Requirements for Decorative Ceramicware To Be Deemed not for Food Use

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 109

[Docket No. 89N-0014]

RIN 0905-AC91

Requirements for Decorative Ceramicware To Be Deemed not for Food

Use

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending its

regulations to require that decorative ceramicware bear a conspicuous

stick-on label on a surface that is clearly visible to consumers and a

permanent statement on the exterior surface of the base of the

ceramicware stating that the piece is not for food use, and that it may

poison food. Alternatively, the regulation provides that a hole may be

bored through the possible food-contact surface of the piece. This

final rule is intended to ensure that decorative ceramicware is not

mistakenly used to hold food.

DATES: Effective July 13, 1994, for all affected products initially

introduced or initially delivered for introduction into interstate

commerce on or after this date.

FOR FURTHER INFORMATION CONTACT: Cora E. Weeks, Center for Food Safety

and Applied Nutrition (HFS-306), Food and Drug Administration, 200 C

St. SW., Washington, DC 20204, 202-205-4681.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of June 1, 1989 (54 FR 23485), FDA issued a

proposed rule: (1) To establish a regulatory limit on the amount of

lead that may leach from glazes and decorations on the food-contact

surface of ceramic food service pitchers, excluding creamers; and (2)

to provide that all decorative or ornamental ceramicware that appears

to be suitable for food use will be considered to be for food use, and

will be regulated as such, unless it bears a conspicuous, permanent

statement molded or fired onto the exterior surface of the base of the

ceramic piece. The agency proposed to require that this statement say,

``Not for Food Use--May Poison Food,'' in letters at least 3.2

millimeters (mm) (0.125 inch (in)) in height, or that a hole be bored

through the potential food-contact surface to make it unsuitable for

food use.

The proposal requested comments on various concerns regarding

ceramic foodware and on the impact of the proposed requirements on

decorative ceramicware that resembles foodware and that contains

leachable lead.

FDA received requests to extend the comment period on the proposed

rule from representatives of domestic and foreign ceramicware

manufacturers, 3suppliers of glazes and decorations containing lead for

the ceramics industry and related trade associations, the European

Economic Community, and the Italian Embassy. The requests stated that

additional time was needed to address the issues raised and to provide

information solicited by FDA in the proposal. FDA responded in a notice

published in the Federal Register of September 1, 1989 (54 FR 36324),

that reopened and extended the comment period until November 30, 1989.

In the Federal Register of July 6, 1992 (57 FR 29734), the agency

announced the availability of revised Compliance Policy Guide (CPG)

7117.07 ``Pottery (Ceramics); Imported and Domestic--Lead

Contamination.'' This revision lowered the guidelines on lead release

from all ceramic foodware. This revision was based, among other things,

on the agency's review of data submitted pursuant to its proposal of

June 1, 1989 (54 FR 23485), and the agency's concerns about the need to

reduce human exposure to lead.

The lead release levels in CPG 7117.07 are guides that the agency

uses in evaluating ceramic foodware for possible adulteration within

the meaning of section 402(a)(2)(C) of the Federal Food, Drug, and

Cosmetic Act (the act) (21 U.S.C. 342(a)(2)(C)). In this final rule,

the agency is not acting on its proposal regarding a legally binding

regulatory limit on the amount of lead that may leach from the food-

contact surfaces of ceramic food service pitchers. The agency is

continuing to review whether the CPG provides adequate protection for

the public health, which would mean that the agency could withdraw its

proposal to establish a regulatory limit, or whether further rulemaking

is necessary.

This final rule pertains only to ornamental and decorative

ceramicware. In the June 1, 1989 (54 FR 23485), proposal, the agency

stated that the then existing policy guidance concerning decorative and

ornamental ceramicware in CPG 7117.07 was too general and vague,

subject to misinterpretation, and not sufficient to ensure that

decorative articles will be distinguishable from food-service articles.

