Pacific Shellfish, Inc., 5040 Cass St., reluctantly conceded to a Food and Drug Administration (FDA) injunction in early February after federal inspectors found bacteria in multiple locations on more than one occasion at the site.
“Our response is that the FDA and Pacific Shellfish have entered into a consent decree and the FDA believes that this is a positive development,” said Cathy McDermott, FDA spokesperson.
While the FDA claimed in a Jan. 24 lawsuit that the fresh and frozen seafood processing facility was in violation of multiple regulations, owner Judd Brown argues that he has been unfairly and publicly singled out based on false assumptions and misinformation.
Inspections in 2004 and 2005 discovered Listeria monocytogenes throughout the facility. The FDA issued an untitled, or private letter, to Pacific Shellfish on Dec. 8, 2004 after the first finding. Brown responded by promising to correct the problem. A subsequent visit in April 2005 found that a “persistent strain of Listeria remained,” this time on a specimen of albacore tuna, on a table used to filet halibut and tuna, on an employee’s cloth glove, on the handle of a hose laid over a filet table and on a floor drain in the processing area.
The bacteria’s presence is undisputed ” it has since been confirmed by Food Microbiologial Laboratories in one of four private tests commissioned by Pacific Shellfish. However, Brown contends that Listeria is a bacterium common among seafood facilities and that it is impossible to eliminate. He also argues that traces of Listeria on raw fish intended to be further processed, or cooked by the customer, are not dangerous. For this reason, his industry has historically not been concerned with Listeria, nor does the FDA regularly test businesses like his for it.
Listeria is described in multiple FDA documents as a “ubiquitous organism” widely distributed in the environment and occurring naturally in many raw foods. It is usually brought to seafood facilities by raw fish products, but tends to grow to dangerous levels when the fish is processed into ready-to-eat (RTE) foods, such as smoked fish or cooked shrimp that can be consumed at the time of purchase. The highest-risk foods include hot dogs, deli meats, pates, unpasteurized milks and fresh soft cheeses. Raw fish has been classified by the FDA as having a low risk of carrying toxic levels of Listeria.
“[Listeria] doesn’t compete well in the raw state, so it wouldn’t grow,” said Mas Hori, retired California Department of Heath Services Food and Drug Branch inspector and current consultant to Pacific Shellfish. Hori noted that Listeria’s presence is often eliminated from raw product, such as filets of fish, when seared or grilled, even when prepared rare. The bacteria usually reside on the surface of the product and are killed with heat.
When allowed to grow, such as in RTE foods, Listeria can reach a toxic level of 1000 organisms known to cause listeriosis. This potentially fatal disease affects 2,500 individuals each year in the United States and kills an average of 500. For reference, 73,000 illnesses and 61 deaths from E. coli bacteria, and 40,000 illnesses and 600 deaths from salmonellosis are documented annually by the Centers for Disease Control and Prevention.
According to the FDA Bad Bug Book of food-borne pathogenic microorganisms, between one and 10 percent of humans may be intestinal carriers of Listeria monocytogenes. Small amounts of the bacteria are rarely harmful to healthy individuals, although persons with impaired immune systems, pregnant women, unborn babies and newborns are highly susceptible.
The largest outbreak of listeriosis resulted from poorly pasteurized Mexican-style soft cheese made by a Los Angeles company. Eighty-six people were sickened and nearly 29 died in 1985. More than two-thirds of the illnesses occurred among mother-newborn pairs.
The most recent outbreak, also from soft cheese, occurred in North Carolina in 2001. The 12 cases included ten pregnant women and one man with a weakened immune system. The listeriosis resulted in five stillbirths, three premature deliveries and two infected newborns.
Brown said he runs a clean operation and only purchases quality fish from his suppliers. Furthermore, he added, there has never been a reported case of listeriosis in San Diego County.
“I have been in business for 26 years,” Brown said. “I have never, ever made anyone sick by any seafood I’ve sold.”
While RTE foods are regularly tested for Listeria because of their high risk of carrying dangerous levels of the bacterium, Brown claims that the raw fish industry is not accustomed to being monitored for it.
The FDA disagrees, and therein lies the crux of Pacific Shellfish’s dispute.
“We have zero tolerance, so any trace of Listeria is not good,” McDermott said. “[Testing in this case] is par for the course ” we always sample for [Listeria].”
Because of its ubiquitous nature, Listeria is very difficult to eliminate from processing environments. In 2004, a petition by 15 national trade associations was filed requesting that the FDA establish a regulatory limit of 100 colony forming units per gram for Listeria monocytogenes in foods that do not support the growth of the microorganism, including raw and preserved fish. The petition does not apply to the higher risk RTE foods, nor has it been adopted by the FDA to date.
