by Marion Nestle

Search results: oysters

Jun 9 2016

CSPI and Public Citizen sue the FDA over absurd delays in regulating the safety of—oysters!

The Center for Science in the Public Interest (CSPI) has sued the FDA for ignoring its 2012 petition to prevent illnesses and deaths caused by eating raw oysters from the Gulf of Mexico contaminated with toxic Vibrio vulnificus.

The lawsuit, filed jointly with Public Citizen, asks the FDA to set standards to make sure these bacteria are “nondetectable in oysters and other molluscan shellfish sold for raw consumption.”

The FDA is supposed to respond to the complaint by July 25.

This issue goes back a long way.  I wrote about it in 2011 in the context of a Government Accountability Office (GAO) report, Food Safety: FDA Needs to Reassess Its Approach to Reducing an Illness Caused by Eating Raw Oysters.

Vibrio vulnificus bacteria are considered “flesh-eating;” they kill half the 30 or so people who eat contaminated raw oysters.   Treating the raw oysters before allowing them to be sold kills the bacteria.  California requires this and nobody eating California oysters gets sick from Vibrio.  As I wrote in 2011:

In 2001, the oyster industry trade association, the Interstate Shellfish Sanitation Conference (ISSC), promised the FDA that this industry would substantially reduce Vibrio infections in oysters within seven years through a program of voluntary self-regulation and education aimed at high-risk groups. If this program failed to reduce the infection rate, the ISSC agreed that the FDA could require oysters to be treated after harvesting to kill pathogenic Vibrio.

So what happened?  Late in 2009, the FDA said it would issue rules, but backed off under pressure from the oyster industry and friendly state officials.

Despite years of warnings and promises that it obviously has no intention of meeting, the Gulf oyster industry has been able to stave off FDA regulations for 15 years at the cost of about 15 preventable deaths a year.

CSPI and Public Citizen are trying the legal route.  I hope it works.

Nov 9 2011

The food politics of–oysters?

The Government Accountability Office (GAO) recently released a tough report on the FDA’s dispute with the Gulf Coast shellfish harvesting industry about oyster safety: Food Safety: FDA Needs to Reassess Its Approach to Reducing an Illness Caused by Eating Raw Oysters.

To better ensure oyster safety, says GAO, FDA should work with the oyster industry to (in my paraphrase):

  • Agree on a nationwide goal for reducing the number of illnesses caused by the consumption of Gulf Coast raw oysters
  • Develop strategies to achieve that goal
  • Recognize that consumer education and time-and-temperature controls have not worked
  • Recognize that the capacity to use postharvest processing methods does not currently exist.

As I explain in my book, Safe Food: The Politics of Food Safety, the FDA for more than a decade has been trying to prevent deaths caused by Vibrio vulnificus bacteria that contaminate raw oysters grown in the Gulf of Mexico.

These “flesh-eating” bacteria proliferate in warm months and are especially deadly; they kill half of the thirty or so people who develop infections from it each year.

In 2001, the oyster industry trade association, the Interstate Shellfish Sanitation Conference (ISSC), promised the FDA that this industry would substantially reduce Vibrio infections in oysters within seven years through a program of voluntary self-regulation and education aimed at high-risk groups.

If this program failed to reduce the infection rate, the ISSC agreed that the FDA could require oysters to be treated after harvesting to kill pathogenic Vibrio.

Postharvest processing involves techniques such as quick freezing, frozen storage, high hydrostatic pressure, mild heat, or low dose gamma irradiation, any of which reduces Vibrio vulnificus to undectable levels.

By most reports, the effect of treatment on the taste and texture of oysters is slight (although raw oyster aficionados might argue otherwise).

The California actions are instructive: In 2003, California refused to allow Gulf Coast oysters from entering the state unless they had undergone postharvest processing.  The result?  Sales of oysters remained the same but oyster-related deaths dropped to zero!

In contrast, states that did not require postharvest processing experienced no change in the number of deaths, meaning that the ISSC program had failed.

Late in 2009, the FDA announced that it intended to issue rules requiring postharvest processing of Gulf Coast oysters in summer months.

But less than a month later, the FDA backed off.  Under protest from Gulf Coast oyster harvesters, state officials, and elected representatives, the FDA agreed to postpone the oyster-processing rules indefinitely.

As the GAO understates the matter,

FDA and the ISSC do not agree on a common V. vulnificus illness reduction goal….If FDA and the ISSC are not in agreement on the illness reduction goal and strategies to achieve it, it will be difficult for the Gulf Coast states to move forward to significantly reduce the number of consumption-related V. vulnificus illnesses.

The GAO report further explains:

the ISSC continues to include California’s results in its illness rate reduction calculation along with Florida, Louisiana, and Texas. Doing so overstates the effectiveness of consumer education and time and temperature controls….

