Food Safety During Transportation Under FSMA

February 3rd, 2014

The FDA announced proposed rules governing food safety during transportation on January 31. This rule, called the “Sanitary Transportation of Human and Animal Food”, would be implemented in stages depending on the size of the business, beginning 1 to 2 years after publication of the final rule. The rule is now open for public comment through May 31, 2014.

The rule would cover all shippers, carriers and receivers of food intended for consumption in the United States. This includes international carriers regardless of the country of ownership. Foods transported into the US for re-export or otherwise not intended for consumption here are excluded.

Exceptions are made for any business that transports food for U.S. consumption but has annual sales less than $500,000. Also, the rule does not cover the transportation of packaged foods, live animals or raw farm produce when shipped by the farm.

You can read the full version of this “unpublished” proposed rule in PDF form at the Federal Register. Access the PDF for download here.

What It Means

There is a long journey ahead before this rule is finalized and enforced. Some of the issues you will want to review and possibly comment about include:

How do the rules govern handling by dockworkers or loaders?

What kinds of sanitation technology are permitted, or required?

What counts as “fully packaged”?

How extensive is the exception for farm-transported foods?

How will these rules be enforced? What penalties will there be?

Ozone and Food Safety in Transportation

DEL has both gaseous and aqueous ozone solutions for food safety applications, some of them designed specifically for transportation. Ask us about how they can make your food transportation safe at the lowest possible cost.


Will FSMA “Root Out Local Food”?

January 28th, 2014

The emerging conflict between sustainable farming methods and the FSMA is a serious issue. As proponents of Safe Sustainable Sanitation™ we’d like to believe the two sides in this issue can be bridged. Our contribution to this bridge is ozone sanitation, which preserves all the natural colors and tastes of foods at the same time it is hell on microorganisms and contaminants.  It’s even recognized as suitable for organic farming.

But at this point the conflict persists. Our next story about it might be titled Food Safety vs. Food Quality—A Cruel Dilemma.

If we understand it right, the “locavores” who advocate for eating locally grown and raised foods do it because they think those foods are higher quality. But now we see dozens of stories online (for examples, here, here and here) about how small farmers—including the ones that cater to those local farmers’ markets—may be forced out of business by the Food Safety Modernization Act.

The local farmers who have complained for months about FSMA focus on two broad issues.  First, they argue that the new regulations raise costs dramatically, for things like water testing. These critics say that the presumptive exemptions for small farms (including the Tester amendment) have so many loopholes that way too many are caught in the noose of higher costs.

The second main complaint is that the FSMA regulates practices that are embedded in specific approaches to farming, most specifically sustainable farming. Numerous small farmers have complained that they will no longer dare to use manure for fertilizer, and may have to revert to the polluting chemicals their customers want them to avoid. Others worry that more “industrial” methods will strip away the freshness and sun-ripened flavor of their produce.

The irony in all this is that these two paradigms, sustainable and risk-managed farming, both want the same thing: a healthier food supply.

We’re working to create a healthier food supply, too. Certainly, reducing the energy demand and chemical load that traditional farming drops into the environment is a reasonable goal. In a properly risk-managed approach, ozone is a good substitute for many of these chemicals, hot water and repeated chemical rinses used to eradicate other chemicals.

At the same time, “sustainable” cannot mean “take your chances.” As a recent post at Consumer Affairs notes, “consumers have it backwards, assigning higher risk to foods that are actually safer.”  The author is referring to the fact that canned veggies are safer than the ones from the field that contain all the dangerous microorganisms. But his more general point is that field-grown produce does sometimes contain health threats. Sustainable farmers will help sustain their markets with clean food, and ozone is a proven way to protect quality while it sheds bacteria.

However this issue plays out, we’ll be here, furnishing cost effective sanitation that retains all the taste, color and texture fresh foods offer.


Can You Use This HACCP Tool?

December 9th, 2013

We browse through basic research abstracts so you don’t have to. You can thank us for it – or commiserate – at the next trade show. Lots of these studies seem so far from fruition that they could only be loved by the academics who debate them.

