oversight

Consumer Product Safety Commission: Injury Data Insufficient to Assess the Effect of the Changes to the Children's Sleepwear Safety Standard

Published by the Government Accountability Office on 1999-04-01.

Below is a raw (and likely hideous) rendition of the original report. (PDF)

                 United States General Accounting Office

GAO              Report to Congressional Committees
                 and the Consumer Product Safety
                 Commission


April 1999
                 CONSUMER PRODUCT
                 SAFETY COMMISSION
                 Injury Data Insufficient to
                 Assess the Effect of the
                 Changes to the Children’s
                 Sleepwear Safety
                 Standard




GAO/HEHS-99-64
                   United States
GAO                General Accounting Office
                   Washington, D.C. 20548

                   Health, Education, and
                   Human Services Division

                   B-281912

                   April 1, 1999

                   To Congressional Committees and
                     the Consumer Product Safety Commission

                   In the late 1960s and early 1970s, reports of children being severely burned
                   when their nightgowns or pajamas caught fire caused concern over the
                   safety of children’s sleepwear. As a result, in 1972 the federal government
                   implemented a safety standard that required children’s sleepwear to be
                   flame-resistant.1 In 1996, the Consumer Product Safety Commission
                   (CPSC) amended this standard to exempt “snug-fitting” sleepwear and
                   sleepwear for children 9 months old or younger.2 Although some industry
                   and consumer advocates applauded this decision, others (including some
                   fire prevention groups) expressed concern that the 1996 changes could
                   lead to an increase in the number of children injured. The fiscal year 1999
                   Appropriations Act covering CPSC and its accompanying conference
                   report directed us to review the data available on burn injuries to children
                   and to discuss the implications of these data for the effect of the recent
                   amendments to the sleepwear standard. Specifically, this report addresses
                   the following questions: (1) how many burn injuries involving children’s
                   sleepwear occurred annually before and after the amendments? and
                   (2) what conclusions, if any, can be drawn from these data about the effect
                   of the changes to the sleepwear standard on the risk of injury?

                   To do our work, we obtained and analyzed data on burn injuries to
                   children involving clothing in general and children’s sleepwear in
                   particular from CPSC and other sources. We reviewed the regulations
                   related to children’s sleepwear and the agency’s documentation
                   supporting these regulations. We also interviewed CPSC staff, health and
                   consumer advocates, and industry representatives to obtain information
                   about burn injuries and the sleepwear standard. We did our work between
                   January and March 1999 in accordance with generally accepted
                   government auditing standards.


                   The exact number of burn injuries associated with children’s sleepwear
Results in Brief   before and after CPSC amended its standard is uncertain. Although CPSC
                   collects some burn injury data from a sample of hospital emergency

                   1
                    Unless otherwise indicated, in this report dates associated with regulations refer to the year a
                   regulation became effective.
                   2
                    Sleepwear is considered snug-fitting under this standard if it follows prescribed measurements and if
                   it touches a child’s body at seven crucial points: the chest, waist, seat, thigh, ankle, wrist, and upper
                   arm.



                   Page 1                                  GAO/HEHS-99-64 Burn Injuries and Children’s Sleepwear
             B-281912




             rooms, few sleepwear-related injuries are reported annually. For example,
             over the period 1990-98, CPSC’s sample of about 100 hospital emergency
             rooms reported a total of only 13 burn injuries that involved children’s
             sleepwear. This included a maximum of four cases in any one year, and in
             some years—including 1998—no cases were reported at all. Consequently,
             although the overall risk of injury appears to be small, these data cannot
             produce precise national estimates, making it difficult or impossible to
             observe trends in the number of injuries over time.

