risk factors.
Although the comparative risk of suffocation based upon filling was
unknown, the greatest common risk factor was that infants were found in
the prone position, face down, in the majority of the 531 deaths.
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. The Commission's preliminary
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. Accordingly, based on the staff's
assessment, the Commission issued a notice of proposed rulemaking (NPR)
proposing an exemption for the Boston Billow Nursing Pillow and
substantially similar nursing pillows that would otherwise be banned
under the Commission's regulations banning infant cushions/pillows. 73
FR 51384.
E. Comments on the NPR
Seven comments were received on the NPR from board certified
lactation consultants, all in support of an exemption of the Boston
Billow Nursing Pillow. According to the commenters, the unique design
and flexibility of the Boston Billow Nursing Pillow provides for better
positioning and comfort of breastfeeding mothers, particularly mothers
who have delivered by Caesarean section, had post-delivery surgery, or
were nursing premature infants.
F. The Final Rule
Based on the staff's assessment, the incident data, and the
comments, the Commission 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. A substantially
similar nursing pillow is a pillow designed to be used only as a
nursing aide for breastfeeding mothers. For example, one that is
tubular in form, C- or crescent-shaped to fit around a nursing mother's
waist, round in circumference and filled with granular material. An
estimated 900,000 new nursing pillows are sold annually and nursing
pillows are used by approximately 1.8 million mothers. Exempting the
Boston Billow Nursing Pillow would increase consumer choice by allowing
consumers an alternative to the nursing pillows already in the
marketplace.
However, the Commission continues to emphasize that 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 of Sudden Infant Death Syndrome (SIDS), recommended that
babies always be placed on their backs when put to sleep. As a result
of this campaign, 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, the Commission has found that 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, the Commission 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, the Commission intends to increase its dissemination of
information 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
[[Page 77495]]
infant suffocation deaths caused by adult pillows, sofa cushions, and
other pillows as well as further reducing incidents involving SIDS.
G. Effective Date
This rule exempts the Boston Billow Nursing Pillow and
substantially similar nursing pillows that would otherwise be banned
under the FHSA. Because the rule grants an exemption, it is not subject
to the requirement under the Administrative Procedure Act (APA) that a
rule must be published 30 days before it takes effect. 5 U.S.C.
553(d)(1). The rule lifts an existing restriction and allows a product
not previously permitted. Thus, the Commission believes it is
appropriate for the rule to become effective upon publication in the
Federal Register.
H. Impact on Small Businesses
The NPR discussed the Commission assessment of the impact that a
rule to exempt the Boston Billow Nursing Pillow and similar nursing
pillows might have on small businesses. There are approximately 15
firms that either manufacture or import nursing pillows. Most, if not
all, firms are considered to be small businesses. Because the exemption
is deregulatory in nature and will not increase production costs on
businesses, 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.
I. Environmental Considerations
The National Environmental Policy Act and the Council on
Environmental Quality Act regulations, and CPSC procedures for
environmental review require the Commission to assess the possible
environmental effects associated with the proposed exemption. As
discussed in the NPR, a proposed exemption for nursing pillows is
expected to have little or no potential for affecting the human
environment, and is considered to fall within the ``categorical
exclusions'' under the CPSC regulations that cover its environmental
review procedures (see 16 CFR 1021.5(c)(1)). The Commission concludes
that the rule would have no adverse effect on the environment and thus,
no environmental assessment or environmental impact statement is
required in this proceeding.
J. 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 exemption 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.
K. Conclusion
0
For the reasons stated above, the Commission amends title 16 of the
Code of Federal Regulations as follows:
PART 1500--HAZARDOUS SUBSTANCES AND ARTICLES: ADMINISTRATION AND
ENFORCEMENT REGULATIONS
0
1. The authority for part 1500 continues to read as follows:
Authority: 15 U.S.C. 1261-1278.
0
2. Amend section 1500.18 by revising paragraph (a)(16)(i) introductory
text to read as follows:
Sec. 1500.18 Banned toys and other banned articles intended for use
by children.
* * * * *
(a) * * *
(16) * * *
(i) Any article known as an ``infant cushion'' or ``infant
pillow,'' and any other similar article, which has all of the following
characteristics (But see Sec. 1500.86(a)(9)):
* * * * *
0
3. 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 are designed to be used only as a nursing aide for
breastfeeding mothers. For example, are tubular in form, C- or
crescent-shaped to fit around a nursing mother's waist, round in
circumference and filled with granular material.
Dated: December 15, 2008.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. E8-30248 Filed 12-18-08; 8:45 am]
BILLING CODE 6355-01-P