[Federal Register Volume 61, Number 87 (Friday, May 3, 1996)]
[Rules and Regulations]
[Pages 19818-19830]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-10978]
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CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Part 1500
Requirements for Labeling of Retail Containers of Charcoal
AGENCY: Consumer Product Safety Commission.
ACTION: Final rule.
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SUMMARY: Under the Federal Hazardous Substances Act, the Commission
issues a rule to change the required labeling for retail containers of
charcoal intended for cooking or heating. The labeling addresses the
potentially lethal carbon monoxide hazard associated with burning
charcoal in confined spaces. The amendments, which include a pictogram,
make the label more noticeable and more easily read and understood and
increase the label's ability to motivate consumers to avoid burning
charcoal in homes, tents, or vehicles.
DATES: The amended rule becomes effective November 3, 1997.1
\1\ The Commission voted 2-1 to issue this rule. Chairman Ann
Brown and Commissioner Thomas H. Moore voted in the majority.
Commissioner Mary Sheila Gall voted in the minority. Each
commissioner issued a separate statement concerning this vote.
Copies of the statements can be obtained from the Commission's
Office of the Secretary, Washington, DC 20207, telephone (301) 504-
0800.
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FOR FURTHER INFORMATION CONTACT: Mary Toro, Division of Regulatory
Management, Office of Compliance, Consumer Product Safety Commission,
Washington, D.C. 20207; telephone (301)504-0400 ext. 1378. Copies of
documents relating to this rulemaking may be obtained from the Office
of the Secretary, Washington, DC 20207, telephone (301)504-0800.
SUPPLEMENTARY INFORMATION:
A. Background
1. Relevant Statutes and Regulations. Since its creation in 1973,
the Consumer Product Safety Commission (``Commission'' or ``CPSC'' has
administered the Federal Hazardous Substances Act (``FHSA''), 15 U.S.C.
1261-1278. Prior to that time, the FHSA was administered by the Food
and Drug Administration (``FDA'').
The FHSA defines ``hazardous substance'' as including any
``substance or mixture of substances which (i) is toxic * * * if [it]
may cause substantial personal injury or substantial illness during or
as a proximate result of any customary or reasonably foreseeable
handling or use * * *.'' Section 2(f)(1)(A) of the FHSA, 15 U.S.C.
1261(f)(1)(A). Hazardous substances are misbranded if they do not bear
the labeling required by section 2(p)(1) of the FHSA, 15 U.S.C.
1261(p)(1).
Section 3(b) of the FHSA, 15 U.S.C. 1262(b), authorizes the
Commission to issue regulations establishing variations from or
additions to the labeling required under section 2(p)(1) if the
Commission finds that the requirements of section 2(p)(1) are not
adequate for the protection of the public health and safety in view of
the special hazard presented by any particular hazardous substance.
Rulemaking under section 3(b) is conducted under the informal notice
and comment procedure provided in 5 U.S.C. 553.
In addition, section 3(a) of the FHSA, 15 U.S.C. 1262(a),
authorizes the Commission to issue regulations declaring products to be
hazardous substances if the Commission finds they meet the definition
of hazardous substance in section 2(f)(1)(A). The purpose of this
authority is to avoid or resolve uncertainty as to the application of
the FHSA. 15 U.S.C. 1262(a).
In 1971, the Food and Drug Administration (``FDA'') issued a rule
under section 3(a) of the FHSA to declare charcoal in containers for
retail sale and intended for cooking or heating to be a hazardous
substance. 36 FR 14,729 (August 11, 1971); 21 CFR Sec. 191.5. At the
same time, FDA issued a rule under section 3(b) of the FHSA to require
a statement on such packages of charcoal that would warn of the
potentially deadly hazard of CO poisoning from charcoal when used in a
confined area. Id. at Sec. 191.7. These rules are currently codified at
16 CFR Secs. 1500.12(a)(1) and 1500.14(b)(6), respectively. The
currently required label is as follows:
BILLING CODE 6355-01-P
[GRAPHIC] [TIFF OMITTED] TR03MY96.049
[[Page 19819]]
BILLING CODE 6355-01-C
The current label is required to appear on both the front and back
panels of bags of charcoal, in the upper 25% of the panels, at least 2
inches below the seam, at least 1 inch above any other reading material
or design element of the bag, and in specified minimum type sizes.
2. Nature of the hazard. [6, Tab B] 2 CO is produced by the
incomplete combustion of fuels such as charcoal. The level of CO
produced from burning charcoal may accumulate to toxic levels in closed
environments. CO is a colorless, odorless gas which reduces the blood's
ability to carry oxygen by reacting with hemoglobin to form
carboxyhemoglobin (COHb). Individuals' reactions to CO exposure vary
depending on several factors, including age, health status, and smoking
habits. Due to the nonspecific symptoms that can be associated with CO
poisoning (e.g., fatigue, lethargy, dizziness, diarrhea, or nausea),
misdiagnoses of both acute and chronic CO poisonings can be expected.
Additionally, CO is odorless, which may contribute to individuals
frequently being unaware of their exposure to CO. High levels of COHb
in the blood can cause death.
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\2\ Numbers in brackets indicate the number of a document as
listed in the List of Relevant Documents in Appendix 1 to this
notice.
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3. Petition from Barbara Mauk. On October 12, 1990, CPSC received a
letter from Barbara Mauk petitioning the Commission to amend the
current label on bags of charcoal. [1] In this letter, the petitioner
described an incident that occurred when she and her son were camping 1
year previously. Her son died from CO poisoning, and she was
hospitalized and treated for CO poisoning, after she brought a still-
warm charcoal grill inside her camper. The petition (No. HP 91-1)
requested that the current label on bags of charcoal be revised to
state that: (1) charcoal produces CO (and, if applicable, other lethal
or toxic fumes), (2) charcoal produces fumes until the charcoal is
completely extinguished, and (3) CO has no odor.
On December 22, 1992, the Commission voted to grant the petition as
to the statements that charcoal produces CO and that CO has no odor,
and to deny the petition as to adding statements that charcoal produces
these fumes until the charcoal is completely extinguished. [2] The
Commission also voted to improve the label's precautionary language,
specifically with reference to ventilation. In this regard, it was
thought that the current label's statement that charcoal should not be
used for indoor cooking or heating unless ventilation is provided is
dangerously misleading. Consumers may assume erroneously that measures
such as opening a door or cracking a window would provide adequate
ventilation. Further, consumers are unlikely to be able to supply the
exhaust hoods, ducting, and powerful positive exhaust fans that are
needed to provide adequate ventilation.
4. Subsequent actions by the Commission. In 1993, the Commission's
staff became aware of data that indicated that a pictogram is needed to
communicate the safety message to those who do not read English. [6,
Tab E(1)] Further, an article, discussed below in section B of this
notice, reported that 73% of the victims in one area over an 11-year
period were members of ethnic minorities, many of whom were Hispanic or
Asian immigrants who could not speak English. [3]
On April 22, 1994, the staff met with members of the charcoal
industry to present the staff's recommendations for revising the
warning label. Industry members indicated a willingness to revise the
warning label, but raised a number of concerns. [6, Tab F] These
concerns were considered in further developing the label.
On June 1, 1994, the Commission directed the staff to prepare, for
the Commission's consideration, a draft notice of proposed rulemaking
(``NPR'') to amend the labeling currently required for packages of
charcoal to warn of the dangers of burning charcoal indoors. The label
to be developed by the staff would: (1) clarify the dangers of burning
charcoal indoors; (2) remove the possibly misleading statement that
implies that charcoal can be safely burned indoors with
``ventilation;'' (3) add color to the signal word panel; (4) include a
pictogram, if feasible; (5) include a Spanish safety message if a
pictogram is not feasible; and (6) include additional features
recommended by the staff to make the safety messages more conspicuous
and understandable.
On April 13, 1995, staff met with industry members again to present
the results of pictogram tests and staff's recommendations for revising
the warning label on packages of charcoal. [6, Tab F] The changes to
the recommended warning label reflected, for the most part, concerns
industry representatives raised at the April 1994 meeting. After
considering the comments made at the April 1995 meeting, the staff
recommended a revised label to the Commission. The staff also described
possible variations of that label for the Commission's consideration.
The proposed label, and the main reasons that various features of the
label were chosen, are described in section D of this notice. The
proposed rule was published in the Federal Register on August 10, 1995,
with a request for public comments, to be submitted no later than
October 24, 1995. 60 FR 40785. The comments received on the proposal,
and the Commission's responses to the comments, are described below in
Section E of this notice.