Still, every once in a while there’s an article that tickles the imagination. Some of these may even have applications to your work. We found one of these in a recent scan of articles abstracted in Science Direct.

The Hazard Analysis Critical Control Point (HACCP) protocols have been in use for a long time, and their conceptual foundations are arguably embedded in the Food Safety Modernization Act’s focus on risk-based prevention. Dozens of ‘how-to’ guides for applying HACCP exist, but there is less information that validates the models in practice.

Measuring HACCP Effectiveness

Now there is a recent study (October 2013) that uses a dataset based on 335 Greek food enterprises to test whether HACCP as a food safety management system is effective in attaining its objectives: hazard identification, hazard assessment, and hazard control.  The data analysis confirmed that this group of businesses’ food safety efforts do correspond to the assumptions of the HACCP protocols.

The take-away we want to share with you is that the authors claim that a food company can use their model to evaluate its own HACCP plan.  They say “The measurement instrument can be used by a food company as a self assessment tool and a benchmarking tool” to improve its own food safety system.

Could You Use This Tool?

We’re curious:  could you use this tool to evaluate your own food safety program?  Or, could you use a tool like this?

Better yet:  do you already use a tool like this to improve your program?

Please email us your thoughts or experiences with this kind of tool. It seems to us that something like this, if it helps, can reduce your costs of compliance as well as improve the quality of your food products.  We’d like to know.


Surface Sanitation in Retail Establishments

November 20th, 2013

Surface sanitation in most retail food establishments is still done the old-fashioned way:  with harsh, messy chemicals that need cleanup after they are used.

Do we really need to say it?  Ozone does the job better, faster, cleaner, and with no obnoxious byproducts. This is not really news.  You can find a brief argument in favor of ozone in the 2010 article in Food Safety Magazine by Angela Fraser and Melvin Pascall. This article includes a reference to the 2001 FDA approval of ozone as an additive to food to kill pathogens.

It’s In the Food Code

As the Food Safety Magazine article points out, some retail establishments are not very good at sanitizing food preparation surfaces. We think one of the reasons for this is that compliance with the Food Code regulations (download your copy of the new Food Code here, just under 9 megabytes and 769 pages) is burdensome and expensive.

We decided to check out the new Food Code to see if the issues of surface sanitation had changed.  We haven’t had time to read the whole thing (has anyone?), but we have scanned the document, and it doesn’t look much different, proving that old habits are hard to change.

The crux of the matter in the Code is that surfaces have to be sanitized after they are cleaned, and on a prescribed timetable. Furthermore, the sometimes-toxic sanitation chemicals commonly used in retail food establishments are themselves subject to regulation if they can leave residues that corrupt food. In other words, you have to make sure the sanitizers are removed before you use the surfaces.  If you have to go through this process every 4 hours (like you would in some cases), it is very expensive.

Some of the Devilish Details

The Code still defines “sanitation”  (in section 1-201.10) in terms of heat and chemicals:

“Sanitization” means the application of cumulative heat or chemicals on cleaned FOOD-CONTACT SURFACES that, when evaluated for efficacy, is sufficient to yield a reduction of 5 logs, which is equal to a 99.999% reduction, of representative disease microorganisms of public health importance.

We have reviewed the science carefully in other applications, and we know that ozone meets the 5-log test for the common microbial threats.  This includes bacteria, viruses, spores and biofilm. Ozone in known applications works on contact, kills the threats, and decays, leaving no residual in the environment.

Ozone is an Option

The theoretical case for ozone as a surface sanitizer in retail food establishments is totally solid. There’s no question that the improvement in sanitation would benefit both consumers and vendors. We hope retailers will begin to look for ozone solutions to benefit both their customers and themselves.


Playing Chicken with Food Safety

October 31st, 2013

When in the world are food producers going to figure this out?  Food safety is a crucial promise of your brand, and if you mess with it you lose.

