#####  172

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##### Guidance for Industry

# Use of unapproved hormone implants in veal calves

Comments and suggestions regarding this guidance should be sent to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Room 1061, Rockville, MD 20852. All comments should
be identified with the Docket No. 2004D-0160. Comments also may be
submitted electronically on the Internet at
<http://www.fda.gov/dockets/ecomments>

If you have questions regarding the guidance document, contact Gloria J.
Dunnavan, Center for Veterinary Medicine (HFV- 230), Food and Drug
Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-1168,
e-mail: <gloria.dunnavan@fda.gov>.

Additional copies of this draft guidance document may be requested from
the Communications Staff (HFV-12), Center for Veterinary Medicine, Food
and Drug Administration, 7500 Standish Place, Rockville, MD 20855, and
may be viewed on the Internet at <http://www.fda.gov/cvm>.

U.S. Department of Health and Human Services

Food and Drug Administration\
Center for Veterinary Medicine\
April 2, 2004

#  172

# Guidance for Industry

# Use of unapproved hormone implants in veal calves

####### 

####### I. Introduction

The U.S. Department of Agriculture's Food Safety and Inspection Service
(FSIS) veterinarians have recently found evidence of unapproved,
growth-promoting animal drug implants in veal calves being presented for
slaughter at several establishments. Veal calves may have been implanted
with growth-promoting hormones that may include progesterone,
testosterone, estradiol, zeranol, and trenbolone. FDA and FSIS have
begun an investigation to determine the extent to which unapproved
animal drug implants are being used in the veal calf industry. This
document provides guidance on the appropriate disposition of veal calves
that have been implanted with such implants.

**FDA's guidance documents, including this guidance, do not establish
legally enforceable responsibilities. Instead, guidances describe the
Agency's current thinking on a topic and should be viewed only as
recommendations, unless specific regulatory or statutory requirements
are cited. The use of the word "should" in Agency guidances means that
something is suggested or recommended, but not required.**

**II. Use of unapproved hormone implants in veal calves**

FDA has not approved any implants that contain hormones for veal calves.
FDA defines veal calves to include any non-ruminating calf, regardless
of breed, intended to be, or having been processed for veal. Because
there is no approved animal drug application providing for the use of
these implants in non-ruminating calves, such use is illegal. Under
section 512 of the Federal Food, Drug, and Cosmetic Act (the Act), use
of an unapproved new animal drug results in the drug being unsafe, and,
therefore, the drugs are adulterated under section 501(a)(5). In
addition, food that bears or contains these drugs is adulterated under
section 402(a)(2)(C)(ii) of the Act.

**III. Special measures to ensure safety of veal for human consumption**

Veal calves that have been implanted with growth-promoting hormones may
be adulterated. However, they may be made acceptable for human
consumption if special precautions are taken. The special precautions
are as follows:

> 1\. The veal calf is not processed for food within 63 days of
> implantation.
>
> 2\. The veal calf has been implanted in accordance with the labeled
> dose for beef, in accordance with the directions on the implant, and
> in the proper location (under the skin of the ear).
>
> 3\. The veal calf is presented for slaughter prior to June 06, 2004.
>
> 4\. The veal calf is presented for slaughter with appropriate
> certification as outlined in a related notice being issued by FSIS.

FDA is basing this 63-day holding period on its determination that by
this time the unapproved drugs will have depleted to the level that does
not pose a risk to human health. FDA considered the information known
about the hormones that may have been implanted. Because trenbolone has
the longest time to deplete from the animals\' tissues, FDA has used
information on trenbolone as the basis for determining the appropriate
holding period. In connection with its approval of trenbolone in adult
cattle, FDA established an acceptable daily intake (ADI) of 0.4 µg/kg
body weight (21 CFR 556.739). An ADI is the measure of exposure to a
drug residue that is known to be safe for humans through toxicological
analysis. Based on the ADI for trenbolone, FDA estimates that the safe
concentrations for trenbolone in edible tissues are as follows:

Liver: 240 µg/kg

Kidney: 480 µg/kg

Muscle: 80 µg/kg

Fat: 480 µg/kg

While residue depletion data for trenbolone in calves are not available,
extrapolations from studies in calves and larger cattle indicate that
the highest dose of trenbolone in an implant (200 mg) would be depleted
below the safe concentration identified above by 63 days after
implantation in a calf.

The agency\'s analysis is based on the best information available at
this time and on the conditions in this policy, including that this is a
one-time event and that illegal implants will not continue to occur.

FDA will work with USDA/FSIS to verify that the calves presented for
slaughter meet these conditions. As part of this process, FSIS plans to
conduct random sampling and analysis of veal tissue for hormone residues
and samples of implants may be sent to FDA, DEN-VAS for identification.
The policy contained in this guidance only applies to veal calves
presented for slaughter prior to June 06, 2004.

FDA stresses that this policy does not excuse any illegal conduct that
has occurred. The agency intends to use its full range of enforcement
options where appropriate and intends to take enforcement actions to
ensure that this activity does not continue. Moreover, the agency
stresses that this policy is based on the premise that there will be no
additional illegal use of these implants in veal calves.

#######