B. CO Poisoning Incidents
The Commission's Division of Hazard Analysis examined available
data concerning CO poisoning incidents. That Division estimates that
there was an average of about 28 non-fire CO-related deaths per year
associated with charcoal grills and hibachis from 1986 to 1992.3
(The annual estimate of non-fire CO deaths fluctuates, with no
discernible pattern. The estimates ranged from 20 in 1987 and 1990 to
38 in 1992.)
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\3\ As noted above, CO is produced as a product of incomplete
combustion. The term ``non-fire'' means that the CO was not produced
by a conflagration or other unintended combustion.
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Data from the CPSC's National Electronic Injury Surveillance System
(``NEISS'') indicate that there was an average of about 300 emergency-
room-treated injuries involving charcoal grills and hibachis annually
from 1991 to 1994. [6, Tab C] After the Commission considered the
proposed rule, the Commission's Hazard Analysis staff reviewed eight
additional incident reports involving CO deaths and injuries associated
with the indoor use of charcoal. These incidents were for the years
1994 to the present. [15] The factors identified in these recent
incidents were very similar to those previously reported.
There were 14 victims reported in the additional incidents: 9 died
and 5 recovered. Where a victim's membership in an ethnic minority was
reported, Hispanics continued to be the group reported most often. The
data indicated that the Hispanic victims either spoke little or no
English. The circumstances indicated that the victims were unaware of
the potential lethal effects of burning charcoal indoors.
Most of the incidents involved a charcoal grill. Information on the
safety labeling on packages of charcoal was not available. However, the
Commission's Office of Compliance has no record of opening a case based
on a violation of the charcoal special labeling
[[Page 19820]]
requirement, and there is no reason to believe that the packages of
charcoal involved in these incidents did not bear labels warning of the
CO hazard.
Many of the incidents occurred when victims burned charcoal in
their homes or in vehicles. Most of the incidents occurred when victims
used charcoal to keep warm. Most of the incidents occurred during the
fall and winter.
An article by Hampson, N.B. et al. (1994), reports that 79 victims
were treated for CO poisoning resulting from burning charcoal indoors
in the Seattle, Washington, area between October 1982 and October 1993.
[3] Fifty-eight (73%) of the victims were members of ethnic minorities,
many of whom were Hispanic or Asian immigrants who could not speak
English. [3] There was no information available, however, documenting
whether they could read English.
C. The Pictogram
The CPSC staff, a charcoal manufacturer, and Dr. Neil B. Hampson of
Washington State each developed a pictogram. [6, Tab E(2)] Each
pictogram was tested according to ANSI Z535.3, American National
Standard for Criteria for Safety Symbols. The pictogram developed by
CPSC staff obtained the highest percentage of correct responses in the
first round of testing. This pictogram achieved 56% correct responses,
with 4% critical confusion. (Critical confusion is where the message
conveyed is the opposite of the intended message.) Based on findings
from the test results, the three pictograms were revised and presented
for a second round of testing. The revised pictogram developed by a
charcoal manufacturer obtained the highest percentage of correct
responses in this round of testing (74% correct responses, with no
critical confusion).
The ANSI Z535.3 test method recommends that, to be selected, a
pictogram should either obtain 85% correct responses with no more than
5% critical confusion or be paired with other features, such as a
verbal message. [10] For the reasons discussed below in responding to
comments on the proposal, the Commission concludes that it is
appropriate to use the pictogram that scored highest in the tests
described above.
D. The Proposed Label
The Commission's Human Factors staff concluded that, as a matter of
optimum label design, it would be desirable for the label to be
consistent with the ANSI Z535.4, American National Standard for Product
Safety Signs and Labels. [6, Tab E(1)] In meetings before the
Commission considered the proposal, however, the industry pointed out
that this optimum label would require the bag to have a minimum of four
colors: red, orange, black, and white. The industry stated that many of
the printing presses for charcoal bags have the capability of printing
only six colors, and that presses capable of printing more than six
colors are very expensive. Generally, most bags already have at least
six colors, and the presently-used colors often do not include one or
more of the colors that would be required by the ``optimum'' label
described above. Industry members stated that customers may consider
the color scheme of a product to be part of its brand identification.
For the reasons given by the industry, the Commission proposed a
label that did not use the colors specified by ANSI, but will still be
conspicuous. [13] Thus, the revised label will not change the present
requirement that the label shall be in a ``color sharply contrasting
with the background'' and that the borderline shall be ``heavy.''
Examples of color combinations that the Commission's staff considers to
be sharply contrasting, in order of expected visual efficiency, are:
black on white; black on yellow; white on black; dark blue on white;
white on dark red, green, or brown; black on orange; dark green and red
on white; white on dark gray; and black on light gray. [9] Examples of
colors that may not be considered sharply contrasting are: black on
dark blue or dark green, dark red on light red, light red on reflective
silver, and white on light gray or tan. See 16 CFR 1500.121(d).
To make the label easier to read and understand, the Commission
proposed that the messages be presented concisely and in an outline
form, be presented in a horizontal format, be left-justified with a
ragged right margin, be in upper and lower case lettering, be in the
appropriate point-type, have an acceptable strokewidth-to-height ratio,
and have sufficient space between lines of text. [6, Tab E(1)]
When the minimum specified type sizes are laid out in the
configuration specified in the revised label, the label is 2 inches
high. The revised label is taller than the currently required label.
The current label also is required to be at least 2 inches from the top
seam. If this required distance were to remain the same, the bottom
edge of the taller revised label would have to be lower on the bag.
This could interfere with existing graphics, which would then have to
be redesigned. This could require additional modifications to printing
plates and increase the cost of the label revision, without providing
any identifiable safety benefit. Therefore, the Commission proposed to
change the minimum allowable distance from the top seam to the label
from 2 inches to 1 inch. This would allow the taller label to be
printed without affecting other printing lower on the bag.
The Commission proposed to retain the current requirements that the
label must be on both the front and back panels of the bag and in the
upper quarter of the panels.
For the reasons stated above and elsewhere in this notice, the
Commission is revising the label required on packages of charcoal to
appear and read as follows:
BILLING CODE 6355-01-P
[[Page 19821]]
[GRAPHIC] [TIFF OMITTED] TR03MY96.050
BILLING CODE 6355-01-C
E. Comments on the Proposal
The Commission received seven comments in response to the notice of
proposed rulemaking. The issues raised by the comments are summarized
below, along with the Commission's responses.
Issue: Pictogram
Comment: Slash vs. ``X.'' Several commenters addressed the use in
the proposed revised label of an ``X'' overlaying the pictogram to
indicate that the actions depicted in the pictogram are prohibited. A
commenter argued that this aspect of the pictogram is not consistent
with any international standard or to ANSI Z535.3 ``Criteria for Safety
Symbols,'' in which prohibited actions are characterized by a single
slash in a circle. Another commenter stated that a single slash ending
at the edges of the circle across three separate pictograms for each at
risk location may be more universally recognized and effective than an
X. The commenter believed this would be more in line with global
marketing standards. This commenter noted that the pictogram was tested
using a population largely made up of Hispanics, and questions whether
the same results would have been obtained with other ethnic groups.
Response: The Commission's Human Factors staff conducted a two-
phase study to determine which pictogram most clearly conveyed the
safety message to the at-risk population. Three pictograms were tested
in the first phase, all of which incorporated a circle with the ANSI-
recommended diagonal slash through the image. The most effective
pictogram was understood by only 56% of the subjects, with 4% critical
confusion. (Critical confusion means that the subjects' response was
the opposite of the correct response.)
The test subjects' responses during the test sessions and
debriefing revealed that some of the subjects thought that the slash
applied to only those items in the circle that actually intersected
with the slash. Other subjects did not understand that the slash was a
prohibition symbol. Subjects recommended the use of an ``X'' to better
communicate the prohibition message. Although the slash is commonly
used to communicate the message of ``no'' or ``don't,'' it was clearly
not effective with some Latin American subjects.
Consistent with ANSI Z535.3, the second round of testing
incorporated design lessons drawn from the results of the first round
of testing. The slash was replaced by an ``X,'' and several minor
design changes were made to the pictograms. The measured comprehension
improved significantly.
Based on the data, Human Factors concluded that using the ``X'' in
place of the slash is fully justified because:
1. The highest comprehension score using a slash was 56% with 4%
critical confusion. All three pictograms tested in the second round
using the ``X'' scored significantly better than the best slash
pictogram tested in the first round. The pictogram ultimately selected
was identified correctly by 74% of the test subjects, with 0% critical
confusion.
2. The primary objective for developing and selecting the pictogram
design was to maximize the effectiveness of the prohibition message, to
never burn charcoal inside a house, tent, or vehicle. Effectiveness was
defined and empirically measured by assessing the explicit
understandability of the pictogram by a sample of at-risk charcoal
users. This is precisely the primary criterion described in ANSI
Z535.3-1991. Section A.1 of ANSI Z535.3-1991 states, ``In the following
procedure, the primary criterion for determining symbol effectiveness
is that of understandability; in other words, that the symbol clearly
conveys the intended message to the appropriate test group.'' Based on
the Commission's primary objective, to maximize effectiveness, and
ANSI's endorsement of that goal, the use of the ``X'' is justified.
