Infant Cushions/Pillows; Termination of Rulemaking Other Than With Respect to Boston Billow Nursing Pillow and Substantially Similar Nursing Pillows, 51386-51388 [E8-20282]
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yshivers on PROD1PC62 with PROPOSALS
51386
Federal Register / Vol. 73, No. 171 / Wednesday, September 3, 2008 / Proposed Rules
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
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15:14 Sep 02, 2008
Jkt 214001
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
Imports, Infants and children, Labeling,
Law enforcement, and Toys.
D. Regulatory Flexibility Act
Certification
PART 1500—HAZARDOUS
SUBSTANCES AND ARTICLES:
ADMINISTRATION AND
ENFORCEMENT REGULATIONS
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.
G. Conclusion
For the reasons stated above, the
Commission proposes to amend title 16
of the Code of Federal Regulations as
follows:
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:
§ 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
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
List of Subjects in 16 CFR Part 1500
Consumer protection, Hazardous
materials, Hazardous substances,
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.
Frm 00009
Fmt 4702
16 CFR Part 1500
Infant Cushions/Pillows; Termination
of Rulemaking Other Than With
Respect to Boston Billow Nursing
Pillow and Substantially Similar
Nursing Pillows
Consumer Product Safety
Commission.
ACTION: Advance notice of proposed
rulemaking; partial withdrawal.
AGENCY:
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.
PO 00000
CONSUMER PRODUCT SAFETY
COMMISSION
Sfmt 4702
SUMMARY: On September 27, 2006, the
Commission issued an advance notice of
proposed rulemaking (ANPR) to assess
whether a rulemaking was necessary to
address any unreasonable risk of injury
or death which may be associated with
the proliferation of infant cushions/
pillows and pillow-like products
intended for infants in the marketplace,
including the Boston Billow Nursing
Pillow. 71 FR 56418. After review of the
comments, incident reports and other
available information, the Commission
has determined there is insufficient data
or product information on infant
cushions/pillows or pillow-like
E:\FR\FM\03SEP1.SGM
03SEP1
Federal Register / Vol. 73, No. 171 / Wednesday, September 3, 2008 / Proposed Rules
products, other than the Boston Billow
Nursing Pillow and substantially similar
nursing pillows, to proceed with further
rulemaking on those products at this
time. Based on these findings, the
Commission terminates the infant
cushion/pillow rulemaking other than
with respect to the Boston Billow
Nursing Pillow and substantially similar
nursing pillows.
The partial termination of the
advance notice of proposed rulemaking
that published in the Federal Register
September 27, 2006 (71 FR 56418) is
effective September 3, 2008.
DATES:
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:
yshivers on PROD1PC62 with PROPOSALS
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 assess
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.
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.
VerDate Aug<31>2005
15:14 Sep 02, 2008
Jkt 214001
B. The ANPR
The Commission issued an 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.
C. Incident Data
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 vast
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 4-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.
PO 00000
Frm 00010
Fmt 4702
Sfmt 4702
51387
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 crescentshaped 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
E:\FR\FM\03SEP1.SGM
03SEP1
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Federal Register / Vol. 73, No. 171 / Wednesday, September 3, 2008 / Proposed Rules
yshivers on PROD1PC62 with PROPOSALS
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 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.
D. Conclusion
In light of the ongoing risks posed by
infant cushions/pillows when used in
the sleep environment, the Commission
finds no justification for repealing the
ban on infant cushions/pillows at this
time. Moreover, after review of the
comments, incident reports and other
available information, the Commission
determines there is insufficient data or
product information on infant cushions/
pillows or pillow-like products
intended for infants, other than with
respect to the Boston Billow Nursing
Pillow and substantially similar nursing
pillows, to proceed with further
rulemaking on those products at this
time. Thus, the Commission is
terminating the rulemaking on infant
cushions/pillows or pillow-like
products, other than with respect to the
Boston Billow Nursing Pillow and
substantially similar nursing pillows
effective upon publication in the
Federal Register for good cause shown
VerDate Aug<31>2005
15:14 Sep 02, 2008
Jkt 214001
in accordance with 5 U.S.C. 553(d)(3).1
A proposed exemption from the ban for
the Boston Billow Nursing Pillow and
substantially similar nursing pillows
appears elsewhere in this Federal
Register.2
Dated: August 27, 2008.
Todd A. Stevenson,
Secretary, Consumer Product Safety
Commission.
[FR Doc. E8–20282 Filed 9–2–08; 8:45 am]
BILLING CODE 6355–01–P
DEPARTMENT OF AGRICULTURE
Forest Service
36 CFR Part 223
RIN 0596–AC79
Sale and Disposal of National Forest
Service System Timber; Timber Sale
Contracts; Market-Related Contract
Term Additions
Forest Service, USDA.
Proposed rule; request for
public comment.
AGENCY:
ACTION:
The Forest Service proposes
amending its regulations to expand the
maximum amount of additional time
certain contracts may receive when
there is a continuous and prolonged
drastic reduction in wood product
prices for 21⁄2 years or longer.
Additionally, the proposed rule
modifies the procedure for selecting the
producer price index to be used in
establishing market-related contract
term additions and emergency rate
redeterminations. Finally, this proposed
rule makes a change to the amount of
additional market-related contract term
addition time that may be added to
timber sale contracts when the normal
operating season specified in a contract
is less than three months.
DATES: Comments must be received in
writing on or before October 3, 2008.
