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A glitch in the glitter over Las Vegas has temporarily turned off some of the city's well-known glitz.
Last December, FDA declared a temporary moratorium on outdoor laser light shows within a 20-mile radius of the three Las Vegas-area airports because the lights were "flash blinding" and distracting airline pilots during takeoffs and landings there.
The lights can go back on when the hotel casinos can demonstrate to FDA and the Federal Aviation Administration that their laser light shows will not distract and temporarily impair aircraft personnel's vision during critical and sensitive flight periods.
In late 1995, the FAA reported to FDA that 52 incidents of aircraft "illuminations" from laser lights had occurred in or near Las Vegas since 1993. Eleven incidents resulted in temporary blindness of flight crew members, and 24 took place during critical flight times.
Although no aircraft accidents occurred, FDA said the temporary ban is necessary to protect public safety. "We must all do our parts to prevent the occurrence of a tragedy that could cost hundreds of lives," FDA said in the moratorium issued Dec. 11, 1995.
FDA also said it would not "hesitate to extend" the moratorium to other cities or nationwide if problems arise in other locations. The ban mainly affects three hotel casinos that hold variances, or permits, from FDA to display laser light shows in the sky. FDA regulates laser light shows, along with all other laser equipment--from surgical instruments to grocery store checkout scanners--under the Radiation Control for Health and Safety Act and the Medical Device Amendments to the federal Food, Drug, and Cosmetic Act.
According to Gary Zaharek, an FDA electrooptics specialist, outdoor high-power laser light displays became popular in Las Vegas about three years ago as a way to attract tourists and customers. Competition had been intense among operators, he said.
FAA began receiving pilot complaints about Las Vegas-area outdoor laser lights in late 1993. The first report involved a pilot who took off from Las Vegas and was treated for corneal irritation at his destination, Phoenix, Ariz. His condition may have been caused when the pilot rubbed his eyes after the laser light incident.
In early 1994, Ralph Kirch, another FDA electrooptics specialist, investigated Las Vegas hotel casinos displaying laser light shows. One was operating without a variance. After several visits by Kirch, the casino agreed to stop showing the laser light shows.
The other three, while variance holders, were not following proper procedures. Among their violations were failing to:
In 1994 and 1995, Kirch and Zaharek made a number of follow-up visits to the laser light show operations and found many repeat violations.
Then, on Oct. 30, 1995, a Southwest Airlines' pilot in control of a flight departing McCarran International Airport in Las Vegas was temporarily blinded by a laser light. According to news reports, the incident was serious enough to force the plane's captain to take control until the pilot regained his sight. "Had it hit me and the other pilot simultaneously, I shudder to think what would have happened," the pilot told reporters.
Under the moratorium, manufacturers and operators will be permitted to beam their laser light shows into the sky only if they can demonstrate that their shows comply with FAA's recommended interim rules. They also must develop and follow quality assurance programs that, among other things, specify radiant power and energy, beam divergence, and pointing accuracy of lasers.
Since the ban, only one variance holder has received FDA's permission to project an outdoor laser light show. That show, a special two-day event, did not include beams into the sky.
At press time in April, FDA was working with FAA, laser industry groups, the U.S. Army and Air Force, the Society of Automotive Engineers, and others to develop final guidelines on projecting laser light shows into airspace.
Paula Kurtzweil is a member of FDA's public affairs staff.
On May 18, 1995, U.S. Judge Walter H. Rice, Southern District of Ohio, Western Division, ruled that live animals, raised for food and intended for slaughter are food under the Federal Food, Drug, and Cosmetic Act. Rice's ruling broke judicial ground because it was the first time a court officially recognized FDA's jurisdiction over live animals intended for slaughter. The judge also reaffirmed that any party who has purchased an adulterated article--including live food animals--may be held liable for introduction of the article into interstate commerce.
Such was the case with two Ohio livestock dealers who, FDA charged, had bought and sold live hogs with illegal amounts of drugs in the animals' tissues.
