Requirements for Labeling of Retail Containers of Charcoal; Proposed Amendments

CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1500

Requirements for Labeling of Retail Containers of Charcoal;

Proposed Amendments

AGENCY: Consumer Product Safety Commission.

ACTION: Proposed rule.\1\

\1\ The Commission voted 2-1 to propose this rule. Chairman Ann

Brown and Commissioner Thomas H. Moore voted for the proposal;

Commissioner Mary Sheila Gall voted against the proposal. Separate

statements by each commissioner are available from the Office of the

Secretary.

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SUMMARY: Under the Federal Hazardous Substances Act, the Commission is

proposing a rule to change the required labeling for retail containers

of charcoal intended for cooking or heating. The labeling addresses the

carbon monoxide hazard associated with burning charcoal in confined

spaces. The proposed amendments, which include a pictogram, are

intended to make the label more noticeable and more easily read and

understood and to increase the label's ability to motivate consumers to

avoid burning charcoal in homes, tents, or vehicles.

DATES: Comments on the proposal should be submitted no later than

October 24, 1995.

ADDRESSES: Comments should be mailed to the Office of the Secretary,

Consumer Product Safety Commission, Washington, D.C. 20207, or

delivered to the Office of the Secretary, Consumer Product Safety

Commission, room 502, 4330 East-West Highway, Bethesda, Maryland 20814-

4408, telephone (301) 504-0800.

FOR FURTHER INFORMATION CONTACT: Sharon White, Project Manager,

Division of Human Factors, Directorate for Engineering Sciences,

Consumer Product Safety Commission, Washington, D.C. 20207; telephone

(301) 504-0468 ext. 1286.

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 1970, the FDA proposed a rule under sections 3(a) and 3(b) of

the FHSA to require a statement on packages of charcoal intended for

household use that would warn of the potentially deadly hazard of

carbon monoxide (``CO'') poisoning from breathing the combustion

products of charcoal when used in a confined area. 35 FR 13887

(September 2, 1970). In 1971, FDA issued a final rule that is currently

codified in 16 CFR 1500.14(b)(6). That section requires the following

borderlined label on containers of charcoal for retail sale and

intended for cooking or heating:

BILLING CODE 6355-01-P

[[Page 40786]]

[GRAPHIC][TIFF OMITTED]TP10AU95.112

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). The symptoms of CO poisoning range from

nausea to death. Each individual's reaction to CO exposure varies,

depending on several factors including age, health status, or smoking

habits. Due to the nonspecific nature of the symptoms that can be

associated with CO poisoning (e.g., fatigue, lethargy, dizziness, or

diarrhea), 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.

\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

cited an incident that occurred when she and her son were camping 1

year previously. After grilling food outside her camper and before

retiring for the night, she brought the grill inside the camper. She

assumed that the charcoal was extinguished, even though the grill was

still warm. Two days after the incident, she and her son were found.

Her son died from CO poisoning, and she was hospitalized and treated

for CO poisoning. Ms. Mauk stated that she knew that CO has no odor and

can be lethal, but she did not know that charcoal can produce CO. She

stated that had she known this, she would have taken the precaution of

making sure the coals were out or left the grill outside. 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 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 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.

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 industry to present staff's

recommendations for revising the warning label on packages of charcoal.

Industry indicated a willingness to revise the warning label, but

raised a number of concerns. [6, Tab F] These concerns were considered

in 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

proposed label 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 again to present the

results of the pictogram tests and staff's current 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 additional comments received at the April 1995

meeting, the staff recommended a label to the Commission. The staff

also described possible variations of that label for the Commission's

consideration. The label the Commission decided to propose, and the

reasons the various features of the label were chosen, are described in

section D of this notice.

B. CO Poisoning Incidents

The Commission's Division of Hazard Analysis examined available

data concerning CO poisoning incidents. [6, Tab C] That Division

estimates that there was an average of about 26 non-fire CO-related

deaths per year associated with charcoal grills and hibachis from 1986

to 1991.3 (The annual estimate of non-fire CO deaths fluctuates,

with no discernible pattern.) Data from the CPSC's National Electronic

Injury Surveillance System (``NEISS'') indicate that there was an

average of about 400 emergency-room-treated injuries involving charcoal

grills and hibachis annually from 1980 to 1993.

\3\ As noted above, CO is produced as a product of incomplete

combustion. The term ``non-fire'' means that the CO was not produced

as the result of a conflagration or other unintended open flame.

