ÿþ<html> <head><script type="text/javascript" src="/foresee/foresee-trigger.js"></script> <title>Standard for the Flammability of Children's Sleepwear </title> </head> <body> <pre> [Federal Register: June 28, 1999 (Volume 64, Number 123)] [Proposed Rules] [Page 34597-34607] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr28jn99-39] [[Page 34597]] ======================================================================= ----------------------------------------------------------------------- CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Parts 1615 and 1616 <strong>Standard</strong> <strong>for</strong> the <strong>Flammability</strong> of <strong>Children</strong>'<strong>s</strong> <strong>Sleepwear</strong>: Sizes 0 through 6X; <strong>Standard</strong> <strong>for</strong> the <strong>Flammability</strong> of <strong>Children</strong>'<strong>s</strong> <strong>Sleepwear</strong>: Sizes 7 through 14; Withdrawal of Proposed Revocation of Amendments AGENCY: Consumer Product Safety Commission. ACTION: Withdrawal of proposed rule. ----------------------------------------------------------------------- SUMMARY: The Commission withdraws its proposed revocation of certain amendments to the standards <strong>for</strong> the <strong>flammability</strong> of <strong>children</strong>'<strong>s</strong> <strong>sleepwear</strong>, sizes 0 through 6X and sizes 7 through 14. As directed by the fiscal year 1999 appropriations legislation <strong>for</strong> 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 <strong>sleepwear</strong> 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 <strong>sleepwear</strong> 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 DATES: The proposed rule is withdrawn on June 28, 1999. <strong>FOR</strong> 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'<strong>s</strong> <strong>sleepwear</strong> standards. As explained in detail below, the Commission believes the reasons <strong>for</strong> the exemptions remain sound.&lt;SUP&gt;1&lt;/SUP&gt; 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 <strong>sleepwear</strong>.&lt;SUP&gt;2&lt;/SUP&gt; The labels and hangtags will inform consumers that these garments are intended to be worn with a snug fit <strong>for</strong> safety. Also in this issue of the Federal Register the Commission corrects some misidentified references in the amendments. &lt;SUP&gt;3&lt;/SUP&gt; --------------------------------------------------------------------------- \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. --------------------------------------------------------------------------- B. Background 1. The Original Standards Since the 1970'<strong>s</strong> there have been federal <strong>flammability</strong> standards to protect <strong>children</strong> whose <strong>sleepwear</strong> becomes ignited by a small open flame. The Department of Commerce (``DOC'') issued the <strong>flammability</strong> <strong>standard</strong> <strong>for</strong> <strong>children</strong>'<strong>s</strong> <strong>sleepwear</strong> in sizes 0 through 6X (16 CFR Part 1615) in 1971. The Consumer Product Safety Commission issued the <strong>flammability</strong> <strong>standard</strong> <strong>for</strong> <strong>children</strong>'<strong>s</strong> <strong>sleepwear</strong> 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 <strong>flammability</strong> standards <strong>for</strong> 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.<strong>S</strong>.C. 1193(a). When the DOC issued the original <strong>standard</strong> 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 <strong>children</strong> were playing with matches and lighters or contacting stove burners. (DOC Analysis of Data from Apparel Burn Cases <strong>for</strong> <strong>Children</strong>'<strong>s</strong> <strong>Sleepwear</strong> <strong>Standard</strong> DOC PFC 3-70.) The <strong>flammability</strong> test that DOC issued focused on burns resulting from these kinds of ignitions. It was not intended to address all fires in which <strong>sleepwear</strong> happened to burn. <strong>For</strong> example, the DOC excluded incidents involved wearing apparel contaminated by flammable liquids when developing the <strong>standard</strong> because of the variability and complexities involved. Rather, the purpose was to ``provide a high and effective level of protection to <strong>children</strong> approximately 5 years of age and younger against unreasonable risk of death or injury suffered as a result of ignition and continued burning of <strong>sleepwear</strong> 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.<strong>S</strong>.C. 2079(b). In 1974, the Commission issued a <strong>flammability</strong> <strong>standard</strong> <strong>for</strong> <strong>children</strong>'<strong>s</strong> <strong>sleepwear</strong> in sizes 7-14. 39 FR 15210. This <strong>standard</strong> was nearly identical to the <strong>standard</strong> <strong>for</strong> smaller sized <strong>sleepwear</strong>. Under both standards a specimen is exposed <strong>for</strong> 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 <strong>sleepwear</strong> 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 <strong>flammability</strong> test while some synthetic ones do. The standards apply to ``<strong>children</strong>'<strong>s</strong> <strong>sleepwear</strong>,'' which before the exemptions was defined as ``any product of wearing apparel'' in the sizes covered by the <strong>standard</strong> ``such as nightgowns, pajamas, or similar or related items, such as robes, intended to be worn primarily <strong>for</strong> 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 <strong>for</strong> sleeping or related activities.(59) &lt;SUP&gt;4&lt;/SUP&gt; --------------------------------------------------------------------------- \4\ Numbers in parentheses refer to documents in the List of Relevant Documents at the end of this notice. --------------------------------------------------------------------------- 2. The Exemptions In the 1990'<strong>s</strong> the Commission began considering whether the standards could be amended so that close-fitting <strong>sleepwear</strong> could be made out of cotton without increasing the risk of fire with such garments. The Commission started this inquiry <strong>for</strong> several reasons. The staff noticed increased marketing of non-<strong>sleepwear</strong> to be used <strong>for</strong> sleeping, particularly cotton long underwear-syle garments. This marketing was confusing <strong>for</strong> consumers and Commission staff as the line between <strong>sleepwear</strong> and underwear (daywear) became increasingly blurred.