[Federal Register: October 25, 1994] ======================================================================= ----------------------------------------------------------------------- CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Parts 1615 and 1616 Standard for the Flammability of Children's Sleepwear: Sizes 0 Through 6X; Standard for the Flammability of Children's Sleepwear: Sizes 7 Through 14 AGENCY: Consumer Product Safety Commission. ACTION: Proposed amendments. ----------------------------------------------------------------------- SUMMARY: The Commission proposes to amend flammability standards applicable to children's sleepwear in sizes 0 through 6X and sizes 7 through 14. The amendments proposed below would revise the definition of ``children's sleepwear'' in the standard for sizes 0 through 6X to exclude garments in some infant sizes and tight-fitting garments from the products which are subject to the standard, and would revise the definition of ``children's sleepwear'' in the standard for sizes 7 through 14 to exclude ``tight-fitting garments.'' The Commission is proposing these amendments because it has reason to believe that the existing children's sleepwear standards may not be limited to those sleepwear garments which present an unreasonable risk of burn deaths and injuries. Information available to the Commission indicates that by removing certain garments which do not present that unreasonable risk of injury, the proposed amendments would afford consumers a wider selection of sleepwear garments for children without diminishing the protection provided by the children's sleepwear standards.1 \1\The Commission voted 2-1 to propose amendments of the children's sleepwear flammability standards, Chairman Ann Brown dissenting. --------------------------------------------------------------------------- DATES: (1) Written Comments concerning the proposed amendments should be received by the Commission not later than January 9, 1995. (2) The Commission will provide opportunity for oral presentations of data, views, and arguments concerning the proposed amendment at a date to be announced. ADDRESSES: Written comments concerning the proposed amendments should be mailed to the Office of the Secretary, Consumer Product Safety Commission, Washington, DC 20207, telephone: (301) 504-0800; or delivered to the Office of the Secretary, room 501, 4330 East-West Highway, Bethesda, Maryland 20814. Comments should be submitted in five copies and captioned ``Amendment of Children's Sleepwear Standards.'' FOR FURTHER INFORMATION CONTACT: Terrance R. Karels, Directorate for Economic Analysis, Consumer Product Safety Commission, Washington, DC 20207; telephone (301) 504-0962, extension 1320. SUPPLEMENTARY INFORMATION: A. Background Provisions of the Flammable Fabrics Act (FFA) (15 U.S.C. 1191 et seq.) authorize issuance of flammability standards and regulations to protect the public from unreasonable risks of death, injury, and property damage from fires associated with products of wearing apparel made from fabric and related materials. In 1971, the Secretary of Commerce issued a flammability standard for children's sleepwear in sizes 0 through 6X to protect young children from death and serious burn injuries which had been associated with ignition of sleepwear garments, such as nightgowns and pajamas, by small open-flame sources. The standard for sleepwear in sizes 0 through 6X became effective in 1972 and is now codified at 16 CFR part 1615. In 1973, authority to issue flammability standards under provisions of the FFA was transferred from the Department of Commerce to the Consumer Product Safety Commission by section 30(b) of the Consumer Product Safety Act (CPSA) (15 U.S.C. 2079(b)). In 1974, the Commission issued a flammability standard for children's sleepwear in sizes 7 through 14. That standard became effective in 1975 and is now codified at 16 CFR part 1616. Both standards prescribe a test which requires that specimens of fabrics, seams, and trim of children's sleepwear garments must self- extinguish after exposure to a small-open flame. Both standards require manufacturers of children's sleepwear subject to their provisions to test prototypes of sleepwear garments with acceptable results before beginning production. Both standards also require manufacturers to sample and test garments from regular production. Failure to comply with the sampling and testing requirements of the standards is a violation of section 3 of the FFA (15 U.S.C. 1192). The standards do not require or prohibit the use of any particular type of fabric or garment design as long as the manufacturer successfully completes the prescribed prototype and production testing. Each standard defines the term ``children's sleepwear'' to mean ``any product of wearing apparel'' in the sizes covered by the standard ``such as nightgowns, pajamas, or similar or related items, such as robes, intended to be worn primarily for sleeping or activities related to sleeping.'' Each standard excludes diapers and underwear from its coverage. See 16 CFR 1615.1(a) and 1616.2(a). B. Garments Subject to the Sleepwear Standards Before the effective date of the standard for children's sleepwear in sizes 0 through 6X, questions arose about the specific types of garments which are subject to the requirements of that standard because they are ``intended to be worn primarily for sleeping and activities related to sleeping.'' To respond to those questions, the Federal Trade Commission (FTC), the agency responsible for enforcement of the standard at that time, published an enforcement polity statement in the Federal Register of March 23, 1972 (37 FR 5982). Briefly summarized, that policy statement announced that in determining whether a garment is ``intended to be worn primarily for sleeping or activities related to sleeping'' the FTC would consider (1) the nature of the garment and its suitability for use by children for sleeping or activities related to sleeping; (2) the manner in which the garment is distributed and promoted; and (3) the likelihood that the garment will be used by children for sleeping or activities related to sleeping in a substantial number of cases. After the Commission issued the flammability standard for children's sleepwear in sizes 7 through 14, the agency became aware of various ``borderline'' garments which may or may not be intended ``primarily for sleeping or activities related to sleeping.'' Some of these garments were described in packaging, labeling, and advertising as ``playwear,'' ``daywear,'' or ``underwear.'' Because the FTC policy statement applied only to sleepwear garments in sizes 0 through 6X, the Commission decided to issue a new policy statement concerning the scope of the standard for sleepwear in sizes 7 through 14, and to revise and reissue the policy statement concerning the scope of the standard for sizes 0 through 6X. The Commission published a proposed revision of the policy statement concerning the scope of the sleepwear standard for sizes 0 through 6X and a new policy statement concerning the scope of the standard for sizes 7 through 14 in 1979; in 1980 the Commission issued final policy statements. Those policy statements were the subject of an action for judicial review