The Foster Farms chicken brouhaha that started on October 7th with an FSIS alert about a salmonella outbreak, illustrates a lot that’s wrong, unfair, incompetent and misinformed about our food safety system, but the bottom line, as we have said many times, is that producers have to take direct proactive steps to ensure that their products are healthy and safe.  There is no institution, no consumer education, and no regulation that can substitute for that.

When producers don’t provide safe foods, the word gets around, and the story will have legs.  Remember cantaloupe?  Like it was yesterday.  And today (October 16) the #1 most emailed story in the New York Times national paper is a piece by widely-read Mark Bittman titled “Should You Eat Chicken?”  Want to guess what the answer is?

This consumer reaction is not limited to self-appointed food experts in national publications, either.  An October 15th story in the CBS Sacramento website talks about consumers switching to organic alternatives.  Food producers know that organic foods are not necessarily safer, but ‘organic’ has a good brand feeling. Consumers are not food safety experts; they react to what they hear in the environment.

There’s enough issues in this story for a full-on finger-pointing barrage.  It’s not our intention to fix any of these issues here, but producers need to keep them top of mind.

  • Unlike the FDA recalls of the past, the USDA did not have a direct recall ability to step in to force the company to do the right thing.  Only under pressure, with time, did Foster Farms claim to address the food safety issue.
  • The high hospitalization rate of people infected with the strains of salmonella in this outbreak is worrisome.  The reason is that the salmonella strains in the Foster Farms outbreak include some that are resistant to certain antibiotics used in both chickens and humans.
  • Along the same lines, it is possible that strains of salmonella are developing a tolerance for heat – that 165 degrees may no longer be enough.
  • Even when Costco removed the rotisserie chickens from displays, they initially left the raw packaged under the theory that consumers would follow safe handling procedures.  Well, they don’t.
  • Foster Farms claimed their food safety procedures were proprietary and wouldn’t discuss them.  The world can see they aren’t very good anyway.

Ozone Can Avoid These Issues

May we ask you to contact us about ozone sanitation at this point? Microorganisms cannot develop ozone tolerance, and the common microbial threats to food are killed completely by ozone.  There is less dosage error with well-designed ozone systems.

Keep your brand safe by keeping your food safe.  Call us.


The Scope of Food Safety Failures

March 21st, 2013

The main reason – really, the only important one – for working to improve food safety is to reduce the incidence of food borne illnesses, hospitalizations, and deaths.

So it’s useful to get a handle on the scope of that challenge.  The amount, kind and source of food borne illnesses helps us evaluate how much investment in food safety is justified.  This is one of the key components of the analysis that underlies the current push to preventive risk management strategies.

Attribution of Food Borne Illnesses

A recent article cited in the Kansas State bites newsletter is must reading if you want to get a handle on this issue.  The article is Attribution of Foodborne Illnesses, Hospitaliations, and Death to Food Commodities by using Outbreak Data, United States, 1998-2008, by John A Painter, et al, of the Center for Disease Control and Prevention.  The authors developed a method to estimate the prevalence of foodborne illnesses for each of 17 food commodities using outbreak data reported by state and local health departments. In other words, the method summarizes and projects to the universe from a more limited set of data, but it is a solid overview of how food safety failures impact human health.

Some Eye-Catching Numbers

The food safety problem is as big as you think it is:

- About 9.6 million persons each year acquire a major food borne illness.
- During 1998-2008, 13,342 food disease outbreaks were reported, causing 271,974 illnesses. This data is part of the basis for projections.
- 46% of illnesses were caused by produce.
- More deaths were caused by poultry than any other product.

The authors organized an extensive dataset, and developed a method to analyze the approximately 9.6 million annual illnesses.  Some of this data is reported in a series of tables available on the CDC website.  The tables are in a technical appendix, and can be downloaded as PDFs.

Results: Product-Based Food Borne Illnesses

“More illnesses were attributed to leafy vegetables (22%) than any other commodity…” and caused 14% of hospitalizations and 6% of deaths.  Leading causes of illnesses from leafy vegetables were norovirius  and e.coli.  Other produce also carried these infection sources, and also various strains of Salmonella were prominent.