Therefore, the agency's purpose in adopting this final rule is to

ensure that such ware, which may leach hazardous amounts of lead into

food, bear adequate indications to distinguish it from ceramic foodware

(i.e., ceramicware intended for holding, storing, or serving food). The

agency has made revisions in the language of Sec. 109.16(a) and (b) (21

CFR 109.16(a) and (b)) to make clear that this regulation pertains only

to ornamental and decorative ceramicware and not to any ceramicware

intended to hold or store food, e.g., ceramic pitchers.

FDA also notes that the provisions of this final rule are not

applicable to items such as children's ceramic tea sets. Such items are

usually small copies of articles intended for food use. They are

designed for use only by children in play activities that may involve

eating or drinking foods placed in or on these products (see HHS News,

April 20, 1993.) Lead in these products could leach into food. Those

that leach excessive amounts of lead will be subject to regulatory

action, and such ware may not obtain status as a nonfood item by virtue

of its bearing any statement that it is not for food use.

On the effective date of this final rule, all ornamental or

decorative ceramicware that appears to be suitable for food use upon

initial introduction or initial delivery for introduction into

interstate commerce will be considered to be foodware and will be

evaluated for lead release by the agency as foodware. Ware that meets

the requirements of this final rule will not be considered to be for

food use.

The agency is also providing notice that it is deleting the

exemption for nonfood service plates from CPG 7117.07. These articles

will be subject to the provisions of this final rule.

II. Summary of and Response to Comments

A. Summary of Comments

Seven letters, containing one or more comments, were received in

response to the proposal on the requirements for decorative ceramicware

that resembles foodware. The comments were submitted by consumer and

environmental advocacy organizations, ceramicware manufacturers and

their suppliers, and individuals.

B. Responses to Comments

1. Several comments requested that FDA allow more flexibility

regarding the exact wording of the permanent statement of unsuitability

for food use and suggested statements for inclusion in the final rule

as alternatives to the proposed statement. These comments expressed

concern that the word ``poison'' would alarm potential purchasers and

could lead them to believe that handling the product is hazardous. The

following alternative statements were suggested: (a) ``Decorative--Not

for Food Use. Pigments are Potentially Toxi66c if Ingested,'' (b) ``Not

for Food Use--Metallic Pigments Fired into Surface are Potentially

Toxic. For Decorative Purposes Only,'' or (c) ``Warning. Glaze Contains

Soluble Lead. Not for Food Use.''

The agency accepts the recommendation to allow for alternative

statements of unsuitability for food use. FDA agrees that some number

of alternative statements can convey the same basic concept as the

proposed statement while providing flexibility in the wording of the

message. However, to adequately denote that the ceramicware is

unsuitable for food use, the permanent statement must clearly advise

the purchaser or potential user that if the article is used to hold

food, a toxic substance may be added to the food as a result.

Alternative (c) does not do so. The alternative statements (a) and (b)

suggested by the comments state that the surface of the ceramic piece

itself contains a toxic substance, but they do not make clear that if

the ceramicware is used for food purposes, such use may result in the

addition of a toxic substance to the food. Therefore, the agency is not

accepting the statements suggested in the comments as acceptable

alternatives.

In Sec. 109.16(b)(1)(i), FDA is providing three alternative

statements of unsuitability that meet the criterion of informing the

purchaser that if the article is used for food, a toxic substance may

be added to the food as a result. The alternative statements are, ``Not

for Food Use. May Poison Food,'' ``Not for Food Use. Glaze contains

lead. Food Use May Result in Lead Poisoning,'' and ``Not for Food Use--

Food Consumed from this Vessel May be Harmful.''

The agency concludes that these three alternative statements of

unsuitability provide the industry with a choice without providing so

many different statements as to confuse consumers. Limiting the number

of variations in the statement is necessary to ensure that consumers

understand that a consistent message is being presented by the

statements that they find on decorative ceramicware.

As an additional matter, the agency believes that statements that

the ware is intended to be decorative may provide useful information to

the consumer about the intended use of the ware. Therefore, FDA is

providing in Sec. 109.16(c)(1) for the use of additional optional

statements such as ``Decorative'' or ``For Decorative Purposes Only''

when such statements are placed after the required statement.

