[Federal Register Volume 59, Number 8 (Wednesday, January 12, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-706]
[[Page Unknown]]
[Federal Register: January 12, 1994]
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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