[Federal Register Volume 71, Number 187 (Wednesday, September 27, 2006)]
[Proposed Rules]
[Pages 56418-56420]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-8265]
=======================================================================
-----------------------------------------------------------------------
CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Part 1500
Infant Cushions/Pillows; Advance Notice of Proposed Rulemaking;
Request for Comments and Information
AGENCY: Consumer Product Safety Commission.
ACTION: Advance notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: Under the Commission's regulations, any infant cushion/pillow
that meets the criteria set forth in the Commission's regulations at 16
CFR 1500.18(a)(16)(i), is currently a banned hazardous substance. In
July 2005, the Commission received a petition from Boston Billows, Inc.
asking the Commission to amend 16 CFR 1500.18(a)(16)(i)(A)-(E) to
provide an exception to the ban when the product is specifically
designed, intended and promoted for mothers to use when breastfeeding
and requested by a Pediatrician or a Board Certified Lactation
Consultant. On July 10, 2006, the Commission voted to grant the
petition to the extent it requests the Commission to commence a
rulemaking process to evaluate whether the Boston Billow nursing pillow
and other infant cushions/pillows or pillow-like products \1\ could
result in an amendment to the existing ban. Accordingly, this advance
notice of proposed rulemaking (ANPR) initiates a rulemaking proceeding
that could result in an amendment to the existing ban on infant
cushions/pillows. This proceeding is commenced under the Federal
Hazardous Substances Act (FHSA).
---------------------------------------------------------------------------
\1\ The term ``infant cushions/pillows or pillow-like products''
used throughout this ANPR means infant cushions/pillows or pillow-
like products intended for use by infants less than one year of age,
including, but not limited to, nursing pillows, infant beanbag seats
or carriers, infant sleep aid pillows or similar products.
---------------------------------------------------------------------------
By this notice, the Commission solicits written comments from
interested persons concerning, in general, the risk of injury
associated with infant cushions/pillows or pillow-like products. The
Commission requests written comments on the regulatory alternatives
discussed in this notice and other possible ways to address these
risks. The Commission also invites interested persons to submit an
existing standard, or a statement of intent to modify or develop a
voluntary standard, to address the risk of injury identified in the
notice.
DATES: Written comments and submissions in response to this notice must
be received by November 27, 2006.
ADDRESSES: Comments should be submitted to the Office of the Secretary
by e-mail at [email protected], or mailed or delivered, preferably in
five copies, to the Office of the Secretary, Consumer Product Safety
Commission, 4330 East West Highway, Bethesda, Maryland 20814. Comments
may also be filed by facsimile to (301) 504-0127. Comments should be
captioned ``Infant Cushions/Pillows ANPR.''
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''). The Commission
initiated a rulemaking proceeding to determine whether a ban was
necessary to address the unreasonable risks of injury and deaths
associated with these types of infant cushions/pillows. 55 FR 42202.
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 under 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 submitted a petition requesting an
amendment to 16 CFR 1500.18(a)(16)(i)(A)-(E) to allow an exception to
the ban when the product is specifically designed, intended and
promoted for mothers to use when breastfeeding and requested by a
Pediatrician or a Board Certified Lactation Consultant. The petitioner
is the manufacturer of the Boston Billow nursing pillow, which is
purportedly designed and promoted to aid mothers when breastfeeding.
The Commission published a notice in the Federal Register on
October 13, 2005, requesting comments on the petition. 70 FR 59726. The
Commission received a total of 5 comments on the petition. The
Commission staff reviewed the petition, the comments, and available
information and prepared a briefing package for the Commission
(available at http://www.cpsc.gov). On July 10, 2006, the Commission
voted 3-0 to grant the petition to commence an ANPR.