2. Some comments expressed concern that statements that ornamental

or de2corative ceramicware is unfit for food use will not protect very

young, illiterate, or non-English speaking people. One of the comments

suggested that FDA permit the use of a symbol to designate ceramicware

that is not suitable for food use. The comments stated that the symbol

should accompany the statement that the ceramicware is unfit for food

use. One comment maintained that the symbol is responsive to concerns

regarding understanding by illiterate persons, non-English speaking

people, and children. The comment suggested that the following symbol,

which includes a goblet and a fork, symbols used in the United Kingdom

to indicate materials and articles that are intended to come into

contact with food, be enclosed within a circle with a bar running

diagonally across the design to indicate that food use is prohibited.

TR12JA94.000

The agency agrees that the symbol may communicate to individuals,

to whom a written statement may not be readily meaningful, that an

article is not foodware. However, because the agency does not have any

information concerning the extent to which the symbol is understood or

recognized by consumers, it is not requiring use of the symbol but is

making its use optional in Sec. 109.16(c)(2), as an additional

cautionary statement to those required in Sec. 109.16(b).

3. Some comments expressed concern that a statement placed on the

exterior surface of the base of a piece, in letters that are only 3.2

mm (0.125 inch) in height, may not be seen by many people. Some

comments requested that the agency require that the statement be placed

on the side of the ceramicware, and that the required size of letters

in the statement be related to the size of the ceramicware on which it

is placed.

FDA agrees that a statement on the side of a piece is more

conspicuous than one placed on the exterior surface of the base.

However, a permanent statement on the side would likely render the

piece useless for ornamental or decorative purposes. To respond to the

concern of the comments, and to better protect the public, FDA is

requiring in Sec. 109.16(b)(1)(i) that a stick-on temporary label

bearing one of the alternative statements, in letters at least 3.2 mm

(0.125 in) in height, be placed on a surface of the piece that is

clearly visible to the consumer. The temporary label will advise the

consumer that the piece is not for food use and of the reason why it is

not for food use. The determination as to the appropriate surface for

the temporary label will depend on the shape of the piece. For example,

the appropriate place on a plate for the temporary label would be the

potential food-contact surface, while on a pitcher a temporary label on

the exterior of the side would be suitable.

The requirement for a temporary label is in addition to the

requirement of a permanent label that the agency proposed (54 FR

23485). The purpose of the proposal was to ensure that decorative

ceramicware would not be used in a manner that is unsafe. The comments

have convinced the agency that the additional requirement for a

temporary label placed on a conspicuous surface is necessary to ensure

that the purposes of this final rule are realized. Without this

requirement, as the comments suggested, there is a significant chance

that a consumer will miss the warning on the base of the ceramicware.

The agency does not agree that the size of the letters in the

permanent statement must be directly related to the dimensions of the

ornamental or decorative ceramicware piece to be seen. If the statement

meets the minimum letter height requirements of Sec. 109.16(b)(1)(ii)

and is adequately contrasted or otherwise differentiated or set out

from the background of the piece, the statement will fully serve its

function. The agency notes that the requirement for conspicuousness in

declarations of net quantity of contents on food labels

(Sec. 101.105(i)) includes the specification that the letter height is

not less than one-eighth inch (or 3.2 mm (0.125 in)) if the declaration

is blown, embossed, or molded on a surface. Using this precedent, the

agency believes that the minimal letter height of the statement of

nonfood use should generally be not less than 3.2 mm (or one-eighth in)

because letters that are less than 3.2 mm (0.125 in) in height may not

be conspicuous enough to be readily seen.

However, the agency recognizes that there may be some ceramicware

articles that appear to be suitable for food use that have bases with

surface areas that are too small to fit the required statement if it

were to be in letters that are 3.2 mm (0.125 inch) in height. For such

articles, the agency is providing in Sec. 109.16(b)(1)(ii) that the

statement be written in the largest letters possible, provided the

letters are at least 1.6 mm (0.062 inch) high.

4. One comment stated that the agency should not impose a minimum

letter size for the permanent statement because of the limited space

available on some articles.

