Food or edible material: processes – compositions – and products – Packaged or wrapped product – Having consumer oriented diverse utility
Reexamination Certificate
2000-11-27
2003-03-25
Cano, Milton I. (Department: 1761)
Food or edible material: processes, compositions, and products
Packaged or wrapped product
Having consumer oriented diverse utility
C426S129000, C426S643000, C426S389000, C426S412000, C426S506000, C426S521000, C426S524000, C452S014000, C452S015000
Reexamination Certificate
active
06537601
ABSTRACT:
BACKGROUND OF THE INVENTION
This application relates to a process of treatment of raw molluscan shellfish, such as crustaceans, and more particularly to a process for destroying bacteria in shellfish and other crustaceans, such as for example bivalve mollusks, as well as to a method of shucking molluscan shellfish without affecting sensory qualities of the shellfish.
In recent years, considerable attention has been paid in the media to tragic results of consumption of raw oysters where the individuals became infected with life threatening pathogenic organisms. Such bacteria as
Vibrio vulnificus
and
Vibrio parahaemolyticus
live in marine environment, especially in warm waters, usually higher than 25 degrees C. Other organisms of concern are. Vibriones:
Vibrio cholerae
O1,
Vibrio cholerae
non-O1,
Vibrio mimicus, Vibrio Fluvalis, Vibrio furnissii, Vibrio hollisae, Vibrio alginolyticus, Listeria monocytogenes,
Salmonella (nontyphoidal) and
Salmonella typhi, Campylobacter jejuni, Escherichia coli, Yersinia enterocolitica, Clostridium botulinum, Clostridium perfringens,
Shigella,
Staphylococcus aureus.
Some other organisms that can cause disease in normal, healthy adults and which were either isolated from seafood or proven pathogen in seafood are: Helminths (Anisaxis simplex and other helminths); Viruses: poliovirus, other picomaviruses, Norwalk/Snow Mountain/small round viruses, or SRVS); Hepatitis A and E and non-B Hepatitis, and bacillus cereus. Additionally, there is a series of organisms that can cause disease most often in special population groups; these are rotavirus and Listeria.
Further, some organisms associated with seafood have uncertain roles as food-borne pathogens; they are
Aeromonas hydrophilla,
Plesiomonas Shigelloides and
Edwardsiella tarda.
Some of the above organisms occur naturally in water; some are the result of water pollution, and some are associated with processing and preparation of food, for example cross-contamination or time/temperature abuse, as well as infected food handlers.
Vibrio Vulnificus
has been isolated from estuarine and marine waters of the U.S. Gulf Coast, East Coast, and West Coast; it was also reported on other continents. The bacteria may transfer from water to the shellfish inhabiting the body of water, especially filter-feeding mollusks, where bacteria can multiply mostly in the gut region.
Vibrio is a genus of motile curved and rod-shaped Gram-negative bacteria. Other well-known vibriones are
Vibrio cholerae
and
Vibrio Parahaemolyticus. Vibrio Parahaemolyticus
is a common cause of gastroenteritis in some cultures, where consumption of raw seafood is particularly high, such as for example Japan.
Vibrio Vulnificus
is a halophilic species, the strains of which are similar to
Vibrio Parahaemolyticus
and
Vibrio alginolyticus. Vibrio Vulnificus
thrives in warm waters. Ingesting uncooked or undercooked shellfish that contain vibriones, especially raw oysters, transmits it. After a brief incubation period, often as short as two hours,
Vibrio Vulnificus
causes septicemia and cellulitis. Physical symptoms include indigestion, cramps, nausea, vomiting, headache, weakness, fever and chills.
Usually, this food poisoning subsides spontaneously within two days. Occasionally, however, it is more severe. Persons with pre-existing hepatic disease or compromised immune system are especially in danger. Infection may occur not only through digestion of raw seafood but also from wound infection following exposure to seawater.
While fatal outcomes are extremely rare, the unfortunate events have been widely publicized, making the public aware of a potential life threatening exposure to the Vibriones and other pathogens. The fear of the bacteria poisoning is so high that the federal government issued a special warning advising the public of the potential dangers of raw oyster consumption. It has also been suggested that no harvesting of oysters be conducted during warm months in the Gulf of Mexico, so as to minimize the health risk associated with such food poisoning. Other serious threat is presented by
Vibrio cholerae
that presents a threat to public health and can even cause an epidemic, if not checked in time. Other seafood-associated organisms are listed above.
Public fear of the potential dangers associated with bacteria poisoning through raw oyster consumption adversely affected an important Louisiana industry—oyster harvesting. Market share of Gulf oysters shrunk, and many fishermen found that even oysters harvested from safe beds are not in such a great demand as they used to be and that the price has fallen drastically.
Still, consumption of raw molluscan shellfish and other crustaceans is so widespread in the South that many restaurants continue to carry raw oysters as part of their menu. Even though many restaurants post a warning sign of the possible danger to a segment of the public with liver or immune system disorders it rarely stops dedicated gourmands.
To prevent poisonous consumption of pathogenic organisms, various methods have been suggested for treating raw shellfish, for example with heat or irradiation, in an effort to eliminate or minimize the public health danger. For example, U.S. Pat. No. 5,679,392 (the '392 patent) issued on Oct. 21, 1997 for “A Heat Treatment of Raw Molluscan Shellfish” discloses a method for preparing raw molluscan shellfish in the shell or out of the shell employing a mild heat treatment and cold storage. According to the '392 patent, the shellfish placed in a polymer or metallized bag is lowered into a circulating bath of water at a temperature of between 120° F.-130° F. for 30-45 minutes, after which time it is cooled in a cold water bath to a temperature between 28° F.-32° F. The product is then transferred to a cool water bath, where it is retained for 15-20 minutes and becomes ready for storage in a refrigerated state at 32° F.-34° F. The patent disclosure asserts that the mollusk remains in a raw state and in the shell throughout the process, while the number of pathogenic bacteria is reduced to an undetectable level.
While this process may be satisfactory for some products, it is believed that heating of the shellfish to a temperature above 120 degrees Fahrenheit for a long period of time (in excess of 15 minutes) will substantially affect the sensory qualities of the product, making it less desirable for consumption as raw shellfish. High heat treatment as a means of controlling microorganisms and bacteria in food products results in diminished taste and reduced nutritional content. Therefore, substantially elevated temperatures are considered unsatisfactory for processing of raw oysters where the purpose of the process is to retain sensory qualities of oysters and sell them on a halfshell.
Ionizing irradiation was tested as one of the methods of destroying harmful bacteria in live shellfish. However, this process is relatively expensive and has not yet obtained approval by the Federal Food and Drug Administration. Other known attempts to purify raw oysters involve depuration, wherein oysters are soaked in a tank of water for days at a time in an attempt to purge and cleanse the mollusk of the bacteria. So far, there have been no reports on the success of this method in destruction of bacteria in raw oysters.
Other suggested methods of destroying
Vibrio Vulnificus
involve cold, freezing, vacuum packaging, use of GRAS (diacetyl) compounds, suspension relaying into offshore water, and food condiment treatment. While some of these methods are relatively simple to implement, most of them have problems—either too expensive, ineffective, time consuming, or failed to receive FDA approval.
It was also suggested to refrigerate oysters immediately after harvesting at 7.2 degrees C. or less in an attempt to control multiplication of bacteria. However, cold treatment greatly reduces but does not eliminate bacteria present in oysters during harvesting for a storage period considered normal for shucked or shell stock oysters.
Heat treatment, for example at 50 degrees C.
Becker Drew
Cano Milton I.
Innovatit Seafood Systems LLC
Keaty Professional Law Corporation
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