             Even if more precise data were available, it would not be possible to draw
             firm conclusions from burn injury data about the effect of the changes to
             the standard without other equally crucial but unobtainable information.
             Assessing the effect of the sleepwear standard would be particularly
             difficult because multiple factors contribute to burn injuries, including the
             ignition source, the child’s behavior, and the fabric and fit of the child’s
             clothing. Furthermore, using injury information to compare the risks
             associated with different types of sleepwear (such as snug-fitting cotton
             versus flame-resistant polyester) would also require information on how
             many consumers actually use each type. Without such data, it would be
             difficult or impossible to distinguish the type of sleepwear associated with
             the most injuries from the type of sleepwear most commonly used.
             However, this information was not gathered for the period before the
             changes in the standard, and it is not yet available for the period since the
             final changes to the standard were made. In the absence of these key data,
             and without baseline data for comparison, it is not possible to determine
             the effect of the sleepwear amendments on the risk of injury to children.


             CPSC was established in 1972 under the Consumer Product Safety Act
Background   (P.L. 92-573) to regulate consumer products that pose an unreasonable
             risk of injury, to assist consumers in using products safely, and to promote
             research and investigation into product-related deaths, injuries, and
             illnesses. CPSC has the authority to issue regulations that establish
             performance or labeling standards for consumer products. In addition,
             CPSC may order a product recall, in which an item is removed from store
             shelves and consumers are alerted to return the item for repair,
             replacement, or refund.3 Although the agency has broad regulatory
             powers, much of its efforts are carried out by nonregulatory methods.
             CPSC often assists in the development or improvement of voluntary safety



             3
              In practice, CPSC rarely uses its regulatory power to order a recall; instead, the agency usually works
             cooperatively with manufacturers to carry out recalls.



             Page 2                                  GAO/HEHS-99-64 Burn Injuries and Children’s Sleepwear
B-281912




standards and addresses product hazards by providing safety information
to consumers.

With about 15,000 consumer products under its jurisdiction, CPSC has to
carefully consider which potential product hazards it will address. The
agency has established criteria for setting priorities to keep within its
budget ($47 million in fiscal year 1999). These criteria include, among
others, the frequency and severity of injuries and deaths, the extent to
which a hazard is likely to be reduced through CPSC’s action, and whether
the hazard affects vulnerable populations, such as children or the elderly.
CPSC staff provide information on these criteria and other factors to the
agency’s three commissioners, who must approve all regulatory changes
by a majority vote.4

In response to widespread concern about the number of burn injuries and
deaths caused by ignited clothing, the Congress passed the Flammable
Fabrics Act in 1953 to legislate a general flammability standard for all
clothing. In 1972, before CPSC was established, the Department of
Commerce implemented an additional, stricter flammability standard for
children’s sleepwear.5 The Department of Commerce’s conclusion that a
more stringent standard was necessary for children’s sleepwear was based
on anecdotal reports of approximately 100 incidents, including news
coverage of a 4-year-old Minnesota child who suffered third-degree burns
when her pajama top caught fire.

The 1972 standard required that fabrics used for children’s sleepwear
self-extinguish when exposed to a small open flame. The standard did not
prescribe specific fabrics or require flame-retardant treatments. However,
while some fabrics, mostly polyester, met the requirement without
treatment, others, mostly cotton, would do so only if treated with a
flame-retardant chemical. In the 1970s, the chemical generally known as
tris was widely used to treat sleepwear, until it was classified as a
potential carcinogen and all garments treated with it were pulled from the
marketplace. In the absence of tris, polyester became widely used to
manufacture children’s sleepwear since it generally could meet the
standard without being treated with a flame-retardant chemical.



4
 CPSC currently has three commissioners, who are responsible for establishing agency policy. One of
these commissioners is designated the chairman; the chairman directs the executive and
administrative functions of the agency.
5
 The 1972 sleepwear standard covered only sizes 0 to 6X; in 1975, CPSC extended the children’s
sleepwear standard to sizes 7 through 14.



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B-281912




In the 1980s, however, many consumers began to express a demand for
natural fibers, such as cotton, for children’s sleepwear. To meet this
demand, retailers began stocking cotton and cotton blend long underwear
sets that did not meet CPSC’s flammability standard for children’s
sleepwear, sometimes intermingling them with flame-resistant sleepwear
on children’s sleepwear racks. CPSC compliance staff, consumer groups,
and industry sources agreed that enforcing the standard had become
difficult and required a significant amount of agency resources.