The agency believes that ceramicware pieces that could be mistaken

as being intended for holding, storing, or serving food would have a

size and configuration similar to food-use ware and would have bases

sufficiently large for88 the required statement. The agency has

accommodated size problems in Sec. 109.16(b)(1)(ii). Therefore, the

agency rejects this comment.

5. One comment expressed concern that, in the past, it has been

difficult, if not impossible, to keep decorative or ornamental

ceramicware from being used to hold food. Therefore, the comment argued

that FDA should not rely on statements to distinguish ceramicware used

for food storage from decorative or ornamental ceramicware. The comment

suggested that FDA consider only ceramicware that has holes bored in

the food-contact surface to be decorative or ornamental.

The agency disagrees with this suggestion. A hole bored through

some decorative or ornamental ceramicware articles would render them

useless for their intended purpose, e.g., pieces in the shape of

pitchers intended for use as vases for fresh flowers, and would damage

the decorative value of others, e.g., commemorative plates. The intent

of this regulation is to distinguish decorative ceramicware from food-

service articles by using specified statements and an optional symbol

in a manner that ensures that those statements will be readily seen and

understood by the consumer. FDA concludes, based on the available

information, that the measures required under this final rule are

appropriate for this purpose.

6. One comment suggested that FDA also require that decorative

ceramicware (when first sold) be accompanied by a booklet in which the

permanent statement is printed in large type. The comment stated that

the booklet should include a paragraph stating that the object is not

to be used to hold, serve, or store food and provide a brief

explanation of the dangers of lead to pregnant women, infants, and

children. The comment further suggested that FDA set out the exact

wording of the text of the suggested booklet in the final rule.

FDA does not have information and data that demonstrate that such a

booklet is necessary to protect consumers from the use with food of

decorative ceramicware. Accordingly, FDA is not requiring manufacturers

to provide such a booklet, although FDA believes that a booklet

describing the potential hazards of misusing decorative ceramicware may

be useful in helping to make consumers aware of the adverse effects of

lead. Therefore, the agency has no objection to the manufacturers

providing such a booklet on their own initiative.

The requirement for a temporary label will respond to the comment's

objective of ensuring that consumers are informed about the intended

use of the ware. In addition, FDA uses consumer education vehicles such

as the FDA Consumer magazine to inform the public about issues

concerning misuse of ornamental ceramicware to avoid lead exposure from

this source. The agency, in ``Lead Threat Lessens, But Mugs Pose

Problem'' in the FDA Consumer of April 1993, and in ``Reducing Exposure

to Lead from Ceramic Ware,'' an FDA Backgrounder of November 1991,

advised consumers to follow label directions on any ornamental product

with a warning that the article is not for food use.

7. One comment stated that the requirement that ornamental or

decorative pieces either bear a permanent statement on the base or have

a hole bored into the food-contact surface is not appropriate for

antique or secondhand articles of value.

The agency advises that this final rule applies to new ornamental

or decorative articles initially introduced, or initially delivered for

introduction, into interstate commerce after the effective date of the

rule and would not apply to antique or secondhand articles of value.

The agency considers the safe use of antique or secondhand

ceramicware to be a subject for consumer education. The agency, in

``Pretty Poison: Lead and Ceramicware'' in the FDA Consumer of July/

August 1987, and in ``Reducing Exposure to Lead from Ceramic Ware'' in

the FDA Backgrounder of November 1991, recommended limiting food use of

ceramicware manufactured before Federal standards were imposed. Dealers

and merchants can help inform consumers about the risk posed by such

ware by affixing stick-on labels or decals to articles of questionable

origin or safety. The labels or decals should state that the articles

are to be used only for decorative or ornamental purposes. The agency

intends to continue to caution consumers that substantial amounts of

lead may leach from antique and other ceramic collectibles into food.

8. One comment stated that certain types of hand-painted and hand-

carved decorative ceramicware, such as ``coromandel porcelain,'' are

not subject to kiln firing as part of or after the decoration and

painting processes. Thus, the required statement cannot be fired onto

the base of such articles. The comment requested that FDA permit the

statement to be painted on the base of the decorative ceramicware with

a permanent paint. The comment further stated that this is the only

commercially practical and feasible method of applying a conspicuous

and permanent statement to this type of ceramicware.