3. Although ANSI clearly defines the slash as the preferred design
to designate prohibition, Section 7.4 of ANSI Z535.3-1991 supports the
search for new and more effective designs. Section 7.4 endorses this
rationale of flexibility and continuous refinement by stating ``If a
new symbol has been tested and found to be acceptable, it and the
results of the testing procedure may be forwarded to the ANSI Z535
Committee for consideration for inclusion in a revision of the present
standard.'' The Commission intends to submit the results of this work
to ANSI so that they may consider the merits of supporting alternate
symbol designs for ethnic or other special populations.
The empirically validated pictogram that was ultimately selected
for the new labeling requirement meets the original CPSC objective of
maximizing effectiveness and is consistent with the principles for
designing labels specified in ANSI Z535.3. Regarding the comment that
the label should be universal and not ethnically sensitive, the label
is designed to be effective for all charcoal users.
Therefore, the Commission concludes that the X symbol is a more
effective communicator of the behavior to be prohibited than is the
slash. Accordingly, no change in the proposed revised label is
warranted in this regard.
Comment: Effectiveness of the pictogram. Commenters contended that
the pictogram fails to satisfy recognized standards of effectiveness.
The commenters state that the ANSI standard requires 85% correct
responses with a maximum of 5% critical confusion, while the CPSC-
proposed pictogram received 74% correct responses with no critical
confusion. One company believes that 74% is significantly different
from 85% and expressed serious concern about a pictogram which failed
recognized
[[Page 19822]]
standards of effectiveness not by 1 or 2%, but by 11%. The fact that
the proposed pictogram had no critical confusion, whereas ANSI allows
up to 5%, is irrelevant to this commenter.
Response: These commenters are incorrect in stating that the CPSC-
tested pictogram does not meet the effectiveness criteria of ANSI.
The particular number of correct responses obtained in the test of
a label depends on the particular test methodology used. Therefore,
there is no precise way to define acceptable and unacceptable scores.
ANSI Z535.3, section A.2.7, states ``A criterion of 85% correct
responses with a maximum of 5% critical confusion is suggested for
acceptance of a given symbol.'' Section A.2.7 of ANSI Z535.3, however,
states that symbols which fail to meet the 85% level should be used
with a supplementary word message, or be supplemented by specialized
training. Thus, ANSI Z535.3 clearly recognizes that scores less than
85% may still be used in certain circumstances.
CPSC's label incorporates the features that ANSI recommends for
labels scoring less than 85% correct responses. Although the pictogram
was tested alone, the recommended label contains both the pictogram and
a written message. Additionally, the CPSC's staff met with the charcoal
industry regarding an information and education campaign to warn
consumers about the dangers of burning charcoal indoors.
The Human Factors staff chose to use an experimental methodology
that was extremely rigorous and that therefore may have biased the
measured comprehension scores downward. This was done to maximize
confidence in the measured scores, and to minimize possible criticism
about inflating the scores through using a less stringent method. The
following factors may tend to lower the percentage of correct responses
in CPSC's tests compared to that which might be obtained using other
test methodologies that would also be acceptable under ANSI Z535.3:
1. ANSI Z535.3 endorses both open-ended testing and multiple-choice
testing. The Human Factors staff chose to use open-ended testing as it
is the most demanding assessment process to measure comprehension. Both
ANSI and the Commission recognize that this rigorous methodology may
negatively influence scores. ANSI Z535.3, Section A.2.6, states ``It
should be stressed that different techniques may not give comparable
results.''
2. The criteria used to select subjects were strongly biased toward
selecting an at-risk sample. Fifty percent of the subjects were
Hispanics who did not read English and were at or below the government
standard for poverty. The remaining half were of no specified ethnicity
who did read English and were below the median income. No middle or
upper income people were included in the test. The Human Factors staff
chose to pursue this methodology in order to assess the pictogram in
the worst-case situation. The objective was to ensure that the selected
pictogram communicates the hazard to the populations that are at
greatest risk. More correct responses might have been obtained if the
sample tested had represented the general population.
3. In order to reduce the possible learning effect associated with
viewing the pictograms in succession, the pictograms were presented out
of context, that is, on a white sheet of paper. They were separated
from each other by pictograms associated with other hazards. Had the
pictograms been tested in context, on bags of charcoal, it is likely
that higher comprehension scores would have been obtained. [15, Tab
D(1), Cahill, 1975]
Furthermore, the International Organization for Standardization
(``ISO''), issued an international standard, ISO 9186, Procedures for
the Development and Testing of Public Information Symbols, that
recommends testing methodologies to evaluate symbols intended to be
used internationally. These methodologies are intended to test the
common effectiveness of symbols for populations of different countries;
the tests were not developed to evaluate labeling in the U.S. Section
5.5.7 of ISO 9186 states, ``If the comprehension score * * * exceeds
66%, then this variant may be used to define the standard image
content.'' Later in the same section, ``For critical referents (e.g.
safety symbols), the 66% criterion should be rigorously adhered to.''
Although ISO 9186 was not designed specifically to test a label such as
the one at issue here, it does show that an acceptance criterion for
understandability of less than 74% has been adopted by a well-known
standards organization.
As noted above, a commenter states that an effectiveness score of
74% is significantly different from the 85% threshold described in the
ANSI standard. The commenter is correct if he is referring to
``significantly different'' in a technical statistical sense; the
difference between 74% and 85% in this test is statistically
significant at the commonly used 95% confidence level. However, the
difference is not significantly statistically different at a 96%
confidence level. [16] More importantly, for the reasons explained
above, this issue is not central to whether the CPSC test scores are
adequate.
The commenter also states that critical confusion is irrelevant.
The Commission disagrees with this conclusion. An individual who is
critically confused, and thus believes that the pictogram means that it
is appropriate to burn charcoal indoors, may be more likely to create
the risk of carbon monoxide poisoning than someone who merely does not
know what the pictogram means. This principle is reflected in the ANSI
standard, which states, at Section A.2.7, ``Where several symbols are
evaluated for a given referent, the symbol that both meets the above
criteria, and performs best in terms of highest percentage of correct
answers and lowest percentage of critical confusion should be
selected.''
Comment: Size of the test group. A commenter contended that the 50-
member test group was too small for this type of testing. According to
the commenter, a minimum of 100-150 subjects should be used.
Response: The number of test subjects used by the Commission is
consistent with ANSI Z535.3, which suggests a minimum of 50 subjects as
the ``best balance between statistical reliability and ease of
testing.'' [10] Thus, in the absence of any specific reason why the
information obtained by using 50 subjects is unreliable, the Commission
concludes that an adequate number of persons were tested.
Comment: Label ``clutter.'' A commenter contended that the
pictogram is small and cluttered compared to the size of the label and
does not conform to an ANSI standard pictogram format, which depicts
one message icon per enclosed symbol.
Response: The selected pictogram conforms to the general principles
described in ANSI Z535.3. A pictogram with only one icon, a house, was
tested in the first round. A number of subjects did not generalize that
pictogram to include vehicles and tents, which are extremely dangerous
places to use charcoal improperly. Subjects suggested including a
vehicle and tent to communicate the message ``Never burn charcoal
inside homes, vehicles, or tents.'' The proposed pictogram includes all
three elements. According to ANSI Z535.3, the intent of the testing
procedure is ``to choose a symbol which best conveys the message.''
Thus, the pictogram selected conforms to the ANSI testing procedure.
Any perception of ``clutter'' could be reduced by making the
pictogram larger. However, this would increase the
[[Page 19823]]
minimum height of the label. The Commission believes the minimum
allowable label height will effectively communicate the desired
messages. The Commission is not requiring a larger label for the
reasons propounded by the industry and discussed below.
For the reasons discussed above, the Commission concludes that the
label will be sufficiently effective.
Comment: Lack of pictogram specificity may discourage charcoal use.
A commenter contends that the pictogram does not identify the danger
associated with charcoal misuse and does not convey what CO is. The
commenter fears that rather than simply warning users about the danger
of using charcoal in confined areas, the pictogram may discourage
charcoal grilling. The commenter also asked what message was received
by the 26% who did not respond correctly.
Response: Admittedly, a pictogram may not be a feasible way to
explicitly communicate the invisible hazard of CO. However, most people
will get the intended concept that they should not burn charcoal inside
homes, vehicles, or tents, even if they will not learn from the
pictogram alone that the hazard is CO. This is shown by the 74% rate of
correct responses for the selected pictogram. Additionally, the
pictogram and the words together convey the complete message.
