PCSGA Tidings

By James Wright, Asso­ciate Edi­tor

Seafood Busi­ness Mag­a­zine, Jan­u­ary 5, 2010

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 SaveOur​Shell​fish​.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

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