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Hazard Analysis staff reviewed 103 incident reports involving CO

deaths and injuries associated with charcoal for the years 1986 to

1994. There were 164 victims reported in the incidents: 111 died and 53

recovered. Most of the victims were males who were exposed to CO while

sleeping. Eighty-seven of the 164 victims were members of ethnic

minorities, and slightly more than half of these were reported to be

Hispanic. The data provide some indication that many of the Hispanic

victims, particularly those who were foreign-born, were of a low

socioeconomic status. The English language literacy for most of these

victims was not reported. However, three reports indicated that a

Spanish translator was present during the investigation. Information

about the victims' awareness of the potential for CO poisoning from

burning charcoal indoors was not available for most of the incidents.

More than half (65) of the incidents involved a charcoal barbecue

grill or hibachi. Information on the safety labeling on the packages of

the charcoal involved in most of these incidents 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 40787]]

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.

Half of the incidents occurred when the victims burned charcoal in

their homes or in areas being used for living purposes. There were 52

cases where it was reported that victims used charcoal to keep warm. In

nine incidents, there was an indication of an attempt to provide some

ventilation. Most of the incidents occurred during the fall and winter.

An article prepared 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. 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 contradicts 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 obtain 85% correct responses with a maximum of 5%

critical confusion. In this case, however, the staff believes that, for

the following reasons, it is appropriate to use the pictogram that

scored highest [6, Tab E(1)]:

1. Stringent criteria were used to select the subjects, which helps

to assure a rigorous test. Fifty subjects were tested (50% Hispanics

who did not read English and were at or below the poverty level, and

50% people who do read English and were below the median income). No

middle or upper income people were included in the test.

2. Had the pictogram been tested in context (i.e., on bags of

charcoal), the 85% level might have been attained.

3. The 74% correct responses for the pictogram chosen does not

differ greatly from the 85% ANSI criterion. Furthermore, the tested

pictogram had no critical confusion in the responses, while ANSI allows

5%. This is significant because a person who believed that the

pictogram meant that it was appropriate to burn charcoal indoors could

be more likely to do so.

Staff previously recommended that if the pictograms did not

adequately communicate the safety message, the safety message should be

presented in both English and Spanish. As discussed above, the

Commission concludes that the pictogram does adequately convey the

message. However, according to the contractor who administered the

test, a clinical psychologist 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 necessarily reach those

Hispanics who do not read English.

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 Spanish.

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 adverse economic effects on the industry. See the

discussion of label size below in section E of this notice.

A charcoal grill manufacturer objected to some features in the

depiction of the grill in the pictograms that were tested. [7] The

manufacturer stated that the depiction of a grill with three legs and a

semi-ellipsoid shaped kettle, as in the tested pictogram, violated

registered trademarks of its brand of grill. The Commission's Human

Factors staff concluded that a pictogram that depicted a grill with

four legs and a shallower shape of the kettle would communicate the

idea of a charcoal grill at least as well as the tested version.

Accordingly, the proposed pictogram differs from the most successful

one tested in those regards. The fact that the Commission is proposing

these changes from the tested pictogram should not be interpreted as an

opinion on the validity of the relevant trademarks or as a waiver of

any right in the nature of ``fair use'' that the Government may have to

use a trademark without authorization.

During the development of the proposed label, the Commission's

staff discussed with industry whether the pictogram should appear above

or to the side of the warning statement. Industry noted that allowing

the pictogram to be beside the warning statement would reduce the

vertical height of the revised label. As discussed below, increasing

the minimum allowed height of the label can have an adverse economic

effect on producers of bags for charcoal. The Commission's staff also

concluded that placing the pictogram to the left of the warning

statement will make the label more appealing visually and thus more

effective. Accordingly, the Commission is proposing to require the

pictogram to be adjacent to, and to the left of, the warning statement.

D. The Warning Statement

The Commission proposes that the revised label should explicitly

state: ``CARBON MONOXIDE HAZARD--Burning charcoal indoors can kill you.

It gives off carbon monoxide, which has no odor. NEVER burn charcoal

inside homes, vehicles, or tents.'' The rationale for the revisions to

the label is discussed briefly below [6, Tab E(1)].

Statement of Hazard. To motivate consumers to comply with the

label, it is important that the label explicitly state the hazard,

i.e., that burning charcoal indoors can kill due to the production of

CO. Thus, the label states ``CARBON MONOXIDE HAZARD.''

