Animal Drug Availability Act 1996
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The Animal Drug Availability Act 1996 (ADAA) is a
United States federal law The law of the United States comprises many levels of codified and uncodified forms of law, of which the most important is the nation's Constitution, which prescribes the foundation of the federal government of the United States, as well as ...
.
President Clinton William Jefferson Clinton ( né Blythe III; born August 19, 1946) is an American politician who served as the 42nd president of the United States from 1993 to 2001. He previously served as governor of Arkansas from 1979 to 1981 and again ...
signed the ADAA into law in October 1996. While still obligated to
public health Public health is "the science and art of preventing disease, prolonging life and promoting health through the organized efforts and informed choices of society, organizations, public and private, communities and individuals". Analyzing the det ...
concerns, the Act intends more rapid drug approval and
medicated feed Medicated feed is an American legal terminology. As of 2019, it was defined in 21 CFR § 558.3. History and synopsis The Animal Drug Availability Act 1996 introduced the term of ''new animal drug'', which should be applied in combination with trad ...
approval to assist the
animal health Veterinary medicine is the branch of medicine that deals with the prevention, management, diagnosis, and treatment of disease, disorder, and injury in animals. Along with this, it deals with animal rearing, husbandry, breeding, research on nutri ...
industry.


Overview

The Animal Drug Availability Act specifies the conditions in which the U.S. Secretary of Health can refuse the application of a new drug. The possibility of an unconsidered hazard is not a permitted ground for refusing an application. The implications of the act include: * more relaxed controls on field studies unless requested and justified by the
Center for Veterinary Medicine The Center for Veterinary Medicine (CVM) is a branch of the U.S. Food and Drug Administration (FDA) that regulates the manufacture and distribution of food, food additives, and drugs that will be given to animals. These include animals from whi ...
; * a strict demand for proof of efficacy; * a definition of adequate and well controlled procedures for
field trial A field trial is a competitive event for gundogs. Field trials are conducted for pointing dogs and setters, retrievers and spaniels, with each assessing the different types various working traits. In the United States, field trials are also co ...
s; * supporting labeling focused on the range of recommended or acceptable dosages; * the creation of
Veterinary Feed Directive A Veterinary Feed Directive (VFD) is, under the law of the United States, a written authorization allowing animal keepers to use animal feed containing specified antibiotics in accordance with Food and Drug Administration (FDA) approved directions ...
drugs as a new category of
animal drugs An animal drug (also veterinary drug) refers to a drug intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals. Regulation United States The U.S. Food and Drug Administration (FDA) has the broad mandat ...
.


Details


Antibiotics in agriculture before ADAA statute

Antibiotic use was once common practice before the ADAA approved the use of
antibacterial An antibiotic is a type of antimicrobial substance active against bacteria. It is the most important type of antibacterial agent for fighting bacterial infections, and antibiotic medications are widely used in the treatment and prevention ...
s in animal feed. For 1985 the estimated annual antibiotic use in the
U.S. The United States of America (U.S.A. or USA), commonly known as the United States (U.S. or US) or America, is a country primarily located in North America. It consists of 50 states, a federal district, five major unincorporated territori ...
are as follows.
Cow Cattle (''Bos taurus'') are large, domesticated, cloven-hooved, herbivores. They are a prominent modern member of the subfamily Bovinae and the most widespread species of the genus ''Bos''. Adult females are referred to as cows and adult ma ...
s were given 1 million pounds of antibiotics, 0.55 million pounds for swine, and 0.67 million pounds for
poultry Poultry () are domesticated birds kept by humans for their eggs, their meat or their feathers. These birds are most typically members of the superorder Galloanserae (fowl), especially the order Galliformes (which includes chickens, quails, ...
as therapeutic use, constituting legitimate
bacterial infection Pathogenic bacteria are bacteria that can cause disease. This article focuses on the bacteria that are pathogenic to humans. Most species of bacteria are harmless and are often beneficial but others can cause infectious diseases. The number ...
treatment. Quantities for subtherapeutic use specified as; increase the daily body weight gain, improve the food-to-
weight gain Weight gain is an increase in body weight. This can involve an increase in muscle mass, fat deposits, excess fluids such as water or other factors. Weight gain can be a symptom of a serious medical condition. Description Weight gain occurs w ...
ratio, and increase the voluntary intake of food equals 3.1 million pounds in cows, feeding swine with 11 million pounds, and poultry with 2 million pounds. For each of these
livestock Livestock are the domesticated animals raised in an agricultural setting to provide labor and produce diversified products for consumption such as meat, eggs, milk, fur, leather, and wool. The term is sometimes used to refer solely to animal ...
species the subtherapeutic use is substantially higher: this contributes unnecessarily to possible microbial resistance. Those quantities preceded the ADAA, so approving veterinary feed including antibiotics for market contributed to progressing livestock medication. In 2003 the over 24 million pounds of antibiotics used for subtherapeutic use were distributed as follows: 10.3 million pounds for swine, 10.5 million pounds fed to poultry, and 3.7 million pounds given to cows.