As a result, in 1991 CPSC decided to begin work to reexamine the
children’s sleepwear standard. In 1994, it formally proposed to amend the
sleepwear standard to exempt snug-fitting sleepwear for children and all
sleepwear for children younger than 6 months old. CPSC relied primarily
on laboratory and analytical evidence, rather than injury data, to support
its proposal. (Because the prohibition against marketing children’s
sleepwear made from non-flame-resistant materials had been in effect for
20 years, only very limited data were available on injuries that had
occurred under alternatives to the existing sleepwear standard.) CPSC
stated that garments are safer if they fit closer to the body because
(1) there is less trapped air for combustion, so the sleepwear will burn less
intensely and may self-extinguish, and (2) there is a reduced possibility for
contacting an ignition source. CPSC also expressed concern that enforcing
a ban against marketing long underwear as sleepwear might prompt
consumers to substitute loose-fitting cotton and cotton blend garments,
such as oversized T-shirts, which CPSC believed to be more hazardous.
Furthermore, CPSC stated that children younger than 6 months old are
relatively immobile and therefore unlikely to go near an ignition source.
When CPSC announced its proposal to amend the standard, it issued a stay
of enforcement that allowed manufacturers and retailers to sell long
underwear or snug-fitting sleepwear that were similar to the proposed
exemptions.

In April 1996, a majority of the commissioners voted to amend the
children’s sleepwear standard to exempt snug-fitting sleepwear and all
infants’ clothing up to size 9 months. The revised standard became
effective in January 1997, but CPSC continued to work on technical
revisions after that date. While making the final changes to the standard,
and to allow manufacturers to adapt their production processes, CPSC
continued the stay of enforcement for snug-fitting underwear or sleepwear
until June 1998. Snug-fitting sleepwear garments meeting the revised
standard were made widely available to consumers during the fall 1998




Page 4                       GAO/HEHS-99-64 Burn Injuries and Children’s Sleepwear
                       B-281912




                       selling season. The final technical changes to the sleepwear standard were
                       published on January 19, 1999.


                       The number of burn injuries associated with children’s sleepwear is
Few Data Are           uncertain, and few data are available. Some information on
Available on Burn      sleepwear-related injuries can be obtained from CPSC’s National
Injuries Involving     Electronic Injury Surveillance System (NEISS), which gathers data from a
                       statistical sample of 101 hospitals across the United States that have
Children’s Sleepwear   emergency rooms.6 NEISS has a broad focus and is intended to allow
                       CPSC to collect data on injuries associated with a wide variety of
                       consumer products, rather than being designed to capture information on
                       specific types of injuries such as burns.

                       Unlike other national data sources, NEISS can distinguish burn injuries
                       associated specifically with sleepwear from burns associated with other
                       clothing. However, very few cases were reported under NEISS’s sleepwear
                       code, and the actual number of annual injuries is uncertain. For example,
                       over the period 1990-98, NEISS reported a total of only 13 cases. This
                       included a maximum of four sleepwear cases annually, and in some years,
                       including 1998, no cases were reported at all. Consequently, although the
                       overall risk of injury appears to be small, these data cannot produce
                       precise national estimates, making it difficult or impossible to observe
                       trends in the number of injuries over time. Data from other sources—for
                       example, the National Fire Incident Reporting System (NFIRS), compiled
                       by the U.S. Fire Administration—are even less useful, because these
                       databases were not designed to permit distinctions between sleepwear
                       and other clothing.

                       In addition, national data on burn injuries must be interpreted cautiously
                       because these data necessarily provide only limited detail about the
                       circumstances surrounding each individual case. Most significantly, none
                       of these sources provides information on whether the clothing or




                       6
                        This representative sample includes about 2 percent of the 5,297 hospitals in the United States that
                       have more than six beds and also have 24-hour emergency rooms. Although a few hospitals with burn
                       centers are included in the NEISS sample, NEISS does not focus on burns specifically but is intended
                       to provide a representative sample of hospitals that treat a wide variety of product-related injuries. For
                       more information on NEISS and other data sets CPSC uses, see Consumer Product Safety
                       Commission: Better Data Needed to Help Identify and Analyze Potential Hazards (GAO/HEHS-97-147,
                       Sept. 29, 1997).



