Currently browsing posts about: Food-safety

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.

A comment by Sophie on my post about the food safety bills needs an immediate response to set the record straight.  She says:

It’s my understanding that this [bill] excludes pet food manufacturers….our pets were the canaries in the coal mine in the 2007 pet food recalls; they helped bring huge awareness to the food safety issue especially when baby formula was tainted with the same melamine problem that pet food was…but yet our pets get left out of the food safety bill?  Something isn’t right here…

On this point, not to worry.  H.R. 2749 most definitely does include pet foods.  Here, for example, is Section 101 (C)(i):

The term ‘retail food establishment’ means an establishment that, as its primary function, sells food products (including those food products that it manufactures, processes, packs, or holds) directly to consumers (including by Internet or mail order).
‘(ii) Such term includes–
‘(I) grocery stores;
‘(II) convenience stores;
‘(III) vending machine locations; and
‘(IV) stores that sell bagged feed, pet food, and feed ingredients or additives over-the-counter directly to consumers and final purchasers for their own personal animals [my emphasis].

All sections of the bill, including recall authority, apply to  pet foods and animal feed, as well as to human foods.  As another example, see Section 420 (c):

Order to Cease Distribution- If the Secretary has reason to believe that the use or consumption of, or exposure to, an article of food may cause serious adverse health consequences or death to humans or animals, the Secretary shall have the authority to issue an order requiring any person who distributes such article to immediately cease distribution of such article [my emphasis again].

In this sense, the bill recognizes that we have only one (global) food supply and that this one (global) food supply feeds people, pets, and farm animals alike.

I don’t track legislation very carefully because bills change so much between the time they are proposed and actually pass.  But I keep getting asked about the bills that seem to have the best chance this year,  H.R. 2749 (which has just been passed by the House) and its equivalent in the Senate, S. 510 (still in the works).  The bills are quite similar.  Both aim to fix the FDA.   Neither aims to fix the system, so forget about combining the food safety functions of USDA and FDA into one agency.  The bills bring the FDA’s rules closer to those of USDA, as they propose science-based food safety standards (much like HACCP) from farm to table.  Best, they give the FDA recall authority as well as a few other goodies.

The bills themselves are miserable to read and it is hard to believe that anyone in government does.  That is why the Congressional Research Service (CRS) does summaries that even legislators can understand.  CRS researchers have now produced blessedly short and hopefully accurate summaries of the House bill as well as the Senate bill.

As my contribution to the cause of clarity, I have done a quick edit of the CRS summaries, with comments in Italics.  The links above are to the original bills so you can plow your way through them to see if this does them justice.   Enjoy!

THE HOUSE BILL, H.R. 2749, requires each food facility to:

(1) Conduct a hazard analysis, (2) Implement preventive controls, and (3) Implement a food safety plan. [This sounds like HACCP, although they aren’t calling it that. I vote yes]

Requires FDA to:

(1) Issue science-based performance standards to minimize the hazards from foodborne contaminants [this means HACCP or its equivalent, and about time too],

(2) Establish science-based standards for raw agricultural commodities [this means some version of farm-t0-table HACCP, long awaited],

(3) Inspect facilities at a frequency determined pursuant to a risk-based schedule [this is an admission that the FDA can’t handle the work load; it will focus on products most likely to be contaminated]

(4) Establish a food tracing system [this will help identify where foods come from]

(5) Assess fees relating to food facility reinspection and food recall [make companies pay for all this, I hope in a way that avoids conflicts of interest],

(6) Establish a program for accreditation of laboratories that perform analytical testing of food for import or export [can’t believe we don’t already have this, but that’s why we need this legislation].

Authorizes FDA to:

(1) Order an immediate cessation of distribution, or a recall, of food [recall authority at last!]

(2) Establish an importer verification program [accountability for importers, at last!]

(3) Quarantine food in any geographic area within the United States [they can’t do this now?].

Defines the term “color additive” to include carbon monoxide that may affect the color of fresh meat, poultry products, or seafood [this will have to meet food additive regulations].

Requires country of origin labeling on food, and annual registration of importers [Yes!].

Provides for unique identifiers for food facilities and food importers [so FDA actually knows who they are].

Deems a food to be adulterated if an inspection is delayed or refused [Yes!].

Requires FDA to establish a corps of inspectors dedicated to inspections of foreign food facilities [Amazing that we don’t already have this].

Reorganizes the FDA field laboratories and district offices [Could this possibly be a euphemism for closing some?].

Gives the FDA Commissioner subpoena authority [Yes!].

Establishes whistleblower protections [OK].

THE SENATE BILL, S. 510, is pretty much the same except that it addresses food bioterrorism [fortunately, a rare event so far]. In addition to most of what is in the House bill, it requires HHS and USDA to prepare the National Agriculture and Food Defense Strategy [If this is done right, it ought to promote the safety of domestic foods and imports].

