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

Posted by DELOzone on March 21, 2013 | Trackbacks

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.

Posted by DELOzone on February 26, 2013 | Trackbacks

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.

Posted by DELOzone on February 19, 2013 | Trackbacks

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:

Preventive Controls for Human Food: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food
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.

Posted by DELOzone on January 7, 2013 | Trackbacks

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?

Posted by DELOzone on December 17, 2012 | Trackbacks

FSMA in the News Again — For All the Wrong Reasons

December 6th, 2012

We haven’t joined the food fight (sorry) over the slow implementation of the Food Safety Modernization Act (FSMA). Basically, we think producers already know enough about the preventive risk management strategy in the FSMA approach to begin working on the underlying issues. Proactive producers are already taking steps to avoid the kinds of disease outbreaks that end up on the evening news.

That’s not to say that the delay in issuing regulations to implement the law is not a problem. The uncertainty it creates for some producers can cause real harm if they invest in techniques that end up being non-compliant, or if they postpone needed food safety improvements waiting for clarity.

That latter point seems to be the problem some organizations see in the delay. The Center for Food Safety and the Center for Environmental Health sued the FDA and the Office of Management and Budget last August claiming that the FDA has “unlawfully delayed” implementing the act for more than a year and a half. Andrew Kimbrell of the Center for Food Safety said at the time “It’s a disgrace that a crucial, lifesaving law sits idle while the bureaucracies of FDA and OMB grind along without a hint of results.”

Apparently these organizations believe that issuing regulations faster will improve the food supply. We’d prefer making sure the regulations are reasonable and useful rather than getting them out quickly. And it seems the FDA has been working on something over the past two years if you look at their “Implementation & Progress” webpage (though the trough leading up to the recent election is gaping – politics, anyone?).

One thing we do know is that taking the issues into court will almost guarantee they will take a very long time to sort out. And legal battles consume enormous resources that could be better spent working on the missing regulations. Plus, do the Centers for Food Safety and Environmental Health really think their lawsuit can actually help the FDA solve its problems with these complex regulations?

A couple days ago (December 3rd), Reuters distributed a story saying that the FDA has hit the ball back into the opponents’ court. The agency seeks a dismissal of the lawsuit on the ground that missing statutory requirements for issuing rules by certain dates is not subject to judicial review.

Back and forth. In the meantime, we do hope someone at FDA has the time to work on these rules.

Posted by DELOzone on December 6, 2012 | Trackbacks

Public or Private Policing?

October 18th, 2012

A Bloomsberg News wireservice article has been published in newspapers around the country in the past few days that questions the effectiveness of the food industry inspecting itself. The article recounts the Listeria-caused death of one man who ate infected cantaloupe, citing a ‘private, for-profit inspection company’ that gave the cantaloupe farmer a clean bill of health.

The point is clear: you can’t trust the industry to police itself.

Politics is Part of the Problem

There is never a full excuse for the kind of outbreak we experienced last year with the cantaloupe. But it’s also true that the guidance supplied by the FDA, which is supposed to be more pointed via the new Food Safety Modernization Act (FSMA), has been spotty at best.

Now a recent Leavitt Partners blog post traces the delay in the clarifications of FSMA to the presidential election campaign. Any new regulations that might increase producers’ costs (and wouldn’t they?) could be used as election campaign fodder, accusing the current administration of destroying jobs by raising costs. Is that a good reason to delay food safety regulations?

Leavitt Partners note that the course of the FSMA regulations will be quite different depending on the outcome of the election. If President Obama wins, the rules will put a heavier emphasis on government, while if Romney wins, there will be more latitude for producers to set best practice standards. Either way, post election, the regulation rollout should accelerate. Too late for the Listeria victims.

Producers Are the Front Line

We think the producers will be on the line for food safety outcomes however the election turns out. The always on, instant distribution of news – especially dramatic news – means that food safety failures will be magnified in the popular press. Whether the failure is due to government mismanagement or private myopia won’t matter to the producers who are caught.

At the heart of FSMA are some good ideas about preventive food safety action. Producers who take these to heart and implement comprehensive quality and infection control programs will be the ones who succeed.

