Consumer Product Safety Commission: Injury Data Insufficient to Assess
the Effect of the Changes to the Children's Sleepwear Safety Standard
(Letter Report, 04/01/99, GAO/HEHS-99-64).

Pursuant to a legislative requirement, GAO reviewed the data available
on burn injuries to children and the implications of these data for the
effect of the recent amendments to the children's sleepwear standard,
focusing on: (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.

GAO noted that: (1) the exact number of burn injuries associated with
children's sleepwear before and after the Consumer Product Safety
Commission (CPSC) amended its standard is uncertain; (2) although CPSC
collects some burn injury data from a sample of hospital emergency
rooms, few sleepwear-related injuries are reported annually; (3) for
example, over the period 1990-1998, CPSC's sample of about 100 hospital
emergency rooms reported a total of only 13 burn injuries that involved
children's sleepwear; (4) this included a maximum of four cases in any
one year, and in some years, including 1998, no cases were reported at
all; (5) 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; (6) 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; (7) 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; (8)
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; (9) 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;
(10) 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; and (11) 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.

--------------------------- Indexing Terms -----------------------------

 REPORTNUM:  HEHS-99-64
     TITLE:  Consumer Product Safety Commission: Injury Data 
             Insufficient to Assess the Effect of the Changes to the
             Children's Sleepwear Safety Standard
      DATE:  04/01/99
   SUBJECT:  Safety standards
             Safety regulation
             Consumer protection
             Accidents
             Children
             Reporting requirements
             Product safety
             Clothing industry
             Data collection
             Comparative analysis
IDENTIFIER:  CPSC National Electronic Injury Surveillance System
             
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Cover
================================================================ COVER


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

Burn Injuries and Children's Sleepwear

(205391)


Abbreviations
=============================================================== ABBREV


Letter
=============================================================== LETTER


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
ï¿½snug-fittingï¿½ 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. 


--------------------
\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. 


   RESULTS IN BRIEF
------------------------------------------------------------ Letter :1

The exact number of burn injuries associated with children's
sleepwear before and after CPSC amended its standard is uncertain. 
Although CPSC collects some burn injury data from a sample of
hospital emergency 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 yearsï¿½including 1998ï¿½no
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. 


   BACKGROUND
------------------------------------------------------------ Letter :2

CPSC was established in 1972 under the Consumer Product Safety Act
(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
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. 

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


--------------------
\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. 

\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. 


   FEW DATA ARE AVAILABLE ON BURN
   INJURIES INVOLVING CHILDREN'S
   SLEEPWEAR
------------------------------------------------------------ Letter :3

The number of burn injuries associated with children's sleepwear is
uncertain, and few data are available.  Some information on
sleepwear-related injuries can be obtained from CPSC's National
Electronic Injury Surveillance System (NEISS), which gathers data
from a statistical sample of 101 hospitals across the United States
that have 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 sourcesï¿½for example,
the National Fire Incident Reporting System (NFIRS), compiled by the
U.S.  Fire Administrationï¿½are 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 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 clothingï¿½including T-shirts, sweatshirts, and long
underwearï¿½for 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 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. 


--------------------
\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). 

\7 Neither NEISS nor NFIRS was intended to account for all
sleepwear-related injuries.  For example, NEISS includes only
injuries treated in hospital emergency roomsï¿½not 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. 

\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
foundï¿½six of the nine cases involved loose-fitting nightgowns or
shirts. 


   COSTLY ADDITIONAL INFORMATION
   WOULD BE NEEDED TO DRAW FIRM
   CONCLUSIONS ABOUT THE EFFECT OF
   THE CHANGES TO THE SLEEPWEAR
   STANDARD
------------------------------------------------------------ Letter :4

Without valid and precise information on injuries associated with
different types of sleepwear both before and after the amendments, it
is not possible to use injury data to draw firm conclusions about the
actual effect of the changes to the children's sleepwear standard. 
Even if these basic data were available, 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. 
Determining the role of any single factor, including sleepwear type,
can be difficult.  For example, in one case we 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 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. 


   AGENCY COMMENTS
------------------------------------------------------------ Letter :5

We provided a draft of this report to CPSC for its review and
comment.  In 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 yearsï¿½a 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 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. 


---------------------------------------------------------- Letter :5.1

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

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




(See figure in printed edition.)Appendix
COMMENTS FROM THE CONSUMER PRODUCT
SAFETY COMMISSION
============================================================== Letter 



(See figure in printed edition.)



(See figure in printed edition.)


*** End of document. ***