Drug – bio-affecting and body treating compositions – Inorganic active ingredient containing – Elemental chlorine or elemental chlorine releasing inorganic...
Reexamination Certificate
1999-07-15
2002-11-05
Pak, John (Department: 1616)
Drug, bio-affecting and body treating compositions
Inorganic active ingredient containing
Elemental chlorine or elemental chlorine releasing inorganic...
C424S438000, C424S439000, C424S441000, C424S442000, C424S661000, C424S665000, C424S718000, C426S332000, C426S335000, C426S532000, C426S807000, C514S081000, C514S129000, C514S557000, C514S574000
Reexamination Certificate
active
06475527
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to a process for the control of enteric bacterial pathogens in animals using chlorate ion.
2. Description of the Prior Art
Despite the efforts of researchers and public health agencies, the incidence of human infections from enteropathogenic bacteria such as Salmonella,
E. coli
O157:H7, and Campylobacter has increased over the past 20 years. For example, the number of actual reported cases of human Salmonella infection exceeds 40,000 per year. However, the Communicable Disease Center estimates that the true incidence of human Salmonella infections in the U.S. each year may be as high as 2 to 4 million. The USDA Economic Research Service has recently reported that the annual cost of the food borne illnesses caused by six common bacterial pathogens, Campylobacter spp.,
Clostridium perfringens, Escherichia coli
0157:H7
, Listeria monocytogenes
, Salmonella spp., and
Staphylococcus aureus
, ranges from 2.9 billion to 6.7 billion dollars (Food Institute Report, USDA, AER, December, 1996). In addition to the impact of enteric pathogens on human health, many of these bacteria also cause significant infections in animals. For example, Salmonella infections in swine alone cost the United States swine industry more than 100 million dollars annually (Schwartz, 1990, “Salmonellosis in Midwestern Swine”, In: Proceedings of the United States Animal Health Assoc., pp. 443-449).
Animal food products remain a significant source of human infection by these pathogens. Contamination of meat and poultry with many bacterial food-borne pathogens, including the particularly onerous pathogens Campylobacter spp.,
Escherichia coli
0157:H7, and Salmonella spp., often occurs as a result of exposure of the animal carcass to ingesta and/or fecal material during or after slaughter. Any of the above-mentioned pathogens can then be transmitted to humans by consumption of meat and poultry contaminated in this manner.
Preharvest control of enteropathogenic bacteria is a high priority to the food industry. However, few products have been developed to facilitate such efforts. Currently, preharvest pathogen control within the poultry industry is accomplished through use of competitive exclusion cultures or probiotics. In fact, at this time, only one such product, developed by Nisbet et al. of the USDA Agricultural Research Service (U.S. Pat. No. 5,478,557) and sold under the trademark PREEPMT (Milk Specialties Biosciences, Dundee, Ill.), is available commercially in the United States. Moreover, the administration of competitive exclusion cultures is preferably targeted to very young animals. Immune lymphokines (ILK) have also been recently developed for protecting poultry from colonization with enteric pathogens as described by Ziprin et al. (1989, Poult. Sci., 68:1637-1642), McGruder et al. (1993, Poult. Sci., 72:2264-2271), Ziprin et al. (1996, Avian Dis., 40:186-192), and Tellez et al. (1993, Avian Dis., 37:1062-1070), and more recently by Kogut et al. (U.S. Pat. Nos. 5,891,443 and 5,691,200). However, despite these advances, the need persists for technologies for controlling enteric pathogens in animals, and particularly for the treatment of animals immediately prior to slaughter.
