Currently browsing posts about: HACCP(Hazard Analysis and Critical Control Point)

Michael Taylor, FDA’s associate commissioner for foods, gave a major speech yesterday at the George Washington University School of Public Health.

In it, he talked about the origin and effectiveness of HACCP (Hazard Analysis and Critical Control Point) controls for preventing food safety problems.  HACCP, he explained, works just like other aspects of public health practice.  It requires:

• understanding the specific food safety hazards that could affect a particular food production operation,

• devising and implementing scientifically validated controls to minimize the hazards,

• monitoring the implementation of preventive controls to verify effectiveness, and

• making corrections and adjustments as needed, based on experience.

He then went on to say how FDA plans to put the Food Safety Modernization Act into action:

We are well on our way to developing a proposed produce safety rule that addresses areas such as employee hygiene, water quality, soil amendments, and animals in the growing area, as FSMA mandates.

In food facilities, such as processing and packaging plants, we will be proposing rules that are grounded in the widely embraced principles of preventive process control for food safety, similar to HACCP.

The law requires each facility to… (1) evaluate the hazards that could affect food safety, (2) specify what preventive steps, or controls, to put in place to minimize or prevent these hazards, (3) specify how the facility will monitor these controls to ensure they are working, (4) maintain routine records of monitoring, and (5) specify what actions the facility will take to correct problems that arise.

For example, in a facility that produces peanut butter, factors such as  ingredient safety, sanitation, and cross contamination would have to be considered. After the outbreak of Salmonella typhimurium in peanut butter in 2008 and 2009, which caused 714 cases of illness, the company had to reevaluate the hazards in its facilities so this wouldn’t happen again.

Such review and correction – and a sharp focus on specific hazards – will become the norm under a system of preventive controls.

Taylor outlined FDA’s vision for preventive controls from farm to table.  Now, if Congress will just give it the resources to do all this, we might actually have a food safety system that functions.

Today’s New York Times has an op-ed, “Crying over raw milk“, about the political fights over raw milk in Wisconsin.  The Wisconsin legislature has introduced a bill allowing dairy farmers to sell raw milk directly to consumers.  The conventional dairy industry is not happy about that.

The author of the piece, Michael Feldman, is dubious about the purported health benefits of raw milk but is quite clear about its economic benefits: “you can’t get $6 a gallon for pasteurized milk.”

Crass economics is behind much of the politics of raw milk these days.  The conventional dairy industry is in trouble: too many cows, too much milk, and not nearly enough regulation of supply.  In contrast, raw milk has passionate advocates willing to pay premium prices.

Not fair, says the dairy industry, which wants raw milk to be regulated:

In a letter to two senior members the Senate Committee on Health, Education, Labor and Pensions, the dairy groups called for a measure obliging all facilities producing raw or unpasteurized milk products for direct human consumption to “register with FDA and adhere to the tried-and-true food safety requirements that are followed by all other facilities producing milk products”.

As for the safety of raw milk, it is useful to take a look at Seattle attorney Bill Marler’s website: “Real Raw Milk Facts.”   There, he summarizes recent cases of illness caused by toxic E. coli and Salmonella contaminants in raw milk.  These constitute a full employment act for attorneys like Marler who represent victims of foodborne illness.

My position on raw milk has long been that people have a right to drink it but it had better be produced safely.  I believe that all foods–no exceptions–should be produced under well designed and carefully followed HACCP plans (or their equivalent) with pathogen testing at intervals commensurate with the level of risk.

But food safety experts tell me that raw milk can never be tested frequently enough to be confident it is safe.

Raw milk carries a greater risk of bacterial contamination than pasteurized milk and people who buy it should know what those risks are.  The risk may be small, but it is finite.  Putting a child at risk of hemolytic uremic syndrome from toxic E. coli just doesn’t make sense to me.

Like Michael Feldman, I’m dubious about the claims made for the health benefits of raw milk.  No question, it tastes better and that may be reason enough to want it.  But until I can be sure that the producer is scrupulous about safety, my personal choice favors pasteurization.

But that’s just me.  You?

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.

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.

As a result of investigations in Colorado, the FDA has just issued one of it’s lovely warnings of “voluntary” recalls, this time of Nestlé ‘s raw Toll House cookie dough (see product list).

