ARTICLE ON FDA'S ATTEMPT TO BAN RAW OYSTER SALES

RAW DEAL
January 5, 2010

The original article can be found at SeafoodBusiness.com

Oyster community rallies against FDA efforts to rein in raw oyster consumption
By James Wright
There are many ways to eat an oyster — smoked, fried, roasted, baked, boiled, broiled, stewed or steamed. Aficionados, though, believe less is more and want their half shells raw, with Mother Nature as chef de cuisine. The federal government, on the other hand, believes slurping raw shellfish is risky business and in October proposed that all oysters from the Gulf of Mexico undergo post-harvest processing (PHP) during the warmer months to kill the Vibrio vulnificus bacteria, a naturally occurring organism that can cause serious — and potentially fatal — gastrointestinal illnesses. Essentially, the feds want to ban raw Gulf oysters for six to eight months a year.

The U.S. Food and Drug Administration contends that mandating validated PHP methods would increase food safety, preventing foodborne illnesses and deaths: According to the Centers for Disease Control and Prevention, about 15 deaths occur annually due to contaminated raw shellfish. The oyster community counters that part of its Southern cultural and culinary heritage is under attack and that current state-mandated health warnings — not to mention an established interstate shellfish monitoring system — are sufficient means of protection and that illnesses are unfortunate, but rare. When retailers, wholesalers, restaurateurs and even Congressmen voiced emotional opposition to the FDA’s proposal, the agency in mid-November sidestepped a firestorm of controversy and seemingly backed off its plans to institute mandated PHP for the 2011 oyster harvest.

Yet the possibility of the FDA cracking down hard on half shells is still very real — as are the fears of going out of business for many small, family-owned companies along the Gulf Coast, where nearly two-thirds of U.S. oysters are produced. But there’s more than oyster supplies and prices at stake: The freedom to choose and the role of government in consumers’ everyday lives are at the heart of this debate, which is sure to continue for months as the FDA assesses the feasibility and economics involved with implementing PHP controls, after which it is expected to push its agenda once again.

“It’s an FDA retrenchment, not a retreat,” says Mike Voisin, president of oyster processor Motivatit Seafoods in Houma, La. “They’re not backing off.”

A new approach

The controversy began on Oct. 17, when Michael Taylor, senior advisor to the FDA commissioner, addressed the Interstate Shellfish Sanitation Conference (ISSC) in Manchester, N.H. Taylor stunned attendees by announcing that the agency would soon implement a new raw shellfish policy, voicing his disappointment that a targeted 60 percent reduction in Vibrio vulnificus-related illnesses had not been achieved in California, Florida, Louisiana and Texas.

“The time has come for a new approach,” Taylor argued, adding that the FDA would require oyster processors to employ one of four approved PHP techniques: high hydrostatic pressure, mild heat pasteurization, individual quick freezing (IQF) and low-dose gamma irradiation. “Seldom is the evidence on a food-safety problem and solution so unambiguous,” Taylor added.

Reaction to the FDA’s new get-tough stance was anything but ambivalent. During a Nov. 13 press conference with Sen. Mary Landrieu (D-La.) with Louisiana and Florida oyster suppliers at his side, Sen. Bill Nelson (D-Fla.) said the proposal was excessive, like “trying to kill a gnat with a sledgehammer.” Oyster fishermen, wholesalers, restaurant operators and food lovers alike united in their outrage and set up online petitions such as SaveOurShellfish.org, hoping that a cascade of complaints would force the agency to scrap its idea. Thousands of signatures have been collected.

The interstate shellfish-safety network was also not impressed. ISSC Executive Board Chairman J. Michael Hickey wrote a letter on Nov. 2 to the FDA, saying he was “surprised, confused and very disappointed” by the agency’s about-face without the group’s input. The ISSC works collaboratively with shellfish-producing states as the primary monitor of water quality and molluscan shellfish safety, and has operated with a memorandum of understanding with the FDA since 1982. Saying the FDA was obligated to communicate with the ISSC before plotting a new policy course, Hickey contended that some states would likely choose not to enforce the federal policy, which could only harm efforts to curb shellfish-related illnesses.

The FDA’s proposal, to many in the oyster industry, was nothing short of betrayal at a time when fishermen and their families from Texas to Florida are struggling to survive, many of them lamenting poor landings from oyster habitats destroyed by Hurricane Katrina in 2005 and Hurricane Ike in 2008.

“I’ve sat next to these people [at FDA] for 25 years, the last 10 when they’ve concurred with the actions of the ISSC,” says Voisin. “Just in September, they said only at-risk groups should be concerned. In October, they go way off the reservation. To wake up one morning and see the 180-degree turn … it’s still shocking to me.”

