MAMMALIAN
BY-PRODUCTS
The Transmissible Spongiform Encephalopathy (TSE) agent is not easy to
test for in rendered animal-origin by-products. The USDA has formulated
rules and regulations that deal with the feeding of mammalian-derived
products. Therefore, no "prohibited" mammalian-derived protein sources
can be fed in the SSQA program. Some protein products derived from mammals
are exempt (non-prohibited) and are approved for use in the SSQA and by
the FDA. Exempt protein product derived from mammals include (a) blood
and blood by-products, (b) milk products, (c) pure porcine protein products,
(d) pure equine protein products, and (e) gelatin. Always refer to the
label directions to determine if products are or are not approved for
use in sheep. More information on mammalian-derived by-products is available
in Appendix B.
FEED ADDITIVES AND MEDICATIONS
PRODUCT USE
Use only FDA-approved products and administer them as directed on the
label. All directions for the use of a medicated feed additive will
be on the label attached to the bag or will be supplied with a bulk
order. NO ONE, including a veterinarian, can legally prescribe the
use of any feed additive other than as directed on the product label.
Extra-label Drug Use (ELDU) does not apply to feed additives or feed
medications. Veterinary Feed Directives (VFD) do not apply to ELDU.
Veterinary Feed Directives pertain to the use of medicated feeds, but
there are presently no products that have been approved for use in sheep
with a VFD. Water medications are not considered feed medications and,
therefore, can be used under the ELDU guidelines provided by the Center
for Veterinary Medicine (CVM) of FDA.
The most important responsibility of a feed manufacturer is to assure
that the feed produced-whether medicated or non-medicated-meets all
legal and intended specifications. All feed-mixing operations, regardless
of size or products used, share this responsibility. The term "medicated
feed" includes all medicated feed products intended to be a substantial
source of nutrients in the diet of an animal. The term includes products
commonly referred to as supplements, concentrates, premix feeds and
base mixes and is not limited to complete feeds. Medicated feeds must
contain the proper drug level and be fed at appropriate levels.
THE
USE OF DRUGS IN DISEASE CONTROL
There are a limited number of drugs that a producer can legally use
for sheep. FDA policy requires that livestock producers use drugs only
in accordance with the label instructions. Uses that are contrary to
label directions would include ignoring labeled withdrawal times, using
the product for a species not indicated on the label, using the drug
to treat a condition not indicated on the label, administering the drug
at a different dosage than stated on the label, or otherwise failing
to follow label directions for use and administration of the drug.
DRUG USE IN DAIRY SHEEP
There are no drugs approved for use in dairy sheep. In order to prevent
drug residues in their milk, sheep being treated should be removed from
the milking string for the remainder of the lactation. Detection of
drug residues is grounds for milk rejection. Milk producers and their
veterinarians should develop a written treatment plan for disease prevention
and control. The Pasteurized Milk Ordinance (PMO) contains guidelines
for Grade A milk production that are set by the Interstate Milk Shippers
(IMS).
FOOD
AND DRUG ADMINISTRATION POLICY
Persons involved in raising, handling, transporting, holding and marketing
of food producing animals are encouraged to establish systems to ensure
that animal drugs are used properly and to prevent the presence of potentially
hazardous drug residues in edible animal products. These control systems
include the following measures:
1. Identifying and tracking
animals to which drugs were administered to preclude the sale of edible
animal tissue, milk or eggs containing illegal residues (identification
may be by specific animal identification, pen or lot, quarantine/segregation,
or other means);
2. Maintaining a system of medication/treatment records that, at a minimum,
identifies the animal(s) treated (individual animals, pens, lots, etc.),
the date(s) of treatment, the drug(s) administered, who administered
the drug(s), the amount administered and the withdrawal time prior to
harvest (and when milk, eggs, etc.
can be used, if appropriate);
3. Properly storing, labeling, and accounting for all drug products
and medicated feeds;
4. Obtaining and using veterinary prescription drugs only through a
licensed veterinarian based on a valid VCPR;
5. Educating all employees and family members involved in treating,
hauling, and selling of the animals on proper administration techniques,
observance of withdrawal times, and methods to avoid marketing adulterated
products for human food. (Food and Drug Administration Compliance Policy
Guides Chapter 25 - Veterinary Drugs).