The remaining 26% of the subjects, who did not give correct
responses, either omitted part of the intended message or completely
missed the concept. However, none of these subjects were left with the
impression that they should not use charcoal or not use it for
grilling. Thus, there is no reason to conclude that the pictogram will
cause any reduction in charcoal sales. The issue of whether the entire
label will cause any reduction in sales is discussed later in this
section.
Issue: Label Proportional to Package
Comment: Keep specified label size as a minimum only. In the
proposal, the Commission specified a minimum required size for the
label and solicited comment on whether to require that bags that are
larger than the smallest bags on the market bear labels that are larger
than the minimum. Two manufacturers commented that if larger warning
labels are required on larger bags, artwork lower on the bags may have
to be changed. Therefore, the commenters recommended that the size be
specified as a minimum, as proposed.
Response: The Commission agrees that requiring larger labels on
larger bags is likely to increase the cost of the rule in some cases by
requiring additional changes to the graphics on the bags. Further, the
Commission lacks data from which to conclude that any benefits of
larger labels on large bags would justify these increased costs.
Accordingly, the Commission is not requiring that the size of the
required labeling increase in proportion to the size of the bag.
Issue: Layout of Label
Comment: Label format. A commenter stated that CPSC's proposed
label arrangement does not conform exactly to ANSI Z535.4 ``Product
Safety Signs and Labels'' guidelines. The commenter mentioned that the
label should be divided into two halves, one half being the pictogram/
graphic panel and the other half being the signal word and word message
panel. Alternatively, the signal word could be centered above the
pictogram and word message panels.
Response: While ANSI Z535.4 provides an example of a label
configuration as described by the commenter, ANSI maintains that
``actual * * * layout * * * may vary depending on application
requirements.'' [10] The differences between the label finally adopted
and ANSI's example were necessary to accomplish the goals of: making
the type size of the safety messages consistent, to the extent
feasible, with that currently specified in Sec. 1500.14(b)(6);
incorporating a legible pictogram; and not unduly increasing the height
of the label. Accordingly, this comment provides no basis for changing
or rejecting the revised label.
Issue: Responsibility of Users
Comment: Fault of users. A commenter asked how many people involved
in the CO events had even ``bothered'' to read the existing warning
label. The commenter also asked how many were under the influence of
alcohol or drugs and would not have seen or paid any attention to a
warning label of any kind.
Response: Information on whether the victims had actually read the
label was not available. Some victims attempted to supply ventilation,
however. In most of the incidents, drug or alcohol use was not
reported.
Issue: Label Language
Comment: Specificity of warning. A commenter stated that the
sentence ``NEVER burn charcoal inside homes, vehicles or tents'' is too
specific. The commenter suggests that the addition of the words ``such
as'' would prevent the public from concluding that it would be safe to
burn charcoal in a confined space other than a home, vehicle, or tent.
Response: The CPSC incident data show that people primarily use
charcoal as a heat source inside homes and, secondarily, in vehicles
and tents. Thus, the label is intended to address use in those areas.
The commenter provides no data showing that other locations are likely
to be involved in this type of incident. Adding words that cannot be
shown to be beneficial is undesirable, since people are more likely to
read a label message if it is short and concise. Additional wording
also could have possible adverse effects on the label's height or
lettering size. Accordingly, the Commission declines to adopt the
suggestion.
Comment: Understanding the term ``carbon monoxide.'' A comment
stated that the label statement that charcoal ``gives off carbon
monoxide'' may be ambiguous to those with minimal education or limited
knowledge of English. For example, the commenter suggested that such
users might think that CO was associated with charcoal ashes. The
commenter suggests that the term ``gas'' be used to link the statement
to the warning hazard.
Response: The Commission has no reason to believe that persons with
a limited command of English would interpret that ashes, or anything
other than a gas or fumes, would be ``given off'' by charcoal. The
charcoal does not ``give off'' ash, but rather becomes ash. In
addition, some consumers are aware that CO is deadly and would
therefore be motivated to comply with the label for that additional
reason. The addition of the word ``gas'' is not likely to be of further
benefit. Thus, no change in the label language in this regard is
needed.
Comment: Spanish and/or English. A commenter notes that the summary
data indicate that Hispanics are at higher risk than the general
population. The commenter states that this problem could be better
addressed if the label's text were in both English and Spanish.
Response: The Commission's staff previously recommended that if the
pictograms tested did not adequately communicate the safety message,
then the message should be presented in both English and Spanish. As
noted above, however, the Commission concludes that the pictogram does
adequately convey the message. Furthermore, according to the clinical
psychologist who administered the test--who regularly works with low-
income Hispanics--many in the target population are unable to read
either English or Spanish. [6, Tab E(2)] Therefore, a safety message in
Spanish instead of a pictogram would not reach
[[Page 19824]]
those Hispanics who do not read Spanish. Additionally, while the
largest single group of minority victims identified in the CPSC data is
Hispanic, others--most notably Asian immigrants who do not read English
or Spanish--would not be informed by a label in either language.
Accordingly, a pictogram appears to be the most effective measure
to address those who do not read English. The Commission does not
believe that a label that combines both English and Spanish warning
statements with a pictogram is warranted. For the reasons discussed
above, the Commission cannot conclude in this case that such a label
would be significantly more effective than one combining a pictogram
and a warning statement in English. Furthermore, including both
languages and a pictogram on the label would increase the size of the
label, with potential additional costs to the industry.
Comment: Children of illiterate immigrants. A commenter suggested
that the Commission overlooked the fact that children of persons
illiterate in English play an important role in the family because the
children can read English and often act as the family's interpreters.
Accordingly, the commenter concluded that the label should consist of a
pictogram and an English language warning that could be understood by
the 12 through 18 year old children of illiterate immigrants. The
commenter suggested an expanded version of the Commission's proposed
label. The commenter suggests the label should be ``comprehensible by a
child with a reading level corresponding to approximately the sixth
grade.''
Response: The Commission is not aware of any data showing that the
children of illiterate immigrants act as interpreters of the warning
label on packages of charcoal. Nevertheless, the revised label for
packages of charcoal, issued below, is written at the seventh grade
level, as is the commenter's suggested label. Thus, most if not all of
the teenagers referred to by the commenter would be able to read the
revised label.
The additional wording suggested by the commenter would not
necessarily increase safe behavior compared to the revised label.
Further, the additional wording could decrease the likelihood that the
label would be read by the user. Accordingly, the Commission is not
adopting this commenter's suggested wording change.
Comment: Other toxic products. A commenter believes that the
current labeling language is very clear; that labeling refers to
``toxic fumes.'' The commenter argues that because toxic fumes other
than carbon monoxide may be emitted from burning charcoal, the current
labeling should not be revised.
Response: Although charcoal produces combustion by-products other
than CO, CO production is the most significant hazard. A specific
reference to CO will better communicate the nature of that hazard,
since many people already are familiar with the lethal potential of CO.
Further, the safety message conveyed by the label addressing the CO
hazard may address the hazard of any other toxic fumes produced by
charcoal. Thus, the current labeling language is being revised to
address only the CO hazard.
Comment: ``Burning'' charcoal. A commenter suggests that the term
``burning charcoal'' implies that a flame must be present in order to
present the hazard. However, smoldering coals are equally dangerous.
The commenter suggests referring to ``lit or partially lit,'' instead
of ``burning,'' charcoal.
Response: Charcoal is a familiar product. Most people know that,
when charcoal is lit, flames are produced initially and that the flames
eventually subside, resulting in glowing charcoal. It is unlikely that
consumers would think that the phrase ``burning charcoal'' suggests
that charcoal is not burning unless it produces a flame. Accordingly,
replacing the word ``burning'' with the longer phrase ``lit or
partially lit'' is not warranted.
Comment: Burn time. A commenter stated that, although the proposed
warning is much more explicit than the previous warning, it still gives
no real indication about how long charcoal ``burns'' and gives off CO
after it no longer seems to be burning. Even with the proposed warning,
some people may still bring CO releasing charcoal into an enclosed area
thinking that it is no longer dangerous.
Response: Information available to the Commission indicates that
most users who are killed or injured by this CO hazard are
intentionally using charcoal indoors as a heat source and are unaware
of the danger. Thus, the revised warning label is intended to address
this primary scenario.
Further, it would be difficult to tell consumers how to determine
when the charcoal is completely extinguished. In addition, it is likely
that adding the sort of information suggested by this commenter would
dilute the label's ability to communicate the primary hazard.
Accordingly, the Commission is not adopting this suggestion.
Comment: First-aid instruction on label. A commenter suggested
that, as with other potentially fatal products, it would help save
lives if the warning label also described what to do in the case of CO
poisoning.