(6) The Commission staff developed [[Page 34598]] enforcement guidelines to try to distinguish between <strong>sleepwear</strong> and non- <strong>sleepwear</strong> garments. However, frequent fashion changes required numerous revisions of these guidelines. The Commission staff believed that this confusion was difficult both <strong>for</strong> consumers attempting to put their <strong>children</strong> in suitable sleeping garments and <strong>for</strong> Commission staff trying to enforce the existing <strong>standard</strong>. Moreover, the Commission staff was concerned that to the extent consumers were turning to long underwear-style cotton garments to satisfy a desire <strong>for</strong> cotton <strong>sleepwear</strong>, this could be placing <strong>children</strong> 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 <strong>for</strong> 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 <strong>children</strong>'<strong>s</strong> <strong>sleepwear</strong> 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 <strong>sleepwear</strong> and garments intended <strong>for</strong> 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 <strong>sleepwear</strong> requirements against garments being used as <strong>sleepwear</strong> 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 <strong>sleepwear</strong> <strong>for</strong> their <strong>children</strong>.(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 <strong>sleepwear</strong> standards.(22) The Commission proposed to do this by amending the definition of ``<strong>children</strong>'<strong>s</strong> <strong>sleepwear</strong>'' in the standards. <strong>For</strong> purposes of the proposed exemption, ``infant garments'' were defined as those labeled 0-6 months; less than 21 inches in length (<strong>for</strong> a one piece garment) or with no pieces longer than 14\1/2\ inches (<strong>for</strong> a two piece garment); and less than 19 inches at the chest. ``Tight-fitting garments'' were defined by specifying maximum dimensions <strong>for</strong> the chest, waist, seat, upper arm, thigh, wrist and ankle <strong>for</strong> each size. These dimensions were based on ASTM standards and an anthropometric study of <strong>children</strong> conducted in 1977 by the University of Michigan. 59 FR 53621. All exempt garments would still have to meet the <strong>flammability</strong> standards <strong>for</strong> 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 <strong>sleepwear</strong> manufacturers and importers, consumers and other interested persons. On September 9, 1996, the Commission issued a final rule amending the <strong>flammability</strong> standards <strong>for</strong> <strong>children</strong>'<strong>s</strong> <strong>sleepwear</strong> to exclude from the definition of ``<strong>children</strong>'<strong>s</strong> <strong>sleepwear</strong>,'' (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 <strong>for</strong> 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 <strong>sleepwear</strong> 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 <strong>for</strong> 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 <strong>sleepwear</strong>. 64 FR 2832. 3. Legislation and Proposed Revocation On October 21, 1998, Congress enacted fiscal year 1999 appropriations <strong>for</strong> the Commission. Public Law 105-276. Section 429 of that law required the Commission to propose to revoke the 1996 amendments to the <strong>sleepwear</strong> standards. The law also required the General Accounting Office (``GAO'') to review burn incident data from the ignition of <strong>children</strong>'<strong>s</strong> <strong>sleepwear</strong> from small open-flame sources <strong>for</strong> 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.<strong>S</strong>.C. 2051 et seq., (2) the Flammable Fabrics Act, 15 U.<strong>S</strong>.C 1191 et seq., (3) the Regulatory Flexibility Act, 5 U.<strong>S</strong>.C 601 et seq., (4) the National Environmental Policy Act of 1969, 42 U.<strong>S</strong>.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'<strong>s</strong> 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, <strong>for</strong> interested persons to present their views on the proposed revocation orally. Twenty-one people provided testimony. The Commission has considered GAO'<strong>s</strong> 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 <strong>for</strong> this decision is discussed below. C. The Basis <strong>for</strong> the Exemptions Still Stands The comments and testimony indicate that people appear to have the false impression that the 1996 amendments abolished all standards <strong>for</strong> <strong>sleepwear</strong>. In fact, the Commission'<strong>s</strong> action was narrowly tailored. The Commission'<strong>s</strong> [[Page 34599]] review of research and injury data indicates that the principal risk from <strong>sleepwear</strong> is posed by loose-fitting garments. The <strong>sleepwear</strong> <strong>standard</strong> continues to cover these types of garments. They must pass the <strong>standard</strong>'<strong>s</strong> <strong>flammability</strong> test, that is, they must self-extinguish when exposed to a small open flame. Thus, the <strong>flammability</strong> standards still cover nightgowns and looser fitting pajamas and robes--the types of <strong>sleepwear</strong> most often involved in clothing-ignited fires. Considerable confusion also exists concerning the purpose of the <strong>flammability</strong> standards and their ability to reduce injuries and deaths due to fires. The original <strong>flammability</strong> <strong>standard</strong> was intended to address fires in which clothing was ignited by a small open flame such as matches or lighters. Thus, the original <strong>standard</strong> 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 <strong>standard</strong> would not address such incidents. The Commission has determined to maintain the 1996 amendments because the basis <strong>for</strong> them remains sound. As discussed in sections E through G below, GAO'<strong>s</strong> reports, as well as comments and information received since the amendments, present no new evidence that would change the rationale <strong>for</strong> the 1996 exemptions. A brief review of the basis <strong>for</strong> 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'<strong>s</strong> work in the early 1990'<strong>s</strong>. Numerous studies from the 1970'<strong>s</strong> and 1980'<strong>s</strong> examined the issue. Several studies in the 1970'<strong>s</strong> placed loose and tighter-fitting garments on manikins to observe their performance when ignited. <strong>For</strong> example, in a 1971 study, when <strong>sleepwear</strong> 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'<strong>s</strong> 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, <strong>for</strong> 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 <strong>for</strong> 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 <strong>children</strong> involving <strong>sleepwear</strong>. (The