[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