Response: The labeling requirements for charcoal under 16 CFR
1500.14(b)(6) specifically state that they supplement the labeling
required for hazardous household substances by section 2(p)(1) of the
FHSA. Section 2(p)(1) requires that the label bear an instruction for
first-aid treatment when ``necessary or appropriate.''
First-aid instructions in labels for packages of charcoal would be
useful only after the users have disregarded or failed to read the
label's warning to not burn charcoal inside. Before a label's first-aid
instruction would be useful under these circumstances, a person would
have to suspect that the symptoms being experienced or observed are
caused by fumes given off by the burning charcoal. The incident data
available to the Commission do not show that consumers realize the
cause of the symptoms being experienced. Thus, the Commission lacks
data at this time from which to conclude that it is necessary or
appropriate to require first-aid instructions for CO poisoning on
packages of charcoal.
Issue: Conspicuousness of Label
Comment: Contrasting colors. A commenter urges the CPSC to set more
concrete requirements for the conspicuousness and legibility of the
warning label. The commenter suggests dark lettering on a white
background with the word ``WARNING'' and the pictogram ``X'' in red.
Response: The Commission agrees that it is important that the
revised label be conspicuous and legible. Accordingly, the Commission
has adopted a number of requirements to achieve these goals. More than
two colors are not necessary to achieve conspicuousness. To enhance the
conspicuousness of the label, the revised label contains: contrasting
colors as specified in 16 CFR 1500.121(d)(1), a pictogram, and an
easily read type size. Other enhancements, including a concise safety
message, make the safety messages easily understood.
Requiring the use of red, white, and a dark color in the label
would, in some cases, require either the redesign of the bag's graphics
or machinery that can print a higher number of colors. As discussed
below in Section G of this notice, the purchase of such additional
equipment could increase the initial, one-time expenses of the rule by
more than 5 times. It also could introduce ongoing expenses that will
not be caused by the rule as adopted. The
[[Page 19825]]
Commission cannot conclude that any increase in effectiveness that
might occur as the result of using these additional colors would
warrant the substantial additional cost of such a rule. Accordingly,
the Commission has not adopted this suggestion.
Issue: Placement of Label
Comment: Margin to seam. A commenter argued that allowing only 1
inch between the top of the warning and the seam of the bag is not
enough. The commenter noted that many people open the bag by tearing
under the seam. This practice could result in tearing through the
warning and rendering it unreadable to the next user of the charcoal
left in the bag. The commenter also stated that because people roll the
top part of the bag down to keep it closed after removing some of the
charcoal, a third warning should be required toward the bottom of the
bag. The commenter argued that, with the present proposal, only the
person who first opens a bag of charcoal has a good chance of seeing
the warning.
Response: The Commission agrees that the revised label could be
obliterated by ripping the bag. However, many bags are constructed so
the top seam can be neatly opened. In any event, the consumer is likely
to see the label before opening the bag. As to the lack of visibility
due to rolling the top of the bag for storage, the label would become
visible again when the bag is unrolled for use. There are no data
showing that the increased costs of placing the warning labels lower on
the bag, or adding another warning label, to address these concerns
would be justified.
Comment: Location of label's borderline. A commenter requested
clarification in the final rule that it is the label's heavy borderline
that should be at least 1 inch ``below the seam and at least 1 inch
above any reading material * * *.'' Otherwise, the commenter expressed
the concern that the rule could be interpreted as applying the 1-inch
clearances to the lettering within the borderline.
Response: The Commission concludes this comment has merit, and the
final rule has been clarified in this regard.
Issue: Typography
Comment: Boldface type and capital letters. A commenter stated that
if boldface type is intended for any part of the label, it should be
clearly specified in the final rule. Also capital letters should be
specified for the statement of hazard, if that is the intent.
Response: The Commission agrees, and this has been clearly
specified in the final rule.
Issue: Effectiveness of Labeling
Comment: Effectiveness of old label. A commenter asked whether the
incidents involving charcoal were occurring as a result of the existing
warning on the label or in spite of the warning? If the latter is true,
the commenter recommends that the Commission consider other
alternatives to address these incidents.
Response: The available information is insufficient to show how the
current label affects users. However, the label currently required is
dangerously misleading since it may imply to the user that it is safe
to burn charcoal indoors. The label needs to be modified to correct
this flaw. Further, for the reasons stated above, the label should be
modified to better address the hazard. Thus, in either of the
situations described by the commenter, it is appropriate to revise the
label.
Comment: Benefits (effectiveness) of new labels. A commenter
contends that the Commission should not impose significant changes in
the labeling requirements for packages of charcoal unless data exist in
the record showing that persons who would burn charcoal indoors with
the current label would not do so with the revised label. Another
company was concerned about the most likely potential benefit to
society instead of the maximum potential benefit, which was estimated
at $134 million.
Response: The Commission is unable to obtain data sufficient to
quantify the effectiveness of the new warning label. However, as
described above, there are several problems with the current label.
The new warning label addresses the deficiencies of the current
label. The revised label eliminates the potentially misleading
statement that implies that consumers can safely burn charcoal indoors
if ventilation is provided. In addition, the label's arrangement and
wording more closely follow principles established by labeling experts
that are intended to make labels more effective. Finally, the new label
incorporates a pictogram, which is likely to make the label more
effective for the at-risk populations that do not read English.
Therefore, the revised label will inform people about the risks of
burning charcoal indoors better than the present label.
The new label need not be very much more effective than the current
label in order to justify its costs.4 The estimated one-time cost
to industry of revising the label is $1 million. If this is viewed as
an investment that will save a life in the future, the benefits of the
rule would exceed its costs if the label revisions avert only one death
within 32 years of the change. (This assumes a value of $5 million for
saving a statistical life and a 5% discount rate. A 10% discount rate
would produce positive net benefits if the death was averted during the
next 16 years.)
---------------------------------------------------------------------------
\4\ The Commission is always interested in ensuring that the
costs of its rules are reasonable in relation to their expected
benefits. For the reasons given below, the Commission believes that
is the case here. However, in this type of proceeding, there is no
statutory requirement that costs and benefits must be determined or
balanced.
---------------------------------------------------------------------------
Making some assumptions may help to visualize the extremely low
degree to which the revised label would need to be effective in
preventing deaths to be cost-effective. One assumption is that the
average estimated number of deaths per year for the 7-year period 1986-
1992 would continue if the label is not changed. Under this assumption
(and with the 5% discount rate, $5 million per life scenario described
above), the label's revision would be cost-effective if it were only
about \1/10\ of one percent effective in reducing deaths.
Issue: Loss of Sales
Comment: Loss of sales. One commenter is more concerned about the
potential for the rule to induce a loss in sales of charcoal than about
any increase in printing costs. Another commenter also is concerned
about a loss of sales, believing that a label change is not justified
by the record.
Response: Seventy-four percent of the pictogram test subjects
understood that the pictogram indicates that they should not burn
charcoal in homes, tents, and vehicles. However, none of the subjects
thought that the pictogram meant that charcoal should not be burned or
should not be used for grilling. This indicates that there should be no
measurable negative impact on sales of charcoal.
Issue: Effective Date
Comment: Length of delay. One company recommends that the effective
date of the final rule be 12 to 18 months after its publication, as
proposed, assuming the final rule is published in January or February
of 1996. Another company requests at least a 30-month effective date
because the company holds up to a 3-year supply of preprinted bags.
According to this commenter, any effective date less than 30 months
should apply only to bags printed, rather than filled, on or after
[[Page 19826]]
the effective date. One commenter recommends that the new rule should
go into effect no later than 12 months from October 1995 so that, by
next winter, charcoal bags will have the new warning label.
Response: An effective date of October 1996, requested by one
commenter, will not allow sufficient time to change over to the new
label. On the other hand, the final rule was not published by February
1996, as assumed by the first commenter, a charcoal manufacturer. The
staff contacted this commenter, who stated that an 18-month effective
date would not be a problem if the rule was published by June 1996.
With publication of the rule in April 1996, and an 18-month effective
date, 26 months from the proposal in August 1995 will have elapsed when
the rule goes into effect. By then, many firms are likely to have
eliminated or substantially reduced their inventories of preprinted
bags in anticipation of these new requirements. This should minimize
bag inventory loss by any company, including the commenter who
requested a 30-month effective date. The Commission is choosing an 18-
month effective date, which will provide sufficient time to deplete
most existing noncomplying inventory. This will eliminate or mitigate
adverse economic consequences from inventory loss.