corresponding average annual estimate involving daywear was 850.) Significantly, injuries associated with <strong>sleepwear</strong> predominantly involved females (71 percent) while burn injuries from daywear usually involved males (69 percent). (25) This tendency <strong>for</strong> <strong>sleepwear</strong>-related burns to involve females was true even when the Department of Commerce developed the original <strong>standard</strong> (DOC Analysis of Data <strong>for</strong> <strong>standard</strong>). Females are more likely to have been wearing nightgowns or looser fitting garments <strong>for</strong> sleeping. Of the 20 nightwear-related cases involving <strong>children</strong> 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 <strong>sleepwear</strong> or daywear used as <strong>sleepwear</strong>. Summaries of these investigations were included in staff memos that were part of the briefing packages <strong>for</strong> 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 <strong>sleepwear</strong> 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 <strong>for</strong> 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 <strong>for</strong> clothing-related incidents involving <strong>children</strong> under 15 was about the same as before the stay.(25) When the staff reviewed the data <strong>for</strong> 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 <strong>sleepwear</strong> 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 <strong>sleepwear</strong> manufacturer who was concerned about thermal underwear being marketed and worn as <strong>sleepwear</strong>. Beginning in 1984, the Commission staff developed a series of enforcement pamphlets to try to distinguish between these types of cotton underwear garments and <strong>sleepwear</strong>.(59) Throughout this time, <strong>sleepwear</strong>-related burn incidents have continued to involve primarily loose-fitting garments such as nightgowns, [[Page 34600]] 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) <strong>For</strong> example, a 1985 study reviewed the Canadian experience with clothing-ignited injuries involving <strong>children</strong> 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 <strong>standard</strong> was only intended to address incidents in which an infant'<strong>s</strong> 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 <strong>sleepwear</strong> 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' <strong>sleepwear</strong> at double the age (i.e., <strong>for</strong> 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 <strong>for</strong> babies 6 months of age and younger. 61 FR 47638. (See also oral testimony of Julie Goldschneider and Commissioner Moore'<strong>s</strong> 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 <strong>sleepwear</strong>. Of these, only three involved <strong>children</strong> 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 <strong>children</strong> under one year old associated with clothing found similar results. ``In ten cases, the clothing involved was specifically identified as <strong>sleepwear</strong>. 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 <strong>sleepwear</strong> <strong>standard</strong> was intended to address.'' 61 FR 47637. The Commission previously considered exempting infants from the <strong>sleepwear</strong> <strong>standard</strong>. In 1977, the Commission proposed to delete coverage of <strong>sleepwear</strong> 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 <strong>for</strong> the 1996 exemptions, the staff found only three reported cases involving <strong>children</strong> 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 <strong>children</strong> under one year old. Both incidents were house fires. It was difficult to determine what type of clothing the <strong>children</strong> were wearing.(62) 3. Experiences of Other Countries Support Exemptions The experiences of several other countries, particularly Canada, bolster the Commission'<strong>s</strong> conclusion that the exemptions would not reduce the level of protection <strong>for</strong> <strong>children</strong>. In 1971 Canada issued <strong>flammability</strong> regulations <strong>for</strong> <strong>children</strong>'<strong>s</strong> <strong>sleepwear</strong> that established a minimal <strong>standard</strong> similar to CPSC'<strong>s</strong> general wearing apparel <strong>standard</strong>. However, <strong>sleepwear</strong>-related burn injuries and deaths continued, and studies showed that garment style was a major factor. Thus, in 1987, Canada revised its <strong>sleepwear</strong> regulations so that there are essentially two regulations; one applies to <strong>sleepwear</strong> considered to be a high fire hazard--such as nightgowns, nightshirts, robes and loose-fitting pajamas--the other to <strong>sleepwear</strong> posing a low fire hazard. Garments presenting a high fire hazard must meet a <strong>flammability</strong> test similar to the U.<strong>S</strong>. <strong>sleepwear</strong> <strong>standard</strong> <strong>for</strong> non-exempt garments. <strong>Sleepwear</strong> posing a low fire hazard must meet a test similar to the Commission'<strong>s</strong> general wearing apparel <strong>flammability</strong> test. Canada considers <strong>sleepwear</strong> of the following types to present a low fire hazard: polo pajamas and sleepers in sizes 0-14x, <strong>sleepwear</strong> designed <strong>for</strong> infants up to 7 kg (15.4 lbs.), and <strong>sleepwear</strong> designed <strong>for</strong> 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'<strong>s</strong> Office of Product Safety told CPSC that the <strong>standard</strong> has been a success.(26) The rationale <strong>for</strong> provisions concerning infants and closer-fitting garments was similar to CPSC'<strong>s</strong>. 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 <strong>for</strong> polo pajamas and sleepers: ``Studies have demonstrated that garment style play [sic] a major role in the <strong>flammability</strong> of <strong>sleepwear</strong>. 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 <strong>standard</strong>. 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 <strong>children</strong>'<strong>s</strong> <strong>sleepwear</strong> are no longer an issue in Canada.''(26) As of May 1999, Canada reports that it still has no reported fire deaths related to <strong>children</strong>'<strong>s</strong> <strong>sleepwear</strong> since 1987.