The second largest source of outbreaks was the dairy commodity.  It accounted for 14% of illnesses and 10% of deaths.  Even though these products are typically pasteurized, infections occur due to improper pasteurization or due to contamination in handling after pasteurization (such as outbreaks of norovirus infections in cheese).  Raw milk was a frequent source of Campylobacter infections, though the data is possibly skewed by reporting bias.

The largest source of deaths was poultry. The most common infection agents were Listeria and Salmonella, with a strong linkage between turkey processed meats and listeriosis between 1998 and 2002.

The authors note that the dataset is incomplete.  For example, the reported outbreaks that form the basis of the research did not include incidents of Toxoplasma or Vibrio vulnificus even thogh these are known agents of food borne illness.

Food Safety Challenges Are in the American Diet

The most common sources of infection are found in foods that are most common in the American diet.  While this is a truism, logically, it still indicates that the problem is widespread and cannot be attributed to unusual foods (like raw milk) that people rarely consume.  We cannot ask people to avoid leaf vegetables and poultry when these are among the most common and useful parts of a healthy diet


Annual Food Policy Conference Coming Up

February 26th, 2013

This is just a brief note to alert you that the annual National Food Policy Conference is coming up April 15 and 16 in Washington DC.  This 36-year-old conference is organized by the Consumer Federation of America (CFA), and many of the topics considered look at how food policy and the consumer interact.  Fees for the conference range from $90 to $325, with the lowest rates for member groups of the CFA.

The agenda includes a wide range of food policy topics.  Panels will discuss the use and value of nutrition research on consumption, the problem of food waste, the impact of immigration reform on the food supply, and the effects of climate change on food supply, among others.  The presentations will end mid-day April 16th.

Anyone interested in food safety will find the April 15th update on the Food Safety Modernization Act useful and important.  Panelists on FSMA will include David Gombas, Senior VP for Fresh Food & Technology of United Fresh, James Gorny of the FDA, and Arian Lotti of the National Sustainable Agriculture Coalition.


FSMA Comments Extended, Meetings Scheduled

February 19th, 2013

The Federal Food and Drug Administration has extended the deadline for public comments on two draft Food Safety Modernization Act (FSMA) rules by 3 months. The original deadline for comments was February 15th, but that would have given the public just 30 days to comment following publication of the draft rules in the Federal Register on January 4th and January 16th.  The FDA extended the deadline after numerous complaints from affected parties.

The two rules open for comment cover preventive controls for human food and produce safety standards for human consumption.

Public Meetings on the Rules

As part of the initial submission of the drafts, the FDA had stated that it would hold public meetings to discuss the rules. These meeting dates are now set as February 28 through March 1, 2013 as published in the Federal Register January 31 and February 13, 2013.

All of this is short notice for producers, but their participation is critical.


FSMA Rules in Public Comment

January 7th, 2013

On January 4th, two years to the date since President Obama signed the new law, dozens of news outlets nationwide reported that the FDA had released two of the 3 proposed rules implementing the Food Safety Modernization Act (FSMA).  The two published rules can be accessed via the FDA’s FSMA start page online.

The two new rules include:

  1. Preventive Controls for Human Food: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food
  2. Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption

Yet to come is a third rule that will govern how food importers will verify that their products meet U.S. standards.

The Administration has been criticized for delaying publication of these rules, possibly for the political reason to avoid a controversy over new regulations. However, most reports of the event cite the shift to risk-based prevention and tracking in the rules positively, coupling the rules with recent food borne illness breakouts as justification for them. The food safety lawyer Bill Marler has published an especially emotional version showing photos of victims of food borne illnesses as the reasons why the law is important.

Rolling Out the Rules

Publication of the rules is the first step toward final implementation.  There is a 120-day public comment period following publication in the Federal Register, followed by possible revisions.  The length of the review and revision period is not fixed, but the rules will take effect 60 days after final publication.  Following publication, small businesses (fewer than 500 employees) would have two years to achieve compliance, and large businesses not otherwise exempt would have one year.

