[Federal Register Volume 64, Number 123 (Monday, June 28, 1999)]
[Proposed Rules]
[Pages 34597-34607]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-16322]
[[Page 34597]]
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CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Parts 1615 and 1616
Standard for the Flammability of Children's Sleepwear: Sizes 0
through 6X; Standard for the Flammability of Children's Sleepwear:
Sizes 7 through 14; Withdrawal of Proposed Revocation of Amendments
AGENCY: Consumer Product Safety Commission.
ACTION: Withdrawal of proposed rule.
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SUMMARY: The Commission withdraws its proposed revocation of certain
amendments to the standards for the flammability of children's
sleepwear, sizes 0 through 6X and sizes 7 through 14. As directed by
the fiscal year 1999 appropriations legislation for the Departments of
Veterans Affairs and Housing and Urban Development, and several
independent agencies, including the Consumer Product Safety Commission,
the Commission previously proposed to revoke the sleepwear amendments.
In accordance with the appropriations legislation, the Commission has
considered all relevant comments and information and has determined not
to revoke the amendments. Elsewhere in this issue of the Federal
Register the Commission is modifying the amendments to require that
tight-fitting sleepwear bear a label and hangtag informing consumers
that the garments should fit snugly. Also in this issue of the Federal
Register the Commission corrects some misidentified references in the
amendments. In that notice the Commission is also clarifying the
definition of infant garments.
DATES: The proposed rule is withdrawn on June 28, 1999.
FOR FURTHER INFORMATION CONTACT: Marilyn Borsari, Office of Compliance,
Consumer Product Safety Commission, Washington, D.C. 20207; telephone
(301) 504-0400, extension 1370.
SUPPLEMENTARY INFORMATION:
A. The Decision
After considering reports issued by the General Accounting Office
and available information and comments, the Commission has decided to
withdraw the January 19, 1999 proposed revocation of exemptions from
the Commission's sleepwear standards. As explained in detail below, the
Commission believes the reasons for the exemptions remain
sound.1 In a separate notice published elsewhere in the
Federal Register, the Commission is issuing a rule modifying the 1996
amendments to require labeling and hangtags on tight-fitting
sleepwear.2 The labels and hangtags will inform consumers
that these garments are intended to be worn with a snug fit for safety.
Also in this issue of the Federal Register the Commission corrects some
misidentified references in the amendments. 3
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\1\ The Commission voted to withdraw the proposed revocation by
two to one. Commissioners Mary Gall and Thomas Moore voted in favor
of withdrawal while Chairman Ann Brown voted against it.
\2\ Commissioners Mary Gall and Thomas Moore voted to require
labeling. Chairman Ann Brown abstained.
\3\ Commissioners Mary Gall and Thomas Moore voted to issue the
corrections. Chairman Ann Brown abstained.
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B. Background
1. The Original Standards
Since the 1970's there have been federal flammability standards to
protect children whose sleepwear becomes ignited by a small open flame.
The Department of Commerce (``DOC'') issued the flammability standard
for children's sleepwear in sizes 0 through 6X (16 CFR Part 1615) in
1971. The Consumer Product Safety Commission issued the flammability
standard for children's sleepwear in sizes 7 through 14 (16 CFR Part
1616) in 1974.
Both of these standards were issued under section 4 of the
Flammable Fabrics Act (``FFA''), which authorizes flammability
standards for a fabric, related material or product when necessary to
``protect the public against unreasonable risk of the occurrence of
fire leading to death or personal injury, or significant property
damage.'' 15 U.S.C. 1193(a).
When the DOC issued the original standard in 1971, it relied upon
reports of cases in which people suffered burns from such activities as
cooking, smoking, burning trash, lighting furnaces, and while children
were playing with matches and lighters or contacting stove burners.
(DOC Analysis of Data from Apparel Burn Cases for Children's Sleepwear
Standard DOC PFC 3-70.) The flammability test that DOC issued focused
on burns resulting from these kinds of ignitions. It was not intended
to address all fires in which sleepwear happened to burn. For example,
the DOC excluded incidents involved wearing apparel contaminated by
flammable liquids when developing the standard because of the
variability and complexities involved. Rather, the purpose was to
``provide a high and effective level of protection to children
approximately 5 years of age and younger against unreasonable risk of
death or injury suffered as a result of ignition and continued burning
of sleepwear garments.'' 36 FR 14063 (July 29, 1971).
Once the Commission was established it took over administration of
the FFA and standards set under it. 15 U.S.C. 2079(b). In 1974, the
Commission issued a flammability standard for children's sleepwear in
sizes 7-14. 39 FR 15210. This standard was nearly identical to the
standard for smaller sized sleepwear.
Under both standards a specimen is exposed for 3 seconds to a small
open flame ignition source that resembles the type of flame that would
result from a child playing with matches or a lighter. The specimens
must self-extinguish, that is, they must stop burning when the ignition
source is removed. 16 CFR 1615.3 and 1616.3. Seams and trim of
sleepwear garments must also pass this test.
This is a performance test and does not require or prohibit any
type of fabric or mandate any flame-retardant treatment. Due to the
characteristics of certain fabrics, however, untreated cotton fabrics
generally will not pass the flammability test while some synthetic ones
do.
The standards apply to ``children's sleepwear,'' which before the
exemptions was defined as ``any product of wearing apparel'' in the
sizes covered by the standard ``such as nightgowns, pajamas, or similar
or related items, such as robes, intended to be worn primarily for
sleeping or activities related to sleeping.'' The standards exclude
diapers and underwear. 16 CFR 1615.1(a) and 1616.2 (a). The definition
has long engendered questions of what garments are intended for
sleeping or related activities.(59) 4
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\4\ Numbers in parentheses refer to documents in the List of
Relevant Documents at the end of this notice.
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2. The Exemptions
In the 1990's the Commission began considering whether the
standards could be amended so that close-fitting sleepwear could be
made out of cotton without increasing the risk of fire with such
garments. The Commission started this inquiry for several reasons. The
staff noticed increased marketing of non-sleepwear to be used for
sleeping, particularly cotton long underwear-syle garments. This
marketing was confusing for consumers and Commission staff as the line
between sleepwear and underwear (daywear) became increasingly
blurred.(6) The Commission staff developed
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enforcement guidelines to try to distinguish between sleepwear and non-
sleepwear garments. However, frequent fashion changes required numerous
revisions of these guidelines. The Commission staff believed that this
confusion was difficult both for consumers attempting to put their
children in suitable sleeping garments and for Commission staff trying
to enforce the existing standard.
Moreover, the Commission staff was concerned that to the extent
consumers were turning to long underwear-style cotton garments to
satisfy a desire for cotton sleepwear, this could be placing children
at an increased risk of injury. The Commission staff believed that,
without reducing safety, specific exemptions from the standards could
respond to marketing practices responding to consumer demands for
cotton, and reduce market confusion and compliance and enforcement
problems.
The Commission published an advance notice of proposed rulemaking
(``ANPR'') on January 13, 1993 that began the process of amending the
children's sleepwear standards. 58 FR 4111. The ANPR discussed the
regulatory alternatives being considered and stated that the Commission
could amend the standards to exempt tight-fitting sleepwear and
garments intended for infants. The ANPR discussed existing standards
and requested comments. On the same date the Commission published the
ANPR it also issued a stay of enforcement stating that it would not
enforce the sleepwear requirements against garments being used as
sleepwear that are labeled and marketed as underwear if those garments
are skin-tight or nearly skin-tight, relatively free of ornamentation,
and made from fabrics such as rib knit, interlock knit or waffle knit.
58 FR 4078.
In response to the ANPR the Commission received 2,173 comments. The
comments were overwhelmingly in favor of the exemption (2,121 in favor,
52 opposed). Many of these responses were form letters. Many letters
came from parents who wanted to have cotton sleepwear for their
children.(8)
The Commission continued its consideration, and on October 25, 1994
issued a notice of proposed rulemaking (``NPR'') proposing to exempt
tight-fitting garments and infant garments from the sleepwear
standards.(22) The Commission proposed to do this by amending the
definition of ``children's sleepwear'' in the standards. For purposes
of the proposed exemption, ``infant garments'' were defined as those
labeled 0-6 months; less than 21 inches in length (for a one piece
garment) or with no pieces longer than 14\1/2\ inches (for a two piece
garment); and less than 19 inches at the chest. ``Tight-fitting
garments'' were defined by specifying maximum dimensions for the chest,
waist, seat, upper arm, thigh, wrist and ankle for each size. These
dimensions were based on ASTM standards and an anthropometric study of
children conducted in 1977 by the University of Michigan. 59 FR 53621.
All exempt garments would still have to meet the flammability standards
for clothing textiles and vinyl plastic film (16 CFR parts 1610 and
1611). The Commission considered the 39 comments it received in
response to the NPR as well as the views expressed in a public meeting
held on April 25, 1995 attended by sleepwear manufacturers and
importers, consumers and other interested persons.
