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

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DATES: The proposed rule is withdrawn on June 28, 1999.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

[[Page 34598]]

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

[[Page 34599]]

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

[[Page 34601]]

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