B. The Product
There has been a proliferation of infant cushions/pillows or
pillow-like products in the marketplace in all different shapes and
sizes that meet some or all of the criteria set forth in the ban. For
example, an infant cushion may have a flexible fabric covering, which
conforms to the body or face of an infant, and is used by a child under
one year of age, but contains a filling that is made of cotton or
polyfill, instead of being filled with a granular material, such as
polystyrene beads or pellets. The Commission believes that an
examination of these different types of infant cushions/pillows or
pillow-like products may now be warranted, given the proliferation of
these products in the marketplace and their varying characteristics,
including sizes, shapes and uses.
C. The Risk of Injury
Between 1985 and 1992, there were 35 infant deaths associated with
the use of infant cushions/pillows. The Commission is unaware of any
deaths or injuries associated with infant cushions/pillows since the
ban on infant cushions and pillows went into effect in 1992. At the
time of the ban, the recommendation from pediatricians was to place
infants to sleep in the prone position (on the
[[Page 56419]]
stomach). In all infant cushion/pillow related deaths where the
position could be ascertained, the infant was in the prone position.
The prone position was likely a major contributing factor to the
suffocation and death of the infant.
Since the ban and following considerable evidence that sleeping in
the prone position is a significant risk factor in sudden infant death
syndrome (SIDS) incidents, a nationwide education campaign was launched
in the United States recommending that infants be placed on their backs
when put to sleep (Back to Sleep campaign). Since the launch of the
Back to Sleep campaign there has been a dramatic drop in the number of
SIDS incidents in the United States. The guidance provided by the
campaign may make it less likely that infants will be placed on their
stomachs to sleep, reducing the likelihood of suffocation. The
Commission staff continues to believe that infant beanbag cushions, and
similar infant cushions/pillows (including the Boston Billow nursing
pillow) pose suffocation risks to infants if infants are placed in the
prone position on them for sleeping. The same risk is not likely to be
posed when infants are placed in the supine position. Accordingly, the
Commission believes that the current regulation should be reexamined to
evaluate the likely use patterns of these products, and any associated
risk of injury.
D. Relevant Statutory Provisions
The petition was docketed under the 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 that 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 ``in normal use or when subjected to
reasonably foreseeable damage or abuse, its design or manufacture
presents an unreasonable risk of personal injury or illness.'' 15
U.S.C. 1261(s).
Under section 2(q)(1)(A) of the FHSA, a toy, or other article
intended for use by children, which is or contains a hazardous
substance accessible by a child is a ``banned hazardous substance.'' 15
U.S.C. 1261(q)(1)(A). Currently, the Commission bans any article known
as an infant cushion or infant pillow which contains a flexible fabric
covering, is loosely filled with granular material (including but not
limited to, polystyrene beads or pellets), is easily flattened, is
capable of conforming to the body or face of an infant and is intended
or promoted for use by children under one year of age. 16 CFR
1500.18(a)(16)(i).
Section 3(f) through 3(i) of the FHSA, 15 U.S.C. 1262(f)-(i),
governs a proceeding to promulgate a regulation determining that a toy
or other children's article presents an electrical, mechanical, or
thermal hazard. As provided in section 3(f), this proceeding is
commenced by issuance of this ANPR. After considering any comments
submitted in response to this ANPR, the Commission will decide whether
to issue a proposed rule and a preliminary regulatory analysis in
accordance with section 3(h) of the FHSA. If a proposed rule is issued,
the Commission would then consider the comments received in response to
the proposed rule in deciding whether to issue a final rule and a final
regulatory analysis. 15 U.S.C. 1262(i).
E. Regulatory Alternatives
One or more of the following alternatives could be used to address
the issues identified with infant cushions/ pillows and pillow-like
products.
1. Amend regulation to allow exemption for certain infant cushions/
pillows and pillow-like products. The Commission could issue a rule
amending the existing ban to exempt certain infant cushions/pillows and
pillow-like products, such as the Boston Billows product, which
currently fall within the scope of the ban, if the Commission finds
that such products do not present an unreasonable risk of injury. If an
exemption is granted, the Commission could still consider a labeling
requirement if it found that such warnings were necessary to adequately
protect children from hazards associated with infant cushions/pillows
and pillow-like products.
