Exemption From Classification as Banned Hazardous Substance; Exemption for Boston Billow Nursing Pillow and Substantially Similar Nursing Pillows, 77493-77495 [E8-30248]
Download as PDF
<![CDATA[
Federal Register / Vol. 73, No. 245 / Friday, December 19, 2008 / Rules and Regulations
Federal Hazardous Substances Act (15
U.S.C. 1261(q)).
■ 3. Amend § 1303.2 by revising
paragraph (b)(2) to read as follows:
List of Subjects in 16 CFR Part 1303
Consumer protection, Hazardous
substances, Infants and children,
Labeling, Lead poisoning.
§ 1303.2
Accordingly, 16 CFR part 1303 is
amended as follows:
■
PART 1303—BAN LEAD-CONTAINING
PAINT AND CERTAIN CONSUMER
PRODUCTS BEARING LEADCONTAINING PAINT
1. The authority citation for part 1303
is revised to read as follows:
■
Authority: Secs. 8, 9, 86 Stat. 1215–1217,
as amended 90 Stat. 506, 122 Stat. 3016, (15
U.S.C. 2057, 2058), Sec. 101, 122 Stat. 3016.
2. Amend § 1303.1 by revising
paragraphs (a) introductory text and (c)
and adding paragraph (d) to read as
follows:
■
§ 1303.1
Scope and application.
(a) In this part 1303, the Consumer
Product Safety Commission declares
that paint and similar surface-coating
materials for consumer use that contain
lead or lead compounds and in which
the lead content (calculated as lead
metal) is in excess of 0.06 percent (0.06
percent is reduced to 0.009 percent
effective August 14, 2009 as mandated
by Congress in section 101(f) of the
Consumer Product Safety Improvement
Act of 2008, Pub. L. 110–314) of the
weight of the total nonvolatile content
of the paint or the weight of the dried
paint film (which paint and similar
surface-coating materials are referred to
hereafter as ‘‘lead-containing paint’’) are
banned hazardous products under
sections 8 and 9 of the Consumer
Product Safety Act (CPSA), 15 U.S.C.
2057, 2058. The following consumer
products are also declared to be banned
hazardous products:
*
*
*
*
*
(c) The Commission has issued the
ban because it has found that there is an
unreasonable risk of lead poisoning in
children associated with lead content of
over 0.06 percent in paints and coatings
to which children have access and that
no feasible consumer product safety
standard under the CPSA would
adequately protect the public from this
risk. The 0.06 percent is reduced to
0.009 percent effective August 14, 2009
as mandated by Congress in section
101(f) of the Consumer Product Safety
Improvement Act of 2008, Public Law
110–314.
(d) Any ban or rule promulgated
under 16 CFR 1303.1 shall be
considered a regulation of the
Commission promulgated under or for
the enforcement of section 2(q) of the
VerDate Aug<31>2005
14:44 Dec 18, 2008
Jkt 217001
Definitions.
*
*
*
*
*
(b) * * *
(2) Lead-containing paint means paint
or other similar surface coating
materials containing lead or lead
compounds and in which the lead
content (calculated as lead metal) is in
excess of 0.06 percent (0.06 percent is
reduced to 0.009 percent effective
August 14, 2009) by weight of the total
nonvolatile content of the paint or the
weight of the dried paint film.
*
*
*
*
*
Dated: December 15, 2008.
Todd A. Stevenson,
Secretary, Consumer Product Safety
Commission.
[FR Doc. E8–30238 Filed 12–18–08; 8:45 am]
BILLING CODE 6355–01–P
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.
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
PO 00000
Frm 00021
Fmt 4700
Sfmt 4700
77493
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, Cshaped 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.
E:\FR\FM\19DER1.SGM
19DER1
77494
Federal Register / Vol. 73, No. 245 / Friday, December 19, 2008 / Rules and Regulations
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
VerDate Aug<31>2005
14:44 Dec 18, 2008
Jkt 217001
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
PO 00000
Frm 00022
Fmt 4700
Sfmt 4700
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
E:\FR\FM\19DER1.SGM
19DER1
Federal Register / Vol. 73, No. 245 / Friday, December 19, 2008 / Rules and Regulations
infant suffocation deaths caused by
adult pillows, sofa cushions, and other
pillows as well as further reducing
incidents involving SIDS.
if any, of new regulations. The
preemptive effect of this exemption is
stated in section 18 of the FHSA. 15
U.S.C. 1261n.
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.
List of Subjects in 16 CFR Part 1500
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,
VerDate Aug<31>2005
14:44 Dec 18, 2008
Jkt 217001
Consumer protection, Hazardous
materials, Hazardous substances,
Imports, Infants and children, Labeling,
Law enforcement, and Toys.
K. Conclusion
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
1. The authority for part 1500
continues to read as follows:
■
Authority: 15 U.S.C. 1261–1278.
2. Amend section 1500.18 by revising
paragraph (a)(16)(i) introductory text to
read as follows:
■
§ 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
§ 1500.86(a)(9)):
*
*
*
*
*
3. Section 1500.86 is amended by
adding a new paragraph (a)(9) to read as
follows:
■
§ 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]
Frm 00023
Fmt 4700
DEPARTMENT OF TRANSPORTATION
Federal Highway Administration
23 CFR Parts 620, 635, 636, and 710
[FHWA Docket No. FHWA–2008–0136]
RIN 2125–AF29
Fair Market Value and Design-Build
Amendments
AGENCY: Federal Highway
Administration (FHWA), DOT.
ACTION: Final rule.
SUMMARY: The FHWA is revising its
regulations to require State departments
of transportation (DOT) and other public
authorities to obtain fair market value as
part of any concession agreement
involving a facility acquired or
constructed with Federal-aid highway
funds. Additionally, the FHWA is
revising its regulations to permit public
agencies to compete against private
entities for the right to obtain a
concession agreement involving such
facilities. Also, the FHWA is revising its
design-build regulations to permit
contracting agencies to incorporate
unsuccessful offerors’ ideas into a
design-build contract upon the
acceptance of a stipend.
DATES: Effective Dates: This rule is
effective January 18, 2009.
FOR FURTHER INFORMATION CONTACT: Mr.
Marcus J. Lemon, Chief Counsel, Mr.
Michael Harkins, Office of Chief
Counsel, or Mr. Steve Rochlis, Office of
Chief Counsel, (202) 366–0740, Federal
Highway Administration, 1200 New
Jersey Avenue, SE., Washington, DC
20590. Office hours are from 7:45 a.m.
to 4:15 p.m., e.t., Monday through
Friday, except Federal holidays.
SUPPLEMENTARY INFORMATION:
Electronic Access and Filing
Internet users may access this
document, the notice of proposed
rulemaking (NPRM), and all comments
received by the U.S. DOT by visiting
https://www.regulations.gov. It is
available 24 hours each day, 365 days
each year. Electronic submission and
retrieval help and guidelines are
available under the help section of the
Web site.
An electronic copy of this document
may also be downloaded by accessing
the Office of the Federal Register’s home
page at: https://www.archives.gov or the
Government Printing Office’s Web page
at https://www.gpoaccess.gov/nara.
I. Background
In recent years, some State and local
governments have entered into
BILLING CODE 6355–01–P
PO 00000
77495
Sfmt 4700
E:\FR\FM\19DER1.SGM
19DER1
]]>Agencies
[Federal Register Volume 73, Number 245 (Friday, December 19, 2008)]
[Rules and Regulations]
[Pages 77493-77495]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-30248]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