Food Microbiologial Laboratories and the FDA would not comment on the levels of Listeria found during tests, but a letter from the private lab described the presence they detected as “insignificant.”
The FDA did not issue a recall of any Pacific Shellfish product or a public warning letter stating the firm’s violations following the 2005 inspection findings. Seven months passed before Brown was notified of the violation and asked to sign an injunction that would impose certain restrictions on his business, as well as admit his fault. Brown refused and hired legal representation from Hyman, Phelps & McNamara, P.C. in Washington, D.C.
A FDA press release issued on Jan. 26, 2006 made the injunction public, charging Brown and Pacific Shellfish with “violating the Federal Food, Drug and Cosmetic Act by permitting ready-to-eat fish”¦to become contaminated.”
Brown’s business does not process RTE fish. All of his products are fresh and raw and sold to the customer as such, with the customary warning that it must be properly cooked to avoid potential illness. Brown claims that during the 2005 FDA inspection, the inspector cited the loin of tuna in question as a RTE product that was intended for raw consumption. The purchaser of the tuna did cook it, Brown said.
The FDA would not comment on this distinction or why it took so long for them to address a violation deemed worthy of an injunction.
Although Brown has adamantly opposed the FDA’s 2005 accusations of persistent unsanitary conditions and Listeria contamination since first notice last November, he entered into a consent decree shortly after the press release. Making national news and the prospect of facing the Department of Justice in court proved more than Brown’s business could withstand.
“That press release was a way to coerce me into signing the injunction decree. They drew my blood doing that,” Brown said. “The cost to litigate would be in the range of $300,000 to $400,000.”
Brown is fighting mad that the FDA took such “draconian measures,” considering Pacific Shellfish has not more than 200 wholesale customers, including restaurants, country clubs, retailers, hotels and caterers. He vehemently denies that his business will be shut down and said that the FDA explicitly agreed to that stipulation in the February consent decree.
“We will be under an injunction decree for an undisclosed period of time,” Brown said. “We will follow these guidelines because it’s being forced down our throat, and once we feel we are confident enough, we will go back to the U.S. district attorney and ask for relief from it.”
According to Hori, the injunction sought against Brown had less to do with Listeria than with his failure to comply with sanitation and record-keeping guidelines, which are harder to enforce.
“The sources I have [at the FDA] are saying that [Brown] had to have done something or somebody said something for them to test for [Listeria], because normally you do not in these cases in raw product,” Hori said.
The FDA’s main concerns during seafood facility inspections are compliance with sanitation and Hazard Analysis Critical Control Points (HACCP) guidelines. HACCP regulations apply to the seafood, meat and fresh juice industries; they are rules customized by each individual facility after determining where their processes might allow any number of hazards to infiltrate the product. The FDA expects every business to follow through with their HACCP plan, even though the plans may vary greatly from one location to the next.
Hori has educated more than 1,000 business owners on HACCP guidelines since they were first imposed on the seafood industry by the FDA in 1996. He argues that it is not FDA policy to monitor Listeria in facilities distributing raw seafood because it is present in 90 percent of them without causing harm. If there has been a change in policy dictating that raw fish will be held to the same standards as RTE fish, he added, then the FDA should announce their intentions instead of cracking down on one individual.
“If they are going to [litigate against Pacific Shellfish for Listeria], then they should notify the industry that these are the steps they are going to take for raw consumption,” Hori said.
A message has been sent by the FDA and heard by Brown’s colleagues, some of whom are shocked that the Pacific Shellfish facility was tested for Listeria, unlike their own.
“[My competitors] have very much cleaned up their acts in the last two weeks since this was filed against me,” Brown said in early February.
While the FDA does not offer any recommendations for preventing Listeria, Hori suggests chemical agents or heat steaming to eliminate bacteria.
“Just because [a facility] looks clean, that doesn’t mean it is,” Hori said.
As part of the consent decree, Brown will be required to work with an outside HACCP consultant and have private laboratories test his facility for Listeria. He had already completed both of those actions prior to the January lawsuit.
Uninvolved in the Pacific Shellfish inspection and subsequent injunction is Brown’s seafood restaurant, The Fishery. Both businesses are located at 5040 Cass St. and Pacific Shellfish’s processing room is visible to diners from the restaurant through a display window. Brown hopes that the restaurant will not be found guilty by association, since it is no different than the other wholesale customers that purchase and sell Pacific Shellfish products.
Brown and a partner opened Pacific Shellfish in 1980, incorporating the business in 1982. They were located in Carlsbad and downtown before moving to Pacific Beach nine years ago. Pacific Shellfish purchases fish from roughly 30 suppliers and sells fresh and frozen processed product to a client base of nearly 200 accounts, all in San Diego County.