Updated: 2005-11-29
BACKGROUND:
Imported and domestic silver -plated hollowware have been found to contain significant quantities of leachable lead. The metal is extractable by acid foods and could cause chronic heavy metal poisoning under continued food use.
REGULATORY ACTION GUIDANCE:
The following represents criteria for detaining or recommending legal action to CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605):
IMPORTS:
The article:
Liquid type foods include viscous foods some examples of which are applesauce,
ketchup, gelatin and puddings, and solid foods in liquid medium some examples
of which are peas, sauerkraut and fruits.
NOTE: The article is not subject to the guideline if:
SPECIMEN CHARGE:
The article was adulterated when introduced into, while in, and is adulterated while held for sale after shipment in interstate commerce within the meaning of said Act 21 U.S.C. 342 (a)(2)(C) in that it contains a food additive, namely lead, which is unsafe within the meaning of 21 U.S.C. 348 because its use and intended use are not in conformity with a regulation or exemption established pursuant to 21 U.S.C. 348.
REMARKS:
If all lots in an import entry were sampled using an invoice on a line by line basis, detain only those lots meeting the above criteria. If one sample (line item) meets the above criteria, the entire entry may be detained without further analysis.
If articles are of domestic manufacture, regulatory action may include all lots from a single batch.
RELEASE OF IMPORT DETENTIONS:
Upon analysis or other examination by the importer to demonstrate suitability for release, the articles may be released on a lot by lot basis with checks by the district laboratory to determine compliance. Release based on labeling of the article as for other than food use where:
Items that are not used to hold liquid or liquid type foods for repeated use or storage but are components of articles under detention may be released upon separation by the importer. For example, although all items in a silver plated hollowware coffee serving set consisting of a tray, coffee pot, creamer and sugar bowl may be detained because one item of the set (e.g., creamer) is found to contain levels of lead in excess of the guideline, those articles in the set that are not used to hold liquids or liquid type foods (e.g., sugar bowl and tray) may be separated by the importer and upon request may be released without examination. Release based on any other conditions must have prior clearance of CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605).
EXEMPTION:
Nonfood service silver-plated hollowware will not be required to meet the guidelines for leachable lead. Nonfood service silver-plated hollowware includes, but is not necessarily limited to, the following types of articles manufactured solely for ornamental display purposes: commemorative articles (pots, plates, cups, etc.), souvenir articles and other highly ornamented silver-plated hollowware articles. This exemption applies provided the articles do not come in place settings for the table and further provided that there is a permanent label on the back of the article stating "Not for Food Use - Article May Poison Food. For Decorative Purposes Only."
*Material between asterisks is new or revised.*
Issued: 10/1/80
Revised: 6/27/88, 3/95, 5/2005