and were set aside by a U.S. Court of Appeals in 1981. See National Knitwear Manufacturers Association v. CPSC, 606 F2d 81 (4th Cir. 1981). In 1984, the Commission issued new policy statements to replace the ones set aside on judicial review. The Commission's 1984 policy statements incorporate and amplify the factors which were identified in the FTC policy as relevant to determining whether a garment is an item of ``children's sleepwear'' because it is intended to be worn ``primarily for sleeping and activities related to sleeping.'' (1)2 The 1984 policy statements are codified at 16 CFR 1615.64 and 1616.65. --------------------------------------------------------------------------- \2\Numbers in parentheses identify reference documents listed in Bibliography at the end of this notice. Requests for inspection of any of these documents should be made at the Commission's Public Reading Room, 4330 East-West Highway, room 419, Bethesda, Maryland 20814, or by calling the Office of the Secretary (301) 504-0800. --------------------------------------------------------------------------- The Commission's issuance of policy statements in 1983 did not definitively resolve all questions about the differences between those children's garments which are sleepwear and are subject to the sleepwear standards and those which are not. In 1984, the Commission staff developed a pamphlet entitled Enforcement Policy on Children's Sleepwear, which described and illustrated various styles of sleepwear and non-sleepwear garments. Since its initial publication, the Commission staff has revised this pamphlet five times. The last publication was in 1989, entitled Supplemental CPSC Staff Guide to the Enforcement Policy Statements of the Flammability Standard for Children's Sleepwear (2). Nevertheless, the Commission staff continued to receive a large volume of inquiries about the status of particular garments as sleepwear or non-sleepwear as well as complaints about alleged violations of the children's sleepwear standards by firms manufacturing or importing garments which were subject to the standards' definitions of ``children's sleepwear'' but which did not meet the requirements of the applicable standard. During the same time, the staff also became aware of an increased demand by consumers for children's sleepwear made from 100 per cent untreated cotton fabric. Although the standards do not prohibit any specific type of fabric in the production of children's sleepwear, 100 per cent cotton fabric cannot pass the flammability tests in the standards unless treated with a flame retardant. In 1991, the Commission decided to re-examine the scope of the children's sleepwear standards and to consider the possibility of amending the definitions of the term ``children's sleepwear'' in the two standards. This undertaking resulted in the initiation of this rulemaking proceeding in 1993. C. Statutory Provisions Section 4(g) of the FFA (15 U.S.C. 1193(g)) provides that a proceeding for issuance or amendment of a flammability standard is initiated by publication in the Federal Register of an advance notice of proposed rulemaking (ANPR). Section 4(g) of the FFA requires that the ANPR must describe the product and the risk of injury under consideration; summarize the regulatory alternatives being considered; provide information about existing standards which may be relevant; invite interested persons to submit comments on the product, risk of injury, and regulatory alternatives under consideration; invite interested persons to submit an existing standard or portion of a standard to the Commission for publication as the proposed standard or amendment; and invite interested persons to submit a statement of intent to develop or modify a voluntary standard to address the risk of injury under consideration. If the Commission decides to continue the proceeding after consideration of comments and submissions received in response to the ANPR, section 4(i) of the FFA requires the Commission to publish a notice of proposed rulemaking (NPR). The NPR must set forth the text of the proposed rule and a preliminary regulatory analysis containing a discussion of the anticipated benefits and costs of the proposed rule and other regulatory alternatives considered by the Commission. Provisions of section 4(d) of the FFA provide that interested persons shall be given the opportunity to make oral presentations of data, views, or arguments as well as to submit written comments on the proposed rule. To issue a final standard or amendment, section 4(j) of the FFA requires the Commission to publish a notice of final rulemaking setting forth the text of the final rule and the Commission's final regulatory analysis of costs, benefits, and alternatives to the rule. Section 4(j) also requires that the notice of final rulemaking must contain the Commission's findings with regard to the provisions and extent of compliance with any voluntary standard that may be applicable to the risk of injury under consideration. Additionally, section 4(b) of the FFA requires the notice of final rulemaking to contain findings that the standard or amendment is needed to protect the public from the unreasonable risk of death, injury, or significant property damage from fires associated with the fabric or product under consideration; is reasonable, technologically practicable and appropriate; and is limited to those fabrics or products which have been determined to present an unreasonable risk of death, injury, or significant property damage. D. Publication of ANPR The Commission began this proceeding to consider amendment of the children's sleepwear standards by publication of an ANPR in the Federal Register of January 13, 1993 (58 FR 4111). The ANPR identified the products under consideration as children's sleepwear garments in sizes 0 through 14, and the risk of injury as death or personal injury from fires resulting from ignition of children's sleepwear (4). As required by section 4(g) of the FFA, the ANPR also described the regulatory alternatives being considered by the Commission. Briefly summarized, the alternatives listed in the ANPR were: (1) Amendment of the children's sleepwear standards to exempt tight-fitting sleepwear garments and sleepwear garments in infant sizes. Children's sleepwear garments exempted from the requirements of the sleepwear standard would be subject to the provisions of the Standard for the Flammability of Clothing Textiles (16 CFR part 1610). That standard prohibits the manufacture, importation, or sale of garments which are ``dangerously flammable because of rapid and intense burning,'' but does not require garments to self-extinguish when exposed to a small open-flame ignition source, or (2) Issuance of an enforcement policy statement to announce that the Commission will not apply the requirements of the children's sleepwear standards to tight-fitting sleepwear garments and garments in infant sizes as long as those garments meet the requirements of the clothing textiles flammability standard. Section 4(g) also requires the ANPR to include information about all standards known by the Commission to be relevant to the proceeding. The ANPR discussed provisions of flammability standards for children's sleepwear issued by