Food Safety and Environmental Health Blog

A Consumer Looks at Food Safety

Roy Costa — Sat, 17 Mar 2012 10:58:37 -0500

To post guest's articles, please contact rcosta1@cfl.rr.com

A Consumer Looks at Food Safety

by Lauren Bailey

It’s a sad fact that many food safety hazards and issues are discovered by accident by a consumer. Consider any food safety scare from the last year: the Jensen Farm cantaloupes from Granada, Colorado, or the E. Coli outbreak in Europe, two huge stories that point to the overall fragility of consumer health and the hefty responsibilities of the food industry. Food safety is a chief concern among U.S. health officials precisely because it involves the entirety of the American people, and yet big mistakes seemingly occur every year.

As consumers, we largely have to assume that wholesale food producers know what they’re doing; we implicitly trust they are meeting regulation standards and that those standards are sufficient to ensure our safety. Every time we purchase of raw fruits and vegetables, when we pick up a cut of meat at the butcher’s, we do so on good faith that the food won’t harm us. But more and more often we hear stories that give us pause over our long-held faith in food. I think these popularized food safety issues are one of the greatest challenges facing the American consumer today.

Allow me to elaborate.

A New Headline Every Day

Whether it’s a story about “pink slime” in processed beef products or alarming BPA levels in canned goods, there’s always a new food scare driving the health section of popular media outlets. It’s enough to create a perpetual atmosphere of fear and distrust among many consumers. But the unfortunate truth is that these huge food scares usually revolve around a highly isolated incident—maybe a dozen people fall seriously ill over a certain contaminated good. But the backlash that follows the story will completely cripple any producer of that good, even if their facility was in no way involved in the food scare. People will understandably have a knee-jerk reaction to stories about potentially hazardous foods if they hear about it 24/7.

In the case of the Jensen Farms cantaloupe scare, with the ensuing listeria outbreak, people steered clear of anything having to do with the fruit for a good while. The infamous case of E. Coli and bagged spinach a few years ago severely hurt overall spinach sales, even though the outbreak was traced to specific producers and not to all spinach sellers. If consumers are told to be wary of a food, they’ll listen. But why is it that we get the most information about food safety from these isolated incidents, and not from the producers themselves?

More awareness in supermarkets

It seems to me that the first step to increase the average consumer’s awareness of food safety should be taken by food producers and distributors. Whenever you step into a supermarket, the only signs you’ll encounter will be those advertising the cheapest deals on goods. Or you’ll be met with a gaggle of products that exclaim their organic or whole grain components. Not enough grocery stores (nor the food items that they sell) warn consumers about the potential health risks of certain foods. The recent CDC report concerning the high sodium consumption of most Americans confirms as much, because the vast majority of us consume far more sodium than we would believe. We do this because it’s never completely clear how much sodium is in many processed or canned goods. We might be able to read the sodium levels on a product, but without a means to contextualize those numbers we won’t know what to do with them.

It’s the same case for any component of a food that’s detrimental in excess: fatty foods, sugary foods, highly processed foods all need to be much more clear about the health risks they pose to the average consumer. If the food industry doesn’t take steps to be more transparent about health benefits and risks of their products, then we can probably expect many more isolated food scares that probably could have been prevented.

By-line:

This guest post is contributed by Lauren Bailey, who regularly writes for accredited online colleges. She welcomes your comments at her email Id: blauren99 @gmail.com.

Food Service Industry Push Back on Letter Grades

Roy Costa — Mon, 12 Mar 2012 19:40:08 -0500

I am for a more fair system when it comes to inspections and grading. The grading numbers may not mean much, and this is because inspections are snap shots of events and there are all sorts of bias and human elements. However, when the facility maintains its records of food safety efforts, its more like seeing a moving picture. When inspections or audits make an evaluation based on what they see, and what they determine to be required in the firm's food safety program, now you have something that has the ability to be meaningful. Its the firm's daily practices that will make or break a sanitation program. Lets start evaluating that.

But wait, that means a food service operation has to have an internal food safety program to evaluate!

Too bad restaurants don't have to do have one, its not required, they "just follow the code".

That mentality doesn't work and all this controversy about grading being a poor measure is true; but it is just a subterfuge for the fact that the FS industry as a whole will not agree to a mandatory self-control program that would allow checks and balances. Fortunately, most of the rest of the supply chain has.

Here is what the FRA has to say about grading in 2005,

http://www.wftv.com/news/news/no-state-issued-letter-grades-for-restaurant-inspe/nJwwH/

and thier stance has not changed, in aspite of the fact that reports from agencies with letter grading support risk reduction has occurred.

If this is to catch on we have to overcome some of the problems that are rightly recognized. Its just we have not understood what food safety management is and applied it to Food Service and this means we have no real measurement we can rely on.

The latest pushback from NYC.

NEW YORK: City Council throws rotten tomatoes at restaurant grades
11.mar.12
New York Daily News
http://www.nydailynews.com/opinion/city-council-throws-rotten-tomatoes-restaurant-grades-article-1.1036545?localLinksEnabled=false
It is but a slight exaggeration to say that everyone who eats in a restaurant in New York City — which means essentially everyone who lives, works or visits — loves the A, B and C placards posted in eatery windows.
Those grades, based on Health Department inspections, have had powerful effects. They have improved restaurant sanitation, reduced food-borne illnesses like salmonella and boosted business at restaurants that have earned the top mark.
What’s not to like?
Ask the City Council and Speaker Christine Quinn.
The industry has fought letter grading from the moment the Bloomberg administration floated the idea. Restaurateurs have griped repeatedly that inspections are too tough, fines are too high and the marks are based on poorly chosen criteria.
Now, Quinn & Co. have produced a survey purporting to find that the program desperately needs reform. A questionnaire asked restaurateurs their opinions about the grading. Of the city’s 24,000 restaurants, 1,297 responded.
Based on the survey, Quinn is calling for a reevaluation of the violation system, an ombudsman to adjust inspection results before hearings are held and an “early warning system” to weed out supposed inconsistencies in inspections.
She needs to get specific and prove her proposals will not undermine the most important consumer protection in recent New York memory.

FDA and Industry-Stop Fighting and Start Cooperating

Roy Costa — Sat, 03 Mar 2012 09:35:29 -0500

Its evident that the FDA regulated food industry does not want to pay user fees. With the political climate being what it is, FDA may not get sufficient funding to carry out its mandates.

If this is the way government and industry decides on what is best for the public health, then the consequences need to be assessed and some sort of alternative developed. See:

http://www.foodengineeringmag.com/articles/print/88970

The problem is that there is no united opinion on on how best to develop an industry led government-private sector initiative that is universally adopted. The the current system of competing private standards has shown its limitations and we need more than this.

The FSMA should become the universal standard for industry compliance and conformance, a radically new approach, but totally common sense.

Much of what the FDA says needs to be done can be done through cooperation, allowing FDA to take a less aggressive position in regulation, This can happen only if voluntary compliance will work and industry will accept FDA standards as the bible, and FDA as the leader.

The potential savings for everyone could be maximized by developing the key programs and criteria that could be used by industry to support the FDA mission. If industry wishes to keep the current model of self inspection and provate standards, in line with the new model of mandatory reporting of FDA compliance, all the better.

Furthermore, FDA should start discussions about interagency agreements and contracts with state and local health departments to provide manpower to see how much can be saved through this approach.

Beyond the current FDA guidance documents, I propose a system that relies on mandatory reporting by the private sector to government.

This measure is not as perfect as an FDA inspector in the field. but competent industry personnel, working under strict management and oversight of FDA is a good half way point.

The electronic reporting requirements can easily be developed. FDA manpower and technology could better be used in this approach.

As a minimum I would suggest:

Establish the food safety criteria to be used by FDA regulated segments, starting with the highest risk operations and develop reporting formats, this should move ahead if the funding issues can be dealt with
Establish the qualification for third party second party and first party inspection for each of the critical sectors newly under FDA, this has to be done anyway
Develop the oversight standards of the agency, not limited to frequency of reporting, criteria for determining risk, and interventions
Establish the reporting database and security measures for the data entry

The application of technology is a key benefit in moving forward, especially if funding is minimal as predicted. Industry already has the experience in electronic reporting, and government should work with industry to further develop the methods already in use to collect and disseminate food safety data and manage risk in the food supply.

Instead of fighting over money, I would suggest a new spirit of can do and a frank discussion of how we can help one another.

Environmental Health Down on the Farm

Roy Costa — Sun, 29 Jan 2012 14:06:01 -0500

As an environmental health professional, I have enjoyed a successful career in hands-on food protection from farm to table. My success in this wide array of conditions has come through the effective application of environmental health principles.

Nowhere in food safety today is environmental health needed more than down on the farm, where the environmental health risks factors are becoming better understood. As a sanitarian and independent food safety auditor, there are some key areas of environmental health in my work on the farm; water quality, animal control, and worker hygienic standards. Private food safety auditors have started calling these the "Three W’s" for Workers-Water-and Wildlife.