I’d like to know if cookie dough is really the problem.  If there is a problem with cookie dough, it’s usually Salmonella. If cookie dough is the culprit, how on earth did this nasty form of E. coli, usually excreted by farm animals, get into it?  Eggs?  Butter?  Chocolate?  Flour?   In the meantime, the tally has reached 65 victims in 29 states: 25 hospitalizations, 7 with severe complications, no deaths.  Here’s the brand new CDC Nestlé Toll House Cookie Dough outbreak page with the statistics.

The roster: spinach 2006, pet food 2007, tomatoes (or was it jalapeno peppers or cilantro) 2008, peanut butter 2009, pistachios 2009. And now cookie dough.

The endless mantra is that we need prevention: HACCP, pathogen testing, and independent third-party verification.

The interesting part about this latest recall – now 2 million pounds and involving 74 products so far – is how the Salmonella contamination was discovered.  According to a lengthy account in USA Today, a small nut company in Illinois, Georgia’s Nut, routinely tests for Salmonella and found the bacteria in nuts purchased from Setton Pistachio of California.  Georgia’s Nut recalled products distributed in the Chicago area.  This company also produces a trail mix for Kraft Foods.  It notified Kraft Foods, which also promptly recalled its products.

I’m guessing that Georgia Nut must follow a HACCP (Hazard Analysis and Critical Control Point) plan.  HACCP is a science-based food safety procedure that requires analyzing where contamination might occur in production processes (hazard analysis), taking steps to prevent contamination at those critical control points, and using pathogen testing to make sure the steps were followed and the plan is working.

HACCP, as I keep complaining, is only required for meat and poultry production on the USDA regulatory side (where is it poorly enforced) and for sprouts, fresh juices, seafood, and eggs on the FDA side.  The producers of everything else are supposed to follow Good Manufacturing Processes, which are considerably less rigorous and, as we saw with the peanut butter recalls (more than 3,800 products from 200 companies) and their health consequences (nearly 700 sick, at least 9 deaths), clearly do not work.

How about HACCP for all foods?  Worth a try?

April 3 update: USA Today reports that Setton Pistachio has not yet issued its own recall (note: this is a good reason why the FDA needs the authority to order recalls), that its California plant passed recent inspections with relatively minor violations, but that its sister plant on Long Island is a mess.  USA Today also reports that Setton Pistachio has had positive tests for Salmonella for months.  What did the company do with the contaminated pistachios?  A mystery.

As we have learned all too often, dishonest food companies cut corners on food safety any time they can get away with it.  That is why inspections are absolutely necessary.  Right now, the inspection system is largely voluntary and all too easily corrupted.  In a series of articles in the New York Times, we now learn that some of the peanut butter caught up in the recent recalls was Certified Organic, and that the plants had passed inspection by USDA-licensed organic certifiers.

As for conventional foods: today’s front-page article expands on flaws in the food inspection system.  Inspectors, for example, are paid by the plants they are inspecting (oops).  Here’s my favorite quote, attributed to Mansour Samadpour, a food safety consultant: “The contributions of third-party audits to foods safety is the same as the contribution of diploma mills to education.”

When I was doing the research for my book, Safe Food, I visited a plant that manufactured meat products.  The plant manager told me that you could butcher a dog in front of the onsite USDA inspector and he would never see it.  I believed him: inspectors only see problems if they know what to look for.

All of this makes me think that inspections need to be done by independent agencies that are rewarded for finding problems, not ignoring them.  Mandatory HACCP (standard food safety procedures) with testing and inspection would help too.   And if the organic food industry wants the public to believe that organic foods are better, it must make sure that production methods meet organic standards in letter and spirit.  Otherwise, why bother to pay more for organic foods?

The USDA needs to close loopholes and insist on the integrity of the inspection system. The FDA needs to figure out a way to get its inspection needs under control.  These are issues for Congress to handle.  I keep wondering:  How bad do things have to get before Congress does something useful about food safety?

The CDC reports more than 500 cases and 8 deaths from Salmonella typimurium in peanut butter produced at a single plant in Georgia owned by Peanut Corporation of America (PCA).

Fortunately, the number of reported cases is going down.FDA officials reveal that the PCA plant has a history of knowingly shipping peanut butter contaminated with Salmonella. But these incidents did not involve the same strain.

The peanut industry says this is one bad peanut and everyone else’s peanuts are OK.

I say (again and again): Peanuts are not kcovered by standard food safety regulations (voluntary Good Manufacturing Practices demonstrably do not work).  We need HACCP food safety regulations – with Pathogen Reduction –  for all foods, from farm to table.

January 30 update: Apparently, the New York Times editorial staff agrees with me!  And no wonder, given what their reporters are saying about ithis incident.