                       Page 5                                  GAO/HEHS-99-64 Burn Injuries and Children’s Sleepwear
B-281912




sleepwear involved in the injuries would meet the children’s sleepwear
standard.7

To obtain additional information on the circumstances surrounding burn
injuries to children, CPSC conducted further investigations of selected
cases. Rather than focus exclusively on reported cases that involved
garments designed as sleepwear, CPSC investigated selected cases
involving all types of clothing. Although CPSC’s safety standard applies
only to garments specifically intended for use as sleepwear, such as
nightgowns and pajamas, parents and children often use other types of
clothing—including T-shirts, sweatshirts, and long underwear—for
sleeping. Injuries associated with these garments are generally not
reported under NEISS’s sleepwear code, even if the garments were used
for sleeping. Instead, such cases may be recorded under the more general
category of clothing-related burns.

To obtain more detailed data on these injuries, as well as others involving
garments designed specifically as sleepwear, CPSC conducted special
investigations of selected clothing-related burn injuries that occurred
between 1993 and 1998. During each investigation, CPSC staff interviewed
family members and asked detailed questions about the incident. For
example, CPSC’s investigation protocol for these cases calls for staff to
ask questions about the time of the accident, the room in which the
accident took place, the part of clothing that first caught fire, and the age
of the clothing.

Many of the injuries represented in the cases CPSC chose to investigate
were severe; for example, one 8-year-old boy suffered third-degree burns
and had to be hospitalized for a month at a specialized burn center. In
addition, most of these injuries were associated with garments that are
beyond the scope of CPSC’s sleepwear standard. For example, of the 40
cases CPSC investigated involving garments used for sleeping, 28 (or
70 percent) involved oversize or loose-fitting T-shirts.8 An additional six

7
 Neither NEISS nor NFIRS was intended to account for all sleepwear-related injuries. For example,
NEISS includes only injuries treated in hospital emergency rooms—not injuries treated in other
settings such as a physician’s office, outpatient clinic, or walk-in medical center. Given the acute and
severe nature of clothing-related burn injuries, however, NEISS’s emergency room data would
probably include information on many such injuries. More seriously, as CPSC staff pointed out, data
systems such as NFIRS that rely on reports from fire departments would miss burn injuries in which a
child or parents were able to put out the flames without assistance from the fire department.
Consistent with this hypothesis, of 40 such cases CPSC investigated, the fire department was called in
only 9.
8
 Thirty-four of these 40 cases were reported to CPSC through NEISS, four cases came to CPSC’s
attention through newspaper clippings, and the other two were reported directly to CPSC by
consumers.



Page 6                                  GAO/HEHS-99-64 Burn Injuries and Children’s Sleepwear
                       B-281912




                       cases involved nightgowns or nightshirts. Of the remaining cases, three
                       involved traditional flame-resistant sleepwear, one involved a tight-fitting
                       T-shirt, and two involved cotton pajamas.9 With so few incidents involving
                       garments subject to the standard, these investigations can provide CPSC
                       with only limited ability to assess the relative number of injuries
                       associated with different types of covered sleepwear.


                       Without valid and precise information on injuries associated with different
Costly Additional      types of sleepwear both before and after the amendments, it is not
Information Would Be   possible to use injury data to draw firm conclusions about the actual effect
Needed to Draw Firm    of the changes to the children’s sleepwear standard. Even if these basic
                       data were available, assessing the effect of the sleepwear standard would
Conclusions About      be particularly difficult because multiple factors contribute to burn
the Effect of the      injuries, including the ignition source, the child’s behavior, and the fabric
                       and fit of the child’s clothing. Determining the role of any single factor,
Changes to the         including sleepwear type, can be difficult. For example, in one case we
Sleepwear Standard     reviewed, a 6-year-old girl accidentally backed into an open space heater
                       that quickly set the nightgown she was wearing on fire. It is uncertain
                       whether either reducing the flammability of the nightgown or improving
                       the design or performance of the space heater could have prevented her
                       injury.