On September 9, 1996, the Commission issued a final rule amending
the flammability standards for children's sleepwear to exclude from the
definition of ``children's sleepwear,'' (1) infant garments sized 9
months or smaller, and if a one piece garment, does not exceed 25.75
inches in length; if a two-piece garment, has no piece exceeding 15.75
inches in length, and (2) tight-fitting garments sized larger than 9
months (meeting maximum dimensions specified for each size). 61 FR
47634. The Commission stated that the amendments would take effect on
January 1, 1997. The Commission also continued the stay of enforcement
on certain underwear garments until March 9, 1998 (it was subsequently
extended until June 9, 1998). 61 FR 47412.
Once manufacturers began to design sleepwear that would meet the
tight-fitting exemption they encountered some design and construction
problems. The staff met with industry members to discuss these
problems. The Commission proposed (63 FR 27877) and then on January 19,
1999 issued in final (64 FR 2833), technical amendments to adjust the
points of measurement for the upper arm, seat and thigh to make a more
practical, wearable garment and to clarify how the sleeve must taper.
The Commission also clarified its policy statements so that infant
garments and tight-fitting garments could be marketed and promoted with
other sleepwear. 64 FR 2832.
3. Legislation and Proposed Revocation
On October 21, 1998, Congress enacted fiscal year 1999
appropriations for the Commission. Public Law 105-276. Section 429 of
that law required the Commission to propose to revoke the 1996
amendments to the sleepwear standards. The law also required the
General Accounting Office (``GAO'') to review burn incident data from
the ignition of children's sleepwear from small open-flame sources for
the period July 1, 1997 through January 1, 1999. As required by the
legislation, GAO completed this review by April 1, 1999. The Conference
Report also directed GAO to assess the information and education
campaign conducted by industry and the Commission (H.R. Rep. No. 769,
105th Cong., 2d Sess. 267 (1998)). The appropriations measure requires
the Commission to issue a final rule revoking, maintaining or modifying
the 1996 amendments and any later amendments by July 1, 1999. The
Commission must consider and substantively address the findings of the
GAO and other information available to the Commission. Congress
specified that the rulemaking conducted with respect to this matter is
not subject to (1) the Consumer Product Safety Act, 15 U.S.C. 2051 et
seq., (2) the Flammable Fabrics Act, 15 U.S.C 1191 et seq., (3) the
Regulatory Flexibility Act, 5 U.S.C 601 et seq., (4) the National
Environmental Policy Act of 1969, 42 U.S.C. 4321 et seq., (5) the Small
Business Regulatory Enforcement Fairness Act of 1996, Public Law 104-
121, or (6) any other statute or Executive order.
As directed, on January 19, 1999, the Commission issued a notice
proposing to revoke the September 9, 1996 amendments, and subsequent
amendments, including the technical amendments and the amendment to the
policy statements. 64 FR 2867. The Commission received over 3,400
comments responding to the proposed revocation. These comments and the
Commission's responses to the principal issues they raised are
discussed in section G below. Although not required by the
appropriations measure, the Commission held a public hearing on April
22, 1999, for interested persons to present their views on the proposed
revocation orally. Twenty-one people provided testimony.
The Commission has considered GAO's reports, written comments
submitted in response to the proposed revocation, oral testimony before
the Commission, and other available information and has determined to
maintain the exemptions. The basis for this decision is discussed
below.
C. The Basis for the Exemptions Still Stands
The comments and testimony indicate that people appear to have the
false impression that the 1996 amendments abolished all standards for
sleepwear. In fact, the Commission's action was narrowly tailored. The
Commission's
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review of research and injury data indicates that the principal risk
from sleepwear is posed by loose-fitting garments. The sleepwear
standard continues to cover these types of garments. They must pass the
standard's flammability test, that is, they must self-extinguish when
exposed to a small open flame. Thus, the flammability standards still
cover nightgowns and looser fitting pajamas and robes--the types of
sleepwear most often involved in clothing-ignited fires.
Considerable confusion also exists concerning the purpose of the
flammability standards and their ability to reduce injuries and deaths
due to fires. The original flammability standard was intended to
address fires in which clothing was ignited by a small open flame such
as matches or lighters. Thus, the original standard was not designed to
reduce injuries sustained in whole house or bedding fires. The
occurrence of such incidents does not undermine the exemptions because
even absent the exemptions, the standard would not address such
incidents.
The Commission has determined to maintain the 1996 amendments
because the basis for them remains sound. As discussed in sections E
through G below, GAO's reports, as well as comments and information
received since the amendments, present no new evidence that would
change the rationale for the 1996 exemptions. A brief review of the
basis for the 1996 amendments follows.
1. Technical Research Supports Tight-Fit
Before issuing the proposed and final exemptions, the Commission
conducted an extensive review of technical research and information
considering the effect garment design can have on clothing fires. The
Commission found that garment design is a major factor; it influences
the probability of ignition, flame spread, duration of burning, and the
amount of heat transferred to the body. (10)
The idea that tight-fitting garments may be less hazardous than
loose-fitting ones did not originate with the Commission's work in the
early 1990's. Numerous studies from the 1970's and 1980's examined the
issue. Several studies in the 1970's placed loose and tighter-fitting
garments on manikins to observe their performance when ignited. For
example, in a 1971 study, when sleepwear garments were burned on
toddler-size manikins the researchers found that a full, loose garment
made of a relatively flammable lightweight fabric is more hazardous
than a close-fitting one made of a heavier cotton. Two manikin studies
from the later 1970's found that closer-fitting cotton ski pajamas were
likely to produce less extensive injuries than looser fitting
nightgowns. A manikin study in 1986 compared five different fabrics and
found that, for each of the fabrics, nightgowns were more hazardous
than pajamas. These are just some of the studies the Commission
considered.(10)
After reviewing all the available literature on the issue of
garment fit and safety, the staff concluded:
The reduced probability of ignition of tight fitting clothing is
related to three factors: the limited supply of oxygen from
underneath the garment, the role the skin plays as a heat sink and
reduced likelihood of contacting the flame source.
Garment configurations in which large air spaces are created
between the body and the garment act as chimneys in which the flame
spread accelerates as it travels an unrestricted path. The resultant
rapid burning is characterized by large flames. The excess fabric
also serves as a fuel supply that makes it difficult for the flames
to be extinguished. Ignition of tight fitting clothing or sections
of tight fitting clothing is characterized by both lower flame
spread and smaller flames, allowing the wearer to take action
sooner. Because tight fitting clothing is less likely to support
propagation, it is often easier to extinguish the flames.
(10) The Commission is not aware of any studies conducted since the
1996 amendments that invalidate these findings.
2. Data Support Exemptions
Tight-fitting. When it issued the 1996 exemptions, the Commission
reviewed available injury data from the period 1980-1994. During that
period, there were an estimated annual average 90 hospital emergency
room-treated thermal burn injuries to children involving sleepwear.
(The corresponding average annual estimate involving daywear was 850.)
Significantly, injuries associated with sleepwear predominantly
involved females (71 percent) while burn injuries from daywear usually
involved males (69 percent). (25) This tendency for sleepwear-related
burns to involve females was true even when the Department of Commerce
developed the original standard (DOC Analysis of Data for standard).
Females are more likely to have been wearing nightgowns or looser
fitting garments for sleeping. Of the 20 nightwear-related cases
involving children under 15 years reported to NEISS during the 1980-
1994 period, 11 involved nightgowns, six involved pajamas (not tight-
fitting), two involved nightshirts, and one involved a polyester
blanket sleeper.(25)
The Commission conducted in-depth investigations of incidents
reported from 1992-1994 involving sleepwear or daywear used as
sleepwear. Summaries of these investigations were included in staff
memos that were part of the briefing packages for the proposed and
final amendments.(12 and 25) Most of the incidents involved loose-
fitting clothing such as nightgowns, nightshirts and tee shirts.
Ignition sources were items such as cigarette lighters, stoves,
matches, and fireplaces. Based on its investigations of NEISS cases,
the staff estimated that about 200 thermal burn injuries involving
daywear used as sleepwear were treated in hospital emergency rooms
during 1994.(25)
In 1993, when the Commission began the rulemaking proceeding that
resulted in the 1996 amendments, the Commission issued a stay of
enforcement for garments that were marketed and labeled as underwear
and were skin-tight or nearly skin-tight. These garments are closer
fitting than traditional pajamas but looser than garments allowed under
the 1996 exemption. The Commission is not aware of any burn incidents
involving such stay garments.(62) If tight-fitting garments posed an
increased risk of fire, one would expect to see an increase in
clothing-related incidents after these stay garments were allowed since
they are even looser than exempt garments. This has not been the case.