On Oct. 5, 1995, livestock dealers Ronald Tuente and Roger Tuente, owners of Tuente Livestock Inc., Yorkshire, Ohio, went out of business after signing a consent order of injunction prohibiting them from buying and selling livestock.
FDA's investigation of the Tuentes and their firm began in September 1987 after the U.S. Department of Agriculture found illegal residues of the animal antibiotic sulfamethazine in the tissue of hogs the Tuentes had sold for slaughter. Sulfamethazine in animals sold for human consumption may cause allergic and other adverse reactions in some people. In addition, it is a potential carcinogen.
Under the Food, Drug, and Cosmetic Act, FDA can hold responsible any party in the distribution chain who introduces an adulterated product into interstate commerce. This includes both the party that actually adulterated the product and any other party that distributes the product after adulteration has occurred.
To ensure that the livestock sold for slaughter do not have illegal residues of drugs, FDA advises livestock dealers to do business with producers who issue drug-free certificates or supply other documentation of animals' medication history. The agency requires the certificates when companies' livestock test positive for illegal drug residues. In addition, FDA requires dealers to segregate each producer's animals or tattoo or tag each animal with a distinct producer's identification. This allows FDA to trace violations to the source.
After inspecting the firm on Sept. 9, FDA's Cincinnati district issued a Notice of Adverse Findings because the firm lacked guarantees from producers that the animals bought were free of illegal levels of drug residues and did not properly identify hogs so that contaminated animals could be traced to the producers.
In a Feb. 9, 1988, letter, Ronald Tuente notified FDA that he was telling his producers about their responsibilities to ensure their animals were drug-free when sold. The agency responded that the only way for Tuente Livestock to waive its responsibility was to get drug-free certificates from its hog producers.
From October 1988 through December 1993, USDA found illegal sulfamethazine drug residues in tissues from 17 hogs Tuente Livestock had sold for slaughter. The department issued several warning letters to Tuente Livestock about the illegal residues and the company's lack of producer identification, such as tattoos.
During that time, FDA inspected the firm several times. During those inspections, investigators observed some animals being tattooed. Ronald Tuente claimed that all animals were tattooed but could not explain why the Agriculture Department was unable to find the tattoos. In addition, Ronald Tuente told FDA investigators he would not ask for drug-free guarantees because he was sure the producers would refuse and sell their animals to someone else.
On Jan. 24, 1994, the Cincinnati district office recommended to FDA's Center for Veterinary Medicine that Tuente Livestock be permanently enjoined from shipping swine in interstate commerce. On April 12, the agency asked the Justice Department to initiate injunction proceedings against Tuente. The department filed the complaint on Aug. 15.
On Sept. 22, Tuente Livestock filed a motion to dismiss the complaint for injunction. The firm sought to dismiss the charges by arguing that living animals are not food and, therefore, FDA had no jurisdiction. The firm also argued that even if livestock were food, FDA still did not have jurisdiction over Tuente because the firm was merely a middleman and did not introduce the animals into commerce.
FDA and the Department of Justice continued to investigate Tuente Livestock's activities by interviewing slaughterhouse employees and USDA veterinarians in Ohio, Michigan, Virginia, and Maryland. Two of the veterinarians told FDA that they had examined shipments of hogs Tuente was selling and found a significant number did not have producer tattoos. In one shipment of 100 hogs, more than half lacked tattoos.
On May 18, 1995, Judge Rice denied Tuente Livestock's motion to dismiss.
During August and September 1995, the Justice Department sought a voluntary consent agreement with Tuente. But the firm refused to obtain drug-free certificates required of dealers whose hogs tested positive for illegal drug residues because, the company argued, FDA did not require that of all dealers.
On Oct. 5, the Tuentes signed a consent order under which they agreed to cancel their state livestock dealer's licenses, and withdraw their registration and bond with the Agriculture Department's Packers and Stockyards Administration. They also notified the court that they had leased their hog-buying facilities to an unrelated third party and were no longer doing business as livestock dealers.