ADDRESSES: Written comments
concerning this notice should be
addressed to USDA Forest Service,
Director of Forest Management, 1400
SUMMARY:
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 terminating the rulemaking other
than with respect to the Boston Billow Nursing
Pillow and substantially similar nursing pillows.
2 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.
PO 00000
Frm 00011
Fmt 4702
Sfmt 4702
Independence Avenue, SW., Mail Stop
1103, Washington, DC 20250–1103.
Comments may also be sent via e-mail
to mrcta@fs.fed.us, or via facsimile to
Lathrop Smith at (202) 205–1045.
All comments, including names and
addresses when provided, are placed in
the record and are available for public
inspection and copying. The public may
inspect comments received at the office
of the Director of Forest Management,
Third Floor, Southwest Wing, Yates
Building, 201 14th Street, SW.,
Washington, DC. Visitors are
encouraged to call ahead to (202) 205–
1496 to facilitate entry to the building.
FOR FURTHER INFORMATION CONTACT:
Lathrop Smith, Forest Management
staff, at (202) 205–0858, or Richard
Fitzgerald, Forest Management staff, at
(202) 205–1753.
Individuals who use
telecommunication devices for the deaf
(TDD) may call the Federal Information
Relay Service (FIRS) at 1–800–877–8339
between 8 a.m. and 8 p.m., Eastern
Standard Time, Monday through Friday.
SUPPLEMENTARY INFORMATION:
Background
Prior to 1980, purchasers of National
Forest timber defaulted very few timber
sale contracts. Cyclic fluctuations in
forest products markets occurred but
were of comparatively short duration
and limited impact. Forest Service
timber sale contract terms were often as
long as the cycles making it possible to
overlap the market price cycles. Prior to
1980, it also was believed that the longterm projection for forest products
prices indicated a continuing trend of
price increases. Under those
circumstances a purchaser could
usually schedule a sale’s harvest for a
time when the markets were good or
were at least good enough that the
purchaser would not lose more money
operating a sale than would be lost in
a default.
Beginning in 1980, the forest products
market began a serious and dramatic
decline, leaving a large number of
purchasers with timber sales bid at
prices far higher than the market was
bringing. Faced with the likelihood of
massive defaults and attendant adverse
economic impacts on industry and
dependent communities, the
government began taking steps to
respond to the adverse economic
impacts. In 1980, 1981, and 1982, the
Chief of the Forest Service granted
timber sale contract term extensions
based on findings of substantial
overriding public interest (48 FR 38862).
The intent of these extensions was to
provide purchasers additional contract
E:\FR\FM\03SEP1.SGM
03SEP1
]]>Agencies
[Federal Register Volume 73, Number 171 (Wednesday, September 3, 2008)]
[Proposed Rules]
[Pages 51386-51388]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-20282]
-----------------------------------------------------------------------
CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Part 1500
Infant Cushions/Pillows; Termination of Rulemaking Other Than
With Respect to Boston Billow Nursing Pillow and Substantially Similar
Nursing Pillows
AGENCY: Consumer Product Safety Commission.
ACTION: Advance notice of proposed rulemaking; partial withdrawal.
-----------------------------------------------------------------------
SUMMARY: On September 27, 2006, the Commission issued an advance notice
of proposed rulemaking (ANPR) to assess whether a rulemaking was
necessary to address any unreasonable risk of injury or death which may
be associated with the proliferation of infant cushions/pillows and
pillow-like products intended for infants in the marketplace, including
the Boston Billow Nursing Pillow. 71 FR 56418. After review of the
comments, incident reports and other available information, the
Commission has determined there is insufficient data or product
information on infant cushions/pillows or pillow-like
[[Page 51387]]
products, other than the Boston Billow Nursing Pillow and substantially
similar nursing pillows, to proceed with further rulemaking on those
products at this time. Based on these findings, the Commission
terminates the infant cushion/pillow rulemaking other than with respect
to the Boston Billow Nursing Pillow and substantially similar nursing
pillows.
DATES: The partial termination of the advance notice of proposed
rulemaking that published in the Federal Register September 27, 2006
(71 FR 56418) is effective September 3, 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 assess 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.
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 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.
C. Incident Data
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 vast 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 4-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
[[Page 51388]]
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 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.
D. Conclusion
In light of the ongoing risks posed by infant cushions/pillows when
used in the sleep environment, the Commission finds no justification
for repealing the ban on infant cushions/pillows at this time.
Moreover, after review of the comments, incident reports and other
available information, the Commission determines there is insufficient
data or product information on infant cushions/pillows or pillow-like
products intended for infants, other than with respect to the Boston
Billow Nursing Pillow and substantially similar nursing pillows, to
proceed with further rulemaking on those products at this time. Thus,
the Commission is terminating the rulemaking on infant cushions/pillows
or pillow-like products, other than with respect to the Boston Billow
Nursing Pillow and substantially similar nursing pillows effective upon
publication in the Federal Register for good cause shown in accordance
with 5 U.S.C. 553(d)(3).\1\ A proposed exemption from the ban for the
Boston Billow Nursing Pillow and substantially similar nursing pillows
appears elsewhere in this Federal Register.\2\
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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 terminating the rulemaking other
than with respect to the Boston Billow Nursing Pillow and
substantially similar nursing pillows.
\2\ 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.
Dated: August 27, 2008.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. E8-20282 Filed 9-2-08; 8:45 am]
BILLING CODE 6355-01-P
