About a week ago I received an e mail from one of my oyster suppliers notifying me of some upcoming rule making over at the FDA. Basically some people at the FDA have come up with a proposal to ban the sale of untreated Oysters from the Gulf of Mexico for eight months out of the year. As a consumer and person who enjoys eating raw oysters this saddens me. As a fishmonger this can hurt me financially. As a free human this bothers my libertarian brain, and the thought of yet more nanny state rules bothers me immensely.
Here is a draft letter that we are asking our members to send to their Congressmen and Senators.
· Please paste this message on your own letterhead.
· Please personalize it by stating how this will impact you and your business.
· Feel free to modify the text as you see fit – but keep the core message.
· Feel use a couple of the bullet points below to make your point.
· Try to keep it to one page (or a page and a half at most) or will you lose them.
· Keep the core message up front - We are asking them to – Push FDA to repeal their mandate and return to the
· We urge you to avoid comparisons with cigarettes which have no environmental or health benefits.
· Please stay positive about steps we have been taking that continue to improve the quality and safety of the products we produce, the sustainability of the industry and the ecological benefits we provide.
· Good tips on addressing and finding your congressperson can be found at:
The FDA has dropped a bombshell on the shellfish community. On October 13th Mike Taylor, senior adviser to the FDA commissioner, explained FDA’s new policy to the Interstate Shellfish Sanitation Conference (
ISSC). The FDA’s new mandate requires Post Harvest Processing (various forms of pasteurization) of oysters harvested from the from May through October, effective May 2011. We are asking our Congressional Representatives to urge the FDA to repeal this edict and return to the Gulf states ISSCwith a pledge to collaborate with state regulators and industry to find workable solutions that will continue to reduce illnesses associated with shellfish.
This unilateral edict from FDA derails decades of cooperative efforts to address the issue among industry, state regulators and the Agency through a group called the Interstate Shellfish Sanitation Conference (
The FDA’s new “guidance” is an attempt to reduce the risk associated oysters from the naturally occurring bacterium Vibrio vulnificus(Vv) that sickens about 30 people a year. When these illnesses occur in immune compromised individuals the outcome is often fatal, resulting in about 15 deaths a year.
By issuing this new “guidance” under existing regulations the FDA avoided the typical rulemaking process, which would have required them to perform an economic impact study and solicit public comment. They suggest that consumers cannot tell the difference between fresh, raw oysters and dead, processed meat and they have stated publicly that they don’t care what the economic impacts are.
We believe that consumers will not accept more expensive, processed oysters as a substitute for the real thing and that the impacts to restaurants, harvesters and dealers will be huge. Hundreds of raw bars will go out of business and thousands of harvesters will be out of work for eight month a year. We ask for your assistance in this urgent matter.
------------ Other points to consider inserting – if one or two of these points strike a chord please feel free to insert it in your letter, but remember to try to keep your letter short------
· Once PHP is mandated it will allow direct competition from products coming from anywhere in the world. In the early 1900’s shellfish canneries in the
· We do not believe that the FDA will stop here. Since 2004 the FDA’s policy has been to discourage the consumption of raw shellfish. Now they have taken the first step in eliminating all individual choice in the matter. If this action goes unchallenged they will push for more closures and more mandated processing of raw shellfish. Industry leaders are prepared to implement greater controls to limit the risk of food born illness, but we cannot tolerate unilateral actions that threaten the very survival of our sustainable industry.
· About 90 Vv illnesses (from all sources) occur each year. About half of these infections are wounds that become infected while swimming. Only about a third (30) are associated with the consumption of oysters. About half of all of Vv illnesses are fatal (approx. 15/year related to shellfish). Almost all of the fatalities are in immune compromised individuals (those with liver cirrhosis, diabetes, AIDs or those taking immunosuppressant drugs).
· According to FDA and CDC data less than 1/10 of one percent of food born illness is associated with shellfish. According to the Centers for Disease Control, an estimated 76 million cases of food-borne illness occur annually, resulting in 325,000 hospitalizations and 5,000 deaths.