Australia, Canada, and New Zealand. The Canadian and New Zealand standards have less stringent flammability performance requirements for tight-fitting children's sleepwear garments than for loose-fitting children's sleepwear. The Canadian standard also makes special provisions for sleepwear garments in infant sizes and children's sleepwear intended for use in hospitals. It is noteworthy that there have been no burn deaths associated with children's sleepwear reported in Canada since its standard was promulgated in 1987. At the same time the Commission published the ANPR, it also announced that it would not enforce the children's sleepwear standards in instances involving garments in sizes 0 through 14 which are labeled and marketed as ``underwear'' if those garments are skin-tight or nearly skin-tight and are essentially identical in design and fit to underwear garments (5). See 58 FR 4078, January 13, 1993. E. Response to ANPR In response to the ANPR, the Commission received more than 2,100 written comments from individuals, firms, and organizations. Comments were received from all 50 states, the District of Columbia, Puerto Rico, the U.S. Virgin Islands, and from United States citizens living abroad (3), (6). More than 95 percent of these comments favored modification of the standards to exempt some or all children's sleepwear garments from their requirements. More than one-third of all comments received in response to the ANPR were in the form of prepared letters with space for the commenter's name, or letters that were identical in their wording (3), (6). The significant issues raised by those comments and the Commission's assessment of those issues is set forth below. 1. Should Consumers Be Able To Purchase Non-Complying Sleepwear Garments if They Desire? Several comments express the view that consumers should be able to purchase children's sleepwear which does not meet the flammability requirements of the children's sleepwear standards-- specifically, children's sleepwear made from untreated 100 percent cotton--rather than garments which are manufactured to comply with the children's sleepwear standards if they choose to do so. Many of these comments state that parents are the parties with primary responsibility for their children's safety. A large number of comments from consumers stated that parents prefer to dress their children in cotton garments for sleeping. Reasons given for preferring untreated 100 percent cotton sleepwear include lower price, increased comfort to the wearer, and the avoidance of skin irritation or unpleasant odors which some comments assert are associated with certain man-made fabrics or fabrics with flame-retardant treatment. Some of these comments express the view that both children's sleepwear standards should be revoked in their entirety (6). Other comments express the view that the government has a duty to establish mandatory safety requirements to protect children from risks of death and serious injury, and that consumer preference must yield to mandatory requirements needed to protect children from serious burn hazards (6). Some comments urge the Commission to extend the flammability requirements of the children's sleepwear standards to cover other children's garments--specifically garments made from light-weight fabrics and long underwear (6). The Commission observes that section 4 of the FFA (15 U.S.C. 1193) authorizes the agency to issue or amend mandatory requirements for the flammability of wearing apparel only when such requirements are ``needed to adequately protect the public against unreasonable risk of the occurrence of fire leading to death, injury, or significant property damage.'' (Emphasis added.) If a flammability standard has been issued under the FFA to address an unreasonable risk of fire deaths or injuries associated with a particular type or class of garments, that standard cannot be amended or revoked solely to accommodate consumer preference for noncomplying garments. However, section 4 of the FFA further requires that in order to issue or amend a standard, the Commission must find, among other things, that the standard or amendment is ``limited'' to include only those garments which have been determined to present an ``unreasonable risk'' of burn deaths or injuries, or significant property damage. Consequently, if the coverage of the children's sleepwear standards currently includes garments which do not present an unreasonable risk of fire leading to death, injury, or significant property damage, the Commission concludes that the scope of the standards could be narrowed to remove those garments from the coverage of the standards. For the same reasons, a flammability standard cannot be broadened to include other types of garments unless the Commission finds that those other types of garments present an ``unreasonable risk'' of fire resulting in death, injury, or significant property damage. In the course of this rulemaking proceeding, the Commission has reviewed information about burn injuries and deaths associated with children's sleepwear garments and other types of children's clothing since 1980. On average, each year about four children younger than fifteen years of age died from fires associated with clothing of all types (10). From its review of burn injury data, the Commission estimates that on average, about 1,150 children were treated each year in hospital emergency rooms for burn injuries associated with clothing of all types during the period from 1980 through 1993. Of that total, the Commission estimates that each year, about 90 burn injuries to children were associated with sleepwear, about 860 were associated with day wear, and about 200 were associated with other types of clothing or unspecified types of clothing (10). From available data, the Commission estimates that virtually no infants younger than one year old were treated in hospital emergency rooms for burn injuries associated with clothing. The Commission also found that most thermal burn injuries associated with sleepwear involved females, whereas most burn injuries associated with daywear involved males. Thermal burn injuries from nightwear were usually associated with nightgowns or pajamas that probably were not tight- fitting (10). This review of information about burn deaths and injuries associated with children's clothing suggests that the children's sleepwear standards in their current form may cover certain garments which do not present an unreasonable risk of burn deaths or injuries: specifically, sleepwear garments for infants younger than one year of age, and some tight-fitting sleepwear garments for children ranging in age from one to about fifteen years old. This information also indicates that notwithstanding the existence of mandatory flammability requirements for children's sleepwear for more than 20 years, burn injuries to children continue to be associated with sleepwear, particularly nightgowns and pajamas (10). For this reason, the Commission concludes that the injury data do not support revocation of the children's sleepwear standards in their entirety. Finally, from this review of information about burn deaths and injuries, the Commission is unable to identify other specific types of children's clothing which may present an unreasonable risk of burn deaths or injuries. For this reason, the Commission is unable to find support from the injury data for extension of the requirements of the children's sleepwear standards to other types of children's garments. 