                       Moreover, using injury information to compare the risks associated with
                       different types of sleepwear (such as snug-fitting cotton versus
                       flame-resistant polyester) would require information on how many
                       consumers actually use each type. Without such data, it would be difficult
                       if not impossible to distinguish the type of sleepwear associated with the
                       most injuries from the type of sleepwear most commonly used. For
                       example, if one type of sleepwear were associated with twice as many
                       injuries, but four times as many children used it, the risk of injury to each
                       individual child might actually be lower. Garments designed specifically to
                       meet the amendments’ criteria for snug-fitting pajamas have been widely
                       available to consumers for only a short time. Consequently, data on

                       9
                        In one of these two cases, CPSC obtained and measured the cotton pajamas involved in the incident
                       and determined that they did not meet the specifications of the new sleepwear standard. In the other
                       case, the pajamas were not available for examination; however, CPSC staff believed, on the basis of
                       information provided by the child’s mother, that these pajamas did not comply with the sleepwear
                       standard. The patterns CPSC reported in these investigations are consistent with data from other
                       sources. For example, we reviewed case files from one burn center that was not included in CPCS’s
                       NEISS sample. These cases involved 12 injuries to children younger than 15 in 1997 and 1998 that the
                       staff at the burn center identified as involving sleepwear. Many of these children suffered severe and
                       debilitating injuries, including third-degree burns, serious lung injuries, and psychological damage.
                       Although burn center staff did not have information on the fabric content of the children’s sleepwear,
                       for nine cases they noted the general type of sleepwear. The results from this small group were similar
                       to those CPSC found—six of the nine cases involved loose-fitting nightgowns or shirts.



                       Page 7                                 GAO/HEHS-99-64 Burn Injuries and Children’s Sleepwear
                  B-281912




                  consumers’ response to the newly available styles are not yet available and
                  may not represent the patterns of use that will prevail in the future. In the
                  absence of these key data, and without baseline data for comparison, it is
                  not possible on the basis of injury data to determine whether one type of
                  sleepwear or clothing is truly more hazardous than another.

                  Although the precise effect of the changes to the standard remains
                  unknown, if additional data were to become available CPSC could use this
                  information as it studies sleepwear-related injuries and informs consumers
                  about ways to help prevent them. However, obtaining such information
                  would be both difficult and costly. To obtain better data on the number of
                  injuries, CPSC would need to either expand the number of hospitals in the
                  NEISS sample or design and implement another large data collection
                  effort. To obtain data on the number of each different type of sleepwear in
                  use, CPSC would also need to undertake an additional data collection
                  effort, as existing market data are not designed to capture information at
                  this level of detail. Finally, to obtain additional detail on the circumstances
                  surrounding burn injuries, CPSC would have to invest additional resources
                  into conducting investigations of selected incidents. In allocating its
                  limited resources, CPSC has to consider its needs for additional data on
                  the many other potential product hazards within its extensive jurisdiction,
                  as well as children’s sleepwear issues.


                  We provided a draft of this report to CPSC for its review and comment. In
Agency Comments   its response, the agency stated that CPSC’s burn injury data are
                  comprehensive and reliable and demonstrate that children’s burn injuries
                  have not increased since the amendments to the sleepwear standard. We
                  disagree. Although few cases are reported and the overall risk appears to
                  be small, CPSC’s data can produce only imprecise national estimates,
                  making it difficult to observe trends in the number of injuries over time.
                  CPSC’s data include only 13 observations over 9 years—a period that
                  extends from before the changes to the standard and the stay of
                  enforcement were proposed to 2 years after the amendments were
                  enacted. As a result, we are unable to draw firm conclusions about trends
                  in the number of injuries over time. We made several changes to the
                  language of the draft report to clarify the reasons for our conclusions.

