![[FDA Home Page]](https://webarchive.library.unt.edu/eot2008/20081005124657im_/http://www.fda.gov/icon/iconhome.gif){kind=icon}
![[Table of Contents]](https://webarchive.library.unt.edu/eot2008/20081005124657im_/http://www.fda.gov/icon/toc.gif){kind=icon}
![[U.S. Food
and Drug Administration]](https://webarchive.library.unt.edu/eot2008/20081005124657im_/http://www.fda.gov/icon/header.gif){kind=icon}
Shortly after 10 p.m. on Sunday, Aug. 11, 1991, at the Houlton, Maine, border crossing, a truck driver for a Canadian fishery backed his tractor-trailer up to a loading dock. His cargo list showed he was carrying 916 kilograms (2,036 pounds) of swordfish. But the fish apparently grew in transit: According to dockside measurements by FDA and the U.S. Customs Service, the load of fish now topped the scales at 1,560 kg (3,467 pounds).
Shortly after 2 p.m. the next day, at a Boston seafood firm, a customs agent put his hat on, signaling to nearby FDA and customs investigators that the firm had unloaded the fish and completed the weight sheet. They joined the agent, who seized the mis-declared fish and the sheet that showed the fish, at 1,528 kg (3,396 pounds), now weighed closer to what FDA and customs had found.
That seizure triggered a full-scale FDA investigation that last year led to a sentence of three years and 10 months in prison, followed by three years' supervised release, for Richard Hart, of Chatham, Mass., owner of Seafood Enterprises Inc., Boston. He pleaded guilty to 28 counts of fraudulent practices and false statements in importing swordfish and one count of conspiracy. He lied about the weights of imported swordfish to avoid FDA's required testing for methyl mercury, generally aimed at big fish because they are the most likely to have illegal levels of the toxin. Mercury poisoning can cause nervous system problems in humans that may damage vision and hearing and even be fatal.
Judge D. Brock Hornby, U.S. District Court for the District of Maine, ruled on Oct. 15, 1996, that the sentencing guideline of two to eight months' imprisonment for Hart's offense "does not adequately reflect harms to society." He therefore followed a more severe guideline, 46 to 57 months' imprisonment.
FDA first learned of Seafood Enterprise's illegal activities early in August 1991, when an informant told John Ridings, an investigator with the agency's New England district office, that Hart was importing swordfish but lying about the weights to avoid mercury testing. The informant said that the fish came through the Houlton port from Nova Scotia and that a shipment was due on Sunday, Aug. 11.
On Wednesday, Aug. 7, Ridings called Seth Taylor, a special agent with the customs office in Houlton. He asked Taylor whether he was interested in a joint investigation. Taylor replied he was.
"I wanted to begin the operation that next Sunday," Ridings says, "and examine every swordfish entry and weigh each swordfish destined for Seafood Enterprises, and see what kind of weights we would come up with."
Around noon on the 11th, Ridings and FDA investigator Richard Vining, now a special agent with the agency's Office of Criminal Investigations, along with Taylor and customs supervisor William Reynolds, arrived at the Houlton crossing to await the shipment to Hart.
At about 10:15 p.m., Brian Hubley, from B & J Fisheries, Nova Scotia, drove in, and submitted a cargo list describing 21 fresh whole swordfish to be delivered to Seafood Enterprises. Customs inspector David Sylvain told Hubley to back his truck up to the loading dock.
The investigators and agents unloaded and weighed each swordfish. Only one fish, weighing 16 kg (35 pounds), could be considered a baby swordfish; fish this size generally contain merely a trace of mercury. Five were quite large: 92 to 143 kg (204 to 317 pounds). But the cargo list showed that half of the fish were babies, and not one was over 72 kg (160 pounds).
Ridings and Taylor interviewed Hubley. The driver cooperated, agreeing to deliver his load to the Boston firm under surveillance by FDA and customs. Taylor followed the truck, while Ridings and Vining met early the next morning with district officials for guidance.
At about 10:30 a.m., at a motel parking lot in Boston, Vining met with investigators Michael Marcarelli and Patricia Ronan, also with FDA's New England district office, and Boston customs duty agent Eddie Murphy to make final plans to seize the shipment of swordfish.
By early afternoon, the investigators had set up surveillance around the firm. And customs agent Taylor, disguised as a passenger in Hubley's truck, went into the firm.
Once the swordfish were unloaded and in the firm's possession, Taylor gave the prearranged signal--putting on his hat--to summon the surveillance team.
Murphy and Ridings met Taylor inside. Taylor identified himself to two employees of the firm. He told them that the Customs Service had seized the mis-declared, therefore illegal, swordfish and was now controlling all areas where records were maintained. Taylor also seized the load's weight sheet just completed by a company employee.