When the Commission issued the tight-fitting exemption, the NEISS
estimate for clothing-related incidents involving children under 15 was
about the same as before the stay.(25) When the staff reviewed the data
for the current proceeding it found no increase in fatalities in the
last 20 years and no trends in injuries since before the stay.(62)
According to National Purchase Diary data, purchases of cotton
sleepwear garments have increased from 9.7 percent in 1992 to 27.5
percent in 1998. More cotton garments are on the market, but there has
not been a corresponding increase in incidents.(61)
In fact, relatively close-fitting garments resembling underwear
have been available long before the stay of enforcement. In 1979, the
Commission received a petition from a sleepwear manufacturer who was
concerned about thermal underwear being marketed and worn as sleepwear.
Beginning in 1984, the Commission staff developed a series of
enforcement pamphlets to try to distinguish between these types of
cotton underwear garments and sleepwear.(59) Throughout this time,
sleepwear-related burn incidents have continued to involve primarily
loose-fitting garments such as nightgowns,
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traditional (loose) pajamas, and oversized tee-shirts.(25)
Complementing the research discussed above and the data, the staff
also conducted a review of literature concerning the association of
closeness of fit and burn severity.(13) For example, a 1985 study
reviewed the Canadian experience with clothing-ignited injuries
involving children under 9 years old. There were 192 cases reported
with statistical analyses performed on 174 cases. The study found that
the two significant predictors of burn severity were the style of
garment and the ignition situation; burns tended to be more severe when
the victims wore loose-fitting clothing and when no adult was
present.(13)
A study published in 1973 used data from the Flammable Fabric
Accident Case and Testing System (``FFACTS'') to determine that close-
fitting garments were associated with less severe burn injuries. The
study concluded that closeness of fit had a stronger influence than
fiber content on burn severity in incidents where the clothing was the
first to ignite.(13)
Infants. Very few incidents involving infants under one year have
been reported. The original standard was only intended to address
incidents in which an infant's clothing was ignited from a brief
exposure to a small open flame. Flame-resistant fabrics burn or char
until the ignition source is removed. Flame retardant sleepwear will
not protect a baby whose crib becomes engulfed in flames. This is the
type of scenario that most often occurs when an infant suffers burn
injuries.(15) Industry representatives reported that infant sizing is
not true to age. As a common rule, according to the retail industry,
parents buy infants' sleepwear at double the age (i.e., for 6 month old
infants, purchasing the 12 month size). The exemption applies to
garments in sizes 9 months and smaller. As the preamble to the final
rule noted, these garments are frequently purchased for babies 6 months
of age and younger. 61 FR 47638. (See also oral testimony of Julie
Goldschneider and Commissioner Moore's April 30, 1996 statement.)
A 1973 review of the FFACTS data base found 434 incidents up to
that date involving persons of any age clothed in sleepwear. Of these,
only three involved children under one year of age. Two of these
involved house or trailer fires and the third was a bedding fire.(13) A
1978 study of 66 burn injuries to children under one year old
associated with clothing found similar results. ``In ten cases, the
clothing involved was specifically identified as sleepwear. Nine of
those cases involved whole-house fires; the other involved a home-made
garment. The Commission concluded that none of these cases involved
risks of injury which the sleepwear standard was intended to address.''
61 FR 47637.
The Commission previously considered exempting infants from the
sleepwear standard. In 1977, the Commission proposed to delete coverage
of sleepwear in sizes below size one. 42 FR 56568. In 1978, the
Commission withdrew this proposal. 43 FR 31348. In the twenty years
since that decision, clothing-ignited fires involving infants have
remained a rare event.
In its review of data for the 1996 exemptions, the staff found only
three reported cases involving children under one year old between 1980
and 1994. Only one of these involved nightwear, and it was a house
fire.(25 and 12) In its review of incidents reported since 1996, the
staff found two involving children under one year old. Both incidents
were house fires. It was difficult to determine what type of clothing
the children were wearing.(62)
3. Experiences of Other Countries Support Exemptions
The experiences of several other countries, particularly Canada,
bolster the Commission's conclusion that the exemptions would not
reduce the level of protection for children.
In 1971 Canada issued flammability regulations for children's
sleepwear that established a minimal standard similar to CPSC's general
wearing apparel standard. However, sleepwear-related burn injuries and
deaths continued, and studies showed that garment style was a major
factor. Thus, in 1987, Canada revised its sleepwear regulations so that
there are essentially two regulations; one applies to sleepwear
considered to be a high fire hazard--such as nightgowns, nightshirts,
robes and loose-fitting pajamas--the other to sleepwear posing a low
fire hazard. Garments presenting a high fire hazard must meet a
flammability test similar to the U.S. sleepwear standard for non-exempt
garments. Sleepwear posing a low fire hazard must meet a test similar
to the Commission's general wearing apparel flammability test. Canada
considers sleepwear of the following types to present a low fire
hazard: polo pajamas and sleepers in sizes 0-14x, sleepwear designed
for infants up to 7 kg (15.4 lbs.), and sleepwear designed for hospital
use in sizes 0-14. Polo pajamas and sleepers have tight waists, ankles
and wrists.(26)
In a 1993 letter, the director of Canada's Office of Product Safety
told CPSC that the standard has been a success.(26) The rationale for
provisions concerning infants and closer-fitting garments was similar
to CPSC's. She stated: ``Infants up to 7 kg (about 5 months old) are
usually under the close supervision of their parents and they are not
crawling, walking or climbing at this age.'' As for polo pajamas and
sleepers: ``Studies have demonstrated that garment style play [sic] a
major role in the flammability of sleepwear. Snug fitting garments with
tight waists, ankles and wrists as polo pajamas and sleepers, are safer
as they are less likely to come into contact with ignition sources, and
burn slowly.'' She stated that no deaths had been reported after the
1987 standard. A five year study to assess the effectiveness of the
regulations was initiated, but because there were so few injuries
reported, the study was discontinued. The Director concluded: ``Since
the Regulations, injuries due to the ignition of children's sleepwear
are no longer an issue in Canada.''(26) As of May 1999, Canada reports
that it still has no reported fire deaths related to children's
sleepwear since 1987.(68)
Several other countries distinguish between loose-fitting sleepwear
such as nightgowns and closer-fitting sleepwear such as pajamas and
make exceptions for infant garments.(13) Australian standards have
three categories: (1) Low fire hazard type fabric, (2) form fitting
clothing designed to reduce fire hazard, and (3) garments not complying
with either of these categories and perceived to be of greater risk.
Garments must be labeled as to their fire hazard category.
The United Kingdom has sleepwear regulations issued in 1987 that
require nightdresses, dressing gowns and similar garments commonly worn
for sleeping by children between 3 months and 13 years to meet
flammability performance requirements. Other garments--such as pajamas,
cotton terry bath robes and garments for babies under 3 months--do not
have to comply with the flammability standard, but must have a
permanent label indicating whether they meet the flammability
standard.(13)
New Zealand's sleepwear standards went into effect in 1980. They
require that sleepwear for children from 1 to 14 years old be made from
fabrics defined as ``low fire risk'' or be made of a closer-fitting
pajama style.(13)
These other countries do not have the extensive death and injury
databases that the U.S. does. Therefore, it is difficult to make
statistical comparisons between burn deaths and injuries before their
standards and after. However, the fact that these other countries have
also distinguished between safer close-fitting
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garments and more hazardous loose ones bolsters the Commission's
conclusions based on its review of research and incident data. Notably,
these other countries all allow garment dimensions larger than those
CPSC specifies.
D. Statutory Provisions
1. Authority for the Exemptions
The original children's sleepwear standards were issued under the
Flammable Fabrics Act (``FFA''), which allows the Commission
(previously the Secretary of Commerce) to issue a flammability standard
for a fabric or product if needed to protect the public against
unreasonable risk of the occurrence of fire leading to death, personal
injury or significant property damage. 15 U.S.C. 1193(a). The
Commission issued the 1996 amendments under the same authority. In
accordance with the procedures in the FFA, 15 U.S.C. 1193(g), the
Commission first issued an ANPR beginning the rulemaking process. 58 FR
4111. After considering the thousands of comments responding to the
ANPR, the Commission issued a notice of proposed rulemaking as required
by the FFA, 15 U.S.C. 1193(i). 59 FR 53616. The Commission issued the
final standard in accordance with section 4(j) of the FFA, 15 U.S.C.
1193(j). 61 FR 47634.
As discussed above, section 429 of the legislation that provided
the Commission's appropriations for fiscal year 1999 required the
Commission to propose to revoke the 1996 sleepwear exemptions and to
issue a rule by July 1 revoking, maintaining or modifying the
amendments. Public Law 105-276. The legislation states that neither the
FFA, the Consumer Product Safety Act, nor any other statute applies to
this proceeding. Thus, the Commission is not required to follow the
process or make the findings the FFA directs. Rather, in determining
what action to take on the 1996 exemptions, Congress instructed the
Commission to ``consider[] and substantively address[] the findings of
the General Accounting Office and other information available to the
Commission.'' Id. As discussed above, the Commission has reconsidered
the information on which the 1996 amendments were based and believes
that information still supports the exemptions. The following sections
discuss the Commission's consideration of the GAO reports and the
comments presented to the Commission.
