[Federal Register Volume 65, Number 109 (Tuesday, June 6, 2000)]
[Notices]
[Page 35945]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-14106]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1277]


Draft Guidance for Industry: Fumonisin Levels in Human Foods and 
Animal Feeds; 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availability of a draft guidance document entitled ``Guidance for 
Industry: Fumonisin Levels in Human Foods and Animal Feeds.'' The 
purpose of this draft guidance is to identify for the industry 
recommended maximum fumonisin levels that FDA considers adequate to 
protect human and animal health and that are achievable in human foods 
and animal feeds with the use of good agricultural and good 
manufacturing practices. FDA considers this guidance to be a prudent 
public health measure during the development of a better understanding 
of the human health risk associated with fumonisins and the development 
of a long-term risk management policy and program by the agency for the 
control of fumonisins in human foods and animal feeds.

DATES: Submit written comments by August 7, 2000.

ADDRESSES: Submit written requests for single copies of the draft 
guidance entitled ``Draft Guidance for Industry: Fumonisin Levels in 
Human Foods and Animal Feeds'' to Henry Kim, Center for Food Safety and 
Applied Nutrition (CFSAN) (address below), or Randall A. Lovell, Center 
for Veterinary Medicine (CVM) (address below). Send one self-addressed 
adhesive label to assist that office in processing your request. The 
draft guidance, CFSAN's ``Background Paper in Support of Fumonisin 
Levels in Corn and Corn Products Intended for Human Consumption,'' and 
CVM's ``Background Paper in Support of Fumonisin Levels in Animal 
Feed,'' may also be accessed at the CFSAN or CVM home page on the 
Internet at http://www.cfsan.fda.gov and http://www.fda.gov/cvm, 
respectively.
    Submit written comments on the draft guidance to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. Comments and requests for copies 
should be identified with the docket number found in brackets in the 
heading of this document.

FOR FURTHER INFORMATION CONTACT:
    Henry Kim, Center for Food Safety and Applied Nutrition (HFS-306), 
Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-
260-0631, FAX 202-205-4422, or
    Randall A. Lovell, Center for Veterinary Medicine (HFV-222), Food 
and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-
827-0176, FAX 301-827-1484.

SUPPLEMENTARY INFORMATION:  FDA has developed a draft guidance document 
regarding the maximum recommended levels of fumonisins in corn used for 
production of human foods and animal feeds. Fumonisins are naturally 
occurring toxins produced by the molds Fusarium moniliforme (F. 
verticillioides), F. proliferatum, and other Fusarium species that are 
common contaminants of corn. Fumonisins have been linked to a variety 
of significant adverse health effects in livestock and experimental 
animals. Although human epidemiological studies are inconclusive at 
this time, based on a wide variety of significant adverse animal health 
effects, FDA believes that an association between fumonisins and human 
disease is possible.
    The purpose of the draft guidance is to identify for the industry 
recommended maximum fumonisin levels that FDA considers adequate to 
protect human and animal health and that are achievable in human foods 
and animal feeds with the use of good agricultural and good 
manufacturing practices. FDA considers this guidance to be a prudent 
public health measure during the development of a better understanding 
of the human health risk associated with fumonisins and the development 
of a long-term risk management policy and program by the agency for the 
control of fumonisins in human foods and animal feeds. Based on 
information obtained from future national and international workshops 
on the risk from exposure to fumonisins, FDA will consider whether to 
establish tolerances, regulatory limits, or action levels, as 
appropriate, for fumonisins in human foods and animal feeds, 
respectively, under 21 CFR Part 109--Unavoidable Contaminants in Food 
for Human Consumption and Food-Packaging Material and under 21 CFR Part 
509--Unavoidable Contaminants in Animal Food and Food-Packaging 
Material.
    The agency has adopted good guidance practices (GGP's) that set 
forth the agency's policies and procedures for the development, 
issuance, and use of guidance documents (62 FR 8961, February 27, 
1997). The draft guidance document entitled ``Guidance for Industry: 
Fumonisin Levels in Human Foods and Animal Feeds'' is being issued as a 
level 1 draft guidance consistent with GGP's. This draft guidance 
represents the agency's current thinking on the control of fumonisins 
in human foods and animal feeds as a prudent public health measure. 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 approach satisfies the requirements of the applicable statute 
and regulations.
    Interested persons may submit written comments to the Dockets 
Management Branch (address above) on the draft guidance by August 7, 
2000. Two copies of any comments are to be submitted, 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. The 
draft guidance, CFSAN's ``Background Paper in Support of Fumonisin 
Levels in Corn and Corn Products Intended for Human Consumption,'' 
CVM's ``Background Paper in Support of Fumonisin Levels in Animal 
Feed,'' and received comments may be seen in the Dockets Management 
Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: May 26, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-14106 Filed 6-5-00; 8:45 am]
BILLING CODE 4160-01-F