Typical tomato wash water used to rinse picking buckets

Downstream effects of the environmental health problems originating on produce farms are huge. The problems reverberate through the the rest of the controls we have in place. Because the risks are not well controlled, we need more and more robust surveillance, traceability and product recall ability, testing; and of course, redress for victims in court. These unfortunate individuals and their families hold the bag at the end of the system without much control. The cost burden on the food industry due to outbreaks is remarkable. The Listeria problem in cantaloupe may cost industry $150 million in legal fees, alone. All of this has happened because we have not effectively established in the produce industry a relatively few environmental health protections that should have been there years ago.

Thinking optimistically, we can fix most of the produce contamination problem during growing and harvesting of produce by effective controls over workers; water supplies and usage in all its forms; and wildlife. We can ease the pressure on the supply chain, and minimize the downstream effects on consumers and society at large.

Agriculture has been side by side with animal husbandry and wild animal populations forever, so we cannot expect to remove the zoonotic reservoirs for pathogens completely in farm environments. Therefore, there will always be some risk in fresh produce; but the residual risks passed on in the supply chain will be better managed during packing, processing and handling downstream, if the microbial burden is low.

Vaccination maybe an option to protect against E coli infection in cattle, since we have one with efficacy; but granted, this protection has had poor discussion and vaccines have not been applied. If we had an effective vaccine and farmers would use it, one would start there. Ideally, we would reduce the incidence of pathogenic E coli in cattle (the reservoir) through vaccination, and then move on to exclude the wild animal populations and clean up water sources.

It is likely that adequate fences and other animal barriers, adequate setbacks (still don’t know what this means in every case), water treatment (when needed), strict adherence to personal hygiene, self-inspection and maintenance will solve most of the E. coli and Salmonella problem in growing areas.

We can do this, but a coordinated national efforts is not so simple, and everything has a cost. Somebody must pay, then somebody must make sure it gets done, and financial resources are not necessarily there.

The farms I see would need about $10,000 to $50,000 (could be higher for some) of initial investment, and probably at least 10% of that for yearly maintenance, to implement effective wild animal exclusion measures. The cost would be borne by the farmer in addition to the many other costs of Good Agricultural Practices(GAP), like personal hygiene, training, use of antimicrobials and water treatment, liquid and solid waste controls, that he currently pays for.

Not all farms need the same intensity of controls; I see irrigation water coming out of deep wells as clean as tap water (Total Coliform < 1 cfu), and often the crops see no foliar applications. I see other situations where the foliar application of water is sourced from the surface, and must be treated.

Animal intrusion risks vary widely also; there are some farms in the Southeast where I see only isolated dogs, cats, or bird exposures with an occasional rodent or ground animal.

On some other occasions, I see systematic deer, pig and other wildlife intrusion and extensive droppings. Sometimes we find feces to the extent where harvesting must be halted, and/or production stopped.

In the western US, I see the cattle operations butted right up to produce production; the Salinas Valley in California has much different space requirements, resource needs, and land use issues then Immokalee in the Florida Everglades. As an aside, during our private investigation of the 2006 spinach E coli matter, I sampled one cow patty from a Salinas area hillside pasture and recovered an E. coli: O157:H7 isolate (but not the outbreak strain). One lucky random sample? Or is this bug seriously rampant in this area?

In addition, there are areas with water diversion and flooding problems (due to drought conditions we have not seen much of this factor in outbreaks) and several other environmental health risks we can point out across the board in agriculture.

This is all manageable, and makes it more manageable for us to put into place all of the other safeguards we now need.

On the farm we have “in your face" environmental health problems similar to those that are already addressed by the existing environmental health profession.

We need environmental health professionals to fix environmental health down on the farm, and they can do it, its as simple as that.

Food Safety Auditors Attacked in Media Feeding Frenzy

Roy Costa — Wed, 25 Jan 2012 01:17:40 -0500

Nothing affects everyday people every day more than the food they eat. So stories about food generate lots of interest. Of course, we all want our meals to be safe, and the industry takes precautions to try to ensure that happens, but in produce safety, there are a lot of misunderstandings and wrong things being said today that have the potential to do more harm than good.

The produce industry has accepted that it has a hazardous group of products, which include melons, berries, leafy green vegetables, cucumbers, papaya and tomatoes, among others. Industry has attempted hazard control since the early 1990’s when produce-borne outbreaks became widespread. At that time, there were few if any requirements for microbial food safety down on the farm. Such efforts now include testing of irrigation water, safe use of fertilizers, exclusion of farm animals, personal hygiene, and the sanitation of the on-farm operations (such as the packing shed at Jensen Farms), but we are not moving fast enough. Keep in mind the demand for fresh fruits and vegetables has increased exponentially in the last 20 years.

We are still waiting after 20 years, for a coordinated effort by government, industry and academia to right the wrongs of the past. What we see in this long drawn out scenario is the basic collapse of our public health infrastructure and our inability to address the shear magnitude on farm environmental health. Years of neglect and political interference have marginalized FDA and public health programs across the board, and it is anybody’s guess what if anything can be done now to improve produce safety. We should probably expect from FDA no more than expanded produce guidance documents and the investigation of third party failures, at least for the foreseeable future.

Guidance is OK (although not completely thought out, or so it appears) and we have a good supply of reports, but FDA admits that application of its guidance documents is not universal; in fact FDA does not know to what extent the industry has adopted these self-stated voluntary programs, or their effectiveness.

Within such a vacuum, industry to protect its vital interests has developed numerous food safety schemes and programs with food safety auditing being one important tool in the tool box. An on-farm food safety tool kit contains science- based standards, lab support, traceability systems and educational programs. All of these programs have spun off businesses that have evolved in the vacuum of regulation.

To expect business interests not to affect a private food safety system is totally naive. To expect auditors to become experts in all the different schemes and guidance may be reasonable from the point of view of FDA, but the reality is that the auditor workforce suffers from the same sorts of deficiencies as many government agencies in terms of knowledge and experience. It is important to point out that new skills are needed in a new discipline such as environmental health down on the farm. That not all risks and not all controls are known on the farm, is a given. To expect auditing companies to mandate and enforce a plethora of rules and demand strict adherence when even our government cannot do this and the science is not strong is ludicrous.

Criticism does come with the territory. Auditors like their close cousin’s “regulators”, are attacked whenever food safety problems come to light in their jurisdiction or sphere of influence. We must grant however, that overlooked gross deficiencies should not have occurred in any proactive and effective system. There should not have been dozens of dead rats on the floor of PCA. Jensen Farms should not have had water dripping from overhead areas on to products. Con Agra should not have operated a peanut butter plant with a wall down and raccoon tracks on the floor of production areas. These obvious problems should have been caught by the auditor or inspector, if not by the firms themselves. These firms should have been proactive, instead some forms just wait around for an auditor to correct deficiencies. This is actually another story that needs be told, and probably a more important one for the advancement of the cause then the constant bashing of auditors and such firms.

In the case of the auditor, what follows negative findings? The auditor writes a report and it gets submitted to a buyer, buying decisions are made, and the auditor moves on. There is no mechanism to enforce anything, or re-inspection, which only exists for his inspector cousins.

Overlooked sanitation issues are troubling to the auditing community because most auditors do catch such obvious defects. Third party assessments are mostly effective; but how effective, none can tell. As in any prevention program, there are no data to show how many outbreaks would have occurred in the absence of such audits. Nevertheless, we have had 2 terrible audits linked to 2 massive outbreaks. This does point to problems in the system, and more discussion will assuredly produce more questions. In essence, what we are seeing is the marginalizing of public health protection by the business model; the model the industry has had to rely on since there are few other public health protections available in farming today.

The media feeding frenzy over this topic will continue until the bare bleached bones of these hapless auditors are exposed for all to see. But just remember that these systems were developed by the buyers to assure a continuing supply of safe fresh fruits and vegetables, not as a defacto regulation of the industry, and auditors are not regulators.

And to my media friends, please also check your facts, stop repeating mistakes like the “Primus auditor should have required the melon wash water to be chlorinated” when the 2009 FDA melon guidance does not require it.

In your frenzy, remember that third party standards are all the public has to protect them, right now.

So OK USA Today, fire away.

http://www.usatoday.com/news/opinion/story/2012-01-24/produce-marketing-association/52780194/1?csp=34news&utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+News-Opinion+%28News+-+Opinion%29

Jensen's hot potato passed to the auditor

Roy Costa — Fri, 20 Jan 2012 22:19:55 -0500

Looks like we will not see then end of the Jensen/Frontera/ Primus Auditor issue for some time. While there is plenty of room for criticism of Jensen, Fonterra, and Primus there are also problems with FDA, and this tragic incident has become a hot potato being passed to and fro by congress.

http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ProduceandPlanProducts/ucm174171.htm

I keep reading FDA's take on this as if they had an actual law in place that people had to follow, and actual inspectors in the field for enforcement, and an educational arm. FDA still has no muscle on the farm, just a law now on the books that is lagging behind. Until they get thier ACT together, it’s not fair to blame the industry for not getting it together when they themselves cannot.