My translation: Despite years of warnings and promises that it has no intention of meeting, the Gulf oyster industry has been able to stave off FDA regulations for ten years at the expense of about 15 preventable deaths a year.

This is yet another example of political pressures blocking the FDA from carrying out its mandated food safety responsibilities.

Let’s hope the GAO report induces Congress to push this industry to get its act in order and the FDA to issue those regulations.

 

Jun 22 2010

Enough about Alaska. What about Gulf seafood?

A reader, Lucas Pattan, writes:

I’m writing to ask if you could do a post over the next few weeks about what you expect the impact of the Gulf spill will be on America’s seafood industry.  GQ has an amazing piece about fishermen and rigmen affected by the Deepwater Horizon, and the information about the fishing industry is pretty frightening [for the GQ piece click here].

I don’t have a crystal ball about the impact of the BP disaster on the Gulf seafood industry, but I’m assuming its effects will cause problems similar to those that happened as a result of the Exxon Valdez oil spill—only worse.

The Exxon Valdez spill occurred in 1989 in cold Alaskan waters.  Fish and wildlife stocks have not fully recovered 21 years later and it will be years before they do.  According to the Wikipedia entry on this event:

Both the long- and short-term effects of the oil spill have been studied comprehensively….The effects of the spill continued to be felt for many years afterwards. Overall reductions in population have been seen in various ocean animals, including stunted growth in pink salmon populations….Almost 20 years after the spill, a team of scientists at the University of North Carolina found that the effects are lasting far longer than expected. The team estimates some shoreline Arctic habitats may take up to 30 years to recover.

The Wikipedia continues with a comment on corporate responsibility:

Exxon Mobil denies any concerns over this, stating that they anticipated a remaining fraction that they assert will not cause any long-term ecological impacts, according to the conclusions of 350 peer-reviewed studies. However, a study from scientists from the NOAA concluded that this contamination can produce chronic low-level exposure, discourage subsistence where the contamination is heavy, and decrease the “wilderness character” of the area.

It looks to me as though the ecological, economic, and corporate effects of this one will be even worse and longer lasting:

  • It’s a bigger and longer lasting spill.
  • The economy of the Gulf states have yet to recover from hurricane Katrina.
  • Oysters don’t swim.
  • Much of the Gulf was already a dead zone created by agricultural runoff and industrial pollution.
  • The waters are warmer and less rich in nutrients.
  • U.S. energy policy still focuses on oil.

At the moment, is seafood from the Gulf region safe to eat?  President Obama says it is.  I hope he’s right

The FDA is sampling oysters, crabs, and shrimp and doing more inspection of seafood processing plants, closing down waters that seem to be contaminated, and doing what it can to make sure that tainted seafood is not getting into the marketplace.

According to a report in Food Chemical News II (June 21), the FDA says it will not re-open oil-contaminated waters to fishing until:

oil from the spill is no longer observable and seafood samples from the area successfully pass both sensory analysis by trained screeners and chemical analysis to ensure there are no harmful oil products found in them.

Smelling the fish to see if it’s OK?  I don’t think so.

Nov 28 2009

Food safety bill deserves support, even from small farmers

Alas, Congress did not pass food safety legislation by Thanksgiving, and I’m getting lots of requests to comment on it.  For example, Johannes G writes: “Marion, I’m usually spot on with you about a lot of things you talk about, but your final comment truly irritates me. We don’t need more regulatory policy, we need a food policy that makes sense.”

Actually, I think we need both.  No question, a better food safety regulatory policy is high on my priority list.  Why?  Because the food industry will never produce safe food voluntarily.  It’s time to give regulation a try, and now is the time.  While the window of opportunity is open, we need to convince Congress to act.

Current legislative proposals

To recap where we are on this: the House passed H.R. 2749, the Food Safety Enhancement Act last July. The Senate is currently considering S. 510, the FDA Food Safety Act.  Some version of these bills seems likely to pass, although it is not at all clear by when.

Although food safety advocates generally agree that we need a single food safety agency that integrates the activities of USDA and FDA, these bills are designed to fix the FDA alone, not the overall food safety system. For a quick take on the provisions of some of the bills under consideration, see the summary chart produced by the Center for Science in the Public Interest.

The bills require science-based (HACCP-type) processes for producing food, starting on the farm. And at long last they authorize the FDA to order recalls or detain foods deemed unsafe. No, the FDA does not already have these basic tools.  It needs them.

One more time on HACCP: It means Hazard Analysis Critical Control Point with Pathogen Reduction.  Translation: identify where in the production process contamination might occur, take steps to prevent contamination from occurring at those points, document that the steps were taken, monitor and inspect periodically to make sure the documentation is accurate, and test to make sure no contamination has occurred.