2. Amend regulation to delete, revise or add criteria to the ban.
The Commission could issue a rule amending the existing ban by
deleting, revising or adding criteria, as the Commission found
necessary to adequately address any risk of injury associated with
infant cushions/pillows and pillow-like products used for sleeping.
Thus, the Commission could either expand or narrow the ban to treat
products of similar risk consistently.
3. Leave existing regulation unchanged. The Commission could leave
the existing ban on infant cushions/pillows unchanged if the Commission
finds that the existing banning criteria adequately address the risk of
injury associated with infant cushions/pillows and pillow-like
products.
4. Repeal existing regulation. The Commission could repeal the
existing ban on infant cushions/pillows if the Commission finds that
the currently banned infant cushions/pillows and pillow-like products
no longer present an unreasonable risk of injury. If the existing
regulation is repealed, the Commission has authority under section 15
of the FHSA, 15 U.S.C. 1274, to pursue corrective actions on a case-by-
case basis. In addition, if the ban is repealed, the Commission could
still consider a labeling requirement if it found that such warnings
were necessary to adequately protect children from hazards associated
with infant cushions/pillows and pillow-like products.
F. Solicitation of Information and Comments
This ANPR is the first step in a proceeding which could result in
an amendment of the current ban on infant cushions/pillows. All
interested persons are invited to submit to the Commission their
comments on any aspect of the alternatives discussed above. In
particular, the Commission solicits the following additional
information on infant cushions/pillows or pillow-like products intended
for use by infants less than one year of age, including, but not
limited to, nursing pillows, infant beanbag seats or carriers, infant
wedges, infant sleep aid pillows, or similar products:
1. The models and model numbers of infant cushions/pillows and
pillow-like products and the annual sales figures for each model from
the time such product was made available in the marketplace;
2. The names and addresses of manufacturers and distributors who
make and sell infant cushions/pillows and pillow-like products;
3. Information on any children believed to have been injured or
killed as a result of infant cushions/pillows and pillow-like products;
4. The circumstances under which these injuries and deaths occur,
including the ages of the victims;
5. The current regulation lists five criteria that define a banned
infant cushion/pillow. Should any of these criteria be revised? Should
any of these criteria be deleted? Are there criteria not in the current
ban that should be added?
6. Whether the risk of injuries and deaths could be reasonably
reduced by (a) Limiting sale of infant cushions/pillows to certain
healthcare products firms or medical professionals, (b) restricting a
consumer's purchase of an infant cushion/pillow to consumers with a
medical professional's written recommendation or prescription, and (c)
[[Page 56420]]
whether any such point-of-sale restriction would be practical or
effective;
7. Other information on the potential costs and benefits of the
regulatory options;
8. The likelihood and nature of any significant economic impact of
a rule on small entities;
9. The basis for, and costs and benefits of, mandating a labeling
or instructions requirement.
Also, in accordance with section 3(f) of the FHSA, the Commission
requests:
(1) Written comments with respect to the risk of injury identified
by the Commission, the regulatory alternatives being considered, and
other possible alternatives for addressing the risk;
(2) Any existing standard or portion of a standard which could be
issued as a proposed regulation;
(3) A statement of intention to modify or develop a voluntary
standard to address the risk of injury discussed in this notice, along
with a description of a plan to do so.
Comments and other submissions should be captioned ``Infant
Cushions/Pillows ANPR'' and e-mailed to [email protected] or mailed or
delivered, preferably in five copies, to the Office of the Secretary at
Consumer Product Safety Commission, 4330 East-West Highway, Bethesda,
Maryland 20814. Comments and other submissions may also be filed by
facsimile to (301) 504-0127. All comments and other submissions must be
received by November 27, 2006.
Dated: September 21, 2006.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. 06-8265 Filed 9-26-06; 8:45 am]
BILLING CODE 6355-01-P