2. Can the Protection Afforded to Children by the Sleepwear Standards Be Maintained if Garments in Infant Sizes and Tight-Fitting Garments Are Exempted From the Standards? This question is the principal issue raised by the ANPR and was the subject of many comments. In order to address this issue, the Commission must also consider its correlative: To what extent have the sleepwear standards prevented burn deaths and injuries to children? After careful consideration of the events leading to issuance of the children's sleepwear standards and all available information about burn injuries and deaths associated with children's sleepwear, the Commission is not able to estimate quantitatively the number of burn deaths and injuries which may have been avoided because of the requirements of those standards. Statistically projectable data are not available about the numbers of deaths and burn injuries associated with children's sleepwear before the issuance of the standard for sizes 0 through 6X (6). Data compiled by the Commission show a measurable reduction in burn deaths and injuries associated with all types of clothing, including children's sleepwear, during the past 20 years (6). However, as many commenters observed, the household environment has also changed during that time period. The number of persons who smoke cigarettes has declined, contributing to a reduction in the number of lighters and matches in the nation's households (6), (14). Voluntary standards have been issued or revised to address many sources of ignition in the household, including gas-fueled ranges and space heaters and kerosene heaters. As noted in the ANPR, sales of both gas- fueled ranges and kerosene heaters have declined in recent years (4). After considering all available information, the Commission has reason to believe that the children's sleepwear standards have contributed to the general decline in burn deaths and injuries associated with clothing, but cannot quantitatively assess the extent of that contribution. a. Can Sleepwear Garments for Infants Be Exempted From the Standard for Sizes 0 Through 6X Without Reducing the Level of Protection That Standard Provides? Many comments urge the Commission to exempt sleepwear garments intended to be worn by infants younger than one year old from the requirements of the standard. These comments observe that infants who are not capable of moving by themselves are not at risk of exposing their clothing to an ignition source (6). Another group of comments opposes exempting garments in infant sizes. These comments state that the Commission considered and rejected such an exemption in 1978. Other comments opposed to such an exemption state that sleepwear garments for infants are not labeled to specify the age of the intended wearer, but rather the body measurements of the intended wearer (6). The Commission has reviewed information about burn deaths and injuries to children younger than one year old associated with sleepwear, including a report prepared in 1978 in conjunction with a proposed exemption for sleepwear garments smaller than size 1 (11). The 1978 report discussed 66 cases in which children younger than one year old sustained burn injuries associated with clothing. In ten cases, the clothing involved was specifically identified as sleepwear; nine of these involved whole-house conflagrations and the other involved a home-made sleepwear garment. Consequently, none of these cases involved risks of injury which the sleepwear standards were intended to address. In all but two of the ten cases involving sleepwear garments, the burn victims were older than six months (11). After considering comments received in response to the ANPR (6), child development literature (12), and available injury data (10), the Commission finds that the sleepwear garments intended for children younger than six months of age may not present an unreasonable risk of burn deaths or injuries to children. For this reason, the Commission has reason to believe that the standard for sizes 0 through 6X in its existing form may not be limited to those garments which present an unreasonable risk of fire leading to death, personal injury, or significant property damage, as required by section 4(b) of the FFA. Consequently, the Commission has preliminarily decided that garments in sizes suitable for children younger than six months of age could be exempted from the requirements of the sleepwear standard for sizes 0 through 6X without decreasing the protection afforded by that standard. The Commission also concludes that the exemption should be stated in terms of maximum dimensions for the chest and length of the garment. Separate maximum length dimensions are specified for one-piece and two- piece garments. The maximum dimensions specified were selected by considering body sizes of children approximately six months old as set forth in ASTM standard D 4910-89 ``Standard Tables of Body Measurements for Infants, Ages 0 to 18 months,'' published by ASTM (formerly the American Society for Testing and Materials) (12). The proposed amendment also requires that an exempted infant garment must be labeled with the words and figures ``0 to 6 mos.'' The label required by the proposed amendment is for the use of the Commission staff when determining whether a garment is exempted from the requirements of the children's sleepwear standard because it is intended to be worn by infants younger than six months old. For this reason, it is not required to be permanently attached to the garment, but must be visible to the consumer when the garment is offered for sale at retail. In addition to meeting the dimensional and labeling requirements, garments in infant sizes must meet the applicable requirements of the flammability standards for clothing textiles and vinyl plastic film (16 CFR parts 1610 and 1611) to be eligible for the exemption from the children's sleepwear standard made by the amendment proposed below. b. Can Tight-Fitting Garments Be Exempted From the Sleepwear Standards Without Reducing the Protection They Provide? Many of the comments favoring exemption of tight-fitting garments from the children's sleepwear standard express the view that cotton sleepwear is as safe or safer than sleepwear which complies with the applicable standard. Other comments express support for an exemption of tight-fitting garments from the sleepwear standards if available information demonstrates that such an exemption would not reduce the protection against burn injuries provided by the standards. A small number of comments express the view that the standards should not be changed because they have effectively reduced risks of serious burn injuries to children from ignition of sleepwear garments (6). After careful consideration of all comments on this issue (6), technical literature (8), (11), injury data (10), and provisions of sleepwear standards in Australia, Canada, New Zealand and the United Kingdom (11), the Commission concludes that tight-fitting garments could be