[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