PREVENTION AND PROCESSING
BACKGROUND INFORMATION
Only products approved by FDA, USDA or EPA can be used in processing and
treatment programs in sheep operations. Records must be maintained for
any pesticide, medication or biological product administered. The records
will include the following:
• Date
• Group identification number
• Individual identification number, if appropriate
• Name of product
• Manufacturer of product administered
• Lot/serial number of product used
• Dosage administered
• Route and location of administration
• Withdrawal period
• Name of person administering the product
All products will be used in accordance with label directions unless
otherwise specified by a legal prescription. A legal prescription will
consist of the drug ordered/prescribed and a dated and signed Treatment
Protocol Book. Extra-label drug use of OTC medications must be labeled
by your supplier with labels outlining procedures as described in your
current signed and dated Treatment Protocol Book in accordance with
FDA-CVM regulations. Extra-label drug use must be prescribed by a veterinarian
according to FDA guidelines.
VETERINARIAN
ASSISTANCE
Find and use a veterinarian who is willing to be involved with the Sheep
Safety and Quality Assurance program. Your veterinarian must understand
that each animal carries the reputation of your business and that of
the entire U.S. sheep industry. The veterinarian must be a team player.
Allowing anyone to jeopardize your business or the industry is not acceptable.
Be cautious about sheep treatment advice from anyone who is not highly
qualified and well-acquainted with the operation. Ask your veterinarian
to find medications that meet all SSQA guidelines.
EXTRA-LABEL DRUG USAGE (ELDU)
There are two classes of drugs - Over the Counter (OTC) and Prescription
Drugs. OTC drugs can be purchased and used as directed on the label
without establishing a relationship with a veterinarian. For example,
the label on penicillin G directs that 1 cc/cwt be given intramuscularly
(IM); so, a 100-pound sheep would get 1 cc. Producers are not allowed
to adjust the dose.
Prescription drugs can be used only on the order of a veterinarian within
the context of a valid Veterinarian-Client-Patient Relationship (VCPR).
Medications used in this fashion must contain an additional label that
contains the contact veterinarian and instructions given, including
the withdrawal time. Drug cost is not considered a valid reason for
extra-label drug use under the Animal Medicinal Drug Use Clarification
Act (AMDUCA) or the regulations promulgated to implement the Act. Records
of such use of medications must be kept in accordance with the criteria.
Compounding of medications to treat sheep by a veterinarian is strictly
regulated by section 530.13 of the Extra-label Drug Use in Animals and
section 608.400, Compounding of Drugs for Use in Animals. The FDA-CVM
has interpreted the regulations to allow extra-label drug use for treating
disease or preventing pending disease. The compounded medication must
meet strict FDA-CVM guidelines. The FDA-CVM policy states that "The
veterinarian will need to be able to defend why the compounded drug
works where a labeled product or an extra-label use of a NADA or human
compound would not".
The Extra-label
Drug Usage policy of the FDA-CVM specifies the following criteria:
A. A careful diagnosis is made by an attending veterinarian within
the context of a valid veterinarian-client-patient relationship.
B. A determination is made that (1) there is no marketable drug
specifically labeled to treat the condition diagnosed, or (2) treatment
at the dosage recommended by the labeling was found clinically ineffective.
C. Procedures are instituted to assure that the identity of the
treated animal is carefully maintained.
D. A significantly extended period is assigned for drug withdrawal
prior to marketing the treated animal and steps are taken to assure
that the assigned time frames are met so that no violative residue occurs.
The Food Animal Residue Avoidance Databank (FARAD) can aid the veterinarian
in making these estimates.
VETERINARIAN-CLIENT-PATIENT
RELATIONSHIPS
Veterinarian-Client-Patient Relationships exist when:
A. The veterinarian has assumed the responsibility for making
clinical judgments regarding the health of the animal and the need for
medical treatment, and the client has agreed to follow the veterinarian's
instructions.