exempted from the standards without reducing the level of protection against burn injuries which they provide to children. Currently available information from technical literature demonstrates that tight-fitting garments are less likely to contact an ignition source and, if ignited, burn less rapidly than loose-fitting garments (8), (11). Burn injury data indicate that in the event of clothing ignition, burn injuries associated with close-fitting garments are less severe than those associated with loose-fitting garments (10). As noted in the ANPR, the Canadian standard for children's sleepwear prescribes flammability requirements for pajamas, nightgowns, and robes which are similar to the requirements of the sleepwear standards codified at 16 CFR parts 1615 and 1616. However, the Canadian standard provides that close-fitting polo pajamas and sleepers, as well as sleepwear garments in infant sizes and sleepwear garments used in hospitals shall meet less stringent flammability requirements which are similar to those of the standard for clothing textiles codified at 16 CFR part 1610 (4). By letter dated September 13, 1993, the Director of Product Safety of the Canadian government advised the Commission that since promulgation of the Canadian sleepwear standards in 1987, no burn deaths associated with children's sleepwear have been reported in Canada. The Director of Product Safety added that a planned five-year study to collect data about burn injuries associated with children's sleepwear in Canada had been discontinued because of a lack of burn cases (11). For these reasons, the Commission concludes that to the extent the children's sleepwear standards in their current form are applicable to tight-fitting sleepwear garments, they may apply to some garments which are not associated with an unreasonable risk of burn deaths and injuries and may not be limited to those garments which present an unreasonable risk, as required by section 4(b) of the FFA. Several comments address the issue of defining the term ``tight- fitting'' garment. Some comments suggest exempting specific types of garments such as ``ski pajamas'' or ``long johns.'' Others state that exempted garments should be required to have specific features, such as tight cuffs at the wrists and ankles. Some comments observe that the Department of Commerce has withdrawn the commercial standard for sizing of children's apparel which is cited in both children's sleepwear standards (6). Section 4(b) of the FFA requires that a flammability standard must be ``stated in objective terms.'' The amendments proposed below exempt ``tight-fitting'' sleepwear garments from the standard for sizes 0 through 6X and the standard for sizes 7 through 14. The proposed amendments define the term ``tight- fitting garment'' by specifying maximum dimensions for the following parts of the garment: Chest, waist, seat, upper arm, thigh, wrist, and ankle (12). The proposed amendments specify the specific points on the garment at which measurements are taken to calculate the maximum dimensions. The maximum dimensions specified for garments in sizes for infants six to 24 months old were selected by considering body sizes of children approximately six months old set forth in a proposed revision of ASTM standard D 4910 (12). The maximum dimensions selected for the various locations on the garment in each size from 2 through 6X are based on dimensions specified in a draft ASTM standard tentatively designated ``Standard Table of Body Measurements for Pre-School Children Sizes 2-6X/7.'' (12) The ASTM committee which is developing this draft standard has several members who are employed by manufacturers of children's garments as well as members from academic institutions. Maximum dimensions of the specified locations on garments in sizes 7 through 14 are based on a report of an anthropometric study of children ranging in age from infancy to the age of 18 years, conducted in 1977 by the University of Michigan (12). Maximum dimensions are given for both boys' and girls' garments in the proposed definition of ``tight-fitting garment'' for the standard for sizes 7 through 14. The Commission is aware that at this time sleepwear garments are not marketed in girls' sizes 9, 11, and 13. However, dimensions for those sizes are provided in the proposed amendments to the standard for size 7 through 14 published below. Garments which are not explicitly labeled and promoted for use by girls must meet the maximum dimensions listed for boys' garments in each size to be exempted from the requirements of the sleepwear standard for sizes 7 through 14. To be eligible for the exemption from the requirements of the children's sleepwear standards, a tight-fitting garment must not exceed the maximum dimensions specified for each size in the amendments proposed below. The proposed amendments also require that an exempted garment must be labeled to indicate the size to which it was manufactured. The size label required by the proposed amendment is for the use of the Commission staff when determining whether a garment meets the dimensional requirements for an exempt sleepwear garment. For this reason, the label is not required to be permanently affixed to the garment, but it must be visible when the garment is offered for sale to consumers. The proposed amendments also require that when offered for sale to consumers, exempted garments in sizes for 6 to 9 months and larger must be clearly and conspicuously labeled with a statement to advise consumers that the garment is not flame-resistant and should be tight- fitting for the safety of the child. If the proposed amendments are issued on a final basis, this labeling statement will be one component of an information and education campaign to advise consumers that the safety of these sleepwear garments is dependent upon their tight fit. Finally, garments exempted from the flammability requirements of the amendments proposed below must comply with applicable provisions of the flammability standards for clothing textiles and vinyl plastic film (16 CFR parts 1610 and 1611). c. Alternatives to an Exemption for Sleepwear Garments in Infant Sizes and for Tight-fitting Garments Some comments suggest that rather than exempt sleepwear garments in infant sizes and tight-fitting garments from the sleepwear standards, the Commission should provide additional guidance about the differences between children's sleepwear and non-sleepwear garments, including long underwear (6). As discussed above, since 1984, the Commission staff has attempted to clarify the standards' definitions of ``children's sleepwear'' garments by written descriptions and drawings and to distinguish sleepwear from non-sleepwear garments in a publication distributed to the children's garment industry. However, the staff has not been able to provide definitive guidance that resolves all questions about the distinction between sleepwear and non-sleepwear garment. Constantly changing styles and fashions in children's apparel have been a major obstacle to this effort. The Commission has reason to believe that further attempts to provide guidance through additional revisions of the staff enforcement policy guides are not likely to meet with success (6), (17). Some comments