(68) Several other countries distinguish between loose-fitting <strong>sleepwear</strong> such as nightgowns and closer-fitting <strong>sleepwear</strong> such as pajamas and make exceptions <strong>for</strong> 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 <strong>sleepwear</strong> regulations issued in 1987 that require nightdresses, dressing gowns and similar garments commonly worn <strong>for</strong> sleeping by <strong>children</strong> between 3 months and 13 years to meet <strong>flammability</strong> performance requirements. Other garments--such as pajamas, cotton terry bath robes and garments <strong>for</strong> babies under 3 months--do not have to comply with the <strong>flammability</strong> <strong>standard</strong>, but must have a permanent label indicating whether they meet the <strong>flammability</strong> <strong>standard</strong>.(13) New Zealand'<strong>s</strong> <strong>sleepwear</strong> standards went into effect in 1980. They require that <strong>sleepwear</strong> <strong>for</strong> <strong>children</strong> 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.<strong>S</strong>. 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'<strong>s</strong> 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 <strong>for</strong> the Exemptions The original <strong>children</strong>'<strong>s</strong> <strong>sleepwear</strong> standards were issued under the Flammable Fabrics Act (``FFA''), which allows the Commission (previously the Secretary of Commerce) to issue a <strong>flammability</strong> <strong>standard</strong> <strong>for</strong> 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.<strong>S</strong>.C. 1193(a). The Commission issued the 1996 amendments under the same authority. In accordance with the procedures in the FFA, 15 U.<strong>S</strong>.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.<strong>S</strong>.C. 1193(i). 59 FR 53616. The Commission issued the final <strong>standard</strong> in accordance with section 4(j) of the FFA, 15 U.<strong>S</strong>.C. 1193(j). 61 FR 47634. As discussed above, section 429 of the legislation that provided the Commission'<strong>s</strong> appropriations <strong>for</strong> fiscal year 1999 required the Commission to propose to revoke the 1996 <strong>sleepwear</strong> 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'<strong>s</strong> 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 <strong>children</strong>'<strong>s</strong> <strong>sleepwear</strong> from small open flame sources <strong>for</strong> 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 <strong>children</strong>'<strong>s</strong> <strong>sleepwear</strong> 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 <strong>sleepwear</strong> <strong>standard</strong> 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 <strong>children</strong>'<strong>s</strong> <strong>sleepwear</strong> before and after CPSC amended its <strong>standard</strong> is uncertain.'' Id. Because few <strong>sleepwear</strong>- related injuries are reported annually to CPSC'<strong>s</strong> 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 <strong>sleepwear</strong> it is not possible to determine the type of <strong>sleepwear</strong> 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 <strong>sleepwear</strong> 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'<strong>s</strong> 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 <strong>sleepwear</strong> or garments used as <strong>sleepwear</strong> 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 <strong>sleepwear</strong>, 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: <strong>For</strong> example, we reviewed case files from one burn center that was not included in CPSC'<strong>s</strong> NEISS sample. These cases involved 12 injuries to <strong>children</strong> younger than 15 in 1997 and 1998 that the staff at the burn center identified as involving <strong>sleepwear</strong>. * * * Although burn center staff did not have information on the fabric content of the <strong>children</strong>'<strong>s</strong> <strong>sleepwear</strong> <strong>for</strong> nine cases they noted the general type of <strong>sleepwear</strong>. 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'<strong>s</strong> 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'<strong>s</strong> criticism that more information on the factors involved in burn injuries is necessary to determine risk is unjustified. GAO'<strong>s</strong> 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 <strong>flammability</strong> of the nightgown or improving the design or performance of the space heater could have prevented her injury.''(55) This example confirms the Commission'<strong>s</strong> conclusions. The girl was wearing a nightgown, precisely the type of clothing the Commission'<strong>s</strong> analysis shows is most likely to be involved in burn injuries. Nightgowns continue to be covered by the <strong>sleepwear</strong> <strong>standard</strong> 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 <strong>sleepwear</strong> (<strong>for</strong> 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 <strong>for</strong> a short period of time so one cannot determine if they are more hazardous. However, close-fitting underwear similar to <strong>sleepwear</strong> has been available under the stay of enforcement since 1993. <strong>For</strong> 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 <strong>standard</strong>. There have not been any reports of incidents involving these types of garments. The GAO report looks at <strong>sleepwear</strong> incident data in isolation. However, the Commission'<strong>s</strong> 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 <strong>sleepwear</strong> amendments directed GAO to assess the information and education (``I&amp;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&amp;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 <strong>sleepwear</strong> 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 <strong>sleepwear</strong> safety. About 63 percent of stores mixed other clothing (such as long underwear and loose- fitting shirts) along with <strong>sleepwear</strong> 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 <strong>sleepwear</strong> and fears that the standards might change made industry reluctant to provide more I&amp;E.(70) The Commission believes that consumers need information to choose appropriate <strong>sleepwear</strong>. 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 <strong>for</strong> tight-fitting <strong>sleepwear</strong>. 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, <strong>sleepwear</strong> 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'<strong>s</strong> responses. 1. General Comments Scope of the Standards and Exemptions Comment: Some commenters had the impression that the exemption eliminated all clothing <strong>flammability</strong> requirements <strong>for</strong> <strong>children</strong>'<strong>s</strong> <strong>sleepwear</strong>. 