In general, a covered small business will have about 2 and ½ years from right now to come into compliance with the rules.

Where do We Stand Now?

In one sense, these rules are old news. Their basic themes and content have been known for most of the past two years (and before that in the sense that the ideas have been developed over a long time).  When we list the highlights of the proposed Preventive Controls rule, we see very familiar items:

  • hazard analysis
  • risk-based preventive controls
  • monitoring procedures
  • corrective actions and verification
  • recordkeeping

Many producers already follow this basic process. In fact, one of the articles reporting the rule promulgation was this LA Times article, which focused on the fact that many California producers had already adopted a “culture of food safety.” Included in this culture are industry-published standards for best practices designed to give consumers confidence in a specific product.

Safety Begins with Sanitation

The rules, the plans, and the process contain good ideas.  They will be effective when they are properly implemented.  At the heart of the matter is the fact that good sanitation practices have to be incorporated into every step of the production process. Without them there will be no enhanced food safety, and under current funding, there will not be enough inspections or enforcement to force changes to happen.

As usual, it is up to producers to take proactive steps to make the rules redundant.


Producers, Start Your Engines

December 17th, 2012

The painfully slow rollout of regulations implementing the Food Safety Modernization Act (FSMA) has many producers tied in knots. But story after story in the news points in the direction that it is better to get started with preventive risk management food safety tactics than to wait for the FDA to publish rules.  The message is simple:

Implement Your Food Safety Plan Now!

Producers need to get this point:  The FDA does not need to wait for rules to be in place before using the authority it has under FSMA.

One of the most threatening things for a food producer today is to have its registration under FSMA suspended.  That means no economic activity generating revenue, despite continuing costs.  This happened recently to peanut processor Sunland Inc. as summarized in many publications including the Leavitt blog.  As David Acheson of Leavitt notes:

FDA’s first use of its new authority in the forced suspension of operations … is bringing to fruition the words that have been repeated for the last two years: Be prepared, and Don’t Wait. And now, despite the number of pending, unissued rules … the time has come. FDA is enforcing this impactful part of the Food Safety Modernization Act.

Acheson goes on to describe a number of food safety lapses at Sunland that might have been prevented with a serious food safety plan.  Not knowing final FSMA rules is no excuse for inaction.

Sins Will Not Be Forgiven

Not in this world, at any rate.  The food safety lawfirm of Marler Clark publishes the popular blog Food Safety News which contains two stories about the follow up to Sunland’s melt down.

In the first article we cite, Food Safety News tells the stories of victims of the salmonella outbreak triggered by Sunland peanut butter and also by earlier massive outbreaks from the mid-2000s that included big brands like Peter Pan.  This article links peanut butter and salmonella (not very appealing) and tells how devastated victims were.  This is a predictable media response, and it shows that there is a strong collective memory at work.  Past outbreaks will not be forgotten.

In the second article, Sunland is reported to have asked the FDA to at least allow the shelling of peanuts stored in its warehouses. The company has received support from local politicians, but it is unclear whether the FDA will be sympathetic to the claim that peanut shelling is different than peanut processing.  Sunland looks to be squirming on the hook in this effort to salvage part of its business – and just what do they plan to do with those shelled peanuts, anyway?

Fiscal Cliff or Not, Plan Implementation is Cheaper

A number of recent posts – like this video – have lamented that the ‘fiscal cliff’ may further postpone the promulgation of regulations because the FDA is starved for cash (see this Food Safety Tech article for more detail on this – requires registration). And people are worried about that – it’s a story that will surface again. In our view, that’s all the more reason to get going now on your food safety planning and implementation.

Apparently Sunland is getting the message.  In the article about peanut shelling, Food Safety News reports that The nation’s largest organic peanut processor plans to clean and re-build areas of its plant and re-open sometime early in 2013 if FDA gives it the green light.

Why put yourself in the position of needing permission from the FDA to operate?