Issue: Size of Label for Small Packages
Comment: Smaller labels. A commenter stated that its smallest
package of charcoal (2.5 lb., 6 inches wide) should be subject to
different minimum label-size requirements (1\1/2\ inches high and 5\1/
2\ inches wide). The commenter indicated that a label that is a minimum
of 1\1/2\ inches high and 5\1/2\ inches wide is needed on this package
to keep the label from running over the sides of the package and
detracting from its appearance. The commenter recommended that this
could be accomplished by moving the signal word panel over the message
panel, and by slightly decreasing the size of the lettering, the
spacing between the safety messages, and the size of the pictogram.
Response: The Commission agrees that the final rule should allow a
label of the size requested on the smallest-size package of charcoal.
The Commission believes this will not unduly compromise the label's
conspicuousness or legibility, and will allow the consumer to see the
entire label on these small bags. However, the proposed configuration
of the label should be maintained by simply making the label smaller.
Using labels of more than one configuration could cause confusion for
consumers. Accordingly, the final rule should allow the smallest
package of charcoal to have a label that is a minimum of 1\1/2\ inches
high and 5\1/2\ inches wide.
Issue: Scope of the Requirement
Comment: Coverage of charcoal for restaurants and other commercial
establishments. A comment suggests that packages supplied to
restaurants and other commercial establishments should not be excluded
from the labeling requirement. The commenter argues that this would put
workers and patrons at risk.
Response: The terms of the rule itself do not limit the locations
to which it will apply. The Commission intends that all packages of
charcoal that are sold at retail and can be regulated under the FHSA
will be subject to the revised requirements. However, the FHSA does not
grant jurisdiction for the Commission to regulate products used only in
commercial establishments.
Under the FHSA, the Commission can, except for toys, regulate only
hazardous substances that are ``intended, or packaged in a form
suitable, for use in the household.'' FHSA Sec. 2(p), 15 U.S.C.
1261(p). Thus, the only packages of charcoal that would not be subject
to the revised labeling requirement are those that are not sold at
retail or are, e.g., in packages that are so large they are not
intended or suitable for use in the household. If it is impractical for
charcoal manufacturers to provide different packages for home and
commercial use, the rule will have the effect of ensuring that packages
of charcoal used in restaurants and other commercial establishments
will have the revised labeling. To the extent that separate packages
are produced, the Commission lacks the authority to take actions solely
to protect workers in commercial establishments or to take actions to
protect consumers from risks that could be adequately reduced by
actions taken under the Occupational Safety and Health Act of 1970. 15
U.S.C. 2080(a). However, the Commission is not aware of any incident of
CO poisoning from charcoal used in a restaurant or similar
establishment.
Comment: Lump charcoal. A commenter stated that perhaps ``lump''
charcoal should not be subject to the labeling requirement. The
commenter speculated that the non-charcoal ingredients in briquet-type
charcoal may contribute to the hazard in the reported cases. The
commenter also speculates that the victims from less developed
countries may be familiar with the safe use of lump charcoal and that
the incidents could be the result of the misleading current labeling
regarding ventilation.
Response: Although there are some differences between lump charcoal
and charcoal briquets, they both present a serious CO hazard if
misused. The CPSC staff performed an experiment comparing the emissions
levels of CO production from both lump and briquet charcoal. The
experiment showed that similar masses of lump and briquet charcoal
produced similar amounts of CO. Although lump charcoal produced about
half of the amount of CO as did an equal volume of charcoal briquets,
the level of CO production from lump charcoal was still well above that
which could produce dangerous concentrations. Thus, there is no basis
for excluding lump charcoal from the scope of the amended rule.
Comment: Other carbon-producing products. A commenter stated that
the rule should apply to ``[a]ny carbon based or carbon producing
product whose end use is combustion and is intended for household use *
* * includ[ing] wood chips, wood chunks, wood logs, coals, products
produced from biomass, etc.'' The commenter argued that these products
also produce CO.
Response: The other products cited by this commenter have not been
shown to be used in confined areas. Such use is needed to create the
hazard addressed by the revised label. These other products produce
enough smoke that it is not feasible to use them in homes, vehicles,
tents, or any confined area. Thus, there is no basis for expanding the
scope of the rule to include these products.
F. Effective Date
The rule applies only to filled containers of charcoal. Marketers
of charcoal, however, have indicated that it is not unusual to have an
inventory of printed bags that would take 1 or 2 years to use up. One
commenter indicated that it has up to 3 years or more of a supply of
preprinted bags in storage. These marketers would prefer that the
revised requirement relate to the date the bag or other container was
printed, so that all existing inventories could be used. However, it
would be impractical for the Commission to determine whether a bag was
printed before the effective date when the bag might not be filled for
some time after that date. Accordingly, the Commission has decided that
the rule will apply to all containers of subject charcoal that are
filled on or after the effective date.
In order to address the marketers' concern about inventories,
however, the
[[Page 19827]]
revised rule will not become effective until sufficient time has passed
for the industry to use up most of its current inventory of printed
bags. The Commission estimates that this will have occurred by 18
months after the final rule is issued, or November 3, 1997. This also
will provide time to revise the plates needed to print the new label,
revise any other plates that may be affected on the bag, conduct
consumer acceptance tests if needed, print new bags, and incorporate
the new bags into production. [15, Tab E] Of course, as the Commission
stated at the time it proposed the revised label, manufacturers who
order additional printing of bags between now and the effective date of
the rule should limit the quantities ordered so that large numbers of
bags will not remain unfilled at the effective date and have to be
discarded or stickered with the new label.
Some manufacturers may wish to voluntarily use the revised label
before the effective date of the final rule. For such firms, the
Commission will, until further notice published in the Federal
Register, consider labels complying with the final rule as complying
with the current requirements of 16 CFR 1500.14(b)(6). (The Commission
previously allowed use of the proposed label before the effective date.
Specific authority for such use is not needed at this time, because
labels that comply with the proposed rule will also comply with the
final rule.)
G. Economic and Product Information [6, Tab G; 15, Tab E]
Charcoal is a solid carbon material made from wood subjected to
extremely high temperature. It is available in lump, briquet, and
powdered forms. To produce charcoal briquets, charcoal is ground, mixed
with other ingredients, and compressed. Lump and briquet charcoal is
used as a fuel in cooking and in specialized scientific, industrial,
and horticultural applications. Recreational cooking consumes
approximately 80-90% of charcoal production. Specialized uses account
for the remainder.
It is estimated that approximately 824,000 tons of charcoal
briquets were sold in 1995. Charcoal briquet sales doubled between 1967
and 1977, were relatively flat during the 1980's, and have risen since
1991. The rising popularity of gas grills may explain the flattening of
sales during the 1980's. Charcoal briquet sales account for
approximately 80-90% of the annual production of charcoal. Lump
charcoal sales are a very small percentage (less than 4%, according to
industry sources) of the annual production of charcoal. Imports
comprise less than 1% of the domestic sales of charcoal.
Supermarkets and hardware, discount, drug, and garden supply stores
sell charcoal to consumers in a variety of types and packages. Three
major types of charcoal briquets are available. One is the standard
briquet. Another is the ``instant-light'' briquet, which is impregnated
with a flammable substance. The third is a ``flavor additive'' briquet
which is produced with an aromatic wood such as hickory or mesquite.
Standard briquets generally are sold in multi-walled (multi-layered) 5,
10, 20, and 40-pound paper bags. The instant-light briquets are
available in similar 2\1/2\, 4, 5, 8, and 15-pound bags. Briquets are
also available in single-use, wax impregnated, ``light-the-bag''
packages. Lump charcoal, which is pure charcoal, is marketed as a
natural product and is available in packaging similar to briquets.
Charcoal also may be sold in other sizes of bags or in corrugated
boxes, depending upon marketing considerations. Based on an informal
study of the market in and around Washington, D.C., the retail price of
charcoal ranges from approximately $.25 to $.75 per pound, depending on
package size, although the retail price of some specialty charcoals may
be higher.
Approximately 10 companies manufacture lump and briquet charcoal in
the United States. Several companies import charcoal. According to
industry representatives, the top five domestic charcoal manufacturers
control an estimated 90-95% of the market, with the leading company
controlling approximately 50%. Manufacturers provide lump charcoal and
charcoal briquets under an estimated 250 different brand names, most of
which are private or ``store'' brands. Relatively few are nationally or
regionally marketed brands.
According to the Barbecue Industry Association (``BIA''), 71
million households owned barbecue grills in 1993. [5] In addition, the
BIA estimates that 58% of grill owners (41 million households) own a
charcoal grill. The peak season for cooking on a grill is from the
start of Daylight Savings Time through Labor Day. However, 52% of
grills are used throughout the year. The number of ``barbecuing
events'' each year (including gas and charcoal fuels) more than doubled
over a 10-year period, with an estimated 2.6 billion occurrences in
1993.
