Search results: fda new food safety rules

Yesterday, the FDA announced yet another voluntary recall of eggs produced by Wright County Egg in Galt, Iowa.  The first announcement on August 13 covered 228 million eggs.  This one adds 152 million for a grand total of 380 million—so far.

In that first announcement, the Wright company said: “Our farm strives to provide our customers with safe, high-quality eggs – that is our responsibility and our commitment.”

That, however, is not how the New York Times sees it.  According to today’s account, Wright has a long history of “run-ins with regulators over poor or unsafe working conditions, environmental violations, the harassment of workers, and the hiring of illegal immigrants.”

OK, so where are we on safety regulation?  The FDA, after many, many years of trying, finally introduced safety regulations for shell eggs.  These supposedly went into effect on July 9.

I recount the history of FDA’s persistence in the chapter entitled “Eggs and the Salmonella problem” in What to Eat. Check out the table  listing the key events in this history from 1980 to 2005.  It’s not pretty.

Preventing Salmonella should not be difficult.  The rules require producers to take precautions to prevent transmission, control pests and rodents, test for Salmonella, clean and disinfect poultry houses that test positive, divert eggs from positive-testing flocks, refrigerate the eggs right away, and keep records.  These sound reasonable to me, but I care about not making people sick.

Problems with Wright County Eggs started in May before the FDA’s mandatory rules went into effect meaning that the procedures were still voluntary.  The recalls this month are after the fact.  Chances are that most of the recalled eggs have already been eaten.

The CDC is tracking this recall and has logged about 200 reports of illness associated with it so far.  It has plenty to say about Salmonella and its hazards.

According to FoodSafetyNews, the first lawsuits have been filed.

As for food safety legislation that would give the FDA the authority to handle these incidents more efficiently—and, let us hope, maybe even prevent them—it is still sitting in the Senate.  For S.510 watchers, Bill Marler has a helpful new analysis.

The recall, by the way, affects eggs sold under many different brands: Lucerne, Albertson, Mountain Dairy, Ralph’s, Boomsma’s, Sunshine, Hillandale, Trafficanda, Farm Fresh, Shoreland, Lund, Dutch Farms, and Kemps in the first round, and now also James Farms, Glenview, and Pacific Coast.

The good news is that cooking kills Salmonella.  I’m buying eggs at farmers’ markets these days.

Addition: Tom Philpott of Grist on Wright County’s unsavory history.

USDA is the agency supposedly responsible for the safety of meat and poultry.  Unlike FDA, which is responsible for the safety of just about all other foods, USDA gets to impose HACCP (science-based food safety regulations) on meat and poultry.  It just doesn’t bother to enforce its own rules.  Hence recent events:

Consumer Reports, which for decades has been testing supermarket chickens for microbial contaminants, has just  tested chickens again. Sigh. Two-thirds were contaminated with Salmonella or Campylobacter. You will be relieved to know that this is an improvement. It was 80% the last time Consumer Reports did the testing.

In an effort to get USDA and the poultry industry moving on this problem, Senator Dianne Feinstein (Dem-CA) has introduced a bill to prohibit the sale of meat that has not been certified free of pathogens. Based on what’s been happening with meat safety, I’m betting it won’t get far.

So let’s talk about meat safety.  For this, we should all be reading USA Today, which seems to be one of the last newspapers in America still funding investigative reporting.  Its latest blockbuster is an account of the 826,000-pound recall by Beef Packers, Inc. (a subsidiary of Cargill) a few months ago. The meat made at least 28 people ill as a result of infections with a strain of Salmonella Newport highly resistant to antibiotics.

That’s bad enough, but it gets worse.  Beef Packers is a major supplier of meat to the USDA’s school lunch program. But oops.  The recall covered meat sent to retailers.  It did not cover meat sent to schools. According to the intrepid reporters at USA Today, USDA bought 450,000 pounds of ground beef produced by Beef Packers during the dates covered by the recall.

USDA should have known better.  Beef Packers had a history of positive Salmonella tests but the USDA did not disclose that information. An official told USA Today that doing so

would discourage companies from contracting to supply product for the National School Lunch Program and hamper our ability to provide the safe and nutritious foods to American school children.

You can’t make these things up.  USA Today provides the documents on its site to prove it.

I missed the earlier article in the USA Today series about school lunches in general and Del Rey Tortillas in particular, a company implicated in 20 cases of school food poisonings since 2003. Check out the article’s quick facts-and-figures about school lunches, the nifty interactive timeline for the Del Rey episodes, and the raft of documents in this case.

Good work, reporters. If you want to know why we need newspapers, here’s a good reason.

As for USDA: the new administration at the agency shows many signs of wanting to do the right thing about food safety but they have to deal with entrenched staff and inspectors who have been cozy with industry far too long.  USDA: deal with it!

Coming soon: updates on FDA and FTC.

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.

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.

I can think of many reasons why school food is such a hot topic these days: kids eat a significant portion of their daily calories in schools, schools set an example for what is appropriate for kids to eat, and schools are a learning environment.  Here’s the latest on what’s happening on the school food scene:

1.  The New York City Education Department announces new rules for school vending machines, as part of its new school wellness policies.  According to the account in the New York Times, the vending machines have been empty since the Snapple contract ended in August (Really?  That’s not what I observed a couple of weeks ago).  The new standards will exclude the worst of the products but the lesser evils will still be competing for students’ food dollars, thereby continuing to undermine the solvency and integrity of the school meal programs.

2. The CDC reports (MMWR, October 5)  that junk food is rampant in schools, but the percentage of schools in which children are not permitted to buy junk food or sodas is increasing in at least 37 states.