I am not defending anyone, but if I were, I could look at the 2009 FDA Guidance for melon and wonder where it says that Jensen should have used a chlorinated hydro cooler to cool melons. FDA says it’s safe to use flowing water of satisfactory quality without an antimicrobial to cool melons. Nowhere does it say melons had to be pre-cooled, anywhere. In fact according to FDA, melons can be field packed and placed directly into a cooler. A hydro cooler (this is a refrigerated, circulated water bath, tank or drench that may also contain ice) is recommended, but the flowing water method is allowable, according to the guidance. Any auditor who would read the Melon Guidance of 2009 would have said FDA has no requirement to use an antimicrobial IN SINGLE PASS WASH WATER.

And here we have more from Leavitt and Partners, a DC consulting firm, taking shots at the auditing company from left field and just repeating the double talk while not really understanding what they are saying. But of course, this is business.

This whole discussion is beginning to smell and is turning into a witch hunt and a diversion for the fact that we have next to no currently enforced laws in produce safety. As result, we see systematic failure of the food safety protection they would afford us. And so industry has taken on itself this huge challenge of agricultural food safety and failures are occurring, and will continue. Third party audits are not designed for public health protection, and even if strengthened they will not their place.

And when and how does FDA propose to notify the industry about the minimum requirements under the FSMA? Most folks I speak to don't have a clue what to do.

This sad scene points not just to failure of audits, but reveals food safety at the primary production level of our food supply has been neglected. It’s going to take decades to educate farmers and to fix the problems spread over millions of acres of land and thousands of farming operations. The failures include FDA not being able to enforce rules or educate the industry, and if I sound like I am repeating myself, I am.

The third party food safety audit system was never intended to stand in the place of regulation. If we as auditors were supposed to enforce FDA Guidance, and now Laws, just how is that supposed to work? There is no mechanism for that.

Where are the thousands of competent people to do this job, the army who understand agriculture and how to do a produce risk assessment, commodity by commodity? How are small producers like the Jensen brothers supposed to cope with the detailed scientific risk assessment he and now thousands like him must by law perform?

This situation has got to be solved by industry and FDA working together, and proper funding and research.

Fix the mess first with regulations and guidance, then maybe there is some justification that Jensen and the rest of us should have known better.

Passing the hot potato is only going to burn more consumers.

http://leavittpartnersblog.com/2012/01/investigation-of-cantaloupe-listeria-outbreak-has-congress-asking-serious-questions-around-third-party-audits/?

Improving the effectiveness of third party food safety audits

Roy Costa — Thu, 24 Nov 2011 11:15:24 -0500

The controversy continues over the value of third party audits in food safety at the fresh produce level, as pointed out by Professor Doug Powell at Kansas State University in his BITES blog.

Jim Prevor, produce industry analyst, says changes are needed, while the law firm Marler-Clark is suing a food safety auditor and a third party auditing firm.

The lingering question remains, "how can we improve this system"?

Third party audits are best implemented when there are regulatory controls over the audited operations, thus underpinning them.

In their absence, third party audits are flawed by a lack of standard government requirements such as the preapproval of equipment, structures, layout and design, waste disposal methods and potable water sources.

Third party food safety audits are currently conducted as part of a firm’s overall quality assurance program. The audits are simultaneously environmental risk assessments, regulatory compliance assessments, evaluations of production processes and analyses of management controls.

Food safety auditors, auditing companies, standard setting and certification bodies, and all players in the produce supply chain share a common interest. These partners should work together through a logical and cooperative approach guided by the best available science, to protect public health, and in so doing, their own interests.

Suggestions for improving the third party food safety auditing processes include:

Changing the roles of the Audit Company, Buyer, and Customer:

Currently, buyers (retailers, middlemen, brokers, marketing groups) require that suppliers schedule and pay for an audit with an auditor or auditing company. Since the auditee makes such arrangements, they are the customers of the audit firm. The auditor is beholden to the “customer” to establish the time and location of the audit in advance. The auditee also negotiates the price, and can even request a particular auditor, although the final decision as to which auditor to assign in generally left to the auditing firm.

If roles are reversed, and the “buyer” becomes the “customer”, then the buyer would schedule the audit, and the buyer would pay for the auditing firm for the audit. The buyer would then receive the audit report directly and have control over its dissemination. Most importantly, this process would allow for an unannounced audit to occur. Auditing firms know that scores of announced audits are often much lower that announced ones, suggesting observational bias that this method might filter out.

The Buyer, as the Customer, would become the driving force behind audits, their timing, stringency, frequency and interpretation.

Fee arrangements and the practical aspects of doing business may pose hurdles to this approach, but the resulting value to buyers may make this method attractive enough to induce changes in the current business models.

Roles of government and auditing firm:

The Food Safety Modernization Act (FSMA) currently addresses the need for auditor competency when working in post-harvest operations under federal jurisdiction and as part of FDA’s “Foreign Supplier Verification Program”. Auditing companies should require that auditors become fully familiar with existing FDA produce safety guidance and the new requirements of the FSMA, especially the requirements for a hazard analysis and science-based controls.

The FDA should begin an effort to meet with buyers and auditing company executives to discuss partnerships, and establish liaison with them to coordinate their activities around meeting the goals of the FSMA.

The FDA should protect auditors under whistle blower protection provisions and require that the Buyers (as the drivers of the model) provide to them all third party documents related to food safety within 10 days. The third party risk assessment findings should drive the need for FDA to conduct its own rapid response risk assessment within 30 days, if and when necessary to protect public health.

Auditing companies should report “automatic failures” resulting from adulteration to FDA within 24 hours.

Transparent communications should happen between the FDA, auditing firms and buyers. FDA should make known its own compliance records in a timely fashion. Third parties should not audit any facility operating under FDA sanctions until such firms are in substantial compliance.

When third party audit criteria are less stringent than federal rules, their value as a risk assessment tool is negated. Risk assessments, especially newly adopted ones such as Global GAP- should be scrutinized. Currently, the failure to have toilets available to field workers in Global GAP would not trigger an automatic failure, this standard also allows hand gel to replace hand washing, such unsanitary practices are not acceptable under the FSMA.

Reassessments by buyers and auditing firms

A buyer should be required to perform a reassessment either through a third party auditing firm or through its own (2nd party) audit, in any operation where corrective actions must be verified.

The following should trigger a reassessment audit;

A Critical Control Point failure in a Hazard Analysis Critical Control Point (HACCP) based system.
An automatic failure of the audit.
Laboratory or others test indicating a microbial, chemical or physical hazard exists in a facility, product or process.
Significant noncompliance with FDA rules (when published).
Significant repeated failures of the food safety management system.

Expanded role of microanalysis

Because auditors have access to a supplier's micro-testing results, they can base risk assessments on the findings. Expanded micro-testing will allow auditors to make better judgments concerning the microbiological quality of products, equipment, and water used in a wide variety of processes and environments.

The government and science community, including researchers, academicians, and practitioners should work together to enable a more accurate microbial risk assessment.

The future of third party audits

In the short-term, there is no viable substitute for third party risk assessments in fresh produce operations. Buyers are not prepared to audit the many suppliers they have by themsleves, and government bodies are not adequately funded to begin the process of regulating the full multitude of suppliers, domestic and international.

In the long-term, an effective FDA would reduce the need for constant oversight by third parties, but this does not appear to be a certainty given the political and economic picture as it appears today.

Self-audits (internal audits or 1^st party audits) are much underutilized. Supplier “self-reporting” directly to buyers could provide data so that audit frequencies could be adjusted using a risk-based approach.

The best alternatives to improve produce safety through third party audits may include:

· Buyer financing and coordination of the audit
Unannounced audits
· FDA involvement in the third party audit process including determining auditor competency, training and oversight
Risk based frequencies for audits based on self-reporting
· Transparency of all audit and inspection findings by all concerned
· Validated physical, chemical and microbial standards
· Expanded use of 1^st and 2^nd party audits

Toilet Paper Audits and the Writing on the Wall

Roy Costa — Sat, 19 Nov 2011 13:04:41 -0500

The noted microbiologist Mansour Samadpour has recently suggested to Bloomberg’s Stephanie Armour that (See Bill Marler's blog)

“You can make these audits useful by writing them on toilet paper. Then someone would at least use them,” said Mansour Samadpour, president of Lake Forest Park, Washington-based IEH Laboratories and Consulting Group, a food-safety consulting firm, in an interview. “They’re worthless. They give a false sense of security.”

http://www.marlerblog.com/legal-cases/the-best-quote-ever/?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+MarlerBlog+(Marler+Blog

Are third party audits currently useless to buyers and to the supplier who pays for them?

I think we need to clarify how the buyers can best use these reports, and how to improve the reporting process rather than throwing stones at one another...no one is shatterproof.

Understand that assuring food safety in the fresh produce supply chain is very different in many ways from assuring the safety of the meat, poultry, dairy or other food industries, most of which are highly regulated.

Currently, there are some alternatives to the independent third party risk assessment on farms, but those solutions are a ways off. Some state regulators are focusing in on the agricultural sector, but today the regulation and enforcement of food safety standards is left to the industry.

