Guidance for Industry: The Safety of Imported Traditional Pottery Intended for Use With Food and the Use of the Term “Lead Free” in the Labeling of Pottery; and Proper Identification of Ornamental and Decorative Ceramicware; Availability, 71133 [2010-29292]
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Federal Register / Vol. 75, No. 224 / Monday, November 22, 2010 / Notices
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–D–0571]
Guidance for Industry: The Safety of
Imported Traditional Pottery Intended
for Use With Food and the Use of the
Term ‘‘Lead Free’’ in the Labeling of
Pottery; and Proper Identification of
Ornamental and Decorative
Ceramicware; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance entitled
‘‘Guidance for Industry: The Safety of
Imported Traditional Pottery Intended
for Use With Food and the Use of the
Term ‘Lead Free’ in the Labeling of
Pottery; and Proper Identification of
Ornamental and Decorative
Ceramicware.’’ FDA is issuing the
guidance in response to recent findings
of lead contamination of imported
traditional pottery labeled as ‘‘Lead
Free.’’ The guidance identifies several
key practices that manufacturers of
pottery may implement to help ensure
that lead contamination of non-lead
glazed (NLG) pottery will not occur and
also reminds manufacturers of existing
requirements for properly labeling
certain ornamental and decorative
ceramicware as not for use for foodhandling purposes.
DATES: Submit either electronic or
written comments on the guidance at
any time.
ADDRESSES: Submit electronic
comments on the guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
written requests for single copies of the
guidance to the Office of Food Safety,
Center for Food Safety and Applied
Nutrition (HFS–317), Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740. Send
two self-addressed adhesive labels to
assist that office in processing your
request. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance.
FOR FURTHER INFORMATION CONTACT:
Michael E. Kashtock, Center for Food
Safety and Applied Nutrition (HFS–
317), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park,
MD 20740, 301–436–2022.
jlentini on DSKJ8SOYB1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:49 Nov 19, 2010
Jkt 223001
I. Background
FDA is announcing the availability of
a guidance entitled ‘‘The Safety of
Imported Traditional Pottery Intended
for Use With Food and the Use of the
Term ‘Lead Free’ in the Labeling of
Pottery; and Proper Identification of
Ornamental and Decorative
Ceramicware.’’ FDA is issuing the
guidance in response to recent findings
of lead contamination of imported
traditional pottery labeled as ‘‘Lead
Free.’’ This contamination is occurring
even with the use of newer production
practices that do not utilize
intentionally added lead (e.g., the use of
non-lead glazes). The guidance
identifies several key practices that
manufacturers of pottery may
implement to help ensure that lead
contamination of NLG pottery will not
occur and also reminds manufacturers
of existing requirements for properly
labeling certain ornamental and
decorative ceramicware items as not for
use for food-handling purposes.
FDA is issuing this guidance as level
1 guidance. Consistent with FDA’s good
guidance practices regulation (21 CFR
10.115), the Agency will accept
comments, but is implementing the
guidance document immediately, in
accordance with 21 CFR 10.115(g)(2),
because the Agency has determined that
prior public participation is not feasible
or appropriate in light of the need to
respond expeditiously to numerous
recent reports of lead contamination of
imported traditional pottery. The
guidance represents the Agency’s
current thinking on food safety
considerations relevant to lead
contamination of NLG traditional
pottery, and labeling considerations for
food use and non food use pottery that
may contain lead. It does not create or
confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternate approach may be
used if such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding the guidance. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
PO 00000
Frm 00067
Fmt 4703
Sfmt 9990
71133
III. Electronic Access
Persons with access to the Internet
may obtain the guidance at https://
www.fda.gov/FoodGuidances or https://
www.regulations.gov.
Dated: November 5, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–29292 Filed 11–19–10; 8:45 am]
BILLING CODE 4160–01–P
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HUMAN SERVICES
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National Institute of Mental Health;
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The meeting will be closed to the
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as amended. The grant applications and
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Dated: November 16, 2010.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–29356 Filed 11–19–10; 8:45 am]
BILLING CODE 4140–01–P
E:\FR\FM\22NON1.SGM
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]]>Agencies
[Federal Register Volume 75, Number 224 (Monday, November 22, 2010)]
[Notices]
[Page 71133]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-29292]
[[Page 71133]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0571]
Guidance for Industry: The Safety of Imported Traditional Pottery
Intended for Use With Food and the Use of the Term ``Lead Free'' in the
Labeling of Pottery; and Proper Identification of Ornamental and
Decorative Ceramicware; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance entitled ``Guidance for Industry: The Safety
of Imported Traditional Pottery Intended for Use With Food and the Use
of the Term `Lead Free' in the Labeling of Pottery; and Proper
Identification of Ornamental and Decorative Ceramicware.'' FDA is
issuing the guidance in response to recent findings of lead
contamination of imported traditional pottery labeled as ``Lead Free.''
The guidance identifies several key practices that manufacturers of
pottery may implement to help ensure that lead contamination of non-
lead glazed (NLG) pottery will not occur and also reminds manufacturers
of existing requirements for properly labeling certain ornamental and
decorative ceramicware as not for use for food-handling purposes.
DATES: Submit either electronic or written comments on the guidance at
any time.
ADDRESSES: Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit written requests for single
copies of the guidance to the Office of Food Safety, Center for Food
Safety and Applied Nutrition (HFS-317), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740. Send two self-
addressed adhesive labels to assist that office in processing your
request. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance.
FOR FURTHER INFORMATION CONTACT: Michael E. Kashtock, Center for Food
Safety and Applied Nutrition (HFS-317), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2022.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance entitled ``The
Safety of Imported Traditional Pottery Intended for Use With Food and
the Use of the Term `Lead Free' in the Labeling of Pottery; and Proper
Identification of Ornamental and Decorative Ceramicware.'' FDA is
issuing the guidance in response to recent findings of lead
contamination of imported traditional pottery labeled as ``Lead Free.''
This contamination is occurring even with the use of newer production
practices that do not utilize intentionally added lead (e.g., the use
of non-lead glazes). The guidance identifies several key practices that
manufacturers of pottery may implement to help ensure that lead
contamination of NLG pottery will not occur and also reminds
manufacturers of existing requirements for properly labeling certain
ornamental and decorative ceramicware items as not for use for food-
handling purposes.
FDA is issuing this guidance as level 1 guidance. Consistent with
FDA's good guidance practices regulation (21 CFR 10.115), the Agency
will accept comments, but is implementing the guidance document
immediately, in accordance with 21 CFR 10.115(g)(2), because the Agency
has determined that prior public participation is not feasible or
appropriate in light of the need to respond expeditiously to numerous
recent reports of lead contamination of imported traditional pottery.
The guidance represents the Agency's current thinking on food safety
considerations relevant to lead contamination of NLG traditional
pottery, and labeling considerations for food use and non food use
pottery that may contain lead. It does not create or confer any rights
for or on any person and does not operate to bind FDA or the public. An
alternate approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding the
guidance. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet may obtain the guidance at
https://www.fda.gov/FoodGuidances or https://www.regulations.gov.
Dated: November 5, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-29292 Filed 11-19-10; 8:45 am]
BILLING CODE 4160-01-P