3.  The Government Accountability Office (GAO) takes the USDA to task for not alerting schools when foods in the school meals programs – meat or peanut butter, for example – have been recalled because they are contaminated with dangerous bacteria.  Usually, the GAO talks straight to government.  I don’t know what happened in this case but here is its first, rather incoherent, recommendation to USDA regarding the USDA’s Food and Nutrition Service (FNS):

To better ensure the safety of foods provided to children through the school meal programs, and to make improvements in three areas related to recalls affecting schools: interagency coordination; notification and instructions to states and schools; and monitoring effectiveness, the Secretary of Agriculture should direct FNS and that the Secretary of HHS should direct FDA to jointly establish a time frame for completing a memorandum of understanding on how FNS and FDA will communicate during FDA investigations and recalls that may involve USDA commodities for the school meal programs, which should specifically address how FDA will include FNS in its prerecall deliberations.

The other recommendations make somewhat more sense.  They begin by repeating the first part up through “the Secretary of USDA should direct FNS to”:

• develop guidelines, in consultations with the Agricultural Marketing Service (AMS) and the Farm Service Agency (FSA), to be used for determining whether or not to institute an administrative hold on suspect commodities for school meal programs.
• work with states to explore ways for states to speed notification to schools.
• improve the timeliness and completeness of direct communication between FNS and schools about holds and recalls, such as through the commodity alert system.
• take the lead among USDA agencies to establish a time frame in which it will improve the USDA commodity hold and recall procedures to address the role of processors and determine distributors’ involvement with processed products, which may contain recalled ingredients, to facilitate providing more timely and complete information to schools.

This needs an editor, but you get the idea.

4.  The GAO has produced yet another report, this one devoted to getting states to comply with federal rules about meal counting and claims.  These are measures designed to make sure that ineligible kids don’t get fed.  I wish I knew how much money such measures cost.  They are a tragic waste.  We need universal school meals.  Period.

5.  And then there is Jamie Oliver, who has transformed the British school meals system and is now attempting to bring his school food revolution to the United States (see the food issue of the New York Times magazine).  One can only wish him luck.

The FDA must be in a bit of a quandary as it waits to see what Congress orders it to do about food safety (see previous post).  But it is not sitting around doing nothing.  Instead, it seems to be unblocking regulations that have been in the works for a long time.

On July 9, the FDA announced a final rule for prevention of Salmonella Enteriditis contamination of shell eggs during production, storage, and transportation.  This might seem unremarkable except for two points: (1) it requires science-based food safety procedures – with pathogen testing – from farm to table (an all-time first), and (2) it was first proposed in 2004 and has been stuck ever since (that’s politics for you).

On July 31, the FDA proposed safety guidance for melons, tomatoes, and leafy greens that would apply to everyone involved in the supply chains for these foods – growers, packers, processors, transporters, retailers, and others.  Guidance, alas, is just that: voluntary.  But this puts the producers of such foods on alert that the guidance could swiftly turn into rules  if Congress gets busy and does what it ought to be doing about food safety.  The guidance is open for comment but it is designed to be implemented within two years.  This is quick in FDA regulatory time.

And now the FDA announces that it is speeding up its system for issuing warning notices to companies in violation of safety regulations.  This is a good step, although it falls far short of recall authority.  For that, Congress must act.

Applaud the FDA and keep fingers crossed that no new outbreaks occur while Congress takes its own sweet time to act.

On Monday this week, Michael Taylor began his new job as special assistant to the FDA Commissioner for food safety.  He will be in charge of implementing whatever food safety laws Congress finally decides to pass.

I know that what I am about to say will surprise, if not shock, many of you, but I think he’s an excellent choice for this job. Yes, I know he worked for Monsanto, not only once (indirectly) but twice (directly). And yes, he’s the first person whose name is mentioned when anyone talks about the “revolving door” between the food industry and government. And yes, he signed off on the FDA’s consumer-unfriendly policies on labeling genetically modified foods.

But before you decide that I must have drunk the Kool Aid on this one, hear me out.  He really is a good choice for this job.  Why?  Because he managed to get USDA to institute HACCP (science-based food safety regulations) for meat and poultry against the full opposition of the meat industry — a truly heroic accomplishment.  His position on food safety has been strong and consistent for years.  He favors a single food agency, HACCP for all foods, and accountability and enforcement.  We need this for FDA-regulated foods (we also need enforcement for USDA-regulated foods, but he won’t be able to touch that unless Congress says so).  So he’s the person most likely to be able to get decent regulations in place and get them enforced.

The Trust for America’s Health and the Robert Wood Johnson Foundation announce the release of a new report on how to fix the food safety system.  The report, Keeping America’s Food Safe: A Blueprint for Fixing the Food Safety System at the U.S. Department of Health and Human Services (HHS), makes a bunch of suggestions for strengthening the FDA.  The FDA, it says, needs to concentrate resources on the highest risks, enforce existing rules (what a concept), establish a position with authority over all food safety programs in the agency, and work with Congress to establish a Food Safety Administration within HHS.

Wait a minute: I thought two agencies were involved in food safety regulation.  Yes, HHS regulates most foods through the FDA, but the USDA regulates meat and poultry.  These are not two separate food systems. Wastes from food animals (USDA-regulated) contaminate fruits and vegetables (FDA-regulated).

Don’t we need one system?  I think we do.

And buried in the mess of bills submitted to Congress and currently under consideration (handily summarized by Bill Marler), are several aimed at doing just that.  This is a great time to weigh in on them, especially since polls show that nearly 75% of Americans are more afraid of food than they are of terrorists.