The “food safety industry” is quite competitive and diverse; private labs compete for market share against auditing firms with labs, auditing firms compete with other auditing firms, standard setting and certification bodies compete, pest control services also compete with chemical suppliers who also own auditing firms.

Therefore, understanding what is being said by firms like IEH Laboratories and Consulting Group about its competitors requires some retrospection.

The testing of agricultural products for safety by labs today is not routine. However, as this trend grows we may eventually see a produce firm that "has passed a Lab test" involved in an outbreak just as we have seen raw meat facilities that have passed government inspection and laboratory analysis involved.

I would like to ask Mr. Mansour if he would be just as critical of labs for giving a "false sense of security" when the products they test cause outbreaks? Is USDA inspection worthless if inspected products cause outbreaks?

It is clear to me that third party audits are needed in the absence of any other outside controls of primary producers at this time. The produce industry, together with the food safety industry that supports it, should consider the following soft spots in this process:

Audits are routinely announced, meaning that the time of the audit is known ahead of time by all parties. An auditing firm that conducts both announced and unannounced audits reports that the differences in the score between the two measures can be 10 percentage points or more. Risk based inspections do not necessarily require unannounced visits as the risk in a process can usually be determined from operations, but at least some announced audits are a good idea.

Buyers currently are empowered by their customers to go outside the recognized certified sellers if product is needed. The pool of unregulated and unsupervised facilities is still large. It is not uncommon to have an audited, certified and even inspected produce operation, operating beside an unregulated unaudited firm. Inconsistencies like that cause animosity and dysfunction.

· The pressure on buyers, especially brokers and other middlemen to buy from anyone, results in placing some operations in a competitive disadvantage. There is no clear answer to this as some operations just simply ignore the requirements that others must follow and can still sell their products.

The standards the third parties use are written by the buyers. These are also the entities that evaluate the findings, and make buying decisions supposedly based on conformance to their standard. Buyers cannot raise the bar so high as to eliminate a large share of the supply chain and thus develop those standards so as to be inclusive of the current levels of sanitation and safety in the industry- which can be less than perfect. I have not seen yet where a low score on an audit has caused an operation to go out of business. An outbreak will do this, but not a low or even failing score. In today's market, if the supplier has needed product, the volume and the physical quality, he will be able to sell it to a customer somewhere with our without a passing grade, even with or without an audit of any type.

Retailers and their own culture effect food safety audit systems in produce.

I was in a well-known market the other day and saw next to the open bin of cracked and otherwise damaged mixed tree nuts (with no traceability), bags of packed nuts, clean and unbroken with source codes. The bagged nuts were about 50% more expensive.

Rather than using audit reports for toilet paper, buyers should instead be using them to make decisions and all involved in the private assurance of produce food safety systems should read the writing on their own wall.

Desperate Times on the Farm

Roy Costa — Sun, 13 Nov 2011 10:07:57 -0500

As we trudge along in food safety at the farm level, the sense of desperation is obvious, but there is hope and movement forward.

Not only is the produce industry reeling from the recent food safety disasters in its products, the pressure is on in the labor market and on the economic front. Growers and packers of fresh fruits and vegetables seem just as isolated as any group in their problem. They are seeking help, and this is positive, and the answer may be a more cooperative approach.

We in food safety must realize we are superimposing a self-regulatory and soon to be regulatory framework on an industry that has not had this to deal with. FDA is supporting industry efforts to self-regulate, and the two together can accomplish much, but we still need produce industry specifications for suppliers based on sound science.

The article below makes a point of the need for cooperative efforts amongst industry and government. Part of that is for FDA to ensure that the standards industry uses to assure safety are effective in very diverse crops.

Some of the audio is a bit garbled, but Tony Piedimonte of Florida's Wm P Hearne company makes some salient points about the industry stance.

Thanks to the Packer for covering the following story.

http://www.thepacker.com/fruit-vegetable-news/Food-safety-labor-issues-discussed-at-Florida-Ag-Expo-133632553.html

A New Role for the Environmental Health Professional in Produce Food Safety

Roy Costa — Tue, 08 Nov 2011 22:45:44 -0500

While the Environmental Health professional’s role in food safety is marginalized in some places (such as in Florida, where the Environmental Health staff conduct less than 10% of the food safety inspections) there is a growing need for their involvement directed toward the safety of fresh produce.

With experience in the safety of water, land use, plans review, wastewater disposal and treatment, soils, vector control, the use of sanitizers, pesticides and the like, I believe the environmental health profession holds one of the best, tangible responses to today’s produce dilemma.

Unless adequate funds become available, the Food Safety Modernization Act, the federal response to the current public health crises affecting our nation’s primary producers, will not provide the solution.

The impact of the repeated outbreaks of foodborne illness should be a stern warning to our nation’s legislators, but they seem oblivious to the problem. When 30 people die from tainted cantaloupe, bells and whistles should be sounding in Washington; instead, its dead air in D.C.

If a terrorist attack killed 30 Americans, would our nation’s leaders say, ”We cannot afford a response...?"

If FDA cannot do this job alone (and why should they?), then we have an untapped resource in our County Public Health Units. There are over 3,000 health departments in the US, with more than enough infrastructures to support the produce food safety regulation/enforcement task, both in facilities and on farms. If properly trained, managed and funded, environmental health professionals could expand the roles they now play in protecting public health, into agriculture.

Rules must be developed and the inspection workforce needs to be trained in a somewhat new discipline, but the qualified Environmental Health Specialist has the capabilities needed now. With proper guidance and support, they can be effective in produce facilities and on farms.

In addition to our local public health professionals, there should also be an expanded role for state Departments of Agriculture and even USDA to help fill in the gaps in produce safety regulation and enforcement.

While we search for ways to prevent the next food safety disaster, consider properly funding and supporting local environmental health protection efforts. Give our county public health units what they need for the effective enforcement of laws and rules and we will see a reduction in foodborne illness.

Lessons Learned from Recent Outbreaks in Fresh Produce-Part 2

Roy Costa — Sat, 05 Nov 2011 11:20:36 -0500

Lessons Learned From Foodborne Illness Outbreaks

Part 2.

Listeria Outbreak in Cantaloupes

“They probably look at themselves as victims too, but as between the person who bought the cantaloupe in the grocery store, who is more of the victim? And does a grocery store have an obligation to its consumer to not sell them products that are contaminated and from entities that have limited assets and insurance. That’s why it is 100% likely that this cantaloupe outbreak is going to bring in everybody in this outbreak, including the retailers and the auditor and Frontera and Jensen Farms because that’s the only way that the victims - whom we all would agree have far less culpability than the other side of the equation - that’s the only way that these people are going to be fairly treated. But it’s going to be a battle”. Bill Marler.

The Listeria outbreak in cantaloupe is still producing cases. Much has been written about the responsibilities of all involved and what needs to happen to correct deficiencies in our approach to food safety in produce, along with much sadness and much controversy.

As attorney Bill Marler has said in this exceptional interview in the Packer, the legal associations of the packinghouse, retailer, distributor, auditor and consumer are clear, and it is sobering.

Reflecting on Mr. Marler’s perspective, we will look at the chain of legal liability and see how it intersects with the chain of causation to see if we can learn something from these monumental, tragic and frightening events.

One must look at the disease pathway to see the intersections clearly, and it is a complex scenario with Listeria monocytogenes due to this pathogens ubiquitous presence in the environment, its likely ability to create bio-films on the surfaces of plants and inanimate objects and its propensity to cause serious illness in the immune deficient.

In terms of the infection pathway, we do not know whether the causative agent spread to the packinghouse and colonized the equipment, or the equipment was already contaminated by another farming operation due to previous use and spread to the packinghouse as pointed out by FoodSafetyNews.

What we have learned is that conditions at the packinghouse allowed propagation of Listeria monocytogenes at this site, and subsequent conditions eventually affected the entire supply chain. Additionally, contaminated products continued to be sold for an extended period, revealing our failed traceability systems .

On the packinghouse level, once the environment is contaminated, Listeria monocytogenes can spread throughout production and create niches for growth. That conditions were ripe for this at Jensen Farns is now clear, but unfortunately in hindsight.

On the product level, we know from FDA that cantaloupe is potentially hazardous, but this hazard was believed to occur only after cutting the melon.We did not understand the clear probability of the pathogen to not just colonize a melon surface, but also proliferate on it. I believe this chain of causation probably involves growth conditions for the pathogen on the surface of the melon, probably post washing. This phenomena should have been realized, but it was not.

The temperature controls at Jensen would not have been sufficient to control LM after colonization of the melon. Growth would begin at the packinghouse cooler and continue through to the cold-supply chain. Any increase in temperatures in the supply chain would result in accelerated growth, thus amplifying the problem for the next user.

At the level of the buyer, the buyer is obliged to ensure conditions at its supplier do not render a product adulterated. The buyer should maintain controls over the supplier. These can include test of water, tests of products, independent audits, self-audits and second party audits along with letters of indemnity and guarantees. Given that the buyer receives products that may be contaminated, controls should be in place in further distribution to reduce the likelihood of any dangerous product reaching the consumer, pointing to the need for more testing nearest to the consumer level and traceability. It’s interesting that industry has vigorously opposed the random testing of products and has effectively killed some of these programs.

