[Federal Register Volume 75, Number 224 (Monday, November 22, 2010)]
[Notices]
[Page 71133]
From the Federal Register Online via the Government Publishing 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.
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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 http://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
http://www.fda.gov/FoodGuidances or http://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