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 <strong>sleepwear</strong> and only one limited style of <strong>sleepwear</strong> (defined as tight fitting) in larger sizes. Other <strong>sleepwear</strong> garments like nightgowns, robes, and looser-fitting pajamas remain subject to the requirements <strong>for</strong> flame resistance. Exempted <strong>children</strong>'<strong>s</strong> <strong>sleepwear</strong> (including infant sizes 0 to 9 months and tight-fitting <strong>sleepwear</strong> in larger sizes) must still meet the less stringent general clothing textile <strong>flammability</strong> 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 <strong>sleepwear</strong> 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 <strong>sleepwear</strong>, 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 <strong>for</strong> Amendments Comment: Some commenters suggested the Commission had an economic motive, responding to influence by the cotton industry, <strong>for</strong> amending the <strong>sleepwear</strong> 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 <strong>for</strong> 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 <strong>sleepwear</strong> 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 <strong>children</strong> would be beneficial. Response: The 1996 amendments exempted specified garments from the <strong>children</strong>'<strong>s</strong> <strong>flammability</strong> <strong>standard</strong>. 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 <strong>standard</strong> 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 <strong>flammability</strong> 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. <strong>Children</strong>'<strong>s</strong> <strong>Sleepwear</strong> Marketing Issues Availability of Tight-Fitting <strong>Sleepwear</strong> 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 <strong>sleepwear</strong> with increasing frequency <strong>for</strong> at least 20 years. During the 1980'<strong>s</strong> the Compliance staff saw an increase in the number of cotton garments labeled as ``long underwear'' or ``playwear'' that appeared to be <strong>sleepwear</strong>. Industry sources estimate that, before the staff started work on the amendments in 1992, the share of total <strong>sleepwear</strong> purchases accounted <strong>for</strong> by complying cotton garments was about 1-2%. According to National Purchase Diary data, cotton <strong>sleepwear</strong> (the consumer'<strong>s</strong> intended use) purchases have increased from 9.7% to 27.5% of the total <strong>sleepwear</strong> purchases from 1992 to 1998. Effect of Cotton <strong>Sleepwear</strong> Sales on FR (Polyester) Sales Comment: One commenter suggested that with the emergence of cotton garments, flame-resistant <strong>children</strong>'<strong>s</strong> <strong>sleepwear</strong> would be forced out of the market and manufacturers would find that they could not sell flame- resistant <strong>sleepwear</strong>. The American Apparel Manufacturers Association stated that ``polyester garments still dominate the market <strong>for</strong> <strong>children</strong>'<strong>s</strong> <strong>sleepwear</strong>. Sales of synthetic pajamas are very strong and are expected to remain so <strong>for</strong> the foreseeable future.'' Response: Information from the National Purchase Diary shows that purchases of <strong>children</strong>'<strong>s</strong> <strong>sleepwear</strong> are increasing. While the proportion of cotton <strong>sleepwear</strong> purchases is growing, the market <strong>for</strong> other <strong>sleepwear</strong> (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 <strong>children</strong>'<strong>s</strong> <strong>sleepwear</strong> purchases in 1998. Garment Returns From Retail Sales Comment: One commenter, a major retailer of <strong>children</strong>'<strong>s</strong> clothing, noted that it has experienced returns of tight-fitting <strong>sleepwear</strong> at about 8% of sales, which it describes as high. Response: The Commission expected some consumer returns of tight- fitting <strong>sleepwear</strong> 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 <strong>for</strong> a larger size. Except <strong>for</strong> 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 <strong>sleepwear</strong> 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 <strong>Children</strong>'<strong>s</strong> <strong>Sleepwear</strong> Trend in Clothing-Related Burn Fatalities Comment: Some commenters asserted that enactment of the <strong>sleepwear</strong> <strong>standard</strong> in 1972 reduced the number of annual <strong>sleepwear</strong>-related burn deaths from 60 to 4. Others have expressed this in reverse--there would be ten times as many deaths without the <strong>sleepwear</strong> <strong>standard</strong>. Response: These assertions are incorrect because they refer to all clothing-related burn deaths reported by the National Center <strong>for</strong> Health Statistics (``NCHS''). The NCHS mortality files providing these data do not distinguish <strong>sleepwear</strong>-related burn cases from other clothing- related burn cases. There are no reliable data on the number of <strong>sleepwear</strong>-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 <strong>children</strong> 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 <strong>children</strong> 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 <strong>Standard</strong> 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 <strong>sleepwear</strong>-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 <strong>standard</strong> changed. The GAO report asserted that CPSC'<strong>s</strong> <strong>sleepwear</strong> burn data were both too sparse to provide reliable national estimates and subject to coding biases possibly leading to underestimation of <strong>sleepwear</strong>-related burns. Response: There is no reason to believe that the number of burn injuries in the U.<strong>S</strong>. is underestimated by CPSC'<strong>s</strong> National Electronic Injury Surveillance System. The NEISS sample of 101 hospitals, 2.2% of the universe of 5,387 U.