Without much chance of getting a single food safety agency, fixing the FDA is a good thing to do.  We can hope that once the FDA bill is passed, Congress will work on legislation to reconcile the inconsistencies in FDA’s and USDA’s food safety rules.  But that cannot happen unless the FDA first has the ability to require science-based food production and can authorize recalls and detentions.

The “scale” problem

This brings us to the problem of small farmers, or what regulatory agencies refer to as the “scale” (translation: size) problem. Steve Gilman, the policy coordinator for the Interstate Council of the Northeast Organic Farming Association (NOFA) sent me a copy of a letter to Senators signed by 70 or so members of the National Sustainable Agriculture Coalition.

This group is deeply worried about the bill’s “unintended negative impact on family farms, value-added agricultural development, conservation and the environment, organic farming, and emerging local and regional food systems.”

The Coalition wants the Senate to consider, among other things:

  • A two-track regulatory system based on the size, type, and diversity of a farm’s production.
  • Rules based on level of risk (“fresh cut, ready-to-eat packaged fruits and vegetables pose a far greater risk than whole produce”).
  • Exemptions for traceability requirements.
  • Scale-appropriate food safety training as outlined in additional legislation (introduced as S. 2758, The Growing Safe Food Act).

I greatly favor support of small farmers.  But I think all farmers – no exceptions – should be producing safe food. Thinking through a food safety plan is not that hard to do and farmers of any size operations should be carefully designing and diligently following HACCP-type plans appropriate to their specific situations.

Farmers who produce foods unlikely to be cooked before eating — raw vegetables, raw milk, raw oysters, for example – should be testing for contaminants on some kind of regular basis at time intervals that depend on the level of risk.

I think testing is so badly needed that I would add support of testing facilities to the Coalition’s legislative wish list.

The scale issues are important and I hope the Senate will consider them seriously, incorporate them into the final legislation, and look for ways to support the food values outlined by the Coalition.   But the fix-the-FDA legislation should not be held hostage to the scale problem.  The FDA needs better methods for protecting the public from the hazards of industrial production methods.  While making sure the FDA gets food safety authority, we need to work hard to get scale-appropriate rules or enforcement for smaller farmers who want to opt out of industrial food production, grow diverse crops, and produce them sustainably.

Nov 17 2009

Want safe meat? Make USDA do its job!

The New York Times reports that the company selling contaminated ground beef responsible for killing two people and making 500 others sick, “stopped testing its ingredients years ago under pressure from beef suppliers.”

Recall that since 1994, the USDA bans E. coli 0157:H7 in ground meat.  It encourages, but does not require, meat companies to test for the pathogen. Why don’t they test?  Because they don’t have to.

If they did test, they might find toxic E. coli and have to cook or destroy the meat.  As the Times reported in depth last month, Testing puts meat companies in “a regulatory situation.”  As one food safety officer put it, slaughterhouses do not want his packing company to test for pathogens: “one, I have to tell the government, and two, the government will trace it back to them. So we don’t do that.”

Instead of requiring safety testing, the USDA uses a “restrained approach.”  As Dr. Kenneth Petersen, an assistant administrator with the USDA’s Food Safety and Inspection Service, told the Times, USDA has the power to require testing but doesn’t use it because it has to take the companies’ needs into consideration: “I have to look at the entire industry, not just what is best for public health.”

The moral?  Meat companies will only produce meat safely if forced to.  As we saw yesterday, oyster companies will only produce safe oysters if they have to.  That’s why we need a food safety system in which all foods have to be produced safely.  What will it take to get Congress to act?

Nov 16 2009

Uh oh. Industry forces FDA to drop oyster safety plan

On November 13, the FDA announced indefinite postponement of rules requiring raw oysters from the Gulf of Mexico to undergo postharvest processing to destroy their content of Vibrio vulnificus, a particularly nasty “flesh-eating” bacterium.  According to accounts in the New York Times and in industry newsletters,  the FDA caved under pressure from the oyster industry and members of Congress representing oyster-harvesting regions in the Gulf.

The FDA has been trying for years to get the oyster industry to clean up its act and use post-harvest technologies to sterilize oysters in order to prevent the 15 or so deaths they cause every year.  The technologies include quick freezing, frozen storage, high hydrostatic pressure, mild heat, and low dose gamma irradiation.  When used, the methods reduce bacteria to undectable levels and deaths from Vibrio vulnificus infections to zero.  As the FDA puts it, “seldom is the evidence on a food safety problem and solution so unambiguous.”