Taylor asked another employee for B & J Fisheries' records. If necessary, he said, he would apply for a search warrant. The employee got owner Hart on the phone.
"Hart told Taylor over the telephone that he would cooperate with us," Ridings says. "But a half-hour later, Taylor got a call from Hart's attorney, who said he would advise Hart not to let us review the records until he reviewed them first."
Without sleep now for 36 hours straight, Ridings and Taylor left for Boston to get a search warrant. On the way, Taylor received a message to call Hart. He did. "Hart told him there was no need for a search warrant, that we could return to the firm and have the B & J records," Ridings says. "So, Taylor returned to the firm and picked up its most recent records on B & J."
On Aug. 14, Ridings received records from the Customs Service on B & J swordfish shipments to Seafood Enterprises. Comparing those records with Hart's, Ridings found that in all shipments, weights on the cargo lists were less than weights actually shipped.
That same day, at Taylor's request, Ridings and Vining returned to Seafood Enterprises to photograph and videotape each swordfish for evidence.
When the investigators compared the cargo lists with Hart's weight sheets on fish received, they soon realized that some of Hart's records were missing. Eventually, Ridings says, Hart admitted he had destroyed records.
A lengthy investigation ensued.
"There were money laundering issues, and all kinds of leads we had to look into," Ridings says. "It took almost a year just to gather information and figure out what the scheme was. Also, this was an international event because Canada is a foreign country. So we had to get special permission to go into Canada to do interviews."
The investigators interviewed some 80 people and compiled and evaluated records on 68 swordfish lots.
They learned that Hart's business relationship with B & J began in 1989. At that time, Ridings says, all shipments of imported swordfish were automatically detained at U.S. borders until the shippers could prove to FDA that at least five of their swordfish shipments tested negative for illegal mercury levels.
"When we looked into our records," Ridings says, "we saw that B & J had never been able to do that. So, legally, their products were still on automatic detention."
But in summer 1989, Hart had petitioned FDA to remove B & J from detention, submitting as evidence records on five B & J shipments that appeared to have acceptable mercury levels.
Unaware that the information was false, FDA took B & J off the agency's detention list, and the fishery shipped its first truckload of swordfish to Hart in July 1989.
"All we had to do from then on to release the B & J shipments was review our list," Ridings says. "The manifests for every shipment showed an average weight of fish of 85 pounds [38 kg], or baby fish. With no significant number of large fish, there was no reason to sample for mercury testing."
On June 13, 1995, a grand jury indicted Hart on 76 counts of fraud and false statements in importing swordfish. The indictment also charged him with 47 counts of money laundering related to unlawful importation. Three days later, Hart was arrested at his Massachusetts home.
On Jan. 26, 1996, Hart pleaded guilty. Evidence showed he had smuggled more than $4 million worth of swordfish into the United States.
B & J Fisheries agreed to cooperate in the investigation. In August 1996, in Bangor, Maine, the owner pleaded guilty to one count of entry of goods by false means into the United States and was assessed more than $50,000 by the U.S. Customs Service.
Dixie Farley is a staff writer for FDA Consumer.
At press time in March, FDA investigators were continuing to assist food companies in deciding how and which flood-drenched products could be salvaged. Many products had been exposed to water possibly contaminated with raw sewage and industrial chemicals.
The flooding began around Jan. 1 and was most severe in the Central Valley of California and the Reno-Carson City, Nev., area, where various FDA-regulated businesses--including medical device firms, drug companies, food warehouses, and blood banks--reported losing millions of dollars worth of products, said Ed Harris, an investigator in FDA's Reno, Nev., resident post. Many firms did not have flood insurance, he said.
Heavy rain and warm temperatures in the Sierra Nevada mountains, where the snowpack was well above normal, resulted in runoff that overtaxed area rivers, lakes and reservoirs. Up to 8 feet (2.4 meters) of water flooded surrounding areas.
Despite sandbagging efforts, waterways overflowed, and residential and business areas were evacuated. Roads became impassable, and in downtown Reno, several casinos and hotels closed for the first time in years. The Reno-Tahoe International Airport was shut down for three days. Nevada's Truckee River peaked at a record-setting 15 feet (4.6 meters).
In the Central Valley, FDA investigators assisted state personnel in determining product damage at FDA-related businesses. One that was particularly hard hit was a juice concentrate firm in Marysville, Calif. The company may have lost up to $2 million worth of products when the Feather River overflowed and swamped the company's plant with 4 feet (1.2 meters) of water. "Fifty-gallon drums were entirely submerged," said Warren Savary, leader of the district food team. "That's how high the water was in the warehouse."