E. The GAO Report on Incident Data
Congress directed GAO to review ``incident data relating to burns
from the ignition of children's sleepwear from small open flame sources
for the period July 1, 1997 through January 1, 1999.'' P.L. 105-276. In
its report GAO said it addressed the questions: ``(1) how many burn
injuries involving children's sleepwear occurred annually before and
after the amendments? and (2) what conclusions, if any, can be drawn
from these data about the effect of the changes to the sleepwear
standard on the risk of injury?''(55)
1. Summary of Report
GAO concluded that data were not sufficient to clearly answer
either of these questions. The report states that ``[t]he exact number
of burn injuries associated with children's sleepwear before and after
CPSC amended its standard is uncertain.'' Id. Because few sleepwear-
related injuries are reported annually to CPSC's sample hospital
emergency rooms, GAO concludes that ``precise national estimates'' are
not possible, and it is therefore difficult to observe injury trends.
Id. The report notes that over the period 1990 to 1998, NEISS reported
only 13 cases and in some years, such as 1998, no cases were reported
at all. The report also asserts that, because multiple factors are
involved in burn injuries, additional information would be necessary to
reach firm conclusions about the effect of the changes. In particular,
the report asserts that without data concerning the numbers of
consumers who use each type of sleepwear it is not possible to
determine the type of sleepwear most likely to be associated with
injuries. Id.
2. Data Are Sufficient To Support Exemption
The GAO report correctly notes that few burn incidents involving
sleepwear have been reported through NEISS over the period 1990 to
1998. However, the fact that only 13 cases have been reported during
this period does not invalidate that data. One can correctly conclude,
as GAO acknowledges, that the risk of injury from such incidents is
small.(55) These data are sufficient to provide an estimate of
injuries, which is the purpose of NEISS.
The GAO report underemphasizes an important part of the
Commission's examination of incident data. Because it is difficult to
obtain details from information in NEISS reports, the Commission
conducts in-depth investigations of selected incidents. The staff
conducted 40 such investigations of clothing-related incidents that
appeared to involve sleepwear or garments used as sleepwear occurring
between 1993 and 1998. As GAO notes, 28 of the 40 cases involved loose-
fitting tee shirts, six cases involved nightgowns or nightshirts, three
involved traditional flame-resistant sleepwear, one involved a tight-
fitting tee-shirt and two involved cotton pajamas. While these
investigations do not provide a statistical analysis, they confirm what
the research shows and what other countries have found. In a footnote,
GAO acknowledges that the patterns from these investigations ``are
consistent with data from other sources.'' The footnote continues:
For example, we reviewed case files from one burn center that
was not included in CPSC's NEISS sample. These cases involved 12
injuries to children younger than 15 in 1997 and 1998 that the staff
at the burn center identified as involving sleepwear. * * * Although
burn center staff did not have information on the fabric content of
the children's sleepwear for nine cases they noted the general type
of sleepwear. The results from this small group were similar to
those CPSC found--six of the nine cases involved loose-fitting
nightgowns or shirts.
(55). Thus, the only additional data GAO discusses affirm the
Commission's assessment that it is looser garments that pose a risk.
The fact that conclusions are based on few cases does not undermine
those conclusions when all available information supports them.
GAO's criticism that more information on the factors involved in
burn injuries is necessary to determine risk is unjustified. GAO's
example in its report illustrates this. The report states that GAO
reviewed a case in which a 6-year-old girl wearing a nightgown backed
into a space heater. From this example, GAO concludes: ``It is
uncertain whether either reducing the flammability of the nightgown or
improving the design or performance of the space heater could have
prevented her injury.''(55) This example confirms the Commission's
conclusions. The girl was wearing a nightgown, precisely the type of
clothing the Commission's analysis shows is most likely to be involved
in burn injuries. Nightgowns continue to be covered by the sleepwear
standard as amended by the 1996 exemptions. Thus, the example is not
relevant to the question of risk posed by exempt garments.
More information concerning the use of different types of sleepwear
(for example from a use survey) is not necessary to an informed and
supported Commission decision, as the report itself illustrates. As GAO
acknowledges, the patterns the Commission has
[[Page 34602]]
observed that loose clothing is more likely to be involved in burn
incidents ``are consistent with data from other sources.''(55) These
patterns have been consistent before the standards were promulgated in
1971 to the present time. They are consistent with research, and they
are consistent with other countries' experiences. With this consistent
information, a use survey is unnecessary.
The report states that tight-fitting pajamas designed to meet the
exemption have only been available for a short period of time so one
cannot determine if they are more hazardous. However, close-fitting
underwear similar to sleepwear has been available under the stay of
enforcement since 1993. For as far back as 15 years prior to the stay
of enforcement, Compliance staff took action against the companies
marketing these garments in violation of the standard. There have not
been any reports of incidents involving these types of garments.
The GAO report looks at sleepwear incident data in isolation.
However, the Commission's decision on the exemptions was based on all
available information since 1971. The NEISS incident data constituted
just one part of this information. The Commission continues to believe
that the incident data support the conclusion that the exempt garments
do not pose an unreasonable risk of burn injuries.
F. The GAO Report on the Information and Education Campaign
The Conference Committee Report on the appropriations bill that
required the Commission to propose to revoke the sleepwear amendments
directed GAO to assess the information and education (``I&E'') campaign
that industry and the Commission conducted (H.R. Rep. No. 769, 105th
Cong., 2d Sess. 267 (1998)). When the Commission issued the 1996
amendments it recognized that consumers needed information about the
changes. The industry, particularly the American Apparel Manufacturers
Association (``AAMA''), volunteered to work with the Commission in
developing appropriate materials and making them available to
consumers. The GAO report assessed the availability of such I&E
materials.
GAO visited more than 70 retail stores in 14 metropolitan areas
across the country. It found hangtags on 73 percent of tight-fitting
sleepwear garments. The most common hangtags were the ones that AAMA
designed. The other types of hangtags varied greatly in design but had
similar language. Fewer than 16 percent of stores displayed consumer
education brochures or signs about sleepwear safety. About 63 percent
of stores mixed other clothing (such as long underwear and loose-
fitting shirts) along with sleepwear in retail displays. GAO concluded
that consumers generally get some information from point of sale
materials, but not to the extent the Commission had envisioned. GAO
found that concerns about the initial acceptance of tight-fitting
sleepwear and fears that the standards might change made industry
reluctant to provide more I&E.(70)
The Commission believes that consumers need information to choose
appropriate sleepwear. The GAO report confirms that some information,
particularly on hangtags, is available, but more needs to be done. The
labeling rule the Commission is adding to the standards should ensure
that consumers have the information they need about the importance of
fit for tight-fitting sleepwear.
G. Comments on the Proposed Revocation
In accordance with the appropriations legislation, on January 19,
1999 the Commission proposed to revoke the 1996 amendments. 64 FR 2867.
The Commission received over 3,400 comments in response. The Commission
heard from fire safety professionals, physicians, parents, farmers,
sleepwear manufacturers and retailers, consumer advocates, and members
of Congress. Although not required by the appropriations language, the
Commission held a public hearing on April 22, 1999. Twenty-one people
testified. Many of these had also sent written comments responding to
the proposed revocation.
Below is a summary of the principal issues the written comments and
the hearing testimony raised, along with the Commission's responses.
1. General Comments
Scope of the Standards and Exemptions
Comment: Some commenters had the impression that the exemption
eliminated all clothing flammability requirements for children's
sleepwear. Others believed that the amendments did not affect loose
pajamas, nightgowns, and robes, which are the kind of nightwear
involved in burn injuries and fatalities.
Response: The Commission exempted infant sleepwear and only one
limited style of sleepwear (defined as tight fitting) in larger sizes.
Other sleepwear garments like nightgowns, robes, and looser-fitting
pajamas remain subject to the requirements for flame resistance.
Exempted children's sleepwear (including infant sizes 0 to 9 months and
tight-fitting sleepwear in larger sizes) must still meet the less
stringent general clothing textile flammability requirements of 16 CFR
1610.
Comment: A number of commenters believed that the Commission issued
the 1996 amendments with the expectation that consumers would switch to
tight-fitting sleepwear from loose-fitting tee-shirts.
Response: The 1996 amendments were intended to provide consumers
who prefer natural fibers (cotton) with a safer alternative to the
loose-fitting, non-complying garments used frequently as sleepwear,
such as long underwear. While the staff did not necessarily expect
consumers using tee-shirts to switch to the tight-fitting garments,
they did anticipate that any such substitutions by consumers could
reduce the number and severity of burn injuries should they occur.