<strong>S</strong>. emergency-room hospitals, includes 4 or 4% of the 119 hospitals that are self-identified burn treatment centers. Although some severely burned <strong>children</strong> may be admitted directly to burn treatment facilities, more often such victims are taken to the nearest hospital emergency room <strong>for</strong> 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 <strong>for</strong> <strong>sleepwear</strong> burns. Each case is carefully reviewed and any serious burn cases are quickly identified and investigated. A change in frequency of <strong>sleepwear</strong>-related pediatric burn injuries would be readily detected, while a change in severity would be more difficult because of the few <strong>sleepwear</strong>-related burn cases reported in NEISS. Infant Exemption'<strong>s</strong> Likely Effect on Burn Injuries Comment: Several commenters (physicians) gave accounts of cases where they believe flame-resistant <strong>sleepwear</strong> could or did, in their opinion, reduce the severity of the injuries sustained by infants and other <strong>children</strong> in fires. In some of these cases, they said <strong>children</strong> 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 <strong>sleepwear</strong>-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 <strong>sleepwear</strong> <strong>for</strong> infants. Response: The typical scenarios involving infants are bedding or larger room/house fires. The <strong>children</strong>'<strong>s</strong> <strong>sleepwear</strong> 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 <strong>sleepwear</strong> 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 <strong>children</strong>'<strong>s</strong> clothing to the CPSC staff. Most of these involved garments or fire scenarios not addressed by the <strong>sleepwear</strong> <strong>standard</strong>. The staff requested <strong>for</strong> 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 <strong>standard</strong> 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 <strong>standard</strong> 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 <strong>children</strong> 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 <strong>sleepwear</strong>. Other commenters argued that although these cases are tragic and still occur, the <strong>standard</strong> (flame-resistance) does not protect against injuries from house fires or the rare infant crib/bedding fires. Response: As discussed above, the <strong>children</strong>'<strong>s</strong> <strong>sleepwear</strong> standards were not intended to address the risk of a whole house or bedding fire. The intent of the <strong>sleepwear</strong> standards is to eliminate the risk of serious personal injury or death from fire as a result of contact between the <strong>sleepwear</strong> garment and a small ignition source. Even flame- resistant <strong>sleepwear</strong> 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'<strong>s</strong> <strong>flammability</strong>. <strong>Children</strong>'<strong>s</strong> <strong>sleepwear</strong> 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'<strong>s</strong> 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 <strong>for</strong> sustained burning. Research indicates that reasonably safe <strong>sleepwear</strong> garments can be made from cotton fabrics that do not [[Page 34605]] meet the <strong>flammability</strong> requirements of the <strong>children</strong>'<strong>s</strong> <strong>sleepwear</strong> standards, i.e. they do not self-extinguish. Comfortable, practical, tight-fitting <strong>sleepwear</strong> can and is being produced that is acceptable to consumers. Fire Safety Comment: One commenter asserted that non-flame resistant cotton <strong>sleepwear</strong> is dangerous based on a local fire department demonstration in which two <strong>sleepwear</strong> garments, one flame-resistant and the other untreated cotton were burned. Response: It is not surprising that the commenter observed that the cotton <strong>sleepwear</strong> ``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'<strong>s</strong> <strong>flammability</strong>. 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'<strong>s</strong> body were burned but portions covered by flame-resistant garments were not. The National Cotton Council stated that cotton <strong>sleepwear</strong> 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 <strong>children</strong>'<strong>s</strong> <strong>sleepwear</strong> 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'<strong>s</strong> 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 <strong>sleepwear</strong> standards beyond those represented by the test method. Upsizing Practices Comment: Commenters noted that parents may ``upsize,'' that is, buy <strong>sleepwear</strong> in sizes larger than their <strong>children</strong>'<strong>s</strong> current size, because they will get longer wear from the garments. In store interviews, customers indicated that if they were to purchase tight-fitting <strong>sleepwear</strong>, they would buy a larger size. Others added concerns that handing down clothes to younger <strong>children</strong> 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 <strong>for</strong> tight-fitting <strong>sleepwear</strong>. The staff contacted manufacturers and retailers <strong>for</strong> this perspective. A representative of a <strong>sleepwear</strong> 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 <strong>sleepwear</strong> 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 <strong>children</strong> with ample room <strong>for</strong> movement and comfort while maintaining the tight fit required by the exemption. The staff also observed <strong>children</strong> 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 <strong>children</strong>'<strong>s</strong> bodies, touching them at many points, thus reducing the likelihood of ignition. Informational labeling is important <strong>for</strong> tight-fitting <strong>children</strong>'<strong>s</strong> <strong>sleepwear</strong> to help consumers distinguish among flame-resistant and non- flame-resistant (tight-fitting) garments. Consumers need to be informed that certain <strong>sleepwear</strong> is no longer flame-resistant and that proper fit is necessary <strong>for</strong> 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 <strong>for</strong> 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'<strong>s</strong> 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 <strong>children</strong>'<strong>s</strong> <strong>sleepwear</strong> <strong>flammability</strong> standards. They argued that this may make the garments more attractive to parents currently avoiding tight-fitting <strong>sleepwear</strong> without compromising the garment'<strong>s</strong> 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 <strong>for</strong> exempted <strong>children</strong>'<strong>s</strong> <strong>sleepwear</strong> when amending the <strong>sleepwear</strong> 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 <strong>for</strong> tight-fitting garments to be exempt from the <strong>children</strong>'<strong>s</strong> <strong>sleepwear</strong> standards, the garment must touch the body at all critical locations. To do this, <strong>children</strong>'<strong>s</strong> <strong>sleepwear</strong> garments must be equal to or less than the body dimension at these locations. Comfortable, tight-fitting <strong>sleepwear</strong> 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 <strong>standard</strong> 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 <strong>sleepwear</strong> 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 <strong>for</strong> 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 <strong>children</strong>'<strong>s</strong> <strong>sleepwear</strong> 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. <strong>Sleepwear</strong> garments manufactured to the dimensions specified in the <strong>sleepwear</strong> standards using such knit fabrics are currently being sold to consumers. 