[Federal Register Volume 73, Number 245 (Friday, December 19, 2008)]
[Rules and Regulations]
[Pages 77493-77495]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-30248]


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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 [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 
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