Guidance for Industry: Lead in Candy Likely to Be Consumed Frequently by Small Children; Recommended Maximum Level and Enforcement Policy, Availability; and Supporting Document: Supporting Document for Maximum Recommended Level for Lead in Candy Likely to Be Consumed Frequently By Small Children; Availability, 67881-67882 [E6-19809]

Download as PDF Federal Register / Vol. 71, No. 226 / Friday, November 24, 2006 / Notices Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one copy. Comments are to be identified 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. Dated: November 15, 2006. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. E6–19887 Filed 11–22–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005D–0481] Guidance for Industry: Lead in Candy Likely to Be Consumed Frequently by Small Children; Recommended Maximum Level and Enforcement Policy, Availability; and Supporting Document: Supporting Document for Maximum Recommended Level for Lead in Candy Likely to Be Consumed Frequently By Small Children; Availability AGENCY: Food and Drug Administration, HHS. cprice-sewell on PROD1PC66 with NOTICES ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry entitled ‘‘Guidance for Industry: Lead in Candy Likely to Be Consumed Frequently by Small Children; Recommended Maximum level and Enforcement Policy,’’ and a supporting document entitled ‘‘Supporting Document for Maximum Recommended Level for Lead in Candy Likely to Be Consumed Frequently By Small Children.’’ The guidance provides a maximum recommended 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 guidance states FDA’s commitment to take enforcement action against candy containing lead at levels that may pose a health risk. 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 VerDate Aug<31>2005 13:24 Nov 22, 2006 Jkt 211001 consumers’ lead exposure to the lowest level that can practicably be obtained. DATES: The guidance and supporting documents are final upon the date of publication. However, you may submit written or electronic comments concerning the guidance and/or supporting document any time. ADDRESSES: Submit written requests for single copies of the guidance and/or supporting document to the Office of Plant and Dairy Foods (HFS–300), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Parkway, College Park, MD 20740. Include a self-addressed adhesive label to assist that office in processing your request. Submit written comments concerning the guidance and/or 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 https:// www.fda.gov/dockets/ecomments. To ensure a timelier processing of comments, FDA is no longer accepting comments submitted to the agency by email. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance and supporting document. 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 20740–3835, 301–436–2022, FAX 301–436–2651, or e-mail: michael.kashtock@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of December 27, 2005 (70 FR 76462), FDA made available a draft guidance for industry entitled ‘‘Lead in Candy Likely to Be Consumed Frequently by Small Children; Recommended Maximum Level and Enforcement Policy’’ and a draft supporting document entitled ‘‘Supporting Document for Maximum Recommended Level for Lead in Candy Likely to Be Consumed Frequently By Small Children’’ and gave interested parties an opportunity to submit comments by March 13, 2006. The agency considered received comments as it finalized this guidance and supporting document. This guidance provides a recommended maximum lead level in candy likely to be consumed frequently by small children. FDA considers the maximum recommended level to be protective of human health and to be PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 67881 achievable with the use of good manufacturing practices in the production of candy and candy ingredients. In response to comments on the draft guidance, this guidance clarifies FDA’s commitment to take enforcement action against candy containing lead at levels that may pose a health risk. FDA notes that it is rescinding previous guidance provided in a 1995 letter to the industry regarding an enforcement level for lead in candy because the level cited in the 1995 letter is no longer regarded as consistent with the agency’s policy of reducing lead levels in the food supply to reduce consumers’ lead exposure to the lowest level that can practically be obtained. In addition, this 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 supporting document entitled ‘‘Supporting Document for Maximum Recommended Level for Lead in Candy Likely to Be Consumed Frequently by Small Children.’’ The 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 can practically be obtained. FDA is issuing this guidance document as a level 1 guidance consistent with FDA’s good guidance practices regulation (21 CFR 10.115). This guidance represents FDA’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 provide 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. You may use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance (see FOR FURTHER INFORMATION CONTACT). If you cannot identify the appropriate FDA staff, call the telephone number listed in the title page of the guidance. II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic E:\FR\FM\24NON1.SGM 24NON1 67882 Federal Register / Vol. 71, No. 226 / Friday, November 24, 2006 / Notices comments regarding this guidance and/ or supporting document at any time. 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 guidance and supporting documents 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 guidance and supporting documents at https://www.cfsan.fda.gov/ guidance.html. Dated: November 16, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–19809 Filed 11–22–06; 8:45 am] BILLING CODE 4160–01–S Dated: November 16, 2006. Anna Snouffer, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 06–9383 Filed 11–22–06; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health BILLING CODE 4140–01–M National Cancer Institute; Notice of Closed Meetings cprice-sewell on PROD1PC66 with NOTICES Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Cancer Institute Special Emphasis Panel, NCI Transition Career Development Award. Date: December 12, 2006. Time: 11 a.m. to 12 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6130 Executive Blvd., Rockville, MD 20852, (Telephone Conference Call). Contact Person: Robert Bird, PhD., Scientific Review Administrator, Resources and Training Review Branch, National Cancer Institute, National Institutes of Health, 6116 Executive Blvd., Room 8113, MSC 8328, Bethesda, MD 20892–8328, 301– 496–7978, birdr@mail.nih.gov. VerDate Aug<31>2005 13:24 Nov 22, 2006 Name of Committee: National Cancer Institute Special Emphasis Panel, SPORE in Lung, H&N, Lymphoma, and Brain Cancers. Date: February 13–15, 2007. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Shamala K. Srinivas, PhD., Scientific Review Administrator, Research Programs Review Branch, Division of Extramural Activities, National Cancer Institute, 6116 Executive Boulevard, Room 8123, Bethesda, MD 20892, 301–594–1224, ss537t@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS) Jkt 211001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Center for Research Resources; Notice of Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the National Advisory Research Resources Council. The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 Name of Committee: National Advisory Research Resources Council. Date: January 18, 2007. Open: 8 a.m. to 12 p.m. Agenda: NCRR’s Director’s Report and other business of the Council. Place: National Institutes of Health, Building 31, 31 Center Drive, Conference Room 10, Bethesda, MD 20892. Closed: 1 p.m. to 5 p.m. Agenda: To review and evaluate grant applications and/or proposals. Place: National Institutes of Health, Building 31, 31 Center Drive, Conference Room 10, Bethesda, MD 20892. Place: Contact Person: Louise E. Ramm, PhD, Deputy Director, National Center for Research Resources, National Institutes of Health, Building 31, Room 3B11, Bethesda, MD 20892, 301–496–6023, lousier@nrr.nih.gov. Any member of the public interested in presenting oral comments to the committee may notify the Contact person listed on this notice at least 10 days in advance of the meeting. Interested individuals and representatives of organizations may submit a letter of intent, a brief description of the organization represented, and a short description of the oral presentation. Only one representative of an organization may be allowed to present oral comments and if accepted by the committee, presentations may be limited to five minutes. Both printed and electronic copies are requested for the record. In addition, any interested person may file written comments with the committee by forwarding their statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver’s license, or passport) and to state the purpose of their visit. Information is also available on the Institute’s/Center’s home page: www.ncrr.nih.gov/newspub/ minutes.htm, where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research; 93.371, Biomedical Technology; 93.389, Research Infrastructure, 93.306, 93.333, National Institutes of Health, HHS) E:\FR\FM\24NON1.SGM 24NON1

