[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.<SUP>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] <SUP>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.<SUP>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.<SUP>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]
BILLING CODE 6355-01-P