That all involved in this distribution chain now bear responsibility is clear. This is not the first outbreak of a pathogen in cantaloupes. That our standards for handling cantaloupes were too low is painfully clear.

At the level of supplier control, the retail industry must start getting smarter about how to qualify its suppliers, currently the industry-required tests of finished products may be driven by a poorly defined risk assessment, or simply rely on industry practices, The bar is now raised extremely high for quality assurance in the produce industry and we should see a move to integrate technology into the food safety effort at a very high level, especially traceability and end products testing. We should see a major emphasis on water quality, in in-process tests and final tests for products, whether they be directly from a farm, from a packinghouse or from a processor. If there is a gaping hole in the producer-buyer-retailer food safety net, it’s the failure to adopt the best microbial standards and best quality assurance standards and traceability for producers.

At the level of the consumer, an acute problem arises with controlling Listeria. Refrigerator temperatures would not be able to prevent the slow the growth of LM; there have been no consumer advisories on how long or at what temperature to keep whole cantaloupes, making this a unique challenge for the consumer.

This melon’s netted surface hinders removal of LM (especially in a bio film) making washing by the consumer of little effect. Before, during and after preparation, it is common for consumers to leave food before serving without temperature controls and to put the leftover items away at some latter time, potentially allowing proliferation in the cantaloupe meat.

Unfortunately, we have not properly educated the consumer about the intricacies of food safety and they simply do not know in every case of contaminated product hitting them, what to do.

But as food safety professionals, we should know what to do.

Events like this can trigger a bit of fear. In a twist of fate and circumstances, I was auditing a firm less than 100 miles away from the site of the Jensen Farms outbreak about a week before the fateful Jensen Farms audit. I met with farmers just like Mr. Jensen.

I have to ask myself, if I was the auditor, would I have spotted the inconsistencies in production?

Would I have understood the critical environmental factors I was seeing and understood the entire process and its role in the growth of LM?

Would I have appreciated the relationship of the factors I was looking at and reacted to the risk of the survival and growth of Listeria monocytogenes on the surface of Jensen Farms' melons?

The answer could be frightening. No, I may not have realized the conditions were ripe for a Listeria outbreak the has killed 28 people to date.

This is a gut wrenching realization and one that has been with me since the day this outbreak began; if we are going to truly perform a valid risk assessment, we need to be carrying a very big bag of tools.

The audit instrument is best used like a surgeon’s scalpel. The scalpel is best for delicately separating the good, from the excellent, from the superior. Sometimes we need a hatchet for the ones that need it, and all we have in our tool kit is a small knife.

We should ask about FDA's prevention role, and the role a strong FDA might have played in preventing this outbreak; and ask about the regulatory scenarios moving forward. Certainly, these events point to the urgent need for FDA to come in and level the food safety playing field. But unfortunately, no one wants to pay for the FDA to do its best work, so now the auditor, the consumer, the packinghouse, the farm the processor, the retailer and the consumer must pay.

Thanks to the strength of our legal process and the skill of our legal firms, that there will be justice in the end. This would bring closure for me, except for the fact that our public health structure is letting us down and my efforts without that crucial element will be forever flawed.

I predict we are going to see more sad stories, failures and more finger pointing, and maybe rightly so.

Lessons Learned-

If there are more hazardous facilities out there, they need to be identified, repaired, or closed.

All produce facilities should be reviewed to make sure they have the correct infrastructure, ideally, before they are allowed to operate.

Buyers must insist on the application of the best quality assurance methods and traceability systems.

Food safety efforts from farm to table need proper financial support.

There needs to be less politics played with food safety and a cooperative effort byindustry and government to protect the consumer.

The education of the American consumer about food safety is woefully lacking.

The US Cannot Afford Food Safety Says AMI

Roy Costa — Mon, 31 Oct 2011 10:59:20 -0500

We are now seeing huge gaps in the food safety net. We also see the effect of the serious pathogens like E coli that have become entrenched in our food animals, thus in our food supply, and in our environment. The failure of agriculture to control E. coli has contaminated the entire food supply, our water and soil.

These events will continue and escalate due to our inability to create a nationwide food safety system form farm to fork and the propensity of these pathogens to proliferate. Glaring deficiencies exist; most notably, flaws in basic sanitation and related practices found at the farm, in restaurants, and in the transportation sector are going without effective controls. These correctable conditions if left uncorrected allow for the persistence of deadly infectious agents in food.

While we as an industry concentrate our prevention efforts in the supply chain, remember that not addressing the starting and ending points of this chain thwarts all other purposes.

A comprehensive approach to the problem must involve a strong response by FDA to both on farm and consumer safety. Without adequate resources, FDA cannot do this job. Without industry support for proper funding the Food Safety Modernization Act will fail. This Act crafted by industry working alongside government addresses concerns in the food supply in the most comprehensive approach yet attempted,

A double standard is evident in the lack of industry support for FDA and FSMA. This is clearly seen in a letter to congress from the American Meat Institute and its signatories.

As long as powerful political interests put political power and influence over public health, food safety in this country will continue to deteriorate. The effect on industry has already been devastating for certain groups, especially for growers of tomatoes, spinach, peanuts; and now the entire melon industry is tainted with the problem of Listeria monocytogenes in cantaloupes.

The many millions of dollars defending lawsuits and untold millions lost in sales, as well as the loss of confidence of the American consumer, and the huge burden for those with resulting health care costs are compelling reasons for industry to support FDA.

Industry paying its fair share is something we should expect. Just "not wanting to pay" to ensure that there is a strong regulatory framework for food safety is not acceptable.

The Role of the Third Party Food Safety Auditor

Roy Costa — Sat, 22 Oct 2011 08:15:35 -0500

As the result of the release of the FDA environmental assessment at Jensen Farms, the roles of all food safety persons involved at Jensen Farms-Frontera have rightfully come under fire. Once again the the nature of industry led food safety regulation itself (food safety auditing) is in question.

That all involved maintain some degree of responsibility for this disaster is without question. When a disaster like this occurs, one must ask who is responsible, but also why did it occur and how can it be prevented in the future.

The produce industry is unregulated and has been since the founding of this country, and this is the primary problem. In the recent past, we have become painfully aware of the inadequacies of our industry led prevention efforts at the farm level. In defense of the effort, while much has been done, it has been a short time to change the nature of agriculture This is what we are doing by implementing food safety strategies in open air and on- farm environments. We must also change the culture; animals on farms, for example, have been a given for centuries.

Food safety auditors executing a buyer driven auditing model rely upon the certification body to develop and manage the standard that guides their work in the field. The standard is not a public health law and it is not developed like one. The auditor has no legal authority to demand records, embargo products, or close an operation, for example.

Enforcement, if you will, has been in the hands of the "buyers". They rely on third party audits, their own second party audits, letters of guarantee and the like, before make buying decisions. Buying decisions should take into account food safety, but supply and demand pressures might induce buyers to purchase from sources without a clear safety margin. However wrong this is, there is nothing illegal about this practice.

Auditors currently are not required to inform FDA of violations, but auditors are currently required to know what regulatory violations have been cited in the records of the firm, and if they were corrected. Auditors are also expected to follow the guidelines of the audit and make an accurate assessment of findings. When this is not done we must ask why.

So there is a connection between the two independent systems of food safety "regulation", but a relationship that is way underutilized.

Auditors conduct prearranged audits to evaluate the conditions of the environment, equipment, water supply, personnel, waste removal, use of chemicals, vector control, general sanitation, equipment hygiene, and structure maintenance, within a sometimes narrow scope of the audit. Regulators should be approving plants and operations in advance, then making frequent unannounced visits to determine compliance with laws and rules. They also have free range to demand any required document and inspect any licensed area. While both touch on the same items, the perspectives and powers are vastly different. The legal process should occur in cases where violations are not corrected or immediate threat to the public is found, and buyers should not purchase from unsafe sources. Auditors cannot perform these vital public health functions, nor can they the directly affect buying decisions.

Generally, FDA guidance and the available research form the basis for the audit criteria. However, issues like severity can be difficult to interpret. For example, in cantaloupes the commodity has not had the type of industry oversight we have in leafy greens or tomatoes (under market orders). But FDA has provided guidance to the melon industry. We should mention this reference below:

Using single pass (or one use) cooling water of sufficient quality for this intended purpose also may be used to cool product.

This is the source of info that indicates single pass water of sufficient quality may be used for washing melons. There is no mention of antimicrobial in this application. For dump tank or flume water, or where direct melon to melon contact occurs in common water, then treatment is indicated. Standards vary greatly as to disinfection of water, and for sanitizing various fruits and vegetables.

The risk assessments are still developing (and so are the politics involved with any industry led effort.) It is telling that according to "commodity thinking" cantaloupes fall into the class of fruits and vegetables with "inedible peels". This narrow definition ignores the other routes of disease transmission with this product. Microbial testing of products and the production environments is not a given. This is telling because in other Listeria susceptible products FDA and USDA demand stringent testing programs for the environment.