FDA agrees that there is a need to provide for the application of

the permanent statement to decorative or ornamental ceramicware that

are not fired after decoration. Accordingly, the agency is providing in

Sec. 109.16(b)(1)(ii) that the statement may be painted onto

ceramicware using permanent paint when the ceramicware is not fired

after decoration.

9. Ceramic product manufacturers commented that if FDA requires the

use of the symbol in the final rule, 6 months is not sufficient time to

have molds or decals available. These manufacturers requested that the

effective date of the final rule be delayed in order to have time to

phase in use of the symbol.

Because FDA is making the use of the symbol optional, manufacturers

who decide to use it are not subject to an FDA-imposed time constraint

in phasing in its use. Therefore, the agency is not extending the

effective date.

III. Conclusions

After review and consideration of comments received in response to

the portion of its June 1, 1989, proposal that relates to ornamental

and decorative ceramicware (54 FR 23485), the agency is adopting that

portion of the proposal as a final rule. The purpose of the regulation

that FDA is adopting is to distinguish ornamental or decorative

ceramicware that may leach excessive amounts of lead into food from

ceramic foodware (i.e., ceramicware intended for holding, storing, or

serving food). Section 109.16 provides that FDA will consider all

decorative or ornamental ceramicware that appears to be suitable for

food use to be for food use and will regulate it as such, unless a

stick-on label bearing one of three specified statements in letters

that are at least 3.2 mm (0.125 in) in height is placed on a readily

visible surface of the ceramicware, and one of the three specified

statements in letters that are at least 3.2 mm (0.125 in) in height is

permanently affixed to the exterior surface of the base of the

ceramicware. However, if insufficient space exists for the permanent

statement to be presented in letters of such height, the statement

shall be in the largest letters that will allow it to fit on the base

of the piece, provided that the letters are at least 1.6 mm (0.062 in)

in height. In the alternative, the manufacturer may bore a hole through

the potential food-contact surface of the decorative ceramicware to

make it unsuitable for food use. The final rule also provides that the

required statement can be painted onto the exterior surface of the base

if the piece is not fired after decoration. Further, the final rule

provides that a symbol may be used, in addition to the statement or

hole bored through the ware, to advise the consumer that the article is

not for food use.

IV. Economic Impact

FDA has examined the economic implications of this final rule to

amend 21 CFR part 109 as required by Executive Order 12866 and the

Regulatory Flexibility Act (Pub. L. 96-354). Executive Order 12866

compels agencies to use a cost-benefit analysis as a component of

decisionmaking. The Regulatory Flexibility Act requires regulatory

relief for small businesses where feasible. FDA has received no new

information or comments that would alter its tentative finding in the

proposal that there is no substantive economic issue, and that this

rule is not a major rule as defined by either Executive Order 12866 or

the Regulatory Flexibility Act.

V. Environmental Impact

The agency considered the environmental effects of this action in

the context of the proposed rule (54 FR 23485). At that time, the

agency prepared an environmental assessment (EA) and concluded that the

proposed action would not have a significant impact on the human

environment and that an environmental impact statement (EIS) was not

required.

One comment received by the agency on the proposed rule stated that

the continued use of lead in consumer products has a major

environmental impact when these products are disposed of, and that FDA

had failed to consider fully the environmental impact of its proposal.

As explained above, the aspect of the proposed rule concerned with the

reduction in limits on the levels of lead leaching from ceramic

foodware has been addressed by a compliance policy guide (CPG) that was

announced in the Federal Register of July 6, 1992 (57 FR 29734). At

that time the agency prepared an EA for the issuance of this CPG in

which, among other things, it addressed the above comment. The

conclusion of that EA was that the agency's action to reduce the limits

on the levels of lead leaching from ceramic foodware may also reduce

the amount of lead that could potentially enter the environment from

landfill leachate. This EA is on public display at the Dockets

Management Branch (address above).