SUMMARY OF THE INVENTION
We have now discovered a method and compositions for controlling food borne enteric bacterial pathogens in animals. Populations of enteropathogenic bacteria may be substantially reduced by treatment of animals with an effective amount of a compound of the formula X
m
(ClO
3
)
n
, wherein X is a cationic moiety and m and n are independently selected from integers necessary to provide a net valency of the compound of 0. The compounds may be administered orally, providing a reduction in the populations of the enteropathogenic bacteria in the alimentary tract of the animal, or they may be applied externally onto the animal to reduce the populations of any such bacteria which may be present as contaminants on the surface of the animal. The method and compositions are particularly useful for the control of Salmonella species, enteropathogenic
Escherichia coli
, and some Clostridia species.
In accordance with this discovery, it is an object of this invention to provide a method for controlling food borne enteropathogenic bacteria in animals.
Another object of this invention is to provide a method for controlling enteropathogenic bacteria in the gastrointestinal tract of animals without adversely effecting populations of commensal or beneficial bacteria.
Yet another object of this invention is to provide a method for significantly reducing the populations of enteropathogenic bacteria in meat producing animals prior to slaughter.
Other objects and advantages of this invention will become readily apparent from the ensuing description.
DETAILED DESCRIPTION OF THE INVENTION
Compounds of the formula X
m
(ClO
3
)
n
, wherein X is a cationic moiety and m and n are independently selected from integers necessary to provide a net valency of the compound of 0, and which compounds release free chlorate ion (ClO
3
−
) while in solution, are effective for controlling or killing several different enteropathogenic bacteria. A variety of cationic moieties are suitable for use herein, and examples thereof include but are not limited to H, alkali-metals, alkaline-earth metals, transition metals, and cationic radicals such as ammonium groups. Generally, chloric acid and salts thereof (i.e., chlorates) are preferred for use herein, with sodium chlorate and potassium chlorate being particularly preferred.
Enteropathogenic bacteria which may be controlled with X
m
(ClO
3
)
n
include but are not limited to Salmonella species, enteropathogenic
Escherichia coli
0157:H7, and some Clostridia species. Without wishing to be bound by theory, these pathogens all possess respiratory nitrate reductases which are capable of reducing the chlorate ion, which is dissociated from these compounds when they are in solution, to the cytotoxic chlorite ion in an anaerobic environment. Consequently, only those bacteria which possess a respiratory nitrate reductase are effected by this invention (i.e., killed by chlorite ion). It is also envisioned that Campylobacter species may be subject to control using the X
m
(ClO
3
)
n
of this invention. Because relatively few other genera and species of bacteria contain these enzymes, including most commensal and mutualistic (beneficial) bacteria, other non-pathogenic bacteria are generally not effected.
Depending upon the route of treatment, the X
m
(ClO
3
)
n
compounds are effective for reducing the populations of the enteropathogenic bacteria within the gastrointestinal tract of animals when administered orally, or for reducing the populations of these bacteria which may be present as contaminants on the surfaces of the animal when applied externally. The process may be used for the treatment of a wide variety of animals, including humans. However, without being limited thereto, the process is preferably used for the treatment of meat-producing animals, such as bovine, fowl, porcine, ovine, and equine, and particularly cattle, chickens, turkeys, ducks, quail, geese, pigs, and sheep.
In a first preferred embodiment, the X
m
(ClO
3
)
n
compounds are administered orally to the subject animal for reducing (killing) populations of the enteropathogenic bacteria in the gastrointestinal tract. Typically, the compounds will be introduced into the alimentary tract by combining with the animal's feed or water, followed by oral ingestion thereof. However, it is also understood that the compounds may be administered separately or in combination with other conventional treatments.
In an alternative preferred embodiment, the X
m
(ClO
3
)
n
compounds are applied onto meat producing animals for reducing populations of the enteropathogenic bacteria on its head, torso and/or appendages. It is generally recognized that the hides, feathers, hair, feet and/or hoofs of such animals often become contaminated with fecal material, and may subs
Anderson Robin C.
Nisbet David J.
Stanker Larry H.
Deck Randall E.
Fado John D.
Pak John
Silverstein M. Howard
The United States of America as represented by the Secretary of
LandOfFree
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