One billion served

The risks from eating raw oysters have been known for many years, and the FDA’s mandatory PHP proposal wouldn’t be the first drastic measure taken to prevent shellfish-related sicknesses. While even the healthiest person can become ill from eating an oyster contaminated with the Vibrio vulnificus or Vibrio parahaemolyticus bacteria, certain people with compromised immune systems — individuals with liver disease such as cirrhosis, chronic kidney disease, iron disorders or diabetes — are considered to be at an even greater risk of contracting the severe or fatal gastrointestinal illness known as vibriosis. Opponents of the FDA plan say the agency’s own research indicates that virtually all shellfish-related deaths happen to members of at-risk populations.

“It’d be putting a public health remedy on a private health problem,” says Voisin, who argues that the 15 deaths recorded annually from raw oyster consumption represent a tiny percentage of the roughly 1 billion raw oyster servings consumed in the United States each year. Voisin says FDA should educate consumers of the risks, much like they did when diabetes from excessive sugar consumption became a huge problem in the 1950s and numerous artificial sweetener options became available. “We didn’t ban the traditional product because an at-risk community could die as a result,” adds Voisin. “We said they mismanaged their personal health problem.”

It’s currently up to individual states whether to require restaurants to post warnings about the risks associated with raw oyster consumption on menus or on signs; the raw bar has long operated with an eat-at-your-own-risk policy, with even the most courageous diners aware of the old saw about only eating raw oysters during months with an “r” in it. Oyster suppliers say advancements in shellfish handling, refrigeration and distribution have made that aphorism more of an old wives’ tale rather than sage advice — although the FDA would beg to differ.

“We no longer believe that measures which reduce this hazard, but fall well short of eliminating it, such as improvements in refrigeration, are sufficient to meet the purpose of the regulation, given the severity of the hazard and the availability of post-harvest processing technologies,” Taylor said in his ISSC address.

Despite outcries from the industry, chefs and consumers, a ban on raw oysters during warmer months has some measure of support among special-interest channels. The Washington, D.C.-based Center for Science in the Public Interest in October listed oysters among the 10 “riskiest” foods that Americans eat and for years has lobbied for preventative measures. Using FDA data, CSPI identified 132 outbreaks from oyster consumption that resulted in 3,409 illnesses since 1990.

“The lives snuffed out prematurely by contaminated oysters should not be coldly dismissed by the shellfish industry or by their allies in Congress as the ‘cost of doing business,’” says CSPI senior staff attorney David Plunkett, decrying a bill titled The Gulf Oyster Protection Act, filed by Rep. Allen Boyd (D-Fla.) in response to the FDA proposal. “The industry has known for years how to prevent these deaths with readily available post-harvest processing techniques. Over 250 people have become ill and half of those have died since 2001, and if this industry-supported legislation passes, the toll of preventable death and disease caused by contaminated oysters will continue to rise.”

Kevin Begos, director of the Franklin County Oyster & Seafood Task Force in Apalachicola, Fla., says the CSPI has “no clue” about how the oyster industry works.

“It’s none of CSPI’s business to tell consumers what type of oysters they should choose. It’s incredibly arrogant of them,” Begos says. “There are people who choose to skydive, believing their parachutes will always open. I would never ride a motorcycle, but I don’t think we should ban them.”

With oysters, the FDA argues, one number speaks volumes: zero. Both FDA and CSPI are trumpeting the success of a 2003 California law that prohibited Gulf oysters from entering the state during summer months unless they had undergone some form of PHP treatment. Between 1991 and 2001, California recorded 40 deaths due to Vibrio vulnificus. Since 2003, no deaths have occurred, according to the FDA, a statistic that emboldened the agency in using California as a policy template.

A mom-and-pop industry

FDA’s primary duty is to promote safety and to eliminate food- and drug-related deaths. Its mandate is not to ensure the survival of shellfish businesses, which argue that mandatory PHP would destroy small companies, harm jobs and tourism and further slow the economy in an already struggling area. Before the FDA vowed to study the Gulf oyster industry’s ability to implement mandatory PHP systems and potential alternatives, something that ISSC demanded, Taylor estimated that 100 percent of production during the warmer months could be handled, far more than the 15 percent that he said currently undergoes treatment.

Oyster suppliers say that is a major miscalculation.

“That’s completely wrong; it’s a myth,” says Begos, adding that the region’s true PHP capacity is closer to 5 or 10 percent of production and that most plants shut down from May to September because they cannot adequately process less-meaty summer oysters. The Gulf Oyster Industry Council estimates PHP oysters account for less than 10 percent of overall production.