An early draft of the label used the term ``CARBON MONOXIDE

POISONING.'' This was changed because industry claimed that the term

could be interpreted by some consumers as inaccurately warning that

charcoal cooking could poison food.

Statement of Consequences. The phrase ``cause death'' in the

current label should be replaced by the more personal phrase ``can kill

you.'' Research indicates that personalizing the warning will make it

difficult for users to conclude that the warning is not directed at

them and, therefore, that it is not important to comply with the

warning.

[[Page 40788]]

Statement of How to Avoid Hazard. The label should clearly state

the action to be taken or avoided. Thus, the label should be revised to

state ``NEVER burn charcoal inside homes, vehicles, or tents.'' The

current statement, ``Do Not Use for Indoor Heating or Cooking Unless

Ventilation Is Provided for Exhausting Fumes to Outside,'' may be

dangerously misleading. It may incorrectly convey to the user that it

is safe to burn charcoal indoors if some sort of ventilation is

provided. Even if charcoal is burned in areas where there is some

ventilation, CO may not be reduced to safe levels.

An industry member stated that advising users that they should

never burn charcoal indoors was unnecessary and too stringent. He cited

the example of restaurants, and some home owners, that cook indoors

with charcoal under a hood with ducting and a high-capacity exhaust fan

to expel the CO to the outside. He also expressed the fear that

changing the wording of the label would make users think there had been

some change in the product that made it more dangerous.

The Commission does not believe that persons who have gone to the

trouble and expense of installing a powered exhaust hood specifically

so they can cook indoors with charcoal are going to think the label

applies to them (except to the extent they should be sure the exhaust

system is operating properly). The Commission concludes that including

language on the label to indicate that charcoal can be burned indoors

if such an exhaust system is used would dilute the primary safety

message and confuse consumers who did not have such a system.

Marketers of charcoal may provide additional explanatory material

about the statement to never use charcoal in homes. And, the label

statement could even be asterisked or footnoted to draw attention to

such material. However, such explanatory material must not negate the

content of the warning for persons without such specialized equipment.

To do so would violate the prohibition against deceptive disclaimers at

16 CFR 1500.122. In addition, packages of charcoal that are supplied

only to restaurants and other commercial establishments are not

required to comply with the FHSA, and are not subject to the

requirements for either the current label or the proposed revised

label.

This industry member also stated that it was safe to burn charcoal

in a fireplace that has a chimney with an open flue. However, the

Commission has information indicating that burning charcoal in a

fireplace may not create a chimney draft sufficient to exhaust CO to

the outside. [11] Accordingly, based on the presently available

information, the Commission concludes that including a statement that

charcoal can be burned in fireplaces would constitute a prohibited

deceptive disclaimer. The Commission seeks comment on this issue,

including specific data on whether, and under what conditions, charcoal

can safely be burned in a fireplace.

Recommended Revised Label. For the reasons stated above, and

elsewhere in this notice, the Commission proposes that the label

currently required on packages of charcoal be revised to appear and

read as follows:

BILLING CODE 6355-01-P

[GRAPHIC][TIFF OMITTED]TP10AU95.113

BILLING CODE 6355-01-C

E. Other Features of the Label

Conspicuousness of the Safety Messages. 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. That

standard specifies that the signal word ``WARNING'' should be written

in black lettering surrounded by an orange background. The signal word

should also be placed at the top of the label and be preceded by the

hazard alert symbol.

Under the ANSI standard for safety labels, the label should also be

surrounded by a black borderline, which in turn should be surrounded by

a white border to make the label more distinct. The Human Factors staff

also recommended that the lettering of the warning statement be in

black on a white background, to maximize readability. In addition, they

recommended that the ``X'' on the pictogram be red, to achieve the

maximum visual impact and warning effect.

The charcoal-bag industry, however, 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 is proposing to not use the

[[Page 40789]]

colors specified by ANSI and described above. Thus, the proposed 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).

Processing Safety Messages. To make the label easier to read and

understand, the Commission proposes 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)]

Type Size. The Commission's Human Factors staff determined that in

order for the label's type to be legible and conspicuous, 18-point type

would be required. [6, Tab E(1)] Thus, the proposed revision specifies

18-point type (3/16 inches) as the minimum allowable type size for the

safety messages. The signal word shall be in at least 27-point type (9/

32 inches).

Label Size. When the minimum specified type sizes are laid out in

the configuration specified in the proposed revised label, the label is

2 inches high. Accordingly, this is the minimum allowable height of the

label, and this size is suitable for the smallest-size bags of charcoal

presently marketed (2.5 lb.).