According to a BIA-sponsored National Family Opinion survey
conducted in the summer of 1993, gas grill owners indicated that they
use their grill about twice as often as charcoal grill owners. [5] This
ratio may not apply year round, since there may be a greater relative
use of gas grills in the winter. If it is assumed that this 2:1 ratio
applies year round, however, the number of barbecuing events attributed
to charcoal is approximately 870 million in 1993. This results in an
estimated exposure of 21 such events per year per household owning a
charcoal grill.
It is estimated that approximately 824,000 tons of charcoal
briquets were sold in the U.S. in 1995. [15, Tab E] This amounts to
about 1.6 billion pounds of briquets, or 160 million bags with an
average weight of 10 pounds. In 1993, there were an estimated 870
million charcoal barbecuing events. Dividing the approximately 809,000
tons of charcoal briquets sold that year by the number of events, the
average amount of charcoal used was about 1.9 pounds per event. If each
household that owns a charcoal grill barbecues 21 times a year, each
such household uses 40 pounds of charcoal briquets per year, or the
equivalent of four 10-lb bags.
As noted above, there are approximately 28 deaths and 300 CO-
related emergency room-treated injuries associated with the use of
charcoal each year. Id. Thus, there was approximately one death for
every 1.5 million households owning charcoal grills (or 0.68 deaths per
million such households). Also, there was one CO injury for every
136,667 households owning charcoal grills (or 7.3 injuries per million
such households). Additionally, the estimated 160 million bags of
charcoal briquets sold in 1995 were associated with approximately one
death for every 5.7 million charcoal briquet bags (0.18 deaths per
million bags). Further, there was one CO injury for about every 0.5
million bags (1.9 injuries per million bags).
The Commission estimates that changing the labeling requirements
for packages of charcoal has the potential for substantial benefits to
society. Based on the CPSC's injury cost model, the average annual
societal cost of an injury from charcoal-related CO poisoning is
approximately $10,000. The annual societal cost of these injuries is
approximately $3 million, given the estimated 300 such injuries per
year.
Additionally, there are an estimated 28 deaths per year from
charcoal-related CO poisonings. Assuming a statistical value of life of
$5 million, these injuries and deaths cost society about $143 million
annually. The avoidance of these injuries and deaths represents the
maximum potential benefits to society of the new labeling requirements.
[[Page 19828]]
If the Commission had mandated the ``optimum'' warning label
described above, which includes additional color requirements, the
costs to industry of changing labels would have included both one-time,
start-up expenses and continuous, ongoing expenses. Start-up expenses
include the cost of new printing equipment, printing plates, artwork,
and negatives. Ongoing expenses would relate to any additional colors
used in the warning label.
Industry representatives indicated that the aggregate start-up
expenses for the ``optimum'' label could have amounted to as much as $6
million. Further, the ongoing costs for the added colors that label
would have required could have been around $4 million per year.
However, the Commission eased the current requirements for the
label placement on bags of charcoal, and did not mandate additional
colors. This will allow continued use of current printing equipment.
Therefore, the costs of the revision that is being adopted are
estimated to be no more than $1 million in start-up expenses, with no
ongoing expenses.
Besides the costs of making changes to charcoal bags, loss of bag
stocks would be incurred if the effective date does not allow for a
substantial reduction in old inventory of unfilled bags. As discussed
above, the effective date of the revised labeling rule will be 18
months after publication of the final rule. This should allow almost
all firms to use up existing inventories of printed bags. As the
Commission stated in the proposal, ``manufacturers who order additional
printing of bags between now and the effective date of the rule should
limit the quantities ordered so that large numbers of bags will not
have to be discarded or stickered with the new label.'' 60 FR at 40790.
Packagers who followed that advice will in effect have had 26 months to
deplete their inventories of preprinted bags.
Only one industry member has indicated that it has more than 2
years inventory. If any preprinted bags remain unfilled at the
effective date, the costs of not using these bags and of discarding
them are not expected to be significant.
No estimates are available of the effectiveness of the revised
label in reducing charcoal-related CO injuries and deaths. However, if
the one-time cost to industry of revising the label ($1 million) is
viewed as an ``investment'' for saving a life in the future, the
benefits of the rule would exceed its costs if the label revisions
avert one death within 32 years of the change. (This assumes a value of
$5 million for saving a statistical life and a 5% discount rate. A 10%
discount rate would produce positive net benefits if the death was
averted during the next 16 years.) Given the present death rate of 28
per year, it is reasonable to believe that such levels of effectiveness
will be achieved.
H. Regulatory Flexibility Act Certification
When an agency undertakes a rulemaking proceeding, the Regulatory
Flexibility Act, 5 U.S.C. 601 et seq., generally requires the agency to
prepare initial and final regulatory flexibility analyses describing
the impact of the rule on small businesses and other small entities.
The purpose of the Regulatory Flexibility Act, as stated in section
2(b) (5 U.S.C. 602 note), is to require agencies, consistent with their
objectives, to fit the requirements of regulations to the scale of the
businesses, organizations, and governmental jurisdictions subject to
the regulations. Section 605 of the Act provides that an agency is not
required to prepare a regulatory flexibility analysis if the head of an
agency certifies that the rule will not have a significant economic
impact on a substantial number of small entities.
The Commission's Directorate for Economic Analysis examined the
potential effects of the revised rule on small entities. [15, Tab E]
Businesses affected by label-change costs may include charcoal
manufacturers (approximately 10 firms), bag suppliers, and firms that
own a charcoal brand name (proprietary or private label brands).
Industry representatives predict that the bulk of the costs of
developing new labels will fall initially on the charcoal
manufacturers. As noted above, these costs may include those associated
with the development or purchase of new printing plates, artwork, and
negatives.
Several private label manufacturers have indicated that they will
be disproportionately affected by a label change. These firms package
charcoal under a large number of brand names, which may require
hundreds of plate changes. In the notice of proposed rulemaking, the
Commission proposed to ease the margin requirements of the current
regulation (i.e., allowing the label to be at least 1 inch, instead of
at least 2 inches, below the seam of the bag) and proposed continued
use of contrasting colors as opposed to use of ANSI colors, which were
originally considered. Easing of the margin requirements and use of
contrasting colors will substantially reduce the cost of the label
change. The costs may be further mitigated if the firms are able to
pass them through to their customers or if their plates are near the
end of their service life. Costs for small firms are not expected to be
significant, due to the relatively small number of brands handled by
such firms.
The rule should not require firms to buy new printing presses. Most
manufacturers will have enough time to use up existing supplies of
printed bags. Bags filled with charcoal before the effective date are
not subject to the revised requirements.
Accordingly, for the reasons given above, the Commission certifies
that the rule will not have significant economic effects on a
substantial number of small entities.
I. Environmental Considerations
Pursuant to the National Environmental Policy Act, and in
accordance with the Council on Environmental Quality regulations and
CPSC's procedures for environmental review, the Commission has assessed
the possible environmental effects associated with the rule to revise
the warning labels for packages of charcoal. [15, Tab E] Analysis of
the potential impact of this rule indicates that it will have no
significant effects on the environment since the effective date enables
almost all firms to deplete existing stocks of empty bags. (Some firms
have indicated that, depending on the time of the year, they may have
as much as a 2-year supply of filled and empty bags.) As previously
noted, bags filled before the effective date will not be affected by
the revised rule. Even if some old inventory of bags remains, as one
commenter contends, the environmental consequences are expected to be
insignificant.
Therefore, because the revised rule would have no significant
impact on the environment, neither an environmental assessment nor an
environmental impact statement is required.
J. Conclusion
For the reasons discussed above, the Commission concludes that the
labeling required by section 2(p)(1) of the FHSA for packages of
charcoal is not adequate for the protection of the public health and
safety, in view of the special hazard of CO poisoning presented by
using charcoal in a confined area. The Commission finds that the
additional label requirements in the revised label issued below are
necessary for the protection of the public health and safety. These
requirements are issued under the authority of section 3(b) of the
FHSA, 15 U.S.C. 1262(b).
Effective date: The final rule is effective November 3, 1997.
[[Page 19829]]
List of Subjects in 16 CFR Part 1500
Consumer protection, Hazardous materials, Hazardous substances,
Imports, Infants and children, Labeling, Law Enforcement, Toys.
For the reasons given above, the Commission amends 16 CFR part 1500
as follows:
PART 1500--HAZARDOUS SUBSTANCES AND ARTICLES; ADMINISTRATION AND
ENFORCEMENT REGULATIONS
1. The authority citation for part 1500 is revised to read as
follows:
Authority: 15 U.S.C. 1261-1278.
2. Section 1500.14 is amended by redesignating paragraphs (b)(6)
(i) and (ii) as paragraphs (b)(6)(i) (A) and (B).