suggest that the Commission should require labeling of all children's sleepwear garments to indicate their relative flammability. Other comments urge the Commission to require labeling of those sleepwear garments which do not meet the flammability requirements of the children's sleepwear standards. These comments state that labeling of some or all children's sleepwear garments would be preferable to prohibiting the sale of garments which do not comply with the requirements of the children's sleepwear standards (6). Research into the effectiveness of labeling indicates that in order for a label to be effective, it must be: (1) Noticed, (2) read and understood, and (3) acted upon. That research also indicates that as consumers become more familiar with a product, they are more likely to ignore information about the product. Additionally, if a product is not perceived as hazardous, the likelihood is greater that a label will go unnoticed (12). Children's sleepwear garments are products that are familiar to most consumers. Generally, those garments are not perceived as presenting a safety hazard. Most sleepwear garments offered for sale to consumers bear labels stating size, price, fiber content, and laundering instructions. All of these factors decrease the likelihood that consumers would notice and read additional label information about the flammability of the garment (12). Even if a label is noticed and read, its message must also be understood before it can be acted upon. Explaining the nature of the flammability hazard associated with children's sleepwear and the steps that should be taken to avoid the hazard would be extremely difficult given the limited space that would be available on a label (12). For these reasons, the Commission concludes that labeling some or all children's sleepwear garments would not be effective as the sole means to communicate the flammability hazard associated with those garments or a practical alternative to the performance requirements of the standards. F. Preliminary Regulatory Analysis As noted above, section 4(i) of the FFA requires the notice of proposed rulemaking to contain a regulatory analysis consisting of: (1) A preliminary description of potential benefits and potential costs of the proposed standard or amendment, and an indication of those likely to receive the benefits and to bear the costs; (2) a discussion of the reasons for not publishing any existing standard submitted in response to the ANPR as the proposed standard or amendment, and for concluding that any statement of intent to develop or modify a voluntary standard to address the risk of injury under consideration is not likely to result in the development of an adequate voluntary standard; and (3) a description of any reasonable alternatives to the proposed standard or amendment, together with a summary description of potential benefits and costs of each alternative and a brief explanation of why each such alternative has not been published as the proposed standard or amendment. 1. Potential Benefits of the Proposed Amendments One potential benefit of the proposed amendments is that a greater variety of children's sleepwear will be available to consumers (14). Consumers may also benefit from decreases in relative prices of children's sleepwear because of increased penetration of the sleepwear market by imported goods. Costs of testing and uncertainty about the applicability of the children's sleepwear standards may have restrained imports of sleepwear to the United States in recent years. Imported garments account for only nine percent of all children's sleepwear sold in 1992, whereas imported garments constituted 52 percent of all sales of adult sleepwear. The exemptions from the children's sleepwear standards made by the amendments proposed below are expected to increase imports of lower- and mid-priced garments, resulting in greater competition within the sleepwear industry, and lower prices to consumers (14). If consumers elect to dress their children in tight-fitting sleepwear garments which are exempted from the requirements of the children's sleepwear standards by the amendments proposed below in place of loose-fitting non-sleepwear garments, the number of burn deaths and injuries associated with non-sleepwear garments worn by children when sleeping may decrease (8), (12), (14). Additionally, domestic manufacturers who decide to produce garments exempted by the proposed amendments may also enjoy greater sales. The ability of domestic manufacturers to produce children's sleepwear garments from cotton rather than man-made fabrics customarily used in the production of complying children's sleepwear may lead to reduced prices of children's sleepwear (14). 2. Potential Costs of the Proposed Amendments The potential cost of the exemptions to the children's sleepwear standards made by the proposed amendment is the possibility of increased societal costs of future burn deaths or injuries associated with the exempted garments (14). However, the Commission has reason to believe that few if any additional burn deaths or injuries to children will result from the proposed amendments. On the basis of epidemiological data, the Commission expects that exempting sleepwear garments in infant sizes from the requirements of the sleepwear standards will not result in increased risk of burn injuries to children younger than six months of age. Infants younger than six months old are not capable of moving by themselves, and for that reason are not likely to come within range of ignition sources when an adult is not present (11), (12). As noted above, the household environment in which children wear sleepwear has changed since the first sleepwear standard was issued in 1971. The number of adults who smoke cigarettes has declined by about 20 million since 1974, resulting in the presence of fewer matches and lighters in the nation's households. Ignition hazards presented by ranges and space heaters have also decreased (6), (14). The Commission also observes that in 1970, sales of all children's sleepwear garments averaged about one and one-half garments per child (14), (15). The average number of sleepwear garments purchased per child each year has not changed appreciably since 1970 (14), (15). Because it is reasonable to assume that children use several garments as sleepwear during the course of a year, a logical inference is that children have probably always used more non-sleepwear garments for sleeping than garments manufactured to comply with the children's sleepwear standards (14). Consequently, providing an exemption from the requirements of the standards for a limited class of sleepwear garments in infant sizes and tight-fitting garments is not expected to increase risks of burn deaths and injuries associated with children's sleepwear. 