7. Compliance Issues Comment: One commenter questioned the Commission'<strong>s</strong> efforts to enforce the amended standards that exempt tight-fitting <strong>sleepwear</strong> garments. Response: Earlier this year, the Commission staff initiated a program <strong>for</strong> CPSC investigators to inspect retail stores throughout the United States to determine whether <strong>sleepwear</strong> marketed and promoted as being tight-fitting meets the measurements required <strong>for</strong> 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 <strong>children</strong>, Labeling, Reporting and recordkeeping requirements, <strong>Sleepwear</strong>, 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 <strong>Children</strong>'<strong>s</strong> <strong>Sleepwear</strong> 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 <strong>Sleepwear</strong> <strong>Flammability</strong> 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, <strong>Children</strong>'<strong>s</strong> <strong>Sleepwear</strong> Project.'' 4. Memorandum from Anthony C. Homan, ECPA, to Terrance R. Karels, Project Manager, dated March 25, 1992, entitled ``Market Sketch--<strong>Children</strong>'<strong>s</strong> <strong>Sleepwear</strong>.'' 5. Briefing Memorandum from Terrance R. Karels to the Commission, dated November 3, 1992. 6. Federal Register notice ``Standards <strong>for</strong> the <strong>Flammability</strong> of <strong>Children</strong>'<strong>s</strong> <strong>Sleepwear</strong>: 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 <strong>for</strong> the <strong>Flammability</strong> of <strong>Children</strong>'<strong>s</strong> <strong>Sleepwear</strong>: 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 <strong>Children</strong>'<strong>s</strong> <strong>Sleepwear</strong> Coalition In Response to the Consumer Product Safety Commission'<strong>s</strong> 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 <strong>Children</strong>'<strong>s</strong> <strong>Sleepwear</strong> 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 <strong>Children</strong>'<strong>s</strong> <strong>Sleepwear</strong> 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 <strong>Sleepwear</strong>,'' and attachment; March 8, 1994. 15. Memorandum from George Sweet, EPHF, to Terrance R. Karels, ECPA, entitled ``Garments Intended <strong>for</strong> Infants''; July 8, 1994. 16. ``Preliminary Regulatory and Regulatory Flexibility Analyses <strong>for</strong> the Proposed Amendments to the <strong>Children</strong>'<strong>s</strong> <strong>Flammability</strong> Standards,'' by Anthony C. Homan, Directorate <strong>for</strong> Economic Analysis; June, 1994. 17. ``Market Sketch--<strong>Children</strong>'<strong>s</strong> <strong>Sleepwear</strong>,'' by Anthony C. Homan, Directorate <strong>for</strong> Economic Analysis; March, 1992. 18. Memorandum from Eva <strong>S</strong>. Lehman, HSPS, to Terrance R. Karels, ECPA, entitled ``Toxicological Evaluation of Fabrics Used in <strong>Children</strong>'<strong>s</strong> <strong>Sleepwear</strong>''; June 7, 1994. 19. Memorandum from Patricia Fairall, CERM, to Terrance Karels, ECPA, entitled ``Compliance History--Enforcement of <strong>Children</strong>'<strong>s</strong> <strong>Sleepwear</strong>''; 6 pages; April 20, 1994. 20. Memorandum from James F. Hoebel, Acting Director, ESME, to Terrance R. Karels, ECPA, entitled ``Amendments to <strong>Children</strong>'<strong>s</strong> <strong>Sleepwear</strong> Standards''; July 7, 1994. 21. Memorandum from Dr. Terry L. Kissinger, EPHA, to Terrance R. Karels, ECPA, entitled ``Proposed Amendment to <strong>Children</strong>'<strong>s</strong> <strong>Sleepwear</strong> Standards''; July 15, 1994. 22. Federal Register notice ``<strong>Standard</strong> <strong>for</strong> the <strong>Flammability</strong> of <strong>Children</strong>'<strong>s</strong> <strong>Sleepwear</strong>: Sizes 0 Through 6X; <strong>Standard</strong> <strong>for</strong> the <strong>Flammability</strong> of <strong>Children</strong>'<strong>s</strong> <strong>Sleepwear</strong>: 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 <strong>for</strong> the <strong>Flammability</strong> of <strong>Children</strong>'<strong>s</strong> <strong>Sleepwear</strong>, 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 <strong>Children</strong>'<strong>s</strong> <strong>Sleepwear</strong> 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 <strong>for</strong> the <strong>flammability</strong> of <strong>children</strong>'<strong>s</strong> <strong>sleepwear</strong>; 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 <strong>for</strong> the <strong>flammability</strong> of <strong>children</strong>'<strong>s</strong> <strong>sleepwear</strong>. 28. Memorandum from Linda Fansler, ESME, to Terrance R. Karels, ECPA, entitled ``Tight Fitting <strong>Children</strong>'<strong>s</strong> <strong>Sleepwear</strong>''; July 14, 1995. 29. Memorandum from Terrance R. Karels, Project Manager, to Warren J. Prunella, Associate Executive Director <strong>for</strong> Economic Analysis, entitled ``<strong>Sleepwear</strong> Market Update''; October 6, 1995. [[Page 34607]] 30. Final Regulatory Analysis <strong>for</strong> amendments of the <strong>children</strong>'<strong>s</strong> <strong>sleepwear</strong> standards by Terrance R. Karels; July 1995. 31. Memorandum from David Schmeltzer, Assistant Executive Director <strong>for</strong> Compliance, to Terrance Karels, Project Manager, entitled ``<strong>Sleepwear</strong> 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 <strong>Children</strong>'<strong>s</strong> <strong>Sleepwear</strong> 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 <strong>Sleepwear</strong> 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 ``<strong>Children</strong>'<strong>s</strong> <strong>Sleepwear</strong>--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 <strong>Children</strong>'<strong>s</strong> <strong>Sleepwear</strong> 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 <strong>sleepwear</strong> <strong>flammability</strong> regulation: Sizing and Labeling''; September 20, 1995. 40. Memorandum from Karen G. Krushaar, OIPA, to Terrance R. Karels, ECPA, entitled ``<strong>Children</strong>'<strong>s</strong> <strong>Sleepwear</strong> 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 <strong>Children</strong>'<strong>s</strong> <strong>Sleepwear</strong> 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 <strong>children</strong>'<strong>s</strong> <strong>sleepwear</strong> <strong>flammability</strong> standards. 