An industry member raised the question of whether the label can or

should be proportionately larger for larger-size bags. The Commission

recommends that larger bags use larger labels to the extent feasible.

The Commission solicits comment on whether it should, in the final

rule, require that labels be proportionately larger for larger bags. If

the Commission requires proportionately larger labels, it could require

larger type sizes for specified ranges of the area of the front and

back panels of the package. Comment is solicited on the appropriate

parameters and on the potential economic effects of larger labels on

larger bags.

The proposed revised label is taller than the currently required

label. The current label is required to be at least 2 inches from the

top seam. In order to maintain this required distance, the bottom edge

of a taller 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 proposed label revision, without

providing any identifiable safety benefit. Therefore, the Commission is

proposing 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 proposes to retain the current requirements that the

label must be on both the front and back panels of the bag and in the

upper 25% of the panels.

F. Economic and Product Information [6, Tab G]

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 pressed into pillow shapes. 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 of charcoal consumption.

Nearly 800,000 tons of charcoal briquets were sold in 1992.

Charcoal briquet sales doubled between 1967 and 1977, were relatively

flat during the 1980's, and have shown a slight rise since 1991. The

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. 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 Washington, D.C. area market, the retail price of charcoal ranges

from approximately $.25 to $.75 per pound depending on package size,

although the retail price of some specialty charcoal 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 150 different brand names, most of

which are private or ``store'' brands. Relatively few are nationally or

regionally marketed brands.

An estimated 47.5 million households own charcoal grills. Based on

a survey conducted by the Barbecue Industry Association, the number of

``barbecuing events'' more than doubled over a 10-year period, with an

estimated 2.3 billion occurrences in 1991. [5] Based on ownership and

usage data obtained through this survey, an estimated 800 million of

these barbecuing events used charcoal. These data indicate that there

was an estimated average of 17 charcoal barbecuing events per year per

household that owned a charcoal grill. It is also estimated that, on

average, each of these households uses the equivalent of 3.4 10-pound

bags of charcoal per year.

There are approximately 26 deaths and 400 CO-related emergency

room-treated injuries associated with the use of charcoal each year.

Thus, there was approximately one death for every 1.8 million

households owning charcoal grills and one CO injury for every 118,750

households owning charcoal grills. Additionally, there were an

estimated 160 million bags of charcoal briquets sold in 1992. Thus,

there was approximately one death for every 6.2 million charcoal

briquet bags (0.16 deaths per million bags) and one CO injury for every

0.4 million bags (2.5 injuries per million bags).

The Commission estimates that changing the labeling requirements

for packages of charcoal has the potential

[[Page 40790]]

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 $4 million, given the estimated 400

such injuries per year. Additionally, there are an estimated 26 deaths

per year from charcoal-related CO poisonings. Assuming a statistical

value of life of $5 million, these injuries and deaths cost society

about $134 million annually. The avoidance of these injuries and deaths

represents the maximum potential benefits to society.

The costs to industry of revising the warning label include one-

time, start-up expenses and continuous, ongoing expenses. Start-up

expenses include the cost of new printing equipment and printing

plates, artwork, and negatives. Ongoing expenses relate to the

additional color requirements of the recommended warning label.

If the Commission were to mandate the ``optimum'' warning label

described above, which includes the additional color requirements,

industry representatives have indicated that aggregate start-up

expenses for the label could amount to as much as $6 million. Further,

the ongoing costs for added colors may be around $4 million per year.

If the start-up expenses are amortized over a 5-year period, the costs

of the revisions to the warning label may amount to about $5.2 million

annually.

However, the Commission is proposing to ease the requirements for

the placement of the label on bags of charcoal and to not mandate

additional colors. The costs of the proposed revision are estimated to

be no more than $1 million in start-up expenses. Easing the recommended

color requirements will allow continued use of current printing

equipment. Since the revised labeling rule is proposed to have an

effective date 12 to 18 months after publication of the final rule, no

additional burden to industry should result. This time should allow

firms to use up existing inventories of printed bags. If any preprinted

bags remain unfilled at that time, the costs of not using these bags

and of discarding them are not expected to be significant.

Benefits to society from the new label would exceed costs at 1%

effectiveness if, as proposed, additional colors are not required and

the current label position requirements are eased. If the label was

required to contain the four specified colors and the position

requirements of the label were not eased, as in the ``optimum'' label

described above, the label would need to be about 4% effective in order

for benefits to exceed costs.

