[Federal Register: December 27, 2005 (Volume 70, Number 247)]
[Notices]
[Page 76462]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27de05-56]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0481]


Draft Guidance for Industry: Lead in Candy Likely To Be Consumed
Frequently by Small Children: Recommended Maximum Level and Enforcement
Policy; Draft Supporting Document: Supporting Document for Recommended
Maximum Level for Lead in Candy Likely To Be Consumed Frequently by
Small Children; 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availability of a draft guidance for industry entitled ``Lead in Candy
Likely To Be Consumed Frequently by Small Children: Recommended Maximum
Level and Enforcement Policy.'' This draft guidance provides a
recommended maximum lead level in candy likely to be consumed
frequently by small children. FDA considers the recommended maximum
level to be protective of human health and to be achievable with the
use of good manufacturing practices in the production of candy and
candy ingredients. The agency is also announcing the availability of a
draft supporting document entitled ``Supporting Document for
Recommended Maximum Level for Lead in Candy Likely To Be Consumed
Frequently by Small Children.'' These two documents are intended to
assist candy manufacturers in achieving reduced lead levels in their
products consistent with the agency's policy of reducing lead levels in
the food supply to reduce consumers' lead exposure to the lowest level
that practicably can be obtained.

DATES: Submit written or electronic comments on the draft guidance by
March 13, 2006. General comments on agency guidance documents are
welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft
guidance and/or draft supporting document to the Division of Plant
Product Safety (HFS-305), Center for Food Safety and Applied Nutrition,
Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD
20740. Send one self-addressed adhesive label to assist that office in
processing your requests.
    Submit written comments on the draft guidance and/or draft
supporting document to the Division of Dockets Management (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
 See the SUPPLEMENTARY INFORMATION section for electronic

access to the draft guidance and draft supporting documents.

FOR FURTHER INFORMATION CONTACT: Michael E. Kashtock, Center for Food
Safety and Applied Nutrition (HFS-305), 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 draft guidance for industry
entitled ``Lead in Candy Likely To Be Consumed Frequently by Small
Children: Recommended Maximum Level and Enforcement Policy.'' This
draft guidance provides a recommended maximum lead level in candy
likely to be consumed frequently by small children. FDA considers the
recommended maximum level to be protective of human health and to be
achievable with the use of good manufacturing practices in the
production of candy and candy ingredients. FDA notes that the
recommended level is not for enforcement purposes. In addition, FDA is
rescinding previous guidance provided in a 1995 letter to the industry
regarding an enforcement level. Finally, this draft guidance reiterates
FDA's enforcement policy toward the use of lead based ink on candy
wrappers as stated in the 1995 letter to the industry. FDA also is
announcing the availability of a draft document entitled ``Supporting
Document for Recommended Maximum Level for Lead in Candy Likely To Be
Consumed Frequently by Small Children.'' The draft supporting document
provides additional background and rationale for the recommended
maximum level. These two documents are intended to assist candy
manufacturers in achieving reduced lead levels in their products
consistent with the agency's policy of reducing lead levels in the food
supply to reduce consumers' lead exposure to the lowest level that
practically can be obtained.
    The agency has adopted good guidance practices (GGPs) that set
forth the agency's policies and procedures for the development,
issuance, and use of guidance documents (21 CFR 10.115). The draft
guidance is being issued as a level 1 draft guidance consistent with
GGPs. The draft guidance represents the agency's current thinking on
lead levels in candy that are achievable with the use of good
manufacturing practices in the production of candy and candy
ingredients and that also provides for the protection of human health.
It does not create or confer any rights for or on any person and does
not operate to bind FDA or the public. An alternative approach may be
used if such an approach satisfies the requirements of the applicable
statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on the draft guidance
and draft supporting document. Submit a single copy of electronic
comments or two paper copies of any mailed comments, except that
individuals may submit one paper copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. The draft guidance and draft supporting document and 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 document at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.cfsan.fda.gov/guidance.html.


    Dated: December 14, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-24494 Filed 12-22-05; 8:45 am]

BILLING CODE 4160-01-S