Motive for Amendments
Comment: Some commenters suggested the Commission had an economic
motive, responding to influence by the cotton industry, for amending
the sleepwear standards.
Response: The amendments were not based on pressure from any
outside interests, but on two principles: (1) safety and (2)
enforcement. As discussed above, the Commission studied this issue for
several years, relying on laboratory and other analytical data,
including injury and death data, to arrive at its conclusions. The
Commission believed that the exemptions would allow more effective
enforcement of the sleepwear standards and would provide a safer cotton
alternative.
Findings Supporting the Amendments
Comment: Two commenters argued that the amendments were issued
without the proper findings of unreasonable risk required by the
Flammable Fabrics Act. One commenter stated that CPSC never showed that
the net effect of the amended standards on all affected children would
be beneficial.
Response: The 1996 amendments exempted specified garments from the
children's flammability standard. Because they were exemptions, the
correct question was not whether these garments posed an unreasonable
risk of fire, but whether taking those garments out of the standard
would reduce the level of safety and expose the public to an
unreasonable risk. As explained in the preamble to the 1996 amendments,
the original 1971 and 1974 flammability standards reached farther than
[[Page 34603]]
necessary to protect the public. Inclusion of infant garments and
tight-fitting garments meant the standards were not reasonably
necessary to protect the public; the standards were not limited to
garments that present an unreasonable risk of injury.
2. Children's Sleepwear Marketing Issues
Availability of Tight-Fitting Sleepwear
Comment: Several commenters thought that tight-fitting garments
have only been available since the exemption became effective in
January 1997, and, therefore, it would be difficult to determine their
safety.
Response: As discussed above, non-flame resistant garments of this
style (skin-tight or nearly skin-tight) have been used as sleepwear
with increasing frequency for at least 20 years. During the 1980's the
Compliance staff saw an increase in the number of cotton garments
labeled as ``long underwear'' or ``playwear'' that appeared to be
sleepwear.
Industry sources estimate that, before the staff started work on
the amendments in 1992, the share of total sleepwear purchases
accounted for by complying cotton garments was about 1-2%. According to
National Purchase Diary data, cotton sleepwear (the consumer's intended
use) purchases have increased from 9.7% to 27.5% of the total sleepwear
purchases from 1992 to 1998.
Effect of Cotton Sleepwear Sales on FR (Polyester) Sales
Comment: One commenter suggested that with the emergence of cotton
garments, flame-resistant children's sleepwear would be forced out of
the market and manufacturers would find that they could not sell flame-
resistant sleepwear.
The American Apparel Manufacturers Association stated that
``polyester garments still dominate the market for children's
sleepwear. Sales of synthetic pajamas are very strong and are expected
to remain so for the foreseeable future.''
Response: Information from the National Purchase Diary shows that
purchases of children's sleepwear are increasing. While the proportion
of cotton sleepwear purchases is growing, the market for other
sleepwear (flame-resistant) has steadily increased in volume from 106.6
million in 1992 to 112.5 million garments in 1998. Flame-resistant
polyester garments reportedly represented over 70% of the total
children's sleepwear purchases in 1998.
Garment Returns From Retail Sales
Comment: One commenter, a major retailer of children's clothing,
noted that it has experienced returns of tight-fitting sleepwear at
about 8% of sales, which it describes as high.
Response: The Commission expected some consumer returns of tight-
fitting sleepwear during the transition period following the exemption
of these garments. Manufacturers contacted by the Commission staff late
in 1998 indicated returns ranging from ``negligible'' to 5%, considered
high. The retailer in the current comment noted that consumers were not
seeking refunds, but rather were exchanging the garments for a larger
size. Except for some marginal costs associated with the transaction
costs of the exchange, retailers are not likely to bear a significant
cost burden associated with returns. With the clarification of
measurements, availability of stretchable fabrics, manufacturer
adjustments to new design and production demands, increasing consumer
familiarity with the fit of this style of garment, returns and
exchanges should decrease.
Costs of Revocation
Comment: Commenters noted that manufacturers and others have borne
significant costs in order to produce and market tight-fitting
sleepwear garments under the exemption. A trade group noted that firms
changed their business practices as a result of the amendments, but
they did not quantify the associated costs. A retail chain reported
that revocation would cost that firm approximately $7 million.
Response: The Commission agrees that there would be some costs to
manufacturers and others associated with revocation, but does not have
information to quantify those costs. The Commission is not basing its
withdrawal of the proposed revocation on the fact that industry would
incur some costs if the amendments were withdrawn.
3. Death/Injury Data Involving Children's Sleepwear
Trend in Clothing-Related Burn Fatalities
Comment: Some commenters asserted that enactment of the sleepwear
standard in 1972 reduced the number of annual sleepwear-related burn
deaths from 60 to 4. Others have expressed this in reverse--there would
be ten times as many deaths without the sleepwear standard.
Response: These assertions are incorrect because they refer to all
clothing-related burn deaths reported by the National Center for Health
Statistics (``NCHS''). The NCHS mortality files providing these data do
not distinguish sleepwear-related burn cases from other clothing-
related burn cases. There are no reliable data on the number of
sleepwear-related deaths before the standards were issued that could be
compared with data assembled thereafter.
Mobility of Infants Wearing Sizes 0-9
Comment: Many commenters rejected the contention that infants
wearing sizes 0-9 months are immobile. ``These children may not be able
to walk; however, they certainly can crawl or roll, which may put them
in a situation where they may be exposed to open flame.''
An industry commenter stated at the April 22 hearing that infant
sizing is not true to age (it is not standardized by regulation). She
stated that an infant who is six months of age wears a 12 month size,
and an infant who is 5 months of age probably wears a 9 month size, and
would not likely be mobile.
Response: In 1993, CPSC staff reported from the literature that
infants' first ambulatory motions usually consist of crawling-type
movements, which begin around 7 to 8 months of age. Industry
representatives had previously reported, as above, that infant sizing
is not true to age. Most likely, an infant six months or younger would
be wearing garments sized 9 months and under. These children are
typically not yet walking or crawling. The definition of infant garment
in section 1615.1(c)(2) accommodates all but the largest 6 month old
infants. (ASTM Standard D 4910-95.)
Relationship of Mobility to the Risk of Burn Injury
Comments: Many commenters rejected the claim that the risk of burn
injury to infants is minimal because of their immobility. Commenters
note that infants are less able to remove themselves from a potentially
dangerous situation. Ignition sources also come to them. Many
commenters argued that the relative immobility of infants puts them at
greater risk, not less, of being severely burned in an otherwise minor
conflagration.
Response: CPSC knows of several incidents in which a fire started
by another child or source approached and ignited the clothing of a
pre-ambulatory infant who thereby sustained severe burns from burning
clothing. However, analyses of over 150 potentially survivable fire and
thermal burn cases involving infants 0-9 months old from
[[Page 34604]]
January 1990 to May 1999 in CPSC files revealed insufficient
information about the type of clothing involved in these cases to
determine whether the type of clothing would affect the likelihood or
severity of injury.
Validity of CPSC Data
Comment: Many commenters questioned the validity of CPSC data
indicating a low, stable frequency of sleepwear-related thermal burn
injuries. They asserted that ``problems in the reporting of burn
injuries'' are a partial explanation that some argue there has been no
increase in the number of burn injuries and deaths since the standard
changed. The GAO report asserted that CPSC's sleepwear burn data were
both too sparse to provide reliable national estimates and subject to
coding biases possibly leading to underestimation of sleepwear-related
burns.
Response: There is no reason to believe that the number of burn
injuries in the U.S. is underestimated by CPSC's National Electronic
Injury Surveillance System. The NEISS sample of 101 hospitals, 2.2% of
the universe of 5,387 U.S. emergency-room hospitals, includes 4 or 4%
of the 119 hospitals that are self-identified burn treatment centers.
Although some severely burned children may be admitted directly to burn
treatment facilities, more often such victims are taken to the nearest
hospital emergency room for stabilization and later transferred to burn
treatment facilities. These transfer cases would be reported through
NEISS. Although estimates of infrequent occurrences are subject to
relatively large variances, NEISS does provide a powerful case-finding
tool with 101 hospitals searching for sleepwear burns. Each case is
carefully reviewed and any serious burn cases are quickly identified
and investigated. A change in frequency of sleepwear-related pediatric
burn injuries would be readily detected, while a change in severity
would be more difficult because of the few sleepwear-related burn cases
reported in NEISS.
Infant Exemption's Likely Effect on Burn Injuries
Comment: Several commenters (physicians) gave accounts of cases
where they believe flame-resistant sleepwear could or did, in their
opinion, reduce the severity of the injuries sustained by infants and
other children in fires. In some of these cases, they said children had
burns on the exposed portions of their bodies while those areas covered
by the flame retarded clothing were not injured. A surgeon heading a
burn treatment facility, estimated that burn units across the country
have treated approximately 472 sleepwear-related thermal burn injuries
to victims 0-9 months old since January of 1997. He argued that the
severity of cases like these could be positively affected by a return
to flame-resistant sleepwear for infants.