And avoid being the lead story on the evening news.

Posted by DELOzone on October 18, 2012 | Trackbacks

FDA/FSMA Registration Postponed

October 5th, 2012

We recently posted about the requirement for all food companies to register with the FDA under the Food Safety Modernization Act (FSMA), beginning this year on October 1.

Hold on to that thought.. until some unknown time in the future.

As many of you know by now, the FDA postponed the registration requirement for an indefinite time. The FDA says there are implementation issues that will take a while to work out. Seems to be a theme with the FSMA, doesn’t it?

If you are already required to register under other provisions, do it. This delay only covers the new FSMA requirement.

We know a lot of you would simply like some clarity and consistency in the implementation of the FSMA, but that seems to be beyond the ability of the FDA at this time. Politics, anyone? Sure, but this is a straightforward case of rules that are very important to the general public, which put food processors at risk for non-compliance, and are not clear.

Not good.

Posted by DELOzone on October 5, 2012 | Trackbacks

Food Safety Reporting by Consumers

October 4th, 2012

The USDA just released a new online consumer complaint reporting system that will add to the information the regulator can use to detect and track food safety problems. As designed, this tool will only affect meat and poultry processors, at least for now, and probably only at the retail distribution level.

However, producers should be alert to the fact that the Food Safety and Inspection Service (FSIS) is actively expanding the ways consumers can complain about food products.

The Consumer Complaint Monitoring System (CCMS)

The new online form augments the existing consumer reporting system that includes the Meat and Poultry Hotline (888-674-6854) and regional reports through FSIS offices. In addition, consumers can access the virtual expert ‘Ask Karen’ online at any time to submit questions about food safety procedures or use live chat 10 am to 4 pm weekdays (the form function is also available on mobile devices at m.askkaren.gov).

Unlike the hotline or the Ask Karen chat, the online complaint form will be available 24 hours per day at https://ccms.fsis.usda.gov/. The system screens users to ensure that they are submitting a meat, poultry or processed egg food safety issue. If they are, it will collect detailed information about the nature of the complaint to help setting priorities and urgency for any response. If consumers do learn about and use this form, FSIS responses will be faster and more targeted.

The Evolving Food Safety System

We don’t think these consumer-focused detection tools will be how most food safety problems are identified. For the foreseeable future, medical forensic and epidemiological analyses will continue to be the methods investigators use to identify, track and evaluate food safety outbreaks. Nevertheless, producers at all points in the food supply chain are increasingly vulnerable – and interdependent – to breakdowns in food processing that are discovered at the retail level.

Posted by DELOzone on October 4, 2012 | Trackbacks

FSMA Food Maker Registration

September 25th, 2012

Sometime between October 1, 2012 and December 31, 2012, most food “facilities” in the United States will be required to register with the FDA under the Food Safety Modernization Act (FSMA). This registration will be required for a facility to introduce any food into commerce within the United States, and for the first time, the Commissioner of the FDA will have the authority to suspend the registration of a food facility. Going forward, every facility will be required to renew registration every two years during even-numbered years.

The FDA is required to promulgate rules subject to public comment under section 415(b) of the Federal Food Drug and Cosmetic Act. Much of the rules development on FSMA is being held up, probably pending the outcome of the next election.

Who Must Register?

A food facility is broadly defined – it includes any factory, processor, storage facility, or establishment that processes, packages, or stores food. This includes any business that imports or exports food into the United States. It also includes any farm that processes food beyond harvesting. Basically, businesses involved in the food product process, including growing, processing, storing and shipping are covered.

Food facilities have had to register previously under section 415 of the Food, Drug and Cosmetic Act, but they must now register (and re-register) under the FSMA in even numbered years between October 1 and December 31.

How Do You Register?

The FDA requires registration using Form 3537. According to the FDA website, this can be achieved online at www.fda.gov.furls between 7 a.m. and 11 p.m. Eastern Standard Time. We were unable to access this page. However, you can register by paper, and the Form 3537 is available for download, as are the instructions for the form (Adobe Acrobat 6.0 is required).

Posted by DELOzone on September 25, 2012 | Trackbacks