Water used in packing operations is required by the third parties to be potable. FDA has not published specifics about how to determine potability in a packinghouse environment, the references simply being for the use of potable water at the start of a washing process. Potability has come to mean that coliform bacteria are not present in a 100 ml sample. There are no guidelines for chemical parameters for safety in the potable supply and no requirements for the wells themselves to be treated or permitted before construction. No FDA requirement I know of demands that the local health departments permit, inspect, and require a certified operator to maintain the water quality.

At Jensen Farms, washwater for cantaloupes was apparently not reused, being simply a single pass wash of cantaloupe without treatment. There is nothing prohibiting washing cantaloupes or any produce in this fashion in the standard as long as the source is potable. This is room for improvement in the third party standard, but until the industry as a whole agrees on water treatment standards for these melons it is unclear how to develop them. This is now apparently a glaring deficiency, and just one amongst a myriad of things not addressed in food safety at the packinghouse level by FDA.

In light of these problems in our food safety systems, auditors and auditing companies have stood in the gap for regulators. I appreciate FDA and its remarks concerning the training of auditors and any classes they could offer would be much appreciated. To date, however, I know of know such training program for industry auditors sponsored by the FDA that is available today. One day that might change.

We also have to thank the FDA for such a well developed theory on causation and it is perfectly clear that the focus should be on the packing environment.

Problems that existed in this plant in this situation are accurately described by FDA in its report. The evidence is clear for the propagation and spread of Listeria monocytogenes through water and surfaces, and "improper cooling" of cantaloupe. Pre cooling to remove field heat as a route of causation makes perfect sense, but pre-cooling is by no means a standard practice on farms or packinghouses in general as pointed out by FDA in its guidance.

The nature of equipment in packinghouses is subject to contamination and often hard to clean; moving heavy crates of products will deteriorate floors; draining is often a problem especially where washing flumes and spray systems are used. Some structures and waste disposal systems are better developed than others for this type of "dirty" packing work; however, there are no standards for construction of a packinghouse.

Currently, there are no regulations for the construction and maintenance of packing equipment; its design, layout or even fundamental function have no legal basis. Regulatory agencies normally have the functions of approving the designs, equipment and plumbing schedules, lighting, finish of walls and floors in a plant. Auditors rate these items according to the dictates of the standard within the scope of the audit. Of course FDA has the authority over such, and it would be best to have regulations of these items, but FDA has not exercised that authority and has only written guidance for general requirements. I appreciate what FDA has done in ferreting out the causation at Jensen/ Frontera, but it would have been much better for them to have published packinghouse rules, and been there before the outbreak to enforce the requirements they address as violations now.

Therefore, in light of these ongoing and serious gaps in food safety, the industry itself has required what it finds to be the best practices to protect itself to the extent it can. That these industry requirements are suited to the needs of the buyer is self-evident and expected. More importantly, things need to change as we understand risks better; but what a tragic way to learn.

Its sad that the farmer in this case did not recognize the difference between his potato line and a "cantaloupe line" nor the distinction between a potentially hazardous product like cantaloupes and a non potentially hazardous raw potato. In crops like potatoes, bulb onions, carrots, beets, there is dirt, the distinctions between risks of different crops do not generally drive standards. However, with melons the risks should have been identified, and the best practices possible followed, and they were not.

In a risk assessment we develop such preventive measures for a variety of crop types and information like this often comes out if properly done. But then, HACCP is not "required" in produce; but training in risk assessments should be mandatory for operators of high risk facilities and especially for auditors.

About the future of third party audits, I think we need the FDA to be conducting their own risk assessments and allow us third parties to simply be the eyes and ears of industry, and not the enforcers of public health protection in this nation.

This is not the role of the third party auditor.

Lessons Learned from Recent Outbreaks in Fresh Produce

Roy Costa — Sun, 09 Oct 2011 20:16:59 -0500

Part 1

Outbreaks in fresh produce, while tragic for victims, nevertheless can have a positive outcome if we can learn how to better prevent them, or at least reduce their occurrence. This four part series will discuss the current produce outbreaks in cantaloupes, cucumbers, celery and strawberries and analyze the information that is known, with the intention of improving our food safety systems.

Recent breakthrough events

While the fresh produce industry in the US continues its food safety efforts, pathogens have recently broken through our safety net in diverse products such as cantaloupes, cucumbers, celery, and strawberries. These events have highlighted our immediate need to strengthen food safety systems in the entire fresh produce industry.

The fresh produce industry utilizes Good Agricultural Practices (GAP), Current Good Manufacturing Practices (cGMP), and Hazard Analysis Critical Control Point (HACCP) systems based primarily on guidance from The US Food and Drug Administration (FDA). Some producers of high risk products bolster these efforts with commodity specific guidelines developed by industry. Firms also utilize microbial sampling programs for water, environments and products, and implement traceability programs. Various agencies may have jurisdiction at the produce/processor level of the fresh produce industry, but most of the growing, packing and transportation of produce remains without consistent government oversight. The Food Safety Modernization Act gives FDA broad new authority to tighten regulations in the fresh produce industry, but the agency has not yet effectively exercised these new powers.

Dynamic Industry Based Food Safety Programs

In the absence of mandatory food safety rules in fresh produce, the industry has developed its own voluntary program for produce safety, including its own standards. These programs consist of science-based standards, policies and procedures, training, sampling, and the maintenance of records to support GAP, GMP and HACCP. The major buyers of fresh produce (retailers such as Costco, Wal-Mart, Publix, Kroger, among many others), insist upon the verification of these safety measures using ongoing third party, second party and self-audits. Government agencies, producers and buyers randomly test products for pathogens, and the industry conducts voluntary product recalls when pathogens are found.

These programs should not be static; preventive measures taken by the industry should change and adapt as we learn more about how pathogens contaminate, proliferate and survive in the chain of production from the farm to the consumer.

While it is not possible to know the route of transmission in every situation, we should still analyze foodborne illness outbreaks. What we do know about pathogens can be just as important as what we do not know. Achieving the ideal of a farm to fork food safety net requires a dynamic response from the entire supply chain to the problem of contamination.

Salmonella Outbreak in Cantaloupe

On March 22, 2011 the Del Monte Company issued a limited voluntary recall of cantaloupes from its Asunción Mita, Guatemala farm, saying they have the potential to be contaminated with Salmonella Panama. Over the course of the ensuing outbreak, authorities identified 20 victims in 10 states linked to this farm by epidemiological investigative techniques.

In this outbreak, as in many others, investigators failed to isolate the causative agent from a suspect melon. This prompted two law suits, one against the FDA, and another against a state epidemiologist. Del Monte asserts that the epidemiological approach used to associate cases with vehicles was flawed; while investigators contend that such a rare serotype could not be caused by anything other than exposure to a common vehicle. FDA points out that almost all victims of illness purchased cantaloupe from stores supplied by the Del Monte farm in the relative time period.

Del Monte, as part of its case against FDA, argues that its food safety program would have prevented such occurrences. Third party audit findings from April, 2011 showed a high degree of conformance with industry standards by this facility, but auditors also found that some sanitation controls needed to be improved. Results of third party audits of the packing facility in question suggested two important corrections:

· Covering an exposed sewage ditch
· Incorporation of daily cleaning and sanitation of the dump tank

FDA #22-03 Import Alert

In July of 2011, FDA banned products from the Asunción Mita facility, concluding that they were produced under insanitary conditions and that they likely contain Salmonella. FDA recently lifted this ban.

In its import alert, FDA recommends that based on previous experience, its food safety personnel should evaluate the following risk factors:

· Safety of water used in irrigation, packing and cooling;
· Manure use and bio-solids, animal management;
· Worker health and hygiene;
· Sanitary facilities in field and packing house, disposal of sewage and silage;
· Maintenance program for cleaning, sanitizing equipment;
· Field and packing facility sanitation;
· Transportation;
· Steps taken to identify and correct insanitary conditions.

Lessons from this event

At this time FDA has not made public its findings from the inspection of the Asunción Mita packinghouse, but some information about sanitary conditions have been reported by third party auditors. A reference for this can be found in a report by the Florida Center for Investigative Reporting.

Covering an exposed sewage ditch

It is not perfectly clear what the source of this sewage is, whether it is “black water”, meaning waste water from toilets and hand sinks, or “gray water” meaning spent water from other sources (wash flume water, floor drains, drainage from refrigeration, etc.).

Regardless of its source, such wastewater is a potential source of pathogens, and facilities are required to dispose of it safely.

In many regions, we rely upon sewage disposal rules written by health agencies for the collection, transference, treatment and disposal of wastewater. Ideally, there is an enclosed piping system to convey the wastewater to a treatment system before disposal of the effluent, such as into the soil in subsurface septic systems. Such effluent can also be discharged directly into a sanitary sewer if one is available, or treated in an onsite sewage treatment system before discharge into a flowing body of water.