Response: The typical scenarios involving infants are bedding or
larger room/house fires. The children's sleepwear standards were not
intended to address the risk of death and injury from exposure to a
whole house or bedding fire. The test method in the standards uses a
three second exposure to a moderate sized flame and a requirement that
the fabric self-extinguish. The ignition source in the fire scenarios
mentioned by commenters is larger and more intense and sustained well
beyond three seconds. The heat released and temperatures produced in
larger fire scenarios easily exceed the temperatures produced by the
small open flame sources. Because of the fabrics' melting and ignition
temperatures and the high temperatures and sustained fire growth that
occurs in these larger fire scenarios, and the many other factors
affecting the outcome of an incident, flame-resistant sleepwear
garments cannot be counted on to provide enough protection to prevent
life-threatening burn injury from occurring in these scenarios.
Comment: Burn centers, burn victims, and others shared information
on various burn injury cases arguing that the exemptions should be
revoked to prevent an increase in burn injuries.
Response: The CPSC staff investigated all cases possible within the
time constraints of this proceeding. Four Shriners burn hospitals
referred 134 cases involving thermal burns from children's clothing to
the CPSC staff. Most of these involved garments or fire scenarios not
addressed by the sleepwear standard. The staff requested for
investigation 30 cases meeting certain criteria relevant to this
proceeding. With permission from the hospitals and victims' families,
the staff completed analysis of 21 cases. The CPSC in-depth
investigations revealed that none of these cases involved garments
exempted from the standard by the 1996 amendments or garments
previously subject to the stay of enforcement.
Several commenters were burn victims or parents of burn victims.
Two of the garments involved in these incidents were nightgowns. These
garments must still be flame-resistant under the 1996 amendments.
Another case involved an infant wearing a cotton sleeper injured in a
bedding fire, a scenario that the standard does not address. One
commenter was a burn victim whose only injury was singed hair when his
``tight-fitting'' (by his description) thermal underwear ignited from a
stove burner. This case and another involving a tight-fitting tee-shirt
illustrate how the fit of a garment can minimize injury severity when
exposed to a small ignition source.
4. Safety-Related Technical Information
Fires Addressed by the Standards
Comment: A number of commenters expressed concerns that the
exemptions would eliminate protection of children from a variety of
fire scenarios, including house fires and bedding/mattress fires.
Others claimed that injuries would be less severe in these cases had
victims been wearing flame-resistant sleepwear. Other commenters argued
that although these cases are tragic and still occur, the standard
(flame-resistance) does not protect against injuries from house fires
or the rare infant crib/bedding fires.
Response: As discussed above, the children's sleepwear standards
were not intended to address the risk of a whole house or bedding fire.
The intent of the sleepwear standards is to eliminate the risk of
serious personal injury or death from fire as a result of contact
between the sleepwear garment and a small ignition source. Even flame-
resistant sleepwear may not prevent burn injury in a whole house or
bedding fire.
Importance of Fit
Comment: A number of commenters expressed concerns that the
combination of non-flame resistant material and loose fit are
dangerous. Others argued that tight fit is a reasonable choice with
reduced likelihood of ignition.
Response: As discussed above, garment fit, along with fiber content
can influence a garment's flammability. Children's sleepwear made from
cotton fabric needs to fit close to the body, to provide an acceptable
level of risk. There is a great deal of information in the literature
discussing the concept of tight-fitting garments being less hazardous
than loose-fitting garments. The ease of ignition increases when the
wearer's clothing stands away from the body and the excess fabric
functions as a connector to the ignition source. Without a tight fit,
if ignition occurs, the oxygen under the garment and the absence of a
heat sink (the body) increase the opportunity for sustained burning.
Research indicates that reasonably safe sleepwear garments can be made
from cotton fabrics that do not
[[Page 34605]]
meet the flammability requirements of the children's sleepwear
standards, i.e. they do not self-extinguish. Comfortable, practical,
tight-fitting sleepwear can and is being produced that is acceptable to
consumers.
Fire Safety
Comment: One commenter asserted that non-flame resistant cotton
sleepwear is dangerous based on a local fire department demonstration
in which two sleepwear garments, one flame-resistant and the other
untreated cotton were burned.
Response: It is not surprising that the commenter observed that the
cotton sleepwear ``flamed up and burned very quickly.'' Light weight,
cellulosic fabrics usually ignite readily when in contact with an
ignition source, burn steadily, and are often difficult to extinguish.
Flame-resistant fabrics made from thermoplastic fibers are not as
easily ignited and have a tendency to shrink away from the heat source.
These fabrics self-extinguish when the flame source is removed.
The fire department demonstration did not take into account garment
design, one of the major factors influencing a garment's flammability.
A tight fit reduces the possibility of ignition occurring. If ignition
of tight-fitting clothing occurs, flame spread is slower and less
intense, allowing the wearer to take action sooner. Because tight-
fitting clothing is less likely to support flame propagation, it is
often easier to extinguish the flames.
Comment: Commenters presented differing views concerning the
relative protection offered by cotton and flame-resistant garments in
house and bedding fires. Medical professionals noted cases where
exposed portions of a child's body were burned but portions covered by
flame-resistant garments were not. The National Cotton Council stated
that cotton sleepwear may be slightly more protective than flame-
resistant garments in a crib or house fire.
Response: The fire scenarios described above are not addressed by
the children's sleepwear standards that define the protection provided
in terms of self-extinguishment after a 3 second exposure to a small
gas burner flame. A number of variables contribute to the outcome of
burn injury such as the circumstances surrounding the incident, the
victim's reaction/activity, the fabric characteristics (weight, weave,
finishes/treatments applied, fiber content, dyes, etc.), size of the
flame and the garment location contacted by the flame, flame
propagation, rate of heat transfer, presence of undergarments, etc.
Much of this data cannot be obtained through investigations. The staff
cannot conclude based on available data that there are substantial
benefits associated with the sleepwear standards beyond those
represented by the test method.
Upsizing Practices
Comment: Commenters noted that parents may ``upsize,'' that is, buy
sleepwear in sizes larger than their children's current size, because
they will get longer wear from the garments. In store interviews,
customers indicated that if they were to purchase tight-fitting
sleepwear, they would buy a larger size. Others added concerns that
handing down clothes to younger children and second hand sales will
interfere with parents using the correct garment size.
Response: Commenters provided no information about whether parents
are actually buying larger sizes for tight-fitting sleepwear. The staff
contacted manufacturers and retailers for this perspective. A
representative of a sleepwear retailer, based on discussions with
parents during garment fittings, believes that parents would probably
purchase only one size larger, otherwise the garment would be too large
(i.e. the legs and sleeves would be too long). A manufacturer/retailer
of successful tight-fitting sleepwear does not believe their customers
are upsizing.
During the development of the technical amendments in 1997, the
staff observed that garments using fabrics with adequate stretch
provided children with ample room for movement and comfort while
maintaining the tight fit required by the exemption. The staff also
observed children wearing garments one size larger than their age-
appropriate size. The differences in garment dimensions between sizes
are small. The larger garments still conformed to the contours of the
children's bodies, touching them at many points, thus reducing the
likelihood of ignition.
Informational labeling is important for tight-fitting children's
sleepwear to help consumers distinguish among flame-resistant and non-
flame-resistant (tight-fitting) garments. Consumers need to be informed
that certain sleepwear is no longer flame-resistant and that proper fit
is necessary for safety.
5. Information and Education Campaign
Confusion in the Market Place
Comment: Many commenters criticized the voluntary information and
education program as inadequate and confusing in the market place.
Several commenters surveyed retail stores and reported on the mixing of
garment types, inconspicuity and inconsistency of label messages, and
absence of information for the consumer.
Response: Many of these criticisms appear valid. Commenters
reported that the current labeling on the hangtags is not distinctive
or conspicuous but is mixed with promotional and brand literature. The
hangtags are not consistent, and wording on permanently-affixed labels
is indistinguishable from size and washing instructions. The
Commission's labeling requirement will address these concerns.
6. Garment Design and Production Issues
Expansion of Tight-Fitting Dimensions
Comment: Several commenters recommended increasing slightly the
dimensions, especially the upper arm, that define a tight-fitting
garment exempt from children's sleepwear flammability standards. They
argued that this may make the garments more attractive to parents
currently avoiding tight-fitting sleepwear without compromising the
garment's safety. A slightly larger garment, they argued, is far safer
than an oversized tee shirt.