--Isadora B. Stehlin
La Hacienda Brands, Inc., Chicago, destroyed on Dec. 5, 1995, over 12,103 kg (over 26,000 pounds) of flour, fava beans, coriander seeds, and other nonperishable items contaminated with rodent filth. Almost two years earlier, the firm had destroyed over 437,800 kg (over 973,000 pounds) of perishable food in its inventory for the same reason.
FDA's Chicago district investigators first found the rodent infestation during a routine inspection of the firm Jan. 26 to Feb. 2, 1994, according to Paul Boehmer, district compliance officer.
"We found mouse and rat excreta on all four floors, and our investigators saw live mice on the third floor on two different occasions during the inspection," Boehmer said.
FDA's investigators collected numerous product samples during the inspection, and sent them to the district's laboratory. The lab identified rodent hair and excrement in all samples, as well as places where rodents had gnawed on food.
The Chicago Department of Health on Jan. 27 placed an embargo on the sale of all food stored in the warehouse.
The U.S. attorney filed a civil suit on Feb. 11 in the U.S. District Court for the Northern District of Illinois, Eastern Division, seeking the forfeiture and destruction of the products. Three days later, on Feb. 14, the U.S. Marshal's Office, at FDA's request, seized the products stored in the warehouse.
Over the next several weeks, the firm destroyed in a local landfill all of the perishable items that had been stored in the warehouse, including fresh yams, onions, eggs, ham, and sausage.
The firm signed a consent decree of condemnation on Nov. 1, 1994, that required the firm to recondition or destroy the remaining nonperishable foods.
Boehmer said that the firm had difficulty raising the $88,000 bond the court required before the products could be released for reconditioning, and a year lapsed before the case progressed.
La Hacienda posted the bond on Nov. 14, 1995, and the products were released from federal custody. According to Boehmer, La Hacienda decided it wasn't worthwhile reconditioning the products, and FDA investigators witnessed the firm's destruction of the foods last Dec. 5.
FDA plans to inspect the firm again.
--Kevin L. Ropp
The shrimp, property of Vernon, Calif.-based seafood importer Red Chamber Co., was being stored at Mercury Cold Storage Inc., a public warehouse in Dover, Fla.
FDA's discovery of the spoiled shrimp in June 1995 stemmed from a tip received in FDA's Florida district office that decomposed shrimp from India might be stored in a Tampa-area warehouse.
The resulting investigation led to Mercury Cold Storage, which FDA's Tampa Bay resident post inspected on June 6, 1995. FDA inspectors noticed the facility was storing immense quantities of imported shrimp. A list provided by the warehouse showed that about 75 percent of the stored shrimp came from China and the rest from India, Malaysia, and other Asian countries.
One week later, FDA Tampa Bay resident post inspector Erny Clausnitzer returned to Mercury Cold Storage and collected five samples of Chinese shrimp stored under Red Chamber's account. FDA's Atlanta laboratory found four of the five specimens decomposed. Based on the analysis, FDA officials believed that the majority of the shrimp at Mercury could be decomposed. But before taking any action, they needed to know the true extent of decomposition.
"We couldn't sample all of it," says Clausnitzer. "Literally tons and tons of it were in the warehouse." So FDA devised a statistical method for testing a small group of samples that would represent Red Chamber's entire shrimp inventory at Mercury Cold Storage.
On July 18, five FDA officials collected a sample from each of 33 lots of frozen shrimp. Of these, 21 were decomposed, and one contained potentially dangerous Salmonella bacteria. Combining this outcome with analysis results from the previous month, FDA officials concluded that 27 of 38 lots of Red Chamber's stored shrimp--or 71 percent--violated federal law by being decomposed or tainted with bacteria.
Meanwhile, Florida state officials placed a "stop sale" on the 27 lots of Red Chamber's product confirmed to be decomposed or contaminated, which barred the shrimp from being moved from the warehouse without state permission. Red Chamber exported the rest of the shrimp stored at the warehouse that was not under the state's stop sale order.
On Aug. 29, deputy U.S. marshals seized the 27 lots, weighing almost 132 metric tons (145 tons). At press time in April, the shrimp, worth an estimated $900,000, was in frozen storage at Mercury Cold Storage awaiting destruction.
--John Henkel