FDA and California state officials assisted the company in determining which drums of juice concentrate could be salvaged. The concentrate was packed inside the drums in double-layer plastic. When the river threatened to overflow again, the company moved its salvageable inventory to its Wapato, Wash., facility, where, in early March, FDA's Seattle district office was monitoring the company's reconditioning efforts.
A concern in the southern Central Valley was the safety of cauliflower and broccoli crops in fields immersed in sewage water carried by the flooding. This posed a risk to consumers because of possible contamination with E. coli, hepatitis, and other human pathogens, Savary said. This was especially a concern for cauliflower and broccoli because they are frequently eaten raw and are not easy to clean. But, according to Steve Kendall, compliance officer for FDA's San Francisco district office, the crops were destroyed and could not be brought to market.
The investigators who went to Nevada assisted investigator Harris, who runs a one-person post in Reno. Because flooding had closed the Reno airport and the railroad to Reno, the five-member team traveled the 200-mile trip by car through the Sierra Nevada Mountains, braving what Harris called "snowy and icy conditions along winding roads."
Once assembled in Reno, the team focused on businesses in the industrial area of Sparks, Nev., a low-lying city next to the Truckee River. The industrial area contains many FDA-regulated businesses, as well as plastics and chemical companies, Harris said.
Submerged in water up to 8 feet deep, the industrial park was barricaded for several days by public hazardous materials personnel, after 55-gallon drums and other containers of unknown substances were seen floating in the area. Workers suspected that the drums may have contained toxic substances used by industrial plants in the area. In addition, two large sewer mains broke upstream.
The investigators called more than 150 FDA product-related companies to determine the extent of flood damage. If a company spokesperson could not be reached, the investigators put the company on an inspection list and, once barricades were lifted, visited the company at least once in the following seven days.
During this period, the six investigators inspected 34 food companies, 12 conveyances and support facilities for interstate airlines, five medical device companies, and four drug firms. In addition, they surveyed 35 other facilities for flood damage.
"The typical scene at these inspections [included] mud-covered floors, parking lots and employees, and mountains of ruined goods--product, furniture, equipment--piled in parking lots," Harris said. He noted that the investigators themselves had to drive down still-flooded streets and wade through mud to reach all the facilities.
According to Harris, the investigators helped companies segregate useable from nonuseable products and advised them on product reconditioning and cleanup. They coordinated their activities with the Washoe County Health Department and the Nevada State Health Division.
Among companies experiencing significant losses were a national discount chain's distribution center, where more than $2 million worth of vitamins, cosmetics and food were damaged beyond use, and a device company that lost 67 percent of its inventory of 200,000 cases of medical examination gloves.
These and other companies were still reconditioning and assessing their financial losses as of early March, Harris said.
--Paula Kurtzweil
Finest Foods Inc., maker of "Mrs. Drake's Sandwiches," violated the decree when it resumed operations without FDA permission after being closed by the agency for unsanitary conditions. The 1993 consent decree requires Finest Foods to get FDA's approval before resuming operations.
Finest Foods, which makes about 11,000 sandwiches a day for retail sale, signed the consent decree in the U.S. District Court for the Eastern District of Louisiana after FDA found recurring sanitation problems. A 1994 amendment to the consent decree allows FDA to shut down Finest Foods' sandwich operation if the company violates the decree provisions.
FDA found such violations in February 1996, when investigators inspected the facility and found Listeria monocytogenes contamination and other conditions, such as filth in the processing plant and unsanitary food handling procedures. L. monocytogenes can be fatal to infants, older adults, and people with weakened immune systems. The conditions FDA found were similar to those that led to the 1993 consent decree.
Following the February inspection, FDA sent a letter saying the plant must cease operations until the violations are corrected.
Under the consent decree, if FDA orders the facility to shut down, the company, with written documentation of corrections, can request reconsideration and stay open until FDA confirms that the shutdown is necessary. On April 23, 1996, FDA delivered another letter to Finest Foods saying the company had failed to address its deficiencies and that it should suspend its operations immediately. That day, the company met with FDA and agreed to the ordered suspension.
FDA told the company that to reopen, it must:
On April 30, FDA told the company it had violated the consent decree by reopening. Finest Foods again suspended operations until May 2, when FDA inspected the facility and allowed the company to reopen.
FDA took the consent decree breach to district court, where, on Dec. 18, Judge Peter Beer found that the company's actions were a "willful violation" of the decree.
In ordering the $2,500 fine, Beer cited only the company for contempt, not the individual defendants, company owners James and Timothy Ganus. He found that their actions "were mitigated by their overall efforts to comply with the consent decree."
Finest Foods has since resumed operation and, FDA officials say, the company has taken measures to stay in compliance with the consent decree.
--John Henkel