Agencies

[Federal Register Volume 71, Number 226 (Friday, November 24, 2006)]
[Notices]
[Pages 67881-67882]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-19809]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0481]


Guidance for Industry: Lead in Candy Likely to Be Consumed 
Frequently by Small Children; Recommended Maximum Level and Enforcement 
Policy, Availability; and Supporting Document: Supporting Document for 
Maximum Recommended Level for Lead in Candy Likely to Be Consumed 
Frequently By Small Children; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a final guidance for industry entitled ``Guidance for 
Industry: Lead in Candy Likely to Be Consumed Frequently by Small 
Children; Recommended Maximum level and Enforcement Policy,'' and a 
supporting document entitled ``Supporting Document for Maximum 
Recommended Level for Lead in Candy Likely to Be Consumed Frequently By 
Small Children.'' The guidance provides a maximum recommended 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 
guidance states FDA's commitment to take enforcement action against 
candy containing lead at levels that may pose a health risk. 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 can practicably be obtained.

DATES: The guidance and supporting documents are final upon the date of 
publication. However, you may submit written or electronic comments 
concerning the guidance and/or supporting document any time.

ADDRESSES: Submit written requests for single copies of the guidance 
and/or supporting document to the Office of Plant and Dairy Foods (HFS-
300), Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5100 Paint Branch Parkway, College Park, MD 20740. 
Include a self-addressed adhesive label to assist that office in 
processing your request.
    Submit written comments concerning the guidance and/or 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 https://www.fda.gov/dockets/ecomments. To 
ensure a timelier processing of comments, FDA is no longer accepting 
comments submitted to the agency by e-mail. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance and 
supporting document.

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 20740-3835, 301-436-2022, FAX 
301-436-2651, or e-mail: michael.kashtock@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of December 27, 2005 (70 FR 76462), FDA 
made available a draft guidance for industry entitled ``Lead in Candy 
Likely to Be Consumed Frequently by Small Children; Recommended Maximum 
Level and Enforcement Policy'' and a draft supporting document entitled 
``Supporting Document for Maximum Recommended Level for Lead in Candy 
Likely to Be Consumed Frequently By Small Children'' and gave 
interested parties an opportunity to submit comments by March 13, 2006. 
The agency considered received comments as it finalized this guidance 
and supporting document.
    This guidance provides a recommended maximum lead level in candy 
likely to be consumed frequently by small children. FDA considers the 
maximum recommended 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. In response to comments on 
the draft guidance, this guidance clarifies FDA's commitment to take 
enforcement action against candy containing lead at levels that may 
pose a health risk. FDA notes that it is rescinding previous guidance 
provided in a 1995 letter to the industry regarding an enforcement 
level for lead in candy because the level cited in the 1995 letter is 
no longer regarded as consistent with the agency's policy of reducing 
lead levels in the food supply to reduce consumers' lead exposure to 
the lowest level that can practically be obtained. In addition, this 
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 supporting document 
entitled ``Supporting Document for Maximum Recommended Level for Lead 
in Candy Likely to Be Consumed Frequently by Small Children.'' The 
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 can practically be obtained.
    FDA is issuing this guidance document as a level 1 guidance 
consistent with FDA's good guidance practices regulation (21 CFR 
10.115). This guidance represents FDA'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 provide 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. You may use an alternative approach if the approach 
satisfies the requirements of the applicable statutes and regulations. 
If you want to discuss an alternative approach, contact the FDA staff 
responsible for implementing this guidance (see FOR FURTHER INFORMATION 
CONTACT). If you cannot identify the appropriate FDA staff, call the 
telephone number listed in the title page of the guidance.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic

[[Page 67882]]

comments regarding this guidance and/or supporting document at any 
time. 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 guidance and supporting 
documents 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 guidance and 
supporting documents at https://www.cfsan.fda.gov/guidance.html.

    Dated: November 16, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-19809 Filed 11-22-06; 8:45 am]
BILLING CODE 4160-01-S

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