B. The veterinarian has sufficient knowledge of the animal to
initiate at least a general or preliminary diagnosis of the medical
condition of the animal. This means that the veterinarian has recently
seen and is personally acquainted with the keeping and care of the animal
by virtue of an examination of the animal or the medically appropriate
and timely visits to the premises where the animal is kept.
C. The veterinarian is readily available for follow-up evaluation
in the event of adverse reactions or failure of the treatment regimen.
TREATMENT PROTOCOL BOOK
Ask your veterinarian to develop a Treatment Protocol Book specific
to your operation. A Treatment Protocol Book should be reviewed regularly
and updated at least every 90 days or as often as appropriate. Maintain
(with revisions) the Treatment Protocol Book on file and at the treatment
facility. As the Treatment Protocol Book is updated, all previous versions
should be kept on file in the office. Updating does not require the
book to be reproduced, but it must have the veterinarian's signature
and the date on which the book was reviewed.
Any medication that is used other than as directed on the label must
have revised administration procedures included in the Treatment Protocol
Book. Ask suppliers to attach a revised label obtained from your veterinarian
to each bottle delivered. These labels must include the veterinarian's
name, address, phone number, revised directions for use and withdrawal
time. Contact your veterinarian for an example Treatment Protocol Book.
VACCINATIONS
The use of biological products for the prevention of diseases will lessen
the chance of resistance or residue problems later in the production
cycle. However, sheep do not always arrive in healthy condition and
immediate treatment may be necessary. Many treatment regimens include
vaccines to stimulate immune system response and lessen the chance of
re-treatment. Vaccines should be considered as an alternative to antibiotics
and other medications that can lead to residue or resistance problems,
even though vaccines can have extended withdrawal times.
All injections must be administered in front of the point of the
shoulder only; no exceptions. Select the injection-site carefully.
Using, as the site for injections, the neck rather than the back or
hindleg, prevents the loss of value in the most desirable cuts of lamb
at the consumption level and reduces the potential for market discounts
in price.
Summary
of Step 1 Criteria That Can Be Achieved By Use Of Objectives and Procedures
1.1 Do not feed "prohibited" mammalian derived protein sources.
[Meat and bone meal or any other prohibited protein sources derived
from mammalian muscle or bone tissue cannot be fed. Some protein products
derived from mammals are exempt (non-prohibited) and are approved for
use in the SSQA program and by FDA; refer to the label on products to
determine whether or not they are approved for use in sheep.]
1.2 Use only FDA approved medicated feed additives in rations.
1.3 Use all medicated feed additives in accordance with the FDA
approved label. (Extra-label use of feed additives is strictly prohibited.
No one has the authority to adjust the dosage of medicated feed additives.)
1.4 Assure that all additives are withdrawn at the proper time
to avoid violative residues.
1.5 Verify drug withdrawal on all sheep sold that are not typical
(medicated ewes) of those in the flock. [Should there be any question
about withdrawal periods being met, the veterinarian will evaluate the
treatment history against information provided by the Food Animal Residue
Avoidance Databank (FARAD), if available, and the animal will be subject
to passing a residue screening test such as the Live Animal Swab Test
(LAST). Residue screening shall be performed under the supervision of
a veterinarian. The results of such testing will determine the appropriateness
for releasing for shipment, but cannot be used to shorten the labeled
withdrawal time. The sheep operation will collect random urine samples
from animals that have received extra-label drugs for residue testing
as directed by their veterinarian.]
1.6 Follow, strictly, all FDA/USDA/EPA guidelines for product
selection.
1.7 Comply with label directions for all treatment regimens unless
otherwise prescribed by a veterinarian.
1.8 Employ extra-label drug use only when prescribed by a veterinarian
with a valid veterinarian-client-patient relationship. (All sheep treated
with medications administered extra-label shall comply with prescribed
extended withdrawal times which have been set by the veterinarian under
the guidelines of a valid veterinarian-client-patient relationship.)
1.9 Administer all products labeled for IM (intra-muscular) use
in the neck region only, in front of the point of the shoulder. [All
products labeled for subcutaneous (SQ, under the skin) use must be administered
SQ in front of the point of the shoulder (in the neck region). No injections
shall be given in locations other than the neck region, regardless of
animal age.]
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