Requirements for Labeling of Retail Containers of Charcoal

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

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(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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