Page 124 - Veterinary Toxicology, Basic and Clinical Principles, 3rd Edition

Regulatory Considerations in Veterinary Toxicology Chapter | 6 91

VetBooks.ir FDA CENTER FOR VETERINARY MEDICINE Protection Agency (EPA), or the USDA, depending on
whether the product is determined to be an animal drug,
Overview
device or food, a pesticide, or an animal/veterinary bio-
The FDA CVM protects public and animal health by logic. A team of individuals within the CVM interact with
ensuring that animal drugs and medicated feeds are safe these agencies to establish the appropriate jurisdiction for
and effective and that food from treated animals is safe to particular products.
eat. The responsibilities of the CVM have a direct effect The CVM’s jurisdiction team often works with the
on the safety of the human food supply and on the safety Center for Veterinary Biologics (CVB) at the USDA’s
Animal and Plant Health Inspection Service (USDA-
to animals that are treated with veterinary products.
APHIS) to determine whether a particular product meets
Before a new animal drug can be legally marketed in the
the definition of a biological product or a new animal
United States, it must be approved by the FDA on the
drug. Unlike biologics for human use, which are regulated
basis of quality, safety, and efficacy. When the drug is to
by FDA (CBER), veterinary biologics are regulated under
be approved for use in food-producing animals, safety to
the Virus-Serum-Toxin Act (VSTA) by USDA-APHIS. In
the target animal species must be demonstrated in addition
Title 9 of the CFR, y101.2 defines biological products as
to safety of food products derived from the treated animals
“all viruses, serums, toxins (excluding substances that are
that are intended for human consumption. Thus, part of
selectively toxic to microorganisms, e.g., antibiotics), or
the preapproval process for drugs intended for use in food-
analogous products at any stage of production, shipment,
producing animals includes the determination of safety of
distribution, or sale, which are intended for use in the
drug residues in animal-derived food products. In addition,
preapproval safety evaluation of certain animal drugs treatment of animals and which act primarily through the
includes a determination of the effects of the animal drug direct stimulation, supplementation, enhancement, or mod-
on the environment and on human health in some cases. ulation of the immune system or immune response. The
Once approved products are on the market, the Center term ‘biological products’ includes but is not limited to
monitors the use of the products through surveillance and vaccines, bacterins, allergens, antibodies, antitoxins, tox-
compliance programs. The CVM’s responsibilities also oids, immunostimulants, certain cytokines, antigenic or
include ensuring that food for animals is safe, manufac- immunizing components of live organisms, and diagnostic
tured properly and under sanitary conditions, and is prop- components, that are of natural or synthetic origin, or that
erly labeled. There are currently no requirements for FDA are derived from synthesizing or altering various sub-
premarket approval of medical devices intended for animal stances or components of substances such as microorgan-
use; however, FDA can take appropriate regulatory action isms, genes or genetic sequences, carbohydrates, proteins,
if a veterinary device is misbranded or adulterated. antigens, allergens, or antibodies.” Additional information
about veterinary biologics and their regulation can be
Currently, the CVM is organized into six offices:
found at the USDA’s website (USDA-APHIS, 2017).
Office of the Director, Office of Management, Office of
The CVM jurisdiction team also works with the
New Animal Drug Evaluation, Office of Surveillance and
EPA’s Office of Pesticide Programs (OPP) to determine
Compliance, Office of Research, and Office of Minor Use
whether a particular product meets the definition of a new
and Minor Species. Most of the offices are further orga-
animal drug or a pesticide. Some products used in or on
nized into major divisions and teams. Information about
animals to treat or prevent parasites are regulated by the
each office and their roles and responsibilities can be
FDA under the FFDCA Act, and some are regulated by
found on the CVM website (FDA/CVM, 2015a).
the EPA under the Federal Insecticide, Fungicide, and
This chapter focuses on FDA regulation of new animal
drugs, briefly describing parts of the approval process and Rodenticide Act (FIFRA). The term “pesticide” means, in
examples of postapproval activities conducted to monitor drug part, any substance or mixture of substances intended for
safety and effectiveness while the drug is marketed. Animal preventing, destroying, repelling, or mitigating any pest,
food is also briefly discussed. A comprehensive description of or intended for use as a plant regulator, defoliant, or des-
these topics is not in the scope of this chapter, but more infor- sicant, other than any article that is a new animal drug
mation is readily available on the CVM website. Some juris- under the FFDCA, or is an animal feed under FFDCA
dictional considerations and definitions are provided first. that bears or contains a new animal drug (40 CFR
y152.3). Pesticide ingredients are evaluated by EPA to
ensure that they meet federal safety standards to protect
Regulation of Animal Health Products: human and animal health and the environment.
Jurisdiction Considerations and Information about EPA’s regulation of pesticides can be
found on the EPA website (US EPA, 2017).
Regulatory Definitions
Animal drugs, devices, and foods are regulated by the
Animal health products are typically regulated by one of FDA under the FFDCA. The CVM’s jurisdiction team
three federal agencies: the FDA, the Environmental also works with colleagues within the CVM and the FDA