The FDA took action on October 16.  It wrote a letter to the industry announcing the new rules.  It would expect oyster producers to use the techniques, especially on oysters harvested in summer months when bacteria levels are higher.  It also issued a background paper on why the techniques are needed, a fact sheet on oyster hazards, and a Q and A on the new policy.

On October 17, FDA official Michael Taylor gave a speech to the oyster industry outlining the policy.

Oops.  The oyster industry did not take well to the idea and went into organized action.

Now, the proposed rules are history.  As the FDA explains:

Since making its initial announcement, the FDA has heard from Gulf Coast oyster harvesters, state officials, and elected representatives from across the region about the feasibility of implementing post-harvest processing or other equivalent controls by the summer of 2011.  These are legitimate concerns.

It is clear to the FDA from our discussions to date that there is a need to further examine both the process and timing for large and small oyster harvesters to gain access to processing facilities or equivalent controls in order to address this important public health goal.  Therefore, before proceeding, we will conduct an independent study to assess how post-harvest processing or other equivalent controls can be feasibly implemented in the Gulf Coast in the fastest, safest and most economical way.

My interpretation: 15 or more preventable deaths a year, every year, from oyster Vibrio must not be enough to elicit industry responsibility or FDA action.  That the FDA was forced to back down so quickly is not reassuring about this administration’s commitment to food safety.  Make no mistake.  This is a major setback to developing a strong food safety system.

One of the ironies here is that the FDA’s approach to oyster safety mirrored the approach taken by the very same Michael Taylor when he worked for the USDA in the mid-1990s.  Then, the administration backed him up on requiring science-based food safety procedures for meat and poulty producers.  This time, it looks like the administration pulled the rug out from under him and forced the FDA to back down.

Note: Thanks to Mike Taylor, safety rules are in place for meat and poultry.  Unfortunately, the current USDA isn’t enforcing them.  I will have more to say on that point in tomorrow’s post.

Another note: Center for Science in the Public Interest, which has been pushing for oyster safety for years, has organized a protest campaign.  Sign up here.

Oct 6 2009

The high human cost of unsafe food

I think we need a whole lot more public outrage about unsafe food.  Maybe the recent front-page articles in the Washington Post and New York Times will do the trick.

Both tell tragic stories of women who developed hemolytic uremia syndrome in response to eating a food contaminated with E. coli O157:H7.  Both reveal the appalling physical and monetary cost of these illnesses.  Recall: we also do not have an effective and affordable health care system.

To me, the most chilling part of the Times investigation had to do with the lack of testing for dangerous pathogens.  No meat packing company wants to test.  Why not?  They know the animals coming into the plant are contaminated.  They know that tests would come up positive.  They know that if they find pathogens, they have to recall the meat.

It’s obvious why meat is contaminated.  The making of hamburger is enough to put anyone off, as the letters to today’s Times attest.  In my book, Safe Food, I discuss a study demonstrating that one pound of commercial hamburger could contain meat from more than 400 cattle.  The Times’ article takes such facts to a personal level.  The 22-year-old woman who ate the tainted hamburger is paralyzed from the waist down and likely never to walk again.

Read these articles and you will understand that meat companies will not do what is needed to produce safe food unless they are forced to.

And it’s not just hamburger that causes problems.  Center for Science in the Public Interest (CSPI) has a new report out on the ten foods that cause the most cases of foodborne illness in America.  Hamburger isn’t even on the list.  Instead, it’s leafy greens, eggs, tuna, oysters, potatoes, cheese, ice cream, tomatoes, sprouts, and berries.  [Addendum October 9: for a critical analysis, see the Perishable Pundit’s comments on the study].

So how come Congress isn’t forcing all food producers to produce safe food?  Could it be because there isn’t enough public outrage to counteract industry pressures and make Congress act?

Put me out of business big box WebBill Marler, who represents both of the victims profiled in those articles, is begging Congress to put him out of business.

His message is clear: get busy and pass meaningful food safety legislation, right now, before it is too late.

I’m hoping these articles and the CSPI report will be seen by senatorial staff who will urge their bosses to support the House bill passed last spring.

Maybe we need hundreds of thousands of people to deluge Congress with appeals to act on food safety, now.

You would like to do this but don’t know how?  Easy.  Find your own representatives online on the House site and your Senator just as easily.  The e-mail addresses are right there waiting to be used.

Addendum: Here’s one rep who is on the job: Rosa de Lauro (Dem-CT).  Take a look at her statement about the Times article.  Where, she wonders, was the USDA while all this was going on?   Doing lots of good things, according to USDA Secretary Tom Vilsack:

No priority is greater to me than food safety and I am firmly committed to taking the steps necessary to reduce the incidence of foodborne illness and protect the American people from preventable illnesses. We will continue to make improvements to reduce the presence of E. coli 0157:H7.

Suggestion: enforce HACCP!