3. In Sec. 1500.14, newly designated paragraph (b)(6)(i)(A) is
amended by Nonvember 3, 1997 after ``products''.
4. Section 1500.14 is further amended in newly designated paragraph
(b)(6)(i)(B), by adding ``packaged before November 3, 1997 after
``charcoal''.
5. Section 1500.14 is further amended by adding a new paragraph
(b)(6)(ii) to read as follows:
Sec. 1500.14 Products requiring special labeling under section 3(b) of
the act.
* * * * *
(b) * * *
(6) * * *
(i) * * *
(ii)(A) Because inhalation of the carbon monoxide produced by
burning charcoal indoors or in confined areas can cause serious injury
or death, containers of such products packaged on or after [insert date
that is 18 months after publication] shall bear the following
borderlined label.
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[GRAPHIC] [TIFF OMITTED] TR03MY96.051
BILLING CODE 6355-01-C
(B) Except as provided in paragraph (b)(6)(ii)(C) of this section,
the following requirements apply to bags of charcoal subject to
paragraph (b)(6)(ii)(A) of this section. The label specified in
paragraph (b)(6)(ii)(A) of this section shall appear within a heavy
borderline, in a color sharply contrasting to that of the background,
on both the front and back panels in the upper 25 percent of the panels
of the bag, and with the outer edge of the borderline at least 2.54 cm
(1 inch) below the seam and at least 2.54 cm (1 inch) above any other
reading material or design elements. The signal word ``WARNING'' shall
be in bold capital letters in at least 7.14 mm (\9/32\ inch) type. The
remaining text of the warning statement shall be in at least 4.763 mm
(\3/16\ inch) type. The phrase ``CARBON MONOXIDE HAZARD'' shall be in
bold. This phrase and the word ``NEVER'' shall be in all capital
letters. The lettering shall have a strokewidth-to-height ratio of 1:6
to 1:8. The label shall be at least 50.8 mm (2 inches) high and 147.5
mm (5\3/16\ inches) wide. The label's lettering, spacing between the
bottom of the letters of one line and the top of the letter of the next
line, and pictogram shall have the size relation to each other and to
the remainder of the label shown in paragraph (b)(6)(ii)(A) of this
section.
(C) For bags of charcoal subject to paragraph (b)(6)(ii)(A) of this
section that are 6 inches or less wide, the minimum label height may be
reduced to 38 mm (1.5 inches) and the minimum width may be reduced to
139.7 mm (5.5 inches). The signal word ``WARNING'' shall be in capital
letters in at least 6.32 mm (0.249 inch) type. The remaining text of
the warning shall be in at least 4.23 mm (0.166 inch) type. All other
requirements of paragraphs 6(b)(ii) (A) and (B) of this section shall
apply to these bags.
Dated: April 29, 1996.
Sadye E. Dunn,
Secretary, Consumer Product Safety Commission.
Appendix 1--List of Relevant Documents
(Note: This list of relevant documents will not be printed in the
Code of Federal Regulations.)
1. Petition HP 91-1 from Barbara Mauk.
2. Letter to Barbara Mauk from Sadye E. Dunn, CPSC, January 28,
1993.
3. Hampson, N.B. et al., JAMA (January 5, 1994).
4. Cost information from industry.
a. The Clorox Company (Kingsford), P.O. Box 493, Pleasanton, CA
94566.
b. King and Spalding, representing Royal Oak Enterprises, Inc.,
1730 Pennsylvania Ave. N.W., Washington, D.C. 20006.
c. Hickory Specialties, Inc., P.O. Box 1669, Brentwood, TN
37024.
5. Barbecue Industry Association survey. Barbecue Industry
Association, 710 East Ogden, Suite 113, Naperville, IL 60563.
6. Briefing package dated July 6, 1995, with Tabs A-H.
TAB A--Background Information on Charcoal Labeling in Briefing
Package memo dated May 18, 1994, accompanied by FDA's Notices of
Proposed and Final Rulemaking dated September 2, 1970, and August
11, 1971, and Petition for Amending Labeling Requirements for
Charcoal Intended for Household Use, dated October 12, 1990.
TAB B--Memorandum from Laureen E. Burton of Directorate for Health
Sciences to Sharon R. White, entitled ``Carbon Monoxide Toxicity
Review for the Charcoal Labeling Project,'' dated March 8, 1994.
TAB C--Memorandum from Leonard Schachter, Directorate for
Epidemiology, Division of Hazard Analysis to Sharon R. White,
entitled ``Charcoal Labeling Project,'' dated December 12, 1994.
TAB D--Memorandum from Charles M. Jacobson, Office of Compliance and
Enforcement to Susan E. Womble, entitled ``Compliance Experience
with Current FHSA Labeling Requirements for Charcoal Briquets,''
dated April 30, 1992.
TAB E--1. Memorandum from Sharon R. White of Directorate for
Epidemiology,
[[Page 19830]]
Division of Human Factors, to The File entitled, ``Proposed
Revisions to Labeling Requirements for Packages of Charcoal'' dated
June 15, 1995.
2. Memorandum from George Sweet of Directorate for Epidemiology,
Division of Human Factors to Sharon R. White entitled, ``Pictogram
Testing for Warning Labels on Charcoal Bags,'' dated June 12, 1995.
TAB F--Logs of Industry Meetings on (1) April 22, 1994, and (2)
April 13, 1995.
TAB G--Memorandum from Mary F. Donaldson of Directorate of Economic
Analysis to Sharon R. White, entitled ``Economic Analysis of a
Revision to Charcoal Labeling,'' dated June 22, 1995.
TAB H--Draft Federal Register Notice--Notice of Proposed Rulemaking.
7. Letter from James C. Stephen, President, Weber-Stephen
Products Co., to Sharon R. White, CPSC, May 11, 1995.
8. Letter from Harleigh Ewell, CPSC, to James C. Stephen,
President, Weber-Stephen Products Co., June 29, 1994.
9. Woodson, W.; Tillman, B.; and Tillman, P., 1992.
10. ANSI Z535.3-1991, American National Standard, Criteria for
Safety Symbols.
11. Perry, E., and Neily, M. (1985). Burning Charcoal Briquettes
in a Fireplace. U.S. Consumer Product Safety Commission, Washington,
DC.
12. Letter from Leonard S. Gryn, Executive Vice President,
Weber-Stephen Products Co., to Harleigh Ewell, CPSC, July 5, 1995.
13. Notice of Proposed Rulemaking, 60 FR 40785 (August 10,
1995).
14. Comments on proposed rule, Nos. CH96-1-1 through CH96-1-7.
15. Briefing package, consisting of a briefing memorandum from
Sharon White, Project Manager, to the Commission, March ____, 1996,
and Tabs B and D-E:
TAB B--Memorandum from Leonard Schachter, CPSC Directorate for
Epidemiology and Health Sciences, to Sharon R. White, entitled
``Deaths and Injuries Associated with Charcoal,'' dated November 28,
1995.
TAB C--1. Memorandum from Sharon R. White, CPSC Directorate for
Engineering Sciences, to File, entitled ``Responses to Comments on
the Proposed Rule on the Labeling Requirements for Packages of
Charcoal,'' dated February 28, 1996.
2. Memorandum from Mary F. Donaldson, CPSC Directorate for Economic
Analysis, to Sharon R. White, entitled ``Response to Comments,
Proposed Rule Amending Labeling on Packages of Charcoal,'' dated
February 28, 1996.
3. Memorandum from Rikki Khanna, CPSC Directorate for Engineering
Sciences, to Sharon R. White, entitled ``Responses to Comment on
Proposed Rule for Labeling of Retail Containers of Charcoal (REF:
CH96-1-3),'' dated February 9, 1996.
4. Memorandum from Mary F. Toro of the Office of Compliance,
Division of Regulatory Management, entitled Charcoal Labeling
Package--Comments on the NPR dated December 13, 1995.
5. Memorandum from Kimberly Long of Directorate for Epidemiology and
Health Sciences to Sharon R. White, entitled ``Comments to Proposed
Rule Amending Package Labeling of Charcoal, FR., Vol. 60, No. 154,
August 10, 1995, pp. 40785,'' dated December 6, 1995.
TAB E--Memorandum from Mary F. Donaldson, CPSC Directorate for
Economic Analysis, to Sharon R. White, entitled ``Economic Analysis
of a Revision to Charcoal Labeling,'' dated December 8, 1995.
16. Memorandum from Mary Ann Danello, Ph.D,. Associate Executive
Director for Epidemiology and Health Sciences, ``Corrected Response
to Comments for Proposed Rule Amending Package Labeling of Charcoal,
FR, Vol. 60, No. 154, August 10, 1995, pp. 4078ff,'' dated April 3,
1996.
[FR Doc. 96-10978 Filed 5-02-96; 8:45 am]
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