Response: Commission staff carefully considered the option to allow
a less than tight fit for exempted children's sleepwear when amending
the sleepwear standards. The reduced probability of ignition of
tighter-fitting clothing is related to three factors: the limited
supply of oxygen from underneath the garment, the role that the body
plays as a heat sink, and reduced likelihood of contacting the flame
source. However, while a tighter-fitting garment can reduce the
possibility of the garment coming in contact with a source of ignition,
a review of the literature did not reveal a specific safe level or
range of fit. The Commission concluded that for tight-fitting garments
to be exempt from the children's sleepwear standards, the garment must
touch the body at all critical locations. To do this, children's
sleepwear garments must be equal to or less than the body dimension at
these locations. Comfortable, tight-fitting sleepwear garments are
currently being manufactured and successfully marketed without making
additional dimensional adjustments with a questionable impact on
safety.
Sewing Tolerances
Comment: An industry commenter again requested that the standard be
amended to allow specific tolerances to accommodate mass-production
variances and sewing errors. Such tolerances, a long-recognized
practice in
[[Page 34606]]
the apparel industry, would provide sleepwear makers and retailers with
a workable margin of error.
Response: The Commission recognizes that tolerances are normally
used in the production of all garments and allow for permissible
variations to the pattern specifications that can occur during cutting
or sewing of the garment. However, adding a production tolerance which
would increase the garment dimensions from those specified in the
amended children's sleepwear standards, would result in a less than
tight-fitting garment. The importance of a tight fit has been stated
earlier. Knit fabrics are available with a sufficient degree of stretch
so that the garment would still fit the intended size child even if the
manufacturer undercuts the fabric somewhat. Sleepwear garments
manufactured to the dimensions specified in the sleepwear standards
using such knit fabrics are currently being sold to consumers.
7. Compliance Issues
Comment: One commenter questioned the Commission's efforts to
enforce the amended standards that exempt tight-fitting sleepwear
garments.
Response: Earlier this year, the Commission staff initiated a
program for CPSC investigators to inspect retail stores throughout the
United States to determine whether sleepwear marketed and promoted as
being tight-fitting meets the measurements required for an exemption.
This program is continuing, and the staff is conducting full
investigations of firms found to be selling or manufacturing violative
merchandise. The staff also learns of potential violations from firm
inspections, incident investigations, and trade complaints.
H. Date of Withdrawal
The proposed revocation of the 1996 amendments is withdrawn on the
date of publication. Because revocation was proposed but never
finalized, withdrawal of the proposal does not make any substantive
change. Therefore, it is unnecessary to delay the withdrawal of the
proposed revocation.
List of Subjects in 16 CFR Parts 1615 and 1616
Clothing, Consumer Protection, Flammable materials, Infants and
children, Labeling, Reporting and recordkeeping requirements,
Sleepwear, Textiles, Warranties.
Conclusion
Pursuant to Public Law 105-276, the Commission withdraws the
proposed revocation of January 19, 1999, 64 FR 2867.
Dated: June 22, 1999.
Sadye E. Dunn,
Secretary, Consumer Product Safety Commission.
List of Relevant Documents
1. Memorandum from Liz Gomilla, Division of Regulatory
Management and Eric Stone, Division of Administrative Litigation, to
Terrance R. Karels, Project Manager, dated March 13, 1992, entitled
``Problems Associated with Enforcement of the Children's Sleepwear
Standards.''
2. Memorandum from Bea Harwood and Terry L Kissinger, EPHA, to
Terrance R. Karels, Project Manager, dated April 20, 1992, entitled
``Injury Data Related to the Sleepwear Flammability Standards and
Information on Surveys of Burn Treatment Centers.''
3. Memorandum from Linda Fansler, ESME, to Terrance R. Karels,
ECPA, dated May 6, 1992, entitled ``Final Report, Children's
Sleepwear Project.''
4. Memorandum from Anthony C. Homan, ECPA, to Terrance R.
Karels, Project Manager, dated March 25, 1992, entitled ``Market
Sketch--Children's Sleepwear.''
5. Briefing Memorandum from Terrance R. Karels to the
Commission, dated November 3, 1992.
6. Federal Register notice ``Standards for the Flammability of
Children's Sleepwear: Sizes 0 Through 6X and 7 Through 14; Advance
Notice of Proposed Rulemaking,'' published by the Consumer Product
Safety Commission; January 13, 1993 (58 FR 4111).
7. Federal Register notice ``Standards for the Flammability of
Children's Sleepwear: Sizes 0 Through 6X and 7 Through 14; Stay of
Enforcement,'' published by the Consumer Product Safety Commission;
January 13, 1993 (58 FR 4078).
8. Tabular summaries of comments and staff responses to comments
to the Advance Notice of Proposed Rulemaking; 50 pages; July 19,
1994.
9. ``Statement by The Children's Sleepwear Coalition In Response
to the Consumer Product Safety Commission's Advance Notice of
Proposed Rulemaking''; March 25, 1993.
10. Memorandum from Linda Fansler, ESME, to Terrance R. Karels,
ECPA, entitled ``Technical Rationale Supporting Tight-Fitting
Children's Sleepwear Garments''; March 14, 1994.
11. Memorandum from Linda Fansler, ESME, to Terrance R. Karels,
ECPA, entitled ``Recent Conversation Between Staff of Consumer and
Corporate Affairs Canada and Commission Staff''; July 17, 1992.
12. Memorandum from Dr. Terry L. Kissinger, EPHA, to Terrance R.
Karels, ECPA, entitled ``Injury Data Related to the Children's
Sleepwear Standards''; February 8, 1994.
13. Memorandum from Dr. Terry L. Kissinger, EPHA, to Terrance R.
Karels, ECPA, entitled ``Results of Review of Available
Literature,'' and attachments; April 1, 1994.
14. Memorandum from George Sweet, EPHF, to Terrance R. Karels,
ECPA, entitled ``Human Factors Issues Regarding Sleepwear,'' and
attachment; March 8, 1994.
15. Memorandum from George Sweet, EPHF, to Terrance R. Karels,
ECPA, entitled ``Garments Intended for Infants''; July 8, 1994.
16. ``Preliminary Regulatory and Regulatory Flexibility Analyses
for the Proposed Amendments to the Children's Flammability
Standards,'' by Anthony C. Homan, Directorate for Economic Analysis;
June, 1994.
17. ``Market Sketch--Children's Sleepwear,'' by Anthony C.
Homan, Directorate for Economic Analysis; March, 1992.
18. Memorandum from Eva S. Lehman, HSPS, to Terrance R. Karels,
ECPA, entitled ``Toxicological Evaluation of Fabrics Used in
Children's Sleepwear''; June 7, 1994.
19. Memorandum from Patricia Fairall, CERM, to Terrance Karels,
ECPA, entitled ``Compliance History--Enforcement of Children's
Sleepwear''; 6 pages; April 20, 1994.
20. Memorandum from James F. Hoebel, Acting Director, ESME, to
Terrance R. Karels, ECPA, entitled ``Amendments to Children's
Sleepwear Standards''; July 7, 1994.
21. Memorandum from Dr. Terry L. Kissinger, EPHA, to Terrance R.
Karels, ECPA, entitled ``Proposed Amendment to Children's Sleepwear
Standards''; July 15, 1994.
22. Federal Register notice ``Standard for the Flammability of
Children's Sleepwear: Sizes 0 Through 6X; Standard for the
Flammability of Children's Sleepwear: Sizes 7 Through 14; Proposed
amendments'' published by the Consumer Product Safety Commission;
October 25, 1994 (59 FR 53616).
23. Federal Register notice ``Continuation of Stay of
Enforcement of Standards for the Flammability of Children's
Sleepwear, Sizes 0 Through 6X and 7 Through 14'' published by the
Consumer Product Safety Commission; October 25, 1994 (59 FR 53584).
24. Comments on proposed amendments.
25. Memorandum from Terry L. Kissinger, Ph.D., EHHA, to Terrance
R. Karels, ECPA, entitled ``Injury Data Related to the Children's
Sleepwear Standards''; July 12, 1995.
26. Letter from Carole LaCombe, Director, Product Safety Canada,
to Eric C. Peterson, Executive Director, Consumer Product Safety
Commission, concerning Canadian standards for the flammability of
children's sleepwear; September 13, 1993.
27. Memorandum from Linda Fansler, ES, concerning telephone
conversation between staff of the Consumer Product Safety Commission
and staff of Consumer and Corporate Affairs Canada on June 18, 1992,
concerning the Canadian standards for the flammability of children's
sleepwear.
28. Memorandum from Linda Fansler, ESME, to Terrance R. Karels,
ECPA, entitled ``Tight Fitting Children's Sleepwear''; July 14,
1995.
29. Memorandum from Terrance R. Karels, Project Manager, to
Warren J. Prunella, Associate Executive Director for Economic
Analysis, entitled ``Sleepwear Market Update''; October 6, 1995.
[[Page 34607]]
30. Final Regulatory Analysis for amendments of the children's
sleepwear standards by Terrance R. Karels; July 1995.