The other part of the proposed rule is covered by this final rule,

i.e., the establishment of labeling requirements for decorative

ceramicware that appears to be suitable for food use. FDA actions that

establish regulations for labeling requirements normally do not require

the preparation of an EA or an EIS under Sec. 25.24(a)(11) (21 CFR

25.24(a)(11)) because such actions meet specific criteria that are

intended to ensure that they will not cause significant environmental

effects. These criteria are that there will be no increase in the

existing levels of use or change in the intended uses of the product or

its substitutes. Because the intent of this final rule is to prevent

decorative ceramicware from being used for food service, we conclude

that these criteria are met, and that the categorical exclusion in

Sec. 25.24(a)(11) applies to the action in this final rule. Therefore,

the comment cited above does not provide a basis to change the agency's

previous determination that there is no significant impact on the human

environment from this action, and that an EIS is not required.

List of Subjects in 21 CFR Part 109

Food labeling, Food packaging, Foods, Polychlorinated biphenyls

(PCB's).

Therefore, under the Federal Food, Drug, and Cosmetic Act and under

authority delegated to the Commissioner of Food and Drugs, 21 CFR part

109 is amended to read as follows:

PART 109--UNAVOIDABLE CONTAMINANTS IN FOOD FOR HUMAN CONSUMPTION

AND FOOD-PACKAGING MATERIALS

1. The authority citation for 21 CFR part 109 is revised to read as

follows:

Authority: Secs. 201, 306, 402, 406, 408, 409, 701 of the

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 336, 342, 346,

346a, 348, 371).

2. New Sec. 109.16 is added to subpart A to read as follows:

Sec. 109.16 Ornamental and decorative ceramicware.

(a) Lead is a toxic metal that is used as a component of glazes and

decorative decals on ceramics, including some ornamental and decorative

ceramicware. The use of ornamental or decorative ceramicware to

prepare, serve, or hold food may result in the leaching of lead from

the glaze or decoration into the food. The provisions of paragraph (b)

of this section are necessary to ensure that ornamental or decorative

ceramicware bear adequate indications that they are not to be used for

food-handling purposes.

(b) Ornamental or decorative ceramicware initially introduced or

initially delivered for introduction into interstate commerce on or

after July 13, 1994 appears to be suitable for food use will be

considered to be for food use unless:

(1) It bears:

(i) A conspicuous stick-on label on a surface clearly visible to

consumers that states in legible script in letters at least 3.2

millimeters (0.125 inch) in height one of the following messages: ``Not

for Food Use. May Poison Food,'' ``Not for Food Use. Glaze contains

lead. Food Use May Result in Lead Poisoning,'' and ``Not for Food Use--

Food Consumed from this Vessel May be Harmful,'' and

(ii) A conspicuous and legible permanent statement of the message

selected from paragraph (b)(1)(i) of this section molded or fired onto

the exterior surface of the base or, when the ceramicware is not fired

after decoration, permanently painted onto the exterior surface of the

base. This permanent statement shall be in letters at least 3.2

millimeters (0.125 inch) in height, except that if insufficient space

exists for the permanent statement in letters of such height, the

statement shall be in the largest letters that will allow it to fit on

the base of the piece, provided that the letters are at least 1.6

millimeters (0.062 inch) in height; or

(2) A hole is bored through the potential food-contact surface.

(c) In addition to steps required under paragraphs (b)(1) and

(b)(2) of this section, the following optional information may be

provided on the ware:

(1) A further explanatory statement concerning the decorative

nature of the piece, such as ``Decorative'' or ``For Decorative

Purposes Only,'' may be used; however, such additional statement shall

be placed after the required statement.

(2) A symbol may be used to advise that a piece of ornamental or

decorative ceramicware is not to be used with food, as illustrated

below.

TR12JA94.001

The circle of the above symbol should be at least 2.54 centimeters (1

inch) in diameter. The symbol may be used on the temporary label or

applied to the base of the piece in the same manner as the permanent

statement.

Dated: January 5, 1994.

Michael R. Taylor,

Deputy Commissioner for Policy.

[FR Doc. 94-706 Filed 1-11-94; 8:45 am]

BILLING CODE 4160-01-F