It also requires FDA to:

(1) Identify preventive programs and practices to promote the safety and security of food [worries about food bioterrorism again];

(2) Promulgate regulations on sanitary food transportation practices [good idea];

(3) Develop a policy to manage the risk of food allergy and anaphylaxis in schools and early childhood education programs [I’m not sure how this got in here]

Requires FDA and CDC to enhance foodborne illness surveillance systems [Good idea].

Requires EPA to assist state, local, and tribal governments in preparing for, assessing, decontaminating, and recovering from an agriculture or food emergency [in the military sense of food security].

There is much, much more in these bills.  Bill Marler, who has actually read the bills, has produced his own summary, which includes definitions and more.  If you are wondering what implementation of these bills might cost, the Congressional Budget Office has done an analysis: a mere $2 billion.

It’s hard to know how seriously to take all this until we see what Congress actually does when it gets back to work.  Stay tuned.

I’m in Alaska this week and out of Internet contact most of the time so it’s been hard to follow the cookie dough story.  It seems that the strain of E. coli found in the cookie dough does not match the strains in the people who have gotten ill from (presumably) eating it.  The FDA can’t figure out how E. coli got into the cookie dough.

When I can get to a computer, I like to check the FDA page on this outbreak, and also the one from the CDC.  But it looks like they are only updating the pages about once a week.  So the quickest way to keep current on this is through Bill Marler’s blog.

[Posted from Anchorage]

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 story thus far:

From January to June 2009, at least 69 people from 29 states have gotten sick with E. coli O157:H7.  Many of them confessed to eating Nestlé’s raw cookie dough.

On June 19, the FDA warned the public not to eat Nestlé’s raw cookie dough.  Nestlé issued a “voluntary’ recall.

Everyone is baffled about how E. coli O157:H7 could have gotten into cookie dough.  They wonder if cookie dough really is the cause.

The voluntary recall isn’t working (most don’t).  Obama Foodorama has no trouble finding plenty of recalled cookie dough on Washington DC shelves.

The Wall Street Journal reports that since 2006, Nestlé has consistently refused to allow FDA investigators to look at their safety records.  The company doesn’t have to.  All those pesky regulatory requirements are voluntary (that word again).

But now, in a spirit of someone more enforced cooperation, Nestlé lets the FDA in.  Bingo.  On June 29, the FDA says it finds E. coli O157:H7 in one batch of cookie dough.    But conversations with FDA officials leave many questions unanswered.

Nestlé is understandably concerned.   The company says it “deeply regrets” what happened and is fully cooperating with the FDA.

OK.  So if we didn’t know it before, we know it now: “voluntary” is a euphemism for not having to do anything.  Doesn’t this suggest the need for some real regulations?

I didn’t know that IBM was in the survey business but apparently it has just asked people what they think about the safety of the food supply.  Fewer than 20% of the 1,000 people who responded said (what a surpise) that they trusted food companies to make safe and healthful foods.

More than 60% said they were worried about food safety and – this one really does surprise me – 83% could name a food that was recalled in the past two years, mostly peanut butter.

IBM’s conclusion?  “These findings underscore how the rise in recalls and contamination has significantly eroded consumer confidence in food and product safety, as well as with the companies that manufacture and distribute these products.”   No kidding.

Now if Congress would only pay attention and do the right thing.

OK, so Bill Marler is a class action lawyer* who makes his living from suing companies that produce unsafe food. I’ll grant that he has a vested interest but I admire the way he never loses sight of the harm done to innocent adults and children.  Cookie dough has a warning label on the package and everyone knows you are not supposed to eat raw cookie dough.  If you eat it, it’s your fault if you get sick, right?  See what he has to say about that one.

In Marler’s view, the warning label on commercial raw cookie dough should read something like this:

THE FDA INSPECTION MEANS NOTHING. THIS PRODUCT MAY CONTAIN A PATHOGENIC BACTERIA THAT CAN SEVERELY SICKEN OR KILL YOU AND/OR YOUR CHILD. HANDLE THIS PRODUCT WITH EXTREME CARE.

And, he asks, “Where is the multi-million dollar ad campaign to convince us of the dangers of uncooked cookie dough, like we do for tobacco?”

I would add a few further questions: What are we going to have to do to get a real food safety system in this country?  By real food safety system, I mean one that requires production of all foods – from farm to table – under science-based food safety plans (HACCP with pathogen reduction), overseen by a single federal agency that unites and rationalizes the current functions of USDA and FDA.

Everyone knows how to produce food safely or a lot more safely than is being done now.  If companies don’t bother, it’s because they don’t have to. You don’t like this?  Complain to Congress!

*Correction: See Mr. Marler’s comment below.  He says he mostly represents individuals.   I do apologize for the error.