3. Existing Standards and Statements of Intent To Develop a Voluntary Standard No existing standard was submitted for publication as the proposed standard in response to the ANPR. No statement of intent to develop or modify a voluntary standard was submitted in response to the ANPR. 4. Alternatives to the Proposed Amendments a. Make No Change to the Standards There would be no change in burn deaths and injuries to children which might otherwise be attributable to the proposed amendments. Consumers would forgo all potential benefits of increased choice of children's sleepwear garments and reductions in prices that might result from issuance of the proposed amendments (14). b. Do Not Amend the Standards; Issue a Statement of Policy to the Effect That the Commission Will Not Apply the Standards to Garments in Infant Sizes or Tight-fitting Sleepwear Garments While this alternative might result in some benefits of increased choice and lower prices to consumers, domestic manufacturers and importers might be reluctant to change business practices in reliance on such a policy statement because of uncertainty about future Commission decisions to change that policy. Such uncertainty might result in continued low levels of imported sleepwear garments and little if any domestic production of exempted garments subject to the provisions of the policy statement (14). G. Impact on Small Businesses In accordance with section 605(b) of the Regulatory Flexibility Act (5 U.S.C. 605(b)), the Commission hereby certifies that the amendments to the children's sleepwear standards proposed below will not have a significant economic impact on a substantial number of small entities, including small businesses, if issued on a final basis (14). The amendments proposed below would provide an exemption from the requirements of the children's sleepwear standards for certain sleepwear garments in infant sizes and certain tight-fitting sleepwear garments. However, no importer or domestic manufacturer is required to produce the exempted garments. Consequently, any economic impact of the proposed amendments, either positive or negative, will result from business decisions of regulated firms rather than any provision of the proposed amendments (14). H. Environmental Considerations The proposed amendments fall within the categories of Commission actions described at 16 CFR 1021.5(c) that have little or no potential for affecting the human environment. Because the proposed amendments, if issued on a final basis, will not change any aspect of the testing required by the standard, the proposed action does not have any potential to produce significant environmental effects. For that reason, neither an environmental assessment nor an environmental impact statement is required. List of Subjects in 16 CFR Parts 1615 and 1616 Clothing, Consumer protection, Flammable materials, Infants and children, Labeling, Records, Textiles, Warranties. Conclusion Therefore, pursuant to the authority of section 30(b) of the Consumer Product Safety Act (15 U.S.C. 2079(b)) and section 4 of the Flammable Fabrics Act (15 U.S.C. 1193), the Commission hereby proposes to amend title 16 of the Code of Federal Regulations, Chapter II, Subchapter D, Parts 1615 and 1616 to read as follows: PART 1615--STANDARD FOR THE FLAMMABILITY OF CHILDREN'S SLEEPWEAR: SIZES 0 THROUGH 6X 1. The authority for Part 1615 continues to read as follows: Authority: Sec. 4, 67 Stat. 112, as amended, 81 Stat. 569-570; 15 U.S.C. 1193. Sec. 1615.1 [Amended] 2. Sections 1615.1 (c) through (m) are redesignated Secs. 1615.1 (d) through (n). 3. Section 1615.1 is amended by revising paragraph (a) and adding new paragraphs (c) and (o) to read as follows: Sec. 1615.1 Definitions. In addition to the definitions given in section 2 of the Flammable Fabrics Act, as amended, the following definitions apply for the purposes of this Standard: (a) Children's Sleepwear means any product of wearing apparel up to and including size 6X, such as nightgowns, pajamas, or similar or related items, such as robes, intended to be worn primarily for sleeping or activities related to sleeping, except: (1) Diapers and underwear; (2) ``Infant garments,'' as defined by paragraph (c) of this section; and (3) ``Tight-fitting garments,'' as defined by section 1615.1(o), below. * * * * * (c) Infant garment means a garment which: (1) If a one-piece garment, does not exceed 68 centimeters (21 inches) in length; if a two-piece garment, has no piece exceeding 37.1 centimeters (14\1/2\ inches) in length; (2) Does not exceed 48.3 centimeters (19 inches) at the chest, calculated by placing the garment on a horizontal, flat surface, with the outer surface of the garment exposed, measuring the distance from arm pit to arm pit, and multiplying that value by two; (3) Complies with all applicable requirements of the Standard for the Flammability Clothing Textiles (16 CFR part 1610) and the Standard for the Flammability Vinyl Plastic Film (16 CFR part 1611); and (4) Bears a label stating ``0-6 mos.'' If the label is not visible to the consumer when the garment is offered for sale at retail, the same figures and letters must appear legibly on the package of the garment. * * * * * (o) Tight-fitting garment means a garment which: (1) In each of the sizes listed below does not exceed the maximum dimension specified below for the chest, waist, seat, upper arm, thigh, wrist, or ankle: -------------------------------------------------------------------------------- -------------------------------- Chest Waist Seat Upper arm Th igh Wrist Ankle -------------------------------------------------------------------------------- -------------------------------- 6-9 mos\3\ Maximum Dimension\1\ Centimeters (inches)........ 45.7 (18) 47.6 (18\3/ 4\) 47 (18\1/ 2\) 14 (5\1/2\) 25.9 8\) 26.7 (10\1/ 2\) 10.5 (4\1/ 8\) 12.8 (5) 12-18 mos Maximum Dimension\1\ Centimeters (inches)........ 49.5 (19\1/ 2\) 49.5 (19\1/ 2\) 50.8 (20) 14.9 (5\7/ 8\) 29.5 (11\5/ 8\) 10.9 (4\1/ 4\) 13.5 (5\1/ 4\) Size 2 Maximum Dimension\1\ Centimeters (inches)........ 50.8 (20) 50.8 (20) 53.3 (21) 15.6 (6\1/ 8\) 29.8 (11\1/ 8\) 14.9 (5\7/ 8\) Size 4 Maximum Dimension\1\ Centimeters (inches)........ 55.9 (22) 53.3 (21) 58.4 (23) 16.8 (6\5/ 8\) 33. 0 (13) 12.1 (4\3/ 4\) 15.9 (6\1/ 4\) Size 6 Maximum Dimension\1\ Centimeters (inches)........ 61.0 (24) 55.9 (22) 63.5 (25) 18.1 (7\1/ 8\) 36.2 (14\1/ 4\) 12.7 (5) 17.8 (7) Size 6X \3\Maximum dimensions are calculated by placing the garment on a horizontal, tha t surface, with the outer surface of the garment exposed; measuring the distances specified below; and m ultiplying that value by two: Chest--measure distance from arm pit to pit. Waist--measure narrowest distance between arm pits and crotch. Seat--measure widest location between waist and crotch. Upper arm--measure a line perpendicular to the sleeve extending from the outer e dge of the sleeve to the arm pit. Thigh--measure a line perpendicular to the leg extending from the outer edge of the leg to crotch. Wrist--measure the width of the end of the sleeve. Ankle--mesure the width of the end of the leg. (2) Has no item of fabric, ornamentation or trim, such as lace, (6) Bears a label stating the size of the garment in following words and figures: ``Size [______ to ______ mos.] or [2-6X].'' If the label is not visible to the consumer when the garment is offered for sale at retail, the same figures and letters must appear legibly on the package of the garment; and (7) When displayed for sale to consumers, is clearly and conspicuously labeled with the following statement: ``Garment is not- flame resistant. For child's safety, garment should be tight-fitting. Loose-fitting clothing is more likely to contact an ignition source and burn.'' * * * * * PART 1616--STANDARD FOR THE FLAMMABILITY OF CHILDREN'S SLEEPWEAR: SIZES 7 THROUGH 14 1. The authority for Part 1616 continues to read as follows: Authority: Sec. 4, 67 Stat. 112, as amended, 81 Stat. 569-570; 15 U.S.C. 1193. 