31. Memorandum from David Schmeltzer, Assistant Executive
Director for Compliance, to Terrance Karels, Project Manager,
entitled ``Sleepwear Briefing Package''; August 24, 1995.
32. Memorandum from Patricia Fairall, Compliance Officer, to
Terrance Karels, Project Manager, entitled ``Compliance Discussion
of the Proposed Amendments to the Children's Sleepwear Standards'';
June 26, 1995.
33. Memorandum from Terry L. Kissinger, Ph.D., EHHA, to Terrance
R. Karels, ECPA, entitled ``Response to Public Comments Received
after Publication of the Notice of Proposed Rulemaking''; July 12,
1995.
34. Memorandum from George Sweet, EPHF, to Terrance R. Karels,
ECPA, entitled ``Human Factors Responses to Sleepwear NPR
Comments''; May 5, 1995.
35. Memorandum from Linda Fansler, ESME, to Terrance R. Karels,
ECPA, entitled ``Response to Comments''; July 14, 1995.
36. Memorandum from Suad Nakamura, Ph.D., EHPS, to Terrance R.
Karels, Project Manager, entitled ``Children's Sleepwear--Response
to Comments on the Notice of Proposed Rulemaking''; July 19, 1995.
37. Memorandum from Patricia Fairall, Compliance Officer, to
Terrance R. Karels, Program Manager, entitled ``Response to Comments
from Proposed Amendments to the Children's Sleepwear Standards
published in the Federal Register on October 25, 1994''; June 26,
1995.
38. Memorandum from Terry L. Kissinger, Ph.D., EHHA, to Terrance
R. Karels, ECPA, entitled ``Response to Letter from John Krasny to
James Hoebel''; August 3, 1995.
39. Memorandum from George Sweet, ESHA, to Terrance R. Karels,
ECPA, entitled ``Issues involved in amendment the sleepwear
flammability regulation: Sizing and Labeling''; September 20, 1995.
40. Memorandum from Karen G. Krushaar, OIPA, to Terrance R.
Karels, ECPA, entitled ``Children's Sleepwear Informational
Campaign''; July 11, 1995.
41. Position statement of the National Fire Protection
Association and the Learn Not to Burn Foundation in Opposition to
the Proposed Amendment of the Children's Sleepwear Standards; July
1995.
42. Letter from John F. Krasny to J.F. Hoebel concerning paper
by Vickers, Krasny, and Tovey entitled ``Some Apparel Fire Hazard
Parameters''; July 17, 1995.
43. Memorandum from Linda Fansler, ESME, concerning telephone
conversation with John Krasny on September 20, 1995.
44. Log of public meeting conducted on April 25, 1995,
concerning proposed amendments of the children's sleepwear
flammability standards.
45. Memorandum from James F. Hoebel, Chief Engineer for Fire
Hazards, to Terrance R. Karels, Project Manager, entitled
``Children's Sleepwear''; October 10, 1995.
46. Memorandum from Warren J. Prunella, Associate Executive
Director for Economic Analysis, to file concerning small business
effects of proposed amendments to the children's sleepwear
flammability standards; February 17, 1995.
47. Memorandum from Warren J. Prunella, Associate Executive
Director for Economic Analysis, to Eric A. Rubel, General Counsel,
concerning requirements for Congressional review of final amendments
to the children's sleepwear standards; undated.
48. Vote sheet to accompany briefing package on children's
sleepwear flammability standards; October 11, 1995.
49. Memorandum from Terrance R. Karels, Project Manager, and
Ronald L. Medford, Assistant Executive Director for Hazard
Identification and Reduction entitled ``Questions Regarding
Children's Sleepwear Amendments,'' with attachments; January 30,
1996.
50. Federal Register notice ``Proposed Technical Changes;
Standard for the Flammability of Children's Sleepwear: Sizes 0
Through 6X; Standard for the Flammability of Children's Sleepwear;
sizes 7 Through 14'' published by the Consumer Product Safety
Commission, May 21, 1998 (63 FR 27877). Corrected on June 11, 1998
(63 FR 31950).
51. Federal Register notice ``Proposed Clarification of
Statement of Policy; Standard for the Flammability of Children's
Sleepwear: Sizes 0 Through 6X; Standard for the Flammability of
Children's Sleepwear; sizes 7 Through 14'' published by the Consumer
Product Safety Commission, May 21, 1998 (63 FR 27885).
52. Federal Register notice ``Final Technical Changes; Standard
for the Flammability of Children's Sleepwear: Sizes 0 Through 6X;
Standard for the Flammability of Children's Sleepwear; sizes 7
Through 14'' published by the Consumer Product Safety Commission,
January 19, 1999 (64 FR 2833).
53. Federal Register notice ``Final Clarification of Statement
of Policy; Standard for the Flammability of Children's Sleepwear:
Sizes 0 Through 6X; Standard for the Flammability of Children's
Sleepwear; sizes 7 Through 14'' published by the Consumer Product
Safety Commission, January 19, 1999 (64 FR 2832).
54. Federal Register notice ``Proposed Revocation of Amendments;
Standard for the Flammability of Children's Sleepwear: Sizes 0
Through 6X; Standard for the Flammability of Children's Sleepwear;
sizes 7 Through 14'' published by the Consumer Product Safety
Commission, January 19, 1999 (64 FR 2867).
55. United States General Accounting Office Report to
Congressional Committees and the Consumer Product Safety Commission,
``Injury Data Insufficient to Assess the Effect of the Changes to
the Children's Sleepwear Safety Standard,'' GAO/HEHS-99-64, April
1999.
56. Memorandum from Martha A. Kosh, OS, to Sadye E. Dunn,
Secretary, OS, ``Sleepwear Revocation,'' list of comments on CF99-1,
March 17, 1999.
57. Memorandum from Martha A. Kosh, OS, to Sadye E. Dunn,
Secretary, OS, ``Sleepwear Revocation,'' list of additional comments
on CF99-1, March 29, 1999.
58. U.S. Consumer Product Safety Commission Public Hearing on
Proposed Revocation of Amendments to Children's Sleepwear Standards,
agenda with presenters, April 22, 1999.
59. Memorandum from Marilyn Borsari, Office of Compliance to
Margaret Neily, Directorate for Engineering Sciences, ``Enforcement
History of Children's Sleepwear Standards,'' May 12, 1999.
60. Memorandum from Terence R. Karels, EC, to Margaret Neily,
ES, ``Children's Sleepwear Revocation Project,'' May 27, 1999.
61. Memorandum from Terence R. Karels, EC, to Margaret Neily,
ES, ``Children's Sleepwear--Issues Related to Proposed Revocation,''
May 27, 1999.
62. Memorandum from C. Craig Morris, EHHA, to Margaret Neily,
ESME, ``Sleepwear-Related Thermal Burns in Children under 15 Years
Old,'' June 1, 1999.
63. Memorandum from C. Craig Morris, EHHA, to Margaret Neily,
ESME, ``Response to Public Comments Related to the Children's
Sleepwear Flammability Requirements for sizes 0 to 9 Months,'' May
28, 1999.
64. Memorandum from Carolyn Meiers, ES, to Margaret Neily, ES,
``Human Factors Issues in Sleepwear,'' May 27, 1999.
65. Memorandum from Carolyn Meters, ES, to Margaret Neily, ES,
``Labeling of Tight-Fitting Sleepwear,'' May 27, 1999.
66. Memorandum from Linda Fansler, ES, to Margaret Neily, ES,
``Review of Foreign Flammability Standards for Children's
Sleepwear,'' May 25, 1999.
67. Memorandum from Linda Fansler, ES, to Margaret Neily, ES,
``Response to Comments Received as a Result of Publishing the
Children's Sleepwear Revocation Proposal,'' May 28, 1999.
68. Log of Telephone Call, Linda Fansler, LSE, with Ms.
Christine Simpson, Health Canada, Product Safety Bureau, March 31,
1999.
69. Memorandum from Margaret L. Neily, ES, to File, ``Analysis
of Public Comments on Proposed Revocation of the 1996 and Subsequent
Amendments to the Children's Sleepwear Flammability Standards,'' May
27, 1999.
70. United States General Accounting Office Report to
Congressional Committees and the Consumer Product Safety Commission,
``Consumer Education Efforts for Revised Children's Sleepwear Safety
Standard'' June 1999.
71. Memorandum from Carolyn Meiers, ES, to Margaret Neily, ES,
``Summary of GAO report, ``Consumer Education Efforts for Revised
Children's Sleepwear Safety Standard,'' May 27, 1999.
72. Briefing Memorandum from Ronald L. Medford, Office of Hazard
Identification and Reduction and Margaret L. Neily, ES, to the
Commission, ``Children's Sleepwear Flammability Standards--Analysis
of Public Comments on the Proposed Revocation of the September 1996
and Subsequent Amendments,'' June 3, 1999.
[FR Doc. 99-16322 Filed 6-25-99; 8:45 am]
BILLING CODE 6355-01-P