[Federal Register Volume 65, Number 76 (Wednesday, April 19, 2000)]
[Notices]
[Pages 20996-20997]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 00-9711]


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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 revised guidance for industry (#98) 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 congeners that may be 
present in anti-caking agents in animal feeds and to offer general 
advice regarding monitoring of these products. This guidance has been 
revised in response to comments.

DATES: Submit written comments at any time.

ADDRESSES: Submit written comments on this guidance document to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Copies of the guidance 
document entitled ``Dioxin in Anti-caking Agents Used in Animal Feed 
and Feed Ingredients'' 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 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.

[[Page 20997]]

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:

I. Background

    In theFederal Register of October 15, 1999 (64 FR 55948), FDA 
published a notice of availability of a guidance entitled ``Dioxin in 
Anti-caking Agents Used in Animal Feed and Feed Ingredients.'' This 
guidance was issued as a Level 1 guidance consistent with FDA's good 
guidance practices (62 FR 8961, February 27, 1997). It was implemented 
without prior public comment because of concern for the public health. 
The guidance was intended to notify 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. The agency received comments 
regarding this guidance and has revised the guidance in response to the 
comments. The following is a discussion of the issues raised by the 
comments.

II. Discussion of Comments

    The agency received two comments on the guidance. One comment was 
from the feed industry objecting to the term ``mined clay products'' 
and one was from a company that produces limestone objecting to the 
term ``lime.''
    (Comment 1) One comment noted that the term ``mined clay products'' 
was not appropriate because materials labeled as silicate and lime also 
tested positive to one or more of the dioxin congeners. We agree with 
the comment that the term was inappropriate for the scope of the 
affected product. FDA was attempting to use a generic term to describe 
the source of products of concern. FDA has revised the guidance 
document by replacing the term ``mined clay products'' with ``clay and 
non-clay anti-caking products.'' We have added the term ``anti-caking'' 
to emphasize that our primary concern is for the use of these products 
in feed and feed ingredients and not when used as litter or absorbents.
    This comment also noted that of the terms montmorillonite, 
bentonite, and ground clay, only montmorillonite has a mineral 
definition. It was also noted that the animal feed industry and its 
suppliers do not follow scientific terminology for classification and 
description of these anti-caking animal feed ingredients. The comment 
recommended that FDA contact the U.S. Geological Survey (USGS) and the 
Clay Minerals Society (CMS) for assistance in mineral terminology. It 
was also suggested that the samples, which were analyzed for dioxin, be 
evaluated for their mineralogy and then properly classified based on 
the mineralogical components according to accepted scientific 
guidelines.
    FDA was aware that many of the terms used by suppliers and the feed 
industry were only loosely based on mineralogy and were often more 
closely associated with some property (e.g., ball clay) of the product 
than mineralogical components. However, FDA did not fully understand 
the scope of the interchanging of the terms used by suppliers of these 
products. FDA agrees that classifying these products based upon the 
mineralogical components according to accepted scientific guidelines is 
preferred. FDA has contacted the USGS regarding analyzing the samples 
for their mineralogy. We have also contacted the USGS and the CMS for 
information on developing a scientifically accurate naming scheme based 
on mineralogy. We plan to seek the assistance of the feed industry and 
the Association of American Feed Control Officials (AAFCO) to implement 
a scientifically accurate naming scheme based on mineralogy.
    (Comment 2) Another comment objected to the use of the term 
``lime.'' The National Lime Association (NLA) noted that limestone is a 
naturally occurring mineral, while lime is not. Lime, according to the 
NLA, consists of either calcium oxide or calcium hydroxide and results 
from reacting ``limestone'' (calcium carbonate) and heat.
    FDA does not dispute the NLA's definition of lime and, as mentioned 
above, has revised the terminology for the products of concern from 
``mined clay products'' to ``clay and non-clay anti-caking products.'' 
FDA realizes that this does not directly address the NLA's concern that 
a product might have been incorrectly identified in the survey. FDA 
reported the findings based on what was on the label of the product 
sampled or by what the product was called by the company when the FDA 
investigator collected it.
    In essence, the concern expressed by the NLA for the correct 
identification of the product is the same as that expressed by the 
other comment and is a concern shared by FDA. We encourage the NLA to 
work with its members, companies producing limestone, the feed 
industry, and AAFCO to ensure a scientifically accurate naming scheme 
is applied to the products supplied to the feed industry.

III. Status of this Guidance

    This guidance represents the agency's current thinking on the 
presence of dioxin congeners in anti-caking agents. 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.
    FDA plans to continue to sample regulated clay and non-clay anti-
caking products for dioxin in conjunction with the Environmental 
Protection Agency and other Government agencies. Plans are also 
underway to sample other feed components for dioxin.

IV. Comments

    As with all of FDA's guidances, the public is encouraged to submit 
to the Dockets Management Branch (address above) written comments with 
new data or other new information regarding this guidance. The comments 
will be periodically reviewed, and, where appropriate, the guidance 
will be amended. The public will be notified of any such amendments 
through a notice in the Federal Register.

    Dated: April 11, 2000.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-9711 Filed 4-18-00; 8:45 am]
BILLING CODE 4160-01-F