· We do not believe that the FDA’s drastic actions will eliminate the problem of Vv illnesses associated with oysters for three reasons: 1) they are not regulating shucked meats 2) some illnesses have been associated with undercooked shellfish, and 3) the FDA cannot control the recreational harvest. Consequently, the industry and the FDA will still continue to face bad press associated with illnesses even after this draconian policy is implemented.
o Exchange information concerning the procedures, the ISSP, and matters that arise from the Conference meetings in a timely manner.
o Resolve problems of interpretations and policy that involved the Procedures, the ISSP, and the
o Recognize that the ISSP and the
· This edict was delivered with no prior warning or opportunity for comment from industry. This is in direct violation of the Agency’s new policy on transparency, ironically touted on the home page of their website.
· Under normal conditions, oysters must either be eaten live or cooked in order to be safe. However, post-harvest processes involve treatments to the oysters that kill and then preserve them in a state similar to eating them raw. It is widely held that these processes change the taste, texture, and color of the oysters. According to Michael Voisin, the co-chairman of the Gulf Oyster Industry Council and owner of a post-harvest processing plant, post-harvest processing usually doubles or triples the cost of an oyster.
· This change in course or “reformulation of policy” was politically motivated. Driven not by new findings or scientific data (standard FDA criteria for change in direction) this “guidance” change was a result of recent outbreaks in peanuts and spinach and the resultant outrage directed at the FDA by Congress.
This May the FDA was endorsing proposed refrigeration controls and the target 60% illness reduction. At some point these controls were deemed no longer acceptable. Considering the way new mandate was developed it shatters the trust and collaboration which had been developed since the
Apparently the FDA now considers
· PHP Capacity Issues:
One of the reasons that Mike Taylor gave in his speech rationalizing the FDA’s decision was that the industry in the Gulf has the capacity to process all of their warm-weather harvested product. This is simply not true. Here are the facts about processed oysters.
Available post harvest treatments (PHT’s) each render a raw live product significantly altered from its traditional and live state. Individual quick freezing of the product with the top shell removed (1/2 shell) renders the live animal dead and frozen – requiring it to be labeled as such. Mild heat pasteurization renders the live animal dead as does high pressure processing which also detaches the adductor muscle of the animal from the shell (resulting in a pre-shucked product still in-shell). Both the mild heat and high pressure products can technically be considered raw and are most often distributed in the refrigerated (unfrozen) state. Each are processed products and must be labeled as such. Certain users of both products report a variable degree of alteration in some or all of the organoleptic (taste, odor, texture and appearance) qualities of the product. These alterations are reported to typically become more pronounced as the product ages over the course of its shelf life.
Irradiated product is reported to remain alive, but is known to have, under some circumstances a reduced live shelf life compared to untreated product. Irradiated oysters must carry the “radura” symbol labeling them as an irradiated product. Commercial distribution and use of this product is insufficient for there to be much real life knowledge of its organoleptic characteristics at end use. There is a known consumer apprehension of irradiated food products which also will have an unknown impact on this product’s marketability.
The current number of facilities which utilize one or more of the above described PHT processes and existing infrastructure to employ them for processing oysters from the Gulf of Mexico could conceivably handle the 300 million lbs of live in shell oysters harvested during the April to November timeframe which is apparently the target of the new FDA direction. However, this harvest would have to be compressed such that much of it occurred during the winter months when oysters are of acceptable quality to freeze. IQF freezing capacity is, by far, the largest component of the PHT processing capacity universe. From June through October – a rough approximation of that period during which oysters are unacceptable for freezing – there would be only 3 facilities, all in the State of Louisiana, which have a history of producing PHT product during that same period. Logistical concerns alone show the critical flaw in FDA’s assertion that PHT “processing capacity in the
· Industry (in collaboration with state regulatory agencies and the FDA through the
· How can we, as a society, justify policies that mandate zero risk when they cause grave economic harm to established industries resulting in the loss of thousands of jobs? When we can eliminate 99.9% of the risk for a certain cost, but eliminating the last fraction of risk eliminates an entire industry - is it justifiable?
· Should government force new regulations on industry to protect a handful of susceptible individuals when the regulations remove consumer choice for the rest of society?
· Where does society draw the line between the need for government protection and the need for the consumer to accept responsibility for his own action? If an immune compromised person chooses to eat raw foods and gets ill or dies, is that a valid reason for the government to step in and ban the sale of raw foods to all of society?