[Federal Register Volume 64, Number 199 (Friday, October 15, 1999)]
[Notices]
[Page 55948]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 99-26886]



[[Page 55948]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99D-4201]


Guidance for Industry: Dioxin in Anti-caking Agents Used in 
Animal Feed and Feed Ingredients; 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 guidance for industry entitled ``Dioxin in Anti-
caking Agents Used in Animal Feed and Feed Ingredients.'' The guidance 
is intended to notify members of the feed industry of recent findings 
regarding the presence of dioxins in mined clays that may be used as 
anti-caking agents in animal feeds and to offer general advice 
regarding monitoring of these clays.

DATES: October 15, 1999. Submit written comments at any time.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.
     Copies of this guidance document may be obtained on the Internet 
from the CVM home page at http://www.fda.gov/cvm/fda/TOCs/
guideline.html. Persons without internet access may submit written 
requests for single copies of the draft guidance to the Communications 
Staff (HFV-12), Center for Veterinary Medicine, Food and Drug 
Administration, 7500 Standish Pl., Rockville, MD 20855. Send one self-
addressed adhesive label to assist that office in processing your 
requests.
FOR FURTHER INFORMATION CONTACT:
     For general questions regarding the guidance document: Judy A. 
Gushee, Center for Veterinary Medicine (HFV-230), Food and Drug 
Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0150, 
e-mail: jgushee@cvm.fda.gov.
     For scientific questions regarding the guidance document: Randall 
A. Lovell, Center for Veterinary Medicine (HFV-222), Food and Drug 
Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0176, 
e-mail: rlovell@cvm.fda.gov.
SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
guidance for industry entitled ``Dioxin in Anti-caking Agents Used in 
Animal Feed and Feed Ingredients.'' Nearly 2 years ago, a multiagency 
investigation tracked a previously unknown source of dioxins in the 
human food supply back to a mined clay anti-caking agent, called ball 
clay, used in animal feeds and feed ingredients. Together, industry and 
Government moved to swiftly eliminate the use of ball clay in the 
animal feeds, and thereby, removed a source of dioxins in the human 
food chain.
     On October 7, 1997, FDA sent a letter regarding this issue to 
members of the feed industry. In that letter, we stated that the 
ultimate origin and the scope of dioxin presence in clay deposits were 
unknown and, for that reason, mined clay products of all types should 
be used with caution in the production of animal feeds. We advised 
companies offering mined clay products for animal feed uses to ensure 
that their products were not contaminated with dioxins.
     Since that time, FDA has been collecting additional data. The 
information thus far indicates that dioxins can be present in mined 
clay products other than ball clay and that dioxin congeners other than 
2,3,7,8-tetrachlorodibenzodioxin may be present in important amounts. 
The guidance that is the subject of this notice summarizes the data and 
suggests the need for increased caution in industry surveillance for 
dioxins in feed ingredients.
     This guidance document is being issued as a Level 1 guidance 
consistent with FDA's good guidance practices (62 FR 8961, February 27, 
1997). It is being implemented immediately without prior public comment 
because of concern for public health. The guidance represents the 
agency's current thinking on the implications of dioxins in mined clays 
used in animal feeds and feed ingredients. 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, regulations, or both.
     Interested persons may submit written comments on the guidance to 
the Dockets Management Branch (address above). 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 guidance and received 
comments are available for public examination in the Dockets Management 
Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: October 5, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-26886 Filed 10-14-99; 8:45 am]
BILLING CODE 4160-01-F