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With nearly 3,000 (and likely many, many more) sickened and over 40killed, it is amazing that the owners of these establishments whopoisoned and killed their customers are not sitting in a jail cell. For those who have forgotten the facts: Jensen Farms Outbreak - As of December 8, 2011, 146 persons infected with any of the fouroutbreak-associated strains of Listeria monocytogenes were reportedto CDC from 28 states. Thirty deaths were reported: Colorado (8),Indiana (1), Kansas (3), Louisiana (2), Maryland (1), Missouri (3),Nebraska (1), New Mexico (5), New York (2), Oklahoma (1), Texas(2), and Wyoming (1). In addition, one woman pregnant at the timeof illness had a miscarriage. Since December 8 th an additional six people have died after suffering Listeriainfections. During the inspection, we also collected environmental swabs fromvarious locations and surfaces throughout your packing facility.FDA conducted laboratory analyses, which determined that 13 of the39 total environmental swabs were positive for outbreak strains ofListeria monocytogenes. PFGE analysis determined that eleven of thepositive swabs matched the strain of Listeria monocytogenesrepresented by cluster #2, one positive swab matched the strain ofListeria monocytogenes represented by cluster #4, and one positiveswab matched the strain of Listeria monocytogenes represented bycluster #3. Further, one swab was positive for a strain of Listeriamonocytogenes that did not match any of the outbreak strains. Thesepositive swabs were taken from different locations throughout thewashing and packing areas in your facility, all of which wereeither food contact surfaces or areas adjacent to food contactsurfaces. This significant percentage of swabs that tested positivefor outbreak strains of Listeria monocytogenes demonstrateswidespread contamination throughout your facility and indicatespoor sanitary practices in the facility. In addition, in its inspection report, the FDA identified thefollowing factors as those that most likely contributed to theintroduction, spread, and growth of Listeria monocytogenes in thecantaloupes: Introduction: There could have been low level sporadic Listeria monocytogenes inthe field where the cantaloupe were grown, which could have beenintroduced into the packing facility A truck used to haul culled cantaloupe to a cattle operation wasparked adjacent to the packing facility and could have introducedcontamination into the facility Spread: The packing facility"s design allowed water to pool on thefloor near equipment and employee walkways; The packing facility floor was constructed in a manner that made itdifficult to clean The packing equipment was not easily cleaned and sanitized; washingand drying equipment used for cantaloupe packing was previouslyused for postharvest handling of another raw agriculturalcommodity. Growth: There was no pre-cooling step to remove field heat from thecantaloupes before cold storage. As the cantaloupes cooled theremay have been condensation that promoted the growth of Listeriamonocytogenes. Wright County Egg Outbreak - The CDC identified a nationwide sustained increase in the numberof Salmonella Enteritidis. From May 1 to November 30, 2010,approximately 1,939 illnesses were reported that are likely to beassociated with Jack DeCoster"s Wright County Egg in Iowa. • Chicken manure located in the manure pits below the egglaying operations was observed to be approximately 4 feet high to 8feet high at the following locations: Layer 1 – House 1;Layer 3 – Houses 2, 7, 17, and 18. The outside access doorsto the manure pits at these locations had been pushed out by theweight of the manure, leaving open access to wildlife ordomesticated animals. • Un-baited, unsealed holes appearing to be rodent burrowslocated along the second floor baseboards were observed insideLayer 1 – Houses 1-9 and 11-13; Layer 2 – Houses 7 and11; Layer 3 – Houses 1, 3, 4, 5, and 6; Layer 4 – House3. • Dark liquid which appeared to be manure was observed seepingthrough the concrete foundation to the outside of the laying housesat the following locations: Layer 1 – Houses 1, 2, 3, 4, 5,8, 11, 12, and 14; and Layer 3 – Houses 1, 8, 13, and 17. • Standing water approximately 3 inches deep was observed atthe southeast corner of the manure pit located inside Layer 1– House 13. • Un-caged birds (chickens having escaped) were observed inthe egg laying operations in contact with the egg laying birds atLayer 3 – Houses 9 and 16. The un-caged birds were using themanure, which was approximately 8 feet high, to access the egglaying area. • Layer 3 – House 11, the house entrance door to accessboth House 11 and 12 was blocked with excessive amounts of manurein the manure pits. • There were between 2 to 5 live mice observed inside the egglaying Houses 1, 2, 3, 5, 7, 9, 10, 11, and 14. • Live and dead flies too numerous to count were observed atthe following locations inside the egg laying houses: Layer 1– Houses 3, 4, 6, 8, 9, 11, and 12; Layer 2 – Houses 7and 11; Layer 3 – Houses 3, 4, 4, 5, 7, 8, 15, 16, 17, and18. The live flies were on and around egg belts, feed, shell eggsand walkways in the different sections of each egg laying area. Inaddition, live and dead maggots too numerous to count were observedon the manure pit floor located in Layer 2 – House 7. Peanut Corporation of America Outbreak - As April 20, 2009, 714 persons infected with the outbreak strainof Salmonella Typhimurium have been reported from 46 states. Infection may have contributed to nine deaths: Idaho (1), Minnesota(3), North Carolina (1), Ohio (2), and Virginia (2). "Turn them loose," Parnell had told his plant manager in aninternal e-mail disclosed at the House hearing. The e-mail referredto products that once were deemed contaminated but were cleared ina second test last year. Parnell ordered products identified with salmonella to be shippedand quoting his complaints that tests discovering the contaminatedfood were "costing us huge $$$$$." Parnell insisted that the outbreak did not start at his plant,calling that a misunderstanding by the media and public healthofficials. "No salmonella has been found anywhere else in ourproducts, or in our plants, or in any unopened containers of ourproduct." Parnell complained to a worker after they notified him thatsalmonella had been found in more products. "I go thru this aboutonce a week," he wrote in a June 2008 e-mail. "I will hold mybreath .......... again." The Law - The Federal Food, Drug, and Cosmetic Act was passed by Congress in1938 in reaction to the growing public safety demands. The primarygoal of the Act is to protect the health and safety of the publicby preventing deleterious, adulterated or misbranded articles fromentering interstate commerce. Under section 402(a)(4) of the Act, afood product is deemed "adulterated" if, inter alia,the food was "prepared, packed, or held under insanitaryconditions whereby it may have become contaminated with filth, orwhereby it may have been rendered injurious to health." Afood product is also considered "adulterated" if itbears or contains any poisonous or deleterious substance which mayrender it injurious to health. If, however, the "poisonous ordeleterious" substance is not an added substance, the food isnot considered adulterated if the quantity of the substance in theparticular food item does not ordinarily render the food injuriousto health. The Act authorizes factory inspections and added injunctions to theenforcement tools at the Food and Drug Administration's (FDA)disposal. Following hearings in the early 1950s, a series of lawsaddressing pesticide residues (1954), food additives (1958), andcolor additives (1960) gave the FDA much tighter control over thegrowing list of chemicals entering the food supply, putting theonus on manufacturers to establish their safety. The Act standstoday as one of the primary means by which the federal governmentenforces food and pharmaceutical safety standards. Chapter III of the Act addresses prohibited acts, subjectingviolators to both civil and criminal liability. Provisions forcriminal sanctions state that: * Felony violations include adulterating or misbranding a food,drug, or device, and putting an adulterated or misbranded food,drug, or device into interstate commerce. Any person who commits aprohibited act violates the FDCA. A person committing a prohibitedact "with the intent to defraud or mislead" is guilty of a felonypunishable by three years imprisonment. * A misdemeanor conviction under the FDCA, unlike a felonyconviction, does not require proof of fraudulent intent, or even ofknowing or willful conduct. Rather, a person may be convicted if heor she held a position of responsibility or authority in a firmsuch that the person could have prevented the violation.Convictions under the misdemeanor provisions are punishable by upto one-year imprisonment or a $1000 fine. The Act also includes provisions for individual liability,specifically. Individuals who are responsible for criminal behaviorare normally named as defendants along with corporate entitiesthrough which crimes are committed. A corporate defendant'swillingness to enter a plea of guilty is accordingly not a basisfor dismissal of charges against an individual. Individualdefendants are generally the highest-ranking officials in a firmwho made decisions that violated the law, along with others whoactively participated in fraudulent activity. Thus, presidents ofcorporations and managers of facilities where violations take placeare often appropriate defendants. References 1. Carol Benjamin and Betsy J. Floman, Federal Food and Drug ActViolations, 31 Am. Crim. L. Rev. 629 (1994). 2. 21 U.S.C. §331. 3. 21 U.S.C. §333(a)(2). 4. See United States v. Park, 421 U.S. 658, 674-77 (1975); UnitedStates v. Dotterweich, 320 U.S. 277, 280-81 (1943). 5. See United States v. Marcus, 82 F.3d 606 (4th Cir. 1996)(President/CEO of generic drug manufacturing firm prosecuted foraltering heart medication formula without adequate testing or FDAapproval); United States v. James V. Mays, 77 F.3d 906 (6th Cir.1996); United States v. Samuel and Patsy Mays, 69 F.3d 116 (6thCir. 1995), cert. denied, 116 S. Ct. 2504 (1996) (President,Secretary/Treasurer, and Operations Manager of juice concentratecompany prosecuted for secretly adding 20,000,000 pounds of sugarto product sold as pure 100% orange concentrate). Can you say "jail time?". We are high quality suppliers, our products such as Track Lighting Spotlights , China Dining Room Pendant Lights for oversee buyer. To know more, please visits Bathroom Mirror Light Fixtures.
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