                  CPSC’s response also stated that the agency’s staff do not rely solely on
                  injury data for its continued support of the amendments but consider
                  other information such as laboratory and analytical evidence. We agree
                  that it is important to consider these other types of information in



                  Page 8                        GAO/HEHS-99-64 Burn Injuries and Children’s Sleepwear
B-281912




examining the changes to the standard. However, because our analysis
focused only on burn injury data, an evaluation of these other types of
information is beyond the scope of this report.

Finally, CPSC commented that because relatively few incidents are
reported, exposure data (information about how many consumers actually
use each sleepwear type) would not be helpful in assessing the relative
safety of various types of sleepwear. Again, we disagree with CPSC’s view.
Although exposure data might be of limited use in quantifying the risk
associated with all sleepwear types as a group, such data would be
necessary if injury data were to be used to compare the risks associated
with different specific types of sleepwear (such as the snug-fitting cotton
allowed under the amended regulations and the flame-resistant fabrics
required under the previous standard). Without such data, it would be
difficult or impossible to distinguish the type of sleepwear associated with
the most injuries from the type of sleepwear most commonly used. For
example, of the sleepwear-related burn incidents CPSC investigated, CPSC
staff believe that three cases involved traditional flame-resistant sleepwear
and no cases involved snug-fitting cotton pajamas. Without the additional
context provided by exposure data, this information could be
misinterpreted to indicate that snug-fitting cotton pajamas are safer than
traditional flame-resistant sleepwear. Although exposure data are useful,
we recognize that they can be difficult and costly to collect. As we stated
in our report, CPSC has to consider its needs for additional data on many
other potential product hazards in allocating its resources.

CPSC also made technical comments about the report that we
incorporated as appropriate. CPSC’s comments appear in the appendix.




Page 9                       GAO/HEHS-99-64 Burn Injuries and Children’s Sleepwear
B-281912




We are sending copies of this report to appropriate congressional
committees and we will also make copies available to others upon request.
If you or your staff have any questions about this report, please contact
Marlene S. Shaul, Associate Director, or Larry Horinko, Assistant Director,
at (202) 512-7014. Major contributors to this report include Sarah L. Glavin
and Sheila R. Nicholson.




Marnie S. Shaul
Associate Director, Education,
  Workforce, and Income Security Issues




William F. Scanlon
Director, Health Financing
  and Public Health Issues




Page 10                      GAO/HEHS-99-64 Burn Injuries and Children’s Sleepwear
B-281912




List of Addressees

The Honorable Christopher S. Bond, Chairman
The Honorable Barbara A. Mikulski, Ranking Minority Member
Subcommittee on VA, HUD, and Independent Agencies
Committee on Appropriations
United States Senate

The Honorable James T. Walsh, Chairman
The Honorable Alan B. Mollohan, Ranking Minority Member
Subcommittee on VA, HUD, and Independent Agencies
Committee on Appropriations
House of Representatives

The Honorable Ann Brown, Chairman
Consumer Product Safety Commission

The Honorable Mary Sheila Gall, Commissioner
Consumer Product Safety Commission

The Honorable Thomas Moore, Commissioner
Consumer Product Safety Commission




Page 11                   GAO/HEHS-99-64 Burn Injuries and Children’s Sleepwear
Appendix

Comments From the Consumer Product
Safety Commission




Now on page 1.




Now on pages 1 and 2.

Now on page 2.




Now on page 5.




                        Page 12   GAO/HEHS-99-64 Burn Injuries and Children’s Sleepwear
                 Appendix
                 Comments From the Consumer Product
                 Safety Commission




Now on page 7.




Now on page 8.




                 Page 13                       GAO/HEHS-99-64 Burn Injuries and Children’s Sleepwear
                 Appendix
                 Comments From the Consumer Product
                 Safety Commission




Now on page 7.




(205391)         Page 14                       GAO/HEHS-99-64 Burn Injuries and Children’s Sleepwear
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