Antibiotic resistant bacteria

The Union of Concerned Scientists estimate healthy hogs receive 5 million pounds of two
tetracycline antibiotics Tetracyclines are a group of broad-spectrum antibiotic compounds that have a common basic structure and are either isolated directly from several species of ''Streptomyces'' bacteria or produced semi-synthetically from those isolated compounds. T ...
, this is 60% greater than the total volume of antibiotics given to sick humans. Medical doctors advise appropriate use of antibiotics, specifically finishing the full antibiotic regimen with consequence of the strongest survivors recuperating and worsening the
infection An infection is the invasion of tissues by pathogens, their multiplication, and the reaction of host tissues to the infectious agent and the toxins they produce. An infectious disease, also known as a transmissible disease or communicable dis ...
. Antibiotics create an environment appropriate for bacteria to evolve resistant strains, since when faced with death any survivors have become more appropriately adapted. This is the same principle as Darwinian evolution by natural selection. The development of resistant
bacteria strain In biology, a strain is a genetic variant, a subtype or Axenic, a culture within a biological species. Strains are often seen as inherently artificial concepts, characterized by a specific intent for genetic isolation. This is most easily observed ...
s can be attributed to antibiotic use because resistance to the drugs was previously unobserved. The
World Health Organization The World Health Organization (WHO) is a specialized agency of the United Nations responsible for international public health. The WHO Constitution states its main objective as "the attainment by all peoples of the highest possible level of ...
states: “Shortly after the licensing and use in livestock of
fluoroquinolone A quinolone antibiotic is a member of a large group of broad-spectrum bacteriocidals that share a bicyclic core structure related to the substance 4-quinolone. They are used in human and veterinary medicine to treat bacterial infections, as wel ...
, a powerful new class of
antimicrobial An antimicrobial is an agent that kills microorganisms or stops their growth. Antimicrobial medicines can be grouped according to the microorganisms they act primarily against. For example, antibiotics are used against bacteria, and antifungals ar ...
s, fluoroquinolone-resistant Salmonella and Campylobacter isolations from animals, and humans increased.” Most production for fast food incorporates antibiotics, but there has been a push by major companies including
McDonald's McDonald's Corporation is an American multinational fast food chain, founded in 1940 as a restaurant operated by Richard and Maurice McDonald, in San Bernardino, California, United States. They rechristened their business as a hambur ...
, Subway and
Carl's Jr. Carl's Jr. Restaurants LLC is an American fast food restaurant chain operated by CKE Restaurant Holdings, Inc., with franchisees in North & South America, Asia, Oceania, Europe and Africa. In 2016, ''Entrepreneur'' listed Carl's Jr. as No. 54 ...
to discontinues fluoroquinolone use in associated feedlots.


Vancomycin-resistant enterococcus infection

VRE infection has been positively correlated to
avoparcin Avoparcin is a glycopeptide antibiotic effective against Gram-positive bacteria. It has been used in agriculture as an additive to livestock feed to promote growth in chickens, pigs, and cattle. It is also used as an aid in the prevention of nec ...
use; around the time of Americas ADAA in 1996
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banned this specific growth promoter and found the flocks at slaughter had a decreased occurrence of VRE to 12% in 1998 from 82% in 1995.{{cite journal, last1=Wegener, first1=Henrik C., last2=Aarestrup, first2=Frank M., last3=Jensen, first3=Lars Bogo, last4=Hammerum, first4=Anette M., last5=Bager, first5=Flemming, title=Use of antimicrobial growth promoters in food animals and ''Enterococcus faecium'' resistance to therapeutic antimicrobial drugs in Europe., journal=Emerging Infectious Diseases, date=1999, volume=5, issue=3, pages=329–35, doi=10.3201/eid0503.990303, pmid=10341169, pmc=2640785


References

Veterinary medicine in the United States Antibiotics United States federal health legislation Acts of the 104th United States Congress Agriculture in the United States Biotechnology products Livestock Medicated feed