[Federal Register Volume 66, Number 218 (Friday, November 9, 2001)]
[Notices]
[Pages 56688-56689]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-28104]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1277]


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 final guidance document entitled ``Guidance for 
Industry: Fumonisin Levels in Human Foods and Animal Feeds.'' The 
purpose of this guidance is to identify for the industry 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 long-term risk management policy and program by the agency for the 
control of fumonisins in human foods and animal feeds. The agency is 
also announcing the availability of the final supporting documents 
entitled ``Background Paper in Support of Fumonisin Levels in Corn and 
Corn Products Intended for Human Consumption,'' and ``Background Paper 
in Support of Fumonisin Levels in Animal Feed.''

DATES: Submit written or electronic comments concerning the final 
guidance and the final supporting documents at any time.

ADDRESSES: Submit written comments on the final guidance to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to 
http://www.fda.gov/dockets/ecomments. Submit written requests for 
single copies of the final guidance entitled ``Guidance for Industry: 
Fumonisin Level in Human Foods and Animal Feeds'' to Henry Kim, Center 
for Food Safety and Applied Nutrition (CFSAN) (address below), or 
Communications Staff (HFV-12), Center for Veterinary Medicine (CVM), 
7500 Standish Pl., Rockville, MD 20855, 301-594-1755. Send one self-
adhesive address label to assist that office in processing your 
request. See the SUPPLEMENTARY INFORMATION section for electronic 
access to these documents.

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, or
    Randall Lovell, Center for Veterinary Medicine (HFV-222), Food and 
Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-
0176.

SUPPLEMENTARY INFORMATION:

I. Background

    On June 6, 2000, FDA issued a draft guidance document that 
presented recommended levels of fumonisins in corn used for production 
of human

[[Page 56689]]

foods and animal feeds. The purpose of the draft guidance was to 
identify for the industry 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. In the Federal Register notice of June 6, 2000 
(65 FR 35945) announcing the availability of the draft guidance 
document, FDA provided a 60-day period for comment on the recommended 
fumonisin levels.
    FDA received 12 comments in response to the June 6, 2000, draft 
guidance. The comments represented the views of seven trade 
associations representing manufacturers of dry and wet milled corn 
products, popcorn, snack foods, processed grain and feed products, food 
and other consumer products, and pet foods; a snack food company; a dry 
miller of corn; a food and food ingredient company; a State health 
department; and a life science society. The majority of the comments 
stated that they supported the recommended fumonisin levels in corn 
used for production of human foods and animal feeds. A number of 
comments suggested changes or modification to the various recommended 
fumonisin levels. FDA has considered the submitted comments and has 
revised the supporting documents as appropriate.

II. Conclusion

    The agency is adopting the recommended fumonisin levels in human 
foods and animal feeds as presented in the draft guidance document. The 
majority of the comments that the agency received supported the 
recommended fumonisin levels. Further, after considering carefully the 
comments that the agency received that suggested modification or 
opposition to aspects of the recommended levels in the draft guidance, 
the agency has determined that no changes are warranted. The final 
supporting documents explain the agency's reasoning in selecting the 
recommended levels.
    FDA considers the final guidance to be a prudent public health 
measure during 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 final guidance document is being issued as a level 1 guidance, 
consistent with FDA's good guidance practices regulation (21 CFR 
10.115). The final 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.

III. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written or electronic comments regarding the final 
guidance at any time. 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 final guidance, the final supporting documents 
entitled ``Background Paper in Support of Fumonisin Levels in Corn and 
Corn Products Intended for Human Consumption,'' and ``Background Paper 
in Support of Fumonisin Levels in Animal Feed,'' and received comments 
are available in the Dockets Management Branch between 9 a.m. and 4 
p.m. Monday through Friday.

IV. Electronic Access

    The final guidance, as well as the final supporting documents 
entitled ``Background Paper in Support of Fumonisin Levels in Corn and 
Corn Products Intended for Human Consumption,'' and ``Background Paper 
in Support of Fumonisin Levels in Animal Feed,'' may be accessed from 
the home pages of CFSAN and CVM on the Internet at http://www.cfsan.fda.gov and http://www.fda.gov/cvm, respectively.

    Dated: November 1, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-28104 Filed 11-8-01; 8:45 am]
BILLING CODE 4160-01-S