In no case should untreated wastewater, or "sewage" as FDA puts it, from a produce operation be disposed of in a ditch, onto the surface of the ground, or discharged into a body of water.

There may be no rules for wastewater discharge in some agricultural operations, or operations may be loosely regulated. This is often the case in the developing world, or in remote rural locations. In such cases, decisions about what to do with wastewater are left up to plant personnel who may lack knowledge of sanitary wastewater disposal. Unsanitary wastewater discharges and lack of compliance with environmental regulations can unfortunately be found in some produce facilities.

Opponents of government regulation should be aware that the imposition of consistent sanitary waste disposal methods are a hallmark of public health controls. Where these are enforced, environmental exposures to sewage are greatly minimized. Where there is no regulation, such hazards are likely to be forgotten or simply not addressed and create problems.

Incorporation of daily cleaning and sanitation of the dump tank

Not all produce is washed before being packed; in this case the facility did wash its melons. The common practice of field-packing, meaning packing directly into boxes or other containers as the final unit-packaging, is common with several commodities, and has some serious concerns.

In certain cases, makeshift washing in the field occurs, such as in barns using tanks of water. In many farming areas water is a precious commodity and is reused. A tank of water used to rinse produce in a barn may remain for an entire day without changing. Thousands of individual pieces of vegetables may be so exposed to pathogens if even one unit has contaminants. To say that on-farm washing systems like this are antiquated is an understatement.

It is a mistake to assume that water used for field packed product is even potable under the meaning of the law. The US Environmental Protection Agency (EPA) provides the standards for potability of water. Because there is yet no clear government regulations as to the application of potability standards to water used for washing produce, the industry relies on periodic microbial testing of water and the available research and advice of experts. Usually, the produce industry relies on tests for the coliform bacterial indicator group to gauge microbial quality. Where a satisfactory result of < 1 CFU in a 100 ml sample is obtained, the water is considered potable.

However, wash water is rarely tested “in process”, the operator assuming that periodic testing of the water source and treatment is all that is necessary. This is often the case where packinghouse operations use washing systems consisting of sprays or flumes.

The third party audit findings for this operation indicate that the facility in question “dumped” its products into a tank of water (dump tank), and that the frequencies for changing this water and cleaning the tank were questionable.

It is common to see confusion on the part of operators of produce packing facilities as to how to control the safety of process water. What the industry has done in past years to satisfy buyer demand for a product that “looks clean” may cause an exposure if re-circulated water systems are not properly tested, treated, cleaned and maintained.

We must improve our controls for process water, but questions remain: How to do we treat such water? What antimicrobial to use? And how do we test its efficacy? And very importantly, what do we do about improvised washing methods often used in field packing?

Listeria Outbreak in Cantaloupe

On September 14, 2011, FDA issued a press release to announce that Jensen Farms, a Colorado operation, issued a voluntary recall of its Rocky Ford-brand cantaloupes after being linked to a multistate outbreak of Listerosis.

At this time there have been 21 deaths and 109 people have been sickened in the outbreak — including the 21 dead — in 23 states from California to the East Coast

(To be continued in Part 2 of this four-part series).

Listeria and Cantaloupes; a Marriage Made in Hell

Roy Costa — Fri, 30 Sep 2011 22:28:55 -0500

Media types looking for a sound bite on Listeria in cantaloupes are pulling their hair out tonight.

You couldn’t ask for a more complicated scenario. Advice like “wash your hands” or “cook your foods” or “don’t cross contaminate” is nearly worthless. Here are some troubling facts

Listeria monocytogenes:

Psychrophilic, multiplication possible all the way to 29 degrees
Ubiquitous, found in almost all environments, terrestrial and aquatic
Found in feces of animals
Most problematic in ready to eat foods
Forms bio films on food prep surfaces that resist sanitizers, nearly impossible to remove once adhesion occurs
Incubation period can be days to months
Huge dose response curve, from 100 or less cells, to 1,000,000 or more
High morbidity and mortality up to 50% of cases
Some strains are pathogenic some are not
Highly virulent strains may be emerging
Targets immune-suppressed victims, fetuses, neonates, pregnant, those on immunosuppressive drugs, those with disorders of the liver, gut, blood
Attaches to nervous tissues, systemic infections

Cantaloupes:

Rough netted exterior traps contaminants
The rind surfaces of these melons likely can support adhesion as well as colonization by many pathogenic bacteria
Melon meat is highly conducive to bacterial multiplication, rich in nutrients and moisture just below the rind
Keeps well under refrigeration
When cut, surface pathogens are transferred into the meat

Combine the two and you have a marriage made in hell.

Is Contaminated Irrigation Water to Blame at Jensen Farms?

Roy Costa — Thu, 29 Sep 2011 14:39:06 -0500

Could it be that the Jensen Farms LM outbreak will be traced to contaminated irrigation water?

Looks like the Arkansas river is the irrigation source for this entire farming region through a series of diversion canals and ditches. We also have to remember that pesticides are also applied using surface water sources in some regions.

For some great pictures of water usage in this region see:

cwrri.colostate.edu/publications/cr/205.pdf

I offer this theory because the low flow rates of the river due to the drought conditions in this region, and the access of the water source to all sorts of animal vectors is a very likely exposure pathway for LM.

For a look at NOAA drought conditions reporting in this region see:

http://www.crh.noaa.gov/product.php?site=pub&product=dgt&issuedby=PUB

The growing region is in Prowers County, in extreme southeastern Colorado.

Given the wide spread of cases over time, this points to pre-harvest contamination, as opposed to post-harvest contamination. Although its been reported that LM was found in the production areas of the packing operation, such may have been introduced through contaminated incoming products.

For the latest from CDC and the report on LM findings from the facility see:

http://www.cdc.gov/listeria/outbreaks/cantaloupes-jensen-farms/092711/index.html

I hope we get the details of this investigation. If drip irrigation is used, and there is little exposure to irrigation water except through the roots, then my theory is less plausible.

In spite of what some people have said about the Del Monte Salmonella cantaloupe outbreak, knowing the cause of outbreaks does help prevention efforts in the future.

http://www.perishablepundit.com/index.php?date=09/07/11#2

We have heard the retail industry insist that more must be done by the growers to prevent these events.

www.barfblog.com/blog/150653/11/09/29/try-harder-retailer-tells-cantaloupe-growers-improve-food-safety

If we are to do more, we need to know what.

Mid Year 2011 Food Safety Insights

Roy Costa — Sun, 17 Jul 2011 13:59:26 -0500

Its good to refelct on where we are every once in a while, this way we can benchmark the face of food safety which is changing all the time. So at mid year 2011, here are my thoughts.

I continue to be surprised by the way the microbes seem to outwit us.

We seem to be making progress in reducing the incidence of some specific pathogens, but others we cannot seem to get a hold on.

Traceability has two sides, it makes industry vulnerable when regulatory feels it needs to act, but it does reduce exposures.

The global transfer of pathogens is really astounding, countries around the globe were somehow invloved in the chain of EHEC O104:H4, but we don't have all the facts. What we know is wherever the reservoir is of EHEC, the bug seems to be able to exploit a pathway and they do not respect borders at all. As we see this spring and summer in the Mystery in the South, this ability applies to states, counties, etc. within borders. And we have done a less than good job of identifying the vectors, vehicles and reservoirs, and controlling them. I don't think we have the capacity to completely stop EHEC at this point in time.

Food safety, probably more so than any other public health problem, must be solved in and by the global food safety community, and the resources to do this work are shrinking.

I am still waiting to see any credible goverment-led food safety initiatives in the mainstream media. We have a lot of insightful writers going at the subject now from a variety of angles, and so there is education at some level, but not the type that has the answer for consumers. More and more, I don't think we have the answer for the consumer. I think we need to tell consumers that and wake them up.

There is a serious backlash to regulation, we still hear about how backyard farmers are going to impacted by the FSMA when all those concerns are simply bogus. Some writers just want to exploit fear to sell copy. Writers continue to say that the local movement is the safe route, its so misleading, yet there may be a grain of truth in some of the argument, and it's a definite trend to watch; a trend that will likely have good and bad effects. Riding the coatails of this movement are the so called "good for you but dangerous foods" like sprouts and raw milk. With advocates again appealing to the anti-regulatory backlash people.

Consumers continue to sue the food industry, which is expected after so many injuries. Litigation is becoming a real thorn for companies and we seem not to be able to prevent the hits.

Well publicized outbreaks can taint an entire industry, sector, commodity and not just the brand, it's all too clear.

The anti-regulatory climate is getting uglier with legislatures and industry teaming up to dismantle monitoring and control orf the food supply by government. We hear industry saying recalling products when pathogens are found, but no outbreak is occurring, is unnecessary.

Yet, the "voluntary" private sector food safety initiates push on and we may be making some headway with suppliers. Third party auditors can carry almost the same clout as regulators, and our ranks are growing. But we don't have the police powers needed to truly protect and we only go when we are invited. In addition, we make recommendations, not requirements.

We are making some progress with primary production, maybe. Based on no major outbreaks in a while with produce, but after the fiasco in the EU, and several recalls in the last few months of produce, I can only say that I am "cautiously optomistic."

