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###### Department of Health and Human Services

###### Food and Drug Administration

          - [Docket No. FDA-2010-D-0571]

# 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                         *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