An FDA spokesperson told SeaFood Business that statements regarding its initial 100 percent estimate were “taken from industry assurances prior to the FDA’s announcement of its intention to make a policy change” and that the agency would work with ISSC, state regulators, the industry and others to better understand the challenges. Its assessment, which should be complete by the ISSC’s March board meeting, will delve into the costs associated with setting up processing technologies, which sources say are considerable.

After years of innovation and experimentation, Motivatit Seafoods developed a reliable system that kills Vibrio with 45,000 pounds per square inch of pressure and also shucks the oysters, which are then held together with a gold-colored band for distribution. But even a company as large as Motivatit, which is heavily invested in HPP and is considered a pioneer with the technology, processes only half its oysters. “Even we would be affected; it’s pretty significant,” Voisin says.

Some processors quick-freeze small portions of their total production, and only a few employ low-heat pasteurization (or a warm- and cold-water bath), as many buyers and consumers say the oyster meat can turn rubbery. Low-dose gamma irradiation, only recently approved by the FDA as a safe process, has not yet been proven to be economically feasible or market acceptable, says Voisin, whose company has completed trial batches of irradiated oysters with University of Florida researchers.

Sal Sunseri, VP of P&J Oyster Co., which has sold oysters from New Orleans’ historic French Quarter since 1876, says efforts to curb consumption of such a “healthy, culturally significant culinary delight” are “unjustified and unprecedented.” P&J doesn’t sell treated oysters and has never been tied to a vibriosis case, Sunseri says, adding that the vast majority of oysters from Louisiana are from “mom-and-pop” companies that can’t afford to make large investments in processing technology.

“The closest analogy is the egg industry, which has a similar matrix where [the FDA is] trying for a 60 percent reduction in illnesses, but those numbers are in the thousands of cases,” Sunseri says. “The focus should be on educating the at-risk group, not devastating a $350 million industry, one of the few No. 1 industries left in Louisiana.”

Standing in solidarity

A Gulf oyster ban may initially cause the most damage in the Gulf of Mexico, but oyster producers across the country are watching the developments with apprehension because they, too, fear what lengths the FDA will go to make the food supply safer.

“The FDA’s proposed ban has all of us from all three coasts extremely concerned,” says Robin Downey, executive director for the Pacific Shellfish Growers Association in Olympia, Wash. “It is our understanding that — just a couple of days prior to Michael Taylor’s announcement — they had intended to enforce this ban across all the country. We do not know why they backed off the East and West coasts at the last minute but we fully expect that if they are successful in making this go forward that we will be next.”

Even in far-removed regions like the Pacific Northwest and New England, the potential of a Gulf oyster ban resonates loudly — a similar bacteria, Vibrio paraehemolyticus, reaches further north, but is responsible for fewer illnesses. Bob Rheault, Ph.D., former owner of Moonstone Oysters in Wakefield, R.I., and the president of the East Coast Shellfish Growers Association, admits a restricted Gulf oyster industry could have a negligible or even positive impact on his business. But he says oyster producers are “standing in solidarity” with their Gulf Coast brethren.

“We know if we let the FDA roll over them we are next,” says Rheault. “The FDA stated their official policy was to discourage the consumption of raw shellfish in 2004. They wanted to include Vibrio parahaemolyticus in this edict, but at the final hour thought better of it. The language they use virtually indicates that the breadth of this action will increase over time. When they do so it will be the end of the shellfish aquaculture industry as I know it.”

This month, the oyster industry will again air out its concerns in the Capitol during the National Fisheries Institute’s annual Walk on the Hill lobbying push, which culminates at its Let the World Be Your Oyster reception on Jan. 20. The hope is that one of several pieces of legislation countering mandatory PHP will make headway.

Jeff Tunks, chef-owner of several restaurants in Washington, D.C., including the New Orleans-style Acadiana, will host this year’s reception. An avid oyster lover and purchaser, Tunks says limits to raw oyster supplies from the Gulf would have an “unbelievably adverse affect on us serving oysters of any kind from anywhere.” Tunks pays 49 cents to $1.20 each for live, unprocessed oysters.

“They could be two, three times that,” says Tunks if PHP was mandated. “Who’s going to pay $45 to $50 for a dozen? That’s a lot of money.”

Few would argue that 15 deaths per year from oyster consumption is an acceptable number; even fewer would admit a zero-tolerance policy is possible. But oyster suppliers say they’re doing all they can to ensure consumer safety through education and technology improvements. What’s more, their product is safer than ever and if people want to eat them raw, as they’ve done for hundreds of years, then that’s their prerogative, not the federal government’s.

“For those 15 people and their families, it’s a big issue,” says Tunks. “But there are so many things out there, from raw spinach and scallions with salmonella and non-pasteurized eggs with E. coli — the list is long and if we have this reaction for everything we wouldn’t be able to serve anything.”

E-mail Associate Editor James Wright at jwright@divcom.com

January 2010