I could go on, but this is probably enough complaining, gloom and doom.

I have not had a GI infection in about 10 years now, so maybe things are getting a little better, who can say?

Making Believe Sprouts are Safe

Roy Costa — Sat, 11 Jun 2011 21:02:36 -0500

In Bill Marler's blog below, he quotes Bill Bagby of Tiny Greens, who sickened scores of people for 4 months with his contaminated sprouts.

http://www.marlerblog.com/legal-cases/bill-bagby-and-tiny-greens-sprout-farm-are-full-of-well-a-fecal-bacteria-salmonella---sprouts-are-ki/

Mr. Bagby says,

"Sprouts are kind of a magical thing," says Bagby, owner of Tiny Greens, a sprout farm in Urbana, Ill. "In terms of vitamins they're just off the charts compared to normal produce."

If this is magic, it is Black Magic of the worst kind. It is not really magic though...its make-believe. And the motive is as always… money. I wonder if Mr. Bagby believes his own statements about the health benefits vs. risk of sprouts? Does he feel eating raw sprouts is worth the risk of losing one’s kidneys?

This is the same ploy we hear from the raw milk industry. If Mr. Bagby was doing all he could to make a safe product, I might have some sympathy for him, but he operated an unsafe and unsanitary operation according to FDA. There is no excuse for the use of unsafe compost.

No responsible grower of any produce item I have ever met would do such a thing.

Mr. Bagby continues to mislead the public, he gives no evidence that his products are safer today than they were yesterday; having an "audit" once a year is not a food safety program. The changes he should have made were likely obvious and likely were put off, that is until he sickened consumers.

FDA’s public stand on sprouts is saddening. These officials know full well that this commodity is too risky to consume, they do not eat them, themselves. Yet, they avoid confronting the issues. After the terrible tragedy in Europe, it is now time for a shot across the bow to the entire sprout industry. We need FDA to say "get rid of the unsafe operations in your industry, make your product safely or we will put you out of business" and not, "it’s an individual decision ". When unsafe cars or tires kill people, we don't hear Washington folks saying "buying these unsafe cars and tires is an individual decision". Its not a matter of "tastes good", or "good for you", these products are too difficult to make safely, even under the best of conditions, and they pose a continuing public health threat.

No respectable, conscientious retailer should ever offer sprouts for sale. A firm like Jimmy Johns seems to me, totally reckless. Even after several illnesses from their sandwiches, they continue to offer sprouts. So I must conclude it’s a popular item and thus the firm is willing to take the risk.

Tiny Greens constituted a public health hazard for at least 4 months when it caused the last outbreak and so my feeling is the operator cannot be relied on in the future. Does he expect his auditor to stop him the next time he takes a short cut with food safety? The next time it could be devastating, knowing what we know now about the ability of the most severe strains of E. coli to contaminate these products.

I am sure FDA is hoping that the sprout industry will "kill itself off", which I believe will eventually happen, but how many consumers will have to die before our public health folks will tell the American public the plain truth, "raw sprouts are too dangerous to eat".

Lets stop all the make-believe.

Hemorrhaging to death is not worth the nutritional benefits of anything...period.

The Chicago Tribune asks, What should Consumers Do About Sprouts?

The answer is easy, "don;t eat them".

http://www.chicagotribune.com/health/ct-met-sprouts-safety-consumers-20110611,0,4296792.story

The Chicago Tribune tried to portray Mr. Bagby and company in a balanced way, but I do not think he deserves a favorable spotlight for his "magical" views.

FDA Funding Uncertian-Industry Steps Forward

Roy Costa — Sat, 04 Jun 2011 11:14:03 -0500

As the result of political and economic pressures, FDA will likely not have the resources it needs to carry out its responsibilities under the FSMA. What this means is that more responsibility will be placed on the food industry to self-govern. The various industry initiatives will need to expand to make up the difference.

Some of the things industry can do in cooperation with FDA include:

Expand education
Create transparency of food safety systems and risk assessments to the consumer level
Continue the research, development and application of food safety technology
Expand testing of products
Foster a Watchdog/Sentinel role
Outreach and assistance to the mid sized and small operations
Expand and apply traceability systems

Former ranking Republican Jack Kingston has called the U.S. food supply “99.99 percent” safe. He goes on to say “We challenge anyone to find a function of government that has a success rate better than 99.99% which the food supply, based on the Obama Administration’s own estimates, currently maintains,” said Kingston spokesman Chris Crawford.

In contrast, The Centers for Disease Control and Prevention said last month that about one in six Americans gets sick, and 3,000 die, from foodborne diseases each year.

if .01 % of the food supply is unsafe, as Mr. Crawford explains, this would mean about 1 million meals a day eaten in the US are unsafe.

The impact to public health aside, the food industry suffers anytime there is a food recall or an outbreak, and there are political and economic outcomes, as we see today in Europe.

Regardless, industry must step forward in an even greater way than currently. I believe we are up to the challenge, but we need coordination and strengthening of the scientific basis for risk assessments and a better way to measure risk-reductions.

If FDA cannot fully apply its powers, it makes sense for industry and FDA to work together in new ways. Lets spend the money that is available in ways that will have a beneficial effect. Creating more bureaucracy is not the answer. We need a leader that both industry and FDA can trust, that can forge the type of cooperative spirit needed. That person has not emerged, yet.

Food Safety Auditing in Produce- is it Working?

Roy Costa — Sat, 30 Apr 2011 21:57:39 -0500

Third party audits of produce are relatively new phenomena. Fueled primarily by the retail sector’s demands for safe year-round supplies of fresh fruits and vegetables, there is a serious industry-led effort underway to evaluate primary production and the resulting supply chain.

While the third party audit model has some similarities with regulatory inspections, there are major differences; Third party audits are buyer driven and may contain some unscientific provisions (one insect in a package, even an intermittent mosquito or ant) fails the audit. Another automatic failure often found in third party assessments is the provision for a blood and body fluid policy. It is universally agreed that the risk of HIV transmission is zero through food, and other bloodborne risks are very remote. Yet, the failure to have a policy on bloodborne pathogens is totally unacceptable to buyers.

There is no sound scientific reasoning behind provisions like these, yet since it is a buyer-driven risk assessment, these “hazards” to the retailer and his “business” are very real.

The standards set by retailers are mostly reasonable, but are often defined in minutia. There may be numerous questions that are so closely related that details become burdensome. For example, there are often a half dozen questions or more on rodent traps alone that must be evaluated independently, such as; are they positioned correctly, numbered, secured, clean, marked as monitored, kept on a schematic, with wall markings, in sufficient number, in sound condition, etc., etc. The intention is to cover every possible threat that a rodent will enter a building without being trapped or poisoned.

The detailed nature of audits sometimes lasting several days, with up to 500 individual questions, and often occurring multiple times in a year can be vexing, counterproductive and exhausting to all involved. Add to this that third parties often demand scientific programs and science-based risk assessments from operators unprepared through education or experience to provide such reasoning, and you have a problematic and sometimes dysfunctional system.

A huge gap emerges between the food safety expert-auditor and his “bible of standards”, and those just now becoming familiar with basic food safety concepts.

Auditors are often the first and primary source of scientific information for produce-facility operators unfamiliar with concepts such as Free Chlorine, Oxidation-Reduction Potential, microbial sampling plans, and interpretation of microbial testing results, ATP bioluminescence technology and other sanitation assessments and controls. Auditors often find themselves as much educating the operator as evaluating their performance. The auditor on the other hand often finds the produce-production manager assigned to food safety educating him on what things really work.

There is a notable lack of food safety knowledge at the primary producer level but there may also be a lack of traditional agricultural knowledge on the part of the auditor. Few auditors have the wide range of experience in public health protection, food safety, environmental health, water, chemistry, vector control, and the life sciences to truly provide an expert evaluation of safety in the agricultural world. Furthermore, it takes years of experience in the field for even qualified auditors to begin to understand the wide range agricultural and facility environments they must work in.

While food safety experts, production managers, and business owners struggle with these issues in produce safety, we should keep in mind that the findings of audits will not necessarily always be indicative of risks, and food safety programs no matter how well intentioned will not always prove effective given the robust exposures often encountered in farming environments. We are yet to stop the harvesting of foods where migratory birds have zeroed in, controlled floods, shot every wild pig, or figured out how to keep deer from jumping 8 foot fences to get to crops.

In light of all the obstacles, it’s encouraging to see contamination events caught quickly, and exposures kept small. More and more the contaminated produce that comes to light is recalled and/or production is stopped before a wide-scale outbreak occurs. This speaks to the food safety efforts of industry as we try to limit the inevitable exposures through testing and intensive traceability systems. Re-call systems are developed with computerized tracking of lot code information, and they recently have proven effective at preventing grand exposures through contaminated produce common just 2 or 3 years ago.

The produce sector is unique perhaps in its willingness to accept strict third party oversight, government regulation, and also to adopt and embrace food safety systems. Given enough time, the safety of produce will be assured. In the meantime, many of us have a lot of work to do.