G. 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. 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. This approach would be impractical for the

Commission to enforce, however, since the staff would have to determine

not only when the bag of charcoal was filled, but when the bag was

printed. Accordingly, the Commission has decided to specify that the

rule applies 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 Commission proposes that the 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 occur on a date that is 12 to 18 months after the

issuance of a final rule. This 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. It will also

provide time for existing inventories of printed bags to be depleted.

Of course, 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. Accordingly, the Commission proposes that

the effective date will be at least 12, but not more than 18, months

after any final rule is published.

Although there can be no guarantee that any final rule will be the

same as the proposed rule, some manufacturers may wish to voluntarily

use the revised label before the effective date of a final rule. For

such firms, the Commission will, until further notice published in the

Federal Register, consider labels complying with the proposal as

complying with the current requirements of 16 CFR 1500.14(b)(6), as

well as with any revised requirements of this section, provided that

such labels are brought into full compliance with the final rule as

supplies are exhausted.

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 proposed 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 proposed rule on small entities. [6, Tab G]

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, printing

equipment, 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. According to information currently

available, the number of small firms that may be disproportionately

affected by a label change is not substantial, as only a few small

firms may fall into this category. Easing of the margin and color

requirements, as proposed, will substantially reduce these firms'

costs. These effects may be further mitigated if the firms are able to

pass costs through to their customers or if their plates are near the

end of their service life. Costs for other small firms are not expected

to be significant, due to the relatively small number of brands and

sizes handled by such firms.

The rule should not require small firms to buy new printing

presses. Manufacturers would be given enough time to use up existing

supplies of printed bags. Bags filled with charcoal

[[Page 40791]]

before the effective date are not subject to the revised requirements.

Accordingly, for the reasons given above, the Commission

preliminarily certifies that the proposed rule, if issued, would not

have significant economic effects on a substantial number of small

entities. However, the Commission solicits comments concerning the

potential effects of the proposed rule on small firms.

I. Environmental Considerations

Pursuant to the National Environmental Policy Act, and in

accordance with the Council on Environmental Quality regulations and

CPSC procedures for environmental review, the Commission has assessed

the possible environmental effects associated with the proposed rule to

revise the warning labels for packages of charcoal. Preliminary

analysis of the potential impact of this proposed rule indicates that

it would have no significant effects on the environment if the

effective date of a rule enables the firms to deplete existing stocks

of filled and 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 would not be affected by the proposed rule. Even if some

old inventory of bags remains and cannot be restickered, the

environmental consequences would not be major.

Therefore, because the proposed 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 preliminarily

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

preliminarily finds that the additional label requirements in the

proposed revised label are necessary for the protection of the public

health and safety and proposes to issue such requirements under the

authority of section 3(b) of the FHSA, 15 U.S.C. 1262(b).

Effective Date

The Commission proposes to make the final rule effective on a date

that is 12 to 18 months after it is published in the Federal Register,

as to charcoal intended for cooking or heating that is placed in

containers for retail sale on or after that date.

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 proposes to amend 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 revising the borderlined label

statement in paragraph (b)(6)(i) and paragraph (b)(6)(ii) as follows:

Sec. 1500.14 Substances requiring special labeling under section 3(b)

of the act.

* * * * *

(b) * * *

(6) * * *

(i) * * *

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(ii) For bags of charcoal, the label specified in paragraph

(b)(6)(i) 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, at

least 1 inch below the seam and at least 1 inch above any reading

material or design elements. The signal word ``WARNING'' shall be in

capital letters in at least 27-point (7.14 mm, \9/32\ inch) type. The

remaining text of the warning statement shall be in at least 18-point

(4.763 mm, \3/16\ inch) type. The lettering shall have a strokewidth-

to-height ratio of from 1:6 to 1:8, and the spacing between the bottom

of the letters of one line of the statement of consequences and the

statement of how to avoid the hazard and the top of the letter of the

next line of that statement shall be about one-fourth of the height of

the type size. The label shall be at least 50.8 mm (2 inches) high. The

label's lettering and pictogram shall have the size relation to each

other and to the remainder of the label as shown in paragraph (b)(6)(i)

of this section.

* * * * *

Dated: August 1, 1995.

Sadye E. Dunn,

Secretary, Consumer Product Safety Commission.

[[Page 40792]]

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 of 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

Engineering Sciences, 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 Engineering

Sciences, 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 NoticeNotice 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 for 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.

[FR Doc. 95-19357 Filed 8-9-95; 8:45 am]

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