2. Section 1616.2 is amended by revising paragraph (a) and adding a new paragraph (m), to read as follows: Sec. 1616.2 Definitions. In addition to the definitions given in section of the Flammable Fabrics Act, as amended (sec. 2, 81 Stat. 586; 15 U.S.C. 1191), the following definitions apply for purposes of this Standard: (a) Children's sleepwear means any product of wearing apparel size 7 through 14, such as nightgowns, pajamas, or similar or related items, such as robes, intended to be worn primarily for sleeping or activities related to sleeping, except: (1) Diapers and underwear; and (2) ``Tight-fitting garments'' as defined by section 1616.2(m), below. * * * * * (m) Tight-fitting garment means a garment which: (1) In each of the sizes listed below does not exceed the maximum dimension specified below for the chest, waist, seat, upper arm, thigh, wrist, or ankle: -------------------------------------------------------------------------------- -------------------------------- -------------------------------------------------------------------------------- -------------------------------- Size 7 Boys\4\ Maximum Dimension\1\ Centimeters (inches)........ 60.2 (23\3/ 4\) 53.5 (21) 60.4 (23\3/ 4\) 17.6 (7) 35 (13\3/ 4\) 12.3 (4\7/ 8\) 16.2 (6\3/ 8\) 2\) Size 8 Boys\2\ Maximum Dimension\1\ Centimeters (inches)........ 62.7 (24\5/ 8\) 55.6 (21\7/ 8\) 63.8 (25\1/ 8\) 18.5 (7\1/ 4\) 36.5 (14\3/ 4\) 38. 2 (15) 12.8 (5) 17.4 (6\7/ 8\) Size 9 Boys\2\ Maximum Dimension\1\ Centimeters (inches)........ 65.1 (25\5/ 8\) 57.1 (22\1/ 2\) 66.1 (26) 19.2 (7\1/ 2\) 38.6 (15\1/ 4\) 13.1 (5\1/ 8\) 40.1 (15\3/ 4\) 13.2 (5\1/ 4\) 18 (7) Size 10 Boys\2\ Maximum Dimension\1\ Centimeters (inches)........ 67 (26\3/ 8\) 59.2 (23\1/ 4\) 68.3 (26\7/ 8\) 59.6 (23\1/ 2\) 70.6 (27\3/ 4\) 19.9 (7\7/ 8\) 42.6 (16\3/ 4\) 13.3 (5\1/ 4\) 18.7 (7\3/ 8\) Size 11 Boys\2\ Maximum Dimension\1\ Centimeters (inches)........ 70 (27\1/ 2\) 61.8 (24\3/ 8\) 74.2 (29\1/ 4\) 20.6 (8) 44.3 (17\1/ 2\) 13.2 (5\1/ 4\) 18.7 (7\3/ 8\) Size 12 Boys\2\ Maximum Dimension\1\ Centimeters (inches)........ 72.9 (28\3/ 4\) 63.8 (25\1/ 8\) 77.9 (30\5/ 8\) 21.6 (8\1/ 2\) 46.4 (18\1/ 4\) 14 (5\1/2\) 19.3 (7\5/ 8\) Size 13 Boys\2\ Maximum Dimension\1\ Centimeters (inches)........ 75.8 (29\7/ 8\) 65.9 (26) 82.2 (32\3/ 8\) 22.5 (8\7/ 8\) 48. 2 (19) 14.2 (5\5/ 8\) 20 (7\7/8\) Size 14 Boys\2\ Maximum Dimension\1\ Centimeters (inches)........ 78.2 (30\3/ 4\) 68 (26\3/ 4\) 86.5 (34) 23.4 (9\1/ 4\) 51.8 (20\3/ 8\) 14.7 (5\3/ 4\) 20.7 (8\1/ 8\) -------------------------------------------------------------------------------- -------------------------------- \4\Garments not explicitly labeled and promoted for wear by girls must not excee d these maximum dimensions. Standard for the Flammability of Vinyl Plastic Film (16 CFR part 1611); (6) Bears a label stating the size of the garment in following words and figures: ``Size [7-14].'' If the label is not visible to the consumer when the garment is offered for sale at retail, the same figures and letters must appear legibly on the package of the garment; and. (7) When displayed for sale to consumers, is clearly and conspicuously labeled with the following statement: ``Garment is not- flame resistant. For child's safety, garment should be tight-fitting. Loose-fitting clothing is more likely to contact an ignition source and burn.'' (15 U.S.C. 1193; 15 U.S.C. 2079(B)) Dated: October 17, 1994. Sadye E. Dunn, Secretary, Consumer Product Safety Commission. Bibliography 1. Federal Register notice ``Flammability Standards for Children's Sleepwear; Statements of Enforcement Policy'' published by the Consumer Product Safety Commission; 4 pages; March 20, 1984 (49 FR 10249). 2. Supplemental CPSC Staff Guide to the Enforcement Policy Statements of the Flammability Standard for Children's Sleepwear-- Garment Diagrams and Assessments, published by the Division of Regulatory Management, Consumer Product Safety Commission; 27 pages; 1989. 3. Memorandum from Terrance R. Karels, ECPA, to the Commission, entitled ``Children's Sleepwear Project''; 12 pages; July 19, 1994. 4. Federal Register notice ``Standards for the Flammability of Children's Sleepwear: Sizes 0 Through 6X and 7 Through 14; Advance Notice of Proposed Rulemaking,'' published by the Consumer Product Safety Commission; 4 pages; January 13, 1994 (58 FR 4111). 5. Federal Register notice ``Standards for the Flammability of Children's Sleepwear: Sizes 0 Through 6X and 7 Through 14; Stay of Enforcement,'' published by the Consumer Product Safety Commission; 1 page; January 13, 1994 (58 FR 4078). 6. Tabular summaries of comments and staff responses to comments to the Advance Notice of Proposed Rulemaking; 50 pages; July 19, 1994. 7. ``Statement by The Children's Sleepwear Coalition In Response to the Consumer Product Safety Commission's Advance Notice of Proposed Rulemaking''; 10 pages; March 25, 1993. 8. Memorandum from Linda Fansler, ESME, to Terrance R. Karels, ECPA, entitled ``Technical Rationale Supporting Tight-Fitting Children's Sleepwear Garments''; 11 pages; March 14, 1994. 9. Memorandum from Linda Fansler, ESME, to Terrance R. Karels, ECPA, entitled ``Recent Conversation Between Staff of Consumer and Corporate Affairs Canada and Commission Staff''; 4 pages; July 17, 1992. 10. Memorandum from Dr. Terry L. Kissinger, EPHA, to Terrance R. Karels, ECPA, entitled ``Injury Data Related to the Children's Sleepwear Standards''; 13 pages; February 8, 1994. 11. Memorandum from Dr. Terry L. Kissinger, EPHA, to Terrance R. Karels, ECPA, entitled ``Results of Review of Available Literature,'' and attachments; 21 pages; April 1, 1994. 12. Memorandum from George Sweet, EPHF, to Terrance R. Karels, ECPA, entitled ``Human Factors Issues Regarding Sleepwear,'' and attachment; 8 pages; March 8, 1994. 13. Memorandum from George Sweet, EPHF, to Terrance R. Karels, ECPA, entitled ``Garments Intended for Infants''; 4 pages; July 8, 1994. 14. ``Preliminary Regulatory and Regulatory Flexibility Analyses for the Proposed Amendments to the Children's Flammability Standards,'' by Anthony C. Homan, Directorate for Economic Analysis; 7 pages; June, 1994. 15. ``Market Sketch--Children's Sleepwear,'' by Anthony C. Homan, Directorate for Economic Analysis; 14 pages; March, 1992. 16. Memorandum from Eva S. Lehman, HSPS, to Terrance R. Karels, ECPA, entitled ``Toxicological Evaluation of Fabrics Used in Children's Sleepwear''; 3 pages; June 7, 1994. 17. Memorandum from Patricia Fairall, CERM, to Terrance Karels, ECPA, entitled ``Compliance History--Enforcement of Children's Sleepwear''; 6 pages; April 20, 1994. 18. Memorandum from James F. Hoebel, Acting Director, ESME, to Terrance R. Karels, ECPA, entitled ``Amendments to Children's Sleepwear Standards''; 3 pages; July 7, 1994. 19. Memorandum from Dr. Terry L. Kissinger, EPHA, to Terrance R. Karels, ECPA, entitled ``Proposed Amendment to Children's Sleepwear Standards''; 7 pages; July 15, 1994. [FR Doc. 94-26100 Filed 10-21-94; 8:45 am] BILLING CODE 6355-01-P