45. Memorandum from James F. Hoebel, Chief Engineer <strong>for</strong> Fire Hazards, to Terrance R. Karels, Project Manager, entitled ``<strong>Children</strong>'<strong>s</strong> <strong>Sleepwear</strong>''; October 10, 1995. 46. Memorandum from Warren J. Prunella, Associate Executive Director <strong>for</strong> Economic Analysis, to file concerning small business effects of proposed amendments to the <strong>children</strong>'<strong>s</strong> <strong>sleepwear</strong> <strong>flammability</strong> standards; February 17, 1995. 47. Memorandum from Warren J. Prunella, Associate Executive Director <strong>for</strong> Economic Analysis, to Eric A. Rubel, General Counsel, concerning requirements <strong>for</strong> Congressional review of final amendments to the <strong>children</strong>'<strong>s</strong> <strong>sleepwear</strong> standards; undated. 48. Vote sheet to accompany briefing package on <strong>children</strong>'<strong>s</strong> <strong>sleepwear</strong> <strong>flammability</strong> standards; October 11, 1995. 49. Memorandum from Terrance R. Karels, Project Manager, and Ronald L. Medford, Assistant Executive Director <strong>for</strong> Hazard Identification and Reduction entitled ``Questions Regarding <strong>Children</strong>'<strong>s</strong> <strong>Sleepwear</strong> Amendments,'' with attachments; January 30, 1996. 50. Federal Register notice ``Proposed Technical Changes; <strong>Standard</strong> <strong>for</strong> the <strong>Flammability</strong> of <strong>Children</strong>'<strong>s</strong> <strong>Sleepwear</strong>: Sizes 0 Through 6X; <strong>Standard</strong> <strong>for</strong> the <strong>Flammability</strong> of <strong>Children</strong>'<strong>s</strong> <strong>Sleepwear</strong>; 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; <strong>Standard</strong> <strong>for</strong> the <strong>Flammability</strong> of <strong>Children</strong>'<strong>s</strong> <strong>Sleepwear</strong>: Sizes 0 Through 6X; <strong>Standard</strong> <strong>for</strong> the <strong>Flammability</strong> of <strong>Children</strong>'<strong>s</strong> <strong>Sleepwear</strong>; sizes 7 Through 14'' published by the Consumer Product Safety Commission, May 21, 1998 (63 FR 27885). 52. Federal Register notice ``Final Technical Changes; <strong>Standard</strong> <strong>for</strong> the <strong>Flammability</strong> of <strong>Children</strong>'<strong>s</strong> <strong>Sleepwear</strong>: Sizes 0 Through 6X; <strong>Standard</strong> <strong>for</strong> the <strong>Flammability</strong> of <strong>Children</strong>'<strong>s</strong> <strong>Sleepwear</strong>; 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; <strong>Standard</strong> <strong>for</strong> the <strong>Flammability</strong> of <strong>Children</strong>'<strong>s</strong> <strong>Sleepwear</strong>: Sizes 0 Through 6X; <strong>Standard</strong> <strong>for</strong> the <strong>Flammability</strong> of <strong>Children</strong>'<strong>s</strong> <strong>Sleepwear</strong>; 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; <strong>Standard</strong> <strong>for</strong> the <strong>Flammability</strong> of <strong>Children</strong>'<strong>s</strong> <strong>Sleepwear</strong>: Sizes 0 Through 6X; <strong>Standard</strong> <strong>for</strong> the <strong>Flammability</strong> of <strong>Children</strong>'<strong>s</strong> <strong>Sleepwear</strong>; 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 <strong>Children</strong>'<strong>s</strong> <strong>Sleepwear</strong> Safety <strong>Standard</strong>,'' GAO/HEHS-99-64, April 1999. 56. Memorandum from Martha A. Kosh, OS, to Sadye E. Dunn, Secretary, OS, ``<strong>Sleepwear</strong> Revocation,'' list of comments on CF99-1, March 17, 1999. 57. Memorandum from Martha A. Kosh, OS, to Sadye E. Dunn, Secretary, OS, ``<strong>Sleepwear</strong> Revocation,'' list of additional comments on CF99-1, March 29, 1999. 58. U.<strong>S</strong>. Consumer Product Safety Commission Public Hearing on Proposed Revocation of Amendments to <strong>Children</strong>'<strong>s</strong> <strong>Sleepwear</strong> Standards, agenda with presenters, April 22, 1999. 59. Memorandum from Marilyn Borsari, Office of Compliance to Margaret Neily, Directorate <strong>for</strong> Engineering Sciences, ``Enforcement History of <strong>Children</strong>'<strong>s</strong> <strong>Sleepwear</strong> Standards,'' May 12, 1999. 60. Memorandum from Terence R. Karels, EC, to Margaret Neily, ES, ``<strong>Children</strong>'<strong>s</strong> <strong>Sleepwear</strong> Revocation Project,'' May 27, 1999. 61. Memorandum from Terence R. Karels, EC, to Margaret Neily, ES, ``<strong>Children</strong>'<strong>s</strong> <strong>Sleepwear</strong>--Issues Related to Proposed Revocation,'' May 27, 1999. 62. Memorandum from C. Craig Morris, EHHA, to Margaret Neily, ESME, ``<strong>Sleepwear</strong>-Related Thermal Burns in <strong>Children</strong> 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 <strong>Children</strong>'<strong>s</strong> <strong>Sleepwear</strong> <strong>Flammability</strong> Requirements <strong>for</strong> sizes 0 to 9 Months,'' May 28, 1999. 64. Memorandum from Carolyn Meiers, ES, to Margaret Neily, ES, ``Human Factors Issues in <strong>Sleepwear</strong>,'' May 27, 1999. 65. Memorandum from Carolyn Meters, ES, to Margaret Neily, ES, ``Labeling of Tight-Fitting <strong>Sleepwear</strong>,'' May 27, 1999. 66. Memorandum from Linda Fansler, ES, to Margaret Neily, ES, ``Review of Foreign <strong>Flammability</strong> Standards <strong>for</strong> <strong>Children</strong>'<strong>s</strong> <strong>Sleepwear</strong>,'' May 25, 1999. 67. Memorandum from Linda Fansler, ES, to Margaret Neily, ES, ``Response to Comments Received as a Result of Publishing the <strong>Children</strong>'<strong>s</strong> <strong>Sleepwear</strong> 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 <strong>Children</strong>'<strong>s</strong> <strong>Sleepwear</strong> <strong>Flammability</strong> Standards,'' May 27, 1999. 70. United States General Accounting Office Report to Congressional Committees and the Consumer Product Safety Commission, ``Consumer Education Efforts <strong>for</strong> Revised <strong>Children</strong>'<strong>s</strong> <strong>Sleepwear</strong> Safety <strong>Standard</strong>'' June 1999. 71. Memorandum from Carolyn Meiers, ES, to Margaret Neily, ES, ``Summary of GAO report, ``Consumer Education Efforts <strong>for</strong> Revised <strong>Children</strong>'<strong>s</strong> <strong>Sleepwear</strong> Safety <strong>Standard</strong>,'' May 27, 1999. 72. Briefing Memorandum from Ronald L. Medford, Office of Hazard Identification and Reduction and Margaret L. Neily, ES, to the Commission, ``<strong>Children</strong>'<strong>s</strong> <strong>Sleepwear</strong> <strong>Flammability</strong> 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 </pre> </body> </html>